https://biospectrumindia.com/rssfeed/news/world world https://biospectrumindia.com/news/57/28626/duo-wins-nobel-prize-in-chemistry-2026-for-their-work-on-homochirality.html https://biospectrumindia.com/news/57/28626/duo-wins-nobel-prize-in-chemistry-2026-for-their-work-on-homochirality.html Thu, 08 Oct 2026 21:42:04 +0530 The 2026 Nobel Prize in Chemistry was awarded to Henri B. Kagan (an emeritus professor at the Université Paris-Sud in France) and Kenso Soai (a Japanese organic chemist, Professor Emeritus in the Department of Applied Chemistry at Tokyo University of Science) for the “discovery of non-linear effects and autocatalysis in asymmetric organic synthesis.” Henri Kagan took the first decisive step in 1986, when he discovered a new way of manipulating chemical reactions. This allowed him to create a greater excess of one of the mirror images than had previously been thought possible. Kenso Soai took the next step. In 1995, a key publica tion describes how he designed the first ever chemical reaction that had the potential to be homochiral. In 2003, he finally succeeded. He presented a reaction in which only one of the two possible mirror images was formed. Other than life itself, no one had previously achieved this feat. Thanks to Henri Kagan and Kenso Soai, we now know how homochirality can emerge. Their discoveries have been decisive for chemists who design reactions for the manufacture of pharmaceuticals. The Nobel Prize in Chemistry 2026 recognises discoveries that have enabled chemists to drive chemical reactions that lead to homochirality. ]]> https://biospectrumindia.com/news/57/28612/piramal-pharma-solutions-launches-new-microbiology-laboratory-at-lexington-sterile-injectable-facility.html https://biospectrumindia.com/news/57/28612/piramal-pharma-solutions-launches-new-microbiology-laboratory-at-lexington-sterile-injectable-facility.html Wed, 07 Oct 2026 18:57:06 +0530 Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organisation (CDMO) and part of Piramal Pharma, has opened a new microbiology laboratory at its sterile injectable facility in Lexington, Kentucky, US. This addition marks a significant step forward in PPS' ongoing $85 million Lexington expansion, aimed at enhancing commercial-scale capabilities and improving operational efficiency. The new laboratory was released for routine GMP use on September 11, 2026, and shortly thereafter, its new sterility testing suite was conditionally approved, making the lab one of the first major components to come online in the expansion. The full manufacturing expansion is expected to be operational in late 2027. The new lab more than triples the site's existing microbiology testing space, supporting improved laboratory workflow and providing additional capacity to accommodate future growth. The added space features three new biosafety cabinets, allowing PPS to run concurrent tests and reduce sample queue times. All incubators have also been consolidated within the new lab, further streamlining workflow and improving monitoring and accessibility across testing activities. ]]> https://biospectrumindia.com/news/57/28604/sun-pharma-establishes-endowed-professorship-at-mount-sinai-with-2-5-m-support-to-advance-derma-care.html https://biospectrumindia.com/news/57/28604/sun-pharma-establishes-endowed-professorship-at-mount-sinai-with-2-5-m-support-to-advance-derma-care.html Tue, 06 Oct 2026 20:52:45 +0530 Sun Pharmaceutical Industries has announced the establishment of the Sun Professorship in Dermatology at the Icahn School of Medicine at Mount Sinai, US. Mark G. Lebwohl, M.D., will be installed as the inaugural professor at Hatch Auditorium at The Mount Sinai Hospital in New York. Supported by a $2.5 million endowment from Sun Pharma, the Sun Professorship will fund academic leadership in dermatology in perpetuity, beginning with Dr Lebwohl as its inaugural incumbent. Based within the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, the professorship will advance research and training, helping translate emerging knowledge into better care and prepare future leaders in the field. Dr Lebwohl is Chairman Emeritus of the Medical Board of the National Psoriasis Foundation and served as President of the American Academy of Dermatology from 2015 to 2016. ]]> https://biospectrumindia.com/news/57/28596/trio-wins-nobel-prize-in-physiology-or-medicine-2026-and-lays-foundation-of-new-era-in-neuroscience.html https://biospectrumindia.com/news/57/28596/trio-wins-nobel-prize-in-physiology-or-medicine-2026-and-lays-foundation-of-new-era-in-neuroscience.html Mon, 05 Oct 2026 20:33:49 +0530 The Nobel Prize in Physiology or Medicine 2026 is awarded for optogenetics, a method that makes it possible to show how nerve cells shape memories, feelings and behaviours in the living brain- Dr Peter Hegemann- A Hertie Senior Research Chair for Neurosciences and a professor of Experimental Biophysics at the Department of Biology, Faculty of Life Sciences, Humboldt University of Berlin, Germany Dr Georg Nagel- A biophysicist and professor at the Department for Neurophysiology at the University of Würzburg in Germany Dr Karl Deisseroth- D.H. Chen Professor of Bioengineering and of Psychiatry and Behavioral Sciences at Stanford University, and Investigator of the Howard Hughes Medical Institute Peter Hegemann and Georg Nagel discovered a remarkable protein, channelrhodopsin, in a single-celled alga, while Karl Deisseroth transformed the protein into a light-controlled switch for nerve cells. The laureates have laid the foundation of a new era in neuroscience. “Optogenetics provides opportunities for mapping the brain in a way that we could once only dream of,” says Per Svenningsson, Chair of the Nobel Committee for Physiology or Medicine. To understand how the brain forms memories, feelings and behaviours has long been a dream for researchers. Karl Deisseroth, Peter Hegemann and Georg Nagel have been awarded the 2026 Nobel Prize in Physiology or Medicine for discoveries leading to optogenetics, which makes it possible to switch on, or off, the activity of individual nerve cells in a living brain. This method is now being used in laboratories around the world to reveal the brain’s mysteries. ]]> https://biospectrumindia.com/news/57/28597/serum-institute-of-indias-hpv-vaccine-cervavac-receives-who-prequalification.html https://biospectrumindia.com/news/57/28597/serum-institute-of-indias-hpv-vaccine-cervavac-receives-who-prequalification.html Mon, 05 Oct 2026 20:38:53 +0530 CERVAVAC®, India’s first indigenously developed gender-neutral Quadrivalent Human Papillomavirus vaccine (qHPV) developed by Serum Institute of India receives prequalification by the World Health Organization (WHO). This regulatory milestone marks the 32nd WHO prequalification for products/biologicals received by Serum Institute of India. Inclusion on the WHO List of Prequalified Vaccines allows CERVAVAC® to be procured by United Nations agencies.  This recombinant quadrivalent HPV vaccine targets HPV types 6, 11, 16 and 18. It is indicated for girls and boys aged 9 through 26 years. Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, “WHO prequalification of CERVAVAC® is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks. We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare” Previously approved for its use in India by the Drugs Controller General of India (DCGI), CERVAVAC® is administered for the prevention of diseases caused by the four HPV types. This includes the prevention of anal cancer in boys and young men, and cervical, vulvar, vaginal, and anal cancers in girls and young women. It is also indicated in preventing genital warts, as applicable to the indicated population. Developed in collaboration with the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC), along with the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation, CERVAVAC® is a recombinant quadrivalent HPV vaccine targeting HPV types 6, 11, 16 and 18.  ]]> https://biospectrumindia.com/features/57/28584/dextran-in-freeze-drying-faster-processing-and-improved-protein-stability.html https://biospectrumindia.com/features/57/28584/dextran-in-freeze-drying-faster-processing-and-improved-protein-stability.html Thu, 01 Oct 2026 00:00:00 +0530 Yet the process presents a familiar challenge for formulation and process development teams: how can drying time be reduced without compromising product quality and stability? The choice of excipient can play an important role. Sucrose and trehalose are widely used as cryo- and lyoprotectants in freeze-dried protein formulations. However, their relatively low glass transition temperatures can restrict the temperatures that can be applied during primary drying, contributing to longer drying cycles. Selected dextran molecular weights offer an interesting alternative because they provide higher glass transition temperatures than sucrose, which may allow higher primary-drying temperatures while maintaining protein activity under suitable formulation and process conditions. Exploring Dextran 1 and Dextran 40 A study by Strøm Larsen et al. investigated dextrans of different molecular weights as cryo- and lyoprotectants, using lactate dehydrogenase (LDH) as a model protein. Nine dextran molecular weights were characterised for relevant glass transition properties, with Dextran 1 and Dextran 40 subsequently evaluated in freeze-drying experiments, both individually and in mixtures, and compared with sucrose. The results demonstrated a clear processing advantage under the conditions of the study. Primary drying was completed after approximately 5 hours for dextran-containing formulations compared with 16.5 hours for sucrose. The higher glass transition temperature of the maximally freeze-concentrated dextran solutions allowed a higher primary-drying temperature, resulting in a more than 60% reduction in primary drying time compared with sucrose in the applied freeze-drying cycle. Importantly, faster processing did not come at the expense of LDH activity in the best-performing dextran formulation. Among the formulations investigated, Dextran 40 provided the highest retained LDH activity following freeze-drying and during accelerated storage. The Dextran 40 formulation retained approximately 97% activity immediately after freeze-drying and 94% after seven weeks at 40°C, compared with approximately 86% and 27%, respectively, for sucrose. Dextran 1 retained approximately 82% immediately after freeze-drying and 54% after seven weeks at 40°C.  These findings illustrate how dextran selection may help address two important formulation-development objectives in lyophilised protein systems: shortening primary drying while supporting protein stability. However, the results should be interpreted as protein- and process-specific rather than as a universal ranking of excipient performance. Molecular Weight Matters The study also demonstrated that the physicochemical properties of dextran vary with molecular weight. Glass transition temperatures generally increased with increasing molecular weight, with the effect most pronounced at lower molecular weights and reaching a plateau around 40 kDa.  This was reflected in the LDH activity results. While both Dextran 1 and Dextran 40 enabled faster primary drying compared with sucrose, Dextran 40 provided the strongest protection of LDH during the applied freeze-drying process and under elevated storage conditions. The study also found no additional benefit from combining Dextran 1 and Dextran 40 compared with using pure Dextran 40. The findings highlight an important consideration for formulation scientists: dextran is not simply one excipient. Its molecular weight can be a formulation parameter in its own right. A Broad Dextran Toolbox from Pharmacosmos Pharmacosmos offers a broad dextran portfolio spanning molecular weights from approximately 500 to over 5,000,000 Da, including pharmaceutical and technical grades, standards, derivatives and customised solutions. Manufactured in a dedicated cGMP facility using a water-based process without organic solvents, our dextrans support major pharmacopoeial requirements including Ph. Eur., USP and JP. We combine carbohydrate expertise, pharmaceutical quality and manufacturing flexibility from development through scale-up. Explore our portfolio at dextran.com or contact dextran@pharmacosmos.com. ]]> https://biospectrumindia.com/news/57/28581/aurobindo-pharma-launches-adquey-in-us-and-establishes-dedicated-dermatology-biz.html https://biospectrumindia.com/news/57/28581/aurobindo-pharma-launches-adquey-in-us-and-establishes-dedicated-dermatology-biz.html Wed, 30 Sep 2026 23:13:48 +0530 Acrotech Biopharma Inc., a biopharmaceutical company focused on developing and commercialising innovative proprietary medicines and a subsidiary of Aurobindo Pharma, has announced the US launch of ADQUEY™ (difamilast 1%) ointment, a non-steroidal topical treatment for mild-to-moderate atopic dermatitis in adults and pediatric patients 2 years of age and older. Difamilast was originally discovered by Otsuka Pharmaceutical and licensed to Acrotech Biopharma for US commercialisation. The launch marks Acrotech’s entry into the US dermatology market and expands the company’s commercial presence into a new strategic therapeutic area. To support the launch of ADQUEY and its long-term ambitions in dermatology, Acrotech has established a dedicated dermatology business unit with specialized commercial capabilities across marketing, sales and field-based engagement. The product will compete in a market estimated to be around $1.3 billion for the twelve months ending July 2026, according to IQVIA MAT. The dedicated dermatology business will focus on building awareness of ADQUEY, engaging with dermatology healthcare professionals and supporting patients throughout their treatment journey, while developing the infrastructure and expertise required to expand Acrotech’s presence in the specialty dermatology market. The launch of ADQUEY builds on Acrotech’s strategy to expand its portfolio of innovative medicines and establish focused commercial platforms in areas of significant patient need. ]]> https://biospectrumindia.com/news/57/28529/maharishi-ayurveda-expands-global-footprint-with-5-m-european-centre-of-excellence-in-the-netherlands.html https://biospectrumindia.com/news/57/28529/maharishi-ayurveda-expands-global-footprint-with-5-m-european-centre-of-excellence-in-the-netherlands.html Wed, 23 Sep 2026 17:11:16 +0530 Maharishi Ayurveda Wellness Hospitality has announced the launch of its new centre at the Maharishi European Research University (MERU) campus in the Netherlands. Developed as part of a €5 million expansion project spanning wellness, hospitality, education and research infrastructure, the centre marks a significant milestone in the organisation's global growth strategy and strengthens its presence in the rapidly expanding European wellness market. Officially inaugurated through traditional Vedic ceremonies, the new facility is envisioned as Maharishi Ayurveda's European Centre of Excellence, bringing together authentic Ayurvedic treatments, Panchakarma therapies, wellness hospitality, practitioner education and scientific research under one integrated campus. As the demand for preventive and holistic healthcare continues to accelerate globally. Industry estimates project the global Ayurveda market to reach approximately $85.8 billion by 2033, while the European Ayurveda market is expected to grow from nearly $1.8 billion in 2025 to over $7.2 billion by 2034, driven by increasing consumer preference for natural, personalised and integrative wellness solutions. During the initial phase, the Netherlands centre is expected to witness approximately 3,000 visitors annually through therapies, wellness retreats, consultations, Panchakarma programmes and educational initiatives. The facility also aims to train more than 100 Ayurveda and wellness professionals every year, contributing to the global expansion of authentic Ayurvedic knowledge and creating new opportunities for skilled practitioners.   ]]> https://biospectrumindia.com/news/57/28471/cipla-announces-exclusive-partnership-with-qilu-pharma-for-the-supply-of-biosimilar-to-keytruda-pembrolizumab-in-us.html https://biospectrumindia.com/news/57/28471/cipla-announces-exclusive-partnership-with-qilu-pharma-for-the-supply-of-biosimilar-to-keytruda-pembrolizumab-in-us.html Sat, 12 Sep 2026 13:26:28 +0530 Invagen Pharmaceuticals Inc, a wholly owned subsidiary of Cipla Limited, has entered into a strategic partnership with Qilu Pharmaceutical Co., for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda® (pembrolizumab), for the United States. As part of the agreement, Qilu will be responsible for development, regulatory registration and supply of the product while Cipla USA Inc. will be responsible for the commercialisation of the asset by leveraging its strong commercial presence in the defined territory. The collaboration reflects both companies’ shared commitment to addressing the growing burden of cancer and improving access to advanced biologic therapies. Commenting on the partnership, Achin Gupta, Managing Director & Global Chief Executive Officer, Cipla, said, “This partnership reflects Cipla’s confidence in the long-term potential of biosimilars and supports our strategy to build a strong oncology-focused portfolio. By combining Qilu’s development strengths with Cipla’s commercial presence and patient-centric legacy, we aim to expand access to high-quality biologics for patients across our focus markets.” ]]> https://biospectrumindia.com/news/57/28450/kaisha-pharma-establishes-kaisha-pharma-international-in-italy.html https://biospectrumindia.com/news/57/28450/kaisha-pharma-establishes-kaisha-pharma-international-in-italy.html Thu, 10 Sep 2026 11:50:22 +0530 Following the recent launch of Kaisha Pharma, the founders have taken the next strategic step in advancing their global customer-centric vision with the establishment of Kaisha Pharma International in Italy.  Kaisha Pharma International has been established as the company’s global business development and customer support hub, dedicated to spearheading strategic customer outreach, market interface and business development across overseas markets.  From its base in Italy, the company will manage customer relationships and ensure customer support for its global pharmaceutical and biotechnology customers across the Americas, Europe, Middle East and Africa (EMEA), Asia-Pacific, and other key international markets.  The company also announced the appointment of Andrea Zambon as Managing Director of Kaisha Pharma International and Global Head of International Business Development.  Andrea Zambon brings extensive international leadership experience within the pharmaceutical packaging industry and specialised drug delivery sector and will be responsible for orchestrating Kaisha Pharma's worldwide business development strategy, strengthening customer relationships, expanding the company's international presence and supporting its long-term international growth objectives.  "The establishment of Kaisha Pharma International marks another important milestone in our journey. When we launched Kaisha Pharma, our vision was clear: to build a truly Global pharmaceutical packaging company. Today's announcement demonstrates that our commitment is already becoming a reality.", said Kairus Dadachanji, Managing Director of Kaisha Pharma.  The establishment of Kaisha Pharma International follows the recent announcement of an initial €45 million capital deployment in Kaisha Pharma, as part of a multi-million-euro long-term investment programme, which is supporting the company's global expansion strategy, advanced manufacturing capabilities, technology partnerships and the introduction of next-generation pharmaceutical packaging solutions.    ]]> https://biospectrumindia.com/news/57/28374/emmes-group-appoints-dr-rama-kondru-as-ceo-to-drive-ai-led-clinical-research-innovation.html https://biospectrumindia.com/news/57/28374/emmes-group-appoints-dr-rama-kondru-as-ceo-to-drive-ai-led-clinical-research-innovation.html Tue, 25 Aug 2026 00:00:00 +0530 This appointment reflects the Board's confidence in Dr. Kondru's ability to drive innovation and operational excellence and underscores its commitment to advancing clinical research through scientific excellence, technology, and artificial intelligence. Dr. Kondru joined the Emmes Group in 2024 and most recently served as CEO of Veridix, the company’s AI, technology, and data sciences business. He assumes the role at a pivotal moment for Emmes: a company built on almost 50 years of scientific rigor now positioned to combine that legacy with modern AI and technology to accelerate the pace of biomedical discovery. Dr. Kondru has demonstrated exceptional leadership in technology-driven innovation across The Emmes Group and brings a combination of scientific expertise, global operating experience, and a track record of scaling technology platforms, making him ideally suited to lead the company's next phase of growth.  "It is a privilege to lead The Emmes Group at such an exciting time for our industry," said Dr. Kondru. "For nearly five decades, Emmes has stood behind some of the most important public health efforts, from the earliest NIH vaccine and infectious disease programs to the trials that helped the world respond to COVID-19. Building on that legacy, we have a unique opportunity to combine AI, technology, and clinical expertise to transform how trials are designed and conducted. Together with our customers, we will help bring life-changing therapies to patients faster while creating long-term value for customers, employees, and investors." Prior to joining The Emmes Group, Dr. Kondru served as Co-CEO of Medidata Solutions, a global leader in cloud-based clinical development technology, where he helped scale one of the industry's most transformative platforms. He brings 25 years of experience across pharmaceuticals, healthcare technology, data science, and academia, and has built technology-driven businesses that accelerate clinical development and improve patient outcomes. Earlier in his career, he served as Senior Vice President and Chief Information Officer for Janssen Americas (Johnson & Johnson) and Vice President and Chief Information Officer for R&D and Innovation at Johnson & Johnson Medical Devices and held leadership roles at UCB Pharma and F. Hoffmann-La Roche. Dr. Kondru earned his bachelor's degree from the Indian Institute of Technology (IIT Bombay) and his Ph.D. from the University of Pittsburgh, where he also completed postdoctoral research. He has served as an Adjunct Professor at Duke University. ]]> https://biospectrumindia.com/news/57/28329/godavari-biorefineries-secures-european-patent-for-novel-anti-cancer-pharmaceutical-composition.html https://biospectrumindia.com/news/57/28329/godavari-biorefineries-secures-european-patent-for-novel-anti-cancer-pharmaceutical-composition.html Mon, 17 Aug 2026 19:40:40 +0530 Mumbai-based Godavari Biorefineries has secured a patent from the European Patent Office for its invention, "Pharmaceutical Composition and a Process to Prepare the Same." The patent covers a pharmaceutical composition that combines novel anti-cancer compounds with a solubilising agent, along with the process to prepare it. The composition is designed to enhance the solubility and bioavailability of the active compounds, thereby improving their therapeutic potential. It has significant applications in the treatment of various cancers, including breast and prostate cancers, particularly through oral administration. The patent adds to Godavari Biorefineries’ oncology-focused intellectual property portfolio.  “In oncology research, identifying a promising compound is only one part of the challenge. How that compound is formulated can determine how effectively it can be developed for therapeutic use. Our research has focused on improving the solubility and bioavailability of these compounds, and the grant of this European patent is an important recognition of that work,” said Dr Sangeeta Srivastava, Executive Director, Godavari Biorefineries. The European grant further expands Godavari Biorefineries' international intellectual property footprint as the Company continues to protect its research across major markets worldwide. ]]> https://biospectrumindia.com/news/57/28312/axtria-to-build-industrys-largest-pharma-specific-ai-engineering-team-scaling-to-1000-by-dec-2026.html https://biospectrumindia.com/news/57/28312/axtria-to-build-industrys-largest-pharma-specific-ai-engineering-team-scaling-to-1000-by-dec-2026.html Fri, 14 Aug 2026 18:53:20 +0530 US-based Axtria Inc., a global leader in AI-first data analytics solutions for the life sciences industry, has announced plans to expand its Forward Deployed Engineering (FDE) organisation to 1,000 engineers by December 2026, creating the industry's largest pharma-specific AI engineering team. The expansion represents one of Axtria's largest investments in AI talent development to date and reflects growing customer demand for engineers who can deploy, scale, and operationalise enterprise AI across commercial, medical, and market access functions. Launched approximately 12 months ago, Axtria's Forward Deployed Engineering model was built on a simple premise: the future of AI in life sciences will be determined not by who has access to the best models, but by who can successfully deploy AI into complex enterprise environments and deliver measurable business outcomes. Today, Axtria's FDEs are embedded within leading life sciences organizations, deploying production-grade AI solutions across commercial and medical operations. Building on this momentum, Axtria is expanding the organisation to 1,000 engineers by December 2026 through a combination of internal talent development and strategic hiring. Through the Axtria Institute, the company is developing life sciences domain experts into certified AI engineers who deploy solutions across Industry leading platforms and Axtria's proprietary platforms—including SalesIQ™, MarketingIQ™ and DataMAx™, helping clients modernise data foundations, improve decision-making, and scale enterprise AI with strong governance and cost efficiency. ]]> https://biospectrumindia.com/news/57/28294/zydus-us-sentynl-therapeutics-expands-rare-disease-portfolio-in-partnership-with-mereo-biopharma.html https://biospectrumindia.com/news/57/28294/zydus-us-sentynl-therapeutics-expands-rare-disease-portfolio-in-partnership-with-mereo-biopharma.html Wed, 12 Aug 2026 13:33:47 +0530 Sentynl Therapeutics, Inc., a US-based biopharmaceutical company and wholly-owned subsidiary of Zydus Lifesciences, and Mereo BioPharma Group plc, a clinical-stage biopharmaceutical company focused on rare diseases, have entered into an option and license agreement for the US commercial and global manufacturing rights to alvelestat for Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD). Alvelestat is a neutrophil elastase inhibitor being readied for Phase 3 and, if approved, would be the first oral treatment for this rare, progressive genetic lung disease affecting an estimated 50,000-80,000 individuals in the United States. The option and license agreement grants Sentynl the exclusive right to acquire a license to commercialise alvelestat for AATD-LD in the United States, with Mereo retaining commercial rights in the rest of the world. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD and on option exercise, it provides funding for the alvelestat Phase 3 development programme, which could be initiated in early 2027. Mereo will receive a non-refundable option fee from Sentynl and, on exercise of the option, the company would also receive up to $40 million in upfront and R&D payments until NDA filing. Under these terms, Mereo would also be eligible to receive double-digit tiered royalties on US net sales of alvelestat. Mereo will lead the global Phase 3 study and regulatory interactions until the study is completed. However, during the option period, the companies will collaborate to advance manufacturing and streamline the Phase 3 study design. ]]> https://biospectrumindia.com/news/57/28231/who-updates-treatment-guidelines-on-visceral-and-post-kala-azar-dermal-leishmaniasis.html https://biospectrumindia.com/news/57/28231/who-updates-treatment-guidelines-on-visceral-and-post-kala-azar-dermal-leishmaniasis.html Wed, 29 Jul 2026 17:47:10 +0530 The World Health Organization (WHO) has issued major updates to its leishmaniasis treatment guidelines for eastern Africa and South-East Asia, recommending new regimens that significantly improve patient care. The new WHO guidelines, released today, are applicable for visceral leishmaniasis (VL, also called kala-azar), a deadly disease, and for post-kala-azar dermal leishmaniasis (PKDL). The updated guidelines include (i) alternative, shorter and safer treatment of primary VL in eastern Africa; (ii) new, shorter, effective and safer treatments for PKDL in eastern Africa and South-East Asia; and (iii) relapse management in immunocompetent VL patients in South-East Asia. Additionally, it updates the safety profile of miltefosine, incorporating the recommendations of the WHO Advisory Committee on the Safety of Medicinal Products, and provides allometric dosing for miltefosine. For a long time, treatment in Africa relied on an injectable drug called sodium stibogluconate (SSG), which requires lengthy treatments and painful daily injections and caused severe side effects. For the first time, WHO recommends SSG-free regimens. However, this medicine remains in use for patients who are not eligible for the newly recommended treatment options. In eastern Africa, an oral drug, miltefosine, is recommended for the treatment of both VL and PKDL in combination with paromomycin injection. In South-East Asia, new, safer, shorter combination therapies using liposomal amphotericin B infusion alone or in combination with oral miltefosine are recommended for people living with PKDL. The new VL treatment in eastern Africa is given over 14 days with one injection less and with less toxicities over the current administration of two injections of sodium stibogluconate and paromomycin over 17 days. In eastern Africa, chronic cases of PKDL used to be treated with toxic sodium stibogluconate given for 30–60 days or with liposomal amphotericin B over 20 days, whereas in South-East Asia, a 12-week regimen of miltefosine was in practice. New recommendations will replace these lengthy and cumbersome treatments. It is expected that almost half of the primary VL and all PKDL patients will potentially benefit from these life-changing recommendations. In addition, the subset of VL patients who relapse will also benefit from the newer, clearer recommendations for its management in South-East Asia. For the remaining VL patients in Africa, who are not eligible for miltefosine combination, they will still have to rely on older regimens, till new therapies are available. Many of the new therapies now recommended by WHO were developed by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) and partners. ]]> https://biospectrumindia.com/news/57/28177/will-trumps-new-tariff-plan-on-generic-drugs-strike-knee-jerk-negative-reactions-in-pharma-stocks.html https://biospectrumindia.com/news/57/28177/will-trumps-new-tariff-plan-on-generic-drugs-strike-knee-jerk-negative-reactions-in-pharma-stocks.html Wed, 22 Jul 2026 16:15:07 +0530 US President Donald J Trump has stated that effective August 1st, 2026, all generic drugs being brought into the United States (US) will continue to have a tariff of zero percent for a two year period of time, after which the tariff will be raised to 100% for a one year period of time, and 200% thereafter. This is apparently being done in order to reshore Generic Pharmaceutical Production into America, with a penalty to those companies that decide not to build plant and equipment within the stated period of time given to them. According to Trump, the objective of this Policy is to protect the people of the United States. The Policy on Patented, Branded, or Innovative Drugs, which has been so successful, will remain as is. Following this announcement, Param Desai, Research analyst - PL Capital said, "Several generic pharma companies already have manufacturing facilities in the US, which could partially mitigate the impact. However, a two-year window appears too short to relocate the entire generic pharmaceutical value chain to the US. Trump's term ends in January 2029, while the major tariff impact begins from August 2028, so the eventual implementation remains uncertain if there is a change in administration. We could see a knee-jerk negative reaction in pharma stocks today, particularly among large-cap generic players, until there is greater clarity on the policy.” Thomas V. Abraham, Research Analyst, Mirae Asset Sharekhan further added, "Will await further clarity but my quick sense is hoping that the manufacture being referred to is not all the drugs but having manufacturing units in the US (just like how the policy was for branded drugs). Most companies have some units (organically or in organically) there and 2 years provides enough time to meet the rules. Additionally, in the last such move, branded drug companies subsequently entered into deals with the government to circumvent the impact of tax and same can be sought by generic companies too. However, will wait to see how market responds to this new tariff. Investors could turn risk averse in the near term as they await clarity." Sharing his perspective, Namit Joshi, Chairman, Pharmexcil said,  "The zero-tariff window through 2028 gives the industry a meaningful runway, and we see this as time we can use productively — to keep strengthening our position across multiple markets rather than relying on any single one. We've been diversifying for a while now — in the Apr–May FY27 period compared to Apr–May FY26, Europe is up 21% and now accounts for over 20% of our total pharma exports, while Latin America (LAC) remains consistent, growing 23.96% over the same two-month period and now representing nearly 8% of our exports — and that strategy continues regardless of today's news. Generics remain a segment where India brings deep expertise and scale, supplying a large share of the world's affordable medicines, and we expect that strength to continue. On the India-US trade talks: we see today's announcement as an opportunity to build even more clarity into the FTA conversations ahead." "The proposed US tariffs on pharmaceutical generics, effective August 2028, could impact the business risk profiles of Indian pharmaceutical exporters, given that the US accounts for nearly one-third of India’s pharmaceutical exports, predominantly generics. That said, several structural strengths provide support. First, the US is heavily reliant on imported generics, with Indian manufacturers supplying about 40% of its demand. This may enable the pass-through of a portion of tariff-related cost increases across the value chain. Second, the two-year implementation window provides companies an opportunity to adapt their supply chains. Lastly, the final tariff structure and the outcome of India–US trade negotiations continue to evolve and therefore warrant close monitoring. Nevertheless, the credit profiles of Indian pharmaceutical companies are expected to remain stable, supported by their strong balance sheets", said Anuj Sethi, Senior Director, Crisil Ratings. ]]> https://biospectrumindia.com/news/57/28160/optrascan-receives-us-fda-510k-clearance-for-digital-pathology-system.html https://biospectrumindia.com/news/57/28160/optrascan-receives-us-fda-510k-clearance-for-digital-pathology-system.html Mon, 20 Jul 2026 17:43:44 +0530 OptraSCAN, Inc., a California-headquartered digital pathology and image analysis company in which Molbio Diagnostics acquired a majority stake in 2025, has received US Food and Drug Administration (FDA) 510(k) clearance (K260755) for the OptraSCAN System. The clearance covers the integrated OptraSCAN System comprising the OS-Ultra Whole Slide Scanner, a color display monitor, and a workstation running the company’s ImagePath Image Management Software, including HER2 Image Analysis Software. Together, the system supports pathologists in the review and assessment of HER2 expression in clinical practice. HER2 assessment plays a critical role in breast cancer characterisation and therapeutic decision-making. As pathology laboratories worldwide continue to transition towards digitised workflows, image analysis technologies are increasingly adopted to support standardisation, reproducibility, and efficiency in pathology review processes. Commenting on the significance of the development for the global pathology community, Dr Reena Nakra, Chief Scientific Officer, Dr Lal PathLabs, said, “Digital pathology is becoming an increasingly important part of modern pathology. We have had the opportunity to work with OptraSCAN and regulatory milestones such as US FDA clearance provide additional confidence in the quality of its digital pathology platform and the clinical robustness of this technology. This milestone is an encouraging step forward for the continued adoption of digital pathology.” ]]> https://biospectrumindia.com/news/57/28146/gates-medical-research-institute-serum-institute-of-india-to-manufacture-new-tb-vaccine-candidate.html https://biospectrumindia.com/news/57/28146/gates-medical-research-institute-serum-institute-of-india-to-manufacture-new-tb-vaccine-candidate.html Fri, 17 Jul 2026 23:50:08 +0530 The Gates Medical Research Institute (Gates MRI) has reached a milestone agreement with the Serum Institute of India (SII) to manufacture M72/AS01E, a novel tuberculosis (TB) vaccine candidate. Currently in a Phase 3 clinical trial, M72/AS01E has the potential to be the first new TB vaccine to be introduced in more than a century, a potential breakthrough against a disease that remains the world’s leading infectious cause of death and disproportionately impacts low- and middle-income countries. With this partnership, Gates MRI and SII will begin the process of transferring the technology and know-how required to manufacture the antigen and enable future large-scale production of M72/AS01E. SII expects to invest more than $100 million of its own resources to strengthen manufacturing readiness and capacity building to support potential future supply. GSK, the original developer of the vaccine, will supply the AS01E adjuvant. Initiating this work well ahead of Phase 3 trial results is a deliberate strategy to ensure readiness to produce and distribute the vaccine and begin meeting global demand as quickly as possible, should the trial be successful and regulatory approvals be granted. Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E, with funding from the Gates Foundation and Wellcome. The double-blind, randomised trial, which started in March 2024, reached full enrollment in April 2025, of 20,000 participants in South Africa, Kenya, Malawi, Zambia, and Indonesia across 54 sites. ]]> https://biospectrumindia.com/news/57/28042/450-life-sciences-leaders-convene-at-axtria-ignite-2026-in-us.html https://biospectrumindia.com/news/57/28042/450-life-sciences-leaders-convene-at-axtria-ignite-2026-in-us.html Mon, 29 Jun 2026 23:07:03 +0530 Axtria Inc., a global leader in AI-first data & analytics solutions and platforms for the life sciences industry, hosted Axtria Ignite 2026 on June 10 and 11 at the Princeton Marriott at Forrestal under the theme "Industrialising Intelligence: The Agentic Enterprise." More than 450 executives from over 100 leading life sciences, MedTech, and biotech organisations gathered to work through the harder question of 2026: what must be true before an enterprise can trust AI to run at machine speed. Day 1 of the by-invitation-only event drew more than 200 attendees to product workshops on practical applications of AI, analytics, and commercial excellence. It included real world success stories and value delivered from agents and hands on experience with live agents. Day 2 featured four mainstage sessions and 16 panels across four tracks: industrialised data and the agentic backbone, agentic AI for business insights, high-performance customer engagement, and the shift from software to agentic ecosystems. Now in its fourth year, Axtria Ignite has become a regular fixture on the calendars of senior commercial and data leaders in life sciences. In his keynote address, Axtria founder and CEO Jaswinder "Jassi" Chadha argued that the foundation determines whether AI in pharma scales. Drawing on three decades in the industry, he pointed to the persistent gap between ambition and execution: roughly 73% of biopharma still reports significant data issues, as many as 89% of AI pilots never reach production, and trust in AI systems has slipped from 61% in 2019 to 53% today, even as the industry races toward a projected 100,000-plus AI agents. Against a pharma accuracy bar of 99.5%, Chadha laid out four things the foundation must carry: an AI-ready data supply chain, a semantic layer for agent accuracy, software guardrails for deterministic precision where stakes are highest, and a governance framework for digital workers at scale. Agents, in his framing, are new hires who must earn trust through validation and audit, not receive it on day one. Co-founder and CTO Navdeep "Navi" Chadha led a mainstage session with senior leaders from Thermo Fisher Scientific and Quest Diagnostics. The discussion moved past future potential to candid accounts of what has worked and what has not, from CFO-certifiable value reporting and integrated risk management to the discipline of defining exit criteria before a proof of concept begins. A recurring lesson surfaced across panelists: change management is the work, not a footnote. Across tracks, the discussions reached a level of candor that does not show up in industry research reports. A senior leader at a major pharma company described her team's unlock: making clear that AI was here to elevate marketers rather than replace them. By her account, adoption now sits above 90%. Axtria presented its annual Ignite Leadership Awards, recognising leaders doing the hard work of transformation inside their organisations. These leaders were recognised for driving enterprise-wide AI transformations and genuinely bringing multiple disciplines together to truly make a difference to the foundation of AI to realise the true value. The 2026 honorees were: Anvita Karara, Vice President, Commercialisation AI Strategy & Analytics, Bristol Myers Squibb Jeremy Pincus, Vice President, Medical Affairs IT, GSK Bharti Rai, Senior Vice President, Biogen The Axtria Bedrock Honour recognised Quest Diagnostics for a 15-year partnership and the recent implementation of an Axtria SalesIQ™ sales force alignment solution across 34 role types and a ~1,300-person field organisation, among the most complex sales force alignments in healthcare. The honour was accepted by John Liffert, Vice President, Commercial Operations, alongside Samantha Barnes-Weaver, Director, National Deployment and Alignments, and Marc Cangemi, Senior Director, Commercial Excellence, Compensation, and Deployment. ]]> https://biospectrumindia.com/news/57/28033/merck-buys-bio-techne-for-11-3-b-to-strengthen-leadership-position-in-life-sciences-market.html https://biospectrumindia.com/news/57/28033/merck-buys-bio-techne-for-11-3-b-to-strengthen-leadership-position-in-life-sciences-market.html Sat, 27 Jun 2026 16:24:26 +0530 Merck KGaA, Darmstadt, Germany, a leading science and technology company, and Bio-Techne Corporation, a Minneapolis-based global provider of life science tools, analytical technologies, and consumables, have entered into a definitive agreement pursuant to which Merck KGaA, Darmstadt, Germany, will, subject to customary closing conditions, acquire Bio-Techne for $73 per share in cash, representing a total enterprise value of approximately $11.3 billion (EUR 9.9 billion), a 36% premium to Bio-Techne's one-month volume weighted average trading price. The transaction would bring together two highly complementary and leading life sciences organisations, uniquely positioned to support customers across the full spectrum of life science workflows – from discovery and translational research through development, testing and commercial manufacturing. Additionally, it would directly deliver on the mid- to long-term strategic agenda of Merck KGaA, Darmstadt, Germany, which focuses on high-growth value drivers, integrated workflows, platformed capabilities and scaling and sourcing innovation through M&A. Bio-Techne would bring to Merck KGaA, Darmstadt, Germany, a globally recognised portfolio of cytokines, growth factors, antibodies, and immunoassay kits. The planned acquisition would also add ProteinSimple, a leader in automated protein detection and analysis instruments, strengthening the analytical and bioprocess solutions of Merck KGaA, Darmstadt, Germany. In addition, Bio-Techne's RNAscope and related in situ hybridisation technologies would strengthen the capabilities of Merck KGaA, Darmstadt, Germany, in spatial biology and diagnostics. ]]> https://biospectrumindia.com/news/57/28007/parexel-launches-biotech-incubator-to-support-early-stage-innovation-.html https://biospectrumindia.com/news/57/28007/parexel-launches-biotech-incubator-to-support-early-stage-innovation-.html Tue, 23 Jun 2026 17:00:27 +0530 Parexel, a leading global clinical development partner providing insights-driven Clinical and Consulting solutions to the world's life sciences industry, has announced the launch of the Parexel Biotech Incubator, a new initiative anchored at the company's North Hills Innovation District global headquarters in Raleigh, US, that connects early-stage therapeutics companies with the clinical and regulatory expertise they need to advance their programmes. The incubator launches alongside an inaugural partnership with Cape Fear BioCapital, a Durham-based seed-stage venture capital firm, and builds on Parexel's growing commitment to supporting early-stage innovation in collaboration with the venture community. The Parexel Biotech Incubator is designed to support emerging therapeutics companies at a stage when development strategy is still taking shape. Participating companies will have access to Parexel's clinical and regulatory expertise - including guidance on development planning, regulatory strategy and clinical trial design - alongside shared physical space that puts them in direct proximity to Parexel's Raleigh-based team and provides a collaborative home rather than resources and investment alone. The partnership with Cape Fear BioCapital is designed to address a gap that early-stage therapeutics companies frequently face, where seed-stage investment and clinical development expertise rarely come together at the right time. Cape Fear BioCapital focuses on advancing companies from early discovery through IND-readiness, and the alliance creates a direct connection between its portfolio companies and Parexel's clinical and regulatory expertise at the stage when development decisions carry the most weight. ]]> https://biospectrumindia.com/news/57/27994/dbt-birac-shines-at-bharat-innovates-2026-in-france.html https://biospectrumindia.com/news/57/27994/dbt-birac-shines-at-bharat-innovates-2026-in-france.html Sat, 20 Jun 2026 18:29:23 +0530 Bharat Innovates 2026, a global accelerator event held from 14–16 June 2026 in Nice, France, showcased 120 Indian deep‑tech startups, 15 premier institutions, and major India–France innovation partnerships, inaugurated by PM Narendra Modi and President Emmanuel Macron. Department of Biotechnology (DBT)- Biotechnology Industry Research Assistance Council (BIRAC) booth was prominently located near the entrance of exhibition area, emphasising on the following: India’s BioEconomy growth, DBT’s championed BioE3 national policy, BIRAC-RDI Fund support for deep-tech innovations, BioSaarthi- mentoring platform to integrate European mentor pool, BRIC’s R&D ecosystem, BIRAC’s translational ecosystem – Bioincubation centres, Biofoundries, Biotech Startups, and others. A panel discussion explored how India can build on its success as the “Pharmacy of the World” and evolve into a globally recognised leader in bio-innovation and bio manufacturing through the convergence of science, entrepreneurship, policy, capital, artificial intelligence, and international collaboration. There were 15 startups nominees of DBT-BIRAC out of 120 startup who were selected for Bharat Innovates 2026. In all, there were 36 out of 120 startups who were BIRAC beneficiaries. This represented a lion’s share contribution of DBT-BIRAC in building high quality national innovation ecosystem. DBT-BIRAC was represented by Dr Manish Diwan, Head, BIRAC-RDIF; Dr Sonali Tandon, Chief Manager & In charge Investment; and Dr Rashi Aggarwal, Programme Officer, BIRAC-RDIF. Three term sheets worth Rs 450 Cr + from BIRAC-RDI Fund were announced for Fermbox Bio, Sea6 Energy, and Revelations Biotech, following first set of beneficiaries in the presence of Sudhir Sethi, Founder and Chairman, Chiratae Ventures; Strategic Advisory Committee member, BIRAC-RDIF. MoU/ agreements between Startup and Industry from the Biotechnology theme were exchanged in the presence of Principal Scientific Advisor, Prof. Ajay K Sood- ATGC Biotech (participating Startup Company under Biotechnology theme) with Albaugh Europe (a division of US based agrochemical company, Swiss Headquartered MNC specializing in crop-protection with formulation plants in Slovenia, Spain) ATGC Biotech and Luxembourg Industries Ltd (Israel based Agrochemical, speciality chemicals & advanced materials company with subsidiaries and manufacturing plants in USA and Brazil) announced a Joint Venture called SEMIOPHORE       ]]> https://biospectrumindia.com/news/57/27983/india-and-france-launch-atl-bridge-to-support-young-innovators.html https://biospectrumindia.com/news/57/27983/india-and-france-launch-atl-bridge-to-support-young-innovators.html Wed, 17 Jun 2026 16:43:25 +0530 Guided by the shared resolve of Prime Minister Narendra Modi and President of the French Republic Emmanuel Macron to deepen innovation-led cooperation between India and France, Atal Innovation Mission, NITI Aayog, and La Fondation Dassault Systèmes have established the India-France ATL Bridge.The initiative will enable collaboration among young innovators in both countries and establishes the first School Innovation Lab in France, inspired by India’s Atal Tinkering Lab framework.The ATL Bridge will serve as a strategic platform for cross-border innovation programmes, entrepreneurial exchanges, knowledge sharing, capacity building and joint innovation activities.By enabling young learners to co-create solutions to real-world challenges, the initiative strengthens early-stage innovation capabilities and deepens bilateral innovation cooperation between India and France. The ATL Bridge initiative forms part of the India–France Innovation Year 2026, reflecting both countries’ commitment to expanding cooperation in science, technology and education.  The model builds on India’s experience with Atal Tinkering Labs, which introduce students to design thinking, robotics, electronics, 3D design and emerging technologies such as artificial intelligence. ]]> https://biospectrumindia.com/news/57/27953/who-searo-and-george-institute-for-global-health-lay-focus-on-digital-health-and-ai-for-ncds.html https://biospectrumindia.com/news/57/27953/who-searo-and-george-institute-for-global-health-lay-focus-on-digital-health-and-ai-for-ncds.html Sat, 13 Jun 2026 13:26:37 +0530 Recognising the growing burden of non-communicable diseases (NCDs) across the WHO South-East Asia Region and the potential of digital health and AI to strengthen primary healthcare systems, WHO and The George Institute for Global Health, India have signed a Project Collaboration Agreement to strengthen the design, implementation, evaluation, and scale-up of evidence-based digital health and AI interventions for primary healthcare and non-communicable disease prevention and management. Non-communicable diseases account for more than half of all deaths in the Region, with nearly half of these deaths occurring before the age of 70. Yet, primary healthcare systems remain ill-equipped to respond to health workers that are concentrated in urban centres, and treatable conditions frequently go undetected or poorly managed at the community level. The objectives of the collaboration between WHO and The George Institute for Global Health, India are to: Advance implementation science for digital health interventions in primary health care, particularly for NCD prevention and management. Generate real-world evidence on the effectiveness, feasibility, scalability, cost-effectiveness and equity impact of digital health programmes integrated within health systems. Support the development of guidance, frameworks, and tools for designing and implementing AI-powered digital health programmes aligned with WHO digital health strategies. Facilitate knowledge exchange and capacity building through technical workshops, webinars, and collaborative learning platforms for policymakers, researchers, and implementers working on digital health. Strengthen collaboration with ministries of health and global partners to support the integration of digital health innovations into national programmes and health system strategies. Create and disseminate technical guidance, evaluation frameworks, and toolkits for responsible AI deployment in LMIC healthcare systems. Support WHO in convening regional dialogue on ethical AI governance, data privacy, and interoperability standards.   ]]> https://biospectrumindia.com/news/57/27746/who-expands-global-biomanufacturing-workforce-network.html https://biospectrumindia.com/news/57/27746/who-expands-global-biomanufacturing-workforce-network.html Fri, 01 May 2026 00:00:00 +0530 The World Health Organization (WHO) has designated a network of regional training centres for biomanufacturing across all six WHO regions, marking a major step forward in strengthening the global workforce needed to produce vaccines, biotherapeutics and other biological products. The designation follows a rigorous global selection process conducted through two calls for expressions of interest and forms part of the WHO Biomanufacturing Workforce Training Initiative established in 2023. This flagship effort addresses critical skills gaps across the biomanufacturing value chain, enabling countries to translate technological advances into sustainable local production. As global efforts continue to expand manufacturing infrastructure and advance technology transfer, WHO is placing equal emphasis on the people and systems required to make these investments sustainable and impactful. The newly designated regional training centres will operate as part of a coordinated global network, delivering hands-on context-specific training aligned with regional priorities, regulatory environments and languages. By partnering with academia and industry, they will expand access to training, strengthen regional expertise and foster collaboration across countries, supporting the development of a skilled and sustainable workforce. ]]> https://biospectrumindia.com/news/57/27747/government-of-burundi-introduces-hpv-vaccine-to-prevent-cervical-cancer.html https://biospectrumindia.com/news/57/27747/government-of-burundi-introduces-hpv-vaccine-to-prevent-cervical-cancer.html Wed, 29 Apr 2026 00:00:00 +0530 Under the leadership of the Ministry of Public Health and with the support of  Gavi, the Vaccine Alliance (Gavi), UNICEF, and the World Health Organization (WHO), Burundi has just launched, on April 29, 2026, the vaccine against the human papillomavirus (HPV), which causes cervical cancer. This major milestone marks a decisive turning point in the fight against cervical cancer, a preventable disease that remains one of the leading causes of death among women in Burundi. From 2017 to 2022, about 1,581 new cases were diagnosed, of which 1,126 resulted in death, illustrating the scale of the public health challenge. Globally, cervical cancer is the fourth most common cancer. In Burundi, it is among the most common cancers in women and represents the leading cause of female cancer-related deaths, in terms of both incidence and mortality. To ensure a successful, coordinated, and widely accepted rollout, the Ministry of Public Health, through the Expanded Program on Immunisation, is mobilising all stakeholders – including decision-makers, health professionals, media, community leaders, and partners – around a coherent national communication strategy and a strong multisectoral commitment. Priority is given to raising awareness and combating misinformation, to inform the public about the benefits of the vaccine and strengthen community trust. Starting in late April 2026, HPV vaccination will be incorporated into the routine immunisation schedule for girls aged 9 to 14 in all health districts across the country. This initiative aims to ensure effective protection and significantly reduce morbidity and mortality linked to this disease.  ]]> https://biospectrumindia.com/news/57/27748/us-fda-approves-first-ever-gene-therapy-for-treatment-of-genetic-hearing-loss.html https://biospectrumindia.com/news/57/27748/us-fda-approves-first-ever-gene-therapy-for-treatment-of-genetic-hearing-loss.html Fri, 24 Apr 2026 00:00:00 +0530 The US Food and Drug Administration (FDA) has approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Otarmeni is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene. US FDA has granted accelerated approval of Otarmeni to Regeneron Pharmaceuticals, Inc. Prior to this approval, no disease modifying treatments existed for OTOF-related deafness. Otarmeni is for patients with preserved outer hair cell function and no prior cochlear implant in the same ear. Genetic mutations cause about half of congenital hearing loss. Variants in the OTOF gene account for 2% to 8% of inherited, non-syndromic cases. Patients with two nonworking copies do not produce otoferlin, disrupting sound signal transmission. Delayed diagnosis can lead to missed treatment windows and lasting speech and language delays. Otarmeni and the administration kit are a one time biologic-device combination product. It includes a dual adeno-associated virus serotype 1 (AAV1) vector gene therapy administered as a single dose per ear surgically into the cochlea via a syringe and catheter provided in the Administration Kit and connected to an infusion pump. Otarmeni delivers a functional copy of the OTOF gene to inner hair cells to restore otoferlin production and auditory signaling. ]]> https://biospectrumindia.com/news/57/27626/biocon-announces-commercial-launch-of-bosaya-and-aukelso-denosumab-biosimilars-in-us.html https://biospectrumindia.com/news/57/27626/biocon-announces-commercial-launch-of-bosaya-and-aukelso-denosumab-biosimilars-in-us.html Wed, 08 Apr 2026 00:00:00 +0530 Bengaluru-based Biocon Limited has announced the commercial launch of Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) in the United States (US). Bosaya™ (biosimilar to Prolia®) and Aukelso™ (biosimilar to Xgeva®) are now available by prescription nationwide through specialty pharmacies and healthcare providers. Both products have been previously approved and granted interchangeable designation by the US Food and Drug Administration (FDA) in September 2025, allowing substitution at the pharmacy level in accordance with state laws. Denosumab products play a critical role in bone health, treating osteoporosis and bone complications associated with cancer. In 2024, denosumab products generated approximately $5 billion in US sales, reflecting the growing need for accessible treatment options. Both biosimilars will be available in the most common presentations: Bosaya™ (biosimilar to Prolia®): 60 mg/mL injection for subcutaneous use in a prefilled syringe. Aukelso™ (biosimilar to Xgeva®): 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength. ]]> https://biospectrumindia.com/news/57/27599/who-recommends-new-diagnostic-tools-to-help-end-tb.html https://biospectrumindia.com/news/57/27599/who-recommends-new-diagnostic-tools-to-help-end-tb.html Tue, 31 Mar 2026 00:00:00 +0530 The World Health Organization (WHO) is urging countries to accelerate action to end tuberculosis (TB) and expand access to lifesaving services by using new innovations such as  diagnostic tests that can be used near the point-of-care and tongue swabs that can help detect the disease faster reaching more people. The new guidelines on tests for TB that can be used near the point-of-care, issued by WHO, mark another step towards faster detection and treatment of one of the world’s deadliest infectious diseases. These portable, simple-to-use tests bring TB diagnosis closer to where people routinely seek care. Available at less than half the cost of many existing molecular diagnostics, they can help countries expand access to testing. The tests can operate on battery power and deliver results in less than one hour, allowing patients to start treatment sooner. The guidelines also recommend easy-to-collect tongue swab samples, as well as a cost-saving sputum pooling strategy to increase testing efficiency for TB and rifampicin-resistant TB. Tongue swabs allow adults and adolescents who cannot produce sputum to receive TB testing for the first time, enabling disease detection among people who are at an increased risk of dying from TB. Sputum pooling, where samples from several individuals are combined and tested together, can significantly reduce commodity costs and machine time, leading to faster results for people and TB programmes – an approach specifically recommended when resources are exceptionally constrained. While new diagnostic tools represent a critical step forward, ending TB will require sustained investment in research and innovation. Global funding for TB research remains far below the estimated annual need of around $5 billion, leaving major gaps in the development of new diagnostics, medicines and vaccines needed to end the epidemic. ]]> https://biospectrumindia.com/news/57/27600/paho-and-global-affairs-canada-renew-cad15-m-partnership-to-advance-womens-health.html https://biospectrumindia.com/news/57/27600/paho-and-global-affairs-canada-renew-cad15-m-partnership-to-advance-womens-health.html Fri, 27 Mar 2026 00:00:00 +0530 The Pan American Health Organization (PAHO) and Global Affairs Canada (GAC) have renewed their partnership through a CAD$15 million agreement to strengthen sexual and reproductive health and rights (SRHR) for women and adolescent girls living in situations of vulnerability in six countries in the Region of the Americas. The collaboration, which spans 2026–2030, builds on a long-standing alliance between PAHO and Canada. Through the Closing the Gaps in Sexual and Reproductive Health and Rights by Strengthening Health Systems for Women and Adolescent Girls (C-Gaps) project, the partnership will continue supporting efforts in Bolivia, Colombia, Ecuador, Guyana, Honduras, and Peru. Aligned with Canada’s Feminist International Assistance Policy and PAHO’s Strategic Plan (2026-2031), the initiative focuses on strengthening service delivery, advancing women’s and girls’ leadership and agency, and promoting enabling environments for SRHR. While countries in the Region of the Americas have improved coverage of services with a focus on primary health care, barriers to access persist, particularly among populations in situations of vulnerability. Addressing these gaps is essential to meet the 2030 Sustainable Development Goals (SDGs) and ensure access to sexual and reproductive health and rights for all women and girls.  ]]> https://biospectrumindia.com/news/57/27601/us-fda-approves-first-gene-therapy-for-severe-leukocyte-adhesion-deficiency-type-i.html https://biospectrumindia.com/news/57/27601/us-fda-approves-first-gene-therapy-for-severe-leukocyte-adhesion-deficiency-type-i.html Fri, 27 Mar 2026 00:00:00 +0530 The US Food and Drug Administration (FDA) has approved Rocket Pharmaceuticals' Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant. Severe LAD-I is a rare, inherited immune deficiency caused by mutations in the ITGB2 gene, which prevent white blood cells from effectively fighting infections.  Kresladi consists of the patient’s own hematopoietic (blood) stem cells (HSCs), which are genetically modified to introduce functional copies of the ITGB2 gene. Following conditioning, a single dose of Kresladi is infused intravenously to address the underlying cause of severe LAD-I by restoring CD18 and CD11a cell surface expression in white blood cells, including neutrophils. ]]> https://biospectrumindia.com/news/57/27126/who-unveils-traditional-medicine-global-library.html https://biospectrumindia.com/news/57/27126/who-unveils-traditional-medicine-global-library.html Fri, 26 Dec 2025 00:00:00 +0530 At the second WHO Global Summit on Traditional Medicine, jointly organised with the Government of India, concluding recently in New Delhi, WHO unveiled the Traditional Medicine (TM) Global Library, a first-of-its-kind digital platform consolidating 1.6 million resources on TM, from scientific studies to indigenous knowledge. With advanced features like Evidence Gap Maps and an AI-powered tool, TMGL GPT, the Library promises to transform access to trusted information and accelerate research worldwide.  The Library will become part of Hinari, one of the world’s largest collections of biomedical and health literature. Hinari is hosted on the Research4Life platform, which provides free or low-cost access to academic and peer-reviewed content to institutions in low- and middle-income countries. Incorporating the Library will allow broader reach and access to traditional medicine knowledge. The Library is expanding access to health information and evidence not only through its global collections but also by curating relevant content in dedicated thematic pages, including traditional midwifery, Ayurveda, anthroposophical medicine, integrative oncology and integrative paediatrics. ]]> https://biospectrumindia.com/news/57/26859/us-fda-moves-to-accelerate-biosimilar-development-and-lower-drug-costs.html https://biospectrumindia.com/news/57/26859/us-fda-moves-to-accelerate-biosimilar-development-and-lower-drug-costs.html Fri, 31 Oct 2025 00:00:00 +0530 The US Food and Drug Administration (FDA) has announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases. In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily. Expensive biologic medications make up only 5% of prescriptions in the US but account for 51% of total drug spending as of 2024. FDA-approved biosimilars are as safe and effective as the branded drugs, yet their market share remains below 20%. To date, FDA has approved 76 biosimilars, corresponding to a small fraction of approved biologics. By contrast, there are more than 30,000 approved generics, exceeding the number of approved brand drugs. Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development. Commenting on this development, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance said, "The recent announcement by the USFDA and CMS is a welcome step that will accelerate biosimilar development and lower drug costs for patients. The simplification of interchangeability guidelines and approval pathways will create a more enabling environment for the industry to diversify in large-molecule space. India already has nearly 130 approved biosimilars, and over the next seven years, more than 55 blockbuster drugs are expected to lose exclusivity in the US. India has long been a trusted partner in ensuring access to quality-assured, affordable medicines for American patients. These reforms will further strengthen the US–India partnership and our shared goal of improving healthcare access and affordability." ]]> https://biospectrumindia.com/news/57/26774/nobel-prize-in-medicine-2025-to-trio-for-groundbreaking-discoveries-of-immune-system.html https://biospectrumindia.com/news/57/26774/nobel-prize-in-medicine-2025-to-trio-for-groundbreaking-discoveries-of-immune-system.html Tue, 07 Oct 2025 00:00:00 +0530 The Nobel Assembly at Karolinska Institutet has decided to award the Nobel Prize in Physiology or Medicine 2025 to: Mary E. Brunkow Institute for Systems Biology, Seattle, USA; Fred Ramsdell Sonoma Biotherapeutics, San Francisco, USA; and Shimon Sakaguchi Osaka University, Osaka, Japan ”for their discoveries concerning peripheral immune tolerance”  Mary Brunkow and Fred Ramsdell made the other key discovery in 2001, when they presented the explanation for why a specific mouse strain was particularly vulnerable to autoimmune diseases. They had discovered that the mice have a mutation in a gene that they named Foxp3. They also showed that mutations in the human equivalent of this gene cause a serious autoimmune disease, IPEX. Two years after this, Shimon Sakaguchi was able to link these discoveries. He proved that the Foxp3 gene governs the development of the cells he identified in 1995. These cells, now known as regulatory T cells, monitor other immune cells and ensure that our immune system tolerates our own tissues. The laureates’ discoveries launched the field of peripheral tolerance, spurring the development of medical treatments for cancer and autoimmune diseases. This may also lead to more successful transplantations. Several of these treatments are now undergoing clinical trials. ]]> https://biospectrumindia.com/news/57/26404/adia-to-invest-usd-200-million-in-meril.html https://biospectrumindia.com/news/57/26404/adia-to-invest-usd-200-million-in-meril.html Sun, 20 Jul 2025 00:00:00 +0530 A wholly owned subsidiary of the Abu Dhabi Investment Authority (“ADIA”) has entered into definitive agreements to invest USD 200 million for a 3% stake in Micro Life Sciences Private Limited (“Meril”), one of India’s leading medical devices companies. This investment values Meril at an enterprise value of USD 6.6 billion. The transaction is subject to regulatory approval by the Competition Commission of India (CCI). Post this investment, Meril will be backed by two globally recognized investors, ADIA and Warburg Pincus.   Founded by the Bilakhia Group, Meril is a global innovator in medical technology (MedTech), with a strong focus on clinically advanced solutions across multiple specialties — including Cardiovascular, Structural Heart, Orthopaedics, Endo-surgery, In-vitro Diagnostics and Surgical Robotics.   Headquartered in Vapi, India, Meril operates state-of-the-art, vertically integrated, and globally certified manufacturing and RCD facilities, across a 100 acre sustainable MedTech campus. The company employs more than 13,000 people, has 35+ global subsidiaries, and serves healthcare systems in 150+ countries. Meril is committed to becoming the world’s leading MedTech company, powered 100% by green energy, reinforcing its commitment to sustainable innovation.   With a robust in-house global RCD ecosystem and a portfolio of 200+ technology platforms, Meril continues to lead in global clinical research and education. Breakthrough innovations such as the Myval Transcatheter Heart Valve (THV) series, MyClip Transcatheter Edge-to-Edge Repair (TEER) system, and the MISSO Surgical Robotic System highlight Meril’s dedication to next-generation innovation. Through its 12+ global training academies, Meril empowers over 10,000 healthcare professionals annually.   Sanjeev Bhatt, Senior Vice President – Strategy, Meril said: “This investment by ADIA reinforces confidence in Meril’s long term vision and global ambitions. This investment will enable us to accelerate growth, attract world-class talent, and further strengthen our RCD and clinical research efforts as we work towards improving the quality of human life through advanced healthcare solutions.”     ]]> https://biospectrumindia.com/interviews/57/26344/scaling-car-t-for-india-how-scalereadys-g-rex-grant-is-empowering-immuneel-therapeutic-.html https://biospectrumindia.com/interviews/57/26344/scaling-car-t-for-india-how-scalereadys-g-rex-grant-is-empowering-immuneel-therapeutic-.html Tue, 08 Jul 2025 00:00:00 +0530 Earlier this year, Immuneel Therapeutics achieved a significant milestone by becoming one of the first Indian companies to receive regulatory approval for the commercial sale of a CAR-T therapy. However, as patient demand surged, Immuneel faced the challenge of scaling its all-in-one manufacturing platform—known for its clinical reliability but limited in cost-effective expansion. Recognising this bottleneck, ScaleReady stepped in with its G-Rex® Grant, selecting Immuneel as a strategic partner in India. Josh Ludwig, Global Director of Commercial Operations at ScaleReady, speaks with BioSpectrum India about how this collaboration marks a turning point in industrial-scale cell and gene therapy (CGT) manufacturing in emerging markets. He delves into how the G-Rex® platform optimises production efficiency, enhances facility throughput, and lays the groundwork for more affordable access to advanced therapies across India and beyond.   What made Immuneel Therapeutics the right fit for this G-Rex® Grant, and how does it reflect ScaleReady's vision for cell and gene therapy in emerging markets like India? Immuneel has received approval from India’s regulatory bodies for commercial production and sale of a CAR-T product earlier this year. The all-in-one-manufacturing platform Immuneel has used to date, to generate the clinical data and manufacture the commercially-approved CAR-T product, is a well-known and widely disseminated all-in-one platform. However, that all-in-one-manufacturing platform is not able to scale out in a cost effective manner, and therefore Immuneel is unable to meet the patient demand for its CAR-T drug. Immuneel recognized that a change of manufacturing platform is needed to enable scaled manufacture, and that the G-Rex platform would enable it to achieve the cost-effective scale out needed meet the demand for its CAR-T drug. Hence, Immuneel Therapeutics was an ideal candidate and ultimately recipient, for a G-Rex grant. How does the G-Rex platform uniquely support industrial-scale CAR-T manufacturing, especially in cost-sensitive geographies like India? All-in-one manufacturing system have the common disadvantage of leaving portions of the system idle for long periods of time. Ultimately that limits throughput, increases cost, including a huge amount of wasted facility space. Prodigy provides a good example of all-in-one manufacturing system deficiencies. As but one example, Prodigy integrates cell separation technology that typically separates T-cells from other cells. The process takes about 2 hours. Thereafter, the T cells are moved into a chamber in the all-in-one-system where cells are typically expanded in quantity for 7 days. Meanwhile, the cell separation technology is completely idle, doing nothing but taking up space during the 7 day expansion period. In a G-Rex centric manufacturing process, no equipment remains idle. While in an all-in-one manufacturing system, the cell separation equipment sits unused while cells are in the expansion phase, a G-Rex process is able to perform T cell isolation for one patient after another, each patient taking 2 hours. With regards to patient throughput, I have included comparisons of each stage here:   During each 8-hour shift of a G-Rex process, cells can be isolated from the apheresis of 4 patients per shift using a G-Rex approach. With one 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 28 patients compared to only 1 patient for Prodigy.   With two 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 56 patients compared to only 1 patient for Prodigy.   With three 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 84 patients compared to only 1 patient for Prodigy. The advantages of G-Rex go far beyond just starting more patient manufacturing process per day in a G-Rex process versus the all-in-one-systems – it also enables a more efficient use of space. During the cell expansion stage, G-Rex can process 48 patients in the amount of space occupied by just one all-in-one manufacturing system. With a projected demand of 200 doses per day, what production and delivery efficiencies does this collaboration aim to unlock in the short and long term? We anticipate the ultimate benefit of the collaboration with be two-fold. First, the cost of CAR-T drug product manufacturing inclusive of labor, burden and material will be merely $18,000 plus the cost of the genetic engineering construct. Second, due to the much higher patient throughput per sq. ft. of facility in comparison to all-in-one-systems, the size of the manufacturing facility will be much smaller than is possible with all-in-one-systems, thereby significantly reducing up-front capital expenditures. What role do you foresee for public-private partnerships in supporting the scalability and affordability of CAR-T in India? Our knowledge in that area is evolving. We are consistently seeing that the governments of low to middle income countries are deeply interested in bringing CAR-T to their citizens, and therefore expect that governments will be eager to reduce the barriers to achieving that objective. Could you share examples from other regions or partners where the G-Rex grant has enabled successful translation of cell therapies from lab to clinic? Through the G-Rex Grant Program, we are collaborating with entities in most parts of the world, including in Asia (India, China, South Korea, Japan, Thailand, Nepal, etc.), Latin America (Mexico, Argentina, Brazil, Chile, etc.), the Middle East (Turkey, Saudi Arabia, Qatar, Israel, UAE, etc.), Oceania (Australia and New Zealand), and much of Western and Eastern Europe.  In fact, about half of our ~300 G-Rex Grants are to entities outside the United States seeking to transition to G-Rex from their current platform.  To us, this represents evidence that those emerging markets value the simplicity, cost- and space-efficiency, and flexibility that the G-Rex approach offers. Are their future plans to expand? Yes - through CellReady, the world’s only G-Rex centric manufacturing facility, we intend to adopt the lean manufacturing efficiencies that were established by entities such as McDonalds to transcend existing CGT manufacturing limitations. That will allow expansion of McDonalds style CGT manufacturing centers globally and result in worldwide dissemination of the world’s most affordable CGT drug products. (ankit.kankar@mmactiv.com ) ]]> https://biospectrumindia.com/news/57/26316/africa-asia-intercontinental-cold-chain-summit-2026-to-build-supply-chain-of-future.html https://biospectrumindia.com/news/57/26316/africa-asia-intercontinental-cold-chain-summit-2026-to-build-supply-chain-of-future.html Wed, 02 Jul 2025 00:00:00 +0530 The Africa-Asia Intercontinental Cold Chain Summit 2026 is set to be a landmark gathering that will bring together global stakeholders to deliberate and forge a shared vision for resilient, inclusive and sustainable cold chain systems across Africa and Asia. Scheduled in April at Kigali, Rwanda, the Summit will convene over 500 senior delegates from more than 30 countries, representing governments, international organizations, private industry, academia and international development agencies. This pioneering Summit is being co-hosted by two leading institutions: NAB-CCM (National Accreditation Body for Cold Chain Management) and FIRAT (Foresight Institute of Research and Development). NAB-CCM is a prominent body driving cold chain standardization, accreditation and capacity-building across sectors including agri-food and healthcare. FIRAT, on the other hand, is a future-focused think tank and implementation institute that specializes in research, policy innovation and sustainable development initiatives across Africa. Together, these two organizations are facilitating a transcontinental platform that aims to address critical cold chain gaps through collaborative action, technology transfer and institutional partnerships. A major outcome of the Summit will be the formal launch of the Africa-Asia Cold Chain Alliance to strengthen Cold Chain Community, a permanent platform for joint action, knowledge exchange, and coordinated investments. This Alliance will serve as a bridge between governments, industry, academia, social bodies and financial institutions committed to building cold chain systems that are context-sensitive, cost-effective and climate-smart. Another important milestone of the Summit will be the adoption of the Kigali Declaration on Transcontinental Cold Chain Cooperation, symbolizing a united commitment to accelerating progress through partnership. Additionally, a strategic document titled the Africa-Asia Cold Chain Roadmap (2026–2030) will be unveiled, outlining a clear framework for infrastructure development, capacity enhancement, innovation scaling and investment mobilisation over the next five years. The Summit is aiming to signing of at least ten formal partnership agreements and memorandums of understanding, alongside the announcement of several cold chain pilot projects and investment commitments across both continents. A comprehensive post-event proceedings report will be published, capturing key innovations, regional case studies and policy insights for global dissemination. This transformative event will bring together representatives from ministries of health, agriculture, trade and environment; multilateral bodies such as FAO, WHO, AfDB, ADB, and UN agencies; private sector leaders in logistics, agribusiness, pharma and refrigeration; academic and research institutions; standards agencies; and investment partners. By acting as a catalyst for innovation, coordination and investment, the Africa-Asia Intercontinental Cold Chain Summit 2026 represents a vital step toward building the supply chains of the future—resilient, equitable and capable of serving billions across two continents. Cold chains—the systems used to store and transport temperature-sensitive goods—are essential. Whether ensuring safe delivery of vaccines or preserving agricultural produce, cold chain infrastructure is key to strengthening food systems, public health, and climate resilience. However, large parts of Africa and Asia continue to face infrastructure deficits, high energy costs, inconsistent regulatory environments and limited rural connectivity, making cold chain development both a challenge and an urgent priority. The Africa-Asia Cold Chain Summit 2026 is being launched at a time when cross-border collaboration is crucial. Through a mix of high-level panels, expert dialogues, and bilateral meetings, the event will focus on strengthening policy and regulatory coherence, advancing innovative cold chain technologies, improving last-mile healthcare logistics and unlocking innovative business models and financial instruments to scale up infrastructure. These efforts are especially important in the face of global food insecurity, emerging health crises and increasing climate volatility.   Bhagwati Prasad ]]> https://biospectrumindia.com/news/57/26270/sartorius-expands-manufacturing-and-rd-capacities-for-innovative-bioprocess-solutions-in-france.html https://biospectrumindia.com/news/57/26270/sartorius-expands-manufacturing-and-rd-capacities-for-innovative-bioprocess-solutions-in-france.html Thu, 19 Jun 2025 00:00:00 +0530 The life science group Sartorius recently celebrated the completion of a multi-year capacity expansion project at the headquarters of its French sub-group Sartorius Stedim Biotech in Aubagne. The investments highlight Sartorius’ commitment to providing customers with innovative fluid management technologies. “By investing in innovation, automation, and sustainability, we are strengthening our ability to meet the evolving needs of our customers while ensuring our competitive positioning and preparing for future growth,” said René Fáber, Member of the Sartorius Executive Board and CEO of Sartorius Stedim Biotech. Sartorius almost doubled cleanroom space in Aubagne, enhancing production lines for 2D and 3D single-use bags. Certified with ISCC Plus , the site uses renewable raw materials for plastic components. In addition, the company adopted ISO 14001 to enhance the environmental performance of its operations. An automated logistics facility accelerates raw material handling, and a cross-functional lab space fosters collaboration with customers. The campus received several sustainability and biodiversity certifications. The Aubagne campus is part of Sartorius’ global expansion of research and production capacities. These investments aim to prepare the company's infrastructure for further organic growth and to strengthen the flexibility and diversification of the production network - supporting consistent delivery reliability and product quality across all regions. ]]> https://biospectrumindia.com/news/57/26235/concerns-about-appropriate-implementation-of-genai-in-healthcare-persist.html https://biospectrumindia.com/news/57/26235/concerns-about-appropriate-implementation-of-genai-in-healthcare-persist.html Thu, 12 Jun 2025 00:00:00 +0530 The new 2025 Future Ready Healthcare Survey Report from Wolters Kluwer Health, conducted in partnership with the independent marketing research firm Ipsos, reveals that while healthcare professionals widely recognise the transformative potential of generative AI (GenAI), most organisations are not yet ready to harness its full value. The survey identifies strong enthusiasm for using GenAI to address the current challenges of workforce shortages, burnout, high healthcare costs, and rising administrative burdens, as well as keen interest in leveraging GenAI to achieve the next level of innovation and efficiency across the enterprise. However, the data also shows a clear disconnect between what organisations say they want to achieve with GenAI and how prepared they are to deliver on that promise. For example, while 80% of respondents cited “optimising workflows” as a top organisational goal, only 63% feel prepared to use GenAI to do so. Nurse staffing and workforce concerns are at the top of the priority list for health GenAI applications. Leaders are focusing on the basics to keep the enterprise running, but clinical staff expect more from the GenAI revolution. Also, formal GenAI policies and guidance are scarce. As a result, concerns about appropriate implementation persist: More than half (57%) believe that overreliance on GenAI may erode clinical decision-making skills, while 55% are concerned that lack of transparency around GenAI’s potential role in making diagnoses could contribute to unclear reasoning behind patient-facing decisions.  ]]> https://biospectrumindia.com/news/57/26193/who-outlines-recommendations-to-protect-infants-against-rsv.html https://biospectrumindia.com/news/57/26193/who-outlines-recommendations-to-protect-infants-against-rsv.html Mon, 02 Jun 2025 00:00:00 +0530 The World Health Organization (WHO) has published its first-ever position paper on immunisation products to protect infants against respiratory syncytial virus (RSV) – the leading cause of acute lower respiratory infections in children globally. Every year, RSV causes about 100 000 deaths and over 3.6 million hospitalizations in children under the age of 5 years worldwide. About half of these deaths occur in infants younger than 6 months of age. The vast majority (97%) of RSV deaths in infants occur in low- and middle-income countries where there is limited access to supportive medical care, such as oxygen or hydration. Published in the Weekly Epidemiological Record (WER), the position paper outlines WHO recommendations for two immunisation products: a maternal vaccine RSVpreF that can be given to pregnant women in their third trimester to protect their infant and a long-acting monoclonal antibody nirsevimab that can be administered to infants from birth, just before or during the RSV season. WHO recommends that infants receive a single dose of nirsevimab right after birth or before being discharged from a birthing facility. If not administered at birth, the monoclonal antibody can be given during the baby's first health visit. Both products were recommended by the Strategic Advisory Group of Experts on Immunisation (SAGE) for global implementation in September 2024. In addition, the maternal vaccine received WHO prequalification in March 2025, allowing it to be purchased by UN agencies. ]]> https://biospectrumindia.com/news/57/26124/us-fda-clears-first-blood-test-for-diagnosing-alzheimers-disease.html https://biospectrumindia.com/news/57/26124/us-fda-clears-first-blood-test-for-diagnosing-alzheimers-disease.html Sat, 17 May 2025 00:00:00 +0530 The US Food and Drug Administration (FDA) has cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (by Fujirebio Diagnostics, Inc.) is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio measures two proteins, pTau217 and β-amyloid 1-42, found in human plasma, a component of blood, and calculates the numerical ratio of the levels of the two proteins. This ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan. Similar FDA-authorised/cleared tests, one from the same company as this new test, are used with cerebrospinal fluid (CSF) samples, which are collected through an invasive lumbar puncture, also called a spinal tap. This new Lumipulse test only requires a simple blood draw, making it less invasive and much easier for patients to access. The new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired. The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information.  ]]> https://biospectrumindia.com/news/57/26114/sanofi-to-invest-at-least-20-b-in-the-us-through-2030-for-rd-and-manufacturing.html https://biospectrumindia.com/news/57/26114/sanofi-to-invest-at-least-20-b-in-the-us-through-2030-for-rd-and-manufacturing.html Thu, 15 May 2025 00:00:00 +0530 French pharmaceutical firm Sanofi has announced its intention to invest at least $20 billion in the United States (US) through 2030. The expected investment includes a significant increase in research and development (R&D) spending and the allocation of billions of dollars to US manufacturing. The announcement comes as Sanofi prepares for the potential launch of numerous new first- or best-in-class medicines across many indications in the coming years, aiming to improve the health of countless Americans. Work being done within the United States by Sanofi and by the hundreds of companies it supports is anticipated to contribute to job creation and innovation in numerous communities that are home to Sanofi and its partners, while also helping to enhance the US supply chain. Paul Hudson, Chief Executive Officer said, "Sanofi's 13,000 US-based employees are pioneering the research and development of first- and best-in-class medicines across numerous therapeutic areas. Our expected investments in the US will be substantial and will help ensure the production of key medicines in the US." Of the total investment, Sanofi will substantially increase spending in the US on R&D to accelerate its science. The company also plans to expand its US manufacturing capacity, both through direct investments in Sanofi sites, as well as through partnerships with other domestic manufacturers, to help ensure the production of medicines in the US. While Sanofi's investment decisions will be adjusted as the external environment continues to evolve, the planned investments are expected to create a significant number of high-paying jobs in multiple states in the coming years. ]]> https://biospectrumindia.com/news/57/26105/roche-announces-550-m-investment-to-expand-diagnostics-manufacturing-hub-in-us.html https://biospectrumindia.com/news/57/26105/roche-announces-550-m-investment-to-expand-diagnostics-manufacturing-hub-in-us.html Tue, 13 May 2025 00:00:00 +0530 Roche has announced plans to invest up to $550 million in its Diagnostics site in Indianapolis, US by 2030. The site will become a major hub for the manufacturing of Roche's continuous glucose monitoring (CGM) systems – marking a new milestone in Roche's long history of revolutionizing healthcare across the globe. Indianapolis serves as the North American headquarters for Roche Diagnostics, part of the Roche Group. "The challenges of diabetes are pervasive, with millions of Americans living with the constant vigilance and countless daily decisions the disease requires," said Brad Moore, President and CEO of Roche Diagnostics North America. "By expanding our manufacturing capabilities in Indianapolis, we ensure reliable access to innovative monitoring solutions for individuals living with diabetes in the US and worldwide." The Indianapolis campus houses key operations, including US research and development, laboratories, manufacturing, distribution, IT and administrative functions. It currently produces approximately 5.2 billion Accu-Chek diabetes test strips annually and serves as one of two global distribution hubs focused on serving the US market and supporting distribution to 53 countries worldwide. Building on more than $800 million in US investments made at Roche US sites since 2015, this new commitment reinforces Roche's longterm dedication to US operations and highlights the country's central role in the company's global strategy. The expansion is expected to generate hundreds of highly-skilled manufacturing jobs and thousands of construction jobs, providing a significant boost to Indiana's economy. It will also enhance domestic production capabilities and reduce dependency on imports – aligning with national efforts to strengthen local manufacturing. ]]> https://biospectrumindia.com/news/57/25993/firat-and-nab-ccm-collaborate-to-transform-africas-cold-chain-landscape.html https://biospectrumindia.com/news/57/25993/firat-and-nab-ccm-collaborate-to-transform-africas-cold-chain-landscape.html Tue, 15 Apr 2025 00:00:00 +0530 The Foresight Institute of Research and Translation (FIRAT), Rwanda and the National Accreditation Body for Cold Chain Management (NAB-CCM), India have signed a Memorandum of Understanding (MoU) to strengthen cold chain systems across Africa. Under this strategic five-year partnership, FIRAT will serve as NAB-CCM’s exclusive implementation partner on the continent. This will help in leading efforts to enhance infrastructure, professional training, facility accreditation, Industry outreach and research initiatives in public health. “This collaboration brings awareness and implementation of cold chain standards to Africa’s doorsteps. By combining NAB-CCM’s global expertise with our local insight, we’re creating resilient, future-ready solutions tailored to African realities,” said Kudirat Adedeji, Managing Director of FIRAT.  Avinash Verma, Founder of NAB-CCM, added, “Our mission is to empower communities through accredited cold chain professionals. Partnering with FIRAT allows us to scale that mission, advancing sustainability, health and education across Africa.” FIRAT is dedicated to advancing cutting-edge research, translating innovative findings into real-world solutions, and fostering innovation across diverse disciplines. Its mission is to drive the sustainable development of Nigeria, Rwanda, and African nations, empowering communities and shaping a brighter future through knowledge, collaboration, and transformative impact. NAB-CCM is the first-of-its-kind ecosystem dedicated to advancing cold chain management. It is a collaborative initiative driven by partnerships between academia, industry and government, focused on providing education, training, awareness, certification, incubation and accreditation within the cold chain community. NAB-CCM ensures that businesses and its workforce involved in manufacturing, storage, transportation and handling of temperature-sensitive goods are well-trained and audited for best practices.   Bhagwati Prasad  ]]> https://biospectrumindia.com/news/57/25984/who-unveils-first-ever-guidelines-on-meningitis-diagnosis-and-treatment.html https://biospectrumindia.com/news/57/25984/who-unveils-first-ever-guidelines-on-meningitis-diagnosis-and-treatment.html Mon, 14 Apr 2025 00:00:00 +0530 The World Health Organization (WHO) has published its first-ever global guidelines for meningitis diagnosis, treatment and care, aiming to speed up detection, ensure timely treatment, and improve long-term care for those affected. By bringing together the latest evidence-based recommendations, the guidelines provide a critical tool for reducing deaths and disability caused by the disease. Despite effective treatments and vaccines against some forms of meningitis, the disease remains a significant global health threat. Bacterial meningitis is the most dangerous form and can become fatal within 24 hours. Many pathogens can cause meningitis with an estimated 2.5 million cases reported globally in 2019. This includes 1.6 million cases of bacterial meningitis which resulted in approximately 240 000 deaths. The new guidelines provide evidence-based recommendations for the clinical management of children over one month of age, adolescents, and adults with acute community-acquired meningitis. They address all aspects of clinical care, including diagnosis, antibiotic therapy, adjunctive treatment, supportive care, and management of long-term effects.  Given the similarities in clinical presentation, diagnosis and management approaches across different forms of acute community-acquired meningitis, the guidelines address both bacterial and viral causes. The guidelines are intended for use by health-care professionals in first- and second-level facilities, including emergency, inpatient, and outpatient services. Policymakers, health planners, academic institutions, and civil society organizations can also use them to inform capacity-building, education, and research efforts. ]]> https://biospectrumindia.com/news/57/25926/who-issues-first-ever-reports-on-tests-and-treatments-for-fungal-infections.html https://biospectrumindia.com/news/57/25926/who-issues-first-ever-reports-on-tests-and-treatments-for-fungal-infections.html Wed, 02 Apr 2025 00:00:00 +0530 World Health Organization (WHO) has published its first-ever reports addressing the critical lack of medicines and diagnostic tools for invasive fungal diseases, showing the urgent need for innovative research and development (R&D) to close these gaps. The fungi in the top ‘critical priority’ category of the WHO’s fungal priority pathogens list (FPPL) are deadly, with mortality rates reaching as high as 88%. Advancements in treatments mean that more people are likely to be living with immunocompromised conditions, which also could mean increases in cases of invasive fungal diseases. This is a complex challenge to manage due to inaccessibility of diagnostic tools, limited availability of antifungal medicines, and a slow and complex R&D process for new treatments. WHO’s report on antifungal drugs highlights that, in the past decade, only four new antifungal drugs have been approved by regulatory authorities in the United States of America, the European Union or China. Currently, nine antifungal medicines are in clinical development to use against the most health-threatening fungi, as detailed in the FPPL. However, only three candidates are in phase 3, the final stage of clinical development, meaning few approvals are expected within the next decade. The new diagnostics report shows that while commercially available tests exist for fungal priority pathogens, these rely on well-equipped laboratories and trained staff, which means that most people in in low- and middle-income countries (LMICs) do not benefit from them. All countries, but particularly LMICs, need faster, more accurate, cheaper and easier testing for a broad range of fungal priority pathogens, including diagnostic tools that can be used at or near point-of-care. ]]> https://biospectrumindia.com/news/57/25906/who-guidance-calls-for-urgent-transformation-of-mental-health-policies.html https://biospectrumindia.com/news/57/25906/who-guidance-calls-for-urgent-transformation-of-mental-health-policies.html Sat, 29 Mar 2025 00:00:00 +0530 The World Health Organization (WHO) has launched new guidance to help all countries reform and strengthen mental health policies and systems. Mental health services worldwide remain underfunded, with major gaps in access and quality. In some countries, up to 90% of people with severe mental health conditions receive no care at all, while many existing services rely on outdated institutional models that fail to meet international human rights standards. The guidance provides a clear framework to transform mental health services in line with the latest evidence and international human rights standards, ensuring quality care is accessible to all. It identifies five key policy areas requiring urgent reform: leadership and governance, service organization, workforce development, person-centred interventions, and addressing social and structural determinants of mental health. The guidance was developed in consultation with global experts, policymakers and individuals with lived experience. The policy guidance also builds on the resources, guidance and tools developed under the WHO QualityRights initiative, aiming to promote a person-centred, recovery-oriented and rights-based approach to mental health.  ]]> https://biospectrumindia.com/news/57/25855/indegene-expands-presence-in-europe-with-new-centre-in-london.html https://biospectrumindia.com/news/57/25855/indegene-expands-presence-in-europe-with-new-centre-in-london.html Wed, 19 Mar 2025 00:00:00 +0530 Bengaluru-based Indegene, a digital-first life sciences commercialisation company, has announced the launch of a new centre in London. This aligns with the company’s long-term growth strategy in Europe, reiterating its commitment to enable life sciences clients in the region to be future-ready. Indegene’s Europe-based clients can now benefit from this centre as a strategic hub for consulting and commercialisation solutions and modernise their operations with an artificial intelligence (AI)-first approach. The company is strengthening its existing employee base in the region, with skillsets spanning a wide range of areas - consulting, creative, data and analytics, engineering and customer experience. “London is a vital healthcare, technology and business innovation hub, with a great talent pool - making it an important market for life sciences companies in the region”, said Manish Gupta, Chairman and CEO, Indegene. “With our new centre, we are better positioned to dial up innovation and engagement with our clients here and help them holistically improve their commercialisation processes with an AI-first approach and stay ahead of the curve.” Indegene launched a new entity in Spain last month. The company already has a significant presence in Europe, with centers in Germany, Ireland, and Switzerland. Last year, Indegene acquired Trilogy Writing & Consulting GmbH (Trilogy), a global provider of specialty medical writing capabilities with teams spread across UK, Germany and US. In 2019, Indegene acquired DT Associates (now DT Consulting), a consulting services company in the UK that supports clients in the healthcare and life sciences space. The world's top 20 global biopharma companies, including many from Europe, trust Indegene for their commercialisation needs.    ]]> https://biospectrumindia.com/news/57/25817/msd-unveils-new-facility-in-us-to-increase-vaccine-production-capacity.html https://biospectrumindia.com/news/57/25817/msd-unveils-new-facility-in-us-to-increase-vaccine-production-capacity.html Tue, 11 Mar 2025 00:00:00 +0530 Merck, known as MSD outside of the United States and Canada, has announced the opening of a new, $1 billion, 225,000-square-foot facility dedicated to vaccine manufacturing at its Durham, North Carolina site in the US. This expansion of the Durham plant is a crucial component of the more than $12 billion Merck has invested toward US capital investment since 2018 focused on expanding domestic manufacturing and research and development capabilities and creating new jobs in the US, with another $8 billion of US capital investment expected by 2028. "Expanding our state-of-the-art manufacturing facility in Durham marks a significant milestone in our efforts to strengthen our production and manufacturing capabilities in the US," said Sanat Chattopadhyay, executive vice president and president, Merck Manufacturing Division. "The cutting-edge technologies employed here empower our workforce and underscore our leadership in innovation to support patients everywhere." The state-of-the-art manufacturing facility leverages best practices and learnings from across the Merck Manufacturing Division network as well as new technical and digital capabilities including data analytics, generative AI, 3D printing and a training centre equipped with a digital twin – a virtual model of the shop floor manufacturing process systems – to accelerate new employee training and simulate process changes before they are implemented. ]]> https://biospectrumindia.com/news/57/25730/biological-e-inks-strategic-partnership-with-bavarian-nordic-to-expand-access-of-chikungunya-vaccine.html https://biospectrumindia.com/news/57/25730/biological-e-inks-strategic-partnership-with-bavarian-nordic-to-expand-access-of-chikungunya-vaccine.html Tue, 25 Feb 2025 00:00:00 +0530 Hyderabad-based Biological E. Limited (BE) has announced a strategic partnership with Bavarian Nordic A/S (OMX: BAVA) to expand access to Bavarian Nordic’s Chikungunya Vaccine in low- and middle-income countries (LMIC). This partnership comprises a technology transfer of the current drug product manufacturing process for the Chikungunya Vaccine, with the option to transfer the drug substance process at a later stage. To that effect, the companies have reached an agreement to expand their capacity to provide future supplies to endemic low- and middle-income countries. The initial technology transfer would be followed by regulatory approval applications and commencement of commercial manufacturing thereafter. BE's existing facilities in Genome Valley, Hyderabad will be augmented to make the Chikungunya Vaccine. The manufacturing of Chikungunya Vaccine at BE is expected to generate up to 300 new jobs. This agreement has come about as Bavarian Nordic continues to explore opportunities in line with its strategy to provide global access to its Chikungunya Vaccine via partners for markets outside the US and Europe. In February 2025, the US Food and Drug Administration (FDA) approved VIMKUNYA (CHIKV VLP) as the first chikungunya vaccine for persons as young as 12 years. An EU approval is pending decision from the European Commission following a recommendation in January 2025 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).   ]]> https://biospectrumindia.com/news/57/25732/thermo-fisher-scientific-buys-solventums-purification-and-filtration-biz-for-4-1-b.html https://biospectrumindia.com/news/57/25732/thermo-fisher-scientific-buys-solventums-purification-and-filtration-biz-for-4-1-b.html Tue, 25 Feb 2025 00:00:00 +0530 American firm Thermo Fisher Scientific Inc. has entered into a definitive agreement with Solventum to acquire its Purification & Filtration business for approximately $4.1 billion in cash. Solventum’s Purification & Filtration business is a leading provider of purification and filtration technologies used in the production of biologics as well as in medical technologies and industrial applications. The Solventum business operates globally with sites across the Americas, Europe, the Middle East, Africa, and the Asia-Pacific region, and has approximately 2,500 colleagues. In 2024, Solventum’s Purification & Filtration business generated approximately $1 billion of revenue. Solventum’s Purification & Filtration business is highly complementary to Thermo Fisher’s bioproduction business. Thermo Fisher has a leading portfolio of offerings in cell culture media and single-use technologies. Solventum’s innovative filtration portfolio broadens Thermo Fisher’s capabilities in the development and manufacturing of biologics, spanning upstream and downstream workflows. The transaction is expected to be completed by the end of 2025 and is subject to customary closing conditions and regulatory approvals. Once the transaction closes, Solventum’s Purification & Filtration business will become part of Thermo Fisher's Life Sciences Solutions segment. Thermo Fisher expects to realise approximately $125 million of adjusted operating income from revenue and cost synergies by year five following the close. ]]> https://biospectrumindia.com/news/57/25727/world-health-organization-releases-first-technical-brief-on-encephalitis.html https://biospectrumindia.com/news/57/25727/world-health-organization-releases-first-technical-brief-on-encephalitis.html Mon, 24 Feb 2025 00:00:00 +0530 World Health Organization (WHO) and Encephalitis International have launched a critical Technical Brief on Encephalitis in London, which identified encephalitis (infectious and autoimmune) as an increasing global threat making it an urgent public health priority. The technical brief outlines the worldwide burden of encephalitis, key actions required to improve prevention, data collection and surveillance, diagnostics and treatment, after care and awareness, and research innovation. “Encephalitis is an increasing global threat. Without urgent attention and investment we will see more needless death and disability from the condition”, said Dr Ava Easton, Chief Executive, Encephalitis International. Encephalitis, a condition caused by infectious and autoimmune causes in individuals, is an often-deadly brain inflammation that can affect anyone regardless of age, sex or ethnicity. It can lead to severe neurological consequences, including permanent brain injury. It arises either from an infection invading the brain, such as Japanese Encephalitis, Scrub Typhus that are more prevalent in India or from the immune system mistakenly attacking the brain (autoimmune encephalitis). WHO and Encephalitis International urge policymakers, public health professionals, healthcare providers, and researchers to engage with this brief and implement its recommendations to save lives and reduce disability associated with encephalitis. According to a recent survey in 2024, 1,548 Japanese Encephalitis cases were reported from 24 states and Union Territories. Dr Ava Easton, added, "The WHO's recognition of encephalitis as a growing global threat marks a pivotal moment. We must act decisively to improve prevention, diagnosis, and care for those affected. Encephalitis disproportionately affects individuals in low-to-middle-income countries (LMIC), where healthcare resources are often limited. To support the implementation of the technical brief's recommendations, Encephalitis International has launched the "Countdown to Change" pilot appeal, aiming to raise £50,000 by 22 February 2025. Donations will fund initiatives to improve diagnostics, treatment, and aftercare for those affected globally.” “The WHO Encephalitis technical brief aims to focus attention on the increasing global threat of encephalitis, prevention strategies and existing gaps in the diagnosis, treatment and care which will help enable more people affected to receive the treatment and care they need to live fulfilling and healthy lives.” said Dr Tarun Dua, Brain Health Unit, Department of Mental Health, Brain Health and Substance Use.   WHO Technical Brief Conclusion: Encephalitis is an increasing global threat with an urgent public health imperative, and represents a significant yet under-recognized global health challenge, marked by substantial mortality, disability burden, and economic impacts. Compounded by large population densities in resource-limited settings, proximity to animals through human encroachment, intensive farming practices, vaccine hesitancy, climate change, urbanization, and global trade, encephalitis is primed to further expand its reach. Trends of emerging and re-emerging viral outbreaks of encephalitis are increasing and identification and recognition of autoantibodies are contributing to the expanding number of autoimmune encephalitis cases. The true global burden of encephalitis is currently unknown – particularly in LMIC, however, the heavy costs associated with neurological sequelae and the impact on families are undisputed and increasingly being recognized. Central to reducing the burden of encephalitis are vaccination strategies, the establishment of robust surveillance systems, the strengthening of health systems. Progress in these areas should be underpinned by quality medical and public health research and the generation of new advances. Public awareness and education also play a pivotal role in reducing encephalitis deaths and disability along with increasing understanding and empathy for the condition and those affected, along with preventative measures. Prioritising encephalitis within global and national health agendas, mobilising resources for targeted interventions, and fostering collaboration among stakeholders can significantly reduce the potential global threat and disease burden. Together, these efforts promise to improve health outcomes, enhance the quality of life for those affected, and build resilient health systems capable of responding to this growing public health challenge.   Symptoms of encephalitis vary but can include: Infectious encephalitis (decreased or altered level of consciousness, personality/ behavioural change, fever and a headache); Autoimmune encephalitis (memory problems, psychiatric symptoms, decreased or altered level of consciousness and personality change).   Death rates following encephalitis can be high.  Survivors may experience long-term challenges such as cognitive impairments, personality changes, epilepsy, and fatigue, making reintegration into daily life difficult. Treatment and cure depend on the underlying cause and may include antiviral medications for autoimmune causes and supportive care to manage long-term symptoms. Encephalitis affects three people every minute globally, yet almost 77% of the population do not know what it is. The lack of awareness leads to delay in diagnosis and treatment, and poorer patient outcomes. By implementing the WHO's recommendations, we can work towards reducing the global impact of this debilitating condition.     ]]> https://biospectrumindia.com/news/57/25643/indegene-expands-footprint-in-europe-launches-new-entity-in-spain-.html https://biospectrumindia.com/news/57/25643/indegene-expands-footprint-in-europe-launches-new-entity-in-spain-.html Thu, 06 Feb 2025 00:00:00 +0530 Bengaluru-based Indegene, a digital-first life sciences commercialisation company, has announced the launch of a new entity in Spain. This move marks a key step in the company’s ongoing strategic expansion in Europe and aligns with Indegene’s commitment to helping life sciences companies accelerate AI-driven innovation and make their operations future-ready. Indegene’s new Spain entity will serve as a key delivery hub for its Europe-based clients, helping them drive hyper-personalisation and significantly elevate healthcare professional (HCP) and patient experience. The company is strengthening its already existing employee base in Spain, with capabilities in medical affairs, data and analytics, creative design, engineering, digital marketing and customer experience. Indegene already has a significant presence in Europe, with centers in the UK, Germany, Ireland and Switzerland. Last year, Indegene acquired Trilogy Writing & Consulting GmbH (Trilogy), a global provider of specialty medical writing capabilities across clinical, regulatory, safety and medical content to life sciences companies. In 2019, Indegene acquired DT Associates (now DT Consulting), a consulting services company in the UK that supports clients in the healthcare and life sciences space. Indegene supports many leading life sciences clients in the region in various ways across the commercialization value chain. “Growing R&D investments, a thriving life sciences innovation ecosystem and a high-quality talent pool make Spain a vital market and talent hub for life sciences companies in Europe”, said Manish Gupta, Chairman and CEO, Indegene. “With our new entity in Spain, we can co-innovate and collaborate much better with clients, helping them use data and AI more effectively to modernize commercialisation processes and fast-track business transformation.” ]]> https://biospectrumindia.com/news/57/25602/lupin-and-avas-launch-namuscla-in-italy.html https://biospectrumindia.com/news/57/25602/lupin-and-avas-launch-namuscla-in-italy.html Tue, 28 Jan 2025 00:00:00 +0530 Global pharma major Lupin, based in Mumbai, and Avas Pharmaceuticals SRL have announced the launch of Lupin’s orphan drug NaMuscla (mexiletine) in Italy. Avas will commercialise NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. NaMuscla is the first and only licensed product for this indication. NDM disorders are a group of rare, inherited neuromuscular disorders which is characterised by the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients. NaMuscla, which has been designated orphan drug status, received EU marketing authorisation in December 2018. Under the terms of the agreement, Avas will initially commercialise NaMuscla as a Class C (Tier 2), while Lupin negotiates with AIFA (Agenzia Italiana del Farmaco) for the reimbursement of the product in Italy. This will ensure consistent access to NaMuscla for patients in Italy, leveraging the established supply network that already serves patients across Germany, France, Spain, Austria, Norway, Sweden, and the UK.   ]]> https://biospectrumindia.com/news/57/25571/united-states-intends-to-withdraw-from-world-health-organisation.html https://biospectrumindia.com/news/57/25571/united-states-intends-to-withdraw-from-world-health-organisation.html Tue, 21 Jan 2025 00:00:00 +0530 The United States has announced its intention to withdraw from World Health Organisation (WHO). US had raised a withdrawal notification from the WHO in 2020 due to the organisation’s mishandling of the COVID-19 pandemic that arose out of Wuhan, China, and other global health crises, its failure to adopt urgently needed reforms, and its inability to demonstrate independence from the inappropriate political influence of WHO member states.   In addition, the WHO continues to demand unfairly onerous payments from the United States, far out of proportion with other countries’ assessed payments.  China, with a population of 1.4 billion, has 300 percent of the population of the United States, yet contributes nearly 90 percent less to the WHO. While withdrawal is in progress, the Secretary of State will cease negotiations on the WHO Pandemic Agreement and the amendments to the International Health Regulations, and actions taken to effectuate such agreement and amendments will have no binding force on the United States, as stated by the US government. The United States was a founding member of WHO in 1948 and has participated in shaping and governing WHO’s work ever since, alongside 193 other Member States, including through its active participation in the World Health Assembly and Executive Board.  ]]> https://biospectrumindia.com/news/57/25556/who-launches-1-5-b-health-emergency-appeal.html https://biospectrumindia.com/news/57/25556/who-launches-1-5-b-health-emergency-appeal.html Fri, 17 Jan 2025 00:00:00 +0530 Conflict, climate change, epidemics, and displacement are converging to create an unparalleled global health crisis, with 305 million people in urgent need of humanitarian assistance in 2025. In response, the World Health Organization (WHO) is calling for $1.5 billion for its 2025 Health Emergency Appeal (HEA), to support life-saving health interventions worldwide. The appeal, launched by WHO Director-General, Dr Tedros Adhanom Ghebreyesus, outlines the critical priorities and resources needed to address 42 ongoing health emergencies, including 17 Grade 3 crises – the most severe emergencies requiring the highest level of response. With health systems stretched to their limits and global financial resources dwindling, $1.5 billion are needed to help people facing the most difficult situations The Appeal highlights four key challenges facing the world currently: climate change, conflict, displacement and disease outbreaks. These are responsible for fueling deeper, longer lasting health crises and putting the world’s most vulnerable at greater risk. The appeal further details the priorities and financial needs for each of the Grade 3 emergencies that WHO is responding to. With the support of donors and partners, WHO aims to fulfill its unique role in health emergencies, while upholding the principles of international humanitarian law, ensuring that no one is left behind even in the most challenging circumstances. WHO is committed to delivering emergency health assistance, including in conflict zones such as the Democratic Republic of the Congo, the occupied Palestinian territory and Sudan. ]]> https://biospectrumindia.com/news/57/25479/world-health-organization-who-academy-opens-in-lyon-france.html https://biospectrumindia.com/news/57/25479/world-health-organization-who-academy-opens-in-lyon-france.html Fri, 20 Dec 2024 00:00:00 +0530 The World Health Organization (WHO) Academy in Lyon, France, officially opened its doors recently with a high-profile inauguration ceremony. The event was attended by WHO Director-General Dr Tedros Adhanom Ghebreyesus; French President Emmanuel Macron, alongside dozens of health ministers, international representatives, donors, and local French partners. The WHO Academy is a revolutionary project which will contribute to a better trained health workforce around the world, through the most ambitious lifelong training programme ever designed in the field of public health. More concretely, through trainings delivered in Lyon and everywhere in the world on its online platform, it will give access to the critical skills and competencies as well as to the latest knowledge and know-how in terms of public health to health professionals, policy-makers, and WHO’s own workforce. Owing to partnerships built with the best academic and research institutes in public health around the globe, the WHO Academy intends to address identified weaknesses in health systems – the first of which being the growing global shortage of health and care workers, projected to reach 10 million by 2030, but also the widening gap in terms of access to the latest research and innovation. The majority of this shortfall will be felt in low- and middle-income countries, particularly in Africa. With the view to build and share access to the most advanced technology for health and care and research and development in the field of health, including AI, the Academy will bring additional capacity and efficiency directly to health systems. The WHO Academy’s new state-of-the-art campus spans 11 000 square meters and includes: twenty-two training rooms, two distance-learning rooms, a simulation centre, an emergency operations centre, a TV recording studio, a modern auditorium and a library. The Academy also has an online learning platform that democratises access to world-class health education. This platform features free, cutting-edge courses on priority health topics, ensuring that professionals across the globe can access high-quality training, regardless of their location.   ]]> https://biospectrumindia.com/news/57/25247/milliporesigma-invests-290-m-in-new-biosafety-testing-facility-in-us.html https://biospectrumindia.com/news/57/25247/milliporesigma-invests-290-m-in-new-biosafety-testing-facility-in-us.html Wed, 09 Oct 2024 19:00:00 +0530 MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, has opened its new €290 million biosafety testing facility in Rockville, Maryland, USA. Biosafety testing and analytical development are fundamental components of drug development and commercialisation for traditional and novel modalities. Global demand for these services is growing at a double-digit rate. The 23,000-square-meter facility will house biosafety testing, analytical development, and cell banking manufacturing services. It consolidates labs currently spread across four buildings into a single facility. This will increase collaboration between scientists and enable a higher level of automation and digitalization to increase Right First Time (RFT). The Life Science business of Merck KGaA, Darmstadt, Germany, has made significant investments over the last five years to expand its biosafety testing capabilities for clients across the globe. The company’s global biosafety testing network includes sites in Shanghai, China; Singapore; Stirling and Glasgow, UK; and Rockville, MD, USA. The new site will feature advanced testing capabilities, including a rapid methods package, designed to accelerate virus testing of bulk harvest material. This package is the first to include the Blazar CHO Animal Origin Free (AOF) panel, a targeted molecular method for detecting virus families. By combining the Blazar CHO AOF panel with assays for mycoplasma, sterility, and retrovirus-like particle detection, test results can be obtained in just 14 days, compared to 35 days with traditional assay methods. ]]> https://biospectrumindia.com/news/57/25236/world-health-organisation-adds-hpv-vaccine-for-single-dose-use.html https://biospectrumindia.com/news/57/25236/world-health-organisation-adds-hpv-vaccine-for-single-dose-use.html Mon, 07 Oct 2024 00:00:00 +0530 The World Health Organisation (WHO) has announced that a fourth WHO-prequalified human papillomavirus (HPV) vaccine product, Cecolin (developed by Xiamen Innovax Biotech) has been confirmed for use in a single-dose schedule. The decision is made based on new data on the product that fulfilled the criteria set out in the WHO’s 2022 recommendations for alternative, off-label use of HPV vaccines in single-dose schedules. This important milestone will contribute to improving sustainable supply of HPV vaccines, allowing more girls to be reached with the vaccines that prevent cervical cancer. More than 95% of the 660,000 cervical cancer cases occurring globally each year are caused by HPV. A growing number of vaccine products initially prequalified for use in a 2-dose schedule can now be used in a single-dose schedule. The single-dose use indication for this additional vaccine, Cecolin, is incorporated into the second edition of WHO’s technical document on considerations for HPV vaccine product choice. A further piece of news is the WHO prequalification on 2 August 2024, of an additional HPV vaccine, Walrinvax (manufactured by Yuxi Zerun), making it the fifth product available on the global market. This will contribute to a more sustainable supply of HPV vaccines, enabling more girls to receive the vaccine.  ]]> https://biospectrumindia.com/news/57/25227/who-approves-first-mpox-diagnostic-test-by-abbott-for-emergency-use-.html https://biospectrumindia.com/news/57/25227/who-approves-first-mpox-diagnostic-test-by-abbott-for-emergency-use-.html Fri, 04 Oct 2024 00:00:00 +0530 The World Health Organisation (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, an important step in improving global access to mpox testing. The approval for emergency use of the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., will be pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply. Early diagnosis of mpox enables timely treatment and care, and control of the virus. Limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus. In 2024, over 30, 000 suspected cases have been reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. In the Democratic Republic of the Congo, only 37% of suspected cases have been tested this year. The presence of the monkeypox virus is confirmed by nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), as stated in the WHO Interim Guidance on Diagnostic testing for the monkeypox virus (MPXV). And the recommended specimen type for diagnostic confirmation of monkeypox virus (MPXV) infection in suspected cases is lesion material. The Alinity m MPXV assay is a real-time PCR test that enables detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for use by trained clinical laboratory personnel who are proficient in PCR techniques and IVD procedures. By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively.   ]]> https://biospectrumindia.com/news/57/25117/who-launches-global-framework-for-understanding-origins-of-new-or-re-emerging-pathogens.html https://biospectrumindia.com/news/57/25117/who-launches-global-framework-for-understanding-origins-of-new-or-re-emerging-pathogens.html Fri, 06 Sep 2024 00:00:00 +0530 With the support of the Scientific Advisory Group for the Origins of Novel Pathogens (SAGO), the World Health Organization (WHO) has published a global framework to help Member States comprehensively investigate the origins of new and re-emerging pathogens. While there are a number of tools available for investigating infectious disease outbreaks, this is the first unified, structured approach to investigating the origins of a novel pathogen. This framework aims to fill that gap by providing a comprehensive set of scientific investigations and studies. It is the first version of a “how-to” guide that will be updated as and when needed, based on feedback from users. The WHO global framework outlines scientific investigations and studies for six technical elements: Early investigations of the first identified cases/ clusters / outbreaks to identify potential sources of exposure, collection of samples at the source, define the characteristics of the novel pathogen involved for establishment of diagnostic assays. Human studies: to understand the epidemiology including clinical presentation, modes of transmission, pathology and earliest presence in syndromic surveillance samples.  Human/Animal interface studies to identify potential animal reservoirs, intermediate hosts and reverse zoonoses. studies to identify insect vectors or other sources of infection as well as earliest presence in the environment. Genomics and Phylogenetics studies to identify precursor strains, genomic characteristics, evolution in intermediate hosts and humans and spatial distribution over time. Biosafety/Biosecurity studies to determine if a breach in laboratory or research activities may have been associated with the first cases. The WHO Global framework has been designed as a resource for scientists, researchers, public health authorities, and investigators in Member States. It provides guidance when and how to initiate such multi-disciplinary investigations and offers recommendations to countries on the capacities and tools needed to successfully implement them.    ]]> https://biospectrumindia.com/news/57/25082/who-launches-global-strategic-preparedness-and-response-plan-to-contain-mpox-outbreak.html https://biospectrumindia.com/news/57/25082/who-launches-global-strategic-preparedness-and-response-plan-to-contain-mpox-outbreak.html Thu, 29 Aug 2024 00:00:00 +0530 The World Health Organization (WHO) has launched a global Strategic Preparedness and Response Plan to stop outbreaks of human-to-human transmission of mpox through coordinated global, regional, and national efforts. This follows the declaration of a public health emergency of international concern by the WHO Director-General on 14 August. The current plan is subject to inputs by Member States, who were briefed on the plan on Friday, 23 August. The plan covers the six-month period of September 2024-February 2025, envisioning a $135 million funding need for the response by WHO, Member States, partners including Africa Centres for Disease Control and Prevention (Africa CDC), communities, and researchers, among others. A funding appeal for what WHO needs to deliver on the plan will be launched shortly. The plan, which builds on the temporary recommendations and standing recommendations issued by the WHO Director-General, focuses on implementing comprehensive surveillance, prevention, readiness and response strategies; advancing research and equitable access to medical countermeasures like diagnostic tests and vaccines; minimising animal-to-human transmission; and empowering communities to actively participate in outbreak prevention and control. Strategic vaccination efforts will focus on individuals at the highest risk, including close contacts of recent cases and healthcare workers, to interrupt transmission chains. At the global-level, the emphasis is on strategic leadership, timely evidence-based guidance, and access to medical countermeasures for the most at-risk groups in affected countries.   ]]> https://biospectrumindia.com/news/57/24987/cepi-and-who-urge-broader-research-strategy-for-countries-to-prepare-for-next-pandemic.html https://biospectrumindia.com/news/57/24987/cepi-and-who-urge-broader-research-strategy-for-countries-to-prepare-for-next-pandemic.html Sat, 03 Aug 2024 00:00:00 +0530 The Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO) have called on researchers and governments to strengthen and accelerate global research to prepare for the next pandemic. They emphasised the importance of expanding research to encompass entire families of pathogens that can infect humans–regardless of their perceived pandemic risk–as well as focusing on individual pathogens. The approach proposes using prototype pathogens as guides or pathfinders to develop the knowledge base for entire pathogen families. At the Global Pandemic Preparedness Summit 2024 held in Rio de Janeiro, Brazil, WHO R&D Blueprint for Epidemics issued a report urging a broader-based approach by researchers and countries. This approach aims to create broadly applicable knowledge, tools and countermeasures that can be rapidly adapted to emerging threats. This strategy also aims to speed up surveillance and research to understand how pathogens transmit and infect humans and how the immune system responds to them. The prioritisation work underpinning the report involved over 200 scientists from more than 50 countries, who evaluated the science and evidence on 28 virus families and one core group of bacteria, encompassing 1652 pathogens. The epidemic and pandemic risk was determined by considering available information on transmission patterns, virulence, and availability of diagnostic tests, vaccines, and treatments.   ]]> https://biospectrumindia.com/news/57/24964/new-global-initiative-to-advance-mrna-vaccine-development-against-human-avian-influenza-h5n1.html https://biospectrumindia.com/news/57/24964/new-global-initiative-to-advance-mrna-vaccine-development-against-human-avian-influenza-h5n1.html Tue, 30 Jul 2024 00:00:00 +0530 A new project aiming to accelerate the development and accessibility of human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates for manufacturers in low- and middle-income countries has been launched. The Argentinian manufacturer Sinergium Biotech will lead this effort leveraging the World Health Organization (WHO) and the Medicines Patent Pool (MPP) mRNA Technology Transfer Programme. Sinergium Biotech has developed candidate H5N1 vaccines and aims to establish proof-of-concept in preclinical models. Once the preclinical data package is concluded, the technology, materials, and expertise will be shared with other manufacturing partners, aiding the acceleration of the development of H5N1 vaccine candidates, and bolstering pandemic preparedness efforts. "This initiative exemplifies why WHO established the mRNA Technology Transfer Programme – to foster greater research, development and production in low- and middle-income countries, so that when the next pandemic arrives, the world will be better prepared to mount a more effective and more equitable response," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. ]]> https://biospectrumindia.com/news/57/24882/agreement-to-explore-optimer-vehicles-for-targeted-delivery-of-sirna.html https://biospectrumindia.com/news/57/24882/agreement-to-explore-optimer-vehicles-for-targeted-delivery-of-sirna.html Mon, 08 Jul 2024 00:00:00 +0530 Aptamer Group plc (AIM: APTA), the developer of novel Optimer® binders to enable innovation in the life sciences industry, is pleased to announce a new agreement with AstraZeneca, a global biopharmaceutical company, to evaluate the Optimer fibrotic liver delivery vehicles for the targeted delivery of siRNA. Following the encouraging results achieved to-date with Aptamer’s fibrotic liver delivery vehicles, the next phase of this research will explore the potential of the non-viral delivery vehicle and its applicability with a tool siRNA. Under the agreement, AstraZeneca will provide an siRNA to be trialled with Aptamer’s Optimer- based delivery vehicle for fibrotic liver cells. Aptamer Group will conduct in-house experimental work to assess the effectiveness of this delivery vehicle with the AstraZeneca’s siRNA. Upon success, Aptamer Group will progress to internally generating demonstrator data in animal models for evaluation by AstraZeneca. Delivery of siRNA to precise cell types and tissues with successful cell internalisation remains a significant challenge for the wider therapeutic application of the technology. Despite this limitation, the siRNA market was still valued at over $13 billion in 2023. Optimer technology could represent a paradigm shift in the targeted delivery of siRNA molecules, due to the high levels of selectivity, high affinity and simple conjugation of siRNA payloads, offered using Optimer delivery systems as non- viral vectors. If successful Optimer-enabled delivery of siRNA could lead to the development of novel compounds that have significant advantages over current cell and tissue-targeting methods. Dr Arron Tolley, Chief Technical Officer of Aptamer Group, said: “We are really excited to work with AstraZeneca to evaluate and optimise our Optimer delivery vehicles. “Partnerships such as this will enable Aptamer Group to make rapid progress in this area, which is a key focus for Optimer technology. Targeted delivery to specific cell types remains a critical unmet need in many applications within the tissue targeting space and, as such, has been part of our strategic focus to support the development of binders with the potential for long-term, high value. Our initial dataset in Optimer targeted delivery has raised significant interest from multiple parties. We are eager to advance to animal model testing and delighted to continue collaborating with AstraZeneca in this endeavour. Reaching proof of principle in animal models will derisk the Optimer delivery platform and bring us closer to delivering targeted and effective gene therapies for patients.” ]]> https://biospectrumindia.com/news/57/24821/11th-edition-of-stempeers-conference-set-to-open-in-chicago-on-5-october-2024.html https://biospectrumindia.com/news/57/24821/11th-edition-of-stempeers-conference-set-to-open-in-chicago-on-5-october-2024.html Tue, 25 Jun 2024 00:00:00 +0530 11th edition of STEMPeers Annual Conference is set to take place at the prestigious David Rubenstein Forum at the University of Chicago, US on October 5, 2024. This event will bring together STEM professionals from around the world to share knowledge, network, and explore new opportunities for career advancement. In the rapidly changing world, building a robust and diverse STEM workforce necessitates systemic and innovative training for the STEM professionals. Since its inception in 2015, STEMPeers is on a mission to empower the next generation of STEM professionals with necessary skills and support through innovative peer-sourced and community-based social entrepreneurship models. With a staggering network of over 25,000 STEM professionals spanning 83 countries and more than 500+ organisations worldwide, STEMPeers' impact has been far-reaching and profound. STEMPeers was recognised in a Nature Biotechnology article as one the leading organizations globally to have career programs for STEM PhDs. STEMPeers has created and nurtured platforms for early-career STEM professionals to connect, learn from each other, and access guidance from experienced mentors, providing valuable opportunities for skill development and networking. Several of their programmes such as Club SciWri, The STEMTimes, MedNess, and Mentor Mantras are examples of cultivating communication and leadership skills in several areas. One of their science communication programmes, Onco-This-Week, was acquired by Rosenblatt Life Science Consultants earlier this year. Their initiatives like the Gurukool program, a one-to-one mentorship model, and the STEMPeers Annual Conference have propelled over 300 industry transitions, facilitated funding exceeding $10K in fellowships to attend scientific conferences, and provided invaluable educational resources and mentorship opportunities. A Cell Press article featured their Gurukool programme. All these initiatives have been carefully crafted to develop technical and leadership skills while promoting social consciousness. The entire programmatic ecosystem catalyses professional and personal growth, facilitating numerous successful career transitions.     ]]> https://biospectrumindia.com/news/57/24807/who-issues-warning-on-falsified-medicines-used-for-diabetes-treatment-and-weight-loss.html https://biospectrumindia.com/news/57/24807/who-issues-warning-on-falsified-medicines-used-for-diabetes-treatment-and-weight-loss.html Sun, 23 Jun 2024 00:00:00 +0530 The World Health Organization (WHO) has issued a medical product alert on falsified semaglutides, the type of medicines that are used for treatment of type 2 diabetes and obesity in some countries. The alert addresses 3 falsified batches of product of semaglutide class of medicines (of specific brand Ozempic), which have been detected in Brazil in October 2023, the United Kingdom of Great Britain and Northern Ireland in October 2023, and the United States of America in December 2023. WHO Global Surveillance and Monitoring System (GSMS) has been observing increased reports on falsified semaglutide products in all geographical regions since 2022. This is the first official notice issued by WHO after confirmation of some of the reports. “WHO advises healthcare professionals, regulatory authorities and the public be aware of these falsified batches of medicines,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “We call on stakeholders to stop any usage of suspicious medicines and report to relevant authorities”. Semaglutides are not part of WHO-recommended treatments for diabetes management due to their current high cost. The cost barrier makes these products unsuitable for a public health approach, which aims to ensure the widest possible access to medicines at the population level and to strike a balance between the best-established standard of care and what is feasible on a large scale in resource-limited settings. Also, there are more affordable treatments available for diabetes, with similar effects to those of semaglutides on blood sugar and cardiovascular risk. WHO is currently working on a rapid advice guideline on possible use of GLP-1 RAs, including semaglutides, for treatment of obesity in adults and as part of a more comprehensive model of care. The term GLP-1 RAs stands for glucagon-like peptide-1 receptor agonists, which include semaglutides, for a class of medicines used for diabetes treatment to lower blood sugar and support weight loss.   ]]> https://biospectrumindia.com/news/57/24782/who-releases-report-on-state-of-development-of-antibacterials.html https://biospectrumindia.com/news/57/24782/who-releases-report-on-state-of-development-of-antibacterials.html Mon, 17 Jun 2024 00:00:00 +0530 The World Health Organization (WHO) has released its latest report on antibacterial agents, including antibiotics, in clinical and preclinical development worldwide. Although the number of antibacterial agents in the clinical pipeline increased from 80 in 2021 to 97 in 2023, there is a pressing need for new, innovative agents for serious infections and to replace those becoming ineffective due to widespread use. First released in 2017, this annual report evaluates whether the current research and development (R&D) pipeline properly addresses infections caused by the drug-resistant bacteria most threatening to human health, as detailed in the 2024 WHO bacterial priority pathogen list (BPPL). Both documents aim to steer antibacterial R&D to better counter the ever-growing threat of antimicrobial resistance (AMR). Not only are there too few antibacterials in the pipeline, given how long is needed for R&D and the likelihood of failure, there is also not enough innovation. Of the 32 antibiotics under development to address BPPL infections, only 12 can be considered innovative. Furthermore, just 4 of these 12 are active against at least 1 WHO ‘critical’ pathogen, critical being the BPPL’s top risk category, over ‘high’ and ‘medium’ priority. There are gaps across the entire pipeline, including in products for children, oral formulations more convenient for outpatients, and agents to tackle rising drug resistance. Encouragingly, non-traditional biological agents, such as bacteriophages, antibodies, anti-virulence agents, immune-modulating agents and microbiome-modulating agents, are increasingly being explored as complements and alternatives to antibiotics. However, studying and regulating non-traditional agents is not straightforward. Further efforts are needed to facilitate clinical studies and assessments of these products, to help determine when and how to use these agents clinically.   ]]> https://biospectrumindia.com/news/57/24778/gavi-launches-four-vaccination-programmes-for-lower-income-countries.html https://biospectrumindia.com/news/57/24778/gavi-launches-four-vaccination-programmes-for-lower-income-countries.html Sat, 15 Jun 2024 00:00:00 +0530 Gavi, the Vaccine Alliance has announced that the lower-income countries it supports can now apply to introduce four additional vaccines: preventive Ebola, human rabies vaccine for post-exposure prophylaxis, multivalent meningococcal conjugate and hepatitis B birth dose. These four vaccine programmes were previously approved by the Gavi Board but put on hold either due to the COVID-19 pandemic (in the case of human rabies for post-exposure prophylaxis and hepatitis B birth dose); pending availability of suitable products (multivalent meningococcal conjugate); or appropriate policy recommendations (preventive Ebola). The latest expansion of Gavi’s vaccine portfolio is in line with Gavi’s commitment to ensure lower-income countries have access to impactful vaccines as soon as possible. The portfolio will be further expanded in Gavi’s next strategic period, from 2026–2030, which will seek to protect more people, against more diseases, faster than ever before. The continuation of all Gavi-supported programmes after 2025 is contingent upon successful fundraising for the Alliance’s next strategic period. ]]> https://biospectrumindia.com/news/57/24736/merck-completes-180-m-investment-to-expand-distribution-centre-in-germany.html https://biospectrumindia.com/news/57/24736/merck-completes-180-m-investment-to-expand-distribution-centre-in-germany.html Thu, 06 Jun 2024 00:00:00 +0530 Merck, a leading science and technology company, has opened its newly expanded Life Science distribution centre in Schnelldorf, Germany. The investment of €180 million added 25,000 square meters to the site, almost doubling its size. It now includes a new manual down filling operation and additional space for the distribution of a wide range of products to laboratories and research facilities all around the world. The site employs 470 engineers, manufacturing and distribution experts. The expansion of the Schnelldorf facility is part of a multi-year investment programme of Merck’s Life Science business sector. It aims to increase the capacity and capabilities to support the growing global demand for critical drugs and to make significant contributions to public health. Since 2020, Merck has announced industrial capacity and capabilities expansion projects in Life Science throughout Europe, China, and the United States, of more than €2 billion. The Life Science Business of Merck is comprised of more than 50 production and testing sites and 64 distribution centres around the world and has more than 27,000 employees in 65 countries. ]]> https://biospectrumindia.com/news/57/24721/find-and-who-sign-new-mou-to-speed-up-innovation-and-access-to-quality-diagnostics.html https://biospectrumindia.com/news/57/24721/find-and-who-sign-new-mou-to-speed-up-innovation-and-access-to-quality-diagnostics.html Tue, 04 Jun 2024 00:00:00 +0530 FIND and the World Health Organization (WHO) have signed a new Memorandum of Understanding (MoU) that lays the foundation for accelerating innovation and achieving equitable accesss to quality diagnostics for people globally. One year on from the historic resolution to strengthen diagnostics, and with FIND as co-lead of the Access to COVID-19 Tools (ACT) Accelerator diagnostics pillar, this new agreement marks a step change in a strengthened partnership between WHO and FIND to speed up both innovation and access to diagnostics, supporting countries to implement the World Health Assembly (WHA) Resolution on diagnostics. This new agreement establishes FIND as the key strategic partner for diagnostics, working with WHO and others to address a number of priority areas including antimicrobial resistance, infectious diseases like HIV, malaria and tuberculosis, and noncommunicable diseases like hypertension, heart disease, cervical cancer and diabetes. Signed on 1 June 2024 at a ceremony attended by Dr Tedros Adhanom Ghebreyesus, Dr Yukiko Nakatani (Assistant Director-General) and Dr Ayoade Alakija (Board Chair of FIND), the MoU will also see the two organizations building new avenues to share knowledge and scale up critical activities to accelerate access to life-saving diagnostics. ]]> https://biospectrumindia.com/news/57/24710/77th-world-health-assembly-adopts-amendments-to-international-health-regulations-2005.html https://biospectrumindia.com/news/57/24710/77th-world-health-assembly-adopts-amendments-to-international-health-regulations-2005.html Mon, 03 Jun 2024 00:00:00 +0530 In a landmark achievement in the global health security agenda, the 77th World Health Assembly agreed to the package of amendments to the International Health Regulations (IHR 2005) based on 300 proposals made by member countries after the Covid-19 pandemic. The targeted amendments to the International Health Regulations (IHR) aim at improving countries’ ability to prepare for and respond to Public Health Emergencies of International Concern (PHEIC) and Pandemic Emergencies (PE). They include provisions for facilitating equitable access to relevant health products during PHEIC and PE, as well as mobilising financial resources to support developing countries in building, strengthening, and maintaining the core capacities required under the IHR (2005). The Working group on International Health Regulations (WGIHR) and Intergovernmental Negotiating Body on Pandemic treaty with country representations began the negotiation process in two separate groups almost two years ago and met a number of times including many resumed sessions on the issue. The processes witnessed a number of close calls with seeming deadlocks over positions taken by the various stakeholders. In order to finalise the package of amendments to IHR, a proposal was put forward in the form of a White Paper by Apurva Chandra, Secretary, Ministry of Health and Family Welfare, Government of India, as Chair of Committee A of the World Health Assembly on 28th May, 2024. It proposed to establish a single drafting group, to be co-chaired by one Bureau member from the Intergovernmental Negotiating Body (INB) and the Working Group on Amendments to the International Health Regulations (2005) (WGIHR) respectively, to consider the matters related to some of the most critical agenda items, the proposed amendments to the IHR (2005), followed by consideration of procedural matters on way forward related to INB negotiations on the Pandemic treaty. The said proposal was approved by all member states by consensus. ]]> https://biospectrumindia.com/news/57/24696/cepi-and-gavi-extend-partnership-to-target-future-disease-outbreaks.html https://biospectrumindia.com/news/57/24696/cepi-and-gavi-extend-partnership-to-target-future-disease-outbreaks.html Thu, 30 May 2024 00:00:00 +0530 The Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance (Gavi), two co-leads of COVAX, the multilateral mechanism that accelerated equitable access to COVID-19 vaccines globally, have expanded their partnership to enhance the rapid development, deployment and access to vaccines against other deadly disease threats with outbreak potential. The signed Memorandum of Understanding will facilitate faster sharing of global health and vaccine information between the two organisations to better prepare for and respond to future epidemics. The goal is to use CEPI and Gavi’s respective areas of expertise to accelerate equitable access to outbreak vaccines for populations most in need, regardless of their ability to pay.   Current and future areas for collaboration include alignment and coordination between Gavi and CEPI on the development, manufacturing and supply of new vaccine candidates against known diseases, as well as a novel or as-yet unidentified threat with pandemic potential, known as ‘Disease X’. The faster that safe and effective new vaccines are developed and equitably deployed based on a country’s need, the faster a new pandemic threat can be contained and controlled, helping to reduce the threat for everyone, everywhere. CEPI and Gavi will also collaborate on policy and advocacy efforts to enhance the global pandemic preparedness architecture. The new collaboration, signed on the sidelines of the 77th World Health Assembly, builds on the strong relationship developed between the two organisations when co-leading the largest and fastest mass global vaccination campaign in history alongside UNICEF and WHO in response to the COVID-19 pandemic.   Image caption- Dr Richard Hatchett, CEO of CEPI (R) and Dr Sania Nishtar, CEO of Gavi ]]> https://biospectrumindia.com/news/57/24669/who-announces-first-investment-round-to-sustainably-finance-health-for-all-mandate.html https://biospectrumindia.com/news/57/24669/who-announces-first-investment-round-to-sustainably-finance-health-for-all-mandate.html Mon, 27 May 2024 00:00:00 +0530 The World Health Organization (WHO) has launched its first-ever Investment Round, as part of a broader plan to transform the way the Organization is funded heading into an era of climate change, mass migration, pandemic threats, an ageing world population, and turbulent geopolitics. The launch marks the start of a year-long series of engagements and events, co-hosted by countries, where Member States and other donors will be invited to contribute funds to WHO’s strategy for 2025 through 2028 and show high-level political commitment to WHO and global health. The Investment Round will culminate in November with a major pledging event to be hosted by Brazil around the G20 Leaders’ Summit. The Government of Brazil announced that as part of its G20 presidency, the country will host high-level events including at the Leaders’ Summit in November to support the Investment Round and rally countries to join the initiative. Qatar Minister of Health Dr Hanan Mohamed Al Kuwari announced a contribution of $ 4 million in fully flexible funds to the Investment Round, and an intention to contribute further. France, Germany, and Norway announced that they would serve as co-hosts for the Investment Round. Further statements of support for the Investment Round came from Dr Gabriel Leung representing the Institute of Philanthropy, and former UK Prime Minister Gordon Brown, who is WHO’s Ambassador for Global Health Financing. Holding an Investment Round was one of the key recommendations put forward by the Member State-led WHO Working Group on Sustainable Financing and approved by Member States to make WHO a predictably, sustainably, flexibly funded organization. Member States have also approved an increase in their assessed contributions, on the pathway to providing 50% of WHO’s base budget by 2030. With the Investment Round, WHO is seeking to expand its donor base by mobilising new contributions from the WHO Member States that have not yet provided voluntary contributions and by tapping into new private sector donors through the WHO Foundation. ]]> https://biospectrumindia.com/news/57/24662/university-of-oxford-designs-computer-simulations-to-guide-future-vaccine-trials.html https://biospectrumindia.com/news/57/24662/university-of-oxford-designs-computer-simulations-to-guide-future-vaccine-trials.html Sat, 25 May 2024 00:00:00 +0530 University of Oxford scientists are launching new computer simulations that will model how we can strengthen the world’s response to some of the viruses most likely to cause the next pandemic. Their work, known as the ‘PREpare using Simulated Trial Optimisation (PRESTO)’ research project, will generate important insights for vaccine developers and public health officials on what vaccine clinical trial designs could help stop the spread of an emerging outbreak. With up to $2.4 million funding from Norway-based Coalition for Epidemic Preparedness Innovations (CEPI), researchers at the University of Oxford’s Pandemic Sciences Institute will simulate real-life scenarios of deadly disease outbreaks in order to model how possible vaccine clinical trials could run and what outcomes they could produce. The infectious threats that will be tested are Nipah, Chikungunya, Lassa, Rift Valley fever, Ebola and related viruses, Coronaviruses and a new or as-yet-identified ‘Disease X’. These diseases are prioritised by CEPI and recognised on the WHO R&D Blueprint. Data from existing CEPI-funded research will be fed into the computer model alongside evidence from previous outbreaks to create hypothetical scenarios looking at how a selected virus could spread, who it could impact and its potential severity.  Findings from these scenarios will be used to produce analysis sheets that rank the suitability of different clinical trial options measuring the efficacy or real-world effectiveness of vaccines against each selected infectious disease.  ]]> https://biospectrumindia.com/news/57/24632/who-prequalifies-takedas-dengue-vaccine.html https://biospectrumindia.com/news/57/24632/who-prequalifies-takedas-dengue-vaccine.html Thu, 16 May 2024 00:00:00 +0530 A new vaccine for dengue has received prequalification from the World Health Organization (WHO). TAK-003 is the second dengue vaccine to be prequalified by WHO. Developed by Takeda, it is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that cause dengue.  WHO recommends the use of TAK-003 in children aged 6–16 years in settings with high dengue burden and transmission intensity. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses.  “The prequalification of TAK-003 is an important step in the expansion of global access to dengue vaccines, as it is now eligible for procurement by UN agencies including UNICEF and PAHO,” said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification.  “With only two dengue vaccines to date prequalified, we look forward to more vaccine developers coming forward for assessment, so that we can ensure vaccines reach all communities who need it.” The WHO prequalification list also includes CYD-TDV vaccine against dengue developed by Sanofi Pasteur.  It is estimated that there are over 100-400 million cases of dengue worldwide each year and 3.8 billion people living in dengue endemic countries, most of which are in Asia, Africa, and the Americas. The largest number of dengue cases reported was in 2023 with the WHO Region of the Americas reporting 4.5 million cases and 2300 deaths. Dengue cases are likely to increase and expand geographically due to climate change and urbanisation. ]]> https://biospectrumindia.com/news/57/24605/epa-fda-and-usda-issue-joint-regulatory-plan-for-biotechnology.html https://biospectrumindia.com/news/57/24605/epa-fda-and-usda-issue-joint-regulatory-plan-for-biotechnology.html Thu, 09 May 2024 00:00:00 +0530 In response to US President Biden's Executive Order 14081, "Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy," the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA) have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The plan helps meet the President's goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination, and efficiency. Through engagement with developers and stakeholders, as well as horizon scanning for novel biotechnology products, the Agencies worked collaboratively to develop a cohesive plan. It incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations. The plan supports a whole-of-government approach to the regulation of biotechnology products. The agencies have identified five major areas of biotechnology product regulation where these actions will focus: Modified plants Modified animals Modified microorganisms Human drugs, biologics, and medical devices Cross-cutting issues EPA, the FDA and USDA intend to clarify and streamline regulatory oversight for genetically engineered (GE) plants, animals and microorganisms; update and expand their information sharing through an MoU to improve and broaden communication and coordination of oversight of modified microbes; and undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category.   ]]> https://biospectrumindia.com/news/57/24565/major-step-in-malaria-prevention-as-three-west-african-countries-roll-out-vaccine.html https://biospectrumindia.com/news/57/24565/major-step-in-malaria-prevention-as-three-west-african-countries-roll-out-vaccine.html Mon, 29 Apr 2024 00:00:00 +0530 In a significant step forward for malaria prevention in Africa, three countries- Benin, Liberia and Sierra Leone– have launched a large-scale rollout of the life-saving malaria vaccine targeting millions of children across the three West African nations. The vaccine rollout, announced on World Malaria Day on 25 April, seeks to further scale up vaccine deployment in the African region. The launch brings to eight the number of countries on the continent to offer the malaria vaccine as part of the childhood immunisation programmes, extending access to more comprehensive malaria prevention. Several of the more than 30 countries in the African region that have expressed interest in the vaccine are scheduled to roll it out in the next year through support from Gavi, the Vaccine Alliance, as efforts continue to widen its deployment in the region in coordination with other prevention measures such as long-lasting insecticidal nets and seasonal malaria chemoprevention. Benin, which received 215,900 doses, has added the malaria vaccine to its Expanded Programme on Immunisation. The malaria vaccine should be provided in a schedule of 4 doses in children from around 5 months of age. In Liberia, the vaccine was launched in the southern Rivercess County and will be rolled out afterwards in five other counties which have high malaria burden. At least 45,000 children are expected to benefit from the 112,000 doses of the available vaccine. Two safe and effective vaccines, RTS,S and R21, recommended by World Health Organization (WHO), are a breakthrough for child health and malaria control. A pilot malaria vaccine programme in Ghana, Kenya and Malawi reached over 2 million children from 2019 to 2023, showing a significant reduction in malaria illness and a 13% drop in overall child mortality and substantial reductions in hospitalizations. In Sierra Leone, the first doses were administered to children at a health centre in Western Area Rural where the authorities kicked off the rollout of 550,000 vaccine doses. The vaccine will then be delivered in health facilities nationwide.     ]]> https://biospectrumindia.com/news/57/24497/nigeria-introduces-new-5-in-1-vaccine-against-meningitis.html https://biospectrumindia.com/news/57/24497/nigeria-introduces-new-5-in-1-vaccine-against-meningitis.html Mon, 15 Apr 2024 00:00:00 +0530 Nigeria has become the first country in the world to roll out a new vaccine (called Men5CV/MenFive conjugate vaccine) recommended by the World Health Organization (WHO), which protects people against five strains of the meningococcus bacteria. MenFive is indicated for active immunization of individuals aged 9 months to 85 years against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, Y, W, and X. The vaccine and emergency vaccination activities are funded by Gavi, the Vaccine Alliance, which funds the global meningitis vaccine stockpile, and supports lower-income countries with routine vaccination against meningitis.   Nigeria is one of the 26 meningitis hyper-endemic countries of Africa, situated in the area known as the African Meningitis Belt. Last year, there was a 50% jump in annual meningitis cases reported across Africa. The new vaccine has the potential to significantly reduce meningitis cases and advance progress in defeating meningitis. This is especially important for countries like Nigeria where multiple serogroups are prevalent. The new vaccine uses the same technology as the meningitis A conjugate vaccine (MenAfriVac), which wiped out meningococcal A epidemics in Nigeria. This multivalent conjugate vaccine was 13 years in the making and was based on a partnership between PATH and the Serum Institute of India. Financing from the UK government’s Foreign, Commonwealth and Development Office was critical to its development.     ]]> https://biospectrumindia.com/news/57/24484/who-sounds-alarm-on-viral-hepatitis-infections-claiming-3500-lives-each-day.html https://biospectrumindia.com/news/57/24484/who-sounds-alarm-on-viral-hepatitis-infections-claiming-3500-lives-each-day.html Tue, 09 Apr 2024 00:00:00 +0530 According to the World Health Organization (WHO) 2024 Global Hepatitis Report, the number of lives lost due to viral hepatitis is increasing. The disease is the second leading infectious cause of death globally, with 1.3 million deaths per year, the same as tuberculosis, a top infectious killer. The report, released at the World Hepatitis Summit, highlights that despite better tools for diagnosis and treatment, and decreasing product prices, testing and treatment coverage rates have stalled.  New data from 187 countries show that the estimated number of deaths from viral hepatitis increased from 1.1 million in 2019 to 1.3 million in 2022. Of these, 83% were caused by hepatitis B, and 17% by hepatitis C. Every day, there are 3500 people dying globally due to hepatitis B and C infections. Updated WHO estimates indicate that 254 million people live with hepatitis B and 50 million with hepatitis C in 2022. Half the burden of chronic hepatitis B and C infections is among people 30–54 years old, with 12% among children under 18 years of age. Men account for 58% of all cases. Funding for viral hepatitis both at a global level or within dedicated country health budgets, is not sufficient to meet the needs. This arises from a combination of factors, including limited awareness of cost-saving interventions and tools, as well as competing priorities in global health agendas.  The report outlines a series of actions to advance a public health approach to viral hepatitis, designed to accelerate progress towards ending the epidemic by 2030. This includes expanding access to testing and diagnostics; shifting from policies to implementation for equitable treatment; strengthening primary care prevention efforts; simplifying service delivery, optimising product regulation and supply; developing investment cases in priority countries; and mobilising innovative financing. ]]> https://biospectrumindia.com/news/57/24472/global-deployment-of-rapid-diagnostic-tests-to-boost-fight-against-cholera.html https://biospectrumindia.com/news/57/24472/global-deployment-of-rapid-diagnostic-tests-to-boost-fight-against-cholera.html Sat, 06 Apr 2024 00:00:00 +0530 The recent arrival of rapid diagnostic test (RDT) kits for cholera in Malawi signals the start of a global programme that will see more than 1.2 million tests distributed to 14 countries at high risk for cholera over the next several months. Countries that will receive kits in the coming weeks in this largest-ever global deployment include those currently severely impacted by cholera outbreaks, such as Ethiopia, Somalia, Syria, and Zambia. This programme will improve the timeliness and accuracy of outbreak detection and response by boosting routine surveillance and testing capacity and helping rapidly identify probable cholera cases. Critically, it will also help countries monitor trends and build an evidence base for future preventive programmes, supporting the achievement of national cholera control and elimination targets. The global cholera diagnostics programme is funded and coordinated by Gavi, the Vaccine Alliance (Gavi), with procurement and delivery to countries led by UNICEF, and undertaken in collaboration with the Global Task Force on Cholera Control (GTFCC), and WHO. It was developed in partnership with FIND, who led development of a target product profile describing the required characteristics of cholera RDTs, and other organisations. Long-term sustainability of the programme depends on successful fundraising for Gavi’s next strategic period, from 2026 to 2030. ]]> https://biospectrumindia.com/news/57/24469/who-unveils-digital-health-promoter-harnessing-generative-ai-for-public-health.html https://biospectrumindia.com/news/57/24469/who-unveils-digital-health-promoter-harnessing-generative-ai-for-public-health.html Thu, 04 Apr 2024 00:00:00 +0530 The World Health Organization (WHO) has announced the launch of S.A.R.A.H., a digital health promoter prototype with enhanced empathetic response powered by generative artificial intelligence (AI). S.A.R.A.H. is a Smart AI Resource Assistant for Health that represents an evolution of AI-powered health information avatars, using new language models and cutting-edge technology. It can engage users 24 hours a day in 8 languages on multiple health topics, on any device. WHO’s digital health promoter is trained to provide information across major health topics, including healthy habits and mental health, to help people optimise their health and well-being journey. It aims to provide an additional tool for people to realize their rights to health, wherever they are. S.A.R.A.H., also known as Sarah, has the ability to support people in developing better understanding of risk factors for some of the leading causes of death in the world, including cancer, heart disease, lung disease, and diabetes. She can help people access up-to-date information on quitting tobacco, being active, eating a healthy diet, and de-stressing among other things.  WHO calls for continued research on this new technology to explore potential benefits to public health and to better understand the challenges. While AI has enormous potential to strengthen public health it also raises important ethical concerns, including equitable access, privacy, safety and accuracy, data protection, and bias. ]]> https://biospectrumindia.com/news/57/24400/who-urges-investments-for-scale-up-of-tuberculosis-screening-and-preventive-treatment.html https://biospectrumindia.com/news/57/24400/who-urges-investments-for-scale-up-of-tuberculosis-screening-and-preventive-treatment.html Mon, 18 Mar 2024 00:00:00 +0530 Ahead of World Tuberculosis (TB) Day, which is marked on 24 March, the World Health Organisation (WHO) has released an investment case for TB screening and preventive treatment. A modelling study developed with Governments of four countries - Brazil, Georgia, Kenya and South Africa - highlights the impact to be achieved from expanding TB screening and preventive treatment. The analysis shows that modest investments could lead to significant health and economic benefits in all four countries, with a return on investment up to $39 gained for every dollar invested. The investment case has been released to support countries in advocating for and allocating increased resources to scale-up TB screening and preventive treatment towards reaching new targets committed by Heads of State at the 2023 UN High-Level Meeting on TB. While global efforts to combat TB have saved an estimated 75 million lives since the year 2000, TB causes 1.3 million deaths each year and affects millions more, with enormous impacts on families and communities. “The investment case outlines the health and economic rationale for investing in evidence-based, WHO-recommended interventions on TB screening and prevention that can contribute to advancing universal health coverage,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Today, we have the knowledge, tools and political commitment that can end this millennia-old disease that remains one of the world’s top infectious killers”. According to the investment report, implementing TB screening plus preventive treatment can substantially reduce TB incidence and mortality. It argues that these crucial public health investments are essential for addressing the needs of vulnerable populations and achieving the End TB targets.   ]]> https://biospectrumindia.com/news/57/24361/international-consortium-embarks-on-57-m-project-to-test-inhaled-nasal-vaccines-against-viral-infection.html https://biospectrumindia.com/news/57/24361/international-consortium-embarks-on-57-m-project-to-test-inhaled-nasal-vaccines-against-viral-infection.html Tue, 12 Mar 2024 00:00:00 +0530 An international consortium of researchers specialising in human challenge studies is embarking on a $57 million project to develop advanced, virus-blocking coronavirus vaccines that could stop SARS-CoV-2 and other coronaviruses from infecting people in the first place. Led by Imperial College London and co-funded by the European Union’s Horizon Europe Programme and the Coalition for Epidemic Preparedness Innovations (CEPI), the consortium of more than a dozen scientific teams and organisations will begin by running trials to select particular viruses and identify the best conditions under which to safely induce infection in healthy volunteers. Researchers at multiple clinical research facilities will use a selected virus to try to infect healthy volunteers who have received an experimental vaccine. Unlike traditional vaccines which are injected into muscle, these experimental vaccines will be inhaled into the lungs or sprayed in the nose and are designed to induce a type of protection known as mucosal immunity, which scientists believe could be the key to stopping onward transmission of coronaviruses. Using harmonised standard operating procedures, the trials will take place across several sites in the UK, Europe, the United States and Singapore and will each involve a small group of young, healthy volunteers. In the challenge trial, volunteers will first receive either a dose of an investigational vaccine designed to provide mucosal coronavirus immunity or placebo before being intentionally exposed to a calibrated dose of SARS-CoV-2.  A model using a seasonal coronavirus called OC43 is also being developed for similar use. ]]> https://biospectrumindia.com/news/57/24328/wave-of-global-commitments-marks-historic-step-towards-elimination-of-cervical-cancer.html https://biospectrumindia.com/news/57/24328/wave-of-global-commitments-marks-historic-step-towards-elimination-of-cervical-cancer.html Wed, 06 Mar 2024 00:00:00 +0530 Governments, donors, multilateral institutions, and partners have announced major new policy, programmatic and financial commitments, including nearly $600 million in new funding, to eliminate cervical cancer. If these ambitions to expand vaccine coverage and strengthen screening and treatment programmes are fully realised, the world could eliminate a cancer for the first time. These commitments were made at the first-ever Global Cervical Cancer Elimination Forum: Advancing the Call to Action in Cartagena de Indias, Colombia, to catalyse national and global momentum to end this preventable disease. The commitments announced at the forum mark a watershed moment to accelerate progress on a promise made in 2020, when 194 countries adopted WHO’s global strategy to eliminate cervical cancer. Nearly $600 million in new funding includes $180 million from the Bill & Melinda Gates Foundation, $10 million from UNICEF, and $400 million from the World Bank.  Cervical cancer is the fourth most common cancer in women worldwide, and continues to disproportionately impact women and their families in low- and middle-income countries (LMICs). ]]> https://biospectrumindia.com/news/57/24074/who-launches-appeal-for-1-5-b-for-key-emergencies-in-2024.html https://biospectrumindia.com/news/57/24074/who-launches-appeal-for-1-5-b-for-key-emergencies-in-2024.html Tue, 16 Jan 2024 00:00:00 +0530 The World Health Organization (WHO) has launched an appeal for $1.5 billion to protect the health of the most vulnerable populations in 41 emergencies around the globe in 2024. The appeal covers the emergencies that demand the highest level of response from WHO, with the aim to reach over 87 million people. It is being issued in a context of complex emergencies cutting across crises of conflict, climate change and economic instability, which continue to fuel displacement, hunger, and inequality. Support in 2024 will enable life-saving healthcare, distribution of critical health supplies and equipment, along with maintenance of essential health services to ensure continuous care. The funding supports direct access to health care for communities in hard-to-reach areas, in partnerships with local organisations, and effective response to monitor, share information and document outbreaks and attacks on health workers. Other important actions are maintenance of existing healthcare systems and building resilience against future threats. The appeal notes the positive value of funding to supporting people with humanitarian needs. Every $1 invested in WHO delivers a return on investment of at least $35. The funding would go to the African Region, with $334 million; the Eastern Mediterranean Region, with $705 million; the European region, with $183 million; the Western Pacific Region, with $15.2 million; the South-East Asia Region, with $49 million; and the Americas Region, with $131 million. ]]> https://biospectrumindia.com/news/57/23953/biolabs-and-promega-collaborate-to-support-young-biotech-companies-worldwide.html https://biospectrumindia.com/news/57/23953/biolabs-and-promega-collaborate-to-support-young-biotech-companies-worldwide.html Wed, 13 Dec 2023 00:00:00 +0530 BioLabs and Promega have announced the expansion of their collaborative efforts to accelerate life science innovation worldwide through support for early-stage startup companies. Promega GmbH in Walldorf, the German branch of global life science manufacturer Promega, will provide equipment, services and training to BioLabs Heidelberg. This initiative further establishes the Rhine-Neckar region as the centre of science innovation in Germany and strengthens the region’s supportive ecosystem for early-stage startup companies. The agreement expands the ongoing collaboration, which began in 2019, between Promega and BioLabs, a mission-driven company focused on empowering entrepreneurs and accelerating the commercialisation of life science innovation worldwide. Promega currently supports all BioLabs locations in the US and France, enabling entrepreneurs to advance their research in the field of life sciences. BioLabs provides fully equipped and supported laboratory and office space, access to a collaborative community, and connections to a global life science network of partners to more than 250 innovative startup companies worldwide. BioLabs’ capital-efficient model minimises the barriers to launch a life science startup and enables entrepreneurs to focus on research, not operations, accelerating the pace of commercial cutting-edge technologies. ]]> https://biospectrumindia.com/news/57/23919/us-fda-approves-first-gene-therapies-to-treat-patients-with-sickle-cell-disease.html https://biospectrumindia.com/news/57/23919/us-fda-approves-first-gene-therapies-to-treat-patients-with-sickle-cell-disease.html Sat, 09 Dec 2023 00:00:00 +0530 The US Food and Drug Administration (FDA) has approved two milestone treatments, Casgevy (Vertex Pharmaceuticals Inc.) and Lyfgenia (Bluebird Bio Inc.), representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilise a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.  Casgevy, a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises. Casgevy is the first FDA-approved therapy utilising CRISPR/Cas9, a type of genome editing technology. Patients’ hematopoietic (blood) stem cells are modified by genome editing using CRISPR/Cas9 technology.  On the other hand, Lyfgenia is a cell-based gene therapy. Lyfgenia uses a lentiviral vector (gene delivery vehicle) for genetic modification and is approved for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events. With Lyfgenia, the patient’s blood stem cells are genetically modified to produce HbAT87Q, a gene-therapy derived hemoglobin that functions similarly to hemoglobin A, which is the normal adult hemoglobin produced in persons not affected by sickle cell disease. Red blood cells containing HbAT87Q have a lower risk of sickling and occluding blood flow. These modified stem cells are then delivered to the patient.  Patients who received Casgevy or Lyfgenia will be followed in a long-term study to evaluate each product’s safety and effectiveness.  ]]> https://biospectrumindia.com/news/57/23849/new-research-shows-failure-of-current-policies-to-eradicate-tb.html https://biospectrumindia.com/news/57/23849/new-research-shows-failure-of-current-policies-to-eradicate-tb.html Fri, 17 Nov 2023 00:00:00 +0530 Researchers from the London School of Hygiene and Tropical Medicine have suggested that half of tuberculosis (TB) transmission occurs before individuals will even access care under existing TB care policies.This investigation suggests that one in two individuals with subclinical TB, who are likely infectious but are not aware of symptoms, will not progress to disease severe enough to seek care.Research presented at The International Union Against TB and Lung Disease’s World Conference on Lung Health revealed how new insights into TB highlight the weakness of current policies designed to eradicate the disease, where individuals need to report symptoms in a clinic before receiving care.The amount of transmission missed was reduced to a third if the study assumed a lower relative infectiousness for subclinical TB. The study, which used a deterministic modelling framework based on 1,000 cohorts of 10,000 individuals, found that 93.5% of TB-infected individuals will not contribute to transmission within 10 years of MTB infection.At The Union World Conference, tuberculosis experts also presented how active case finding (ACF) could reduce the 52,000 TB cases in Cambodia, of which nearly 50% go undiagnosed. With this figure often higher in minority and hard-to-reach communities, scientists stressed the importance of focusing ACF efforts in these areas.Researchers conducted mobile case findings across 26 remote communities, which resulted in over 8,000 patients being screened. More than 5% of these people were diagnosed with TB – with 321 TB patients receiving treatment that they would not have otherwise, constituting an increased detection of 370%.These results demonstrated the positive impact of adopting a policy of ACF in reducing transmission of TB within the community, coupled with widening invaluable access to diagnostic facilities.Children and adolescents experience a disproportionate burden of TB. The WHO recently released its Global Tuberculosis Report, which highlighted that an estimated 1.25 million children and young adolescents fell ill with TB in 2022, making up 12% of the global TB burden.The Union World Conference on Lung Health (from 15 to 18 November in Paris) is convened by the International Union Against Tuberculosis and Lung Disease, the world’s first global health organisation, committed to eradicating tuberculosis and lung disease. ]]> https://biospectrumindia.com/news/57/23843/roche-launches-automated-serology-hepatitis-e-virus-tests.html https://biospectrumindia.com/news/57/23843/roche-launches-automated-serology-hepatitis-e-virus-tests.html Thu, 16 Nov 2023 00:00:00 +0530 Swiss firm Roche has announced the launch of the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus (HEV) infections in countries accepting the CE mark. Elecsys Anti-HEV IgM is an immunoassay for the in vitro qualitative detection of IgM antibodies to HEV in human serum and plasma, and is used as an aid to detect an acute or recently acquired HEV infection. Elecsys Anti-HEV IgG is an immunoassay for the in vitro quantitative determination of IgG antibodies to HEV in human serum and plasma, and is used as an aid to detect a recent or past HEV infection. The new assays are available for use on the cobas® e 411 analyser, cobas e 601/602 modules, and the cobas e 402 and cobas e 801 analytical modules.  By testing for HEV infection, clinicians can support their patients to identify the cause of their symptoms and determine appropriate treatment, monitor for progression to severe acute HEV and prevent severe disease progression with antiviral treatment. Recognising the value of diagnostics, the World Health Organization (WHO) has developed an “Essential Diagnostics List” which includes in-vitro diagnostics that should be available in all countries to increase timely and life-saving diagnoses. This year for the first time, tests for HEV are included to aid in the diagnosis and surveillance of HEV infection.   ]]> https://biospectrumindia.com/news/57/23839/illumina-launches-global-health-access-initiative-for-acceleration-of-pathogen-sequencing-in-lmics.html https://biospectrumindia.com/news/57/23839/illumina-launches-global-health-access-initiative-for-acceleration-of-pathogen-sequencing-in-lmics.html Tue, 14 Nov 2023 00:00:00 +0530 Illumina Inc., a global leader in DNA sequencing and array-based technologies, has announced the launch of the Global Health Access Initiative to support access to pathogen sequencing tools for public health in low- and middle-income countries (LMICs). The programme, developed with guidance from customers, funders, and market facilitators including the nonprofit FIND, will provide reduced pricing structures for eligible sequencing products from Illumina to qualified global health funding entities and address key international logistics and supply chain challenges. Currently, pricing for sequencing instruments and consumables can vary by country or region, which is challenging for funders and donors and can limit broad implementation. Illumina's Global Health Access Initiative will provide discounted prices for a range of sequencing applications, including drug resistance profiling in tuberculosis, whole-genome sequencing of emerging and reemerging viruses to monitor virus evolution and support outbreak response, broad respiratory pathogen detection for influenza-like illness surveillance, wastewater and other environmental surveillance applications to track pathogens, and antimicrobial resistances at the population level. ]]> https://biospectrumindia.com/news/57/23698/cepi-to-harness-iqvias-expertise-in-implementing-global-clinical-research-strategies.html https://biospectrumindia.com/news/57/23698/cepi-to-harness-iqvias-expertise-in-implementing-global-clinical-research-strategies.html Mon, 16 Oct 2023 00:00:00 +0530 IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services, and The Coalition for Epidemic Preparedness Innovations (CEPI) have announced a strategic collaboration to advance the 100 Days Mission. In conjunction with national and regional collaborators, CEPI and IQVIA will aim to enhance the world’s preparedness to rapidly conduct life-saving clinical research for vaccines and other biological countermeasures against emerging infectious diseases. CEPI will harness IQVIA’s extensive clinical research expertise and innovative solutions, as well as its global reach, to support its goal of strengthening pandemic preparedness clinical research capability in Low- and Middle-Income Countries (LMICs) to accelerate vaccine development when faced with future viral threats.   As part of its mission to enable faster and more equitable responses to future viral threats, CEPI will support the establishment of regional consortia, comprised of and led by national and regional stakeholders, to bolster research preparedness across LMICs. The regional consortia will identify gaps and needs in regional clinical research capability, and oversee the building of sustainable research capacity that can be swiftly put into action to respond to infectious disease outbreaks. IQVIA will play a crucial role as a global service provider, utilising its global reach and bandwidth to support the regional consortia and CEPI to fill gaps that will accelerate the generation of high-quality data during an outbreak response.  ]]> https://biospectrumindia.com/news/57/23676/who-introduces-new-version-of-skin-ntds-mobile-application.html https://biospectrumindia.com/news/57/23676/who-introduces-new-version-of-skin-ntds-mobile-application.html Mon, 09 Oct 2023 00:00:00 +0530 The World Health Organization (WHO) has announced the release of an enhanced version of its Skin NTDs App, a valuable tool designed to assist front-line health workers in diagnosing and managing skin-related neglected tropical diseases (skin NTDs).  This development is the result of a collaborative effort between WHO and Until No Leprosy Remains (NLR). NLR transferred the content of its SkinApp, which encompassed information on skin NTDs, 24 common skin diseases, and some HIV-related skin conditions, to the WHO Skin NTDs App. This collaboration has resulted in a comprehensive and user-friendly resource that aligns with the latest WHO recommendations. This software application will rapidly furnish healthcare professionals with practical information for a particular disease, encompassing its clinical characteristics, treatment protocols, and geographic prevalence The WHO Skin NTDs App represents a significant step forward in the fight against NTDs affecting the skin. By providing health workers with a robust and accessible tool, WHO aims to enhance early detection, streamline treatment and ultimately improve the lives of individuals affected by these diseases.     ]]> https://biospectrumindia.com/news/57/23656/who-recommends-r21-vaccine-for-malaria-prevention-in-updated-advice-on-immunisation.html https://biospectrumindia.com/news/57/23656/who-recommends-r21-vaccine-for-malaria-prevention-in-updated-advice-on-immunisation.html Tue, 03 Oct 2023 00:00:00 +0530 The World Health Organization (WHO) has recommended a new vaccine, R21/Matrix-M (developed by the University of Oxford and the Serum Institute of India), for the prevention of malaria in children. The recommendation follows advice from the WHO: Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Group (MPAG) and was endorsed by the WHO Director-General following its regular biannual meeting held on 25-29 September.  WHO also issued recommendations on the advice of SAGE for new vaccines for dengue and meningitis, along with immunization schedule and product recommendations for COVID-19.  WHO also issued key immunisation programmatic recommendations on polio, IA2030 and recovering the immunization programme. The R21 vaccine is the second malaria vaccine recommended by WHO, following the RTS,S/AS01 vaccine, which received a WHO recommendation in 2021. Both vaccines are shown to be safe and effective in preventing malaria in children and, when implemented broadly, are expected to have high public health impact. Malaria, a mosquito-borne disease, places a particularly high burden on children in the African Region, where nearly half a million children die from the disease each year. Demand for malaria vaccines is unprecedented; however, available supply of RTS,S is limited.  The addition of R21 to the list of WHO-recommended malaria vaccines is expected to result in sufficient vaccine supply to benefit all children living in areas where malaria is a public health risk.     ]]> https://biospectrumindia.com/news/57/23481/investments-in-digital-to-accelerate-improvements-in-healthcare-world-bank.html https://biospectrumindia.com/news/57/23481/investments-in-digital-to-accelerate-improvements-in-healthcare-world-bank.html Mon, 21 Aug 2023 00:00:00 +0530 Digital technology can strengthen health systems, improve health financing and public health, and increase reach to underserved populations, according to a new World Bank report launched recently. The report also finds that digital technology and data are especially helpful to prevent and manage chronic diseases, care for both young and aging populations, and prepare for future health emergencies and health risks triggered by climate change. The report, Digital-in-Health: Unlocking the Value for Everyone, was launched during the G20 Health Ministers Meeting in Gandhinagar. It presents a new way of thinking from simple digitisation of health data to fully integrating digital technology in health systems: Digital-in-health. This means, for example, infusing digital technologies in health financing, service delivery, diagnostics, medical education, pandemic preparedness, climate and health efforts, nutrition, and aging. The report also underscores that the successful use of digital technologies must be inclusive of all population groups, and ensure access to digital infrastructure, modern technologies, and skills, especially for vulnerable people. “Designed with people at the centre, digital technology can make health services more personal, prevent healthcare costs from increasing, reduce differences in care, and make the job easier for those who provide health services,” said Mamta Murthi, Vice President for Human Development, World Bank. “We hope that this report will give governments confidence and practical guidance, regardless of the country’s stage of digital maturity or fiscal challenges.”  To help countries embrace a digital-in-health approach, the report proposes three essential areas to guide investments: Prioritise evidence-based digital investments that tackle the biggest problems and focus on the needs of patients and providers. Connect the regulatory, governance, information, and infrastructure dots so that patients know that data is safe and health workers can use digital solutions transparently. Scale digital health for the long run based on trust with sustainable financing, and improved capacity and skills for digital solutions.   ]]> https://biospectrumindia.com/news/57/23475/who-launches-new-global-initiative-on-digital-health.html https://biospectrumindia.com/news/57/23475/who-launches-new-global-initiative-on-digital-health.html Sun, 20 Aug 2023 00:00:00 +0530 The World Health Organisation (WHO) and the G20 India presidency announced a new Global Initiative on Digital Health (GIDH) at the Health Minister’s Meeting of the G20 Summit hosted by the Government of India. The new GIDH initiative will operate as a WHO-managed network and platform to support the implementation of the Global Strategy on Digital Health 2020–2025. WHO serves as the Secretariat for the strategy implementation to converge and convene global standards, best practices and resources to fast track digital health system transformation.   The GIDH initiative aims to bring countries and partners together to achieve measurable outcomes by: developing clear priority-driven investment plans for digital health transformation; improving reporting and transparency of digital health resources; facilitating knowledge exchange and collaboration across regions and countries to accelerate progress; supporting whole-of-government approaches for digital health governance in countries; and increasing technical and financial support to the implementation of the Global Strategy on Digital Health 2020–2025 and its next phase. WHO and partners have announced substantial commitments in cash and kind from multiple stakeholders to support the launch of this new Initiative.   ]]> https://biospectrumindia.com/news/57/23381/who-publishes-new-global-action-plan-on-epilepsy-and-other-neurological-disorders.html https://biospectrumindia.com/news/57/23381/who-publishes-new-global-action-plan-on-epilepsy-and-other-neurological-disorders.html Fri, 21 Jul 2023 00:00:00 +0530 The World Health Organisation (WHO)’s Intersectoral Global Action Plan (IGAP) on epilepsy and other neurological disorders, published in all six UN languages, sets out the actions needed to improve access to care and treatment for people living with neurological disorders through a comprehensive, coordinated response across sectors. Neurological disorders are the leading cause of disability-adjusted life years and a 2020 Lancet paper cites them as the second leading cause of death globally, accounting for 9 million deaths a year. Despite the high global burden of neurological conditions, access to both services and support for these conditions is insufficient, especially in low- and middle-income countries.  The action plan outlines five strategic objectives: to raise policy prioritization and strengthen governance; to provide effective, timely and responsive diagnosis, treatment and care; to implement strategies for promotion and prevention; to foster research and innovation and strengthen information systems; and to strengthen the public health approach to epilepsy. Actions suggested under each strategic objective are aimed at countries and partners, with WHO providing technical support and guidance in the implementation of the plan. There are 10 global targets with measurable indicators to track the achievement of the objectives by 2031. To achieve these targets, the plan also outlines the close collaboration required between stakeholders in the health sector and beyond, as well as the need to support the participation and empowerment of people with neurological disorders, their carers and families. ]]> https://biospectrumindia.com/news/57/23366/using-ai-to-speed-up-vaccine-development-against-disease-x.html https://biospectrumindia.com/news/57/23366/using-ai-to-speed-up-vaccine-development-against-disease-x.html Thu, 20 Jul 2023 00:00:00 +0530 Norway-based Coalition for Epidemic Preparedness Innovations (CEPI), and the Houston Methodist Research Institute (HMRI), US have announced a partnership to combine cutting-edge artificial intelligence (AI) technology with established laboratory techniques to speed up development of future vaccines against novel viral threats (also known as Disease X). Disease X is a placeholder name that was adopted by the World Health Organisation in February 2018 on their shortlist of blueprint priority diseases to represent a hypothetical, unknown pathogen that could cause a future epidemic. HMRI will lead a consortium including experts from Argonne National Laboratory (University of Chicago), J Craig Venter Institute, La Jolla Institute, The University of Texas Medical Branch, and The University of Texas, Austin. CEPI will provide up to $4.98 million to HMRI to advance the application of AI to analyse the structures of viruses from priority viral families from which the next Disease X is likely to emerge. These AI approaches will be used to identify target pieces of protein in the virus that stimulate the immune system, known as epitopes. The HMRI-led consortium will initially focus their efforts on paramyxoviruses and arenaviruses, viral families which include the likes of Nipah virus and Lassa virus, respectively. AI experts from the HMRI, University of Texas-Austin, La Jolla Institute, and Argonne National Laboratory (University of Chicago) will use machine-learning approaches to optimise the design of potential epitopes. The University of Texas Medical Branch will then validate the immunogenicity of these potential vaccine candidates using established preclinical models. Should a new pathogen emerge in future, vaccine developers could quickly respond by selecting AI-identified epitopes that would have already been validated in preclinical tests, thereby enabling vaccine candidates to be moved quickly into clinical testing.   ]]> https://biospectrumindia.com/news/57/23361/childhood-immunisation-begins-recovery-after-covid-19-backslide.html https://biospectrumindia.com/news/57/23361/childhood-immunisation-begins-recovery-after-covid-19-backslide.html Wed, 19 Jul 2023 00:00:00 +0530 Global immunisation services reached 4 million more children in 2022 compared to the previous year, as countries stepped up efforts to address the historic backsliding in immunisation caused by the COVID-19 pandemic. According to data published by the World Health Organisation (WHO) and UNICEF, in 2022, 20.5 million children missed out on one or more vaccines delivered through routine immunisation services, compared to 24.4 million children in 2021. In spite of this improvement, the number remains higher than the 18.4 million children who missed out in 2019 before pandemic-related disruptions, underscoring the need for ongoing catch-up, recovery and system strengthening efforts. The vaccine against diphtheria, tetanus and pertussis (DTP) is used as the global marker for immunisation coverage. Of the 20.5 million children who missed out on one or more doses of their DTP vaccines in 2022, 14.3 million did not receive a single dose, so-called zero-dose children. The figure represents an improvement from the 18.1 million zero-dose children in 2021 but remains higher than the 12.9 million children in 2019. Early stages of recovery in global immunisation have not occurred equally, with the improvement concentrated in a few countries. Progress in well-resourced countries with large infant populations, such as India and Indonesia, masks slower recovery or even continued declines in most low-income countries, especially for measles vaccination.     ]]> https://biospectrumindia.com/news/57/23351/novartis-acquires-rna-medicine-delivery-startup-dtx-pharma-for-500-m.html https://biospectrumindia.com/news/57/23351/novartis-acquires-rna-medicine-delivery-startup-dtx-pharma-for-500-m.html Mon, 17 Jul 2023 00:00:00 +0530 DTx Pharma, a US-based preclinical stage biotechnology startup addressing the delivery challenges of oligonucleotide therapeutics with its Fatty Acid Ligand Conjugated OligoNucleotide (FALCON) platform, has been acquired by Swiss multinational pharmaceutical corporation Novartis. The FALCON platform enables the delivery and activity of small interfering RNA (siRNA) therapeutics to tissues beyond the liver, enhancing biodistribution and cellular uptake. DTx Pharma's lead programme is currently in preclinical development, with FDA Orphan Drug Designation, for the treatment of Charcot-Marie-Tooth Disease Type 1A (CMT1A). CMT1A is a progressive, neuromuscular, autosomal-dominant disease that can lead to life-long loss of muscle function and disability. Currently, there are no approved therapeutics addressing PMP22, the underlying genetic cause of CMT1A, for the estimated 150,000 patients living with the debilitating disease in the United States and Europe. In addition to the CMT1A programme, Novartis has acquired full rights to the FALCON platform and two other early-stage programmes in neuromuscular and central nervous system (CNS) indications. Under the terms of the agreement, Novartis will make an upfront payment of $500 million and additional payments of up to $500 million upon completion of pre-specified milestones.   ]]> https://biospectrumindia.com/news/57/23312/12-african-countries-to-receive-18-m-doses-of-first-ever-malaria-vaccine.html https://biospectrumindia.com/news/57/23312/12-african-countries-to-receive-18-m-doses-of-first-ever-malaria-vaccine.html Mon, 10 Jul 2023 00:00:00 +0530 Twelve countries across different regions in Africa are set to receive 18 million doses of the first-ever malaria vaccine over the next two years. The roll out is a critical step forward in the fight against one of the leading causes of death in the continent. The RTS,S/AS01 vaccine, developed by a public–private partnership in 2001 between GlaxoSmithKline (GSK) and Programme for Appropriate Technology in Health or PATH's Malaria Vaccine Initiative, with support from the Bill and Melinda Gates Foundation to PATH, has been administered to more than 1.7 million children in Ghana, Kenya and Malawi since 2019 and has been shown to be safe and effective, resulting in a substantial reduction in severe malaria and a fall in child deaths. At least 28 African countries have expressed interest in receiving the malaria vaccine. In addition to Ghana, Kenya and Malawi, the initial 18 million dose allocation will enable nine more countries, including Benin, Burkina Faso, Burundi, Cameroon, the Democratic Republic of the Congo, Liberia, Niger, Sierra Leone and Uganda, to introduce the vaccine into their routine immunisation programmes for the first time. This allocation round makes use of the supply of vaccine doses available to Gavi, Vaccine Alliance via UNICEF. The first doses of the vaccine are expected to arrive in countries during the last quarter of 2023, with countries starting to roll them out by early 2024. ]]> https://biospectrumindia.com/news/57/23226/who-prequalifies-additional-hpv-test.html https://biospectrumindia.com/news/57/23226/who-prequalifies-additional-hpv-test.html Sat, 17 Jun 2023 00:00:00 +0530 The World Health Organisation (WHO) has added a fourth test to the list of prequalified tests for human papillomavirus (HPV). Although most HPV infections clear up on their own, some high-risk types could lead to cervical cancer. Testing for HPV infection is an integral part of cervical cancer screening. WHO’s prequalification (PQ) programme for in vitro diagnostics (IVDs) evaluates a range of tests, including those used for the detection of high-risk HPV genotypes in cervical cancer screening. The addition of another product to the PQ list expands the range of high-performance tests that are available to countries, especially in instances where governments, UN agencies, or partners rely on the WHO scheme to aid their procurement. The recent addition of Roche Molecular Systems Inc.’s cobas HPV assay now brings the total number of listed tests up to four, joining QIAGEN GmBH’s careHPV Test, Abbott GmbH’s Abbott RealTime High Risk HPV, and Cepheid AB’s Xpert HPV. Even in countries where the HPV vaccine is introduced, screening programmes remain critical to identify and treat cervical pre-cancer and cancer, to reduce cervical cancer incidence and deaths.   ]]> https://biospectrumindia.com/news/57/23219/nccn-debuts-roadmap-for-improving-thyroid-cancer-care-in-lmics.html https://biospectrumindia.com/news/57/23219/nccn-debuts-roadmap-for-improving-thyroid-cancer-care-in-lmics.html Thu, 15 Jun 2023 00:00:00 +0530 The National Comprehensive Cancer Network (NCCN), an alliance of 33 cancer centers in the United States, is introducing a new global resource to improve thyroid cancer care in low- and middle-income countries (LMICs) at the upcoming World Congress on Thyroid Cancer, in London. During the event, NCCN Senior Vice President and Chief Medical Officer, Wui-Jin Koh, MD, will present on NCCN's ongoing global work to define and advance high-quality, high-value, patient-centered cancer care. As part of that work, the non-profit alliance of leading cancer centers recently published the new NCCN Framework for Resource Stratification of NCCN Guidelines (NCCN Framework) for Thyroid Carcinoma, available free-of-charge at NCCN.org/global. The new resource will debut in front of more than 1,000 cancer care providers from across the globe on June 17, 2023. NCCN Framework exists for numerous cancer types—covering more than 80 percent of cancer diagnoses—plus supportive care topics such as pain management, palliative care, and breast cancer prevention and detection. The NCCN Framework for Thyroid Carcinoma is the first new cancer type to be added to this library in recent years. More than 500,000 people are diagnosed with thyroid cancer worldwide every year. The NCCN Framework for Thyroid Carcinoma provides guidance on the optimal treatment approach for differentiated thyroid cancers in resource-constrained settings. ]]> https://biospectrumindia.com/news/57/23192/who-and-global-fund-announce-commitment-for-enhanced-collaboration-to-tackle-communicable-diseases.html https://biospectrumindia.com/news/57/23192/who-and-global-fund-announce-commitment-for-enhanced-collaboration-to-tackle-communicable-diseases.html Thu, 08 Jun 2023 00:00:00 +0530 The World Health Organisation (WHO) and the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) have signed a new and revised Strategic Framework for Collaboration, designed to build stronger and more resilient health systems and maximise collaboration and impact in support of country, regional and global responses to major communicable diseases.  The new five-year framework builds on the previous agreement signed in 2018. It aligns with the 2023-2028 Global Fund Strategy and the WHO General Programme of Work, which put communities at the centre of the health response and also address pandemic preparedness and challenges posed by climate change. The framework fits with broader collaboration platforms to accelerate support to countries to achieve the health-related Sustainable Development Goals (SDGs) including Universal Health Coverage (UHC).  Through this new framework, WHO and the Global Fund will be leveraging their comparative strengths across 35 areas for collaboration divided into 4 categories: Health policies and normative guidance Advocacy and health governance Health products and innovations Technical support and capacity building ]]> https://biospectrumindia.com/news/57/23177/european-commission-who-launch-initiative-to-strengthen-global-health-security.html https://biospectrumindia.com/news/57/23177/european-commission-who-launch-initiative-to-strengthen-global-health-security.html Mon, 05 Jun 2023 00:00:00 +0530 The World Health Organisation (WHO) and European Commission have announced the launch of a landmark digital health partnership.   In June 2023, WHO will take up the European Union (EU) system of digital COVID-19 certification to establish a global system that will help facilitate global mobility and protect citizens across the world from on-going and future health threats, including pandemics. This is the first building block of the WHO Global Digital Health Certification Network (GDHCN) that will develop a wide range of digital products to deliver better health for all. Based on the EU Global Health Strategy and WHO Global strategy on digital health, the initiative follows the 30 November 2022 agreement between Commissioner Kyriakides and Dr Tedros to enhance strategic cooperation on global health issues. This further bolsters a robust multilateral system with WHO at its core, powered by a strong EU. This partnership will include close collaboration in the development, management and implementation of the WHO GDHCN system, benefitting from the European Commission’s ample technical expertise in the field. A first step is to ensure that the current EU digital certificates continue to function effectively. This partnership will work to technically develop the WHO system with a staged approach to cover additional use cases, which may include, for example, the digitisation of the International Certificate of Vaccination or Prophylaxis. Expanding such digital solutions will be essential to deliver better health for citizens across the globe.   ]]> https://biospectrumindia.com/news/57/23156/g20-global-pharma-summit-2023-series-to-be-held-across-20-major-cities.html https://biospectrumindia.com/news/57/23156/g20-global-pharma-summit-2023-series-to-be-held-across-20-major-cities.html Fri, 26 May 2023 00:00:00 +0530   The Chief Minister of Andhra Pradesh, YS Jagan Mohan Reddy, recently unveiled the brochure of the highly anticipated G20 Global Pharma Summit 2023 Series. The launch of this series signifies a significant step towards addressing global healthcare challenges and promoting technological advancements. Following the resounding success of the Global Tech Summit held in various G20 cities, including Vizag, Zurich, Amsterdam, and Rome, the G20 Global Pharma Summit Series and G20 Health Summit Series will be hosted in major cities across the G20 countries. The cities include Riyadh, Seoul, Tokyo, Rome, Paris, New York, Melbourne, Beijing, London, and New Delhi. These global summits will serve as unparalleled platforms for experts, researchers, and industry leaders to come together, share knowledge, and contribute to the advancement of healthcare and technology on a global scale. The G20 Global Pharma Summit Series and G20 Health Summit Series led by the Pulsus Group are organised in collaboration with esteemed international partners, such as Walsh Medical Media from the USA, Conference Series from the UK, Longdom Group from Belgium, Ashdin Publishing from the Middle East, and EuroSciCon from the European Union Conference Group.  These summits aim to identify and recognize subject experts in major fields of healthcare and technology, offering them a unique platform to showcase their expertise and contribute to global advancements. Additionally, the events provide an opportunity for startup companies to promote their ventures, network with potential investors and collaborators, and raise funds to further their innovative projects.  Chief Minister YS Jagan Mohan Reddy expressed his support and highlighted the importance of showcasing investment opportunities in Vizag and Andhra Pradesh during the series of summits.   ]]> https://biospectrumindia.com/news/57/23139/us-fda-approves-new-treatment-for-pneumonia-caused-by-certain-difficult-to-treat-bacteria.html https://biospectrumindia.com/news/57/23139/us-fda-approves-new-treatment-for-pneumonia-caused-by-certain-difficult-to-treat-bacteria.html Wed, 24 May 2023 00:00:00 +0530 The US Food and Drug Administration (FDA) has approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. The FDA has granted the approval of Xacduro to US-based Entasis Therapeutics, established in 2015 as a spin-out from and with initial funding from AstraZeneca. According to the World Health Organisation, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines. Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam. Sulbactam kills A. baumannii whereas durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii. Xacduro is administered by intravenous infusion. Patients should not receive Xacduro if they have a history of known severe hypersensitivity to components of Xacduro, sulbactam or other beta-lactam antibacterial drugs. The FDA granted Xacduro Fast Track, Qualified Infectious Disease Product and Priority Review designations for this application.  ]]> https://biospectrumindia.com/news/57/23129/who-establishes-global-network-to-detect-and-prevent-infectious-disease-threats.html https://biospectrumindia.com/news/57/23129/who-establishes-global-network-to-detect-and-prevent-infectious-disease-threats.html Mon, 22 May 2023 00:00:00 +0530 The World Health Organisation (WHO) and partners are launching a global network to help protect people from infectious disease threats through the power of pathogen genomics. The International Pathogen Surveillance Network (IPSN) will provide a platform to connect countries and regions, improving systems for collecting and analyzing samples, using these data to drive public health decision-making, and sharing that information more broadly. Pathogen genomics analyses the genetic code of viruses, bacteria and other disease-causing organisms to understand how infectious they are, how deadly they are, and how they spread. With this information, scientists and public health officials can identify and track diseases to prevent and respond to outbreaks as part of a broader disease surveillance system, and to develop treatments and vaccines. Despite recent scale-up in genomics capacity in countries as a result of the COVID-19 pandemic, many still lack effective systems for collecting and analyzing samples or using those data to drive public health decision-making. There is not enough sharing of data, practices, and innovations to build a robust global health surveillance architecture. Budgets that soared during the pandemic, allowing a rapid build-up of capabilities, are now being slashed, even in the wealthiest countries. The IPSN will tackle these challenges through a global network, connecting geographies and disease-specific networks, to build a collaborative system to better detect, prevent and respond to disease threats.  ]]> https://biospectrumindia.com/news/57/23096/google-launches-ai-powered-solutions-to-accelerate-drug-discovery.html https://biospectrumindia.com/news/57/23096/google-launches-ai-powered-solutions-to-accelerate-drug-discovery.html Wed, 17 May 2023 00:00:00 +0530 Google Cloud has announced two new artificial intelligence (AI)-powered life sciences solutions to accelerate drug discovery and precision medicine for biotech companies, pharmaceutical firms, and public sector organisations. Available worldwide today, the Target and Lead Identification Suite helps researchers better identify the function of amino acids and predict the structure of proteins; and the Multiomics Suite accelerates the discovery and interpretation of genomic data, helping companies design precision treatments.  Google Cloud's Target and Lead Identification Suite enables biopharma companies to bring therapeutics to market faster by enabling more efficient in silico drug design. Its target identification will help companies quickly predict antibody structures, assess the structure and function of amino acid mutagenesis, and accelerate de novo protein design. This solution also enables lead optimisation that can be used to discover novel, high-quality candidates at low cost for Quantitative Structure Activity Relationship (QSAR) studies or for Free Energy Perturbation (FEP) calculations. In addition, Google Cloud's Multiomics Suite advances precision medicine care by transforming multiomics data into insights to advance scientific discoveries.  ]]> https://biospectrumindia.com/news/57/23085/who-calls-for-accelerated-action-to-reduce-anaemia.html https://biospectrumindia.com/news/57/23085/who-calls-for-accelerated-action-to-reduce-anaemia.html Mon, 15 May 2023 00:00:00 +0530 The World Health Organisation (WHO) has launched its first-ever comprehensive framework on reducing anaemia, calling on countries to accelerate action to halve anaemia prevalence in women of reproductive age by 2025. Progress on reducing anaemia has been slow and the world is not on track to reach the global target. Anaemia is a serious global public health problem, affecting 571 million women and 269 million young children worldwide. In 2019, anaemia affected 40% of children between 6 months and 5 years of age, 37% of pregnant women and 30% of women 15–49 years of age. It is most prevalent in low- and middle-income countries. The new framework sets forth ways to address the direct causes, risk factors and broad social inequities that are fundamental drivers for anaemia. It describes the necessarily comprehensive approach that brings together multiple sectors and actors, and lays out key action areas to improve the coverage and uptake of interventions Acknowledging that health remains the predominant sector for delivering many of the recommended interventions, the framework also proposes actions that other societal stakeholders can take. These include governments, civil society, academia, researchers, funding agencies, international organisations and media. Each has its particular role to perform in reducing anaemia and keeping people healthy.   ]]> https://biospectrumindia.com/news/57/23082/roche-launches-institute-of-human-biology-to-accelerate-breakthroughs-in-rd-.html https://biospectrumindia.com/news/57/23082/roche-launches-institute-of-human-biology-to-accelerate-breakthroughs-in-rd-.html Fri, 12 May 2023 00:00:00 +0530 Swiss pharmaceutical firm Roche has announced the launch of the Institute of Human Biology (IHB) focusing on advancing research in the field of human model systems such as organoids. Leveraging human model systems, the institute aims to accelerate drug discovery and development by improving the understanding of how organs function and how diseases develop. Ultimately, this will help to bring medicines to patients faster. These efforts will also enable early testing of which drug candidates are safe and which molecules would work best for each patient. Human model systems are miniature 2D or 3D living 'replicas' of human tissues and organs that scientists create from human stem cells. By mirroring human and disease biology more accurately than animal models, they can also help reduce the reliance on animal testing. In addition, human model systems may enable the discovery of new human biology (in health and disease) and identification of drug targets that are impossible to find with classical discovery approaches. Scientists and bioengineers from academia and the pharmaceutical industry will work together at the newly launched institute based in Basel, Switzerland. The IHB is expected to grow to around 250 scientists and bioengineers over the next four years. ]]> https://biospectrumindia.com/news/57/23032/gavi-outlines-plans-to-build-sustainable-supply-of-malaria-vaccines.html https://biospectrumindia.com/news/57/23032/gavi-outlines-plans-to-build-sustainable-supply-of-malaria-vaccines.html Sat, 29 Apr 2023 00:00:00 +0530 The world’s first effective malaria vaccine is finally available, but supply must grow significantly to meet demand. With an estimated 40-60 million doses currently to be needed by 2026 alone, growing to 80-100 million doses of vaccines needed each year by 2030, Gavi, the Vaccine Alliance, has published a white paper outlining actions that must be taken by governments, vaccine manufacturers and health agencies to meet this goal. With 475,000 deaths of children under the age of 5 in 2021 on the African continent alone, malaria remains one of Africa’s biggest killers, despite concerted efforts that have seen the global death toll drop by a third since 2000. The pre-qualification of the world’s first malaria vaccine – RTS,S/AS01e, developed and manufactured by GSK and which took more than three decades to develop – will save more lives, while a second vaccine, R21/Matrix-M, developed by Oxford University and manufactured by Serum Institute of India (SII), could also be prequalified and recommended by WHO very soon. The major impediment that now stands in the way of a widespread roll out of malaria vaccines in endemic countries is supply. According to Gavi’s market shaping roadmap for malaria vaccines, a production target of 40-60 million doses by 2026 is needed to meet countries’ needs, increasing to 80-100 million doses by 2030. Such an outcome would require countries and partners to work together in key areas such as demand forecasting, boosting the number of suppliers and technology transfer, the report argues. The report also outlines Gavi’s commitment to additional co-financing to ensure countries can access doses, support for countries to make timely applications, and fostering further innovation in malaria vaccination and greater integration with existing interventions. ]]> https://biospectrumindia.com/news/57/23018/who-takes-new-initiative-to-improve-pandemic-preparedness.html https://biospectrumindia.com/news/57/23018/who-takes-new-initiative-to-improve-pandemic-preparedness.html Thu, 27 Apr 2023 00:00:00 +0530 To help countries better prepare for future pandemics, the World Health Organisation (WHO) has launched a new initiative that provides guidance on integrated planning for responding to any respiratory pathogen such as influenza or coronaviruses. The new Preparedness and Resilience for Emerging Threats Initiative, or PRET, incorporates the latest tools and approaches for shared learning and collective action established during the COVID-19 pandemic and other recent public health emergencies.  Through the initiative, WHO will use a mode of transmission approach to guide countries in pandemic planning, given that many capacities and capabilities are common among groups of pathogens. PRET answers the call for technical guidance and support for promoting and strengthening integrated preparedness and response, as outlined in World Health Assembly resolutions.  The PRET Initiative’s first module focuses on respiratory pathogens, including influenza, coronaviruses, and respiratory syncytial virus. Given the ongoing COVID-19 pandemic and the possible threat of avian influenza, this module will enable countries to critically review, test, and update their respiratory pandemic planning efforts to ensure they have the functional capacities and capabilities in place. A process is underway to identify the next group of pathogens, such as arboviruses, to be addressed under this initiative. This will follow priorities identified through the ten proposals to strengthen the global architecture for health emergency preparedness, response, and resilience (HEPR).    ]]> https://biospectrumindia.com/news/57/22984/abbott-announces-new-global-consortium-partnership-to-address-viral-outbreaks.html https://biospectrumindia.com/news/57/22984/abbott-announces-new-global-consortium-partnership-to-address-viral-outbreaks.html Fri, 21 Apr 2023 00:00:00 +0530 American multinational medical devices and healthcare company Abbott is partnering with the Climate Amplified Disease and Epidemics (CLIMADE) consortium, a group of more than 100 global scientists in public health agencies, academia and industry focused on using data science technology and diagnostic testing to assess and potentially mitigate the impact climate change has on disease outbreaks. Research has found that climate change could impact more than half of known infectious diseases, which commonly spread via water or animals carrying diseases, such as West Nile virus and malaria. As part of the consortium, scientists trained in infectious diseases, bioinformatics and data science will develop technologies that can aggregate environmental, weather and viral sequencing data sets to predict if conditions could cause a disease outbreak. If a potential outbreak is identified, resources and rapid surveillance testing can be sent to that location to prevent further spread. The CLIMADE consortium will be focused on improving surveillance tools and expanding access to resources to decrease the impact of climate amplified diseases and epidemics.  Abbott and its partners in the Abbott Pandemic Defense Coalition will provide viral sequencing and testing data as part of the technology being developed and can provide diagnostic testing for potential outbreaks. ]]> https://biospectrumindia.com/news/57/22955/major-boost-to-progress-in-tuberculosis-testing-as-diagnostics-partners-come-together.html https://biospectrumindia.com/news/57/22955/major-boost-to-progress-in-tuberculosis-testing-as-diagnostics-partners-come-together.html Mon, 17 Apr 2023 00:00:00 +0530 Foundation for Innovative New Diagnostics (FIND) and partners have announced a set of agreements between FIND, Johns Hopkins University, University of California San Francisco (UCSF), Rutgers University and Heidelberg University Hospital that bring together the Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB), DriveDx4TB (a Unitaid-funded project led by FIND), Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND-TB) and Rapid Research in Diagnostics Development for TB Network (R2D2) projects to form the largest-ever coordinated effort to accelerate tuberculosis (TB) diagnostic development. A Joint Steering Committee with representatives from each project has been established, to coordinate technology scouting activities, and refer products with potential to the appropriate project, depending on their needs and development stage. In-country clinical trials of different technologies will also be coordinated, leveraging a global clinical trial network spanning 10 low- and middle-income countries where the TB burden is highest. The 2030 goal of ending the TB epidemic remains ambitious, but the roadmap to get there is clear and diagnostic testing is a critical element to stop transmission and save lives. ]]> https://biospectrumindia.com/news/57/22956/africa-cdc-launches-pathogen-genomics-and-bioinformatics-fellowship-programme.html https://biospectrumindia.com/news/57/22956/africa-cdc-launches-pathogen-genomics-and-bioinformatics-fellowship-programme.html Mon, 17 Apr 2023 00:00:00 +0530 The Africa Centres for Disease Control and Prevention (CDC), a public health agency of the African Union has launched the Africa PGI – Pathogen Genomics and Bioinformatics Fellowship Programme, a continental workforce development programme targeting public health laboratories in the African Union Member States to improve the use of pathogen genomic data for outbreak detection and disease surveillance. Building on existing efforts and to further expand genomics capacity beyond COVID-19, the Africa CDC in partnership with the African Society for Laboratory Medicine (ASLM), and regional centers of excellence has developed and launched the Africa PGI Pathogen Genomics & Bioinformatics Fellowship Programme. The Africa PGI – Pathogen Genomics and Bioinformatics Fellowship Programme has 3 tracks; a wet-lab track (Next-Generation Sequencing of pathogens), a dry-lab track (Public health bioinformatics data analytics, interpretation, and reporting), and a track on genomic epidemiology to be included at a later stage. Overall, the fellowship programme aims to support technical experts and future leaders in public health pathogen genomics and bioinformatics in Africa. Over the course of the fellowship, participants will be trained on core competencies with a focus on genomics and data analytics for outbreak detection, viral and bacterial disease surveillance, antimicrobial resistance, and malaria surveillance. The fellowship will also provide opportunities for alumni and institutional networks to foster future collaborations across Africa. ]]> https://biospectrumindia.com/news/57/22957/therapy-for-rare-bone-disorder-shows-promise-in-us-based-clinical-trial.html https://biospectrumindia.com/news/57/22957/therapy-for-rare-bone-disorder-shows-promise-in-us-based-clinical-trial.html Mon, 17 Apr 2023 00:00:00 +0530 A clinical trial at the National Institutes of Health (NIH), in the US, found that a medication, denosumab, significantly reduced abnormal bone turnover in adults with fibrous dysplasia, a rare disease marked by weak and misshapen bones. Bone turnover, a process in which old bone is continuously replaced with new bone, is unusually accelerated in fibrous dysplasia and contributes to bone abnormalities. The study of eight participants was carried out by researchers from the National Institute of Dental and Craniofacial Research (NIDCR) and the NIH Clinical Center. The results showed that denosumab may improve patients’ quality of life by enabling healthy bone formation. Fibrous dysplasia stems from gene mutations that cause scar-like (fibrous) tissue to replace healthy bone starting in early childhood. These fibrous lesions, which are marked by accelerated bone turnover, weaken bones, leading to bone deformities, fractures, physical disabilities, and pain. In some cases, the lesions can press up against organs and nerves, impairing functions like vision and breathing. Denosumab is a medication licensed by the US Food and Drug Administration to treat bone problems from osteoporosis and cancer.  This trial is the culmination of 25 years of clinical research at NIDCR to understand the underlying mechanisms of fibrous dysplasia and to identify promising treatments. ]]> https://biospectrumindia.com/news/57/22952/who-lays-focus-on-improving-access-to-novel-covid-19-treatments.html https://biospectrumindia.com/news/57/22952/who-lays-focus-on-improving-access-to-novel-covid-19-treatments.html Sat, 15 Apr 2023 00:00:00 +0530 The World Health Organisation (WHO) together with Unitaid and with the support of Medicines Law & Policy, have published a briefing document to support country access to affordable COVID-19 treatments.  This briefing document is a factual explanation of some of the legal instruments that WHO Member States can use to promote public health and access to COVID 19 therapeutics in the framework of their multilateral trade obligations and rights, and according to their national legislation and level of development.  It is intended to support countries dealing with challenges at the intersection of public health and intellectual property, to increase access to novel COVID-19 therapeutics and to facilitate alternative and more affordable sourcing of such treatments, where possible.  The briefing document contains background information and resources on the therapeutics landscape and WHO recommendations; an overview of the Medicines Patent Pool licenses for oral antivirals and the implications for country access; the WHO COVID-19 Technology Access Pool; other licenses relevant to COVID-19 therapeutics; and guidance on the use of Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities.  ]]> https://biospectrumindia.com/news/57/22877/yale-university-and-who-to-scale-up-behavioural-sciences-for-better-health-initiative.html https://biospectrumindia.com/news/57/22877/yale-university-and-who-to-scale-up-behavioural-sciences-for-better-health-initiative.html Thu, 30 Mar 2023 00:00:00 +0530 The Yale Research Initiative on Innovation and Scale (Y-RISE) and the World Health Organisation’s (WHO) Behavioural Insights Unit (BI-Unit) have signed a Memorandum of Understanding (MoU) agreeing to work together over the next two years to contribute to the shared goals of promoting and enabling systematic use of the behavioural and social sciences in public health, designing, and scaling up evidence-based behavioural interventions. Behavioural insights can help improve understanding on how and why people behave in ways that affect their health, and help design policies and services that address behavioural factors for improved physical and mental well-being. WHO and Y-RISE will work together to respond to requests for technical support for the planning and design stage of pilot behavioural interventions as well as requests for examining complexities of scaling up behavioural interventions. They will also give strategic advice in the area of application of behavioural sciences to public health and capacity building. Under the scope of this new partnership, Yale and WHO will exchange of information about latest advances in scaling of behavioural interventions; lead collaborative projects to examine the impact of behavioural interventions in public health, including the complexities of scaling up such interventions; jointly develop research proposals and presentations for stakeholders interested in applying behavioural science approaches to their programming; and deliver joint trainings on the science of scaling up behavioural sciences in public health policies and programmes. ]]> https://biospectrumindia.com/news/57/22868/who-certifies-azerbaijan-and-tajikistan-as-malaria-free.html https://biospectrumindia.com/news/57/22868/who-certifies-azerbaijan-and-tajikistan-as-malaria-free.html Wed, 29 Mar 2023 00:00:00 +0530 The World Health Organisation (WHO) has certified Azerbaijan and Tajikistan for achieving elimination of malaria in their territories. The certification follows a sustained, century-long effort to stamp out the disease by the two countries. Certification of malaria elimination is the official recognition by WHO of a country’s malaria-free status. The certification is granted when a country has shown – with rigorous, credible evidence – that the chain of indigenous malaria transmission by Anopheles mosquitoes has been interrupted nationwide for at least the past three consecutive years.  A country must also demonstrate the capacity to prevent the re-establishment of transmission.  Azerbaijan detected its last case of locally transmitted Plasmodium vivax (P.vivax) malaria in 2012 and Tajikistan in 2014. With this announcement, a total of 41 countries and 1 territory have been certified as malaria-free by WHO, including 21 countries in the European Region.  Malaria control efforts in Azerbaijan and Tajikistan were strengthened through a range of investments and public health policies that enabled the governments, over time, to eliminate the disease and maintain malaria-free status. Both Azerbaijan and Tajikistan utilise national electronic malaria surveillance systems that provide nearly real-time detection of cases and allow for rapid investigations to determine if an infection is local or imported. Additional interventions include biological methods of larvae control, such as mosquito-eating fish, and water management measures to reduce malaria vectors. ]]> https://biospectrumindia.com/news/57/22871/hj-foundation-opens-new-health-centre-in-congo.html https://biospectrumindia.com/news/57/22871/hj-foundation-opens-new-health-centre-in-congo.html Wed, 29 Mar 2023 00:00:00 +0530 Harish Jagtani’s HJ Foundation, a non-profit organisation focused on providing healthcare services to underprivileged sections of society, has opened a new healthcare centre in Kinshasa, Congo. This new facility will exclusively serve residents of the local community who are struggling to access affordable healthcare. The centre will offer a wide range of free medical services, including general medicine, dialysis, ophthalmology and prosthetic limbs. It will provide basic laboratory testing, as well as radiology services. Harish Jagtani, a Jaipur-born industrialist and philanthropist, has been operating in the Democratic Republic of Congo for the past two decades and has been running various businesses, such as cargo, real estate and healthcare. His foundation has been serving the people of this country relentlessly by hosting regular health camps, such as dialysis, malaria, ophthalmology and many more. Jagtani said, “Through this clinic, the foundation will have its own dialysis centre to treat patients suffering from kidney infections. It will also have a service called ‘Jaipur Foot’, which will take care of people living with disabilities by distributing prostheses for both upper and lower limbs.”  He added, “I’m pleased to inform you that malaria will also be fully covered by the foundation, which will dispense the drugs required for its treatment during its campaign against this mosquito menace. This clinic will, additionally, offer hospitalisation to all patients waiting to undergo cataract and glaucoma surgery.” ]]> https://biospectrumindia.com/news/57/22841/who-steps-up-director-generals-flagship-initiative-to-combat-tuberculosis.html https://biospectrumindia.com/news/57/22841/who-steps-up-director-generals-flagship-initiative-to-combat-tuberculosis.html Fri, 24 Mar 2023 00:00:00 +0530 The World Health Organisation (WHO) has announced the expanded scope of the WHO Director-General’s (DG) Flagship Initiative on tuberculosis (TB) over the period from 2023 to 2027 to support fast-tracking progress towards ending TB and achieving Universal Health Coverage (UHC) by 2030.  The WHO DG flagship initiative on TB builds on the progress achieved and lessons learned from 2018-2022. It aims to scale up the delivery of quality care to people living with TB through equitable access to WHO-recommended rapid diagnostics, shorter all-oral treatment for infection and disease, increasing their access to social protection and other innovations including digital tools for health. As part of the DG Flagship initiative, a special call to action is being issued by WHO and partners urging Member States to accelerate the rollout of new WHO-recommended shorter all-oral treatment regimens for drug-resistant TB. Drug-resistant TB continues to be a pressing public health concern, taking a significant toll on individuals affected by TB, communities, and healthcare systems worldwide. In 2021, nearly half a million people fell ill with multidrug- or rifampicin-resistant TB (MDR/RR-TB), only one in three accessed treatment. In September 2023, the UN General Assembly will convene three High-Level Meetings focusing on UHC, pandemic preparedness and response and ending TB. There are clear linkages between these agendas and the Heads of State will deliberate to accelerate action, including on the goal to end TB.  ]]> https://biospectrumindia.com/news/57/22846/world-bank-provides-100-m-to-improve-healthcare-systems-in-bosnia-and-herzegovina.html https://biospectrumindia.com/news/57/22846/world-bank-provides-100-m-to-improve-healthcare-systems-in-bosnia-and-herzegovina.html Fri, 24 Mar 2023 00:00:00 +0530 The World Bank Board has approved a EUR92.30 million ($100 million equivalent) Health Sectors Programmatic Development Policy Loan for Bosnia and Herzegovina (BiH). The programme will provide budget support to underpin policy efforts by BiH authorities to improve the financial sustainability of the healthcare systems and quality of health services its citizens receive. This programme aims to improve the financial sustainability of health institutions, by helping clear arrears in the health sector and introduce measures that would prevent the generation of new arrears. It also aims to introduce incentives for improved service delivery and stronger primary healthcare, as well as reforms to improve environmental management and strengthen tobacco control. The design of this programme was informed and supported by a complementary World Bank programme, the Health Systems Improvement Project, and technical assistance, including a functional review of the sector’s performance and ongoing activities to strengthen the transparency and accountability of health systems in BiH. The World Bank portfolio of active projects in BiH comprises 12 operations totaling around $720 million. Areas of support include healthcare, road modernisation, employment and social protection, energy efficiency, local infrastructure, environment. ]]> https://biospectrumindia.com/news/57/22826/who-signs-partnership-agreement-with-mapaction.html https://biospectrumindia.com/news/57/22826/who-signs-partnership-agreement-with-mapaction.html Tue, 21 Mar 2023 00:00:00 +0530 MapAction has signed the Standby Partnership Agreement with the World Health Organisation (WHO) which will allow the UK-based emergency response and disaster preparedness charity to have greater impact in health emergencies.  The agreement will see MapAction volunteers ready on standby to deploy to any health emergency operations at the request of WHO. This will help bring the organisation’s unique data-driven approach to saving lives in even more health crises worldwide.  The Standby Partnership Agreement will streamline and simplify how MapAction can deploy to WHO emergency operations at short notice. The agreement states that MapAction will maintain a roster of standby personnel for the rapid mobilisation and deployment of pre-screened individuals to WHO emergency operations. MapAction has already lent data management, geospatial and mapping support in 13 health-related emergency deployments worldwide since 2014. Teams of volunteers from the Oxfordshire-based charity were involved in providing support in the Ebola crisis in West Africa, as well as during the more recent COVID-19 pandemic. A team of MapAction volunteers is also currently working on a project to reduce the impacts of cholera in Malawi.  ]]> https://biospectrumindia.com/news/57/22791/pfizer-invests-43-b-to-advance-battle-against-cancer.html https://biospectrumindia.com/news/57/22791/pfizer-invests-43-b-to-advance-battle-against-cancer.html Mon, 13 Mar 2023 00:00:00 +0530 American pharmaceutical company Pfizer Inc. has entered into a definitive merger agreement under which Pfizer will acquire Seagen, a US-based biotechnology company that discovers, develops and commercialises transformative cancer medicines, for $229 in cash per Seagen share for a total enterprise value of $43 billion. The Boards of Directors of both companies have unanimously approved the transaction. Seagen expects to generate approximately $2.2 billion of revenue in 2023, representing 12% year-over-year growth, from its four in-line medicines, royalties and collaboration and license agreements. When combining the expected strong growth trajectories for these medicines with candidates that could emerge from Seagen's pipeline, subject to clinical trial and regulatory success, Pfizer believes Seagen could contribute more than $10 billion in risk-adjusted revenues in 2030, with potential significant growth beyond 2030. Seagen is a pioneer in antibody-drug conjugate (ADC) technology, with four of the twelve total FDA-approved and marketed ADCs using its technology industry-wide. ADCs are a transformative modality that is emerging as a powerful tool across a broad range of cancers designed to preferentially kill cancer cells and limit off-target toxicities. Seagen has developed a leadership position in ADC technologies since its founding 25 years ago, with groundbreaking and proprietary technology that is positioned for significant growth in 2023 and beyond.  ]]> https://biospectrumindia.com/news/57/22784/polio-programme-in-pakistan-renews-ties-with-medical-associations.html https://biospectrumindia.com/news/57/22784/polio-programme-in-pakistan-renews-ties-with-medical-associations.html Fri, 10 Mar 2023 00:00:00 +0530 Renowned paediatricians and medical associations have renewed full support to the Pakistan Polio Eradication Programme to interrupt wild poliovirus transmission this year. Office-bearers of the Pakistan Paediatrics Association (PPA), Pakistan Islamic Medical Association (PIMA), Pakistan Medical Association (PMA) and their provincial chapters, and doctors, including paediatricians from the seven polio endemic districts of southern Khyber Pakhtunkhwa, pledged to promote polio vaccines and routine immunisation at a roundtable meeting held at the National Emergency Operations of Center (NEOC) for Polio Eradication in Islamabad recently. The meeting was held to rally support from medical professionals to increase vaccine acceptance in parents and caregivers and counter negative misperceptions among communities about vaccines. The programme is making initiatives to stamp out paralytic poliovirus from Pakistan and efforts to increase community engagement and dialogue. Repeated immunisations have protected millions of children from polio, allowing almost all countries in the world to become polio-free, besides the two endemic countries of Pakistan and Afghanistan. ]]> https://biospectrumindia.com/news/57/22769/merck-assumes-2023-to-be-challenging-with-negative-foreign-exchange-effects.html https://biospectrumindia.com/news/57/22769/merck-assumes-2023-to-be-challenging-with-negative-foreign-exchange-effects.html Thu, 09 Mar 2023 00:00:00 +0530 Merck, a leading science and technology company, delivered profitable growth despite challenges in fiscal 2022. Group net sales increased by 12.9% (organically: 6.4%) to € 22,232 million compared with the previous year. Sales growth was driven by all regions and business sectors, particularly Life Science. The Big 3 businesses – Process Solutions and Life Science Services, new Healthcare products as well as Semiconductor Solutions – accounted for almost 90% of the organic growth in sales. But Merck assumes that 2023 will be a challenging year. Based on current assumptions, Merck expects negative foreign exchange effects of about -1% to -4% to weigh on both net sales and EBITDA pre. The growth of its life science business sector is subject to higher volatility due to the varying developments across product groups and customer segments. Increased research and development activity as well as higher production volumes among pharmaceutical companies, especially in the biopharmaceutical segment, are the key drivers of growth in the key business. ]]> https://biospectrumindia.com/news/57/22779/new-who-guide-to-enhance-advocacy-for-life-saving-emergency-care.html https://biospectrumindia.com/news/57/22779/new-who-guide-to-enhance-advocacy-for-life-saving-emergency-care.html Thu, 09 Mar 2023 00:00:00 +0530 A new practical guide released by the World Health Organisation (WHO) supports non-governmental organisations to more effectively advocate for life-saving emergency care. Around the world, acutely ill and injured people seek care every day for medical, surgical and obstetric emergencies, including injuries resulting from road traffic crashes. The guide clearly defines the role that non-governmental organizations can have and offers concrete actions for more effective and impactful advocacy. Developed collaboratively by WHO, including the WHO Global Alliance for Care of the Injured, and the Global Alliance of NGOs for Road Safety, Advocating for emergency care: a guide for non-governmental organisations is especially targeted towards non-governmental organisations that operate with limited resources. It proposes a step-by-step advocacy framework that encourages its users to assess the terrain, prepare to act, take action and review progress. A series of case studies from around the world and links to useful resources are also included. Rudi Eggers, Director of the WHO Department of Integrated Health Services said, “This new guide furthers WHO’s mandate to strengthen emergency care systems and support the development of quality, timely emergency care accessible to all.” ]]> https://biospectrumindia.com/news/57/22783/us-finds-temperature-stable-tb-vaccine-safe-with-prompt-immune-response.html https://biospectrumindia.com/news/57/22783/us-finds-temperature-stable-tb-vaccine-safe-with-prompt-immune-response.html Wed, 08 Mar 2023 00:00:00 +0530 A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. The Phase 1 trial was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the US. A non-temperature stable form of the candidate previously had been tested in several clinical trials. However, this was the first clinical trial of any subunit TB vaccine candidate in a temperature-stable (thermostable) form. The investigators note some limitations in this small trial. For example, no established correlates of protection define what immune responses are required for vaccine-induced protection from TB disease. Therefore, it is not possible to say whether the enhanced immune responses seen in the thermostable vaccine formulation would translate to improved protective vaccine efficacy. Nevertheless, they conclude, results of this trial demonstrate “a proof-of-concept that adjuvant-containing vaccines can be formulated in a freeze-dried single-vial presentation without detrimentally impacting clinical immunogenicity or safety characteristics.” ]]> https://biospectrumindia.com/news/57/22782/new-emergency-medical-department-set-up-to-support-health-needs-in-afghanistan.html https://biospectrumindia.com/news/57/22782/new-emergency-medical-department-set-up-to-support-health-needs-in-afghanistan.html Tue, 07 Mar 2023 00:00:00 +0530 The World Health Organisation (WHO), through support from the European Civil Protection and Humanitarian Aid Operations (ECHO), has launched a new emergency medical department in Mirwais Regional Hospital in Kandahar, Afghanistan.   Mirwais Regional Hospital in Kandahar City is a 600-bed facility serving nearly 2 million people in the Region. Despite this, 357 000 people in the region, which has been extensively affected by conflict, live in an underserved area with little access to health care services, especially outside of the city. The new Emergency Unit aims to serve better the people of Kandahar and the neighbouring Helmand, Zabul and Oruzgan. Mirwais Regional Hospital is also the teaching hospital for Kandahar University's Faculty of Medicine. The emergency room has a 15-bed capacity, in which WHO has supplied the required medical equipment, including patient beds, patient monitors, suction machines beside cupboards, 2 ventilators, patient mattresses and linen. WHO is also providing medical kits and supplies. ]]> https://biospectrumindia.com/news/57/22785/bangladesh-launches-two-medical-convoys-for-surgeries-in-children.html https://biospectrumindia.com/news/57/22785/bangladesh-launches-two-medical-convoys-for-surgeries-in-children.html Tue, 07 Mar 2023 00:00:00 +0530 Qatar Red Crescent Society (QRCS) recently launched two medical convoys in Bangladesh, deploying volunteering medical professionals from Hamad Medical Corporation (HMC) and Sidra Medicine to perform general surgery and cardiac catheterisation operations for children at Teknaf Hospital (Cox's Bazar) and the National Institute of Cardiovascular Diseases (NICVD) (Dhaka), respectively. They involve free-of-charge surgeries and cardiac catheterisations for low-income refugees at camps and the host community, while the health facilities are struggling in those underserved and overpopulated areas and the other international organisations are focusing on different humanitarian/health needs. This causes health complications and threatens the lives of hundreds of poor patients. During day 1, they performed 17 catheterszations, out of the target of 90 catheterisations for children with congenital heart defects, at a cost of $179,135. At the same time, the general surgery convoy delegation arrived at Teknaf Hospital and met the hospital’s management to discuss the action plan, review the operating room’s equipment and medical consumables store, and examine the patients who would be treated, totaling 140 surgeries, at a cost of $83,751.  ]]> https://biospectrumindia.com/news/57/22780/who-promotes-access-to-ear-and-hearing-care-in-communities.html https://biospectrumindia.com/news/57/22780/who-promotes-access-to-ear-and-hearing-care-in-communities.html Sat, 04 Mar 2023 00:00:00 +0530 The World Health Organisation (WHO) has released a new primary ear and hearing care training manual to assist countries in building the capacity of their health workforce to provide ear and hearing care at the community level.  The manual is a practical guide on the prevention, identification and management of hearing loss and common ear diseases and can be used to train health workers and doctors who work at community level primary healthcare facilities. It contains modules on the mechanism of hearing, conducting ear examination and hearing assessment, guidance on prevention, management, and referral of common ear diseases, as well as rehabilitation of hearing loss. It includes hands on practical activities for skill development.    In most places, services for ear and hearing problems remain mainly limited to the tertiary or secondary levels of care, and are provided by highly skilled professionals such as ear, nose and throat (ENT) specialists and audiologists.  Globally, there is shortage of highly trained ear and hearing care professionals which is a big challenge towards providing ear and hearing care for all. The majority of low- and middle-income countries have less than one ENT specialist and one audiologist per million population.    Governments must take steps to integrate ear and hearing care and empower their workforce through training programmes.  ]]> https://biospectrumindia.com/news/57/22781/new-grant-to-improve-management-of-healthcare-waste-in-egypt.html https://biospectrumindia.com/news/57/22781/new-grant-to-improve-management-of-healthcare-waste-in-egypt.html Thu, 02 Mar 2023 00:00:00 +0530 The World Bank has announced a $9.13 million grant from the Global Environment Facility (GEF) to expand the scope of the Greater Cairo Air Pollution Management and Climate Change Project in Egypt. This grant will reinforce the environmental benefits of the original project, both at the local and global levels, by improving the management of electronic and healthcare waste.  The original project - approved in 2021- supports Egypt’s efforts to reduce pollution in Greater Cairo, with a focus on reducing vehicle emissions, improving the management of solid waste, and strengthening the air and climate decision-making system. The generation of healthcare waste is rapidly increasing in Egypt, as in other countries, as a result of COVID-19, expanding healthcare systems, increased utilization of single-use items, and poor waste segregation practices. The current treatment and disposal practices of healthcare and electronic waste need to be improved in order to reduce the release of more uPOPs (unintentional persistent organic pollutants). Public health studies indicate that exposure to uPOPS poses many health threats including respiratory problems, skin disorders, acute brain damage, stroke, asthma, coughing, bronchitis, reduced lung development, and high blood pressure. Workers who collect and process this waste are at the greatest risk as they come into direct contact with hazardous material.          ]]> https://biospectrumindia.com/news/57/22688/global-research-links-mental-health-and-self-harm-with-encephalitis.html https://biospectrumindia.com/news/57/22688/global-research-links-mental-health-and-self-harm-with-encephalitis.html Wed, 22 Feb 2023 00:00:00 +0530 Two new, ground-breaking research papers, from authors in the UK and Mexico published for World Encephalitis Day on 22nd February 2023, have identified that Encephalitis patients are at a high risk of suicide and self-harm.  The UK paper titled ‘Mental health outcomes of encephalitis’, an international web-based study, surveyed 445 respondents from 31 countries and found that 37.5% of survivors of Encephalitis reported they had thought about or attempted suicide.  The Mexican paper ‘Suicidal thoughts and behaviors in Anti-Nmdar Encephalitis: Psychopathological features and clinical outcomes’ published in the Journal of Neuropsychiatry and Clinical Neurosciences, gained data from 120 patients and found that 12.5% of patients had suicidal behaviours during early stages of the illness with nearly half carrying out a suicide attempt. Both papers have been released in association with the Encephalitis Society to help raise awareness of World Encephalitis Day which takes place on 22nd February 2023.  Encephalitis is an inflammation of the brain.  It can occur at any age, in any part of the world and is caused either by infection, usually viral, or by a person’s own immune system going wrong.  There are over 5,00,000 reported cases of encephalitis around the world each year with mortality up to 40% depending on the cause.   Dr Ava Easton, CEO of the Encephalitis Society and co-author on both papers said, “These impactful and important research papers raise awareness that suicidality can be a not uncommon and serious manifestation of encephalitis in the early stages as a result of the illness, during relapses, and perhaps later in people’s journey of recovery." ]]> https://biospectrumindia.com/news/57/22612/abbott-buys-cardiovascular-systems-inc-for-890-m.html https://biospectrumindia.com/news/57/22612/abbott-buys-cardiovascular-systems-inc-for-890-m.html Thu, 09 Feb 2023 00:00:00 +0530 American firms Abbott and Cardiovascular Systems, Inc. (CSI) have announced a definitive agreement for Abbott to acquire CSI, a medical device company with an innovative atherectomy system used in treating peripheral and coronary artery disease. Under terms of the agreement, CSI stockholders will receive $20 per common share at a total expected equity value of approximately $890 million. CSI is a leader in devices for atherectomy, a minimally invasive treatment for plaque build-up in arteries that can restrict blood flow. Procedural use of atherectomy can help maximise the benefits of standard balloon angioplasty or stent treatments in restoring blood flow in complex arterial disease. CSI also has an early-stage pipeline of complementary vascular intervention devices in development. "The acquisition of CSI will add new, complementary technologies to Abbott's leading vascular device offerings," said Lisa Earnhardt, executive vice president, Medical Devices, Abbott. "CSI has a talented and experienced team and a leading atherectomy system that will allow Abbott to provide physicians more tools to help patients live fuller lives." Scott Ward, CSI's chairman, president and chief executive officer said, "We believe combining with Abbott delivers value to our patients, physician customers, employees and stockholders while continuing our work to save limbs and save lives every day."   ]]> https://biospectrumindia.com/news/57/22600/world-health-organisation-releases-new-global-breast-cancer-initiative-framework.html https://biospectrumindia.com/news/57/22600/world-health-organisation-releases-new-global-breast-cancer-initiative-framework.html Tue, 07 Feb 2023 00:00:00 +0530 The World Health Organisation (WHO) has released a new Global Breast Cancer Initiative Framework providing a roadmap to attain the targets to save 2.5 million lives from breast cancer by 2040. The new Framework recommends to countries to implement the three pillars of health promotion for early detection, timely diagnosis and comprehensive management of breast cancer to reach the targets.   There are more than 2.3 million cases of breast cancer that occur each year, which make it the most common cancer among adults.   The newly published framework leverages proven strategies to design country-specific, resource-appropriate, health systems for the delivery of breast-cancer care in low- and middle-income settings. It outlines three pillars of action with specific key performance indicators:   Recommending countries to focus on breast cancer early-detection programmes so that at least 60% of the breast cancers are diagnosed and treated as early-stage disease. Diagnosing breast cancer within 60 days of initial presentation can improve breast cancer outcomes. Treatment should start within three months of first presentation. Managing breast cancer so that at least 80% of patients complete their recommended treatment. Accelerating the implementation of WHO’s Global Breast Cancer Initiative has the potential to avert not only millions of avoidable female cancer deaths but also the associated, intergenerational consequences of these deaths.   ]]> https://biospectrumindia.com/news/57/22575/launch-of-global-individual-patient-data-platform-for-tuberculosis-treatment.html https://biospectrumindia.com/news/57/22575/launch-of-global-individual-patient-data-platform-for-tuberculosis-treatment.html Thu, 02 Feb 2023 00:00:00 +0530 The World Health Organisation (WHO) has announced the publicly accessible global individual patient data (IPD) platform for tuberculosis treatment (TB-IPD), an initiative that will increase the knowledge base for normative guidance on optimal treatment modalities for tuberculosis (TB) and stimulate TB research.  This secure platform already contains individual records with treatment outcomes of over 5,000 TB patients with commitments from additional data contributors to increase this number to up to 50,000 during 2023 including data on TB treatment in children and pregnancy. The TB-IPD platform provides a powerful opportunity for learning and advancement of the field of TB treatment. Requests for access to data from, or to contribute more data to the TB-IPD platform can be made as of today by following the processes described on the TB-IPD platform website. Secure storage, data protection and quality control mechanisms compliant with modern data privacy and human right laws, appropriate governance structures and acknowledgement of data owners are critical for success and these were key considerations for WHO during development of the concept and the selection of the team at UCL as the data curator. ]]> https://biospectrumindia.com/news/57/22555/investments-key-to-sustain-progress-for-eliminating-neglected-tropical-diseases-who.html https://biospectrumindia.com/news/57/22555/investments-key-to-sustain-progress-for-eliminating-neglected-tropical-diseases-who.html Tue, 31 Jan 2023 00:00:00 +0530 On World Neglected Tropical Disease (NTD) Day, on 30th January, the World Health Organisation (WHO) releases a new progress report, entitled “Global report on neglected tropical diseases 2023” highlighting the progress and challenges in delivering NTD care worldwide, against a backdrop of COVID-19-related disruptions. Although as many as 179 countries and territories reported at least one case of NTDs in 2021, 16 countries accounted for 80% of the global NTD burden. Around 1.65 billion people were estimated to require treatment for at least one NTD, globally. The new progress report shows that the number of people requiring NTD interventions fell by 80 million between 2020 and 2021, and eight countries were certified or validated as having eliminated one NTD in 2022 alone. As of December 2022, 47 countries had eliminated at least one NTD and more countries were in the process of achieving this target.  The new report emphasises greater efforts and investments required to reverse delays and accelerate progress towards the NTD road map targets by 2030. Promoting country ownership and accountability, as well as the sustainability and predictability of financing, including more robust domestic funding, are key to achieving the NTD road map goals and enabling countries to deliver on their commitments to provide quality NTD services to affected populations.   ]]> https://biospectrumindia.com/news/57/22538/who-and-gilead-sciences-to-enhance-access-to-treatment-for-visceral-leishmaniasis.html https://biospectrumindia.com/news/57/22538/who-and-gilead-sciences-to-enhance-access-to-treatment-for-visceral-leishmaniasis.html Fri, 27 Jan 2023 00:00:00 +0530 The World Health Organisation (WHO) and US-based biopharmaceutical firm Gilead Sciences have signed a new agreement for the donation of 304,700 vials of AmBisome (liposomal amphotericin B for injection), for the treatment of visceral leishmaniasis (VL) in countries most impacted by the disease, extending their previous agreement to 2025. The new three-year collaboration (2023-2025), estimated at $11.3 million also includes financial assistance that will support improved coverage and access to diagnosis and treatment for affected communities due to visceral leishmaniasis. The product donation will benefit affected populations in high-burden countries such as Bangladesh, Ethiopia, India, Kenya, Nepal, Somalia, South Sudan, Sudan, and Uganda along with expansion to include Eritrea, and Yemen as new recipients to treat severe and complicated cases. Gilead Science’s financial assistance will support WHO’s global efforts to prevent, control, and eliminate visceral leishmaniasis and its impact on the disadvantaged and vulnerable populations in many endemic countries. Visceral leishmaniasis also known as kala-azar, is endemic in 80 countries worldwide. It is the most serious form of leishmaniasis as it is fatal without treatment. The disease is highly endemic in Brazil, the Indian subcontinent, and East Africa. As a result of this longstanding collaboration, VL morbidity in South East Asia was reduced by more than 82 percent and the case fatality decreased by 95 percent. An estimated 50,000–90,000 new cases occur worldwide each year. Over 90 percent of new cases are reported from seven countries: Brazil, Ethiopia, India, Kenya, Somalia, South Sudan, and Sudan. However, just six years ago, case estimates ranged up to 300,000 cases per year.    ]]> https://biospectrumindia.com/news/57/22522/cepi-and-institut-pasteur-de-dakar-to-boost-manufacturing-of-affordable-vaccines-for-global-south.html https://biospectrumindia.com/news/57/22522/cepi-and-institut-pasteur-de-dakar-to-boost-manufacturing-of-affordable-vaccines-for-global-south.html Mon, 23 Jan 2023 00:00:00 +0530 Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) and the Institut Pasteur de Dakar (IPD), Africa have announced a partnership that will advance equitable access to vaccines in Africa and contribute to the African Union’s goal of increasing African manufacturers’ share of vaccine supply to the continent to 60% by 2040. The collaboration will boost the manufacturing of affordable vaccines at IPD’s facilities in Dakar, and reserve capacity to produce vaccines specifically for Global South countries during future outbreaks and pandemics to combat the kind of inequity that characterised the response to COVID-19. CEPI is creating a new network of vaccine manufacturers in Global South countries to substantially increase the world’s capacity and capability to produce vaccines against emerging outbreaks and pandemic threats. IPD will initially receive up to $15 million in grant funding over three years, with the option to extend the partnership’s scope and funding to a total of up to $50 million over 10 years.  The first phase of the partnership will support the development and sustainability of IPD’s manufacturing facilities for routine and outbreak vaccinations across multiple vaccine technologies and prepare them to begin supplying vaccines to Global South countries within 100 days of a new pathogen being identified. ]]> https://biospectrumindia.com/news/57/22505/who-announces-plans-to-establish-tb-vaccine-accelerator-council.html https://biospectrumindia.com/news/57/22505/who-announces-plans-to-establish-tb-vaccine-accelerator-council.html Thu, 19 Jan 2023 00:00:00 +0530 Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organisation (WHO) has announced plans to establish a new Tuberculosis (TB) Vaccine Accelerator Council. The Council will facilitate the licensing and use of effective novel TB vaccines catalysing high-level alignment between funders, global agencies, governments and end users in identifying and overcoming barriers to TB vaccine development. Despite countries making bold commitments to end TB by 2030, in the Sustainable Development Goals, the WHO End TB Strategy and the 2018 political declaration on the fight against TB, the epidemic shows no sign of slowing down. In 2021, approximately 10.6 million people fell sick with TB, and 1.6 million died. Drug-resistance continues to be a major problem with close to half a million people developing drug-resistant TB every year. BCG is currently the only licensed TB vaccine. While it provides moderate efficacy in preventing severe forms of TB in infants and young children, it does not adequately protect adolescents and adults, who account for close to 90% of TB transmissions globally. A recent WHO commissioned study, An investment case for new tuberculosis (TB) vaccines estimates that, over 25 years, a vaccine that is 50% effective in preventing disease among adolescents and adults could avert up to 76 million new TB cases, 8.5 million deaths, 42 million courses of antibiotic treatment and US$ 6.5 billion in costs faced by TB affected households, especially for the poorest and most vulnerable. A vaccine that is 75% effective could avert up to 110 million new TB cases and 12.3 million deaths. The study further suggests that every $1 invested in a 50% effective vaccine could generate an economic return of $7 in terms of averted health costs and increased productivity.   ]]> https://biospectrumindia.com/news/57/22483/who-updates-covid-19-guidelines-on-masks-treatments-and-patient-care.html https://biospectrumindia.com/news/57/22483/who-updates-covid-19-guidelines-on-masks-treatments-and-patient-care.html Sun, 15 Jan 2023 00:00:00 +0530 The World Health Organisation (WHO) has updated its guidelines on mask wearing in community settings, COVID-19 treatments, and clinical management. This is part of a continuous process of reviewing such materials, working with guideline development groups composed of independent, international experts who consider the latest available evidence and the changing epidemiology. WHO continues to recommend the use of masks by the public in specific situations, and this update recommends their use irrespective of the local epidemiological situation, given the current spread of the COVID-19 globally. WHO advises that a COVID-19 patient can be discharged from isolation early if they test negative on an antigen-based rapid test. Without testing, for patients with symptoms, the new guidelines suggest 10 days of isolation from the date of symptom onset. Previously, WHO advised that patients be discharged 10 days after symptom onset, plus at least three additional days since their symptoms had resolved. For those who test positive for COVID-19 but do not have any signs or symptoms, WHO now suggests 5 days of isolation in the absence of testing, compared to 10 days previously. WHO has extended its strong recommendation for the use of nirmatrelvir-ritonavir (also known by its brand name ‘Paxlovid’). Nirmatrelvir-ritonavir was first recommended by WHO in April 2022. WHO strongly recommends its use in mild or moderate COVID-19 patients who are at high-risk of hospitalisation. ]]> https://biospectrumindia.com/news/57/22466/indegene-expands-europe-presence-with-new-centre-in-germany.html https://biospectrumindia.com/news/57/22466/indegene-expands-europe-presence-with-new-centre-in-germany.html Tue, 10 Jan 2023 00:00:00 +0530 Bengaluru-based Indegene, a digital-first, life sciences commercialisation company, has announced the launch of a new centre in Germany, expanding its client-focused consulting and management team in the region. With this centre, Indegene is further strengthening its presence in Europe to help life sciences companies fast-track digital transformation across the commercialisation value chain. Indegene’s local expert teams will work closely with clients in Germany and across Europe to provide consulting services and healthcare solutions. Indegene already has a significant presence in Europe, with centres in the UK, Ireland, and Switzerland. In 2019, Indegene acquired DT Associates, a consulting services company in the UK, supporting clients in the healthcare and life sciences space. Indegene supports many leading life sciences clients in the region in a variety of ways across the commercialization value chain. Medicine spending in Germany is expected to rise from $64.6 billion in 2021 to $76-96 billion at a CAGR of 4.5-7.5% (2022-2026).  With six operation hubs and 16 offices located across North America, Europe, and Asia, Indegene’s client base includes 19 of the 20 largest biopharmaceutical companies, many emerging biotech companies, and medical device companies. ]]> https://biospectrumindia.com/news/57/22401/cepi-expands-partnership-with-brighton-collaboration-to-support-safety-assessment-of-vaccine-candidates.html https://biospectrumindia.com/news/57/22401/cepi-expands-partnership-with-brighton-collaboration-to-support-safety-assessment-of-vaccine-candidates.html Thu, 22 Dec 2022 00:00:00 +0530 Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration, based at The Task Force for Global Health, have announced the expansion of a partnership contributing to the safety of future vaccines to prevent and respond to pandemics. The CEPI-funded Safety Platform for Emergency Vaccines (SPEAC), managed by the Brighton Collaboration, provides crucial scientific expertise from an international network of vaccine safety experts to CEPI-backed projects.  The team played a key role during the development and roll-out of COVID-19 vaccines through the Brighton Collaboration’s efforts to create harmonized guidelines for collection of data on potential side effects. The renewed partnership will see CEPI provide up to $23 million over four years to broaden the scope of the Safety Platform for Emergency vACcines (SPEAC) programme to deliver world-leading vaccine safety guidance and support for CEPI’s 5-year strategy – known as CEPI 2.0 – and the organisation’s 100 Days Mission which aims to compress the development of new vaccines against pathogens with pandemic potential to just 100 days. SPEAC will continue its ongoing work to support the safety assessment of vaccines and platforms in the CEPI portfolio, and will implement additional projects building on the lessons of its work to date. These include developing guidance and tools to safely enable earlier inclusion of special populations, such as pregnant women, into clinical trials; and supporting the digital transformation of vaccine safety endpoint definitions and tools by building a mobile application for the collection of safety data during early use of new vaccines. ]]> https://biospectrumindia.com/news/57/22378/price-reduction-for-expanding-access-to-highly-effective-mdr-tuberculosis-treatment.html https://biospectrumindia.com/news/57/22378/price-reduction-for-expanding-access-to-highly-effective-mdr-tuberculosis-treatment.html Mon, 19 Dec 2022 00:00:00 +0530 Viatris, a global healthcare company headquartered in the US, MedAccess, and TB Alliance have announced a new agreement to reduce the price of pretomanid, a drug used to treat multidrug-resistant (MDR) tuberculosis (TB), by 34%. Pretomanid is part of two new treatment regimens with high efficacy and shorter treatment durations recently recommended by the World Health Organisation (WHO) as the preferred regimens for most drug-resistant tuberculosis patients. Pretomanid (Pa) is used in combination with bedaquiline (B), linezolid (L), and sometimes moxifloxacin (M) to form BPaL and BPaLM – six-month, all-oral treatment regimens, found to be effective at curing 89-91% MDR-TB patients.  In July 2020, the Drug Controller General of India (DCGI) had approved the TB drug pretomanid (developed specifically for certain drug-resistant forms of the disease) for conditional access under the National Tuberculosis Elimination Program (NTEP), making India the second country in the world to provide regulatory approval for this product.  A volume guarantee to be provided by MedAccess to Viatris will see the ceiling price of pretomanid reduced to $240 Ex Works  per six-month treatment course. It will help to bring both BPaL and BPaLM substantially closer to $500 per patient course. Governments and global procurers are expected to make direct savings of $15.6 million thanks to the guarantee, with additional savings for national healthcare budgets as they care for fewer patients with long-term MDR-TB. The new ceiling price will be available to more than 140 governments, and NGOs and public sector procurers purchasing pretomanid in those countries.   ]]> https://biospectrumindia.com/news/57/22362/study-reveals-recommended-anticoagulant-therapy-for-covid-19-patients.html https://biospectrumindia.com/news/57/22362/study-reveals-recommended-anticoagulant-therapy-for-covid-19-patients.html Wed, 14 Dec 2022 00:00:00 +0530 The AustralaSian COVID-19 Trial (ASCOT) has pinpointed the most efficient level of blood thinning treatment needed for patients hospitalised with COVID-19, in a study published in the New England Journal of Medicine Evidence and presented at the American Society for Hematology conference. Patients in hospital with COVID-19 are at increased risk of blood clots (or thromboses), which in turn may contribute to development of organ failure. Almost all these patients will receive some degree of blood thinning medication. In an international study, the ASCOT team conducted a randomised clinical trial to test different levels of anticoagulation (or blood thinning) in more than 1,500 patients in Australia, New Zealand, India and Nepal. They found that an intermediate level of anticoagulation had an 86% probability of being better than low dose anticoagulation. A higher therapeutic dose did not show any benefit. Anticoagulant use is recommended in all guidelines including in India but the most effective and safest dose is not known. This trial was done to find out the dose that provided the most benefit at the lowest risk. This trial is especially relevant to India as 1273 out of 1526 participants were recruited in Indian hospitals.  According to Professor Vivekanand Jha, Executive Director at The George Institute for Global Health, India, “Even as the case numbers were low in Australia and New Zealand, existing network relationships allowed us to take the trial to India and Nepal, where COVID-19 was active and successfully complete this study that asks a question of global relevance. The rapid subject recruitment during the difficult time of the delta wave is a testimony to the commitment of site investigators and study staff in these centres.”   ]]> https://biospectrumindia.com/news/57/22345/agilent-unveils-new-customer-experience-centre-in-us.html https://biospectrumindia.com/news/57/22345/agilent-unveils-new-customer-experience-centre-in-us.html Fri, 09 Dec 2022 00:00:00 +0530 Agilent Technologies Inc. has announced the opening of a new Customer Experience Center (CEC) in Lexington, MA, in the US, focused on solutions from Agilent genomics and diagnostics product portfolios. The facility will serve as a regional hub for Agilent representatives to showcase and demonstrate both product capabilities and complete workflow solutions to customers. Hands-on training, education, assay development, and optimization are critical to a laboratory’s success. Scientists are looking for suppliers to support their discovery work and product and solution development efforts. The new Agilent CEC delivers an immersive experience for pathologists, clinicians, and researchers to increase their confidence in using Agilent products to meet the unique needs of their lab. The facility is strategically located where Agilent has a high concentration of genomics and pathology customers who can easily access the CEC.The new CEC boasts an efficient layout to demonstrate workflows for next-generation sequencing (NGS) and pathology in clinical and research applications. It also provides a location for novel application development and collaborations. The suite of Agilent genomics and pathology instrumentation, paired with the expertise of Agilent’s technical staff, provides the necessary combination to support customers with needed comprehensive training while continuing to foster collaboration between Agilent and their customers. ]]> https://biospectrumindia.com/news/57/22318/who-recommends-new-name-for-monkeypox-disease.html https://biospectrumindia.com/news/57/22318/who-recommends-new-name-for-monkeypox-disease.html Tue, 29 Nov 2022 00:00:00 +0530 Following a series of consultations with global experts, the World Health Organisation (WHO) will begin using a new preferred term “mpox” as a synonym for monkeypox. Both names will be used simultaneously for one year while “monkeypox” is phased out. Assigning names to new and, very exceptionally, to existing diseases is the responsibility of WHO under the International Classification of Diseases (ICD) and the WHO Family of International Health Related Classifications through a consultative process which includes WHO Member States. WHO, in accordance with the ICD update process, held consultations to gather views from a range of experts, as well as countries and the general public, who were invited to submit suggestions for new names. Based on these consultations, and further discussions with WHO’s Director-General Dr Tedros Adhanom Ghebreyesus, WHO recommends that the synonym mpox will be included in the ICD-10 online in the coming days. It will be a part of the official 2023 release of ICD-11, which is the current global standard for health data, clinical documentation and statistical aggregation. The issue of the use of the new name in different languages was extensively discussed.  The preferred term mpox can be used in other languages. ]]> https://biospectrumindia.com/news/57/22295/us-establishes-website-for-self-reporting-covid-19-test-results.html https://biospectrumindia.com/news/57/22295/us-establishes-website-for-self-reporting-covid-19-test-results.html Sat, 26 Nov 2022 00:00:00 +0530 Reporting a positive or negative test result just became easier through a new website from the National Institutes of Health (NIH) in the YS. MakeMyTestCount.org, developed through NIH’s Rapid Acceleration of Diagnostics (RADx) Tech programme, allows users to anonymously report the results of any brand of at-home COVID-19 test. Lab tests have a well-established technology system for sharing test results. RADx Tech has been working on a system to standardise test reporting for at-home tests in a secure manner. The MakeMyTestCount.org website is built on this system for logging test results. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) supported development of MakeMyTestCount.org through the RADx Tech programme.   The RADx initiative was launched on April 29, 2020, to speed innovation in the development, commercialisation, and implementation of technologies for COVID-19 testing. ]]> https://biospectrumindia.com/news/57/22283/who-to-identify-pathogens-likely-to-cause-future-outbreaks-and-pandemics.html https://biospectrumindia.com/news/57/22283/who-to-identify-pathogens-likely-to-cause-future-outbreaks-and-pandemics.html Wed, 23 Nov 2022 00:00:00 +0530 The World Health Organisation (WHO) is launching a global scientific process to update the list of priority pathogens, agents that can cause outbreaks or pandemics, to guide global investment, research and development (R&D), especially in vaccines, tests and treatments. WHO is convening over 300 scientists who will consider the evidence on over 25 virus families and bacteria, as well as “Disease X.” Disease X is included to indicate an unknown pathogen that could cause a serious international epidemic. The experts will recommend a list of priority pathogens that need further research and investment. The process will include both scientific and public health criteria, as well as criteria related to socioeconomic impact, access, and equity. The list was first published in 2017 and the last prioritisation exercise was done in 2018. The current list includes COVID-19, Crimean-Cong haemorrhagic fever, Ebola virus disease and Marburg virus disease, Lassa fever, Middle East respiratory syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), Nipah and henipaviral diseases, Rift Valley fever, Zika and Disease X. The revised list is expected to be published in the first quarter of 2023. ]]> https://biospectrumindia.com/news/57/22277/merck-buys-imago-biosciences-for-1-35-b-to-expand-growing-haematology-portfolio.html https://biospectrumindia.com/news/57/22277/merck-buys-imago-biosciences-for-1-35-b-to-expand-growing-haematology-portfolio.html Mon, 21 Nov 2022 00:00:00 +0530 Merck, known as MSD outside the United States and Canada, and Imago BioSciences, Inc. have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Imago for $36.00 per share in cash for an approximate total equity value of $1.35 billion. Robert M. Davis, president and chief executive officer, Merck said, “This acquisition of Imago augments our pipeline and strengthens our presence in the growing field of haematology.” Imago is a clinical stage biopharmaceutical company developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases. Imago’s lead candidate bomedemstat (IMG-7289), an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, is currently being evaluated in multiple Phase 2 clinical trials for the treatment of essential thrombocythemia (ET), myelofibrosis (MF), and polycythemia vera (PV), in addition to other indications. Under the terms of the acquisition agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Imago. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Imago’s outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the successful completion of the tender offer, Merck’s acquisition subsidiary will be merged into Imago, and any remaining shares of common stock of Imago will be canceled and converted into the right to receive the same $36 per share price payable in the tender offer.  ]]> https://biospectrumindia.com/news/57/22251/samsung-raises-the-bar-with-bioelectric-impedance-analysis-sensor-in-galaxy-watch.html https://biospectrumindia.com/news/57/22251/samsung-raises-the-bar-with-bioelectric-impedance-analysis-sensor-in-galaxy-watch.html Tue, 15 Nov 2022 00:00:00 +0530 Samsung has announced that Galaxy Watch has brought another revolution in the digital health and wellness space with ground-breaking Bioelectric Impedance Analysis sensor. A joint research team from Louisiana State University, Pennington Biomedical Research Center and the University of Hawaii Cancer Center performed a study to assess the accuracy of body composition data gathered from smartwatches. The study published by the American Journal of Clinical Nutrition (AJCN) reveals that Samsung Galaxy Watch could contribute to preventing or reducing obesity in its users. The study also found that Galaxy Watch devices were accurate in measuring body composition, with a precision comparable to laboratory results. The study underscores the promise of wearables in helping prevent or reduce obesity, a condition that is responsible for approximately 60% of cardiovascular disease deaths. Considered to be a chronic disease, obesity develops over time because of overnutrition and lack of physical activity. The ability to self-monitor one’s behaviour, particularly with data derived from wearables, improves the user’s understanding of their behaviour patterns, which resulted in an increase in physical activity in nearly 60% of users.     ]]> https://biospectrumindia.com/news/57/22228/global-vaccine-market-report-2022-focuses-on-consistent-inequities.html https://biospectrumindia.com/news/57/22228/global-vaccine-market-report-2022-focuses-on-consistent-inequities.html Thu, 10 Nov 2022 00:00:00 +0530 The World Health Organisation- WHO's Global Vaccine Market Report 2022, published on 9 November, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently struggling to access vaccines that are in-demand by wealthier countries. Limited vaccine supply and unequal distribution drive global disparities. The human papillomavirus (HPV) vaccine against cervical cancer has only been introduced in 41% of low-income countries, even though they represent much of the disease burden, compared to 83% of high-income countries. Affordability is also an obstacle to vaccine access. While prices tend to be tiered by income, price disparities see middle-income countries paying as much, or even more, than wealthier ones for several vaccine products. To drive ambitious action to deliver equitable access to vaccines, the report calls on governments to act on: clear immunisation plans and more aggressive investment and stronger oversight of vaccine development, production and distribution; regional research and manufacturing hubs; and pre-agreeing rules for government collaboration in times of scarcity on issues such as vaccine distribution, intellectual property and the circulation of inputs and goods. Recommended actions for industry include: focusing research efforts on WHO priority pathogens, ensuring transparency, facilitating technology transfer, and committing to specific equity-driven allocation measures. International organizations and partners should prioritize Immunization Agenda 2030 goals, support country-driven initiatives and push for the application of resolutions on market transparency. ]]> https://biospectrumindia.com/news/57/22221/who-inks-new-memorandum-of-understanding-on-health-workforce-priorities.html https://biospectrumindia.com/news/57/22221/who-inks-new-memorandum-of-understanding-on-health-workforce-priorities.html Wed, 09 Nov 2022 00:00:00 +0530 The World Health Organisation (WHO) has signed a Memorandum of Understanding (MoU) with the five members of the World Health Professions Alliance (WHPA): FDI World Dental Federation (FDI), International Pharmaceutical Federation (FIP), International Council of Nurses (ICN), World Physiotherapy, and World Medical Association (WMA). Together these five organisations represent more than 41 million health professionals worldwide and assemble essential knowledge and experience from the key health professions in more than 130 countries. This signing ceremony represents an historic event, bringing together the five global organisations representing the world’s dentists, pharmacists, nurses, physiotherapists and physicians with WHO to enhance their joint collaboration on protecting and investing in the health workforce to provide safe, quality and equitable care in all settings. It reflects the importance of investing in the health workforce through a multi-stakeholder integrated approach. It provides a framework for joint action between the five organisations and the WHO. They specifically commit to collaborate on priority health workforce issues as well as universal health coverage, noncommunicable diseases, and ageing populations. The framework will also contribute to reinforcing national and regional health systems and services. ]]> https://biospectrumindia.com/news/57/22211/roche-introduces-navify-brand-for-digital-health-solutions.html https://biospectrumindia.com/news/57/22211/roche-introduces-navify-brand-for-digital-health-solutions.html Mon, 07 Nov 2022 00:00:00 +0530 Roche announced recently at the HLTH 2022 meeting in Las Vegas, NV, US, that its digital health portfolio will now be available under the navify brand. The navify digital solutions help providers and patients 'navigate' and 'clarify' a wide range of touchpoints by activating insights that provide evidence on how to optimise operational processes and clinical decision making in healthcare. navify brings new ways to improve interoperability of digital infrastructure. Today limited abilities to seamlessly connect and share data costs healthcare systems an est. $30 billion in the US alone. It uses advanced analytics to deliver operational excellence, improved workflows, and patient-centric ways of working, A worldwide shortage of up to 15 million healthcare workers is predicted by 2030- providers face increasing workloads with less resources - finding additional efficiencies is a priority, navify generates advanced medical insights that augment clinical decision support. 2 in 3 physicians are unsure if they are over- or underusing diagnostics, compared to their peers. Moritz Hartmann, Head of Roche Information Solutions said, "We are creating open digital ecosystems with labs, hospitals and medtech companies to bring the latest innovations faster to society to better serve patients, and to support clinicians in providing care for patients. These activities support our strategy to deliver insights that drive personalised care."  ]]> https://biospectrumindia.com/news/57/22213/eli-lilly-to-begin-rollout-of-tempo-personalised-diabetes-management-platform-in-us.html https://biospectrumindia.com/news/57/22213/eli-lilly-to-begin-rollout-of-tempo-personalised-diabetes-management-platform-in-us.html Mon, 07 Nov 2022 00:00:00 +0530 Eli Lilly and Company will begin rollout of its first connected platform, the Tempo Personalised Diabetes Management Platform, later this year in the US. The technology aims to help adults living with type 1 or type 2 diabetes and clinicians make informed, data-backed decisions to manage treatment with Lilly insulins. The platform consists of three key components – the Tempo Smart Button; a compatible app, TempoSmart; and a prefilled insulin pen, Tempo Pen – which work together to deliver personalised guidance for adults with diabetes. The Smart Button was cleared by the US Food and Drug Administration on September 16. The compatible app was developed in partnership with Welldoc and is a private label iteration of the company's BlueStar, a diabetes management app, customised to receive insulin dose-related data from the Tempo Smart Button. Healthcare providers will have access to a clinician hub, Tempo Insights, where they can access data shared by their patients through the app and track patients' progress.  ]]> https://biospectrumindia.com/news/57/22205/avantor-opens-new-distribution-centre-in-ireland-to-support-biopharma-market.html https://biospectrumindia.com/news/57/22205/avantor-opens-new-distribution-centre-in-ireland-to-support-biopharma-market.html Thu, 03 Nov 2022 01:05:00 +0530 Avantor, Inc. has opened a new distribution centre in Dublin, Ireland. The nearly 69,000-square-foot facility is the most advanced distribution centre in Avantor's global network and places mission-critical products and operational support close to Avantor's customers, enhancing the security of supply. The new facility will offer certified Good Manufacturing Practice (cGMP) warehousing, on-site clean rooms, batch-to-batch traceability, custom palletization, inbound and outbound product quality inspections and vendor managed inventory solutions. The distribution centre is Avantor's second in Ireland, adding to its current footprint of 76,000-square-feet. The facility will also create 40 new jobs, adding to the 200 associates the company currently employs in Ireland. The site is part of a global footprint that includes more than 200 manufacturing, distribution and sales centers in over 30 countries that help ensure life-changing medicines reach patients quickly. This most recent investment demonstrates Avantor's commitment to strengthening its global biopharma supply chain. In October 2022, a new manufacturing and distribution hub in Singapore began initial operations. In 2021, the company opened a new logistics hub in Westminster, Massachusetts, a single-use solutions facility in Hillegom, Netherlands and completed major capacity expansions for critical process ingredients, excipients and single-use clean rooms in multiple sites across its network in Europe and the US.  These investments are in addition to capabilities and capacity added through the acquisitions completed in 2021 including Ritter GmbH, RIM Bio, and Masterflex. ]]> https://biospectrumindia.com/news/57/22200/johnson-johnson-buys-abiomed-for-16-6-b-to-strengthen-medtech-biz.html https://biospectrumindia.com/news/57/22200/johnson-johnson-buys-abiomed-for-16-6-b-to-strengthen-medtech-biz.html Wed, 02 Nov 2022 00:00:00 +0530 Johnson & Johnson and Abiomed have entered into a definitive agreement under which Johnson & Johnson will acquire through a tender offer all outstanding shares of Abiomed, for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion which includes cash acquired. Abiomed shareholders will also receive a non-tradeable contingent value right (CVR) entitling the holder to receive up to $35.00 per share in cash if certain commercial and clinical milestones are achieved. The transaction was unanimously approved by both companies’ boards of directors. The transaction broadens Johnson & Johnson MedTech’s (JJMT) position as a growing cardiovascular innovator, advancing the standard of care in one of healthcare’s largest unmet need disease states: heart failure and recovery. Abiomed is a leading, first-to-market provider of cardiovascular medical technology with a first-in-kind portfolio for the treatment of coronary artery disease and heart failure, an extensive innovation pipeline of life-saving technologies, and an 18-year track record of profitable growth. Abiomed operates in one of the fastest growing medtech segments with significant expansion opportunities in indication, geography, and product. ]]> https://biospectrumindia.com/news/57/22193/thermo-fisher-buys-the-binding-site-group-for-2-6-b.html https://biospectrumindia.com/news/57/22193/thermo-fisher-buys-the-binding-site-group-for-2-6-b.html Tue, 01 Nov 2022 00:00:00 +0530 Thermo Fisher Scientific Inc. has entered into a definitive agreement to acquire The Binding Site Group, a global leader in specialty diagnostics, from a shareholder group led by European private equity firm Nordic Capital, in an all-cash transaction valued at £2.25 billion, or $2.6 billion at current exchange rates. Serving clinicians and laboratory professionals worldwide, The Binding Site provides specialty diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders. The Binding Site’s Freelite offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications. Headquartered in Birmingham, United Kingdom, The Binding Site has more than 1,100 employees globally and is an active and influential contributor to the broader scientific community. As an established leader in a fast-growing segment in which patient care has shifted towards early diagnosis and monitoring via regular testing, The Binding Site has an attractive financial profile. Its business has been growing approximately 10% annually and is on track to deliver more than $220 million of revenue in 2022. The strong clinical value of The Binding Site offering enables doctors across the globe to support millions of patients every year. ]]> https://biospectrumindia.com/news/57/22185/thermo-fisher-to-invest-59-m-for-clinical-research-lab-expansion-in-us.html https://biospectrumindia.com/news/57/22185/thermo-fisher-to-invest-59-m-for-clinical-research-lab-expansion-in-us.html Fri, 28 Oct 2022 00:00:00 +0530 The PPD clinical research business of Thermo Fisher Scientific Inc., has announced plans to invest $59 million to significantly expand its laboratory operations in Highland Heights, Kentucky, US helping customers deliver life-changing medicines to patients. The current facility, which includes central lab and biomarker operations, provides biopharma customers with high-quality laboratory services to accelerate drug development. Much of the expansion involves adding to the business’ sample management and testing capacity to support new therapeutics, including vaccines and cell and gene therapy products. The current 71,600-square-foot operation will grow to 114,000 square feet and be completed in stages by the end of 2024, creating 200 new jobs over the next five years. The current operation employs nearly 650 Ph.D.-level scientists, analytical laboratory staff and other scientific and support professionals. The Highland Heights central lab, elements of which have been operating since 1988, offers safety testing including automated chemistry, urinalysis and hematology, anatomic pathology, flow cytometry, microbiology and molecular assays. The central lab also offers a wide variety of other services, such as clinical sample management, processing and storage, kit design and preparation for collection of clinical samples, and sample testing services. The biomarker lab provides support for regulated biomarkers with immunoassays, flow cytometry and molecular assays.   ]]> https://biospectrumindia.com/news/57/22164/idia-and-who-strengthen-strategic-collaboration-to-support-scale-up-of-health-innovations.html https://biospectrumindia.com/news/57/22164/idia-and-who-strengthen-strategic-collaboration-to-support-scale-up-of-health-innovations.html Tue, 25 Oct 2022 08:00:00 +0530 The World Health Organisation (WHO) and the International Development Innovation Alliance (IDIA) have agreed to renew their strategic collaborative agreement to support the scaling of health innovations to the end of 2023 to jointly accelerate health impact.   The collaboration was established in the beginning of 2021 to create a shared agenda and enable close collaboration and complementarity between the two entities to promote and facilitate the demand, supply, assessment, and scale-up of health innovations for the benefit of low- and middle-income countries. Collaboration between IDIA members and WHO covers the following five areas: Innovation Demand; Innovation Supply; Innovation Assessment; Innovation Scale-up; and Innovation Scaling Skill Development. WHO supports Member States to link impactful innovations to where they are most needed in countries. Given IDIA’s unique experience and status as a key collaboration platform for innovation funders around the world, the collaboration accelerates collective impact in tackling the greatest challenges in global health. ]]> https://biospectrumindia.com/news/57/22101/2023-to-be-highly-lucrative-for-drug-developers-across-therapeutic-areas-report.html https://biospectrumindia.com/news/57/22101/2023-to-be-highly-lucrative-for-drug-developers-across-therapeutic-areas-report.html Wed, 12 Oct 2022 12:00:00 +0530 Citeline (formerly ‘Informa Pharma Intelligence’) has recently published the “Key Potential Drug Launches in 2023” report sharing insights on a longer-term outlook of some key late-stage drugs projected to hit the market in 2023. Chronic Heart Failure (CHF) remains a key area of attention for drug makers. In this scenario, Furoscix is a reformulation of the diuretic furosemide which has been developed for the treatment of decompensated heart failure and designed to be self-administered in the outpatient setting through a subcutaneous infusion via a wearable, on-body drug delivery system. Currently, the Prescription Drug User Fee Act (PDUFA) date for Furoscix is set at October 8 2022 following a resubmission of an NDA in April 2022 which included data from the Phase III FREEDOM HF trial, where the overall and heart failure-related costs of treating congestion in patients with CHF were investigated. Simultaneously, Omecamtiv Mecarbil is another soon-to-be-launched drug, which will provide additional means of improving outcomes on top of the standard of care for those patients with more advanced stages of CHF.  In the Oncology space, for Bone Marrow Transplant and Stem Cell Transplant, Gamida Cell’s omidubicel is a nicotinamide (NAM)-enabled stem cell therapy being studied for use in allogeneic hematopoietic (bone marrow) stem cell transplants for patients with hematologic malignancies like acute lymphocytic leukemia. In June 2022, Gamida Cell completed its submission to the FDA for omidubicel’s biologics license application, with a final decision expected in June 2023 if there are no delays. Breyanzi has demonstrated encouraging results in the Phase I/II TRANSCEND-CLL-004 trial, reporting higher observed overall response rates compared to other investigational CD 19-directed CAR-T therapies, such as Kymriah. Breyanzi looks set to emerge as a revolutionary option for this last-line treatment setting, pending its supplemental approval in 2023. For Haematology, Vertex had announced that global regulatory filings for exa-cel (CTX001) in transfusion-dependent beta-thalassemia (TDT) and sickle cell disease are expected by the end of 2022 which if successful, could in 2023 make it the first CRISPR/Cas 9 based product ever approved, an important boost for the gene editing technology. ]]> https://biospectrumindia.com/news/57/22068/cepi-partners-with-intravacc-to-develop-intranasal-betacoronavirus-vaccine.html https://biospectrumindia.com/news/57/22068/cepi-partners-with-intravacc-to-develop-intranasal-betacoronavirus-vaccine.html Thu, 06 Oct 2022 13:00:00 +0530 Norway-based CEPI, the Coalition for Epidemic Preparedness Innovations, and Dutch vaccine clinical development and manufacturing organization Intravacc, have announced the latest funding award to advance the development of vaccines that provide broad protection against SARS-CoV-2 (including its variants) and other Betacoronaviruses. CEPI will provide seed funding of up to $4.8 million to Intravacc - a world leader in translational research and development of preventive and therapeutic vaccines - to advance the development of a broadly protective Betacoronavirus vaccine candidate, which can be delivered intranasally.   This funding will support preclinical development and testing of Intravacc’s subunit vaccine candidate (Avacc 101), which is based on its Outer Membrane Vesicle (OMV) platform. The technology has the potential to be rapidly adapted to address outbreaks of disease caused by emerging Betacoronavirus strains and variants, and, also to protect against pre-emergent Betacoronaviruses (i.e., before they “spillover” from animals to infect humans). Specifically, the Avacc 101 vaccine candidate will be designed to provide broad protection against SARS-CoV-1, SAR-CoV-2, and MERS-CoV. This platform will enable presentation of universal Spike molecules and will include “epitopes” that can also elicit T-cell responses. Unlike the COVID-19 vaccines currently in use, this candidate will be delivered intranasally. This method of administration could help to produce the mucosal immunity needed to block viral infection thereby reducing person-to-person transmission.   ]]> https://biospectrumindia.com/news/57/22062/who-launches-first-blueprint-for-dementia-research.html https://biospectrumindia.com/news/57/22062/who-launches-first-blueprint-for-dementia-research.html Wed, 05 Oct 2022 02:10:00 +0530 “Although dementia is the 7th leading cause of death globally, dementia research accounts for less than 1.5% of total health research output. Sadly, we are falling behind implementing the Global action plan on the public health response to dementia 2017-25. Addressing dementia comprehensively requires research and innovation to be an integral part of the response”, says Dr Soumya Swaminathan, Chief Scientist, World Health Organisation (WHO). Strategies are needed to better understand, prevent, and treat the underlying diseases that cause dementia and, at the same time, provide care and support for people with dementia and their carers. Moreover, dementia research needs to be conducted within an enabling environment, where collaborations are fostered, and equitable and sustained investment is realized.   With these objectives, WHO has developed a blueprint for dementia research, the first WHO initiative of its kind for noncommunicable diseases. The blueprint is designed to provide guidance to policy makers, funders, and the research community on dementia research, making it more efficient, equitable, and impactful. Specifically, the blueprint for dementia research builds on and applies lessons learned from WHO efforts to prioritize research and coordinate research activities for infectious diseases; and considers the entire dementia research spectrum, incorporating diagnostics and therapeutics, as well as emerging scientific and technological advances such as artificial intelligence, multiomics, and biomarkers. ]]> https://biospectrumindia.com/news/57/22053/roche-launches-next-generation-sars-cov-2-rapid-antibody-test.html https://biospectrumindia.com/news/57/22053/roche-launches-next-generation-sars-cov-2-rapid-antibody-test.html Mon, 03 Oct 2022 08:00:00 +0530 Roche has announced the launch of the SARS-CoV-2 Rapid Antibody Test 2.0 in markets accepting the CE Mark. The test is the next generation of Roche's existing SARS-CoV-2 Rapid Antibody Test, which launched in July 2020. The SARS-CoV-2 Rapid Antibody Test 2.0 offers broader use than its original configuration, which focused on recovered patients, to now include vaccinated individuals as well. The test has also been updated to improve the detection of antibodies against variants of the virus, and continues to be investigated against new variants of concern. The SARS-CoV-2 Rapid Antibody Test 2.0 can be used by healthcare professionals in point of care settings outside clinical labs and near to patients with a capillary sample. The test should help healthcare professionals to identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection or vaccination. The SARS-CoV-2 Rapid Antibody Test 2.0 is beneficial in situations where timely decisions are needed, laboratory SARS-CoV-2 testing is not available, or finger prick sampling is the better option over a venous blood draw. Healthcare professionals can further use the test to help patients check their antibody status and to determine whether they still have a detectable antibody response from prior vaccination. The test's launch is in partnership with South Korea-based SD Biosensor Inc., with whom Roche has a global distribution agreement and launched a range of rapid antigen and antibody tests in more than 50 countries worldwide.  ]]> https://biospectrumindia.com/news/57/21992/bill-melinda-gates-foundation-announces-1-27-b-to-improve-healthcare.html https://biospectrumindia.com/news/57/21992/bill-melinda-gates-foundation-announces-1-27-b-to-improve-healthcare.html Thu, 22 Sep 2022 11:10:00 +0530 During United Nations General Assembly week, the Bill & Melinda Gates Foundation—alongside governments, philanthropies, the private sector, NGOs, and global and community leaders— has announced commitments totalling $1.27 billion to improve and save millions of lives. $912 million was pledged to the Global Fund to fight AIDS, tuberculosis and malaria.   The funding will help accelerate efforts to end HIV, TB, and malaria by 2030 and build resilient health systems needed to protect against future pandemics. It also will be instrumental in reducing the disproportionate impact of these diseases on women and girls.   The funding will address overlapping global crises that have reversed the progress already made toward achieving the UN Sustainable Development Goals (Global Goals). The foundation's sixth annual Goalkeepers Report notes that nearly every indicator of the Global Goals is off track at the halfway point for achieving them by 2030.    At the Global Fund Replenishment Conference, governments and the private sector joined together to pledge a record-high level of commitment that will advance the goal of achieving good health and well-being for all. The funding will go toward the Global Fund's goal of saving 20 million more lives from HIV, TB, and malaria; building more resilient health systems to prevent future pandemics, and putting the world back on track to end these diseases by 2030. Today's pledge includes the foundation's largest commitment yet to the Global Fund of $912 million.     ]]> https://biospectrumindia.com/news/57/21999/thermo-fisher-partners-with-pennsylvania-biotechnology-centre.html https://biospectrumindia.com/news/57/21999/thermo-fisher-partners-with-pennsylvania-biotechnology-centre.html Thu, 22 Sep 2022 09:45:00 +0530 The Pennsylvania Biotechnology Centre (PABC) has announced that Thermo Fisher Scientific has become a founding sponsor supporting the PABC campus in Doylestown, Pa., and their new B+Labs incubator in Philadelphia, US where emerging life science companies can accelerate their journey to commercialization. Philadelphia recently ranked as one of the top markets in the US for life sciences, with continuous growth and $4 billion in new construction that supports the industry’s expansion. Through PABC’s existing campus and the new B+Labs incubator, PABC serves a critical need in the region for incubator space that includes the same state-of-the-art technologies that are accelerating drug discovery in other major cities. As a founding sponsor of B+Labs, which is a partnership between the PABC and Brandywine Realty Trust, Thermo Fisher will provide its advanced technology and expertise to emerging biotech residents. “With more companies looking to move to Philadelphia and recent growth in the life sciences regionally, there is an urgent need for more support at early stages of development,” said Louis Kassa, CEO of Hepatitis B Foundation, Blumberg Institute, Pennsylvania Biotechnology Centre. “Incubators and accelerators play a significant role in the success of start-ups, and by working with partners such as Thermo Fisher we have the resources to support this success at scale.” ]]> https://biospectrumindia.com/news/57/21991/novo-nordisk-invests-200-m-to-develop-first-quantum-computer-for-life-sciences-research.html https://biospectrumindia.com/news/57/21991/novo-nordisk-invests-200-m-to-develop-first-quantum-computer-for-life-sciences-research.html Wed, 21 Sep 2022 16:00:00 +0530 The Novo Nordisk Foundation has awarded a grant of $200 million (DKK 1.5 billion) to establish the first full-scale quantum computer for the development of new medicines and provide new insights into climate change and the green transition, which is not possible with classical computers today. The ambitious Novo Nordisk Foundation Quantum Computing Programme launched in collaboration with the University of Copenhagen includes world-leading researchers in quantum computing from Denmark, Canada, The Netherlands and the USA.  By applying next-generation quantum computing to the life sciences, the Novo Nordisk Foundation and its partners have the ambition to deliver revolutionary and applicable new insights which will transform the understanding of crucial scientific problems that pose a huge unmet medical and environmental need. Quantum technologies will be key in the advent of personalised medicine by allowing the analysis of immense genomic data sets, as well as adding clarity to the complex interactions of the human microbiome, or by accelerating drug discovery and development of new medicines. The ambition is that a quantum computer will also be a fundamental tool in designing new sustainable materials, delivering new energy-saving solutions or assisting with new approaches to decarbonisation. The Novo Nordisk Foundation Quantum Computing Programme is a collaboration between the Novo Nordisk Foundation and the Niels Bohr Institute at the University of Copenhagen, which will run for the next 12 years.   ]]> https://biospectrumindia.com/news/57/21976/rockefeller-foundation-pledges-15-m-to-fight-aids-tuberculosis-and-malaria.html https://biospectrumindia.com/news/57/21976/rockefeller-foundation-pledges-15-m-to-fight-aids-tuberculosis-and-malaria.html Tue, 20 Sep 2022 00:00:00 +0530 US-based Rockefeller Foundation has announced that it will commit $15 million to the Global Fund to Fight AIDS, tuberculosis (TB), and malaria ahead of the Fund's Seventh Replenishment Conference on September 21. This year, the Global Fund partnership aims to raise $18 billion to protect hard-fought gains against these infectious diseases in the face of COVID-19 and to finance ongoing projects through 2025. "Fifty million people are alive today because of the Global Fund's work to fight HIV, tuberculosis, and malaria," said Dr Rajiv J. Shah, President of The Rockefeller Foundation.  This year, The Rockefeller Foundation's Global Fund pledge will finance the Laboratory Systems Strengthening Catalytic Fund, a mechanism for accelerating the development of public health laboratories across low- and middle-income countries (LMICs). Dr Naveen Rao, Senior Vice President of Health at The Rockefeller Foundation said, "The Global Fund gives labs the resources to expand their workforce and build networks for sharing information about emerging threats. Robust labs are key for preventing the next pandemic, and that's why we're proud to support the Laboratory Systems Strengthening Fund." According to the Fund's newly released 2022 Results Report: 23.3 million people have received lifesaving antiretroviral therapy for HIV; 5.3 million people have been treated for TB; 148 million cases of malaria have been treated. In 2020, for the first time in its history, the Global Fund saw declines in key health indicators across all three priority diseases. That year, HIV testing fell by 22% and prevention services by 11%. TB deaths increased, fueled by a surge in undiagnosed and untreated cases. Malaria deaths also significantly increased in 2020, due in part to Covid-19 disruptions for critical health services.   ]]> https://biospectrumindia.com/news/57/21978/adb-approves-10-m-to-strengthen-covid-19-vaccination-in-maldives.html https://biospectrumindia.com/news/57/21978/adb-approves-10-m-to-strengthen-covid-19-vaccination-in-maldives.html Tue, 20 Sep 2022 00:00:00 +0530 The Asian Development Bank (ADB) has approved a $10 million grant under its Asia Pacific Vaccine Access Facility to help Maldives upgrade storage facilities and strengthen the distribution and administration of COVID-19 vaccines. Through the government’s Expanded Programme on Immunization (EPI), more than 70% of Maldives’ population has received the first two COVID-19 vaccine doses while nearly 30% has received at least one booster shot as of mid-September. Booster vaccination is ongoing and has recently been extended to cover people aged 12­–49. The government is also planning to expand initial two-dose vaccination to 5–11 year-olds starting September.    The project will construct a central cold storage facility in Hulhumalé that is climate-resilient and powered by renewable energy, replacing the temporary facility in Malé. This comes with adequate space to properly store vaccines, medical supplies, and laboratory equipment. There will be dedicated areas for repairing and maintaining cold chain equipment, managing vaccine waste, and hosting a backup server for national immunization data. ADB’s financing will promote the digitalization of vaccine information management by providing equipment to set up a national health data centre and mobile devices for public health staff collecting data at all health centers. This will help link the national health networks to all islands, atolls, and the Greater Malé area.     ]]> https://biospectrumindia.com/news/57/21952/global-guidance-framework-for-responsible-use-of-life-sciences.html https://biospectrumindia.com/news/57/21952/global-guidance-framework-for-responsible-use-of-life-sciences.html Wed, 14 Sep 2022 09:00:00 +0530 The World Health Organisation (WHO) has issued the Global guidance framework for the responsible use of the life sciences. The Framework calls on leaders and other stakeholders to mitigate biorisks and safely govern dual-use research, which has a clear benefit but can be misused to harm humans, other animals, agriculture and the environment. This is the first global, technical and normative framework for informing the development of national frameworks and approaches for mitigating biorisks and governing dual-use research. It aims to safely unlock the great promise for new and improved ways to improve global health offered by life sciences and related technologies. The Framework addresses the decades-long challenges of preventing the accidental and deliberate misuse of biology and other life sciences, as well as how to manage governance and oversight to both accelerate and spread innovation, while mitigating negative impacts. The life sciences are increasingly crossing over with other fields, such as chemistry, artificial intelligence and nanotechnology, which changes the landscape of risks, with those that span multiple sectors and disciplines more likely to be missed. Looking at how to manage the increasing pace of advances in the life sciences, the Framework outlines the need for anticipatory and responsive governance mechanisms, including foresight approaches, which are participatory and multi-disciplinary ways of exploring trends, emerging changes, systemic impacts and alternative futures. ]]> https://biospectrumindia.com/news/57/21941/new-global-fund-for-pandemic-prevention-and-preparedness.html https://biospectrumindia.com/news/57/21941/new-global-fund-for-pandemic-prevention-and-preparedness.html Mon, 12 Sep 2022 05:00:00 +0530 The new financial intermediary fund (FIF) for pandemic prevention, preparedness, and response (PPR) was officially established by the FIF Governing Board at its inaugural meeting from 8-9 September 2022.  The fund will provide a dedicated stream of additional, long-term financing to strengthen PPR capabilities in low- and middle-income countries and address critical gaps through investments and technical support at the national, regional, and global levels. The fund will draw on the strengths and comparative advantages of key institutions engaged in PPR, provide complementary support, improve coordination among partners, incentivize increased country investments, serve as a platform for advocacy, and help focus and sustain much-needed, high-level attention on strengthening health systems. The first calls for proposals for investments to be funded by the FIF will open in November 2022. The World Bank will serve as the FIF’s trustee and host the Secretariat, which will include technical staff seconded from the World Health Organization (WHO). The Governing Board will appoint a Technical Advisory Panel, chaired by WHO, and comprising leading experts to assess and make recommendations to the Governing Board on the technical merits of proposals for funding, ensuring linkages to the International Health Regulations, as part of the broader global PPR architecture. ]]> https://biospectrumindia.com/news/57/21897/zenix-trial-shows-effectiveness-of-bpal-regimen-for-drug-resistant-tb.html https://biospectrumindia.com/news/57/21897/zenix-trial-shows-effectiveness-of-bpal-regimen-for-drug-resistant-tb.html Thu, 01 Sep 2022 13:00:00 +0530 The results of ZeNix, a Phase 3 clinical trial that took place in 11 sites across Georgia, Moldova, Russia, and South Africa, revealed that the BPaL treatment remains effective against highly drug-resistant strains of tuberculosis (TB) with reduced dosage and/or duration of the linezolid component of the regimen. Along with the maintenance of efficacy, there was a decrease in linezolid-associated side effects that accompanied the reduced dosage or duration of linezolid. The results from the trial, which was led by TB Alliance, a global non-profit TB drug developer, were published in the New England Journal of Medicine.    A government-led study of the regimen in India called mBPaL commenced in October 2021 and is now enrolling patients at three sites out of a planned 11. It is scheduled to reach its primary completion in 2023 after enrolling 400 patients.    ]]> https://biospectrumindia.com/news/57/21885/apollo-hospitals-eclipse-group-to-set-up-cancer-centre-in-tanzania.html https://biospectrumindia.com/news/57/21885/apollo-hospitals-eclipse-group-to-set-up-cancer-centre-in-tanzania.html Tue, 30 Aug 2022 13:00:00 +0530 Apollo Hospitals has forayed into Tanzania by signing a Memorandum of Understanding (MoU) with Eclipse Group, Africa to set up a cancer care centre in the Msasani area, Dar es Salaam, Tanzania. With this partnership, Apollo will provide healthcare services with advanced cancer care treatments.The 60-bedded state-of-the-art cancer centre will offer comprehensive cancer care right from diagnosis to treatment. It will offer medical, surgical, and radiation treatment to cancer patients across age groups, from paediatric to adults. It will offer best-in-class treatment and care with a team of experienced oncologists, cancer care management and some of the world's finest technology, to make quality cancer care accessible to over 55 million people in Tanzania. ]]> https://biospectrumindia.com/news/57/21843/-gamaleya-center-develops-delta-and-omicron-adapted-sputnik-v-vaccine.html https://biospectrumindia.com/news/57/21843/-gamaleya-center-develops-delta-and-omicron-adapted-sputnik-v-vaccine.html Tue, 23 Aug 2022 14:05:00 +0530 The Gamaleya National Research Center of Epidemiology and Microbiology (Gamaleya Center) and the Russian Direct Investment Fund (RDIF) have announced the development of the Sputnik V vaccine specifically adapted against Delta and Omicron variants of coronavirus.The new version of Sputnik V has been Delta- and Omicron-adapted as Omicron is currently the dominant variant around the globe. This new version is also addressing the L-452-R mutation in Omicron BA5 variant which was not present in the BA1 variant.The Delta and Omicron-adapted version of Sputnik V is the most promising version of the vaccine specifically adapted to new variants as compared to those tailored against the combination of the original strain and Omicron variant.The Sputnik V vaccine adapted against the Delta and Omicron variants provides for a significant reduction in the viral load in the lungs of animals infected with the Omicron BA5 variant. ]]> https://biospectrumindia.com/news/57/21833/roche-develops-covid-19-test-to-differentiate-latest-subvariants.html https://biospectrumindia.com/news/57/21833/roche-develops-covid-19-test-to-differentiate-latest-subvariants.html Mon, 22 Aug 2022 15:15:00 +0530 Roche and its subsidiary TIB Molbiol have developed a COVID-19 test for researchers that detects and differentiates the latest subvariant of interest BA.2.75. The test specifically targets two of the known unique mutations in BA.2.75, which allows clear differentiation against other notable subvariants.   Since it was first detected in India in May 2022, cases of BA.2.75 have been reported in more than a dozen countries. The BA.2.75  is a subvariant related to the  Omicron variant. The subvariant  is being monitored by both the World Health Organization as well as the Centers for Disease Control and Prevention. It has not reached the level of a Variant of Concern, but differentiating it from BA.4 and BA.5 allows for improved tracking to understand how it is spreading.   The available research use only test, VirSNiP SARS-CoV-2 Spike 147E 152R, adds to the broad suite of COVID-19 test kits developed by Roche and TIB Molbiol, for instance for the detection of the recent BA.4 and BA.5 subvariants, as well as other mutations present in the Omicron SARS-CoV-2 variant.   ]]> https://biospectrumindia.com/news/57/21819/apcc-with-iba-belgium-to-offer-proton-therapy-training-education-globally.html https://biospectrumindia.com/news/57/21819/apcc-with-iba-belgium-to-offer-proton-therapy-training-education-globally.html Thu, 18 Aug 2022 15:45:00 +0530 Apollo Proton Cancer Centre (APCC) and Ion Beam Applications (IBA), Belgium, signed an agreement to offer proton therapy training and education for clinicians in Asia and across the globe. Apollo Proton Cancer Centre will impart knowledge through its advanced training and education programme on proton therapy to clinicians.    Olivier Legrain, Chief Executive Officer, IBA, said, “We are looking forward to collaborating with Apollo to provide high-quality training and education to Proton Therapy users in Asia without them travelling to another continent.”   Dr Preetha Reddy, Executive Vice Chairperson, Apollo Hospitals Enterprise said, “With APCC becoming Asia’s first and exclusive Proton Beam Training Institute in association with IBA, it will provide valued access to clinicians across the world and also be a pivotal contributor to research in Oncology and Proton Therapy.”   ]]> https://biospectrumindia.com/news/57/21812/who-releases-updated-guidance-on-national-strategic-planning-for-tb.html https://biospectrumindia.com/news/57/21812/who-releases-updated-guidance-on-national-strategic-planning-for-tb.html Wed, 17 Aug 2022 17:25:00 +0530 The World Health Organisation (WHO) is releasing new guidance to support national strategic planning for tuberculosis (TB) response. The guidance encourages the use of a people-centric focus in the development of a national TB strategic plan (NSP). It highlights the importance of government stewardship and ownership, promotes alignment with national health strategy and other health programmes and emphasises multi-stakeholder and multi-sectoral engagement as one of the key steps for multisectoral accountability for TB.   The guidance for national strategic planning for tuberculosis was developed to better align with global commitments and the latest developments in TB and public health and builds on lessons learned from using the 2015 toolkit. The document will be complemented by the guidance for conducting reviews of TB programmes, which will be published by the end of this year.   The guidance is intended for use in developing standalone TB strategic plans, or in developing TB interventions as part of multi-disease or national health sector plans. It describes good practices and steps for developing a TB NSP in line with WHO’s End TB Strategy, and the proposed structure and components of the TB NSP.   A webinar to present the new guidance and share perspectives and experiences from countries, civil society and partners will be held on September 6, 2022.       ]]> https://biospectrumindia.com/news/57/21787/optrel-launches-first-n95-respirator-with-transparent-window.html https://biospectrumindia.com/news/57/21787/optrel-launches-first-n95-respirator-with-transparent-window.html Thu, 11 Aug 2022 11:40:00 +0530 Optrel, a leading manufacturer of respiratory protection, has launched the P Air Clear, the world's first NIOSH-approved N95 respirator with a transparent window.   The P Air Clear is an important breakthrough for healthcare workers, educators, geriatrics and the deaf and hard of hearing population. It offers the highest quality protection with the added benefit of a transparent window, eliminating the communication barrier posed by traditional masks.    Swiss-made with the highest quality material for comfort and function, the P Air Clear features a transparent window, a latex-free head harness and an adjustable nose clip.   "Optrel is committed to bringing world-class respiratory protection solutions to the market," said Grant Cooper, CEO of Optrel, Inc. "The past few years have demonstrated the need for us to expand beyond our core industrial market with respiratory protection that meets the needs of workers in healthcare, education, and a variety of other industries. These new markets demand innovative products that offer superior protection without hindering interpersonal communication.  The P Air Clear strikes a balance between protecting workers and bridging the communication barrier posed by traditional N95 masks." ]]> https://biospectrumindia.com/news/57/21778/azenta-announces-agreement-to-acquire-b-medical-systems-for-410-m.html https://biospectrumindia.com/news/57/21778/azenta-announces-agreement-to-acquire-b-medical-systems-for-410-m.html Tue, 09 Aug 2022 15:10:00 +0530 US-based Azenta has entered into a definitive agreement to acquire B Medical Systems and its subsidiaries, a market leader in temperature-controlled storage and transportation solutions that enable the delivery of life-saving treatments across the globe. The cash purchase price to be paid at closing will be approximately €410 million. Additional cash consideration, up to €50 million, may be paid upon achievement of certain future performance milestones. The transaction is expected to close in October 2022.The acquisition complements Azenta’s cold chain capabilities, adding differentiated solutions for reliable and traceable transport of temperature-sensitive specimens. “We are excited to add B Medical into our growing portfolio of offerings,” said Steve Schwartz, President and CEO, Azenta. “B Medical has done an outstanding job carving out a strong market position in the vaccine cold chain, and we see a breadth of opportunities to drive even further value from the portfolio by leveraging the Azenta platform.” ]]> https://biospectrumindia.com/news/57/21771/pfizer-buys-global-blood-therapeutics-for-5-4-b.html https://biospectrumindia.com/news/57/21771/pfizer-buys-global-blood-therapeutics-for-5-4-b.html Mon, 08 Aug 2022 19:40:00 +0530 Pfizer and Global Blood Therapeutics (GBT) have entered into a definitive agreement under which Pfizer will acquire GBT, a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities, starting with sickle cell disease (SCD).    Under the terms of the transaction, Pfizer will acquire all the outstanding shares of GBT for $68.50 per share in cash, for a total enterprise value of approximately $5.4 billion, including debt and net of cash acquired.    GBT developed Oxbryta® (voxelotor) tablets, a first-in-class medicine that directly targets the root cause of SCD. Oxbryta was approved in the United States in November 2019 and is also approved in the European Union, United Arab Emirates, Oman and Great Britain. Net sales for Oxbryta were approximately $195 million in 2021. Leveraging its global platform, Pfizer plans to accelerate distribution of GBT’s innovative treatment to parts of the world most impacted by SCD.   In addition, GBT is developing GBT021601 (GBT601), an oral, once-daily, next-generation sickle hemoglobin (HbS) polymerization inhibitor in the Phase 2 portion of a Phase 2/3 clinical study. GBT601 has the potential to be a best-in-class agent targeting improvement in both hemolysis and frequency of vaso-occlusive crisis (VOC). GBT’s promising pipeline also includes inclacumab, a fully human monoclonal antibody targeting P-selectin which is being evaluated in two Phase 3 clinical trials as a potential quarterly treatment to reduce the frequency of VOCs and to reduce hospital readmission rates due to VOCs. Both GBT601 and inclacumab have received Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA). If approved, GBT’s pipeline and Oxbryta have the potential for an SCD franchise that could achieve combined worldwide peak sales of more than $3 billion. ]]> https://biospectrumindia.com/news/57/21763/us-declares-monkeypox-virus-as-public-health-emergency.html https://biospectrumindia.com/news/57/21763/us-declares-monkeypox-virus-as-public-health-emergency.html Fri, 05 Aug 2022 17:15:00 +0530 The US Department of Health and Human Services (HHS) has announced the ongoing spread of monkeypox virus in the US as a Public Health Emergency (PHE). The action will further strengthen and accelerate the Biden-Harris Administration’s response in recognition of the continued rapid transmission of monkeypox in the US and globally, and to signal the seriousness and urgency with which the administration is responding.    The PHE declaration is in concert with the Food and Drug Administration’s (FDA) work to explore new strategies that could help get vaccines to affected communities across the country, including using the new dose-sparing approach that could increase the number of doses available, up to five-fold.   The public health emergency also carries important implications for data sharing with the federal government. Fifty-one jurisdictions have already signed data use agreements that will provide the Centers for Disease Control and Prevention (CDC) with information related to vaccine administration.    HHS has shipped more than 602,000 doses of the JYNNEOS vaccine to states and jurisdictions, an increase of 266,000 in the past week. HHS has allocated 1.1 million doses to states and jurisdictions in total and is making more doses available as jurisdictions use their current supply. HHS also announced that it has accelerated the delivery of an additional 150,000 doses to arrive in the US next month. The doses, which were slated to arrive in November will now arrive in the US in September.   ]]> https://biospectrumindia.com/news/57/21745/new-global-alliance-to-end-aids-in-children-by-2030.html https://biospectrumindia.com/news/57/21745/new-global-alliance-to-end-aids-in-children-by-2030.html Tue, 02 Aug 2022 00:00:00 +0530 Globally, only half (52%) of children living with HIV are on life-saving treatment, far behind adults where three quarters (76%) are receiving antiretrovirals, according to the data that has just been released in the UNAIDS Global AIDS Update 2022. Concerned by the stalling of progress for children, and the widening gap between children and adults, UNAIDS, UNICEF, WHO and partners have brought together a global alliance to ensure that no child living with HIV is denied treatment by the end of the decade and to prevent new infant HIV infections. The new Global Alliance for Ending AIDS in Children by 2030 was announced by leading figures at the International AIDS Conference taking place in Montreal, Canada. Consultations by the alliance have identified four pillars for collective action: closing the treatment gap for pregnant and breastfeeding adolescent girls and women living with HIV and optimizing continuity of treatment; preventing and detecting new HIV infections among pregnant and breastfeeding adolescent girls and women; accessible testing, optimized treatment, and comprehensive care for infants, children, and adolescents exposed to and living with HIV; and addressing rights, gender equality, and the social and structural barriers that hinder access to services.    ]]> https://biospectrumindia.com/news/57/21703/pfizers-comirnaty-tops-chart-as-best-selling-drug-in-2021-citeline-report.html https://biospectrumindia.com/news/57/21703/pfizers-comirnaty-tops-chart-as-best-selling-drug-in-2021-citeline-report.html Wed, 27 Jul 2022 08:05:00 +0530 Citeline has recently published the 'Top 10 Best Selling Drugs' report, for data intelligence and analysis on the top performing pharma products by revenues in 2022 and insights on the major themes affecting the highest-grossing drugs and the companies behind their continued development.   2021 saw the global rollout of vaccines being accelerated for the prevention of COVID-19 and these drugs have rightfully made it to the list of top-selling drugs.    Sitting at the top of the leaderboard as the best-selling drug during 2021 is Comirnaty, irrespective of being its first year on the market. This is the first time that a single product has achieved more in annual sales than any other in the history of the pharmaceutical market. The $41.1 billion in revenues that Pfizer reported is not just a record, but this number is almost twice as large as Humira’s peak annual sales of $21.2bn.    Moderna, being unable to match Pfizer’s scale of manufacturing and international exporting, can console itself with equally astonishing Spikevax sales of $17.7 billion in a single year, despite having no prior experience in drug marketing.   It remains to be seen how durable sales will be through 2022, as many individuals in western countries completed their primary vaccination courses during 2021. However, with recommendations slowly expanding into younger age groups, and booster programs being favoured to counter subsequent waves of new variants, these two drugs will certainly feature prominently as we adjust to COVID-19’s endemicity. Most forecasts indicate that 2022 will be another highly lucrative year for vaccine developers, with new pricing models through 2023 offsetting a strong decline in volume thereafter.     ]]> https://biospectrumindia.com/news/57/21652/haleon-launches-as-independent-company-focused-on-consumer-health.html https://biospectrumindia.com/news/57/21652/haleon-launches-as-independent-company-focused-on-consumer-health.html Mon, 18 Jul 2022 20:40:00 +0530 Haleon has been launched as an independent company focusing on consumer health, completing its demerger from GSK. The newly listed business is driven by its purpose to deliver better everyday health with humanity. Trading commenced on the London Stock Exchange (LSE), with Brian McNamara, CEO, Haleon, leading the opening ceremony to signal the start of trading. Trading on the New York Stock Exchange (NYSE) is set to follow1, and a similar market-opening event will take place on July 20, 2022. Haleon will continue to develop category-leading brands that address real consumer health need while focusing on future innovation across its entire portfolio. The company expects to deliver medium-term annual organic revenue growth of 4-6 per cent. Despite huge improvements in medicine, data and technology, everyday health remains elusive for too many people. Haleon aims to change this through a two-pronged approach. First, by working to remove barriers to better everyday health, and second, by aiming to empower 50 million people a year by 2025 to be more included in opportunities for better everyday health. ]]> https://biospectrumindia.com/news/57/21524/merck-digital-sciences-studio-to-help-healthcare-startups.html https://biospectrumindia.com/news/57/21524/merck-digital-sciences-studio-to-help-healthcare-startups.html Thu, 30 Jun 2022 00:00:00 +0530 Merck, known as MSD outside the United States and Canada, has announced the launch of the Merck Digital Sciences Studio (MDSS) to enable the generation of innovative technologies for drug discovery and development. MDSS will support early-stage biomedical startups with direct investment, access to powerful Azure Cloud computing and opportunities to pilot their technologies in collaboration with discovery and clinical scientists at Merck. Starting today, Merck welcomes applications for 12 spots for the first MDSS cohort. Startups developing artificial intelligence (AI) and machine learning (ML) applications will be prioritized. The MDSS is a collaboration between Merck and the New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology corporation, with investments from the Merck Global Health Innovation Fund, Northpond Ventures and McKesson Ventures. Technology support will be provided by Microsoft for Startups. The MDSS will have locations in Newark, NJ and Cambridge, MA. “Startups in the biopharmaceutical industry fuel innovation, create high-quality jobs and generate great opportunities for a stronger, more diverse and inclusive life-sciences ecosystem,” said Simon Nynens, CEO of NJII. “NJII looks forward to providing the programming, coaching, and connections to bring these ideas to life.”   ]]> https://biospectrumindia.com/news/57/21493/novartis-pledges-250-m-to-end-ntds-and-malaria.html https://biospectrumindia.com/news/57/21493/novartis-pledges-250-m-to-end-ntds-and-malaria.html Mon, 27 Jun 2022 00:00:00 +0530 The World Health Organization (WHO) has announced that Novartis pharmaceutical corporation is committing $250 M to the fight against neglected tropical diseases (NTDs) and malaria. This comes in the wake of the Kigali Summit on Malaria and NTDs, which was held alongside the 26th Commonwealth Heads of Government meeting (CHOGM), on 23 June 2022. The Kigali Declaration, announced at the event, aims to mobilize the political will and commitments required to achieve the United Nation’s Sustainable Development Goal 3 (the health goal), which includes NTDs, and to deliver the targets set in WHO’s NTD road map for 2021–2030. The financial commitment announced by Novartis will help fund cutting-edge research and development, and will focus specifically on developing new, effective treatments for three NTDs (Chagas disease, dengue and visceral leishmaniasis), in addition to cryptosporidiosis and malaria.   ]]> https://biospectrumindia.com/news/57/21459/sunsmart-global-uv-app-by-who-promotes-public-health.html https://biospectrumindia.com/news/57/21459/sunsmart-global-uv-app-by-who-promotes-public-health.html Tue, 21 Jun 2022 00:00:00 +0530 A new app for mobile phones that provides localized information on ultraviolet (UV) radiation levels has been launched by the World Health Organization (WHO), the World Meteorological Organization (WMO), the United Nations Environment Programme (UNEP) and the International Labour Organization (ILO). The SunSmart Global UV app provides five-day UV and weather forecasts at searchable locations. It highlights time slots when sun protection is required with the aim of helping people around the world know when to use sun protection, in an effort to reduce the global burden of skin cancer and UV-related eye damage.  Globally, it is estimated that over 1.5 million cases of skin cancer (melanoma and non-melanoma combined) were diagnosed globally in 2020. During the same period, more than 120,000 people across the world lost their lives to this highly preventable disease. One of the main factors contributing to these cancers is excess UV radiation from thinning of the earth’s stratospheric ozone layer resulting from the release of certain manmade chemicals. The UV App has been launched to coincide with the first day of summer in the northern hemisphere. By increasing the public’s awareness and helping to reduce the incidence of skin cancer, this application ultimately supports the achievement of UN Sustainable Development Goal 3, which aims to ensure healthy lives and well-being worldwide by 2030.     ]]> https://biospectrumindia.com/news/57/21444/who-unveils-parkinsons-disease-technical-brief.html https://biospectrumindia.com/news/57/21444/who-unveils-parkinsons-disease-technical-brief.html Wed, 15 Jun 2022 00:00:00 +0530 Globally, the prevalence of Parkinson's disease (PD) has doubled in the past 25 years with global estimates in 2019 showing over 8.5 million individuals living with PD. Despite the significant impact of PD, there is inequality in the availability of resources and services to provide treatment and care especially in low- and middle-income countries (LMIC). The World Health Organisation (WHO) Neurology Atlas (2017) provides estimates of 0.03 neurologists per 100 000 population in low-income countries and 4.75 per 100 000 population in high-income countries. In line with the Intersectoral global action plan on epilepsy and other neurological disorders, a technical brief entitled “Parkinson disease: a public health approach” has been published. The technical brief outlines the global burden, treatment gaps, crucial areas for intervention in PD and several areas for action, including: • global health policies to implement strategies focused on PD; • prevention and reduction of risks for PD including education and awareness; • assured access to treatment and care, including access to, and education of, an interdisciplinary workforce trained in neurological disorders; and • delivery of services and the management of PD at various levels of health systems.   ]]> https://biospectrumindia.com/news/57/21387/pandemic-led-acceleration-in-innovation-has-given-boost-to-indian-health-sector-idc-research.html https://biospectrumindia.com/news/57/21387/pandemic-led-acceleration-in-innovation-has-given-boost-to-indian-health-sector-idc-research.html Tue, 07 Jun 2022 17:40:00 +0530 A new whitepaper, commissioned by Lenovo & Intel and led by IDC, highlights key challenges and drivers transforming the healthcare landscape across the Asia Pacific. Titled ‘Leveraging High-Performance Compute Infrastructure to Address the Genomic Data Challenge in Life Sciences’, the paper underlines humanity’s greatest challenges where genomics research-led intervention could impact significantly.    A key highlight from the paper states that while the pandemic-led acceleration in innovation has given a boost to the Indian healthcare sector, genomics high-performance computing (HPC) infrastructure that is key to drug/vaccine discovery & precision medicine, is still at a startup stage for nearly 57 per cent of surveyed organisations in India. This trend is also seen across a few other APAC regions surveyed: Japan and Korea lead in having advanced (3+ years) infrastructure.   The survey was conducted across 150 pharmaceutical and biotech companies across five key markets in Asia – India, Singapore, Thailand, Japan, and Korea.   When it comes to solving the biggest challenges facing societies and mankind, 40 per cent of the decision-makers in India are certain that genomics is fundamental to developing a precision medicine strategy to treat chronic illness, rare diseases, and lifestyle disorders. Unsurprisingly, 33 per cent of the organisations surveyed across Asia Pacific mirror this drift, followed by 21 per cent who believe genomics can improve the development of drugs and vaccines which is also a priority for 20 per cent of organisations in India.    In the entire context of genomics data, cyber threats are a key challenge for only 3 per cent of the organisations in India, while more than 80 per cent feel strongly about their cybersecurity strategy indicating it as the lowest amongst the hurdles.  ]]> https://biospectrumindia.com/news/57/21367/who-partners-with-american-society-of-clinical-oncology-for-cancer-care-innovations.html https://biospectrumindia.com/news/57/21367/who-partners-with-american-society-of-clinical-oncology-for-cancer-care-innovations.html Mon, 06 Jun 2022 00:00:00 +0530 The World Health Organization (WHO) has joined forces with the American Society of Clinical Oncology, Inc. (ASCO), the world’s leading association of physicians and oncology professionals, to develop and promote cancer care innovations that are specifically designed to enhance health outcomes, and take account of the contexts in which patients live. The aim is to overcome some of the current inequities that exist in access to cancer care. The new partnership will enable ASCO and WHO to develop a coordinated approach to support WHO Member States and cancer centres with improved access to quality care by linking facility-level quality improvement activities with national strategies. This will accelerate implementation of WHO cancer initiatives in breast, cervix and childhood cancers. Programmes planned under the WHO–ASCO partnership include developing evidence-based quality indicators that can be used to assess the quality of a facility’s care – with a focus on breast cancer and palliative care – and, scaling global best practices with an aim to advance innovation in improving quality of care. WHO and ASCO will draw on and synthesize key insights from stakeholders in their respective networks, including care providers, researchers, patients, and governmental authorities. By leveraging one another’s resources and establishing networks and quality tools, WHO and ASCO can amplify efforts towards providing high-quality care to more patients with cancer around the globe. ]]> https://biospectrumindia.com/news/57/21357/gsk-confirms-proposed-demerger-of-its-consumer-healthcare-biz-to-form-haleon.html https://biospectrumindia.com/news/57/21357/gsk-confirms-proposed-demerger-of-its-consumer-healthcare-biz-to-form-haleon.html Wed, 01 Jun 2022 17:40:00 +0530 GSK has confirmed that the circular concerning the proposed demerger, the consolidation of GSK shares and certain new arrangements with Haleon and Pfizer to give effect to the demerger, as well as the Prospectus concerning the proposed admission of the Haleon ordinary shares, have each been submitted to the Financial Conduct Authority for approval.   It is expected that the Haleon ordinary shares will be admitted to the Premium listing segment of the Official List of the FCA and admitted to trading on the Main Market of the London Stock Exchange on Monday 18 July 2022. The application will also shortly be made to list American Depositary Shares representing Haleon ordinary shares on the New York Stock Exchange.   Following the demerger, GSK will focus purely on biopharmaceuticals, prioritising investment towards the development of innovative vaccines and speciality medicines. Its R&D approach will continue to focus on the science of the immune system, the use of human genetics and advanced technologies. Over the next five-year period, GSK expects to deliver compound annual growth in sales and adjusted operating profit of more than 5 per cent. and more than 10 per cent., respectively, at constant exchange rates (with 2021 as the base year).   Following completion of the Demerger and listing of Haleon, GSK intends to carry out the GSK Share Consolidation. As part of the Demerger, GSK proposes to enter into new arrangements with Pfizer and Haleon and to amend certain existing arrangements with Pfizer.   ]]> https://biospectrumindia.com/news/57/21345/jubilant-pharma-inks-vaccine-manufacturing-agreement-with-us-for-149-6-m.html https://biospectrumindia.com/news/57/21345/jubilant-pharma-inks-vaccine-manufacturing-agreement-with-us-for-149-6-m.html Tue, 31 May 2022 10:25:00 +0530 Jubilant Pharmova has announced that Jubilant Pharma, a wholly-owned subsidiary of the company, through one of its wholly-owned subsidiaries, Jubilant HollisterStier (JHS)- a leading US-based pharmaceutical contract manufacturer, has entered into a cooperative agreement for $149.6 million with the Army Contracting Command, in coordination with the Joint Programme Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services.   The effort was funded under the American Rescue Plan, this agreement will enable the company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025.   This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024.     ]]> https://biospectrumindia.com/news/57/21314/pfizer-launches-new-initiative-to-improve-health-equity-in-45-lower-income-countries.html https://biospectrumindia.com/news/57/21314/pfizer-launches-new-initiative-to-improve-health-equity-in-45-lower-income-countries.html Wed, 25 May 2022 18:10:00 +0530 Pfizer has launched ‘An Accord for a Healthier World.’ The initiative aims to provide all of Pfizer’s patented, high-quality medicines and vaccines available in the US or the European Union on a not-for-profit basis to 1.2 billion people in 45 lower-income countries. The Accord seeks to greatly reduce the health inequities that exist between many lower-income countries and the rest of the world.   The Accord countries include all 27 low-income countries as well as 18 lower-middle-income countries that have transitioned from low to lower-middle-income classification in the last ten years. Pfizer will work with healthcare officials in Rwanda, Ghana, Malawi, Senegal and Uganda to identify early insights and opportunities to ensure all medicines and vaccines can reach those in need.   This will include expertise to support diagnosis, healthcare professional education and training along with supply chain management and other infrastructure enhancements. Learnings from these five countries will be applied to support the rollout for the remaining forty countries.   Pfizer will also collaborate with Accord participants to identify quick and efficient regulatory pathways and procurement processes to reduce the longer amount of time it can take to make new medicines and vaccines available in these countries.   Under the Accord, Pfizer has committed to providing 23 medicines and vaccines that treat infectious diseases, certain cancers, and rare and inflammatory diseases. The Accord also aims to establish faster access to Pfizer’s future pipeline medicines and vaccines on a not-for-profit basis to the 45 countries, particularly those that treat diseases that disproportionately impact global health.       ]]> https://biospectrumindia.com/news/57/21307/who-launches-new-guide-on-integrating-eye-care-in-health-systems.html https://biospectrumindia.com/news/57/21307/who-launches-new-guide-on-integrating-eye-care-in-health-systems.html Wed, 25 May 2022 00:00:00 +0530 A new World Health Organization (WHO) guide on eye care was recently launched at the event - Universal Health Coverage and Eye Care: Promoting Country Action - attended by government officials, WHO representatives and non-governmental organizations in the eye care sector. The Eye Care in Health Systems: Guide for Action provides practical, step-by-step, guidance to support Member States in planning and implementing the recommendations of the World report on vision with the goal to provide integrated people-centred eye care services. This new resource leads Member States through a four-step process: situation analysis; development of an eye care strategic plan and monitoring framework; development and implementation of an operational plan; and establishing and maintaining ongoing review processes. Currently, more than 2 billion people are living with a vision impairment and of these, at least 1 billion people are needlessly living with poor vision due to lack of access to eye care services. This burden is not borne equally: 90 percent of people with vision impairment or blindness live in low- and middle-income countries. Often, all that is needed is a cost-effective intervention, such as a pair of spectacles or cataract surgery.   ]]> https://biospectrumindia.com/news/57/21193/who-launches-first-ever-global-report-on-infection-prevention-and-control.html https://biospectrumindia.com/news/57/21193/who-launches-first-ever-global-report-on-infection-prevention-and-control.html Mon, 09 May 2022 00:00:00 +0530 The COVID-19 pandemic and other recent large disease outbreaks have highlighted the extent to which health care settings can contribute to the spread of infections, harming patients, health workers and visitors, if insufficient attention is paid to infection prevention and control (IPC). But a new report from the World Health Organization (WHO) shows that where good hand hygiene and other cost-effective practices are followed, 70% of those infections can be prevented.  The new WHO report provides the first-ever global situation analysis of how IPC programmes are being implemented in countries around the world, including regional and country focuses. While highlighting the harm to patients and healthcare workers caused by healthcare-associated infections (HAIs) and antimicrobial resistance, the report also addresses the impact and cost-effectiveness of infection prevention and control programmes and the strategies and resources available to countries to improve them. The report reveals that high-income countries are more likely to be progressing their IPC work, and are eight times more likely to have a more advanced IPC implementation status than low-income countries. Indeed, little improvement was seen between 2018 and 2021 in the implementation of IPC national programmes in low-income countries, despite increased attention being paid generally to IPC due to the COVID-19 pandemic. WHO will continue to support countries to ensure IPC programmes can be improved in every region. WHO is calling on all countries around the globe to increase their investment in IPC programmes to ensure quality of care and patient and health workers’ safety.  ]]> https://biospectrumindia.com/news/57/21053/gsk-acquires-late-stage-biopharma-firm-sierra-oncology-for-1-9-b.html https://biospectrumindia.com/news/57/21053/gsk-acquires-late-stage-biopharma-firm-sierra-oncology-for-1-9-b.html Thu, 14 Apr 2022 00:00:00 +0530 GlaxoSmithKline plc (GSK) and Sierra Oncology, Inc have entered into an agreement under which GSK will acquire Sierra Oncology, a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion. Myelofibrosis is a fatal cancer of the bone marrow impacting the normal production of blood cells. Anaemia represents a high unmet medical need in patients with myelofibrosis. At diagnosis, approximately 40% of patients are already anaemic, and it is estimated that nearly all patients will eventually develop anaemia. Momelotinib has a differentiated mode of action with inhibitory activity along key signalling pathways. This activity may lead to beneficial treatment effects on anaemia and reduce the need for transfusions while also treating symptoms. In January 2022, Sierra Oncology announced positive topline results from the MOMENTUM phase III trial. The study met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anaemia. Momelotinib complements GSK’s Blenrep (belantamab mafodotin), building on GSK’s commercial and medical expertise in haematology. If the transaction is completed and momelotinib is approved by regulatory authorities, GSK expects momelotinib will contribute to GSK’s growing specialty medicines business, with sales expected to begin in 2023, with significant growth potential and a positive benefit to the Group’s adjusted operating margin in the medium term. ]]> https://biospectrumindia.com/news/57/21049/global-pharma-companies-announce-precision-cancer-consortium-.html https://biospectrumindia.com/news/57/21049/global-pharma-companies-announce-precision-cancer-consortium-.html Wed, 13 Apr 2022 00:00:00 +0530 The Precision Cancer Consortium (PCC) has announced the formation as a new collaboration of pharmaceutical companies with a shared vision of enabling access to comprehensive testing for all cancer patients globally. The PCC will drive a variety of initiatives aimed at increasing patient access to precision diagnostics using comprehensive genomic testing, including next generation sequencing (NGS). The PCC's founding members are Bayer, GlaxoSmithKline, Novartis, and Roche. Despite significant treatment advances that target specific molecular alterations in cancer cells, many patients still do not undergo biomarker testing necessary to inform their treatment options. Currently, stakeholders may not be aware of the benefits of comprehensive genomic testing or may not know how to translate results into appropriate patient care. In addition to limited use of precision diagnostics in routine cancer treatment, there are other challenges related to recruiting patients into research studies investigating targeted therapies in biomarker subgroups defined by genomic alterations. "With cancer, the earlier patients are diagnosed and begin treatment, the better their outcomes tend to be. Precision diagnostics, including comprehensive genomic testing, are an important part of developing treatment plans that can help patients," explains Espen Walker (Roche), Chair of the Precision Cancer Consortium. "The PCC is focused on addressing these barriers across the cancer ecosystem with the aim of improving outcomes for patients."   ]]> https://biospectrumindia.com/news/57/21017/new-risk-sharing-facility-to-help-countries-procure-additional-covid-19-vaccine-doses.html https://biospectrumindia.com/news/57/21017/new-risk-sharing-facility-to-help-countries-procure-additional-covid-19-vaccine-doses.html Thu, 07 Apr 2022 00:00:00 +0530 MedAccess, the Open Society Foundations and Gavi, the Vaccine Alliance have announced a new partnership to create a Risk Sharing Facility to help countries procure additional COVID-19 vaccine doses, including variant-adapted doses in response to risks and shocks. The $200 million Facility is designed to enable countries to protect more of their people and support COVAX’s ambitions to make COVID-19 vaccine procurement more sustainable and more tailored to country needs. The Gavi COVAX Advance Market Commitment (Gavi COVAX AMC) provides COVID-19 vaccines free of charge for 92 of the world’s lowest-income countries, helping them to meet the objectives set out in their national vaccination strategies – with more than 1.2 billion doses already shipped to AMC countries. In addition, AMC countries can also use the COVAX Cost-Sharing Mechanism to order more doses using domestic resources or low-cost financing from their multilateral development bank (MDB) partners, enabling them to protect more people, more quickly. The new guarantees are aimed at increasing take-up of the Cost-Sharing Mechanism by facilitating the financing of orders. MedAccess will provide a $100 million procurement guarantee to enable COVAX to order more doses from manufacturers on behalf of AMC countries choosing to participate in cost-sharing. By purchasing through COVAX, countries benefit from lower prices per dose negotiated for a range of COVID-19 vaccines. The Open Society Foundations will provide a further procurement guarantee of up to $ 00 million alongside MedAccess, through the Soros Economic Development Fund. This will help COVAX to respond to country requests for additional doses in the event of a future shock or demand spike. ]]> https://biospectrumindia.com/news/57/20965/university-of-glasgow-names-flagship-research-centre-after-john-shaw-kiran-mazumdar-shaw-.html https://biospectrumindia.com/news/57/20965/university-of-glasgow-names-flagship-research-centre-after-john-shaw-kiran-mazumdar-shaw-.html Tue, 29 Mar 2022 17:45:00 +0530 The University of Glasgow has honoured John Shaw, former Vice-Chairman of Biocon, and Kiran Mazumdar-Shaw, Executive Chairperson of Biocon and Biocon Biologics, by naming the University’s new research centre after them.  The Mazumdar-Shaw Advanced Research Centre will be home to over 500 researchers from a range of disciplines, facilitating world-changing collaborative research. The £116 million building will officially open in June 2022.  John Shaw, who is a Glasgow University graduate, along with his wife Kiran Mazumdar-Shaw had gifted $7.5 million to the University in July 2019. Their donation has been used to set up a new research hub within the University campus and to create a Professorial Chair, the Mazumdar-Shaw Chair of Molecular Pathology. The donation was used to help fund the building of the Mazumdar-Shaw Advanced Research Centre and create a Professorial Chair, the Mazumdar-Shaw Chair of Molecular Pathology. Mazumdar-Shaw said: ”John and I are honoured to have this fantastic research facility bear our name. The decision to gift to Glasgow was easy, we both feel very strongly that there is a responsibility to share wealth to make a difference. The ARC is about catalysing change in research and that resonates with us. Philanthropy can be a catalyst for change, growth, improvement and development. We are both grateful that we are in the fortunate position to contribute to John’s alma mater and help the University achieve its aspirational goals.”   ]]> https://biospectrumindia.com/news/57/20923/unicef-inks-supply-agreement-with-pfizer-for-oral-covid-19-treatment.html https://biospectrumindia.com/news/57/20923/unicef-inks-supply-agreement-with-pfizer-for-oral-covid-19-treatment.html Tue, 22 Mar 2022 00:00:00 +0530 United Nations Children's Fund (UNICEF) has signed a supply agreement with Pfizer for the procurement of up to 4 million treatment courses of the new oral antiviral medicine nirmatrelvir/ritonavir (PAXLOVID) in 2022. UNICEF procurement of PAXLOVID is dependent on country demand, clinical recommendations and necessary approvals. In December 2021, the US Food and Drug Administration issued an Emergency Use Authorization for the use of the Pfizer drug for the treatment of mild to moderate cases of COVID-19. PAXLOVID is currently under assessment by the World Health Organization (WHO). This agreement will help ensure that low- and middle-income countries (LMICs) have timely access to this novel COVID-19 therapeutic. Supply will be made available for procurement and delivery to 95 LMICs, which includes some upper-middle income countries. UNICEF will work closely with WHO and Access to COVID-19 Tools Accelerator (ACT-A) partners such as The Global Fund and Unitaid to ensure equitable access to the drug. ]]> https://biospectrumindia.com/news/57/20888/thermo-fisher-expands-clinical-research-labs-capacity-in-us.html https://biospectrumindia.com/news/57/20888/thermo-fisher-expands-clinical-research-labs-capacity-in-us.html Tue, 15 Mar 2022 00:00:00 +0530 Thermo Fisher Scientific Inc. is investing $97 million to expand its clinical research operations in Richmond, Virginia, US. The facilities, which include laboratory operations acquired with the purchase of PPD, Inc. in December 2021, will support increasing demand across biopharma for consistent, high-quality laboratory services to accelerate drug development. Over the next three years, Thermo Fisher expects to add nearly 150,000 square feet and more than 500 new employees in Richmond. The existing laboratory services operation in Richmond comprises more than 300,000 square feet, making it one of the largest laboratories of its kind in the world, and it employs more than 1,200 professionals, including Ph.D.-level scientists, analytical laboratory staff and other scientific professionals. The bulk of the expansion will occur in immunochemistry and chromatography functions, as well as subsequent enhancements in biomarker and vaccine sciences. ]]> https://biospectrumindia.com/news/57/20798/uk-pledges-160-m-to-boost-global-vaccine-development.html https://biospectrumindia.com/news/57/20798/uk-pledges-160-m-to-boost-global-vaccine-development.html Tue, 01 Mar 2022 00:00:00 +0530 The Coalition for Epidemic Preparedness Innovations (CEPI), based in Norway, has welcomed a £160 million pledge from the UK Government to advance its work against the COVID-19 crisis and build the critical tools and partnerships needed to reduce, or even eliminate, future epidemic and pandemic threats. The announcement comes ahead of the UK government hosting CEPI’s Global Pandemic Preparedness Summit on 7 to 8 March in London. The event aims to raise funds for CEPI’s goal, backed by the UK during its G7 presidency last year, to cut the time it takes to develop new vaccines to 100 days, including ‘variant-proof’ vaccines that will work against multiple future COVID-19 variants. The UK government invested more than £88 million to support the development of the Oxford-AstraZeneca vaccine. To date, the UK has also donated 32.2 million COVID-19 vaccine doses, of which 25.3 million have gone to COVAX, a global scheme to get more vaccines to developing countries. ]]> https://biospectrumindia.com/news/57/20745/milliporesigma-to-invest-more-than-500-m-in-technology-scale-up.html https://biospectrumindia.com/news/57/20745/milliporesigma-to-invest-more-than-500-m-in-technology-scale-up.html Thu, 24 Feb 2022 00:00:00 +0530 MilliporeSigma, the U.S. and Canada Life Science business sector of Merck KGaA, Darmstadt, Germany, has announced the closing of the transaction to acquire Exelead, following regulatory clearances and the fulfillment of other customary closing conditions, for approximately $780 million in cash. The business combination is expected to enable the Life Science business to provide its customers with comprehensive end-to-end contract development and manufacturing organization (CDMO) services across the mRNA value chain. The Life Science business plans to further invest over € 500 million to scale up Exelead's technology over the next ten years. "With the addition of Exelead's leading capabilities and highly experienced team, our Life Science business achieves an important milestone in becoming one of the leading CDMO players in mRNA vaccines and therapeutics, offering an integrated CDMO across the mRNA value chain from pre-clinical to commercial," said Matthias Heinzel, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Life Science. "mRNA holds much promise as a treatment well beyond Covid-19 and we will further invest in this technology to help realize its potential." ]]> https://biospectrumindia.com/news/57/20667/who-prequalifies-first-monoclonal-antibody-tocilizumab-to-treat-covid-19.html https://biospectrumindia.com/news/57/20667/who-prequalifies-first-monoclonal-antibody-tocilizumab-to-treat-covid-19.html Tue, 15 Feb 2022 00:00:00 +0530 Aiming to increase access to recommended treatments for COVID-19, the World Health Organisation (WHO) has added tocilizumab, a monoclonal antibody, to its list of prequalified treatments for COVID-19. To date, six COVID-19 treatments have been prequalified by WHO, including the three presentations (three vials, each with a different quantity) of the product prequalified recently.  The three prequalified products are manufactured by the originator company, Roche, but the listings should pave the way for more companies coming forward to seek WHO prequalification, thereby increasing the number of quality-assured products and creating competition leading to potentially lower prices. The prequalification of these products will also facilitate low- and middle-income countries’ authorization of them as COVID treatments. Tocilizumab is a monoclonal antibody that inhibits the Interleukin-6 (IL-6) receptor. Interleukin-6 induces an inflammatory response and is found in high levels in patients critically ill with COVID-19. WHO recommends tocilizumab only for patients diagnosed with severe or critical COVID-19. It should be administered by a healthcare worker in a monitored clinical setting along with the current standard of care for COVID-19, which includes oxygen, corticosteroids, and other medications.   ]]> https://biospectrumindia.com/views/57/20659/we-are-extremely-happy-and-welcome-this-budget-jeevam-health-.html https://biospectrumindia.com/views/57/20659/we-are-extremely-happy-and-welcome-this-budget-jeevam-health-.html Tue, 01 Feb 2022 17:00:00 +0530 “We are extremely happy and welcome this budget which focuses on digital health programmes in the healthcare segment. Covid has had a drastic impact on people and it’s important to keep our mental health a priority. The government's support in launching National Digital Health Ecosystem will help in transforming the medical infrastructure in our country. We look forward to working closely with the government on this and also coming up with programs for our clients on ways to cope with mental health.”    ]]> https://biospectrumindia.com/news/57/20459/pfizer-evaluates-omicron-based-covid-19-vaccine-in-18-to-55-years-old.html https://biospectrumindia.com/news/57/20459/pfizer-evaluates-omicron-based-covid-19-vaccine-in-18-to-55-years-old.html Tue, 25 Jan 2022 00:00:00 +0530 Pfizer Inc. and BioNTech SE have announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age. The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines. “While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. ]]> https://biospectrumindia.com/news/57/20351/benevolentai-expands-collaboration-with-astrazeneca-focused-on-sle-heart-failure.html https://biospectrumindia.com/news/57/20351/benevolentai-expands-collaboration-with-astrazeneca-focused-on-sle-heart-failure.html Thu, 13 Jan 2022 17:05:00 +0530 BenevolentAI, a leading clinical-stage AI drug discovery company, has expanded its AI-driven drug discovery collaboration with AstraZeneca, doubling the number of disease areas being explored through the partnership.    The expansion builds on the collaboration initiated in 2019 and adds systemic lupus erythematosus (SLE) and heart failure (HF) to ongoing work to identify multiple novel targets in chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF).   The collaboration has already achieved two major milestones, with the first novel targets added to AstraZeneca’s portfolio for both CKD and IPF.    The Benevolent Platform is disease agnostic, meaning it can be applied to any disease and is capable of generating novel targets at scale. Scientists and technologists from both companies will use the Benevolent Platform™ and biomedical Knowledge Graph — which uniquely includes AstraZeneca proprietary data with public and licensed data from scientific literature, patents, genetics, chemistry, clinical trials and more — to better understand underlying disease mechanisms and identify novel targets.   ]]> https://biospectrumindia.com/news/57/20314/oxford-university-develops-blood-test-to-detect-cancer-and-metastasis.html https://biospectrumindia.com/news/57/20314/oxford-university-develops-blood-test-to-detect-cancer-and-metastasis.html Thu, 06 Jan 2022 00:00:00 +0530 A University of Oxford study outlines a new type of blood test that can be used to detect a range of cancers and whether these cancers have spread (metastasised) in the body. The study analysed samples from 300 patients with non-specific but concerning symptoms of cancer, such as fatigue and weight loss, who were recruited through the Oxfordshire Suspected CANcer (SCAN) pathway. The researchers assessed whether the test could distinguish patients with a range of solid tumours from those without cancer. Their results show that cancer was correctly detected in 19 out of every 20 patients with cancer using this test. In those with cancer, metastatic disease was identified with an overall accuracy of 94%. These results make this the first technology to be able to determine the metastatic status of a cancer from a simple blood test, without prior knowledge of the primary cancer type. This test shows promise to help clinicians detect cancer and assess cancer stage in the future.  Future studies with larger patient cohorts will further evaluate this technique for the earlier detection of new cancers and potential clinical applications. ]]> https://biospectrumindia.com/news/57/20306/pfizer-and-biontech-partner-to-design-first-mrna-based-shingles-vaccine.html https://biospectrumindia.com/news/57/20306/pfizer-and-biontech-partner-to-design-first-mrna-based-shingles-vaccine.html Wed, 05 Jan 2022 00:00:00 +0530 Pfizer Inc. and BioNTech SE have announced a new research, development and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV), a debilitating, disfiguring and painful disease that impacts about one in three people in the United States during their lifetime. The collaboration builds on the companies’ success in developing the first approved and most widely used mRNA vaccine to help prevent COVID-19. This is the third collaboration between Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the COVID-19 vaccine collaboration initiated in 2020. Under the terms of the agreement, the companies will leverage a proprietary antigen technology identified by Pfizer’s scientists and BioNTech's proprietary mRNA platform technology used in the companies’ COVID-19 vaccine. The parties will share development costs. Clinical trials are planned to start in the second half of 2022. Pfizer will have rights to commercialize the potential vaccine on a global basis, with the exception of Germany, Turkey and certain developing countries where BioNTech will have commercialization rights. The companies will share gross profits from commercialization of any product. ]]> https://biospectrumindia.com/news/57/20251/find-invests-21m-to-develop-affordable-multi-pathogen-diagnostic-platforms.html https://biospectrumindia.com/news/57/20251/find-invests-21m-to-develop-affordable-multi-pathogen-diagnostic-platforms.html Fri, 24 Dec 2021 00:00:00 +0530 Switzerland-based FIND, the global alliance for diagnostics, has announced an investment of $21 million to accelerate the development, manufacturing, and launch of affordable, multi-pathogen, molecular diagnostic platforms, specifically for use in decentralized settings in low- and middle-income countries (LMICs). Following an open call for partners and a competitive selection process, four companies with promising new platforms have been selected for investment: Biomeme, Inc (USA), Bioneer Corporation (Republic of Korea), Qlife Holding AB (Sweden) and SD Biosensor, Inc (Republic of Korea). The investment is funded by the German Federal Ministry of Education and Research (BMBF) through KfW and other donors, by way of grants to FIND. It will support the companies for a period of 12 months to develop assays for the differential diagnosis of COVID-19 and other respiratory pathogens (such as influenza) and to optimize their systems to meet the needs of LMICs, in addition to the requirements for authorization under the World Health Organization (WHO) emergency use listing (EUL) and/or prequalification process (PQ). The funds will also support the companies’ manufacturing processes, to enable price reductions and increased volumes, and support regulatory submissions. The companies are aiming to complete product development of the multi-respiratory pathogen tests by late 2022 with a view to commercial launch of the products in 2023. ]]> https://biospectrumindia.com/news/57/20239/pfizer-receives-us-fda-eua-for-covid-19-pill.html https://biospectrumindia.com/news/57/20239/pfizer-receives-us-fda-eua-for-covid-19-pill.html Thu, 23 Dec 2021 00:00:00 +0530 Pfizer Inc. has announced that the US Food and Drug Administration (FDA) has authorised the emergency use of PAXLOVID (nirmatrelvir and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate. With PAXLOVID now authorized for emergency use, Pfizer stands ready to start delivery in the US immediately. In November 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of PAXLOVID, with delivery fulfillment expected to be completed in 2022.   ]]> https://biospectrumindia.com/news/57/20237/bd-acquires-scanwell-health-to-expand-digital-at-home-testing.html https://biospectrumindia.com/news/57/20237/bd-acquires-scanwell-health-to-expand-digital-at-home-testing.html Wed, 22 Dec 2021 00:00:00 +0530 BD (Becton, Dickinson and Company) has completed the acquisition of privately held Scanwell Health Inc., a leader in smartphone-enabled at-home medical tests. BD collaborated with Scanwell to develop the app used with the recently launched BD Veritor™ At-Home COVID-19 Test, the first at-home COVID-19 test that uniquely uses a smartphone camera and app to capture and interpret results, eliminating the human subjectivity in other visually read at-home antigen tests. Scanwell will become the foundational digital platform upon which BD plans to develop at-home diagnostic tests for a range of infectious diseases including COVID-19/influenza A+B, group A strep and additional menu for detecting infections and managing chronic disease. The Scanwell app is a key differentiator in the market for at-home COVID-19 testing. To date, no other company uses the phone's camera to capture the image of the test that is then analyzed and interpreted by the app. Other COVID-19 home tests use smartphones as part of their process, but BD Veritor™ At-Home COVID-19 Test is the first and only test to use the smartphone as the analyzer to digitally interpret the test results and provide a definitive POSITIVE or NEGATIVE digital display of testing results.  ]]> https://biospectrumindia.com/news/57/20229/merck-acquires-chord-therapeutics-to-expand-neuro-inflammatory-pipeline.html https://biospectrumindia.com/news/57/20229/merck-acquires-chord-therapeutics-to-expand-neuro-inflammatory-pipeline.html Tue, 21 Dec 2021 00:00:00 +0530 Switzerland-based Chord Therapeutics is being acquired by Merck, a leading science and technology company. The strategic acquisition enables Merck to expand its neurology pipeline to develop Chord's lead drug candidate, CRD1 (cladribine), for the treatment of gMG and NMOSD. Chord Therapeutics was launched in October 2020 by leading healthcare venture capital firm Omega Funds, the sole investor in the company's $16 million Series A financing. Cladribine is a well characterized molecule that has been extensively studied across multiple sclerosis (MS) and oncologic disorders and has shown promising results in exploratory studies in generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorders (NMOSD). Merck plans to leverage its existing capabilities to further develop an oral cladribine product, tailored specifically for those indications. ]]> https://biospectrumindia.com/news/57/20219/serum-institute-novavaxs-covid-19-vaccine-gets-who-eul-nod.html https://biospectrumindia.com/news/57/20219/serum-institute-novavaxs-covid-19-vaccine-gets-who-eul-nod.html Fri, 17 Dec 2021 00:00:00 +0530 World Health Organization (WHO) has issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named CovovaxTM, is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries. CovovaxTM was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally. "This is yet another milestone in our fight against COVID-19, Covovax is now WHO approved for emergency use, showing excellent safety and efficacy", said Adar Poonawalla, CEO, Serum Institute of India.         ]]> https://biospectrumindia.com/news/57/20164/astrazenecas-evusheld-gets-eua-nod-in-us-for-covid-19-prevention.html https://biospectrumindia.com/news/57/20164/astrazenecas-evusheld-gets-eua-nod-in-us-for-covid-19-prevention.html Thu, 09 Dec 2021 18:35:00 +0530 AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune-compromised due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.Gagandeep Singh Bedi, MD, AstraZeneca India Pharma added, "The US Food and Drug Administration’s EUA approval of AZD7442 for the prevention of COVID-19 is an important milestone globally. We welcome this news and the opportunity it provides to support the unmet needs of high risk and immune-compromised patients and we have already initiated engagements with the relevant health authorities in India to provide them with the latest evidence. Recent data from the Phase III PROVENT trial showed a robust efficacy profile and AZD7442 has so far demonstrated protection of up to six months against COVID-19 in this population.” ]]> https://biospectrumindia.com/news/57/19946/pegasystems-with-google-cloud-to-improve-personalisation-in-health.html https://biospectrumindia.com/news/57/19946/pegasystems-with-google-cloud-to-improve-personalisation-in-health.html Thu, 11 Nov 2021 13:05:00 +0530 Pegasystems has announced a collaboration with Google Cloud that will help improve experiences in healthcare with better data insights and personalization.   The partnership between Pega and Google Cloud will bring together the capabilities of Google Cloud’s Healthcare Data Engine and Pega’s suite of intelligent healthcare solutions.    Organisations will be better positioned to deliver optimal care and health outcomes to millions of people by combining Google Cloud’s efficient, comprehensive data platform and Pega’s personalised recommendations.   The partnership with Google Cloud will allow Pega’s clients to configure their applications so Google Cloud’s Healthcare Data Engine -- which enables advanced analytics and AI in a secure, compliant, and scalable cloud environment -- seamlessly works with Pega’s healthcare solutions.   These solutions include Pega Care Management, Pega Customer Service for Healthcare, Pega Sales Automation for Healthcare and Pega Customer Decision Hub. Google Cloud’s Healthcare Data Engine harmonizes data from multiple sources, including medical records, claims, clinical trials, and research data, providing a foundation for Pega to facilitate and optimize millions of individualized, data-based conversations between consumers and health organisations, including service and claims interactions, and care navigation activities.       ]]> https://biospectrumindia.com/news/57/19912/mercks-oral-covid-19-pill-receives-world-first-authorization.html https://biospectrumindia.com/news/57/19912/mercks-oral-covid-19-pill-receives-world-first-authorization.html Fri, 05 Nov 2021 00:00:00 +0530 Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics have announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (UK) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. In the U.K., LAGEVRIO® is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application. Merck is actively working to submit applications to other regulatory agencies around the world. ]]> https://biospectrumindia.com/news/57/19904/logistics4pharma-gains-aeo-status-for-frankfurt-facility-.html https://biospectrumindia.com/news/57/19904/logistics4pharma-gains-aeo-status-for-frankfurt-facility-.html Wed, 03 Nov 2021 11:40:00 +0530 Logistics4Pharma, a pharmaceutical logistics and cold chain specialist, has recently completed GDP certification and ISO 9001:2015 quality management certifications for its Frankfurt, Germany cold chain storage and logistics facility. It also achieved the status of Authorised Economic Operator (AEO) which certifies the facility operates at the highest level of security and provide customers with the benefits of customs simplification procedures.    These advances follow a recent completion of a successful inspection from German Authorities validating compliance with good distribution practice (GDP) regulations for the storage and transportation of active pharmaceutical ingredients (APIs) and finished drug products. Logistics4Pharma has also passed a recent audit from the Luftfahrt-Bundesamt (LBA) renewing Regulated Agent status under the supervision of the German Aviation Administration.    “Throughout the COVID-19 pandemic, we have seen deep impacts across the supply chain which have been further exacerbated by global storage and transportation challenges,” said Kees Schmidt, Head of Operations at Logistics4Pharma. “While our team was already working to high standards and expanding its services pre-pandemic, these trends amplified the urgency of our efforts. We will continue to strengthen our compliance and commercial solutions to deliver deeper value to our European customers looking for a reliable cold-chain packaging, storage, and logistics partner in Frankfurt and around the world.”   Logistics4Pharma offers solutions tailored to meet individual customer needs, with a range for warehousing options (-15 to -25 DegC, 2 to 8 Deg C and 15 to 25 DegC), passive and active packaging solutions, transportation by air, land and sea, documentation, and customs clearance for active pharmaceutical ingredients (APIs), dangerous goods, and finished drug products. There are further plans to enhance the offer at the Frankfurt facility and include ultra-deep freeze capacity (-80 DegC) in the coming 12 months.    The company will be onsite in booth 18H12 at CPhI Worldwide from November 9 to 11, Italy.        ]]> https://biospectrumindia.com/news/57/19911/nih-to-study-long-term-effects-of-covid-19-in-pregnancy.html https://biospectrumindia.com/news/57/19911/nih-to-study-long-term-effects-of-covid-19-in-pregnancy.html Wed, 03 Nov 2021 00:00:00 +0530 The National Institutes of Health (NIH), US will support a four-year follow-up study on the potential long-term effects of COVID-19 on women infected with SARS-CoV-2 during pregnancy. The study will also follow their offspring for any potential long-term effects. The effort is part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, which aims to understand why some individuals who have had COVID-19 don’t fully recover or develop symptoms after recovery. Known as post-acute sequelae of SARS-CoV-2 infection (PASC), or more commonly as Long COVID, these conditions affect all ages. Long-term effects include fatigue, shortness of breath, difficulty concentrating, sleep disorders, fevers, anxiety and depression. The current study will enroll some participants from an earlier study by the Maternal-Fetal Medicine Units (MFMU) Network, a 36-site research collaboration supported by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Researchers hope the study findings will inform efforts to reduce the risk of Long COVID after pregnancy and to treat its symptoms. ]]> https://biospectrumindia.com/news/57/19777/roche-ibex-medical-analytics-to-develop-ai-based-pathology-applications.html https://biospectrumindia.com/news/57/19777/roche-ibex-medical-analytics-to-develop-ai-based-pathology-applications.html Mon, 18 Oct 2021 12:00:00 +0530 Roche has entered an agreement with Israel-based Ibex Medical Analytics to jointly develop an embedded image analysis workflow for pathologists to seamlessly access Ibex's AI algorithms, insights, and decision support tools using NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software.    Collaborations with leading AI companies like Ibex are made possible through Roche's Digital Pathology Open Environment, which allows pathologists to securely access third-party AI-powered technology alongside Roche's growing menu of AI-based image analysis tools.   Ibex's Galen platform was recently granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) and is CE marked in Europe for breast and prostate cancer detection in multiple workflows. Through this alliance, customers using Roche Digital Pathology will gain access to Ibex's innovative tools, such as algorithms that analyse prostate and breast biopsies, in addition to the AI tools already provided by Roche. ]]> https://biospectrumindia.com/news/57/19727/who-recommends-groundbreaking-malaria-vaccine-for-children.html https://biospectrumindia.com/news/57/19727/who-recommends-groundbreaking-malaria-vaccine-for-children.html Thu, 07 Oct 2021 00:00:00 +0530 The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine, developed by British drugmaker GlaxoSmithKline (GSK), among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019. GSK is working with partners to develop solutions to ensure equitable and long-term access to the RTS,S vaccine for the people who need it.  GSK has committed to donate up to 10 million RTS,S doses for use in the pilots, and to supply up to 15 million doses annually, following a recommendation and funding for wider use.  A Product Transfer, including technology transfer for long-term antigen production, is also underway with Bharat Biotech. GSK will now work closely with partners, funders and governments to support additional supply of the vaccine, and has committed to make the 15 million annual doses available at no more than 5% above cost of production. ]]> https://biospectrumindia.com/news/57/19706/who-prioritises-diabetes-cancer-treatments-in-essential-medicines-lists.html https://biospectrumindia.com/news/57/19706/who-prioritises-diabetes-cancer-treatments-in-essential-medicines-lists.html Wed, 06 Oct 2021 00:00:00 +0530 The World Health Organisation (WHO) has published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials to treat serious bacterial and fungal infections.   The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients.   The list includes Sodium-Glucose Co-transporter-2 (SGLT2) inhibitors empagliflozin, canagliflozin and dapagliflozin as second line therapy in adults with type 2 diabetes.    Four new medicines for cancer treatment were added to the model lists. They are Enzalutamide, as an alternative to abiraterone, for prostate cancer; Everolimus, for subependymal giant cell astrocytoma (SEGA), a type of brain tumour in children; Ibrutinib, a targeted medicine for chronic lymphocytic leukaemia; and Rasburicase, for tumour lysis syndrome, a serious complication of some cancer treatments.   The listing for imatinib was extended to include targeted treatment of leukaemia. New childhood cancer indications were added for 16 medicines already listed, including for low-grade glioma, the most common form of a brain tumour in children.     ]]> https://biospectrumindia.com/news/57/19619/ge-healthcare-buys-bk-medical-for-1-45-b-expand-ultrasound-portfolio.html https://biospectrumindia.com/news/57/19619/ge-healthcare-buys-bk-medical-for-1-45-b-expand-ultrasound-portfolio.html Fri, 24 Sep 2021 08:45:00 +0530 GE has entered into an agreement to acquire BK Medical, a leader in advanced surgical visualisation, from Altaris Capital Partners for a cash purchase price of $1.45 billion. BK Medical is headquartered in Boston and Copenhagen with more than 650 employees and is delivering double-digit revenue growth.   The transaction is expected to create value by further strengthening BK Medical, including through significant synergies with the benefit of GE’s technology and commercial scale.   It will enable BK Medical’s Active Imaging platform to reach new customers and new markets around the world, and the combination of GE Healthcare’s diagnostic imaging technology with BK’s ability to enable decision-making and surgical visualisation in the intervention will allow better decision-making throughout the care continuum.   GE Healthcare expects BK Medical to deliver rapid revenue growth as well as margin expansion and free cash flow growth.    GE Healthcare also expects a high-single-digit return on invested capital by year five. The parties expect the transaction to close in 2022, subject to review by the relevant regulatory authorities.     ]]> https://biospectrumindia.com/news/57/19533/sanofi-buys-kadmon-for-1-9-b-to-strengthen-transplant-biz.html https://biospectrumindia.com/news/57/19533/sanofi-buys-kadmon-for-1-9-b-to-strengthen-transplant-biz.html Thu, 09 Sep 2021 17:20:00 +0530 Sanofi has entered into a definitive merger agreement with Kadmon Holdings, a biopharmaceutical company that discovers, develops and markets transformative therapies for disease areas of significant unmet medical needs. The acquisition supports Sanofi’s strategy to continue to grow its general medicines core assets and will immediately add Rezurock (belumosudil) to its transplant portfolio.    Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and paediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.   Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). The Sanofi and Kadmon Boards of Directors unanimously approved the transaction.     The transaction is expected to be modestly dilutive to Sanofi’s EPS in 2022.     ]]> https://biospectrumindia.com/news/57/19527/illumina-merck-to-develop-tests-for-identifying-cancer-mutations.html https://biospectrumindia.com/news/57/19527/illumina-merck-to-develop-tests-for-identifying-cancer-mutations.html Wed, 08 Sep 2021 19:00:00 +0530 Illumina and Merck have announced a partnership to develop and commercialise tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD).   Patients whose tumours are HRD-positive may be eligible for targeted treatment by a class of precision medicines called PARP inhibitors.   The HRD tests will leverage Illumina's TruSight Oncology 500 (TSO 500) content, enabling the most comprehensive genomic profiling assays in a single workflow.   The strategic partnership builds on an initial study conducted with Merck and leverages Illumina's relationship with Myriad Genetics to expand international access to the proprietary technology in Myriad's FDA approved myChoice CDx companion diagnostic test.   Illumina will develop a new HRD CDx test for the EU and the UK to aid in the identification of ovarian cancer patients with positive HRD status who are eligible for treatment with LYNPARZA (olaparib), a first-in-class PARP inhibitor, jointly developed and commercialized by Merck and AstraZeneca.   In addition, Illumina will develop and commercialise a research use only (RUO) HRD assay that will be add-on content for the TSO 500 RUO panel. Illumina plans to launch this product globally, excluding the US and Japan.       ]]> https://biospectrumindia.com/views/57/19463/usfda-gives-nod-to-unique-stroke-rehabilitation-system.html https://biospectrumindia.com/views/57/19463/usfda-gives-nod-to-unique-stroke-rehabilitation-system.html Mon, 30 Aug 2021 00:00:00 +0530 The US Food and Drug Administration (FDA) has approved US-based MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke, a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms, using vagus nerve stimulation (VNS).   The Vivistim System is intended to be used, along with post-stroke rehabilitation therapy, in patients who have had an ischemic stroke, to electrically stimulate the vagus nerve, a nerve that runs from the brain down to the abdomen—to reduce deficiencies in upper limb and extremity motor function and to improve patients' ability to move their arms and hands.   An implantable pulse generator (IPG), which generates a mild electrical pulse, is implanted just under the skin in the chest of the patient. Attached to the IPG is a lead wire that is implanted under the skin and leads up to electrodes that are placed on the left side of the neck where the vagus nerve is.   The Vivistim System, a prescription device, may be used in both clinical and at-home settings to provide VNS.   It is not approved for use outside of its intended use to stimulate the vagus nerve during chronic ischemic stroke rehabilitation therapy for moderate to a severe loss of upper extremity function. It should not be used in patients with vagotomy, which is the surgical removal of part of the vagus nerve.     ]]> https://biospectrumindia.com/news/57/19443/global-covid-19-surgery-study-bags-guinness-world-records.html https://biospectrumindia.com/news/57/19443/global-covid-19-surgery-study-bags-guinness-world-records.html Thu, 26 Aug 2021 17:05:00 +0530 A study led by the University of Birmingham and Edinburgh experts has been awarded the Guinness World Records title for the world’s largest scientific collaboration - involving over 140,000 patients in 116 countries.   The record for ‘Most authors on a single peer-reviewed academic paper’ is now held by the Universities of Birmingham and Edinburgh after 15,025 scientists around the globe contributed to major research into the impact of COVID-19 on surgical patients.   Funded by the National Institute for Health Research (NIHR), the researchers concluded that patients waiting for elective surgery should be treated as a vulnerable group and access COVID-19 vaccines ahead of the general population – potentially helping to avoid thousands of post-operative deaths linked to the virus.   This could be particularly important for Low- and Middle-income Countries (LMICs) where access to vaccination remains limited and mitigation measures such as nasal swab screening and COVID-free surgical pathways to reduce the risk of virus-related complications are not available for many patients.   Overall, the scientists estimated that global prioritisation of pre-operative vaccination for elective patients could prevent an additional 58,687 COVID-19-related deaths in one year.    The COVIDSurg Collaborative international team of researchers published its findings in BJS, Europe’s leading surgical journal, after studying data from 1,667 hospitals in countries including Australia, Brazil, China, India, UAE, UK and USA.       ]]> https://biospectrumindia.com/news/57/19430/who-focuses-on-re-emerging-pathogens-of-epidemic-pandemic-potential.html https://biospectrumindia.com/news/57/19430/who-focuses-on-re-emerging-pathogens-of-epidemic-pandemic-potential.html Tue, 24 Aug 2021 12:05:00 +0530 The World Health Organization (WHO) has issued an open call for experts to serve as members of the new WHO Scientific Advisory Group for the Origins of Novel Pathogens (SAGO). The SAGO will advise WHO on technical and scientific considerations regarding the origins of emerging and re-emerging pathogens of epidemic and pandemic potential, and will be composed of a wide range of experts acting in their personal capacity. SAGO will also guide WHO on next steps for understanding the SARS-CoV-2 origins. In its capacity as an advisory body to WHO, the SAGO will advise on the development of a WHO global framework to define and guide studies into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential. It will also focus on prioritizing studies and field investigations into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential, in accordance with the WHO global framework; and provide information and views to assist the WHO Secretariat in the development of a detailed work plan of the SAGO. The body will provide additional advice and support to WHO, as requested by the WHO SAGO Secretariat, which may include participation in future WHO-international missions to study the origins of SARS-CoV-2 or for other emerging pathogens. ]]> https://biospectrumindia.com/news/57/19422/pfizer-buys-trillium-therapeutics-for-2-26-b.html https://biospectrumindia.com/news/57/19422/pfizer-buys-trillium-therapeutics-for-2-26-b.html Mon, 23 Aug 2021 16:00:00 +0530 American pharma firm Pfizer Inc. and Trillium Therapeutics Inc. have entered into a definitive agreement under which Pfizer will acquire Trillium, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. Under the terms of the agreement, Pfizer will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share, in cash. This represents a 118% premium to the 60-day weighted average price for Trillium. Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies. TTI-622 and TTI-621 are novel, potentially best-in-class SIRPα-Fc fusion proteins that are currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies. Andy Schmeltz, Global President & General Manager, Pfizer Oncology. “The proposed acquisition of Trillium builds on our strong track record of leadership in Oncology, enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe.  ]]> https://biospectrumindia.com/news/57/19298/hungary-certifies-bharat-biotechs-covaxin-with-gmp-compliance.html https://biospectrumindia.com/news/57/19298/hungary-certifies-bharat-biotechs-covaxin-with-gmp-compliance.html Thu, 05 Aug 2021 10:00:00 +0530 Bharat Biotech's COVID-19 vaccine Covaxin has received Good Manufacturing Practices (GMP) compliance certificate from Hungary. National Institute of Pharmacy and Nutrition, Hungary has certified the GMP for the manufacture of Covaxin.The certificate of GMP is now listed on the EudraGMDP database which is the collection of records of the European Community of manufacturing authorisations and certificates of Good Manufacturing Practice.Bharat Biotech intends to submit documentation for emergency use authorisation to several additional countries worldwide, the company said.A tweet by Bharat Biotech mentions, "Another milestone in our account as COVAXIN receives GMP certificate from Hungary. This marks the 1st EUDRAGDMP compliance certificate received by Bharat Biotech from European regulatory. ]]> https://biospectrumindia.com/news/57/19297/sanofi-to-buy-mrna-therapeutics-firm-translate-bio-for-3-2b.html https://biospectrumindia.com/news/57/19297/sanofi-to-buy-mrna-therapeutics-firm-translate-bio-for-3-2b.html Wed, 04 Aug 2021 17:30:00 +0530 Sanofi has entered into a definitive agreement with Translate Bio, a clinical-stage mRNA therapeutics company, under which Sanofi will acquire all outstanding shares of Translate Bio for $38.00 per share in cash, which represents a total equity value of approximately $3.2 billion (on a fully diluted basis). The Sanofi and Translate Bio Boards of Directors unanimously approved the transaction.   “Translate Bio adds an mRNA technology platform and strong capabilities to our research, further advancing our ability to explore the promise of this technology to develop both best-in-class vaccines and therapeutics,” said Paul Hudson, CEO, Sanofi. “A fully owned platform allows us to develop additional opportunities in the fast-evolving mRNA space. We will also be able to accelerate our existing partnered programmes already under development. Our goal is to unlock the potential of mRNA in other strategic areas such as immunology, oncology, and rare diseases in addition to vaccines.”   In June 2018, Sanofi and Translate Bio entered into a collaboration and exclusive license agreement to develop mRNA vaccines which was further expanded in 2020 to broadly address current and future infectious diseases.   There are two ongoing mRNA vaccine clinical trials under the collaboration, the COVID-19 vaccine Phase 1/2 study with results expected in Q3 2021 and the mRNA seasonal influenza vaccine Phase 1 trial with results due in Q4 2021. The acquisition builds on Sanofi’s establishment of a first-of-its-kind vaccines mRNA Center of Excellence.     ]]> https://biospectrumindia.com/news/57/19226/sun-pharma-signs-agreement-with-cassiopea-for-acne-drug-in-us-and-canada.html https://biospectrumindia.com/news/57/19226/sun-pharma-signs-agreement-with-cassiopea-for-acne-drug-in-us-and-canada.html Mon, 26 Jul 2021 10:55:00 +0530 Sun Pharmaceutical Industries and Cassiopea, a speciality pharmaceutical company developing and preparing to commercialise prescription drugs with novel mechanisms of action (MOA) to address long-standing essential dermatological conditions announced the signing of License and Supply Agreements for Winlevi (clascoterone cream 1 per cent) in the US and Canada. Winlevi has been approved by the United States Food & Drug Administration (FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older.   Under the terms of the above-referred agreements, Sun Pharma will have the exclusive right to commercialise Winlevi in the US and Canada, and Cassiopea will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $45 million, potential commercial milestones totalling up to $190 million and customary double-digit royalties. The agreements will close upon the expiration of the HSR waiting period.    Winlevi is expected to be available in the US in the Q4 of 2021.   Abhay Gandhi, CEO, North America, Sun Pharma, said, "Sun Pharma is pleased to enter into a collaboration with Cassiopea. Winlevi is a new class of topical medication in dermatology and will complement our existing oral acne portfolio. The addition of Winlevi further strengthens our position in the acne segment and reinforces our deep commitment to caring and making a difference in the lives of patients."   Diana Harbort, CEO, Cassiopea, commented, “We are pleased to partner with Sun Pharma. Sun Pharma has a strong established US dermatology presence and will make Winlevi widely available to dermatology health care providers and their patients. Following this transaction, Cassiopea will be expecting substantial revenue streams for the foreseeable future and will be well funded to continue the development of its innovative dermatology pipeline.”   The FDA approved Winlevi (clascoterone cream 1 per cent) in August 2020 for the topical treatment of acne vulgaris in patients 12 years and older.    ]]> https://biospectrumindia.com/news/57/19204/nih-expands-biomedical-research-with-microsoft-azure.html https://biospectrumindia.com/news/57/19204/nih-expands-biomedical-research-with-microsoft-azure.html Wed, 21 Jul 2021 16:00:00 +0530 Microsoft Azure has joined the US-based National Institutes of Health’s (NIH) Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative as the newest cloud service provider to support biomedical research. The addition of this latest industry partner will further the STRIDES Initiative’s aim to accelerate biomedical research in the cloud by reducing economic and process barriers as well as providing cost-effective access to cloud platforms, training, cloud experts, and best practices for optimizing research in the cloud. “The cloud can help democratize access to high-value research data and the most advanced analytical technologies for all researchers. Expanding our network of providers and access to the most advanced computational infrastructure, tools, and services provides the agility and flexibility that researchers need to accelerate research discoveries,” said Andrea T. Norris, Director of NIH’s Center for Information Technology and NIH Chief Information Officer. “Partnering with Microsoft Azure as a cloud service provider furthers our goals to enhance discovery and improve efficiency in biomedical research.” In just a few years, the STRIDES Initiative has expanded access to critical infrastructure and cutting-edge cloud resources for NIH researchers, as well as NIH-funded researchers at more than 2,500 academic institutions across the nation. ]]> https://biospectrumindia.com/news/57/19151/lupin-launches-tavaborole-topical-solution-in-us-market.html https://biospectrumindia.com/news/57/19151/lupin-launches-tavaborole-topical-solution-in-us-market.html Tue, 13 Jul 2021 16:55:00 +0530 Lupin announced the US launch of Tavaborole Topical Solution, 5 per cent having received approval from the United States Food and Drug Administration (FDA). The product will be manufactured at Lupin’s facility in Pithampur. Tavaborole Topical Solution, 5 per cent, is the generic equivalent of Kerydin Topical Solution, 5 per cent, of Anacor Pharmaceuticals, and is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Tavaborole Topical Solution (RLD: Kerydin), 5 per cent has an estimated annual sales of $53 million in the US. ]]> https://biospectrumindia.com/news/57/19107/metropolis-healthcare-haystackanalytics-launch-nextgen-tb.html https://biospectrumindia.com/news/57/19107/metropolis-healthcare-haystackanalytics-launch-nextgen-tb.html Wed, 07 Jul 2021 15:35:00 +0530 Metropolis Healthcare has launched NEXTGEN TB, whole-genome sequencing of tuberculosis utilising the Next Generation Sequencing (NGS) platform for rapid identification of drug resistance in TB patients and providing genotypic level information on drug-resistant genes for up to 18 Anti - TB antibiotics.   Partnering with HaystackAnalytics (start-up incubated at SINE, IIT Bombay), Metropolis Healthcare plans to offer this test in Sri Lanka, Mauritius, the UAE, Kenya, Zambia, Ghana, Tanzania as well as three other African countries to help their fight against tuberculosis.   The 18 drugs covered are Streptomycin, Isoniazid, Rifampicin, Ethambutol, Pyrazinamide, Kanamycin, Amikacin, Capreomycin, Ofloxacin, Moxifloxacin, Gatifloxacin, Ethionamide, Para-amino salicylic acid, Linezolid, Clofazimine, Bedaquiline, Pretomanid, and Delaminid.   NEXGEN TB has a better turnaround time with much faster and reliable results. Additionally, any novel drug resistance genetic mutations can be identified by whole-genome sequencing using NGS.   Ameera Shah, Promoter and MD, Metropolis Healthcare, “It’s an honour to partner with homegrown start-up, HaystackAnalytics to help launch NEXTGEN TB, as its need has become essential to this world. With TB being around long enough for everyone to know how lethal it could be, it is a sheer moment of pride to be able to launch such a test as we hope this could help us cope through the silent pandemic which has been smouldering against us for so many years.”   Dr Niranjan Patil (MD, Microbiology), Scientific Business head- Infectious diseases, Microbiology & Molecular biology- Head & Biosafety officer, Metropolis Healthcare said, “Whole-genome sequencing-based tests such as Nextgen TB not only identifies the TB species involved & in one go it helps reduce the time for performing anti TB drug susceptibility from weeks to just seven to 10 days thus saving crucial time for initiation of evidence-based treatment regimens as well as complementing the TB culture-based tests. It also helps to identify any novel mutations responsible for TB drug resistance which is an added advantage." ]]> https://biospectrumindia.com/news/57/19074/lupin-gets-us-fda-nod-for-solosec-to-treat-trichomoniasis.html https://biospectrumindia.com/news/57/19074/lupin-gets-us-fda-nod-for-solosec-to-treat-trichomoniasis.html Thu, 01 Jul 2021 20:05:00 +0530 Lupin Pharmaceuticals, the US-based wholly-owned subsidiary of global pharma major Lupin, announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) to expand the use of SOLOSEC (secnidazole) to include the treatment of trichomoniasis in adults.    Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the US, affecting an estimated three to five million people every year. SOLOSEC was approved in the US in 2017 for the treatment of bacterial vaginosis (BV) in adult women. The supplemental approval makes SOLOSEC the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.    “The FDA’s approval for the additional indication for SOLOSEC to treat trichomoniasis builds upon our commitment to support women’s health and provides health care professionals with an option to treat patients with trichomoniasis and bacterial vaginosis (BV). Research demonstrates that approximately 70 per cent of women with trichomoniasis are PCR positive for BV,” said Jon Stelzmiller, President – Specialty, Lupin Pharmaceuticals.    SOLOSEC is now available for both treatments of patients and their partners. The FDA approval of SOLOSEC for the treatment of trichomoniasis in men was granted based on four open-label trials in males; one comparative study with metronidazole and ornidazole in males only and three single-arm studies in males and females.11 Parasitological evaluation was performed both pre-and post-treatment and reported cure rates ranging from 91.7 per cent (165/180) to 100 per cent (30/30) at time points ranging from two to 20 days (n=437, 211 males and 226 females). ]]> https://biospectrumindia.com/news/57/19055/axio-biosolutions-bags-fda-clearance-for-axiostat-patch.html https://biospectrumindia.com/news/57/19055/axio-biosolutions-bags-fda-clearance-for-axiostat-patch.html Wed, 30 Jun 2021 12:40:00 +0530 Bengaluru-based Axio Biosolutions has announced FDA 510(k) clearance of its haemostatic product Axiostat Patch, which helps control moderate to severe bleeding in vascular procedures, surgical debridement sites, puncture sites and more.   Axiostat Hemostatic Patch is based on a protonated bioadhesive technology that works by providing a strong mechanical barrier to the injury site. It controls bleeding from puncture sites within minutes of application, providing a barrier to bacteria protection while reducing the ambulation time in patients significantly.    Axiostat had also received CE mark in Europe earlier and is approved in over 40 countries worldwide. Over half a million units have been deployed since inception globally especially on battlefields to control bleeding from trauma injuries.   Commenting on the latest development, Leo Mavely, Founder and CEO, Axio Biosolutions said, “This is a major milestone for us as the FDA clearance opens the door for us to enter markets such as cardio-vascular, haemodialysis and military bleeding control in the US. Axiostat is already a market leader for these in many countries and we intend to bring this technology to the US customers soon.”   ]]> https://biospectrumindia.com/news/57/19036/who-issues-first-global-report-on-ai-usage-in-health.html https://biospectrumindia.com/news/57/19036/who-issues-first-global-report-on-ai-usage-in-health.html Tue, 29 Jun 2021 00:00:00 +0530 Artificial Intelligence (AI) holds great promise for improving the delivery of healthcare and medicine worldwide, but only if ethics and human rights are put at the heart of its design, deployment, and use, according to new World Health Organisation (WHO) guidance published recently. The report, Ethics and governance of artificial intelligence for health, is the result of 2 years of consultations held by a panel of international experts appointed by WHO. “Like all new technology, artificial intelligence holds enormous potential for improving the health of millions of people around the world, but like all technology it can also be misused and cause harm,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This important new report provides a valuable guide for countries on how to maximize the benefits of AI, while minimizing its risks and avoiding its pitfalls.” WHO’s new report cautions against overestimating the benefits of AI for health, especially when this occurs at the expense of core investments and strategies required to achieve universal health coverage. It also points out that opportunities are linked to challenges and risks, including unethical collection and use of health data; biases encoded in algorithms, and risks of AI to patient safety, cybersecurity, and the environment.     For example, while private and public sector investment in the development and deployment of AI is critical, the unregulated use of AI could subordinate the rights and interests of patients and communities to the powerful commercial interests of technology companies or the interests of governments in surveillance and social control. ]]> https://biospectrumindia.com/news/57/19028/lupin-launches-hiv-drugs-in-us.html https://biospectrumindia.com/news/57/19028/lupin-launches-hiv-drugs-in-us.html Mon, 28 Jun 2021 10:50:00 +0530 Lupin announced the launch of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg, having received approval from the United States Food and Drug Administration (FDA). Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg, are the generic equivalent of Truvada Tablets 200 mg/300 mg, of Gilead Sciences, Inc, and indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.    It is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (RLD: Truvada) had estimated annual sales of $ 2.1 billion in the US (IQVIA MAT March 2021). ]]> https://biospectrumindia.com/news/57/19016/fda-issues-eua-to-first-oral-fluid-rapid-test-for-sars-cov-2-antibodies.html https://biospectrumindia.com/news/57/19016/fda-issues-eua-to-first-oral-fluid-rapid-test-for-sars-cov-2-antibodies.html Fri, 25 Jun 2021 00:00:00 +0530 Diabetomics, Inc., with operations in US & India, has announced the granting of an Emergency Use Authorization (EUA) by the US Food and Drug Administration for the Company's CovAb™ SARS-CoV-2 Ab point-of-care test. The product had also received a CE mark for marketing in the EU earlier. CovAb™ is the first and only rapid, oral fluid-based, point-of-care antibody test authorized by the FDA for use under an EUA. Unlike other COVID-19 antibody tests that require a blood draw, the CovAb™ test only requires an oral fluid sample obtained with a simple swab of the gumline, making it easy and painless. The test is CLIA-waived, is all-inclusive, does not require any additional components or instrumentation, and test results are available within 15 minutes. In addition to being rapid and noninvasive, the CovAb™ test has sensitivity of 97.6% and specificity of 98.8%. The CovAb™ test was developed and is manufactured in the US. "We are excited to bring this revolutionary new COVID-19 antibody test to market, which offers an easy and quick testing option to determine antibody status," said Srinivasa Nagalla, M.D., Diabetomics CEO. "The CovAb™ test can be easily administered to adults and children with no discomfort and provides quick results." ]]> https://biospectrumindia.com/news/57/18986/sun-pharma-celgene-to-resolve-patent-litigation-for-generic-revlimid-in-us.html https://biospectrumindia.com/news/57/18986/sun-pharma-celgene-to-resolve-patent-litigation-for-generic-revlimid-in-us.html Tue, 22 Jun 2021 10:35:00 +0530 Sun Pharmaceutical Industries along with one of its wholly-owned subsidiaries announced that they have reached an agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US.    According to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to US FDA approval) certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.    As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals. ]]> https://biospectrumindia.com/news/57/18917/disposable-syringes-market-size-to-reach-11-19-bn-by-2026-polaris-market-research.html https://biospectrumindia.com/news/57/18917/disposable-syringes-market-size-to-reach-11-19-bn-by-2026-polaris-market-research.html Mon, 14 Jun 2021 20:45:00 +0530 The global disposable syringes market size is expected to reach $11.19 billion by 2026, growing at a CAGR of 5.6 per cent during the forecast periods according to a new study published by Polaris Market Research. The Report ‘Disposable Syringes Market By Product Syringes Type (safety and conventional); By Application (Immunization Injections, Therapeutic Injections); By Region: Segment Forecast 2018-2026’ provides a thorough and detailed analysis into the workings with an overview of present trends and future insights.   North America is the leader in the segment but soon will be offset by expanding Asia pacific in the forecast period. The drivers to the disposables market can be attributed to favourable government initiatives and directives that have pursued market growth. The government initiatives to check the spread of fatal diseases such as HIV also boosts the market over coming years.   Europe is the second-largest market in the forecast period. Both America and Europe will consolidate share owing to a higher number of injectable drugs that are occupying volume lately. Furthermore, concerns of stick injuries and improvements in quality have given impetus to growth.   Key players play an active part by focusing on product improvement and increasing the number of clinical trials, thus consolidating presence in the region. North America is the leading consumer of disposal syringes today. Half of the revenue earned is contributed by North America itself but might lose some of its dominance to expanding the Asia Pacific. Europe retains the second-largest position in the market with both America and Europe attributing dominance to a large number of injectable drugs available today.   China and India are valued as the most important players in the use and throw type today, due to growing healthcare infrastructure and high population densities in the two nations. Furthermore, large-scale immunisation drives carried out at the behest of the government is noted for driving growth in the market today. The active interest shown by the US and Europe in both India and China by providing quality syringes pushes it notches further.   The key players include Becton, Dickinson and Company, B Braun Melsungen, Medtronic, Smiths Medical and Retractable Technologies. ]]> https://biospectrumindia.com/news/57/18914/lupin-receives-uk-marketing-authorisation-for-luforbec.html https://biospectrumindia.com/news/57/18914/lupin-receives-uk-marketing-authorisation-for-luforbec.html Mon, 14 Jun 2021 15:50:00 +0530 Luforbec 100/6 µg pMDI is indicated for regular treatment of asthma and the symptomatic treatment of patients with severe COPD   Lupin announced that its UK subsidiary, Lupin Healthcare (UK) has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Luforbec (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pressurised metered-dose inhaler (pMDI), the first branded generic of Fostair (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pMDI, which has the potential to offer significant cost savings for the NHS.   Luforbec 100/6 µg pMDI is indicated for regular treatment of asthma and the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 <50 per cent predicted normal).   “We are truly delighted to receive the first marketing authorisation for generic Fostair 100/6 µg pMDI in the UK. This is an important milestone for our respiratory franchise as we expand our product offering across the globe,” said Vinita Gupta, CEO, Lupin. “At Lupin, we remain committed to serving patients suffering from respiratory diseases with quality and cost-effective treatment.”   “The approval of Luforbec 100/6 µg pMDI is a pivotal milestone for the UK and a welcome step for Lupin as we draw on our strong expertise in inhalation research and development and expand our respiratory portfolio. We are proud to support healthcare providers and patients by continuing to invest in specialised treatments for chronic diseases,” said Thierry Volle, President - EMEA, Lupin. ]]> https://biospectrumindia.com/news/57/18834/ocugen-expands-covaxin-commercialisation-rights-to-include-canada.html https://biospectrumindia.com/news/57/18834/ocugen-expands-covaxin-commercialisation-rights-to-include-canada.html Fri, 04 Jun 2021 10:30:00 +0530 Biopharmaceutical company Ocugen and Bharat Biotech have entered into an amendment to their co-development, supply, and commercialisation agreement to expand Ocugen’s exclusive territory to commercialise COVAXIN to now also include Canada, in addition to Ocugen’s existing rights to commercialise COVAXIN in the US. “This amendment to expand our rights to commercialise COVAXIN into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries. As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorisation under interim order for emergency use in Canada. We believe COVAXIN has the potential to play a key role in saving lives from COVID-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” said Dr Shankar Musunuri, Chairman of the Board, CEO, and Co-founder of Ocugen. “COVAXIN has demonstrated an excellent safety record in human clinical trials and vaccine administration under emergency use in India. Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that COVAXIN is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring COVAXIN to the US market and now to the Canadian market,” said Dr Krishna Ella, CMD, Bharat Biotech. As consideration for Bharat Biotech’s grant of the rights to commercialise COVAXIN in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXINTM in Canada. Similar to the US profit share arrangement, Ocugen will retain 45 per cent of the profits from sales of COVAXIN in Canada. ]]> https://biospectrumindia.com/news/57/18826/organon-co-launches-womens-health-company-in-india.html https://biospectrumindia.com/news/57/18826/organon-co-launches-womens-health-company-in-india.html Thu, 03 Jun 2021 10:55:00 +0530 Organon India will be launched in India as a wholly-owned subsidiary of Organon & Co, a global healthcare company focussed on meeting the healthcare needs of women. The company will focus its efforts on building a healthier every day for every woman. In India, Organon will be operating in women’s healthcare, fertility, dermatology, respiratory and bone health products in their portfolio. Organon India will be operating with its in-house sales force and alliance partners across the various markets.  “As a business strategy, we will listen to women to understand their healthcare needs and find solutions which are relevant to them. We will consistently make efforts to ensure availability and access to quality healthcare products for women,” said Anjan Sen, who will lead the operations for India and countries in the South Asia region.  The Organon Executive Leadership Team will ring the opening bell at the New York Stock Exchange (NYSE) today to mark the first day of active trading. Recognising the need to listen to and act on women’s experiences to address the challenges in women’s health, Organon gathered voices from around the world to create the 'Wall of Voices', a multimedia installation outside of the NYSE sharing powerful perspectives, voices, and images. ]]> https://biospectrumindia.com/news/57/18773/rdif-unicef-ink-sputnik-v-vaccine-supplyagreement.html https://biospectrumindia.com/news/57/18773/rdif-unicef-ink-sputnik-v-vaccine-supplyagreement.html Fri, 28 May 2021 09:00:00 +0530 Human Vaccine LLC, a wholly owned subsidiary of the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) has announced the signing of an agreement for the supply of 220 million doses of two-dose Sputnik V Russian COVID-19 vaccine with the United Nations International Children's Emergency Fund (UNICEF). This amount is sufficient to vaccinate 110 million people. The supply agreement with UNICEF for Sputnik V vaccine will broaden access to help meet vaccine demand around the world. Procurement and delivery of the vaccine by UNICEF is subject to the vaccine receiving WHO Emergency Use Listing. The decision is expected soon on the Sputnik V application for WHO Emergency Use Listing that was submitted in October 2020. Concurrently, RDIF will be holding a separate discussion with Gavi, the Vaccine Alliance to see the Sputnik V vaccine considered for inclusion in the COVAX Facility’s Portfolio of COVID-19 vaccines. The COVAX Facility (co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO) together with UNICEF aims to help end the acute phase of the global pandemic by the end of 2021 by providing rapid, fair and equitable access to safe and effective vaccines to all participating countries and territories regardless of income level, thus enabling the protection of frontline health care and social workers, as well as other high-risk and vulnerable groups. ]]> https://biospectrumindia.com/news/57/18758/vetter-wins-axia-best-managed-companies-award.html https://biospectrumindia.com/news/57/18758/vetter-wins-axia-best-managed-companies-award.html Thu, 27 May 2021 10:35:00 +0530 Vetter, a leading contract development and manufacturing organisation (CDMO), has won the Axia Best Managed Companies Award for the second time. The pharmaceutical service provider was again honoured for its clear vision, innovative approaches, sustainable management culture and sound financial management.  Every year, Deloitte Private, the German business journal WirtschaftsWoche, Credit Suisse and the Bundesverband der Deutschen Industrie (the Federation of German Industries) select which medium-sized companies are best managed and thus receive the renowned award. In keeping with the current pandemic situation, the ceremony was held on a small scale at the headquarters of the family-owned company in Ravensburg. Vetter presented convincing evidence in the evaluated categories – starting with the competent handling of the current challenges posed by the COVID-19 pandemic, to the successful acquisition of a new production site in Vorarlberg, Austria, as well as its new company strategy, Vetter Next 2029, which is currently in progress. “From the development of visionary strategies and innovative processes to effective corporate governance structures and healthy corporate culture – as an award winner, Vetter is characterised by entrepreneurial excellence. Once again, they have set new standards in several key areas of corporate governance,” emphasised Lutz Meyer, partner and head of Deloitte Private. “This award is dedicated to our 5,500 staff members worldwide,” said Senator h.c. Udo J Vetter, Chairman of the Advisory Board and member of the owner family. “The special spirit of our family-owned company is particularly evident in these challenging times.” For the company and its staff members, winning the award once again is considered both a trusted confirmation and a strong motivation.  Managing Directors Thomas Otto and Peter Soelkner shared, “We are honoured to receive the Axia Best Managed Companies Award for the second time in a row. Vetter is focused on acting proactively and sustainably – now and into the future.” ]]> https://biospectrumindia.com/news/57/18753/merck-accelerates-scale-up-of-lipids-to-meet-covid-19-demand.html https://biospectrumindia.com/news/57/18753/merck-accelerates-scale-up-of-lipids-to-meet-covid-19-demand.html Wed, 26 May 2021 18:20:00 +0530 Merck has launched a new, high-purity synthetic cholesterol product to meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics. The product has been launched nine months ahead of schedule. “Tapping into two decades’ experience of developing and manufacturing high-quality lipids, we designed a proprietary process to bring our new SAFC synthetic cholesterol product to market nearly a year early,” said Andrew Bulpin, Head of Process Solutions, Life Science, Merck. “With the introduction of our new SAFC synthetic cholesterol product, we have increased our capacity by 50 times, helping bio manufacturers bring lifesaving therapies to patients faster.” The neutral lipid, used in commercially marketed products, is more than 99 per cent pure; offers high batch-to-batch consistency and is scalable under commercial GMP.  The launch of the new product follows the company’s acquisition of AmpTec, a Hamburg, Germany, based mRNA contract development and manufacturing organisation. By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, Merck can provide a truly integrated offering across the mRNA value chain. Merck has more than 20 years of experience developing and manufacturing high-quality lipids, following GMP processes. The company provides regulatory support through all phases of clinical development and commercialisation, as well as deep analytical expertise.     ]]> https://biospectrumindia.com/news/57/18737/who-goodwill-ambassador-for-leprosy-urges-countries-not-to-overlook-the-disease.html https://biospectrumindia.com/news/57/18737/who-goodwill-ambassador-for-leprosy-urges-countries-not-to-overlook-the-disease.html Wed, 26 May 2021 10:15:00 +0530 As the 74th World Health Assembly (WHA) gets underway, WHO Goodwill Ambassador for Leprosy Elimination Yohei Sasakawa is urging countries not to overlook leprosy amid the global coronavirus pandemic and aim for zero leprosies. 30 years ago this month, the WHA adopted a resolution to eliminate leprosy as a public health problem.  The resolution adopted at the 44th WHA in 1991 called for the elimination of leprosy as a public health problem at the global level by the year 2000. 'Elimination' was defined as reaching a prevalence rate of the disease of less than 1 case per 10,000 population. This was achieved globally by the end of 2000 and almost all countries have since replicated that success at the national level. In April, the fight against leprosy entered a new phase with the launch by the WHO of 'Towards Zero Leprosy: Global Leprosy (Hansen's disease) Strategy for 2021-2030.' The targets include zero leprosy patients in 120 countries and a 70 per cent decrease in new cases detected globally by 2030. Yohei Sasakawa, who has visited over 100 countries since first being appointed Goodwill Ambassador in 2001, welcomes the new strategy and believes it will accelerate momentum towards a leprosy-free world. But he cautioned, "These are ambitious targets, so commitments from national governments will be required if they are to be achieved. I realise these are challenging times, but we mustn't allow leprosy to be overlooked amid COVID-19."   Goodwill Ambassador Sasakawa, who has been involved in efforts against leprosy for nearly half a century with The Nippon Foundation, the Japanese non-profit grant-making organisation he serves as chairman, said the 30th anniversary of the WHA resolution on eliminating leprosy is an appropriate moment to recall the spirit that brought countries together in a sense of common purpose against leprosy.     ]]> https://biospectrumindia.com/news/57/18727/glenmark-receives-us-fda-approval-for-icatibant-injection.html https://biospectrumindia.com/news/57/18727/glenmark-receives-us-fda-approval-for-icatibant-injection.html Tue, 25 May 2021 11:05:00 +0530 Glenmark Pharmaceuticals (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr 1 Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies. This marks Glenmark's first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina. According to IQVIA sales data for the 12 months ending March 2021, the Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe market2 achieved annual sales of approximately $223.4 million. Glenmark's current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 ANDA's pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> https://biospectrumindia.com/news/57/18709/livingstone-health-opens-ardennes-healthcare-in-singapore.html https://biospectrumindia.com/news/57/18709/livingstone-health-opens-ardennes-healthcare-in-singapore.html Fri, 21 May 2021 18:15:00 +0530 The primary healthcare arm of SGX-listed multidisciplinary healthcare specialist Livingstone Health Holding (Livingstone Health) launched Ardennes Healthcare (Ardennes), a one-stop health screening and radiology centre.  Ardennes will be poised to offer laboratory and radiology-based services such as blood tests, X-ray and ultrasound to these corporate clients as well as middle-upper PMETs. Ardennes, a wholly-owned subsidiary of Livingstone Health’s 51 per cent-held Phoenix Medical Group (PMG), will be led by an experienced clinical team.  Ardennes is expected to increase its range of services to include mammography and bone density scans over the next financial year ending March 31, 2022. Dr Wilson Tay, CEO, Livingstone Health, said, “The healthcare screening service is in line with the Group’s mission to offer multi-disciplinary healthcare. Patients will receive a comprehensive screenshot of their health in a convenient and timely manner while having the option to be referred to a trusted network of specialists should the need arise.”  ]]> https://biospectrumindia.com/news/57/18707/ngs-sample-preparation-market-to-surge-amid-cancer-diagnostics-study.html https://biospectrumindia.com/news/57/18707/ngs-sample-preparation-market-to-surge-amid-cancer-diagnostics-study.html Fri, 21 May 2021 17:40:00 +0530 The global next-generation sequencing (NGS) sample preparation market is expected to surpass a valuation of $4 billion by 2031, expanding at a whopping CAGR of approximately 16 per cent across the 2021-2031 forecast period, according to a recent report published on the market by award-winning and ESOMAR-certified market research consulting firm. NGS has revolutionised genomic research, paving the way for highly effective diagnosis of numerous chronic and infectious diseases, a fact that is boding well for market growth. Historically, the market accrued significant gains, surpassing $750 million in value in 2019. In recent years, NGS has been widely deployed in clinical oncology to advance personalised cancer treatment. The technique has proven useful in identifying novel and rare cancer mutations, detecting familial cancer mutation carriers, and providing a molecular rationale for appropriate targeted therapy. Consequently, prominent manufacturers are introducing a slew of sample preparation products, with opportunities being ample across the Asian markets. For instance, in May 2021, BGI Group signed an MoU with Ethiopian Biotechnology Institute (EBiT) to conduct the HPV genotyping pilot project and complete 2,000 sample screenings from Ethiopia, to establish a new model of HPV screening, diagnosis, and treatment. Key takeaways from the market study: High demand for NGS sample preparation kits, reagents, and consumables By application, NGS sample preparation for drug and biomarker discovery poised to reach higher echelons Academic and research institutes to remain primary NGS sample preparation end, users Presence of robust healthcare system to pivot NGS sample preparation product sales across the US. India to extensively deploy NGS sample preparation products to augment prenatal screening According to a senior research analyst, prominent NGS sample preparation product manufacturers are testing uncharted waters by foraying into domains such as animal and plant health, to develop highly advanced diagnostic approaches and address multiple ailments, widening expansion prospects. ]]> https://biospectrumindia.com/news/57/18706/dcal-announces-study-results-for-vitamin-d-deficiency.html https://biospectrumindia.com/news/57/18706/dcal-announces-study-results-for-vitamin-d-deficiency.html Fri, 21 May 2021 17:25:00 +0530 Dishman Carbogen Amcis Ltd (DCAL), a global outsourcing partner for the pharmaceutical industry, welcomes the results of a new study that provides critical insights into the treatment of vitamin D deficiency in obesity and fat malabsorption syndromes. The research was conducted by Boston University School of Medicine and supported in part by a grant from Dishman Carbogen Amcis' wholly-owned subsidiary CARBOGEN AMCIS. DCAL partnered with Dr Michael Holick, Professor of Medicine, Physiology and Biophysics and Molecular Medicine, Boston University School of Medicine, to determine whether alternative vitamin D-type substances provide significant health benefits in people suffering from impaired distribution and metabolism of vitamin D. “We believe that partnerships with academic institutions help uncover important insights and make great discoveries that benefit the pharmaceutical industry and, most importantly, the patients directly”, said Arpit Vyas, Global MD, DCAL. The study results will benefit obese people and, e.g., patients who have undergone gastric bypass surgery, which quite generally results in vitamin D malabsorption. Thus, those patients run an elevated risk of bone diseases like osteoporosis and osteomalacia due to softening of the bones. Researchers observed that a form of vitamin D, known as 25-hydroxyvitamin D3 (Calcifediol), was absorbed faster and better than the same dose of vitamin D. “This vitamin D metabolite is better absorbed in patients with fat malabsorption syndromes and since it is not as fat-soluble, it does not get diluted in the body fat and is effective in raising and maintaining blood levels,” said Dr Michael Holick. “Therefore, using 25-hydroxyvitamin D3 could be a novel approach for treating vitamin D deficiency in patients with fat malabsorption syndromes.” CARBOGEN AMCIS provided the 25-hydroxyvitamin D3 capsules, which were produced at its parent company DCAL's Bavla facility in Ahmedabad, specifically for this study. ]]> https://biospectrumindia.com/news/57/18702/lives-in-the-balance-lays-focus-on-women-children-health-during-covid-19-response-recovery.html https://biospectrumindia.com/news/57/18702/lives-in-the-balance-lays-focus-on-women-children-health-during-covid-19-response-recovery.html Fri, 21 May 2021 13:05:00 +0530 Lives in the Balance was organised by Partnership for Maternal, Newborn & Child Health (PMNCH) a multi-constituency partnership hosted by the World Health Organization (WHO), together with the CORE Group, Global Financing Facility for Women, Children, and Adolescents, and Gavi, the Vaccine Alliance which was attended by more than 1000 global citizens.  Key Speakers included Anuradha Gupta, CEO, Gavi, the Vaccine Alliance; Lopa Banerjee, Chief, Civil Society Section, UN Women; Vandita Morarka Founder & CEO, One Future Collective, India, Helen Clark, Former Prime Minister, New Zealand and Board Chair of PMNCH, Mia Mottley - Prime Minister, Barbados, Michelle Bachelet - UN High Commissioner, Human Rights, Borge Brende, President, World Economic Forum, Jennifer Klein, Executive Director, White House Gender Policy Council, US. “The knock-on impact of the pandemic on childhood vaccination in lower income countries has been devastating, with millions of children missing out on timely, life-saving immunisations,” said Anuradha Gupta, Deputy Chief Executive Officer of Gavi, the Vaccine Alliance.  Clark stated, “COVID-19 is deepening and magnifying social inequalities compounded by ethnicity, gender, income, geography, and other factors. We must act now, not just to protect progress previously made, but also to work towards a world that is far more equitable than the one that existed before the pandemic.” A seven-point call to action on COVID-19, backed by PMNCH’s 1,000-member platform, seeks to protect and prioritise the rights and health of women, children, and adolescents during the COVID-19 response and recovery. The call seeks to strengthen investment, policies, and services for the recovery of health services, as well as protection of rights and future socio-economic resilience.  The statements, aligning with the PMNCH call to action, outlined a significant array of efforts to improve SRHR, gender equality, service quality, and adolescent health and well-being, among other priorities.   In addition to the ongoing and catastrophic direct impact of COVID-19 in many parts of the world, women, children, and adolescents are affected indirectly because of widespread disruptions to essential health, nutrition, and social services under lockdown conditions. This increases the risk of mortality and morbidity, including from treatable and preventable causes, denying the right to protection and care. ]]> https://biospectrumindia.com/news/57/18701/indica-labs-ibex-to-deliver-ai-powered-clinical-workflows-for-digital-pathology.html https://biospectrumindia.com/news/57/18701/indica-labs-ibex-to-deliver-ai-powered-clinical-workflows-for-digital-pathology.html Fri, 21 May 2021 12:15:00 +0530 Indica Labs, an industry leader in quantitative digital pathology and image management solutions, and Ibex Medical Analytics, a pioneer in artificial intelligence (AI)-based cancer diagnostics, announced an agreement to integrate the Galen AI-based cancer diagnostics platform into the HALO AP digital pathology workflow platform. The HALO AP platform was developed by Indica Labs to address the needs of digital anatomic pathology labs. The platform can be fully integrated within existing LIS or HIS solutions or can operate as a standalone case and image management system for anatomic pathology. Furthermore, HALO AP supports a full range of tissue-based assays and workflows, including synoptic reporting, tumour boards, secondary consults, quantitative analysis, and AI-assisted workflows. HALO AP is used by some of the largest anatomic pathology laboratories in the world, including NeoGenomics and the National Cancer Institute (NCI). Ibex’s Galen platform uses strong AI algorithms that support pathologists in improving the quality of cancer diagnosis and providing productivity-enhancing insights that help reduce turnaround times. ]]> https://biospectrumindia.com/news/57/18699/oral-hygiene-can-aggravate-covid-19-complications-aap-study.html https://biospectrumindia.com/news/57/18699/oral-hygiene-can-aggravate-covid-19-complications-aap-study.html Fri, 21 May 2021 10:50:00 +0530 American Academy of Periodontology (AAP) in its recent report mentioned that there is a direct connection between oral hygiene and COVID-19. Dr James G Wilson, President, AAP, says, "It is well-established that systemic inflammation is not only linked with periodontal disease, but to several other respiratory diseases as well. Therefore, maintaining healthy teeth and gums in an effort to avoid developing or worsening periodontal disease is absolutely crucial in the midst of a global pandemic like COVID-19, which is also known to trigger an inflammatory response.” Furthermore, a report by McGill University in Montreal, Canada, has found a direct link between gums with inflammation and infection and even connected how oral hygiene can play a part in aggravating COVID-19 complications and even lead to deaths. According to this study people that have gums issues or periodontitis are 8.8 times more likely to die of COVID-19. Not just his, such people are 3.5 times more likely to require hospitalisation for COVID-19 and 4.5 times more likely to require a ventilator. It has also come to light that oral health plays a pivotal role even in the post-recovery period. Shedding more light on this, Dr Mohendar Narula, Founder and Chairman, MyDentalPlan Healthcare says, “Taking care of your gums and oral hygiene was always vital but it has become even more significant during this pandemic. In this second wave of COVID-19, oral symptoms are on the rise. However, maintaining optimum gum health with simple steps such as brushing twice a day, tongue cleaning, flossing and gargles can help people combat these life-threatening diseases even better. Furthermore, professional dental cleanings twice a year and regular dental check-ups are known to minimise the severity of COVID-19 and the associated complications.”     ]]> https://biospectrumindia.com/news/57/18697/rousselot-biomedical-launches-phenol-functionalised-gelatin.html https://biospectrumindia.com/news/57/18697/rousselot-biomedical-launches-phenol-functionalised-gelatin.html Fri, 21 May 2021 10:30:00 +0530 Rousselot, a brand of Darling Ingredients, and the global leader of collagen-based solutions expands its range of purified, pharmaceutical-grade, modified gelatins with the launch of X-Pure GelDAT – Gelatin Desaminotyrosine. X-Pure GelDAT offers purity and consistency at scale, vital to the successful development of biomedical applications used in the human body. Dr Jeff Daelman, Business Development Manager at Rousselot Biomedical said, “Based on our extensive experience and scientific expertise in modified gelatins, we created a versatile, effective and scalable alternative to GelTYR. Rousselot Biomedical delivered a tailored X-Pure GelDAT solution, from the customer’s initial briefing into pre-clinical trials in less than a year." Rousselot’s proprietary, scalable process means products with customised functionalities can be produced in a standardised, purified, traceable and consistent manner. Rousselot offers the best of both worlds: a customised yet consistent product on which both researchers and large pharmaceutical manufacturers can rely. “Rousselot’s X-Pure GelDAT’s research-grade is functionally equivalent to the GMP grade material, so researchers have less risk of having to re-validate their biomaterial prior to clinical trials. Compromising on quality in early research can also cause significant scale-up issues and delays in preparation for clinical trials. X-Pure GelDAT can be used throughout every development phase,” said Dr Daelman. ]]> https://biospectrumindia.com/news/57/18687/neoscan-solutions-launches-mri-scanner-for-babies.html https://biospectrumindia.com/news/57/18687/neoscan-solutions-launches-mri-scanner-for-babies.html Thu, 20 May 2021 17:30:00 +0530 Neoscan Solutions has invented an MRI scanner for babies. The smaller and lighter MRI scanner can be placed directly in the children's ward of the hospital. Key to the much smaller design is the use of digitizers and AWGs by Spectrum Instrumentation that offer sub-nanosecond, coherence precision to generate the scanner signals and capture the results. Neoscan will be shortly installing its first devices in German hospitals where it can be seen in operation by prospective customers as it takes images of babies. The certification process with a CE mark is expected to be completed before the end of 2021. Says Stefan Roell, Founder, Neoscan Solutions in Germany, "We have designed an MRI scanner specifically for newborns and infants which means that the hole in the middle is only 30cm in diameter, not 60cm. As a result, the scanner is much smaller (170cm x 150cm x 110cm) and can go through standard doorways. With a weight of only 2000 kg, it can be located on standard floors and, needing only ten square metres, it can be installed in a spare room directly on the children's ward. Carrying a sleeping baby only a few meters to the MRI is a big advantage, saving a long journey through the building and the need for sedatives to keep the baby motionless for the scan." "As a start-up, we could not afford to create specialised hardware and so we used this route of high quality, standard cards providing a platform to run our software on," added Dr Roell. Firstly, to shrink the size, the team had to develop a dry magnet that would create the standard 1.5 Tesla field inside the hole, but without requiring liquid helium. This is done by an inner, cylindrical magnet generating 2.5T and then an outer cylindrical magnet that counteracts theinner field to provide strong, active magnet shielding so that there is no stray magnetic field left beyond about 1m from the device's cover.The second innovation was in control electronics. Current MRI scanners typically require three big racks of specially developed electronics, that have been custom designed and built by the MRI manufacturer. Neoscan Solutions chose a different approach. The team used a PC that runs the software that Neoscan has created plus high-end measurement PC cards from Spectrum Instrumentation. The signals for the MRI are generated by the M4i.6620-x8 and M2p.6546-x4 AWGs (Arbitrary Waveform Generators) and then analysed using an M2p.5968-x4 digitizer. The system used Spectrum's SCAPPsoftware drivers that enable a Graphics Processor with 5000 cores to perform the parallel processing, instead of using only 8 or 16 cores of a normal CPU. ]]> https://biospectrumindia.com/news/57/18691/thermo-fisher-ucsf-to-open-cell-therapy-manufacturing-centre-in-us.html https://biospectrumindia.com/news/57/18691/thermo-fisher-ucsf-to-open-cell-therapy-manufacturing-centre-in-us.html Thu, 20 May 2021 00:00:00 +0530 Thermo Fisher Scientific Inc., and the University of California, San Francisco (UCSF) have announced they have formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies. Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot, state-of-the-art cell therapy development, manufacturing and collaboration center in leased space on UCSF's Mission Bay campus, which includes biomedical research facilities and hospitals. The site will offer clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support, to UCSF and other partners. Expected to open in 2022, the facility will also serve as a central location where customers and UCSF researchers will have access to Thermo Fisher's broad portfolio of Cell Therapy Systems (CTS) reagents, consumables, and fit-for-purpose instrumentation and compliant software. The CTS product portfolio is designed to work together, and seamlessly transition from research to clinical manufacturing to address cell therapy production workflow challenges. ]]> https://biospectrumindia.com/news/57/18657/oxford-university-oracle-expedite-identification-of-covid-19-variants.html https://biospectrumindia.com/news/57/18657/oxford-university-oracle-expedite-identification-of-covid-19-variants.html Tue, 18 May 2021 00:00:00 +0530 The emergence of more infectious variants of the COVID-19 virus is threatening to slow the global recovery and potentially thwart current vaccine immunity. To help governments and medical communities identify and act on these variants faster, Oxford University and Oracle have created a Global Pathogen Analysis System (GPAS) combining Oxford’s Scalable Pathogen Pipeline Platform (SP3) with the power of Oracle Cloud Infrastructure (OCI). This initiative builds on the work of a Wellcome Trust-funded consortium including Public Health Wales, the University of Cardiff, and Public Health England. First used for tuberculosis, SP3 has been repurposed to unify, standardize, analyze, and compare sequence data of SARS-CoV-2, yielding annotated genomic sequences and identifying new variants and those of concern.  SP3’s processing capability has been enhanced with extensive new development work from Oracle, enabling high performance and security plus 7 by 24 worldwide availability of the SP3 system in the Oracle Cloud.   The SP3 system will now deliver comprehensive and standardized results of COVID-19 analyses within minutes of submission on an international scale. The results will be shared with countries around the globe in a secure environment. Coupled with the extensive machine learning capabilities in the Oracle Cloud, collaborating scientists, researchers, and governments worldwide can process, analyze, visualize, and act on a wide collection of COVID-19 pathogen data for the first time. This includes identifying variants of interest and their potential impact on vaccine and treatment effectiveness. For example, analytics dashboards in the system will show which specific strains are spreading more quickly than others and whether genetic features contribute to increased transmissibility and vaccine escape. Already, Oxford has processed half the world's SARS-CoV-2 sequences, more than 500,000 in total. The next step will be to extend this service to all pathogens while simultaneously collaborating with scientists from research establishments, public health agencies, and private companies to ensure this work can inform decision making on pandemic response strategies worldwide. The platform will be free for researchers and non-profits to use worldwide. ]]> https://biospectrumindia.com/news/57/18631/ficci-supportive-of-trips-waiver-proposal-to-ramp-up-covid-19-vaccines-manufacturing.html https://biospectrumindia.com/news/57/18631/ficci-supportive-of-trips-waiver-proposal-to-ramp-up-covid-19-vaccines-manufacturing.html Thu, 13 May 2021 15:40:00 +0530 FICCI is encouraged by the US support for the ‘TRIPS waiver’ proposal, first advocated by India and South Africa as one vital tool to address the concerns on availability of COVID-19 vaccines. "We are confident, if accepted in the WTO and implemented, the temporary waiver would go a long way to enable scaling up of manufacturing and ensuring timely availability of affordable COVID-19 vaccines and essential medical products," says FICCI. While the Indian Government is currently working towards the multilateral solution, there are other proposals eg invoking ‘Compulsory Licenses’ to alleviate the shortage of vaccines. However, it may not lead to ‘enhancing’ the manufacturing capacity in the near future. This is due to the fact that lack of availability of essential raw materials and inputs poses significant constraint to the quick expansion of production capacity of the COVID vaccines. Further, several regulatory and safety issues will have to be addressed, and this may take some time.  The provision of Compulsory Licensing must be used cautiously and with utmost discretion. If not used judiciously, it may discourage innovator companies, which have heavily invested in R&D, and turn out to be counterproductive to the present situation. Further, FICCI strongly believes that in the larger and long-term interest of the country and its citizens, India should not rush to do anything unilaterally that may undermine its present efforts to arrive at a ‘multilateral solution’ on this issue. This approach will be more acceptable to the global business and larger community worldwide. Our efforts should be to find a ‘fine balance’ between effectively managing India’s present public health concerns on the one hand, amply demonstrating that India values and respects the global rules on IPR / TRIPS Agreement, on the other. The immediate focus has to be on connecting with the ‘right’ global companies to facilitate ‘technology transfer’ and voluntary licenses to Indian companies that have the capacity and capability for mass-production of COVID vaccines. This will be a definite game-changer and help in creating a robust manufacturing ecosystem with scalability in the country. FICCI believes that the government has initiated steps in this direction, and we believe that these should be concluded soon.   ]]> https://biospectrumindia.com/news/57/18583/novavax-to-supply-nvx-cov2373-to-covax-facilty.html https://biospectrumindia.com/news/57/18583/novavax-to-supply-nvx-cov2373-to-covax-facilty.html Fri, 07 May 2021 11:05:00 +0530 Novavax, Inc announced that it has finalised an advance purchase agreement (APA) with Gavi, the Vaccine Alliance for the supply of its recombinant protein-based COVID-19 vaccine candidate to the COVAX Facility. Under the APA, Novavax is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. Under a separate purchase agreement with Gavi, the Serum Institute of India (Serum Institute) is expected to manufacture and deliver the balance of the 1.1 billion doses of Novavax' vaccine. Stanley C Erck, President and Chief Executive Officer, Novavax said, "This arrangement is the culmination of a collaboration among CEPI, Gavi, Serum Institute and Novavax, who are partnering in our urgent mission to deliver significant amounts of vaccines to all countries, regardless of income level.” Under the APA, Novavax expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the investments Novavax received from the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI invested nearly $400 million in Novavax in the spring of 2020 to advance preclinical and early clinical development, manufacturing scale-up, technology transfer, and manufacturing capacity reservation for NVX-CoV2373. Dr Richard Hatchett, CEO CEPI stated, ”With this agreement in place, the Novavax vaccine candidate will play a vital role in our mission to protect those most at risk from COVID-19, wherever they are in the world.” "Today's agreement with Novavax marks a major step towards COVAX's objective of building the world's largest and most diverse portfolio of COVID-19 vaccines, and a major step towards our goal of delivering 2 billion doses of safe and effective vaccines in 2021," said Dr Seth Berkley, CEO, Gavi. Together, Novavax and Serum Institute expect to initiate delivery of the cumulative 1.1 billion doses in the third quarter of 2021, pending receipt of appropriate regulatory authorisations. Under the APA, Novavax will receive an upfront payment from Gavi later this month and an additional payment after it secures emergency use listing for its vaccine by the WHO. In addition, Novavax has agreed to provide additional doses in the event that Serum Institute cannot materially deliver expected vaccine doses to the COVAX Facility.   ]]> https://biospectrumindia.com/news/57/18582/ge-healthcare-strengthens-pet-imaging-portfolio-with-new-acquisition.html https://biospectrumindia.com/news/57/18582/ge-healthcare-strengthens-pet-imaging-portfolio-with-new-acquisition.html Fri, 07 May 2021 00:00:00 +0530 GE Healthcare has announced the acquisition of Zionexa, a leading innovator of in-vivo oncology and neurology biomarkers that help enable more personalized healthcare. The company aims to develop and bring to market Zionexa’s pipeline biomarkers, as well as the recently FDA-approved PET imaging agent, Cerianna™ (fluoroestradiol F-18), which is used as an adjunct to biopsy for the detection of estrogen receptor (ER) positive lesions to help inform treatment selection for patients with recurrent or metastatic breast cancer. Zionexa, a privately owned company, formed in 2018 and headquartered in Aubière, France, employs 24 people in France and the U.S., all of whom will transfer to GE Healthcare. Additionally, GE Healthcare will hire approximately 70 new dedicated employees within the company’s U.S. Pharmaceutical Diagnostics team, headquartered in Marlborough, Massachusetts. Currently, when treating metastatic breast cancer patients, oncologists base clinical decisions on biopsy results which only represent the sampled area of the tumor. However, estrogen receptor (ER) expression – one of the most common breast cancer biomarkers - can vary both within the primary tumor and across different lesions. Cerianna, an adjunct to biopsy, widens the diagnostic lens for oncologists with a whole-body view of ER positive lesions, helping to provide the patient with a more informed diagnosis, potentially enabling more targeted and individualized treatment plans and avoiding the selection of inappropriate or less effective therapies. ]]> https://biospectrumindia.com/news/57/18579/bd-announces-intent-to-spin-off-diabetes-care-business.html https://biospectrumindia.com/news/57/18579/bd-announces-intent-to-spin-off-diabetes-care-business.html Thu, 06 May 2021 18:00:00 +0530 BD (Becton, Dickinson and Company), a leading global medical technology company, has announced its board of directors has unanimously authorised management to proceed with a plan to spin off the company's Diabetes Care business as an independent, publicly traded company (NewCo). "The decision to spin off our Diabetes Care business is part of our active portfolio management and consistent with our BD 2025 strategy to Grow, Simplify and Empower," said Tom Polen, chairman, CEO and president of BD. "The spinoff will allow BD to strengthen its growth profile, enables a greater investment focus on our other core businesses and high-growth opportunities, and makes a greater impact for our customers and patients." While NewCo will be a new, publicly traded company, the Diabetes Care business has roots in BD's introduction of the world's first specialized insulin syringe in 1924. The Diabetes Care business has played a leading role in driving the adoption of insulin syringes and insulin pens combined with pen needles as the leading modality for insulin injection. Today, the Diabetes Care business is the leading producer of diabetes injection devices, producing approximately 8 billion injection devices annually and serving about 30 million patients — more than any other company in the world. NewCo's revenue and manufacturing footprint are geographically diverse. In fiscal 2020, the Diabetes Care business generated revenues of nearly $1.1 billion, with 48% of revenues generated outside of the United States, including 17% of revenues from emerging markets. NewCo will have manufacturing sites in the United States, Ireland, and China, and is expected to have office locations in New Jersey and Massachusetts. Devdatt (Dev) Kurdikar, 52, currently worldwide president of BD Diabetes Care, will be chief executive officer of NewCo. Kurdikar joined BD in February 2021. ]]> https://biospectrumindia.com/news/57/18526/western-powers-lose-while-russia-china-gain-with-covid-19-vaccine-diplomacy.html https://biospectrumindia.com/news/57/18526/western-powers-lose-while-russia-china-gain-with-covid-19-vaccine-diplomacy.html Wed, 28 Apr 2021 12:35:00 +0530 With vaccine diplomacy, Russia and China are gaining leverage on the cheap while fulfilling commercial goals. In most cases, they are not donating vaccines, but selling them; in China’s case, state-owned firms are competing with private ones for the supply of shots. China and Russia are focusing their efforts on regions where they are courting favours from emerging countries (for instance Asia for China), or directly competing with western powers for influence (such as eastern Europe, and in particular the western Balkans, for both China and Russia), or in regions where they have only a limited presence so far (as is the case for Latin America, which is traditionally within America’s sphere of influence). Vaccine diplomacy comes with risks. In Russia, and to a lesser extent also in China, conflicting priorities between vaccinating the domestic population and exporting shots will remain acute throughout 2021. To tackle this issue, both countries are opening additional factories (at home and abroad). However, it is unlikely that extra production lines will help to ease supply issues before the second half of 2021; setting up vaccine factories is technically challenging and it takes a minimum of six months before they are operational. In the coming years, this will reinforce the global standing and leverage of Russia and China in emerging countries, helping both countries to gain influence and pursue their interests around the world. The longer term consequence of today’s vaccine diplomacy will be a further fragmentation of the global order. Agathe Demarais, Director, Global Forecasting, Economist Intelligence Unit (EIU) and author of the report, says, “With vaccine diplomacy, Russia and China seek to leverage resentment against western countries, which have pre-booked more than half of the global supply of vaccines this year and are prioritising immunising their own populations.” Demarais adds, “Vaccine diplomacy is not about sending shots as a one-off operation. Both Russia and China are establishing vaccine facilities across the world and training local workers from emerging countries, betting that such a strategy will boost their presence on the ground for decades to come.”   ]]> https://biospectrumindia.com/news/57/18523/sanofi-leverages-manufacturing-capacity-for-global-supply-of-covid-19-vaccine.html https://biospectrumindia.com/news/57/18523/sanofi-leverages-manufacturing-capacity-for-global-supply-of-covid-19-vaccine.html Tue, 27 Apr 2021 20:00:00 +0530 Sanofi has entered into an agreement with Moderna, under which Sanofi will help manufacture Moderna´s COVID-19 vaccine, supporting the COVID-19 pandemic and vaccine supply needs. Sanofi will leverage its established infrastructure and manufacturing expertise at its site in Ridgefield, NJ, to perform fill and finish of up to 200 million doses of Moderna’s COVID-19 vaccine, starting in September 2021. This marks Sanofi’s third commitment to provide manufacturing support. Earlier this year, Sanofi announced the company will provide support to BioNTech for 125 million doses for the European Union. In February, Sanofi announced one of its manufacturing site in France would support Johnson & Johnson for the production of its COVID-19 vaccine at a rate of approximately 12 million doses per month. Sanofi is the only large manufacturer to support all three vaccine efforts. Sanofi is also collaborating with GSK on a COVID-19 vaccine candidate using the same recombinant protein-based manufacturing technology as one of Sanofi’s seasonal influenza vaccines, combined with GSK’s established pandemic adjuvant platform. ]]> https://biospectrumindia.com/news/57/18496/chinese-covid-19-vaccines-crucial-for-developing-nations-globaldata.html https://biospectrumindia.com/news/57/18496/chinese-covid-19-vaccines-crucial-for-developing-nations-globaldata.html Fri, 23 Apr 2021 13:15:00 +0530 Beijing-based pharmaceutical company Sinovac Biotech’s CoronaVac vaccine was recently found to be 49.6 per cent effective in real-world data from Brazil. However, considering the global demand for COVID-19 vaccines and the supply-demand gaps, Chinese vaccines remain crucial for developing nations’ vaccination programmes irrespective of real-world data, says GlobalData. China has so far provided COVID-19 vaccine aid to more than 50 developing nations and Sinovac Biotech alone has already supplied over 150 million doses to other countries.  Prashant Khadayate, Pharma Analyst, GlobalData, comments,“Chinese vaccines have shown varied efficacy rates across countries in clinical trial settings from just over 50 per cent to 79 per cent. Real-world data serves to validate the data observed in a clinical trial setting. However, low efficacy observed in real-world data will not hurt the future uptake as developed nations have already stockpiled large quantities of COVID-19 vaccines from leading manufactures like Pfizer, Moderna, AstraZeneca, and Johnson & Johnson, leading to inadequate supply for developing nations.”  According to GlobalData’s ‘Coronavirus Disease (COVID-19) Pharma Executive Briefing – April 20, 2021’, among the top 15 economies, Brazil and Mexico are the only two countries that have approved Chinese vaccines.  It is important to note that most of the COVID-19 vaccines being supplied to developing countries are by companies based out of Russia, China, and India.  As a result, the WHO-backed COVAX initiative has slashed the number of vaccines to be delivered by the end of May from about 240 million doses to 145 million doses. Moreover, the COVAX initiative was only able to supply 41 million doses so far of its two billion doses promised by the end of 2021.   Khadayate concludes, “The supply of COVID-19 vaccines from China are expected to improve further and be of increased importance amid the supply issues within India in the wake of second wave of COVID-19.”  ]]> https://biospectrumindia.com/news/57/18494/current-therapies-for-new-sars-cov-2-variants-require-adjustments-globaldata.html https://biospectrumindia.com/news/57/18494/current-therapies-for-new-sars-cov-2-variants-require-adjustments-globaldata.html Fri, 23 Apr 2021 12:40:00 +0530 The emergence of new SARS-CoV-2 variants have been detected in over 40 countries and are disrupting drug development worldwide. The prevalence of these more transmissible strains is growing fast and may require adjustments to current therapies to ensure they retain clinical efficacy, says GlobalData. Nancy Jaser, Pharma Analyst, GlobalData, comments, “More data is now required for all potential and current COVID-19 therapies given the rapid spread of variant strains. While monoclonal antibody treatments will likely be more scrutinised due to their specific targets, vaccine development also needs to be re-assessed to determine efficacy and durability across the various platforms.” “Eli Lilly’s mAbs, bamlanivimab and etesevimab, will likely stumble in attempts to gain full FDA approval given the antiviral resistance observed against B.1.351, P.1., and the New York variant, B.1.526. However, optimism remains for its mAb combination to prove effective against the UK B.1.1.7 variant, which is currently the most dominant in the US with 7,500 reported cases.” Regeneron and Eli Lilly were both granted an EUA for mAbs against COVID-19. According to recent data, Lilly's single mAb (bamlanivimab) is not effective against most variants, while the combo (bamlanivimab/etesevimab) is slightly better with potency detected against B.1.1.7. The FDA revoked the EUA for bamlanivimab as monotherapy. However, Regeneron's mAb combo (casirivimab/imdevimab) has been proven to be the most effective against the emerging variants. Data shows that the South African variant can escape from most mAb therapies. Experts believe this B.1.351 variant is more heavily mutated than the UK B.1.1.7 strain and will be the most difficult to contain.  Top-line Phase III trial data for Regeneron’s antibody cocktail REGEN-COV (casirivimab and imdevimab) was positive, meeting its primary endpoint by reducing the risk of hospitalisation or death by 70 per cent compared to placebo. REGEN-COV also met all secondary endpoints which included reducing the duration of symptoms by four days. With an EUA already granted in the US, Regeneron plans to submit a BLA including this most recent Phase III data. Further, FDA updates indicate that REGEN-COV is the only mAb therapy that has retained potency against these emerging strains.   ]]> https://biospectrumindia.com/news/57/18425/thermo-fisher-receives-fda-eua-nod-for-high-throughput-covid-19-test.html https://biospectrumindia.com/news/57/18425/thermo-fisher-receives-fda-eua-nod-for-high-throughput-covid-19-test.html Fri, 23 Apr 2021 00:00:00 +0530 Thermo Fisher Scientific Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit. The modular solution processes samples in a four-step process requiring minimum hands-on time, laboratory space and staffing resources. It was introduced as an automated real-time PCR test that can analyze up to 8,000 COVID-19 samples in a single day. It empowers clinical and public healthcare laboratories to scale gold standard PCR testing with minimal staffing needs and a secured supply of kits, reagents and consumables to meet the rising testing demands. "India is experiencing a more intense second wave of COVID-19. This has compelled the country to take rigorous measures of ramping up testing capacity and adopt a nationwide testing regime. While a lab-based PCR test is the most suitable technology in terms of reliability, quick turnaround time and scalability, it still lacks the adequate testing volume to satisfy the status quo. With the approval of Amplitude Solution, Thermo Fisher can help to quickly double or even triple the country's testing capacity”, said Amit Chopra, managing director, India and South Asia, Thermo Fisher Scientific. The Amplitude Solution uses Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, a quick, highly sensitive multiplex diagnostic test that contains the assays and controls needed for the qualitative detection of nucleic acid from SARS-CoV-2, the virus responsible for causing COVID-19. The kit's multi-gene target design and updated interpretive software may help labs detect SARS-CoV-2 variants. Speaking on the matter, Kapil Sood, senior director, life sciences solutions, Thermo Fisher Scientific, said, "With the onset of vaccination, there continues to be demand for frequent routine testing to control the outbreak. While each state conducts testing on different capacities, a new approach for scaling the testing volume is essential to safeguard human life. Our high-yielding, automated solution can help laboratories quickly scale COVID-19 testing to volumes needed to help reduce the spread of disease and restore economies and communities.” ]]> https://biospectrumindia.com/news/57/18490/minapharm-to-manufacture-40-million-doses-of-sputnik-v-per-year.html https://biospectrumindia.com/news/57/18490/minapharm-to-manufacture-40-million-doses-of-sputnik-v-per-year.html Thu, 22 Apr 2021 16:10:00 +0530 The Russian Direct Investment Fund (RDIF), Egypt’s Minapharm, the regional leader in recombinant DNA technology, and its Berlin-based subsidiary ProBioGen AG announce the agreement to produce over 40 million doses per year of the world’s first registered vaccine against COVID-19, Sputnik V. The parties intend to commence technology transfer immediately. The rollout of the vaccine is expected in Q3, 2021. RDIF and Minapharm will initially supply over 40 million doses per year. Production will take place in Minapharm’s biotech facility in Cairo for global distribution. Minapharm’s German subsidiary, ProBioGen AG, aims to undertake efforts for process optimisation to further increase the production scale taking advantage of its expertise in viral vector technology and manufacturing process development for vaccines and gene therapy. Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented: “Agreement with Minapharm marks our first partnership in MENA region to produce Sputnik V. RDIF is in cooperation with the leading pharmaceutical producers globally as Sputnik V is registered in 61 countries.” Wafik Bardissi, Chairman and CEO, Minapharm, added, “This agreement is a natural expansion to Minapharm’s regional leadership in biotechnologies, capitalising on the vast international experience in cellular engineering and adenoviral vector technology of its wholly owned German subsidiary ProBioGen AG. We are pleased to join the RDIF in combatting the global COVID-19 pandemic.” ]]> https://biospectrumindia.com/news/57/18451/covid-19-vaccine-coverage-wont-hit-60-mark-in-92-poorest-countries-until-2023-.html https://biospectrumindia.com/news/57/18451/covid-19-vaccine-coverage-wont-hit-60-mark-in-92-poorest-countries-until-2023-.html Fri, 16 Apr 2021 15:30:00 +0530 Just 10 nations with less than half the world’s population are administering three-quarters of all COVID-19 vaccine doses, while the poorest countries have barely begun vaccinating due to lack of funding and supply. The US alone is expected to have at least 300 million excess doses of vaccine by the end of July 2021, according to new research released. The new research paper outlines a three-part plan to strengthen US leadership for safe, effective, and equitable global vaccine access, which is needed urgently. The recommended approach combines: Further US commitments to strengthen COVAX; US leadership to develop a plan to make excess vaccine doses available as soon as possible; and Comprehensive approaches to ramping up safe and reliable global vaccine manufacturing capacity. The Gavi COVAX  Advance Market Commitment (AMC) Investment Opportunity launch on Thursday, April 15th, co-hosted by the US, will provide an opportunity for the US to articulate more clearly its broader leadership role for the global response.  The paper is authored by Dr Mark McClellan, Director, Duke-Margolis Center for Health Policy and former US FDA Commissioner; Dr. Krishna Udayakumar, Director, Duke Global Health Innovation Center; Dr Michael Merson, prior Director of the WHO Global Programme on AIDS and prior founding Director of the Duke Global Health Institute; Gary Edson, President of the COVID Collaborative and former US Deputy National Security Advisor and Deputy National Economic Advisor; and Dr Scott Gottlieb, Resident Fellow at the American Enterprise Institute and former US FDA Commissioner.   Additional points: At the current rate of vaccine delivery, the world’s 92 poorest countries won’t reach 60 per cent coverage until 2023 or beyond. Beyond access to vaccines, reaching high and equitable vaccination rates, especially in low-resource settings, will require significant investment and assistance in supply chain and logistics, training and availability of health workers, appropriate regulatory oversight, and efforts to combat vaccine misinformation and hesitancy. It is in the US interest to proactively and urgently address COVID-19 vaccine inequity. Furthermore, vocal US leadership on the global stage is imperative for a more effective and coordinated global response at a time when nations such as China and Russia are attempting to gain influence through vaccine diplomacy. ]]> https://biospectrumindia.com/news/57/18444/thermo-fisher-to-acquire-cro-firm-ppd-for-17-4-b.html https://biospectrumindia.com/news/57/18444/thermo-fisher-to-acquire-cro-firm-ppd-for-17-4-b.html Thu, 15 Apr 2021 21:00:00 +0530 Thermo Fisher Scientific Inc. and PPD, Inc. have announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt. This represents a premium of approximately 24% to the unaffected closing price of PPD's common stock on the Nasdaq as of Tuesday, April 13, 2021, or 32% to the 60-day VWAP inclusive of that date. PPD provides a broad range of clinical research and laboratory services to enable customers to accelerate innovation and increase drug development productivity. A leader in the growing $50 billion clinical research services industry, PPD has more than 26,000 colleagues operating in nearly 50 countries. In 2020, the company generated revenue of $4.7 billion. Upon close of the transaction, PPD will become part of Thermo Fisher's Laboratory Products and Services Segment. "Pharma and Biotech is our largest and fastest growing end market, and our customers value us as a strategic partner and an industry leader. The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers with important clinical research services and partner with them in new and exciting ways as they move a scientific idea to an approved medicine quickly, reliably and cost effectively," said Marc N. Casper, chairman, president and chief executive officer, Thermo Fisher Scientific. "Longer term, we plan to continue to invest in and connect the capabilities across the combined company to further help our customers accelerate innovation and drive productivity, while driving further value for our shareholders." David Simmons, chairman and chief executive officer, PPD, said, "This is a very exciting announcement for our shareholders and will provide customers with an even better opportunity to bring meaningful innovation to the market faster and more efficiently. Thermo Fisher is a world-class company with a very similar culture and values and will provide a great foundation for our colleagues to continue to deliver for our customers and to develop their own skills and careers." ]]> https://biospectrumindia.com/news/57/18430/who-includes-bds-mdr-tb-assay-in-updated-guidelines.html https://biospectrumindia.com/news/57/18430/who-includes-bds-mdr-tb-assay-in-updated-guidelines.html Wed, 14 Apr 2021 09:05:00 +0530 BD (Becton, Dickinson and Company) has announced that its BD MAX™ Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay was included in the moderate complexity automated NAAT class of molecular diagnostic technologies that were recognized for high diagnostic accuracy for tuberculosis testing by the World Health Organization (WHO) in advance of an update to its guidelines for TB diagnostic tests. Laboratorians and clinicians can use the BD MAX™ MDR-TB Assay to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain mutations associated with resistance to two important first-line drugs, isoniazid (INH) and rifampicin (RIF), enhancing the information available to direct the optimal treatment for their patients. The BD MAX™ MDR-TB Assay is an in vitro diagnostic device with CE mark available in Europe and other countries around the world. The PCR-based molecular diagnostic test is an integrated diagnostic test intended to help in the detection and diagnosis of TB, and INH and RIF resistance in a single assay. "BD is keenly focused on the fight against antimicrobial resistance and we believe the BD MAX™ MDR-TB Assay will make a real impact on the detection of MDR-TB and better inform which treatment regimen to use for TB patients," said Dave Hickey, president of Life Sciences for BD. "This recognition by WHO is a significant milestone for this product and furthers BD's commitment in the fight to end TB. We look forward to WHO releasing its updated guidelines later this year." ]]> https://biospectrumindia.com/news/57/18372/novavax-initiates-covid-19-vaccine-clinical-trial-crossover.html https://biospectrumindia.com/news/57/18372/novavax-initiates-covid-19-vaccine-clinical-trial-crossover.html Tue, 06 Apr 2021 11:55:00 +0530 Novavax, Inc has announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company's COVID-19 vaccine candidate. Crossover ensures the administration of the active vaccine to all participants in the trials and has begun for Novavax's Phase 2b trial in South Africa and its pivotal Phase 3 trial in the UK. Under Novavax's updated clinical trial protocols, all participants in the UK and the US Phase 3 trials will be offered the opportunity to receive an additional round of injections. Participants who elect to do so will receive an additional two-dose regimen of either vaccine (for those who originally received placebo) or placebo (for those who originally received a vaccine). Participants in the South Africa Phase 2b trial will receive either an active vaccine for those who initially received a placebo or a booster dose of an active vaccine for those who initially received the active vaccine. Participants across all three trials will remain blinded to their courses of treatment to preserve the ability to assess efficacy in each trial, and all will be followed for up to two years to monitor the safety and durability of protection of the vaccine. In the trials taking place in South Africa and the UK, half of the participants initially received the active vaccine while two-thirds of participants in PREVENT-19, the trial being conducted in the US and Mexico, initially received the active vaccine. "The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term," said Filip Dubovsky, Chief Medical Officer, Novavax. The company is also planning a crossover in the PREVENT-19 study, for which the company expects to read out initial clinical data during the second quarter. ]]> https://biospectrumindia.com/news/57/18336/new-study-finds-pfizer-vaccine-less-effective-against-south-african-variant.html https://biospectrumindia.com/news/57/18336/new-study-finds-pfizer-vaccine-less-effective-against-south-african-variant.html Fri, 26 Mar 2021 14:50:00 +0530 The Pfizer Coronavirus vaccine is moderately less effective against the South African variant, but neutralizes the British variant and the original SARS-CoV-2 strain very well, according to a new vaccine study conducted by Ben-Gurion University of the Negev scientists. Their findings were published this week in the prestigious journal Cell Host & Microbe. The scientists looked at the effectiveness of the vaccine against the original viral strain, the British and the South African variants, as well as strains that harbour combined changes in the viral spike. They are continuing to test other circulating variants as they constantly emerge with the hope to identify potentially risky mutations that can compromise the vaccine. Their findings indicate that the Pfizer vaccine is effective against the original SARS-CoV-2 strain and the British variant, but provides weakened protection against the South African variant and the combined British-South African variants. “Our findings show that future variants could necessitate a modified vaccine as the virus mutates to increase its infectivity,” says Principal Investigator, Prof Ran Taube, Shraga Segal Department of Microbiology, Immunology and Genetics in the Faculty of Health Sciences. Prof Taube and his team also compared neutralising antibody levels following administration of one and two doses of the vaccine, as opposed to levels in patients that have recovered from COVID-19. They found that vaccination provided optimal levels of protection, when compared to the lower levels of protection that were observed in recovered patients. Additional researchers include first author Alona Kuzmina, a research investigator in Prof Taube’s lab, and collaborating investigators from Soroka University Medical Center in Beer-Sheva - Yara Khalaila, Olga Voloshin, Ayelet Keren-Naus, Liora Bohehem, Yael Raviv, Prof Yonat Shemer-Avni, and Dr Elli Rosenberg. This study was supported by the Israel Ministry of Science and Technology grant no 3-16897, the Israel Science Foundation grant application no 755/17 and the BGU COVID-19 Research Taskforce.   ]]> https://biospectrumindia.com/news/57/18259/roche-to-acquire-genmark-diagnostics-for-1-8-b.html https://biospectrumindia.com/news/57/18259/roche-to-acquire-genmark-diagnostics-for-1-8-b.html Mon, 15 Mar 2021 19:05:00 +0530 Roche and GenMark Diagnostics have announced that they have entered into a definitive merger agreement for Roche to fully acquire GenMark at a price of $24.05 per share in an all-cash transaction. This corresponds to a total transaction value of approximately $1.8 billion on a fully diluted basis. This price represents a premium of approximately 43 per cent to GenMark’s unaffected closing share price on February 10, 2021, the last trading day before a media report was published speculating about a potential sale process. Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all outstanding shares of GenMark’s common stock, and GenMark will file a recommendation statement containing the unanimous recommendation of the GenMark board that GenMark stockholders tender their shares to Roche. GenMark’s syndromic panel testing portfolio will complement Roche’s current molecular diagnostics portfolio and the Roche global network will enable expanded reach for GenMark’s products. GenMark’s ePlex system drives lab efficiency through streamlined order-to-reporting workflow and enables better patient outcomes by rapidly diagnosing a patient’s symptoms. “Acquiring GenMark Diagnostics will broaden our molecular diagnostics portfolio to include solutions that can provide lifesaving information quickly to patients and their healthcare providers in the fight against infectious diseases,” said Thomas Schinecker, CEO Roche Diagnostics.  “As a part of Roche, we can accelerate our mission to enable rapid diagnosis of infectious disease to improve patient outcomes,” said Scott Mendel, CEO, GenMark Diagnostics.  The transaction is expected to close in the 2nd quarter of 2021 and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of GenMark’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.     ]]> https://biospectrumindia.com/news/57/18190/carb-x-funds-gsk-to-develop-new-vaccines-for-preventing-serious-infections.html https://biospectrumindia.com/news/57/18190/carb-x-funds-gsk-to-develop-new-vaccines-for-preventing-serious-infections.html Tue, 02 Mar 2021 00:00:00 +0530 CARB-X is funding the GSK Biologicals and its affiliate GSK Vaccines Institute for Global Health (GVGH), based in Siena, Italy, to develop new vaccines to prevent serious infections caused by two different pathogens. Together, the two awards could be worth potentially more than $18 million if project milestones are met, subject to available funding. GSK’s two vaccine projects target the prevention of: Group A Streptococcus (Strep A) infections, commonly known as Strep Throat, a major reason for antibiotic prescriptions and cause of immune-mediated diseases. The CARB-X award is worth up to $8.2 million, plus up to an additional $4.2 million if the project meets certain milestones.  Infections caused by Salmonella enterica, which cause invasive nontyphoidal salmonellosis (iNTS) disease and typhoid fever, major causes of death among children and significant health challenges primarily in sub-Saharan African countries.  The CARB-X award is for $2.2 million to support the development of this new vaccine. If project milestones are met, the project could be eligible for up to $4.0 million in additional funding.   There are currently no vaccines available against Group A Streptococcus or iNTS, both of which are rapidly developing resistance to existing antibiotics.  “Vaccines not only prevent infections, they also reduce the need for antibiotics, helping to curb the spread of drug resistance,” said Erin Duffy, R&D Chief, CARB-X, a non-profit global partnership led by Boston University and dedicated to supporting the development of innovative therapeutics, preventatives and diagnostics to address antibiotic-resistant bacterial infections.   “As part of GSK’s overall Global Health approach, GVGH is dedicated to working with partners to develop effective and affordable vaccines that protect vulnerable communities against some of the most prevalent diseases causing high morbidity and mortality in developing countries, said Francesco Berlanda Scorza, Director, GVGH.”  ]]> https://biospectrumindia.com/news/57/18172/egypt-approves-sputnik-v-covid-19-vaccine.html https://biospectrumindia.com/news/57/18172/egypt-approves-sputnik-v-covid-19-vaccine.html Thu, 25 Feb 2021 15:00:00 +0530 The Russian Direct Investment Fund (RDIF) announces the approval of the Russian Sputnik V vaccine against coronavirus by the Egyptian Drug Authority.  Egypt is the 35th country in the world to approve Sputnik V. It is also the most populated country in the Middle-East with over 100 million people.  Egyptian Drug Authority has approved the vaccine under the emergency use authorisation procedure.  Kirill Dmitriev, CEO, Russian Direct Investment Fund, said, “Egypt is the most populated country of the Middle-East and the decision of the Egyptian Drug Authority to include Sputnik V in the national vaccine portfolio demonstrates the appreciation of safety and efficacy of the vaccine. Sputnik V is now approved in 35 countries around the world and the number of registrations will keep increasing in coming weeks as the Russian vaccine is widely recognised as one of the best in the world.” ]]> https://biospectrumindia.com/news/57/18164/mexico-receives-first-batch-of-sputnik-v-vaccine-.html https://biospectrumindia.com/news/57/18164/mexico-receives-first-batch-of-sputnik-v-vaccine-.html Wed, 24 Feb 2021 14:55:00 +0530 The Russian Direct Investment Fund (RDIF) has announced the delivery of the first batch of Sputnik V vaccine against coronavirus to Mexico.  On February 3, 2021 the Federal Commission for the Protection against Sanitary Risk of Mexico (COFEPRIS) approved Sputnik V under the emergency use authorisation procedure without additional clinical trials in the country. Mexico has become the first country of North America to approve Sputnik V.  Sputnik V is approved for use in more than 30 countries making the vaccine one of the world's top three coronavirus vaccines in terms of the number of approvals issued by regulatory authorities. Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented, “RDIF supports the efforts of the Government of Mexico to protect the population with a safe and effective Russian Sputnik V vaccine. Cooperation between Russia and Mexico on the vaccine is a great example of pooling efforts to jointly fight the pandemic and save lives. The positive decision of COFEPRIS to grant an emergency use authorisation to Sputnik V provides people of Mexico with access to one of the best vaccines in the world.” ]]> https://biospectrumindia.com/news/57/18159/who-announces-no-fault-compensation-programme-for-covid-19-vaccines.html https://biospectrumindia.com/news/57/18159/who-announces-no-fault-compensation-programme-for-covid-19-vaccines.html Tue, 23 Feb 2021 19:10:00 +0530 The World Health Organization (WHO) and Chubb Limited, through ESIS Inc, a Chubb company, signed an agreement on behalf of the COVAX Facility on February 17, 2021 for the administration of a no-fault compensation programme for the 92 low- and middle-income countries and economies eligible for support via the Gavi COVAX Advance Market Commitment (AMC) of the COVAX Facility. The programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022. By providing a no-fault lump-sum compensation in full and final settlement of any claims. “This no-fault compensation mechanism helps to ensure that people in AMC-eligible countries and economies can benefit from the cutting-edge science that has delivered COVID-19 vaccines in record time,” said Dr Tedros Adhanom Ghebreyesus, Director-General, WHO. “The no-fault compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects,” said Dr Seth Berkley, CEO, Gavi. The COVAX no-fault compensation programme will be operationalised through its web portal (www.covaxclaims.com) by March 31, 2021. The programme is financed initially through Gavi COVAX AMC donor funding. WHO is working with Chubb to secure insurance coverage for the programme with Chubb as lead insurer. “Chubb is proud and honoured to work with the World Health Organization and its partners on the critically important COVAX programme,” said Evan G Greenberg, Chairman and Chief Executive Officer, Chubb. ]]> https://biospectrumindia.com/news/57/18118/alivecor-astrazeneca-bring-non-invasive-potassium-monitoring-solutions.html https://biospectrumindia.com/news/57/18118/alivecor-astrazeneca-bring-non-invasive-potassium-monitoring-solutions.html Wed, 17 Feb 2021 15:35:00 +0530 AliveCor, the leader in AI-based personal ECG technology and provider of enterprise cardiology solutions, has announced a new collaboration with AstraZeneca, a global science-led biopharmaceutical company, to research new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas. The collaboration will translate AliveCor's potassium detection technology and science, which enables potassium measurement outside of blood draws, into real-world disease management applications and solutions. The cross-industry collaboration expands the research and development of AliveCor's Kardia-K AI platform, which received ‘Breakthrough Device Designation’ status from the FDA to screen for elevated levels of blood potassium. Kardia-K is being built using AliveCor's proprietary deep neural network, and analyses electrocardiograms (ECGs) to measure a patient's potassium levels without requiring any blood from the patient. Aman Bhatti, Head of BioPharma Partnerships, AliveCor, said, "Our collaboration with AstraZeneca exemplifies how pharmaceutical and digital health companies can work together to drive the future of medicine.” ]]> https://biospectrumindia.com/news/57/18109/who-approves-astrazenecas-covid-19-vaccine-under-emergency-use-listing.html https://biospectrumindia.com/news/57/18109/who-approves-astrazenecas-covid-19-vaccine-under-emergency-use-listing.html Tue, 16 Feb 2021 16:30:00 +0530 AstraZeneca’s COVID-19 vaccine has been granted emergency use listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65. The authorisation of COVID-19 Vaccine AstraZeneca manufactured by AstraZeneca, and Covishield manufactured by Serum Institute of India (SII), enables global access to the vaccine during the pandemic. The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval. This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. AstraZeneca and SII will now work with the COVAX Facility to begin supplying the vaccine around the world, with the majority going to low and middle-income countries as quickly as possible. Pascal Soriot, Chief Executive Officer, AstraZeneca, said, “Today’s approval endorses that the vaccine can be used to help protect populations across the world, including adults over 65 years and in countries where different variants of the SARS-CoV-2 virus are in circulation.” Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, “I am happy and relieved that with the WHO's EUL we will be able to start the deliveries to African and other low and middle-income countries immediately. Countries with a large population must be protected as soon as possible.” AstraZeneca’s COVID-19 vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings. ]]> https://biospectrumindia.com/news/57/18106/fda-grants-eua-to-bds-sars-cov-2-flu-assay.html https://biospectrumindia.com/news/57/18106/fda-grants-eua-to-bds-sars-cov-2-flu-assay.html Mon, 15 Feb 2021 18:10:00 +0530 BD (Becton, Dickinson and Company), a leading global medical technology company, has announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for a new molecular diagnostic test for both SARS-CoV-2 and Influenza A+B that can return results in two to three hours. The new test also has been CE marked to the IVD Directive (98/79/EC). The new EUA includes updated information in the test's instructions for use that addresses variants of the SARS-COV-2 virus, including variants from the UK and South Africa. The BD® SARS-CoV-2/Flu assay is run on the BD MAX™ System and distinguishes between SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus using a single specimen. "The guidelines from the US Centers for Disease Control and Prevention (CDC) recommend testing for both Flu and SARS-CoV-2 for all patients who are hospitalised and for patients who will not be hospitalised but for whom a positive result will change clinical management," said Dr Charles K Cooper, Vice President, Medical and Scientific Affairs for Integrated Diagnostic Solutions, BD.  The BD® SARS-CoV-2/Flu for BD MAX™ System kits are now available for order in the United States and Europe. The test is the latest addition to the company's comprehensive COVID-19 diagnostics response. "Our diagnostic solutions for COVID-19 and Flu will help inform timely diagnosis and, ultimately, may contribute to faster and clinically appropriate patient management and treatment," said Dave Hickey, President, Life Sciences BD. ]]> https://biospectrumindia.com/news/57/18096/eurofins-launches-quantitative-igg-assay-to-identify-sars-cov-2-abs.html https://biospectrumindia.com/news/57/18096/eurofins-launches-quantitative-igg-assay-to-identify-sars-cov-2-abs.html Fri, 12 Feb 2021 17:35:00 +0530 Eurofins has launched a new CE marked serological assay for the identification and quantification of antibodies to SARS-CoV-2. This ELISA kit can support vaccination campaigns by confirming the success of vaccination and monitoring the antibody levels over time. Vaccination against COVID-19 is a critical element in the fight against the pandemic. The spike protein covers the surface of the SARS-CoV-2 virus and is responsible for attachment and invasion of human cells. All currently approved vaccines use the spike protein to train the immune system to detect and neutralise this virus. The GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG is an ELISA assay designed to mimic this target by using the native, trimeric form of the spike protein and detect all long-lasting IgG antibodies raised by a vaccination or natural infection. A standard curve allows for quantification to monitor if antibody levels increase or decrease over time.  Supplementary to vaccination monitoring, the kit shows excellent clinical performance in detecting antibodies raised naturally by a true SARS-CoV-2 infection. 15 days after symptom onset, the assay identifies antibodies to the spike protein in 97 per cent of patients with a PCR confirmed infection. A diagnostic specificity of 99.94 per cent was validated with over 500 samples from healthy controls. Validation of the test with capillary blood samples enables the use with self-sampling devices for less invasive and more comfortable sample collection that could simplify large scale screening programmes. ]]> https://biospectrumindia.com/news/57/18094/thermo-fishers-ion-chromatography-systems-now-available-to-order-online-.html https://biospectrumindia.com/news/57/18094/thermo-fishers-ion-chromatography-systems-now-available-to-order-online-.html Fri, 12 Feb 2021 16:40:00 +0530 In response to laboratories' need to minimise in-person contact during the pandemic, Thermo Fisher Scientific now offers its essential Thermo Scientific Dionex Easion and Thermo Scientific Dionex Aquion ion chromatography (IC) systems through easy, online ordering. "Environmental laboratories rely on IC technology to undertake anion analyses in line with the Environmental Protection Agency (EPA) Method 300, while academic settings commonly use these foundational IC systems for teaching purposes," said Dino Alfano, Vice President and General Manager, Ion Chromatography and Sample Preparation, Thermo Fisher Scientific. "However, during these unprecedented times, laboratories globally are facing great difficulties maintaining their infrastructure without in-person interaction with sales representatives. To alleviate this burden, we've made our decades-long experience of engineering state-of-the-art IC instrumentation available at the click of a button, with simplified online quote generation, ordering and order tracking for our Dionex Easion and Dionex Aquion IC systems.” The newly introduced online purchase option makes it possible for environmental and academic laboratories to order the complete Dionex Easion and Dionex Aquion IC product packages — including anion or cation column sets and corresponding suppressors — in a single contactless transaction. As a result, laboratories can quickly get their new all-inclusive IC systems up and running without requiring any additional pumps or ancillary items. Built as a technologically advanced, easy-to-use, compact instrument, the Dionex Easion IC system addresses the water analysis application needs of environmental and academic laboratories. At the same time, the Dionex Aquion IC system is designed to bring a new level of robustness and reproducibility to common IC analyses.  Both the Dionex Easion and Dionex Aquion IC systems operate on the intuitive, user-friendly Thermo Scientific Chromeleon Chromatography Data System (CDS) software. ]]> https://biospectrumindia.com/news/57/18082/azerbaijan-to-conduct-trials-of-sputnik-v-azd1222-vaccine-cocktail.html https://biospectrumindia.com/news/57/18082/azerbaijan-to-conduct-trials-of-sputnik-v-azd1222-vaccine-cocktail.html Thu, 11 Feb 2021 00:00:00 +0530 The Russian Direct Investment Fund (RDIF) announces that the Ministry of Health of the Republic of Azerbaijan has issued a permit on February 8 to conduct clinical trials in the country of a combined use of Sputnik V and the vaccine developed jointly by AstraZeneca and Oxford University. Clinical trials will begin till the end of February.  The world’s first combined vaccine use will be conducted in line with clinical trials protocol registered on December 24, 2020. The study will allow evaluating the immunogenicity and safety of the combined use of Sputnik V and the vaccine jointly developed by AstraZeneca and Oxford University.  Kirill Dmitriev, CEO, Russian Direct Investment Fund, said, “The partnership for the clinical study of the combination of the AZD1222 vaccine with the adenoviral vector Ad26 of the Sputnik V vaccine has become the first and very important example of such cooperation in the world.” Alexey Repik, Chairman of the Board of Directors, R-Pharm, said, “This pilot study is vital for developing of a new approach to the prevention of COVID-19, moreover the leading scientific and clinical centres of Azerbaijan will be able to make their own important contribution in this direction.” ]]> https://biospectrumindia.com/news/57/18076/thermo-fisher-mindray-unveil-clinical-chemistry-analysers-in-us-canada.html https://biospectrumindia.com/news/57/18076/thermo-fisher-mindray-unveil-clinical-chemistry-analysers-in-us-canada.html Wed, 10 Feb 2021 13:55:00 +0530 Thermo Fisher Scientific has announced a partnership with Mindray to make available to customers two clinical chemistry analysers in the US and Canada for drug screening in clinical and drug court laboratories. Stefan Wolf, President, Clinical Diagnostics Business, Thermo Fisher Scientific said, "Through this exclusive partnership with Mindray we are able to address the needs of our customers in commercial labs, hospitals and the criminal justice field. Now we can better cater to the needs of those laboratories seeking to expand or increase their testing volumes, and laboratories working to consolidate and centralise their testing sites with these two medium- to high-throughput instruments." To provide access to drug testing, Thermo Fisher and Mindray have entered into an agreement to offer the FDA-cleared and Health Canada–approved BS-480 (400 tests/hour) and BA-800M (800 tests/hour) analysers to toxicology labs. Thermo Fisher will also provide an extensive menu of wet lab–validated Thermo Scientific DRI and CEDIA drugs of abuse immunoassay reagents with the instruments to enable the screening of urine samples for the presence of a given drug or a class of drugs. Taken together, the world-class DRI and CEDIA drugs of abuse immunoassay reagents, validated on Mindray's instruments, bring a combination of performance and reliability from a single source in a cost-effective, plug-and-play solution. The solution streamlines the drug screening workflow and automates it to reduce risk of human error. The instruments also come with onboard software that has many advanced features, including sample/reagent probe collision protection, sample aggregate detection and a five-minute daily push-button self-service maintenance programme. Thermo Fisher began distributing, installing, training and servicing Mindray BS-480 and BA-800M instruments in the US and Canada last month. ]]> https://biospectrumindia.com/news/57/18062/lebanon-registers-sputnik-v-covid-19-vaccine-.html https://biospectrumindia.com/news/57/18062/lebanon-registers-sputnik-v-covid-19-vaccine-.html Mon, 08 Feb 2021 12:50:00 +0530 The Russian Direct Investment Fund (RDIF) has announced the registration of the Russian Sputnik V vaccine against coronavirus by the Ministry of Health of Lebanon. The vaccine was approved under the emergency use authorisation procedure without additional clinical trials in the country. Sputnik V has been approved earlier in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua and Republika Srpska (entity of Bosnia and Herzegovina). Kirill Dmitriev, CEO, Russian Direct Investment Fund, said, “To date Sputnik V has been included in the national portfolio of vaccines against coronavirus by 20 countries, and this number will be increasing. Approval granted by the Ministry of Health will provide the population of Lebanon access to one of the best vaccines in the world.” ]]> https://biospectrumindia.com/news/57/18039/mexico-becomes-first-n-american-country-to-approve-sputnik-v-vaccine.html https://biospectrumindia.com/news/57/18039/mexico-becomes-first-n-american-country-to-approve-sputnik-v-vaccine.html Wed, 03 Feb 2021 17:20:00 +0530 The Russian Direct Investment Fund has announced the registration of the Russian Sputnik V vaccine against coronavirus by the Federal Commission for the Protection against Sanitary Risk of Mexico (COFEPRIS). The vaccine was approved under the emergency use authorisation procedure without additional clinical trials in the country. Mexico has become the first country of North America to approve Sputnik V and the 17th country in the world. Sputnik V had been approved earlier in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia and Armenia. Kirill Dmitriev, CEO, Russian Direct Investment Fund, said, “We welcome the decision of regulatory authorities of Mexico to register Sputnik V vaccine and include it in the national portfolio of vaccines against coronavirus. Partnership between Russia and Mexico will save many lives and protect the population by using one of the best vaccines in the world. High efficacy of Sputnik V was confirmed yesterday by data published in one of the most respected medical journals The Lancet.”   ]]> https://biospectrumindia.com/news/57/18032/sputnik-vs-ph-iii-clinical-trial-results-confirm-high-efficacy-safety.html https://biospectrumindia.com/news/57/18032/sputnik-vs-ph-iii-clinical-trial-results-confirm-high-efficacy-safety.html Tue, 02 Feb 2021 18:50:00 +0530 The Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund (RDIF) announce that the Lancet has published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine’s high efficacy and safety. In the interim efficacy analysis of the randomised, double-blind, placebo-controlled clinical trial, where data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo), the two-dose treatment of Sputnik V administered 21 days apart demonstrated efficacy of 91.6 per cent against COVID-19. Alexander Gintsburg, Director, Gamaleya Research Institute of Epidemiology and Microbiology, said: “The publication of internationally peer reviewed data on Sputnik V’s clinical trial results is a great success in the global battle against the COVID-19 pandemic.” Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented, “The data published by The Lancet proves that not only Sputnik V is the world’s first registered vaccine, but also one of the best.” Cecil Czerkinsky, Research Director, National Institute of Health and Medical research (Inserm), France, said, “The interim results of the phase 3 clinical trial of Sputnik V COVID adenovirus vector vaccine are fairly impressive. This vaccine appears to be highly efficacious and immunogenic across age groups.” Len Seymour, Professor, Gene Therapies, Department of Oncology, University of Oxford, UK, commented, “The data indicate that the Sputnik V vaccine shows encouraging activity, including in a cohort of participants aged 60 and above.” Importantly, the study included 2,144 volunteers over 60 years old with the maximum ages of 87 years (vaccine group) and 84 years (placebo group), showing great safety results for the elder age strata.   ]]> https://biospectrumindia.com/news/57/18023/novartis-renews-partnership-with-who-to-eradicate-leprosy.html https://biospectrumindia.com/news/57/18023/novartis-renews-partnership-with-who-to-eradicate-leprosy.html Mon, 01 Feb 2021 18:05:00 +0530 A renewed partnership agreement signed by Novartis and the World Health Organization (WHO) will drive the global push towards making leprosy history. The five-year extension of the partnership – which was first signed in 2000 – will see Novartis continue to donate multi-drug therapy (MDT) medicines to treat leprosy up to the end of 2025. "Leprosy can be cured and prevented. With a comprehensive approach, we can see the end of leprosy,” said Dr Lutz Hegemann, Chief Operating Officer, Global Health, Novartis. “By supplying this treatment free of charge to WHO over the last 20 years we have helped over seven million people be cured of leprosy. We look forward to helping increasingly few over the coming years.” Novartis is working with WHO and the Global Partnership for Zero Leprosy – together with other stakeholders – to develop improved access to MDT globally. An additional future step seems certain to include the rollout of prophylaxis programmes in affected countries.  “WHO welcomes the extension of this long-standing partnership with Novartis. Multi-drug therapy has been a cornerstone of the programme to eliminate leprosy,” said Dr Ren Minghui, Assistant Director-General, Universal Health Coverage / Communicable and Noncommunicable Diseases, WHO. “We need to ensure we are reaching the last patients who are often in remote areas or informal settlements. It is in these deprived communities where much of the world's remaining leprosy is concentrated.” The new agreement with WHO also covers the continuing donation of triclabendazole for the treatment of fascioliasis. ]]> https://biospectrumindia.com/news/57/18015/who-proposes-new-road-map-for-neglected-tropical-diseases-.html https://biospectrumindia.com/news/57/18015/who-proposes-new-road-map-for-neglected-tropical-diseases-.html Fri, 29 Jan 2021 18:15:00 +0530 A new World Health Organization (WHO) road map for neglected tropical diseases (NTDs) proposes ambitious targets and innovative approaches to tackle 20 diseases which affect more than a billion mainly poor people and which thrive in areas where access to quality health services, clean water and sanitation is scarce. Targets include the eradication of dracunculiasis (guinea worm) and yaws and a 90% reduction in the need for treatment for NTDs by 2030. `Ending the neglect to attain the Sustainable Development Goals: a road map for neglected tropical diseases 2021–2030´ aims to accelerate programmatic action and renew momentum by proposing concrete actions focused on integrated platforms for delivery of interventions. “If we are to end the scourge of neglected tropical diseases, we urgently need to do things differently,” said Dr Tedros Adhanom Ghebreyesus, Director-General, WHO. “It involves working across sectors in delivering programmes for all the 20 NTDs and promote equity and country ownership" said Dr Mwelecele Ntuli Malecela, Director, Department of Control of Neglected Tropical Diseases, WHO. The road map, developed through a wide consultative process involving countries, partners, stakeholders, the scientific community and academia, provides opportunities to evaluate, assess and adjust programmatic actions as and when needed over the next decade, by setting clear targets and milestones: reduce by 90% the number of people requiring treatment for NTDs at least 100 countries to have eliminated at least one NTD eradicate two diseases (dracunculiasis and yaws) reduce by 75% the disability-adjusted life years (DALYs) related to NTD Additionally, the road map will track 10 cross-cutting targets and disease specific targets that include a reduction by more than 75% in the number of deaths from vector-borne NTDs such as dengue, leishmaniasis and others.  ]]> https://biospectrumindia.com/news/57/18009/sanofi-to-support-manufacturing-supply-of-pfizer-biontech-covid-19-vaccine.html https://biospectrumindia.com/news/57/18009/sanofi-to-support-manufacturing-supply-of-pfizer-biontech-covid-19-vaccine.html Thu, 28 Jan 2021 18:40:00 +0530 Sanofi and BioNTech have entered into an agreement under which Sanofi will support manufacturing and supply of BioNTech’s COVID-19 vaccine which is being co-developed with Pfizer. Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt from summer of 2021. “We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved. The announcement is a pivotal step towards our industry’s collective goal of putting all the effort in to curb this pandemic,” said Paul Hudson, Chief Executive Officer, Sanofi. “We have made the decision to support BioNTech and Pfizer in manufacturing their COVID-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so. First and foremost, we will do this by continuing to develop our own COVID-19 vaccines candidates, in parallel with this industrial cooperation.” ]]> https://biospectrumindia.com/news/57/17971/royal-philips-merck-to-offer-ai-backed-fertility-treatment-solutions.html https://biospectrumindia.com/news/57/17971/royal-philips-merck-to-offer-ai-backed-fertility-treatment-solutions.html Thu, 21 Jan 2021 08:50:00 +0530 Royal Philips, a global leader in health technology, has announced a multi-year partnership with Merck, a leading science and technology company, to develop clinical-grade digital solutions for highly personalised fertility treatment. Leveraging digital health technologies, advanced informatics and mobile, AI-enabled ultrasound diagnostics, these solutions will aim to better inform patients and clinicians about the choice and timing of fertility treatment to maximise the chances of conception.  Jeroen Tas, Chief Innovation & Strategy Officer, Royal Philips said, “The journey for aspiring parents is sometimes a difficult one, and by collaborating with Merck, a world leader in fertility treatment, we aim to develop integrated digital solutions that improve the patient experience and can ultimately have a positive impact on health outcomes.”  “We believe that the future of IVF will be unlocked through digital health technologies that empower professionals and patients to be better connected,” said Michelangelo Canzoneri, Global Head, Digital and Data, Healthcare, Merck. “Together, this collaboration will push our two companies to think beyond tomorrow and discover new solutions that can empower people to realise their dreams of parenthood,” added Jan Kirsten, Head, Global Business Franchise for Fertility, Merck.   ]]> https://biospectrumindia.com/news/57/17968/cphi-p-mec-china-2020-poised-to-stimulate-renewed-growth-across-pharma-supply-chain.html https://biospectrumindia.com/news/57/17968/cphi-p-mec-china-2020-poised-to-stimulate-renewed-growth-across-pharma-supply-chain.html Wed, 20 Jan 2021 20:00:00 +0530 The recently hosted CPhI & P-MEC China 2020 – organised by Informa Markets and CCCMHPIE and co-organised by Shanghai Sinoexpo Informa Markets International Exhibition Co, Ltd – attracted a remarkable 46,157 visits of professional pharma visitors, including 5,105 international attendees taking part online. The hybrid event has helped stimulate renewed growth and partnerships across the pharma supply chain, with the pharma industry looking well positioned for 2021. The ingredients, machinery and manufacturing sectors reported particularly robust attendance – with full implementation of the Marketing Authorisation Holder (MAH) system, coupled with priority review pathways from the NMPA (National Medical Products Administration) driving much new demand. In fact, 2,958 companies from the pharma supply chain attended – including Pfizer, Sanofi, Capsugel, Dupont, Merck, BASF, Fosun Pharma, Hengrui Medicine, Yangtze River Pharmaceutical and Fette. Finally, to celebrate the 20th anniversary of CPhI China, the organising committee awarded a ‘CPhI China 20th Anniversary Founding Exhibitor Award’ and ‘P-MEC China 15th Anniversary Founding Exhibitor Award’ on the opening day at the CPhI China 20th anniversary reception. For international online attendees, the event teamed up with PharmaSources.com to launch the Virtual Expo Connect (VEC), which ran for a full month in December and connected pharma in China with overseas customers. “2021 promises to be a celebration of the pharma industry with vaccine distribution now underway and we look forward to helping the industry meet both online and in person so it can continue its work in discovering and delivering vital therapies to patients,” commented Laura Murina, Brand Manager, Informa. CPhI & P-MEC China 2021 will return to SNIEC (from December 16-18, 2021) with a comprehensive online and offline offering – providing access to vital connections in person and through enhanced digital pharma platforms. ]]> https://biospectrumindia.com/news/57/17941/medtronic-unveils-adaptive-deep-brain-stimulation-trial-in-parkinsons-patients.html https://biospectrumindia.com/news/57/17941/medtronic-unveils-adaptive-deep-brain-stimulation-trial-in-parkinsons-patients.html Fri, 15 Jan 2021 11:50:00 +0530 Medtronic plc, the global leader in medical technology, announced the first enrolment in ADAPT-PD (Adaptive DBS Algorithm for Personalised Therapy in Parkinson's Disease), its trial evaluating the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson's Disease (PD). Adaptive deep brain stimulation is an investigational feature of the Percept™ PC device that could be enabled if approved. The randomised study will take place across 12 study sites at leading movement disorders research centers in the US, Europe, and Canada. An estimated 36 subjects will undergo a total evaluation period of 15 months. The primary endpoint of ADAPT-PD will compare standard continuous DBS (cDBS) to aDBS for hours of 'On' time without troublesome dyskinesias, a measure of treatment efficacy versus side effects, as reported by patient diary. Dr Helen Bronte-Stewart, John E Cahill Family Professor, Department of Neurology and Neurological Sciences, Stanford University and who is the North American principal investigator for the ADAPT-PD study, enrolled the first patient at the Stanford Movement Disorders Center. ADAPT-PD will be using the Percept PC DBS system with investigational aDBS feature. While the aDBS feature is investigational and has not been approved for commercial use, the Percept PC device (cDBS) was approved by the FDA in June 2020. "The recently initiated ADAPT-PD is the first trial to gather clinical evidence to unlock those capabilities," said Mike Daly, Vice President and General Manager, Brain Modulation business, which is reported as part of the Restorative Therapies Group at Medtronic. "aDBS technology will allow DBS to be responsive in real-time, communicating with the patient's brain, as needed - which could reduce the amount of programming burden on a clinician," added Professor Andrea Kühn, Head, Movement Disorders and Neuromodulation, Charité University Hospital, Berlin.   ]]> https://biospectrumindia.com/news/57/17939/who-to-expand-monitoring-of-emerging-variants-of-sars-cov-2.html https://biospectrumindia.com/news/57/17939/who-to-expand-monitoring-of-emerging-variants-of-sars-cov-2.html Thu, 14 Jan 2021 18:30:00 +0530 Global scientists are intensifying research into COVID-19, as the World Health Organization (WHO) moves to expand its scientific collaboration and monitoring of emerging variants of SARS-CoV-2, the virus that causes COVID-19. A day-long virtual meeting of scientists from around the globe, convened by WHO, brought together more than 1750 experts from 124 countries to discuss critical knowledge gaps and research priorities for emerging variants of the virus. The consultation was structured around six thematic areas covering epidemiology and mathematical modelling, evolutionary biology, animal models, assays and diagnostics, clinical management and therapeutics and vaccines. There was a consensus on the importance of integrating the new SARS-CoV-2 variants research into the global research and innovation agenda while enhancing coordination across disciplines. “Our collective goal is to get ahead of the game and have a global mechanism to quickly identify and study variants of concern and understand their implications for disease control efforts,” said Dr Ana Maria Henao Restrepo, Head, R&D Blueprint, WHO. It is normal for viruses to mutate, but the more the SARS-CoV-2 virus spreads, the more opportunities it has to change. High levels of transmission mean that we should expect more variants to emerge. “So far an astounding 350000 sequences have been publicly shared, but most come from just a handful of countries. Improving the geographic coverage of sequencing is critical for the world to have eyes and ears on changes to the virus,” said Dr Maria Van Kerkhove, Technical Lead on COVID-19, WHO. Scientists highlighted the importance of national data platforms to document critical clinical, epidemiological and virus data that facilitates the detection and assessment of new SARS-CoV-2 variants. ]]> https://biospectrumindia.com/news/57/17934/who-announces-global-stockpiling-of-ebola-vaccine.html https://biospectrumindia.com/news/57/17934/who-announces-global-stockpiling-of-ebola-vaccine.html Wed, 13 Jan 2021 18:10:00 +0530 A global Ebola vaccine stockpile to ensure outbreak response has been established. The effort was led by the International Coordinating Group (ICG) on Vaccine Provision, which includes the World Health Organization (WHO), UNICEF, the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF), with financial support from Gavi, the Vaccine Alliance. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp and developed with financial support from the from the government of the US. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Dr Tedros Adhanom Ghebreyesus, Director-General, WHO said, “This new stockpile is an excellent example of solidarity, science and cooperation between international organisations and the private sector to save lives.” The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. Henrietta Fore, UNICEF Executive Director said, “This Ebola vaccine stockpile is a remarkable achievement - one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” IFRC Secretary General, Jagan Chapagain said, “With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” Dr Natalie Roberts, Programme Manager, MSF Foundation said, “An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. ]]> https://biospectrumindia.com/news/57/17926/serum-institute-codagenix-initiate-ph-1-dosing-of-covi-vac-vaccine.html https://biospectrumindia.com/news/57/17926/serum-institute-codagenix-initiate-ph-1-dosing-of-covi-vac-vaccine.html Tue, 12 Jan 2021 13:15:00 +0530 US based Codagenix Inc and the Serum Institute of India Pvt Ltd (SII) have announced that the first patient has been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19.   Designed as a randomised, double-blinded, placebo-controlled dose-escalation study, the Phase 1 trial will evaluate a total of 48 volunteers at multiple dose levels to determine the safety and tolerability COVI-VAC. In addition, the study will evaluate the vaccine's ability to provoke an immune response – measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. Codagenix expects to report initial data from the study by mid-2021. Pending results of the Phase 1 trial, Codagenix and SIIPL expect to begin advanced clinical testing in mid-2021. The trial is being conducted by hVIVO in London, UK, a subsidiary of Open Orphan plc. J Robert Coleman, CEO, Codagenix said, "Importantly, as a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus. This could prove critical as new variants of SARS-CoV-2 have begun to emerge.” Charlie Petty, Principal, Adjuvant Capital and Codagenix board member said, "We are optimistic that COVI-VAC can play an important role in achieving equitable access to protection from SARS-CoV-2, and the Serum Institute of India is the ideal partner to achieve our large-scale distribution amibitions.” COVI-VAC was developed with Codagenix's Synthetic Attenuated Virus Engineering (SAVE) platform, which uses synthetic biology to re-code the genes of viruses into safe and stable vaccines. ]]> https://biospectrumindia.com/news/57/17917/algeria-becomes-first-african-country-to-register-sputnik-v.html https://biospectrumindia.com/news/57/17917/algeria-becomes-first-african-country-to-register-sputnik-v.html Mon, 11 Jan 2021 16:45:00 +0530 The Russian Direct Investment Fund (RDIF) has announced the registration of the Sputnik V vaccine against coronavirus by the National Agency of Pharmaceutical Products of People's Democratic Republic of Algeria. The vaccine was registered under the emergency use authorisation procedure. Sputnik V has been registered under the same procedure earlier in Argentina, Bolivia and Serbia. Supplies of the vaccine to Algeria will be facilitated by international partners of RDIF in India, China, South Korea and other countries. Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “RDIF welcomes the first registration of Sputnik V vaccine in Africa. The supplies of the vaccine to Algeria will help protect the population and support the full recovery of economic activity”. ]]> https://biospectrumindia.com/news/57/17904/merck-expands-mrna-capabilities-for-vaccines-treatments-and-diagnostics.html https://biospectrumindia.com/news/57/17904/merck-expands-mrna-capabilities-for-vaccines-treatments-and-diagnostics.html Fri, 08 Jan 2021 00:00:00 +0530 Merck has announced the acquisition of AmpTec, a leading Hamburg, Germany-based, mRNA contract development and manufacturing organisation (CDMO). The deal strengthens Merck’s capabilities to develop and manufacture mRNA for its customers for use in vaccines, treatments and diagnostics applicable in COVID-19 and many other diseases. Financial terms were not disclosed. Stefan Oschmann, Chairman of the Executive Board and CEO, Merck said, “By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, we are able to provide a truly differentiated and integrated offering across the mRNA value chain, which will significantly decrease supply chain complexity and enhance speed-to-market.” Guido Krupp and Peter Scheinert, Managing Directors and Founders, AmpTec said, “AmpTec’s more than 40 employees are thrilled to join Merck and are confident that our PCR-based technology and combined expertise will allow us to offer customers innovative technologies, products and services to help advance life-enhancing therapeutics.” In addition to specialising in mRNA technology, AmpTec has a diagnostics business that focuses on producing customised long RNAs and DNAs for in vitro diagnostics. It will complement Merck’s diagnostics business, which specialises in providing critical raw materials, components and services for in vitro diagnostics manufacturers. Merck is continuing to invest in mRNA as a modality and will scale up this technology both at AmpTec’s existing site in Hamburg and at Merck’s global headquarters in Darmstadt, Germany. ]]> https://biospectrumindia.com/news/57/17860/eurofins-unveils-ngs-service-to-identify-viral-mutations.html https://biospectrumindia.com/news/57/17860/eurofins-unveils-ngs-service-to-identify-viral-mutations.html Thu, 31 Dec 2020 00:00:00 +0530 Eurofins Genomics has launched an optimised, cost-effective, SARS-CoV-2, next-generation sequencing service providing full length viral genome sequences. The best-in-class ARTIC NGS Oligo mix synthesised by Eurofins Genomics’ Synthesis branch will be commercially available shortly. The new NGS service and ARTIC NGS oligo kit are Eurofins’ latest additions to a comprehensive product portfolio to support researchers globally in the development of vaccines and in their fight against the COVID-19 pandemic. The increasing diversity of SARS-CoV-2 variants and the potential threat of increased virulence, higher infectivity and altered epitopes of these newly evolving viral strains, underline the need to identify, trace and track mutations over the complete viral genome. Whole genome SARS-CoV-2 sequencing identify mutant strains and spot emerging risks, including potentially immune and vaccine evasive variants, at an early stage. The service and oligo mix are based on a protocol by the ARTIC consortium, which is used for SARS-CoV-2 sequencing worldwide. The ARTIC approach utilises an oligo pool for multiplexed PCR amplification of the complete viral genome. Eurofins Genomics’ sophisticated bioinformatic pipeline assembles and compares the resulting contiguous full-length SARS-CoV-2 isolate sequences and delivers a report for conclusive interpretation. The new service exploits Eurofins Genomics scalable, automated, standardised laboratory information management system (LIMS) controlled high throughput next generation sequencing facility. As announced on December 23, 2020, Eurofins is offering part of its sequencing capacity for free to public healthcare authorities who do not have emergency budgets available to detect the VUI2020-12/01 strain reported to be currently fast-spreading in the UK. ]]> https://biospectrumindia.com/news/57/17858/six-uk-returnees-test-positive-for-new-uk-variant-of-sars-cov-2.html https://biospectrumindia.com/news/57/17858/six-uk-returnees-test-positive-for-new-uk-variant-of-sars-cov-2.html Tue, 29 Dec 2020 15:05:00 +0530 Government of India took cognizance of the reports of mutant variant of SARS- CoV-2 virus reported from the UK and put in place a pro-active and preventive strategy to detect and contain the mutant variant.  The entire issue was examined at length by NTF on December 26, 2020 and the NTF concluded that there is no need to change either the existing National Treatment Protocol or existing Testing Protocols in view of the mutant variant. NTF also recommended to conduct enhanced genomic surveillance. From November 25 to December 23, 2020 midnight, about 33,000 passengers disembarked at various Indian airports from the UK. All these passengers are being tracked and subjected by States/UTs to RT-PCR tests. So far only 114 have been found positive. These positive samples have been sent to 10 INSACOG labs (NIBMG Kolkata, ILS Bhubaneswar, NIV Pune, CCS Pune, CCMB Hyderabad, CDFD Hyderabad, InSTEM Bengaluru, NIMHANS Bengaluru, IGIB Delhi, NCDC Delhi) for genome sequencing. A total of 6 samples of 6 UK returnee persons have been found to be positive with the new UK variant genome. 3 in NIMHANS, Bengaluru, 2 in CCMB, Hyderabad and 1 in NIV, Pune. All these persons have been kept in single room isolation in designated Health Care facilities by respective State Governments. Their close contacts have also been put under quarantine. Comprehensive contact tracing has been initiated for co-travellers, family contacts and others. Genome sequencing on other specimens is going on. It is important to note that the presence of the new UK Variant has already been reported by Denmark, Netherlands, Australia, Italy, Sweden, France, Spain, Switzerland, Germany, Canada, Japan, Lebanon and Singapore, so far. ]]> https://biospectrumindia.com/news/57/17841/global-partners-seek-urgent-cooperation-to-end-paediatric-aids.html https://biospectrumindia.com/news/57/17841/global-partners-seek-urgent-cooperation-to-end-paediatric-aids.html Mon, 28 Dec 2020 16:20:00 +0530 Global partners that are committed to ending paediatric AIDS have come together to call on countries to rapidly scale up access to optimal, child-friendly HIV treatment for infants and children. The partners include the United Nations Children’s Fund, the World Health Organisation (WHO), UNAIDS, the United States President’s Emergency Plan for AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Unitaid, the Elizabeth Glaser Paediatric AIDS Foundation, and the Clinton Health Access Initiative (CHAI). The United States Food and Drug Administration (FDA) recently gave tentative approval for the first generic formulation of dolutegravir (DTG) 10 mg dispersible tablets. This approval was the result of an innovative partnership between Unitaid, CHAI and ViiV Healthcare, together with generic suppliers, which accelerated the timeline of development by several years. This now means that WHO-recommended, preferred first line DTG-based antiretroviral treatment is now available in more affordable and child-friendly generic formulations for young children and infants as young as four weeks of age and weighing more than 3 kg. Suppliers have indicated their ability to meet global scale-up ambitions. Accurate forecasts of demand are critical to inform production planning and delivery timelines. The partners are committed to support national governments as they develop rapid transition plans from existing suboptimal HIV treatment to DTG-based treatment for infants and children, including advocacy for political commitment, mobilising international and domestic resources, new policies and guidelines, managing medicine supply, distribution and stock, training healthcare workers and sensitising and engaging affected communities to ensure demand and treatment literacy for children living with HIV and their caregivers in order to ensure rapid uptake of these new formulations. ]]> https://biospectrumindia.com/news/57/17820/sputnik-v-azd1222-vaccine-cocktail-could-become-long-term-immunization-strategy.html https://biospectrumindia.com/news/57/17820/sputnik-v-azd1222-vaccine-cocktail-could-become-long-term-immunization-strategy.html Tue, 22 Dec 2020 12:45:00 +0530 The Russian Direct Investment Fund (RDIF), The Gamaleya National Center, AstraZeneca and R-Pharm have signed an agreement aimed at the development and implementation of a clinical research programme to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the AZD1222 vaccine, developed by AstraZeneca and the University of Oxford. The agreement was announced on a video-conference with Vladimir Putin, the President of Russia. The parties have also agreed to develop scientific and business relations and explore the possibilities for joint use of the Sputnik V vaccine and the AZD1222 vaccine in order to create more effective and long-term immunisation against potential new coronavirus infections. Clinical trials of the combination of AZD1222 vaccine with Sputnik V's human adenoviral vector type Ad26 will begin soon. R-Pharm will be among the organisations funding the trial. ]]> https://biospectrumindia.com/news/57/17817/belarus-first-foreign-country-to-register-sputnik-v-vaccine.html https://biospectrumindia.com/news/57/17817/belarus-first-foreign-country-to-register-sputnik-v-vaccine.html Mon, 21 Dec 2020 18:10:00 +0530 The Russian Direct Investment Fund (RDIF), has announced that Sputnik V, the Russian vaccine against coronavirus, has been registered by the Ministry of Health of the Republic of Belarus, in Eastern Europe. Thus, Belarus has become the first foreign country to officially register the vaccine. Vaccination of volunteers in Belarus began on October 1 as part of double-blind, randomised, placebo-controlled clinical trials of the Sputnik V vaccine funded by RDIF, involving 100 people in eight medical institutions selected as research centres in Belarus. The Ministry of Health of Belarus has also considered the data obtained during the Phase III clinical trials of the vaccine in Russia. On December 14, the Gamaleya National Center and RDIF announced the third and final control point analysis of data received 21 days after administering the first dose to volunteers. The efficacy of the vaccine is 91.4%. Calculation was based on the analysis of data of volunteers (n = 22 714) who received both the first and second doses of the Sputnik V vaccine or placebo at the third and final control point of 78 confirmed cases in accordance with the Phase III clinical trials protocol. The vaccine demonstrated 100% efficacy against severe coronavirus cases. There were 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group. Development of local production of the Sputnik V vaccine in Belarus is currently underway in partnership with RDIF.   ]]> https://biospectrumindia.com/news/57/17809/kaye-introduces-vaccine-temperature-logger-for-cold-chain-market-.html https://biospectrumindia.com/news/57/17809/kaye-introduces-vaccine-temperature-logger-for-cold-chain-market-.html Fri, 18 Dec 2020 17:15:00 +0530 German firm Kaye has been a leader for over 60 years in the Validation and Monitoring of critical process data. With its introduction of the Kaye Log-80 Vaccine temperature logger and KayeTrack Cloud Kaye has applied the same quality principles to ensure the validation and safety of the Cold Chain. This NFC Logger with an external probe allows the precise recording and monitoring of products that are using Dry Ice pellets for Cold Chain shipment and storage. Shipments of vaccines and plasma at -70°C (-94°F) are very sensitive for breaking of the container seal, which will quickly allow the internal temperatures to rise to a critical level. Drugs, vaccines, blood and biological materials are extremely sensitive to temperature variations. They must be kept and transported within a controlled temperature range during storage and transit; these are well-known facts. However, during the recent fight against the COVID-19 Pandemic and with vaccines on the horizon, the demand for 24/7 temperature monitoring within the Cold Chain received another requirement, ultra-low measurements down to -70C. Besides the technology of monitoring at ultra-cold temperatures, the requirement of fast access to the temperature data without disturbing the integrity of the packaging, is foremost. Any removal of the logging device from the package, use of USB and local software applications will impede the process flow. Threshold LEDS allow the recipient to quickly see if the threshold limits have been breached, and with a quick swipe of an NFC device, all data is loaded to a local smartphone application and to the KayeTrack cloud, with corresponding email alerts, emailed PDF reports and GPS location information. The Kaye Log -80 Vaccine Temperature Logger is an extension of Kaye’s Cold Chain solutions. From Thermal Validation, Continuous Monitoring, and Cold Chain Loggers, Kaye is committed to providing accurate, reliable, secure data and systems to help ensure the quality of all Pharma/Biotech products.    ]]> https://biospectrumindia.com/views/57/17769/cnh-industrial-supports-new-covid-19-research-study-by-telethon-foundation.html https://biospectrumindia.com/views/57/17769/cnh-industrial-supports-new-covid-19-research-study-by-telethon-foundation.html Mon, 14 Dec 2020 14:50:00 +0530 The ongoing pandemic emergency has focused the public spotlight on research institutes, pharmaceutical companies, and organizations that can potentially give us the tools to fight COVID-19. Among the many institutes that have sprung into action is the Telethon Foundation, which is once again at the forefront with a team coordinated by the world-renowned medical scientist and academic, Prof Andrea Ballabio. As the director of the Telethon Institute of Genetics and Medicine (TIGEM), an Italian center of excellence for research located in Pozzuoli, near Naples in Italy, Prof Ballabio has launched a targeted study on the SARS-CoV-2 strain, the virus that causes COVID-19. The research project will be structured into three core phases. The first: sequencing the entire viral genome, thereby making it possible to pinpoint the strain and its mutations over time. The second: understanding the change in cells affected by the virus, analyzing their inflammatory process. The third: studying the microbiological species present in swabs to ascertain the possibility of COVID-19 presenting as a co-infection with other pathogens. In this way, the researchers will be able to identify the best pharmacological modulations to combat SARS-CoV- 2. It is also thanks to funding received from external companies that the study will be applied on a large scale. Once again UK-based CNH Industrial is providing active support. Specifically, the company has allocated $100,000 (over €90,000) of its $2 million Solidarity Fund, which is intended to specifically help individuals and communities affected by the virus. The contribution reinforces the longstanding, six-year partnership between CNH Industrial and Telethon, which has seen the level of donations exceed €1,100,000 to date.   ]]> https://biospectrumindia.com/news/57/17766/astrazeneca-to-use-sputnik-v-vaccine-in-clinical-trials-to-boost-own-vaccine-efficacy.html https://biospectrumindia.com/news/57/17766/astrazeneca-to-use-sputnik-v-vaccine-in-clinical-trials-to-boost-own-vaccine-efficacy.html Mon, 14 Dec 2020 00:00:00 +0530 After the Sputnik V vaccine’s clinical trial preliminary results showed its efficacy at above 90 percent, the Russian Direct Investment Fund (RDIF) and Gamaleya Institute on November 23, 2020 offered AstraZeneca to use one of the two components (human adenoviral vectors) of the Sputnik V vaccine in AstraZeneca’s clinical trials. AstraZeneca accepted RDIF’s proposal and will begin clinical trials of its vaccine in combination with Sputnik V’s human adenoviral vector type Ad26 by the end of 2020. This research will allow AstraZeneca’s scientists to study the possibility of boosting their vaccine’s efficacy through the application of this combined approach. Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented: “This unique example of cooperation between scientists from different countries in jointly fighting coronavirus will play a decisive role in achieving a final victory over the pandemic globally. We hope that other vaccine producers will follow our example.” ]]> https://biospectrumindia.com/news/57/17733/retinai-collaborates-with-novartis-for-new-age-solutions-in-ophthalmology.html https://biospectrumindia.com/news/57/17733/retinai-collaborates-with-novartis-for-new-age-solutions-in-ophthalmology.html Tue, 08 Dec 2020 17:10:00 +0530 Swiss firm RetinAI Medical AG announces a multi-year collaboration with Novartis Pharma AG under which RetinAI’s IT solutions and artificial intelligence tools shall be employed to support multiple projects in ophthalmology and digital health. Both companies have previously worked successfully on pilot projects in this disease area. The first project under the new Master Agreement will support a multi-centre international clinical study involving patients with neovascular age-related macular degeneration (nAMD). The study is designed to investigate the influence of optical coherence tomography (OCT) image solutions using artificial intelligence (AI) on the assessment of disease activity. The study will be conducted in several clinical centres in numerous European countries and Canada, involving more than 500 patients. For this study, RetinAI will provide its CE-marked web-based software platform, RetinAI Discovery®, a data management platform to efficiently process data at scale across imaging platforms and devices. Discovery® is used today by professionals to navigate imaging data, compute imaging biomarkers and track changes over time for some of the most common forms of eye diseases. RetinAI’s tools also support diagnostic analyses and clinical workflows as well as patient monitoring & adherence to treatment. Dirk Sauer, Global Development Head, Ophthalmology Franchise, Novartis Pharma AG, sees RetinAI as a strategic partner for advancing eye care through digital innovation: “With previous projects, RetinAI’s services have enabled us to enhance and more efficiently structure retina scans and data collected from our clinical studies. Together with RetinAI, we are working on end-to-end solutions to generate swift and comprehensive disease insights to better treat patients and improve patient outcomes.” Dr Carlos Ciller, CEO, RetinAI, commented: “RetinAI is excited to expand and intensify our partnership with Novartis who is one of the top pharma companies in ophthalmology with deep competence, dedication and focus on digital innovation in eye care. We believe using RetinAI’s technologies to support patients treated with ophthalmic medications will provide enhanced disease insights and create opportunities for more precise treatments.” ]]> https://biospectrumindia.com/news/57/17714/bayer-launches-cell-and-gene-therapy-platform.html https://biospectrumindia.com/news/57/17714/bayer-launches-cell-and-gene-therapy-platform.html Fri, 04 Dec 2020 17:10:00 +0530 Bayer AG has announced the launch of a Cell and Gene Therapy (C&GT) Platform within its Pharmaceuticals division. Through this strategic platform, the company further consolidates its emerging leadership in the field and takes a deeply transformative step for its business. Stefan Oelrich, Member of the Board of Management, Bayer AG and President Pharmaceuticals Division said, “With the establishment of Bayer’s own C&GT Platform our company will propel its presence in this area. This will complement our existing C&GT pipeline which already includes five advanced assets with at least three investigational new drugs annually for the next years.“ In order to build up its presence in C&GT, Bayer is strengthening its internal C&GT capabilities. At the same time, the company is pursuing external strategic collaborations, technology acquisitions and licensing. The goal is to build robust platforms with broad application across different therapeutic areas. Strategically, Bayer focuses on selected areas of C&GT, such as stem cell therapies (with focus on induced pluripotent cells or iPSCs), gene augmentation, gene editing and allogeneic cell therapies in different indications. With the acquisition of BlueRock Therapeutics in 2019 and the recent acquisition of Asklepios Biopharmaceutical, successfully closed on December 1, 2020, the first partners are integrating into Bayer’s C&GT Platform. The role of Bayer’s C&GT Platform is to steer strategically, ensuring the different parts of the organisation complement each other and combining the best in Biotech and Pharma know-how. Wolfram Carius, Head, C&GT Platform, Bayer said, “A dedicated C&GT Platform is vital to accelerate innovation at its source, and to ensure its translation into tangible therapies for patients who have no time to wait.” As part of the Pharmaceuticals Division, the C&GT Platform will combine multiple backbone functions providing support across the entire value chain for the research and development of cell and gene therapies. This includes expertise in Research and Preclinical Development, CMC (Chemistry, Manufacturing and Controls), Clinical Development, Commercial, Strategy Implementation and Project Management. With a high level of flexibility, it will orchestrate operations from science to launch in order to generate and maintain a sustainable pipeline, with the goal to bring breakthrough science to market as fast as possible. ]]> https://biospectrumindia.com/news/57/17697/uk-grants-temporary-authorisation-for-emergency-use-of-pfizer-covid-19-vaccine.html https://biospectrumindia.com/news/57/17697/uk-grants-temporary-authorisation-for-emergency-use-of-pfizer-covid-19-vaccine.html Wed, 02 Dec 2020 15:15:00 +0530 Pfizer Inc and BioNTech SE announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorisation for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorisation following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorisations or approvals. The distribution of the vaccine in the UK will be prioritised according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI). Albert Bourla, Chairman and Chief Executive Officer, Pfizer said, “As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.” Ugur Sahin, MD, CEO and Co-Founder, BioNTech said, “We believe that the roll-out of the vaccination programme in the UK will reduce the number of people in the high-risk population being hospitalised. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The MHRA’s decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95 per cent (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose. Today’s decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2. In July 2020, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorised for emergency use. That agreement was increased to 40 million doses in early October. The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts. Dr Alok Roy, Chair FICCI Health Services Committee and Chairman Medica Group of Hospitals said, “It is a much -awaited need of the time. It is the vaccine which is seen as the best chance for the world to get back to some semblance of normality amid a global pandemic which has killed nearly 1.5 million people and upended the global economy. According to the UK government the vaccine is effective by 70-80%. If this fact is true, then it will be a game changer. However, in India as the temperature is warmer than the European countries we will have to wait till we get approval from the Indian Government.” ]]> https://biospectrumindia.com/news/57/17664/merck-partners-with-siemens-for-digitalization-of-production.html https://biospectrumindia.com/news/57/17664/merck-partners-with-siemens-for-digitalization-of-production.html Thu, 26 Nov 2020 17:40:00 +0530 Merck has announced a collaborative partnership with Siemens for the digitalisation of production. This partnership is to result in the development of a process control system for the modular production of innovative materials and products for the electronics, pharmaceutical and life science industries. A first state-of-the-art, modular plant in this production environment is to be built at the Darmstadt site of Merck by 2022. In the first phase, Merck will invest €10 million in the realisation of this plant. The project is part of a €1 billion investment programme announced last year for global headquarters in Darmstadt up until 2025. It will also be funded by the German Federal Ministry of Economic Affairs and Energy because, thanks to the modular, flexible and efficient technology, the carbon footprint of production can be reduced. Kai Beckmann, CEO Performance Materials and Executive Board member of Merck responsible for the Darmstadt site said. “The time needed from the product idea to market readiness is a critical success factor. The resulting technology platform for standardised, modular production will also be usable in product development in the future. This allows data-based decisions to be made as early as the product development phase and applied seamlessly to the production process.” “We are delighted to be partnering with Merck. This will create new opportunities for us to drive forward modular production and to meet growing requirements for chemical and pharmaceutical processes in our joint development work,” said Eckard Eberle, CEO, Siemens Process Automation. The objective of this collaboration between Merck and Siemens is the joint development of an overall system for automating the modular production of tomorrow. Special software components (Module Type Packages, MTP) form the basis for managing modular production equipment. Using a supervisory control system, known as the process orchestration layer (POL), various production modules can be interlinked to an overall process. In the future, this should occur without additional programming effort – similar to the USB standard for electronic devices. Merck is taking on the establishment of the production infrastructure; Siemens is responsible for the development of POL technology. ]]> https://biospectrumindia.com/news/57/17651/second-interim-data-analysis-of-sputnik-v-vaccine-indicates-95-efficacy-rate.html https://biospectrumindia.com/news/57/17651/second-interim-data-analysis-of-sputnik-v-vaccine-indicates-95-efficacy-rate.html Tue, 24 Nov 2020 18:55:00 +0530 Gamaleya Center and the Russian Direct Investment Fund (RDIF) have announced positive results obtained during the second interim data analysis of the largest double-blind, randomised, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers. Interim trial results have once again confirmed the high efficacy of the Sputnik V vaccine, the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors. Evaluation of efficacy was carried out among volunteers (n = 18,794) 28 days after receiving the first dose (seven days after the second dose) of the vaccine or placebo upon reaching the second control point of the trial in compliance with the clinical trial protocol. The analysis demonstrated a 91.4 per cent efficacy rate for the Sputnik V vaccine. According to the protocol of Phase III clinical trials of the Sputnik V vaccine, its interim efficacy is calculated at three statistically significant representative control points - upon reaching 20, 39 and 78 cases of novel coronavirus infection among volunteers both in the placebo group and in the group that received the vaccine. The second interim analysis of the Sputnik V vaccine efficacy was carried out on the basis of 39 confirmed cases identified in the placebo group (31 cases) and in the vaccine group (8 cases). The ratio of the placebo group to the vaccinated group is 1 to 3. Preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they have already formed a stable immune response, indicates the efficacy rate of the vaccine is above 95 per cent. The next interim data analysis will be conducted upon reaching the third control point of 78 confirmed coronavirus cases among the study participants. Final data analysis will be available by the end of Phase III clinical trials. As of November 24 more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and the second dose of the vaccine at 29 medical centres in Russia as part of the ongoing clinical trials. Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India. ]]> https://biospectrumindia.com/news/57/17649/cost-of-sputnik-v-dose-to-be-less-than-10-for-international-markets.html https://biospectrumindia.com/news/57/17649/cost-of-sputnik-v-dose-to-be-less-than-10-for-international-markets.html Tue, 24 Nov 2020 17:45:00 +0530 The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), announces the cost of the Russian Sputnik V vaccine for international markets will be less than $10 per dose starting from February 2021, which is less than $20 for the two doses necessary to vaccinate one person. Thus, Sputnik V will be two or more times cheaper than foreign vaccines based on mRNA technology with similar efficacy rates. For Russian citizens, vaccination with Sputnik V will be free of charge. Currently, RDIF and partners have launched production of the lyophilized (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius. Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates. The first foreign deliveries of the Russian Sputnik V vaccine will be made to customers in January 2021 based on existing partnerships with foreign manufacturers. Those customers, who have recently submitted their requests, will be able to receive the first batches of the vaccine starting from March 2021. As of November 24, more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and the second dose of the vaccine at 29 medical centers in Russia as part of the ongoing clinical trials. Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India.   ]]> https://biospectrumindia.com/news/57/17638/accenture-ip-paris-to-address-critical-challenges-faced-by-humanity.html https://biospectrumindia.com/news/57/17638/accenture-ip-paris-to-address-critical-challenges-faced-by-humanity.html Mon, 23 Nov 2020 15:55:00 +0530 Accenture and the Institut Polytechnique de Paris (IP Paris) have entered into a five-year strategic partnership to co-develop solutions in response to the major social, economic, and environmental challenges that humanity faces.  Led by Jean-Marc Ollagnier, CEO, Accenture Europe; Olivier Girard, CEO, Accenture, France and Benelux; Eric Labaye, President, Institut Polytechnique de Paris; and Jean-Paul Cottet, Executive Director, École Polytechnique Foundation. Building on IP Paris Interdisciplinary Research Centres, academic and research chair - known as the ‘Chair of Technology for Change’- seeks to promote industry transformation and emergence of innovative business models to foster environmental and social sustainability. Established initially for a period of five years, the Chair of Technology for Change will be an integral part of research and education activities carried out at IP Paris. The Chair will strongly contribute to a certificate, level of which will be based on the students' degree of commitment toward these critical issues. Chaired by Thierry Rayna, Professor, Innovation Management, École Polytechnique and Research Director, Innovation Interdisciplinary Institute (i3, a joint CNRS, École Polytechnique, Mines ParisTech, Télécom Paris research lab), the Chair of Technology for Change will build on expertise of IP Paris' 30 research laboratories and 950 faculty members. Eric Labaye, President, IP Paris, said, "This new long-term partnership between IP Paris and Accenture, bringing together science, technology, and industry expertise, is a major step in our aspiration to train responsible leaders and develop leading-edge interdisciplinary research on the world's most pressing issues." Jean-Marc Ollagnier, CEO, Accenture Europe, said, "The combination of Accenture's technology expertise and deep industry knowledge with the academic excellence of IP Paris will provide the scientific world with a unique opportunity to promote the latest research-based innovation more widely and rapidly and offer businesses easier access to the latest academic breakthroughs.” Olivier Girard, CEO, Accenture France and Benelux, said, "Our collaboration with IP Paris on realising the potential of technology for change is consistent with Accenture's commitment to provide cutting-edge expertise and support the development of tomorrow's talent." The Chair of Technology for Change will organise annual events bringing together representatives of general public, academics, businesses, and policy-makers to focus on these issues. The Chair will also publish a yearly report on latest research surrounding these issues. ]]> https://biospectrumindia.com/news/57/17621/accuray-dhl-to-support-delivery-of-advanced-cancer-treatment-technology.html https://biospectrumindia.com/news/57/17621/accuray-dhl-to-support-delivery-of-advanced-cancer-treatment-technology.html Thu, 19 Nov 2020 12:30:00 +0530 Accuray Incorporated and DHL Supply Chain have entered into a global service parts logistics partnership that will further strengthen the Accuray aftermarket supply chain and expand the company's high quality customer service globally. The goal of the agreement is to provide medical care teams with continual access to the radiotherapy technologies they need to deliver shorter, personalised and effective treatments to patients with cancerous or benign tumours, or neurologic disorders. Mike Hoge, SVP, Global Operations, Accuray said, "We are excited to partner with DHL. The Accuray supply chain and service teams are focused on ensuring our customers have seamless access to our lifesaving equipment.” DHL Supply Chain will establish a dedicated global service logistics network that will span 34 warehousing sites in 16 countries to support Accuray service technicians with increased reliability and enhanced visibility on parts for its advanced radiotherapy systems. Three regional Control Centres in Columbus, Ohio, USA, Budapest, Hungary and Singapore will provide 24/7 support to the network, supervising the global operations and tracking vendor performance. DHL's proprietary software tools, including mySupplyChain will provide live, real-time visibility on inventory in transit for technicians in the field and provide the Accuray supply chain teams with enhanced reporting on performance.     Alongside the inventory management and end-to-end visibility that DHL will provide for the replenishment of forward stocking locations and deliveries to service technicians, it will also manage the reverse logistics of all parts to the Accuray central distribution centre in Columbus, Ohio, USA. DHL's sister divisions, DHL Express and DHL Global Forwarding, will provide support with air freight, ocean freight and time definite international shipping and customs clearance for Accuray outbound and inbound transportation. Jaime Hooker, VP, Service Logistics, DHL Supply Chain Americas said, "Our new partnership represents the perfect opportunity to demonstrate our Service Logistics team's global capabilities and our commitment to keep our service promises anywhere, anytime in support of a truly vital business.” The new partnership will be effective beginning February 2021. ]]> https://biospectrumindia.com/news/57/17613/fda-approves-first-self-testing-at-home-kit-for-covid-19.html https://biospectrumindia.com/news/57/17613/fda-approves-first-self-testing-at-home-kit-for-covid-19.html Wed, 18 Nov 2020 00:00:00 +0530 The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor's offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.   The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit's light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection. ]]> https://biospectrumindia.com/news/57/17608/unilever-identifies-mouthwash-technology-to-reduce-viral-load-of-sars-cov-2.html https://biospectrumindia.com/news/57/17608/unilever-identifies-mouthwash-technology-to-reduce-viral-load-of-sars-cov-2.html Tue, 17 Nov 2020 15:50:00 +0530 Unilever has confirmed that preliminary lab test results show that a mouthwash formulation containing CPC Technology, reduces 99.9 per cent of SARS-CoV-2, the virus that causes COVID-19, after 30 seconds of rinsing. The preliminary test results on SARS-CoV-2 build on existing Unilever research published on the biology research platform bioRxiv, and follow ongoing discussions in the global medical and scientific community around the potential use of mouthwash as an additional measure to reduce the transmission of the virus. Research into the duration of the effect continues, but a previous study on a small group of patients infected with COVID-19 suggest that viral load – the amount of virus particles a person is carrying - may be reduced in the mouth for up to six hours by using mouthwashes containing CPC. These preliminary test results, showing the efficacy of CPC Technology against the SARS-CoV-2 virus, are the latest in a large range of studies that are evaluating the efficacy of mouthwash technology against a number of viruses. In the tests we have done, only CPC Technology has to date shown positive results consistently. Glyn Roberts PhD, Head, Unilever Oral Care R&D, says, “The results of the study are a promising step on our journey to understanding how mouthwashes could help reduce the spread of coronavirus, alongside other preventative measures. Although our research is ongoing, we are sharing the results now so people can consider introducing a CPC-based mouthwash into their daily routine. Professor Iain Chapple, Head, Research for Institute of Clinical Sciences, University of Birmingham, UK, says, “Given its long history of safe use, and wide availability across the world, using a mouthwash that contains CPC Technology could offer a simple, effective, and safe step for people to take alongside existing COVID-19 protection and prevention measures as recommended by their health authorities.” Dr Angela Rasmussen, PhD, Associate Research Scientist, Center of Infection and Immunity, Columbia University School of Public Health, adds, “Other research on the duration of effect of CPC in a mouthwash on bacteria and coronavirus would suggest that the reduction in infectious viral load is likely to be sustained over time.” ]]> https://biospectrumindia.com/news/57/17603/lead-pharma-partners-with-roche-focusing-on-immune-mediated-diseases.html https://biospectrumindia.com/news/57/17603/lead-pharma-partners-with-roche-focusing-on-immune-mediated-diseases.html Mon, 16 Nov 2020 17:50:00 +0530 Lead Pharma, a clinical stage pharmaceutical company, designing and developing innovative medicines for the treatment of immune mediated diseases and cancer based in The Netherlands, has announced that it has entered into a collaboration and license agreement with Roche to develop oral small molecules to treat a broad range of immune mediated diseases. In this single target research collaboration Lead Pharma and Roche will collaborate in research activities up to the selection of a pre-clinical candidate after which Roche will be responsible for further development and global commercialisation. Under the terms of the agreement, Lead Pharma will receive an upfront payment of €10 million, and will be eligible to receive research funding and pre-clinical milestone payments; total potential payments including research, development, regulatory and sales milestones may add up to an aggregate of €260 million, plus royalties on worldwide sales. “Our ambition is to develop life-changing treatments for patients. We are delighted to team up with Roche to pursue this goal”, said Frans van den Berg, Chief Executive Officer, Lead Pharma. “Partnering is a key element of our strategy, this collaboration is yet another validation of the value of Lead Pharma’s innovation power.” Arthur Oubrie, Chief Scientific Officer, Lead Pharma, added: “This is the second project we partner with one of the largest pharmaceutical companies under our Discover, Design and Deliver platform. Our rigorous target selection process, translational screening cascade, and smart medicinal chemistry have been essential to bring this project to this stage. We are keen to collaborate with our colleagues at Roche to bring this novel approach to patients.” “We are committed to advancing innovative science and transformative medicines for people affected by different immune mediated diseases”, says James Sabry, Global Head, Roche Pharma Partnering. “We are looking forward to further building on our expertise in this field and collaborating with Lead Pharma, aiming to make a difference for those patients.”   ]]> https://biospectrumindia.com/news/57/17594/cole-polytechnique-sanofi-launch-health-data-sponsorship-programme.html https://biospectrumindia.com/news/57/17594/cole-polytechnique-sanofi-launch-health-data-sponsorship-programme.html Fri, 13 Nov 2020 00:00:00 +0530 Created to address technological developments and data issues in the medical field, the “Numerical Innovation and Data Science for Healthcare” sponsorship program has been inaugurated, by Olivier Bogillot (President of Sanofi France), Yves Laszlo (Provost of École Polytechnique), and Jean-Paul Cottet (Executive Director of the École Polytechnique Foundation). The research and teaching aspects of the program create a link between machine learning, statistical modeling, and medicine. The use of Artificial Intelligence (AI) for database analysis has gradually been adopted by the medical world in recent years. The “Numerical Innovation and Data Science for Healthcare” sponsorship program seeks to further develop these analytical methods and test their applications. The program will have access to large biological databases in order to help improve the patient experience in the healthcare system, including by developing algorithms to identify patient sub-groups for adapting treatments and better customizing the patient’s experience. The courses of the sponsorship program are integrated into several programs at École Polytechnique such as the Ingénieur Polytechnicien Program or the Master 2 level “Mathematics for Life Sciences” or “Data Science” programs. For example, in the second year of the Ingénieur Polytechnicien Program, several collective scientific projects on the topic will be offered to students, and the courses will cover a variety of topics such as the application of data science techniques to health or the modeling of biological phenomena such as epidemics.   Bringing together key players from the worlds of data science and health, the teaching and research aspects of the “Numerical Innovation and Data Science for Healthcare” sponsorship program will help to serve all parties, by improving the patient experience and developing the use of AI in this field. ]]> https://biospectrumindia.com/news/57/17591/parexel-announces-new-collaboration-for-covid-19-clinical-serology-testing.html https://biospectrumindia.com/news/57/17591/parexel-announces-new-collaboration-for-covid-19-clinical-serology-testing.html Thu, 12 Nov 2020 17:35:00 +0530 Parexel has announced a strategic collaboration with Synexa Life Sciences, a world-leading expert in biomarker and bioanalytical science based in South Holland, and Drawbridge Health, founded in by GE Ventures and GE Healthcare, focused on delivering comprehensive solutions for COVID-19 clinical serology testing. The tripartite collaboration will provide a more streamlined solution for blood sample collection and serology testing for accurate clinical decision-making and improved patient outcomes. Synexa, which has developed a suite of high-performance clinical assays assessing antibodies indicating prior infection or conferring immunity to COVID-19 infection, has identified the OneDraw™ Blood Collection Device by Drawbridge Health as a leading patient-centric, remote sample collection approach for obtaining high-quality blood samples that are stabilised and can be easily shipped for assay analysis. Parexel will offer Synexa Life Sciences’ serology test and Drawbridge Health’s OneDraw™ Blood Collection Device to customers as part of the company’s more than 125 ongoing COVID-19-related clinical trials and projects. “Our strategic collaboration with Synexa and Drawbridge Health will enable Parexel to significantly improve the clinical trial experience for our patients participating in pivotal COVID-19 clinical trials,” said Sy Pretorius, MD, Executive Vice President and Chief Medical & Scientific Officer, Parexel. “Remote sample collection for serology testing removes the various obstacles of in-person collection and improves accessibility for patients in need.” The strategic collaboration comes at a time when data-driven clinical research and accurate population health information are imperative in the management of COVID-19 and in the event of  future pandemics. Paul O’Riordan, CEO, Synexa Life Sciences said, “The OneDraw Blood Collection Device has worked very well with our panel of COVID-19 antibody assays, opening up the opportunity for large-scale distributed sampling in clinical trial or sero-prevalence studies.” “Providing solutions for antibody testing in support of clinical trials and ongoing sero-surveillance studies for COVID-19 is a timely and important step for Drawbridge,” said Lee McCracken, CEO of Drawbridge Health. ]]> https://biospectrumindia.com/news/57/17582/sputnik-v-vaccine-demonstrates-92-efficacy.html https://biospectrumindia.com/news/57/17582/sputnik-v-vaccine-demonstrates-92-efficacy.html Wed, 11 Nov 2020 16:55:00 +0530 The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), has announced that the Sputnik V vaccine, the world’s first registered vaccine against coronavirus (registered on the 11th of August under the emergency use authorization mechanism) created on the well-studied platform of human adenoviral vectors, demonstrated high efficacy. The confirmation is based on the first interim data from the largest double-blind, randomized, placebo-controlled Phase III clinical trials in Russia involving 40,000 volunteers. The trials evaluated efficacy among over 16,000 volunteers who received the vaccine or placebo 21 days after the first injection. As a result of a statistical analysis of 20 confirmed cases of coronavirus, the case split between vaccinated individuals and those who received the placebo indicates that the Sputnik V vaccine had an efficacy rate of 92% after the second dose. Separately, in September the vaccine was first administered to a group of volunteers from the “red zones” of Russian hospitals. The observation of additional 10,000 vaccinated volunteers representing medics and other high-risk groups under the civil use of the vaccine out of clinical trials also confirmed the vaccine’s efficacy rate of over 90 percent. The data received will be published by Gamaleya Center researchers in one of the world’s leading peer-reviewed medical academic journals following an independent valuation of the data by leading epidemiology experts. As of November 11, as part of the clinical trials in Russia’s 29 medical centers, more than 20,000 volunteers were vaccinated with the first dose and over 16,000 volunteers with the first and the second dose of the vaccine. In addition, as of November 11, no unexpected adverse events were identified as part of the research. Currently, Sputnik V Phase III clinical trials are approved and are undergoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India. ]]> https://biospectrumindia.com/news/57/17577/beckman-coulter-launches-covid-19-test-in-countries-accepting-ce-mark-.html https://biospectrumindia.com/news/57/17577/beckman-coulter-launches-covid-19-test-in-countries-accepting-ce-mark-.html Tue, 10 Nov 2020 18:40:00 +0530 Beckman Coulter has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 98.3% sensitivity at 15-30 days post-symptom onset. Beckman Coulter's IgM assay is part of a full suite of testing solutions the company is developing to inform clinical and public health decision making during the COVID-19 pandemic. Beckman Coulter is also developing a SARS-CoV-2 antigen test and quantitative IgG assay. Beckman Coulter's antibody assays and its other planned SARS-CoV-2 offerings run on the organization's award-winning immunoassay analyzers, including the DxI 800 high-throughput analyser, which is capable of processing 200 samples per hour. The full suite of testing solutions, including the IgM & IgG assays currently available and the antigen and quantitative IgG assay under development, provide valuable information in clinical decision making for patients suffering from COVID-19. The Beckman Coulter IgM assay detects antibodies that may emerge earlier in the course of infection and then dissipate, while the IgG test detects antibodies associated with the longer-term immune response. Beckman Coulter's assays can be performed in automated or high-throughput immunoassay formats. The Access SARS-CoV-2 IgM test can also be run on Beckman Coulter's Access 2 analyser, a compact, table-top analyser enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, this test seamlessly integrates into laboratory workflows, making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing. ]]> https://biospectrumindia.com/news/57/17547/mbf-healthcare-partners-promotes-josh-weber-as-md.html https://biospectrumindia.com/news/57/17547/mbf-healthcare-partners-promotes-josh-weber-as-md.html Fri, 06 Nov 2020 09:35:00 +0530 MBF Healthcare Partners, a leading healthcare-focused private equity firm based in Coral Gables, Florida, has promoted Josh M. Weber as the Managing Director. Weber joined MBF in 2017 as the Director of Business Development to lead the firm’s proprietary deal origination strategy. Since joining MBF he has sourced, negotiated, and closed on eleven acquisitions for the firm’s portfolio, including two transformational acquisitions. “Josh’s ability to consistently add value to our companies and their management teams, his strong relationships with founders and intermediaries, along with his strategic insight, have contributed to his continued success at MBF. This promotion reflects Josh’s ability to support multiple initiatives across our portfolio and his enhanced engagement in the oversight of the firm’s operations,” said Miguel “Mike” Fernandez, MBF’s Chairman. ]]> https://biospectrumindia.com/news/57/17540/fda-grants-eun-to-orthos-vitrossars-cov-2-antigen-test.html https://biospectrumindia.com/news/57/17540/fda-grants-eun-to-orthos-vitrossars-cov-2-antigen-test.html Thu, 05 Nov 2020 13:25:00 +0530 Ortho Clinical Diagnostics, a global leader of in vitro diagnostics based in the US, announced that the US Food and Drug Administration (FDA) accepted the company's Emergency Use Notification (EUN) for the new VITROS® SARS-CoV-2 Antigen test, designed to detect active SARS-CoV-2 infection. On October 23, 2020, Ortho submitted an Emergency Use Authorisation (EUA) request to the FDA and achieved CE Mark, allowing test distribution throughout the European Union (EU). With high sensitivity and specificity, Ortho's SARS-CoV-2 antigen test offers exceptional utility for mass-scale testing where appropriate. Ortho's test is a viable alternative to real-time polymerase chain reaction (PCR) testing for individuals with known or suspected exposure to SARS-CoV-2 or who are displaying symptoms suggestive of viral infection. Compared to PCR, Ortho's test may be better able to identify individuals with COVID-19 who are infectious because the test is offered with 100 per cent sensitivity with samples with a CT count of less than 34.  "As COVID-19 cases continue to rise across the globe, Ortho is working to bring to market COVID-19 solutions that help labs meet an ever-growing testing demand and best serve their communities with high-quality, accurate, cost-effective tests that run at high volumes," said Chris Smith, Chairman,  CEO, Ortho Clinical Diagnostics. The VITROS SARS-CoV-2 Antigen test is also the first test to run on Ortho's high-throughput, fully automated VITROS® platform from swabs, rather than the blood and body fluid samples typically run by the systems. Samples for Ortho's SARS-CoV-2 antigen test can be collected in bulk, stored at room temperature for up to 24 hours or 48 hours if refrigerated, and contrary to PCR tests, which can take hours to obtain results, run on Ortho's high-throughput VITROS® Systems, which are capable of processing up to 130 antigen samples per hour. Ortho manufactures its SARS-CoV-2 antigen test in Rochester, New York, and will soon scale up production in Pencoed, UK. The test will be available worldwide in large volumes beginning in early November 2020. ]]> https://biospectrumindia.com/news/57/17541/hitlab-announces-7th-annual-international-innovators-summit.html https://biospectrumindia.com/news/57/17541/hitlab-announces-7th-annual-international-innovators-summit.html Thu, 05 Nov 2020 00:00:00 +0530 HITLAB has announced that the 7th annual Innovators Summit is returning in 2020 as a completely virtual event. HITLAB’s 2020 Innovators Summit will be a unique, international, twenty-four-hour, three-day digital health showcase, delivered to your personal office on December 1st, 2nd, and 3rd. This unique event includes three full days of virtual networking sessions, panel interviews, keynote addresses from industry leaders such as Merck, Johnson & Johnson, Novartis and many more. Each featured event is carefully curated for engaging an international audience of digital health experts. HITLAB is pleased to introduce an international consortium of event sponsors and knowledge partners, reflective of the broad community of digital health experts and enthusiasts who will be attending the event. Joining the 2020 HITLAB Innovators Summit are Merck Global Health Innovation Fund, Livongo, Jacobs Technion-Cornell Institute at Cornell Tech, Ellipsis Health,Rock Health, New York City Economic Development Corporation (NYC EDC), and the Canadian Technology Accelerators (CTA), a global initiative led by the Government of Canada’s Trade Commissioner Service that launched its 2020 cohort of digital health innovators. The 2020 Innovators Summit will welcome distinguished speakers from the World Health Organization, Merck, Novartis,Johnson & Johnson, Columbia Business School, IIT Delhi, SUNY Downstate, Cornell Tech, Ministry of Health & Family Welfare – Government of India, Ellipsis Health, Rock Health and many more. ]]> https://biospectrumindia.com/news/57/17484/sanofi-gsk-to-support-covax-with-200-m-doses-of-covid-19-vaccine.html https://biospectrumindia.com/news/57/17484/sanofi-gsk-to-support-covax-with-200-m-doses-of-covid-19-vaccine.html Wed, 28 Oct 2020 15:25:00 +0530 Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines. Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine if approved by regulatory authorities and subject to contract, to the COVAX Facility. Both Companies intend to contribute to COVAX’s ambition to ensure successful COVID-19 vaccines reach those in need, whoever they are and wherever they live, once they obtain appropriate approvals. The COVAX Facility is part of COVAX, a global collaboration of governments, global health organizations, businesses and philanthropic organizations working to accelerate development, production, and equitable access to COVID-19 vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO and forms the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator. Through the COVAX Facility’s efforts, vaccines will be distributed in participating countries through the WHO’s recently published Allocation Framework, and the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) Values Framework which has begun to frame future guidance on vaccine use. These allocation principles aim to ensure that people in all parts of the world will get access to COVID-19 vaccines once they are available. In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. Sanofi expects the Phase 1/2 study to start in the fourth quarter of 2020, with earliest potential approval in the second half of 2021. ]]> https://biospectrumindia.com/news/57/17451/gilead-receives-fda-approval-for-covid-19-drug-remdesivir.html https://biospectrumindia.com/news/57/17451/gilead-receives-fda-approval-for-covid-19-drug-remdesivir.html Fri, 23 Oct 2020 15:25:00 +0530 The US Food and Drug Administration has approved the antiviral drug Veklury (remdesivir) for use in adult and paediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalisation. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.  This approval does not include the entire population that had been authorised to use Veklury under an Emergency Use Authorisation (EUA) originally issued on May 1, 2020. In order to ensure continued access to the paediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorise the drug's use for treatment of suspected or laboratory confirmed COVID-19 in hospitalised paediatric patients weighing 3.5 kg to less than 40 kg or hospitalised paediatric patients less than 12 years of age weighing at least 3.5 kg.  “This approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic,” said Stephen M Hahn, Commissioner, FDA. The approval of Veklury was supported by the agency's analysis of data from three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19. Important information about using Veklury to treat COVID-19 for its approved use is available in the prescribing information which includes dosing instructions, potential side effects and drug interactions. Possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering. The FDA granted this application Fast Track and Priority Review designations. The Agency also granted this application a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats.   ]]> https://biospectrumindia.com/news/57/17437/ge-healthcare-unveils-first-contrast-enhanced-guided-biopsy-solution.html https://biospectrumindia.com/news/57/17437/ge-healthcare-unveils-first-contrast-enhanced-guided-biopsy-solution.html Thu, 22 Oct 2020 00:00:00 +0530 GE Healthcare has announced the availability of Serena Bright™ in the United States. Serena Bright™ is the industry’s first contrast-enhanced guided biopsy solution and will help empower clinicians and patients in their fight against breast cancer. Receiving U.S. Food and Drug Administration 510(k) clearance in June, this technology allows clinicians to conduct breast biopsy exams with contrast guidance using the same mammography equipment, in the same room and with the same staff as the screening or diagnostic mammogram. Serena Bright may help decrease these delays, allowing follow-up biopsy procedures to be done in a matter of days, rather than waiting several weeks for MRI biopsy. When compared to MRI-biopsy guided therapy, the potential benefits of Contrast Enhanced Spectral Mammography (CESM) biopsy include shortened procedure time and improved overall patient experience. Key to this technology’s application is GE Healthcare’s SenoBright™ HD CESM, a diagnostic breast exam with iodine-based contrast that provides high sensitivity for more accurate breast cancer diagnosis. By highlighting areas of unusual blood flow to localize lesions that need to be biopsied, CESM biopsy – Serena Bright™ – provides excellent image quality to help improve clinical confidence. ]]> https://biospectrumindia.com/news/57/17395/oxford-researchers-offer-covid-19-viral-diagnosis-in-less-than-5-min.html https://biospectrumindia.com/news/57/17395/oxford-researchers-offer-covid-19-viral-diagnosis-in-less-than-5-min.html Fri, 16 Oct 2020 01:05:00 +0530 Scientists from Oxford University’s Department of Physics have developed an extremely rapid diagnostic test that detects and identifies viruses in less than five minutes. The method, published on the preprint server MedRxiv, is able to differentiate with high accuracy SARS-CoV-2, the virus responsible for COVID-19, from negative clinical samples, as well as from other common respiratory pathogens such as influenza and seasonal human coronaviruses. Working directly on throat swabs from COVID-19 patients, without the need for genome extraction, purification or amplification of the viruses, the method starts with the rapid labelling of virus particles in the sample with short fluorescent DNA strands. A microscope is then used to collect images of the sample, with each image containing hundreds of fluorescently-labelled viruses. Machine-learning software quickly and automatically identifies the virus present in the sample. This approach exploits the fact that distinct virus types have differences in their fluorescence labeling due to differences in their surface chemistry, size, and shape. The scientists have worked with clinical collaborators at the John Radcliffe Hospital in Oxford to validate the assay on COVID-19 patient samples which were confirmed by conventional RT-PCR methods. The researchers aim to develop an integrated device that will eventually be used for testing in sites such as businesses, music venues, airports etc., to establish and safeguard COVID-19-free spaces. They are currently working with Oxford University Innovation (OUI) and two external business/finance advisors to set up a spinout, and are seeking investment to accelerate the translation of the test into a fully integrated device to be deployed as a real-time diagnostic platform capable of detecting multiple virus threats. They hope to incorporate the company by the end of the year, start product development in early 2021, and have an approved device available within 6 months of that time.     ]]> https://biospectrumindia.com/news/57/17380/world-bank-approves-12-b-for-covid-19-vaccine-support-in-developing-countries.html https://biospectrumindia.com/news/57/17380/world-bank-approves-12-b-for-covid-19-vaccine-support-in-developing-countries.html Thu, 15 Oct 2020 00:00:00 +0530 The World Bank’s Board of Executive Directors has approved an envelope of $12 billion for developing countries to finance the purchase and distribution of COVID-19 vaccines, tests, and treatments for their citizens.  The financing, which aims to support vaccination of up to a billion people, is part of an overall World Bank Group (WBG) package of up to $160 billion through June 2021 to help developing countries fight the COVID-19 pandemic. It adds new financing to the World Bank’s COVID-19 emergency response programs that are already reaching 111 countries. This financing package helps signal to the research and pharmaceutical industry that citizens in developing countries also need access to safe and effective COVID-19 vaccines.   It will also provide financing and technical support so that developing countries can prepare for deploying vaccines at scale, in coordination with international partners. In implementing the program, the World Bank will support multilateral efforts currently led by WHO and COVAX.   In addition to purchasing COVID-19 vaccines, the WBG financing will also support countries to access to COVID-19 tests and treatments, and expand immunization capacity to help health systems deploy the vaccines effectively.  This includes supply chain and logistics management for vaccine storage handling, trained vaccinators, and large-scale communication and outreach campaigns to reach communities and households.   ]]> https://biospectrumindia.com/news/57/17372/jj-temporarily-halts-covid-19-vaccine-trial.html https://biospectrumindia.com/news/57/17372/jj-temporarily-halts-covid-19-vaccine-trial.html Tue, 13 Oct 2020 00:00:00 +0530 American multinational firm Johnson & Johnson has temporarily paused further dosing in all COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following the guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians. Adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies. As stated by the company, "A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol. As noted in the ENSEMBLE study protocol, Johnson & Johnson has robust mechanisms in place to protect the safety of participants in its clinical trials. While the company informs all study investigators, we typically do not communicate study pauses publicly." The company has also stated that, "We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information." ]]> https://biospectrumindia.com/news/57/17359/lilly-to-supply-covid-19-ab-therapy-for-lmics.html https://biospectrumindia.com/news/57/17359/lilly-to-supply-covid-19-ab-therapy-for-lmics.html Fri, 09 Oct 2020 01:05:00 +0530 Eli Lilly and Company and the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, have entered into an agreement to facilitate access to future Lilly therapeutic antibodies (Abs) under development for the prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus, to benefit low- and middle-income countries (LMICs). Therapeutic antibodies have the potential to prevent and treat COVID-19, reducing the burden on healthcare systems worldwide. This effort to bring equitable access to novel treatments is part of the COVID-19 Therapeutics Accelerator, an initiative launched by the Gates Foundation, Wellcome, and Mastercard to speed the development of and access to therapies for COVID-19. Commercial manufacturing will commence in April 2021 at the FUJIFILM Diosynth Biotechnologies facility in Denmark, where the Therapeutics Accelerator reserved manufacturing capacity in an agreement announced in April.  The Gates Foundation based its decision to collaborate with Lilly for the manufacturing capacity on pre-set criteria, including available information regarding safety, efficacy and ability to implement in lower-resource settings. Lilly has already started the manufacturing technology transfer at risk, in anticipation of regulatory authorization for its antibody therapy. In the interest of making supply of COVID-19 therapeutic innovations available globally as quickly as possible, Lilly will make certain volumes of its antibody therapeutic manufactured in other facilities available to lower-income countries prior to April 2021, pending the timing of regulatory authorization. Lilly and its collaboration partners will continue to be responsible for research and development of the product. Lilly's collaborators, AbCellera Biologics Inc., Shanghai Junshi Biosciences Co., Ltd. and Columbia University have agreed to waive their royalties on the Lilly therapeutic antibodies distributed in low- and middle-income countries as part of this initiative. ]]> https://biospectrumindia.com/news/57/17351/genome-editing-tool-wins-nobel-prize-2020-in-chemistry.html https://biospectrumindia.com/news/57/17351/genome-editing-tool-wins-nobel-prize-2020-in-chemistry.html Thu, 08 Oct 2020 00:00:00 +0530 The Royal Swedish Academy of Sciences has decided to award Emmanuelle Charpentier and Jennifer A. Doudna the Nobel Prize in Chemistry 2020, for the development of a method for genome editing. Emmanuelle CharpentierMax Planck Unit for the Science of Pathogens, Berlin, Germany Jennifer A. DoudnaUniversity of California, Berkeley, USA   Emmanuelle Charpentier and Jennifer A. Doudna have discovered one of gene technology’s sharpest tools: the CRISPR/Cas9 genetic scissors In 2012, Charpentier and Doudna reported “that the Cas9 endonuclease can be programmed with guide RNA engineered as a single transcript to cleave any double-stranded DNA sequence”. Their discovery has led to widespread applications of the CRISPR-Cas9 system as a powerful and versatile tool in genome editing. Coupled with the availability of genome sequences for a growing number of organisms, the technology allows researchers to explore these genomes to find out what genes do, move mutations that are identified as associated with disease into systems where they can be studied and tested for treatment, or where they can be tested in combinations with other mutations. The technology has enabled efficient targeted modification of crops and is currently being developed to treat and cure genetic diseases, for instance by modifying hematopoietic stem cells to treat sickle cell disease and β-thalassemia. Finally, it should be emphasised that the power of the CRISPR-Cas9 technology also raises serious ethical and societal issues. It is of utmost importance that the technology is carefully regulated and used in responsible manner. To this end, the World Health Organization has recently established a global multi-disciplinary expert panel to examine the scientific, ethical, social and 11 (13) legal challenges associated with human genome editing, with the aim to develop a global governance framework for human genome editing. ]]> https://biospectrumindia.com/news/57/17316/navigo-proteins-repligen-achieve-key-milestone-in-developing-affinity-resin-for-covid-19-vaccines-purification.html https://biospectrumindia.com/news/57/17316/navigo-proteins-repligen-achieve-key-milestone-in-developing-affinity-resin-for-covid-19-vaccines-purification.html Thu, 01 Oct 2020 00:00:00 +0530 Navigo Proteins GmbH, a premier protein engineering company specializing in novel affinity ligand development based in Germany, and Repligen Corporation, a US headquartered life sciences company focused on bioprocessing technology leadership has announced their successful development of an affinity ligand targeting the SARS-CoV‑2 spike protein, to be utilized in the purification of COVID-19 vaccines. The program has entered stage two, which is focused on both scaling up manufacturing of this ligand, and on the development and validation of the related affinity chromatography resin. The affinity resin aims to provide end users with a rapid, high purity capture step, decreasing processing time and potentially improving overall yield in the manufacturing of critical COVID-19 vaccines. Repligen anticipates that the final resin product will be commercially available in early 2021. Ralf Kuriyel, Repligen Senior Vice President R&D said, "We are very pleased to report this progress through our partnership with Navigo Proteins, which enables us to rapidly screen and develop commercially viable affinity ligands and resins to support the development and scale-up of COVID-19 vaccines. We look forward to providing additional feedback in the coming months as customers evaluate the potential of this chromatography ligand and resin in COVID-19 applications." Dr. Henning Afflerbach, CEO of Navigo Proteins stated, "This joint endeavor is the logical continuation of our journey to develop platform-based purification solutions for biopharmaceutical downstream processing. Our affinity chromatography technology - Precision Capturing®- is a solution to cope with ever-increasing regulatory and capacity requirements of the entire biopharmaceutical manufacturing industry, including vaccines." With a surge in the demand for global coronavirus vaccine manufacturing capacity, Navigo and Repligen initiated the development of a robust and scalable purification product for COVID-19 vaccine manufacturing. Spike proteins are a characterizing feature of SARS-CoV-2, the virus that causes COVID-19. The spike protein is the primary antigen being evaluated in clinical trials to induce an immune response as a COVID-19 vaccine. Under the strategic partnership, Navigo Proteins and Repligen deployed their expertise in discovery, development, manufacturing and commercialization of customized chromatography affinity ligands and resins to provide a rapid purification solution to support the development and scale-up of potential COVID-19 vaccines. ]]> https://biospectrumindia.com/news/57/17272/fda-sets-up-coe-for-digital-health-.html https://biospectrumindia.com/news/57/17272/fda-sets-up-coe-for-digital-health-.html Fri, 25 Sep 2020 02:10:00 +0530 The US Food and Drug Administration (FDA) has announced that it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence (CoE) is an important step in furthering the agency's overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products. The FDA will continue to build and formalize the coordinating structure and operation of the Digital Health Center of Excellence as part of an effort to modernize digital health policies and regulatory approaches, and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology.  The agency is appointing Bakul Patel as the first director. Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010. The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight.  Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. ]]> https://biospectrumindia.com/news/57/17248/illumina-signs-acquisition-deal-with-grail-for-8b.html https://biospectrumindia.com/news/57/17248/illumina-signs-acquisition-deal-with-grail-for-8b.html Tue, 22 Sep 2020 01:05:00 +0530 Illumina, Inc. and GRAIL have announced that they have entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion upon closing of the transaction. In addition, GRAIL stockholders will receive future payments representing a tiered single digit percentage of certain GRAIL-related revenues. The agreement has been approved by the Boards of Directors of Illumina and GRAIL. Strategic Benefits Increases Illumina’s Directly Accessible Total Addressable Market and Offers Multiple Future Growth Opportunities. GRAIL extends Illumina’s portfolio to include cancer screening, diagnosis and cancer monitoring, creating a portfolio of best-in-class, proprietary tests in each of the major oncology testing application areas. Oncology test utilization and payor coverage is accelerating, and the total NGS oncology opportunity is expected to grow at a CAGR of 27% to $75 billion in 2035. Accelerates Adoption of NGS-Based Early Multi-Cancer Detection Test to Reach More Patients Faster. Illumina plans to leverage its global scale, manufacturing and clinical capabilities to support GRAIL’s commercialization efforts, realize the total addressable market potential and drive significant growth in the clinical value chain. Enhances Illumina’s Position in Clinical Genomics. NGS is poised to revolutionize oncology care, and this acquisition allows Illumina to participate more fully in the high value clinical solutions that are enabled by its NGS sequencing technology. With GRAIL, Illumina will continue as a leading sequencing innovator and partner, while also becoming a proprietary test provider. ]]> https://biospectrumindia.com/news/57/17107/fda-issues-eua-to-abbotts-covid-19-antigen-test.html https://biospectrumindia.com/news/57/17107/fda-issues-eua-to-abbotts-covid-19-antigen-test.html Thu, 27 Aug 2020 00:00:00 +0530 Abbott has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others. Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing. ]]> https://biospectrumindia.com/news/57/17099/astrazeneca-begins-ph-i-trial-for-covid-19-drug.html https://biospectrumindia.com/news/57/17099/astrazeneca-begins-ph-i-trial-for-covid-19-drug.html Wed, 26 Aug 2020 00:00:00 +0530 British–Swedish multinational pharmaceutical firm AstraZeneca has announced that the first participants have been dosed in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19. The trial, called NCT04507256, will evaluate the safety, tolerability and pharmacokinetics of AZD7442. The trial will include up to 48 healthy participants in the UK aged 18 to 55 years and is funded by the Defense Advanced Research Projects Agency (DARPA), part of the US Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. Should AZD7442 prove to be tolerated and have a favourable safety profile in the trial, AstraZeneca will progress it into larger late-stage Phase II and Phase III trials to evaluate its efficacy as a potential preventative and treatment approach against COVID-19. Synthesised in the laboratory, mAbs aim to mimic natural antibodies. The treatment has the potential to be given as a preventative option for people exposed to the virus, and to treat and prevent disease progression in patients already infected by the virus. AZD7442 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the mAbs were optimised by AstraZeneca with half-life extension and reduced Fc receptor binding. The half-life extended mAbs should afford at least six months of protection from COVID-19. ]]> https://biospectrumindia.com/news/57/17094/qiagen-launches-digital-test-for-rapid-detection-of-covid-19.html https://biospectrumindia.com/news/57/17094/qiagen-launches-digital-test-for-rapid-detection-of-covid-19.html Tue, 25 Aug 2020 00:00:00 +0530 QIAGEN N.V. has announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus, which is the case of COVID-19. The launch of this antibody test, which was developed in partnership with the Australian digital diagnostics company Ellume, comes after the submission by QIAGEN of this unique antibody test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). First shipments are planned for late August 2020. A CE-IVD marking for Europe and other markets is planned in the coming weeks. The new serological test has been shown to have sensitivity of 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%). The test is performed on the eHub, a small portable digital device that provides reliable results in 10 minutes. Each eHub can handle up to eight patient samples simultaneously and can perform up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. The same platform is being used for QuantiFERON-TB Access, a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB disease burden. ]]> https://biospectrumindia.com/news/57/17090/fda-issues-eua-for-convalescent-plasma-therapy.html https://biospectrumindia.com/news/57/17090/fda-issues-eua-for-convalescent-plasma-therapy.html Mon, 24 Aug 2020 00:00:00 +0530 The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product. This action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing. The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19. The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence. ]]> https://biospectrumindia.com/news/57/17077/jj-to-acquire-momenta-pharma-for-6-5b.html https://biospectrumindia.com/news/57/17077/jj-to-acquire-momenta-pharma-for-6-5b.html Fri, 21 Aug 2020 00:00:00 +0530 American multinational firm Johnson & Johnson has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. (Momenta), a company that discovers and develops novel therapies for immune-mediated diseases in the US, in an all cash transaction for approximately $6.5 billion. This acquisition provides an opportunity for the Janssen Pharmaceutical Companies of Johnson & Johnson to broaden its leadership in immune-mediated diseases and drive further growth through expansion into autoantibody-driven disease. The transaction will include full global rights to nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody. Nipocalimab gives Janssen the opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation from the U.S. Food and Drug Administration. Momenta’s expertise in FcRn mechanisms is especially important for nipocalimab as it supports and accelerates the development of a medicine designed to target a number of autoantibody-driven conditions across several of Janssen’s established therapeutic areas. Janssen expects nipocalimab to contribute to its goals of achieving above-market growth over the mid and long term. In addition to Momenta’s employees and lead asset nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets. The acquisition was driven by the significant opportunity seen in nipocalimab, along with the scientific capability Janssen is acquiring with the Momenta team. Janssen’s plans for additional assets in the Momenta pipeline will be determined as more data become available and could offer further upside potential. ]]> https://biospectrumindia.com/news/57/17066/regeneron-roche-to-increase-global-supply-of-anti-viral-antibody-cocktail.html https://biospectrumindia.com/news/57/17066/regeneron-roche-to-increase-global-supply-of-anti-viral-antibody-cocktail.html Wed, 19 Aug 2020 00:00:00 +0530 US based Regeneron Pharmaceuticals, Inc. and Swiss firm Roche have announced that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron's investigational anti-viral antibody cocktail, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic.  This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Under the terms of the agreement, each company has committed to dedicate a certain manufacturing capacity to REGN-COV2 each year, and the collaborators have already begun the technology transfer process. Each company will bear its own distribution expenses in their designated territories.  The collaborators will jointly fund and execute the ongoing Phase 3 prevention and Phase 1 healthy volunteer safety studies, as well as any additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the U.S., following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S.  ]]> https://biospectrumindia.com/news/57/17056/sanofi-to-acquire-principia-biopharma-for-3-68b.html https://biospectrumindia.com/news/57/17056/sanofi-to-acquire-principia-biopharma-for-3-68b.html Tue, 18 Aug 2020 00:00:00 +0530 French multinational pharmaceutical firm Sanofi and Principia Biopharma Inc., a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases in the US, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100  per share in cash, which represents an aggregate equity value of approximately $3.68 billion (on a fully diluted basis). The Sanofi and Principia Boards of Directors unanimously approved the transaction. Principia’s Bruton tyrosine kinase (BTK) inhibitors add to Sanofi’s efforts to accelerate and build a portfolio of the next generation of transformative treatments for autoimmune diseases. BTK is present in the signaling pathways of key innate and adaptive cell types of the immune system. Being able to block or disrupt these signaling processes can help in stopping inflammation and tissue destruction related to autoimmune diseases and target some of the underlying pathophysiology.  In 2017, Sanofi formed a collaboration with Principia under which Principia granted Sanofi an exclusive, worldwide license to develop and commercialize BTK inhibitor ‘168 in multiple sclerosis and other central nervous system diseases. ]]> https://biospectrumindia.com/news/57/17057/europes-largest-initiative-to-accelerate-therapy-development-for-covid-19.html https://biospectrumindia.com/news/57/17057/europes-largest-initiative-to-accelerate-therapy-development-for-covid-19.html Tue, 18 Aug 2020 00:00:00 +0530 CARE (Corona Accelerated R&D in Europe) a new consortium supported by the Innovative Medicines Initiative (IMI) public-private partnership has announced its launch to accelerate the discovery and development of urgently needed medicines to treat SARS-CoV-2, the virus that causes COVID-19. With a grant totaling € 77.7 million, CARE is funded by cash contributions from the European Union (EU) and cash and in-kind contributions from eleven European Federation of Pharmaceutical Industries and Associations (EFPIA) companies and three IMI-Associated Partners. CARE is a 5-year project bringing together 37 partners from Belgium, China, Denmark, France, Germany, the Netherlands, Poland, Spain, Switzerland, the UK and the US, and is led by VRI-Inserm (French National Institute of Health and Medical Research, Paris, France), Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Beerse, Belgium), and Takeda Pharmaceuticals International AG, (Zurich, Switzerland). It integrates partners’ COVID-19 projects ongoing since February 2020. As a member of the CARE consortium, Boehringer Ingelheim will be leading the work stream of the consortium focusing on the development of virus neutralizing antibodies. Furthermore the company will provide antiviral molecules from its legacy HIV and HCV portfolio and small molecule candidates from a complete screen of its molecule library. CARE aims to create effective therapies with a positive safety profile for the COVID-19 pandemic (drug repositioning), and develop new drugs and antibodies specially designed to tackle the SARS-CoV-2 virus.  The consortium builds on three pillars: Drug repositioning, by screening and profiling compound libraries contributed by partners with the aim of rapidly progressing molecules to advanced stages of clinical testing. Small-molecule drug discovery based on in silico screening and profiling of candidate compounds directed against SARS-CoV-2 and future coronavirus targets. Virus neutralizing antibody discovery using fully human phage and yeast display, immunisation of humanised animal models, patient B cells and in silico design. ]]> https://biospectrumindia.com/news/57/17032/bayer-to-acquire-kandy-therapeutics-for-450m.html https://biospectrumindia.com/news/57/17032/bayer-to-acquire-kandy-therapeutics-for-450m.html Thu, 13 Aug 2020 14:00:00 +0530 German multinational pharmaceutical and life sciences company Bayer and KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, have announced that Bayer will acquire KaNDy Therapeutics Ltd. to expand its drug development pipeline in women’s healthcare. KaNDy Therapeutics Ltd. recently completed the Phase IIb with NT-814, a first in class, non-hormonal, once-daily, oral neurokinin-1,3 receptor antagonist, publishing positive data for the treatment of frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The start of Phase III clinical trial is expected for 2021. Once approved, the compound could generate peak sales potential of more than Euro 1 billion globally. Under the terms of the agreement Bayer will pay an upfront consideration of $425 million, potential milestone payments of up to $450 million until launch followed by potential additional triple digit million sales milestone payments. Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020. ]]> https://biospectrumindia.com/news/57/17024/nih-enrolling-ph-iii-trials-of-monoclonal-abs-to-prevent-covid-19.html https://biospectrumindia.com/news/57/17024/nih-enrolling-ph-iii-trials-of-monoclonal-abs-to-prevent-covid-19.html Wed, 12 Aug 2020 10:00:00 +0530 Two Phase 3, randomized, placebo-controlled, double-blind clinical trials testing whether experimental monoclonal antibodies (mAbs) can prevent infection by SARS-CoV-2 coronavirus are now enrolling healthy adults at clinical trial sites in the United States. Many of the trial sites and study investigators are part of the COVID-19 Prevention Network(link is external) (CoVPN), recently established by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health. SARS-CoV-2 is the virus that causes coronavirus disease 2019 (COVID-19). The trials are enrolling adults who are at risk of infection due to close contact at work or home to persons with SARS-CoV-2 infection. One trial is being conducted jointly by NIAID and trial sponsor Regeneron Pharmaceuticals of Tarrytown, New York. It will evaluate Regeneron’s investigational double mAb combination, REGN-COV-2, which is designed to bind to two points on the SARS-CoV-2 spike protein and prevent it from entering healthy cells. The trial will enroll approximately 2,000 asymptomatic adults who are household contacts of persons with SARS-CoV-2 infection. A second trial, sponsored by Eli Lilly and Company of Indianapolis, Indiana, and implemented in collaboration with NIAID, will evaluate LY-CoV555, a mAb isolated from a recovered COVID-19 patient by scientists at AbCellera (Vancouver, British Columbia, Canada) and the NIAID Vaccine Research Center, and developed by Eli Lilly and Company. Up to 2,400 participants will be randomized to receive intravenous infusion of either LY-CoV555 or placebo. ]]> https://biospectrumindia.com/news/57/17022/russia-under-scanner-for-launching-covid-19-vaccine-too-fast.html https://biospectrumindia.com/news/57/17022/russia-under-scanner-for-launching-covid-19-vaccine-too-fast.html Tue, 11 Aug 2020 18:00:00 +0530 Recent reports from Russia claim that one of their COVID-19 vaccine candidates has completed all three phases of human clinical trials successfully and is ready for a launch. According to President Vladimir Putin, Russia has become the first country to officially register a coronavirus vaccine. The vaccine has been developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with the Russian Defence Ministry. "We said that on 10 August we started to deliver the vaccine to remote Russian districts: 50 percent of the vaccine for this year’s regular vaccination programme will be delivered by 31 August 2020. The rest will be delivered to the southern regions in September and October, according to the vaccination plan. Under the President’s instructions, we have developed additional materials for vaccination, which are now in the final stage of agreement with the Finance Ministry", said Russian Health Minister Mikhail Murashko. But scientists across the globe have raised concerns about the speed of development of this vaccine, suggesting that researchers might be cutting corners after coming under pressure from the authorities to deliver. The World Health Organisation (WHO) has also stepped in and has urged the country to follow the established guidelines to produce a 'safe and effective vaccine'. Another major concern here is that while scientists are questioning the process of vaccine development, Russia claims that more than 20 countries from around the world have shown interest in producing this vaccine, with India being one of them. "If the news about Russian vaccine is true, then this is the best news for humans. If Russians have crossed the much-awaited threshold, then others will follow too. This is indication that the fight against COVID- 19 will end soon", said Dr Alok Roy- Chair FICCI Health Services Committee & Chairman Medica Group of Hospitals. ]]> https://biospectrumindia.com/news/57/16981/siemens-healthineers-obtains-first-fda-eua-authorization-for-cov2g-ab-test.html https://biospectrumindia.com/news/57/16981/siemens-healthineers-obtains-first-fda-eua-authorization-for-cov2g-ab-test.html Wed, 05 Aug 2020 15:15:00 +0530 German fim Siemens Healthineers has announced that it has received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody (Ab) test. This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 %. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein, specifically S1RBD—a key protein on the surface of the SARS-CoV-2 virus—within their focus. The COV2G antibody test is available on an expansive installed base of analyzers installed in the U.S. and in countries that accept the CE mark worldwide. SARS-CoV-2 Total antibody assay [COV2T] is currently being used by several reputed clinical laboratories and institutions on the company's reliable high throughput automated chemiluminescence analyzers including Atellica Solution, ADVIA Centaur and Dimension EXL series for sero-surveillance. SARS-CoV-2 Total antibody assay [COV2T] that detects both IgM and longer-lasting IgG antibodies is available in India since June 2020. ]]> https://biospectrumindia.com/news/57/16964/agilent-merck-danaher-invest-in-enzymatic-dna-printer.html https://biospectrumindia.com/news/57/16964/agilent-merck-danaher-invest-in-enzymatic-dna-printer.html Wed, 05 Aug 2020 07:30:00 +0530 Paris based DNA synthesis company DNA Script has announced a $50 million extension to its Series B financing, bringing the total investment of this round to $89 million. This oversubscribed round is led by Casdin Capital and joined by Danaher Life Sciences, Agilent Technologies, Merck KGaA, Darmstadt, Germany, through its corporate venture arm, M Ventures — three of the world’s leaders in oligo synthesis — LSP, the Bpifrance Large Venture Fund and Illumina Ventures. Eli Casdin, Founder and Chief Investment Officer of Casdin Capital, will join DNA Script’s Board of Directors. Funding from this investment round will enable DNA Script to accelerate the development of its suite of enzymatic DNA synthesis (EDS) technologies — in particular, to support the commercial launch of the company’s SYNTAX™ DNA benchtop printer. DNA Script will soon begin testing the SYNTAX™ system with a select group of partners, with plans to launch a beta testing program later this year and take orders for the DNA printer by next year. Over the long term, funding from the Series B financing will enable DNA Script to further develop the company’s core enzymatic synthesis technology — in particular, towards the development of new synthesis platforms — as well as to ramp up its commercial and manufacturing capabilities. ]]> https://biospectrumindia.com/news/57/16965/siemens-healthineers-to-acquire-varian-for-16-4b.html https://biospectrumindia.com/news/57/16965/siemens-healthineers-to-acquire-varian-for-16-4b.html Tue, 04 Aug 2020 08:25:00 +0530 German firm Siemens Healthineers AG and Varian Medical Systems, Inc. in the US have announced that they have entered into an agreement, pursuant to which Siemens Healthineers shall acquire all shares of Varian for USD 177.50 per share in cash. This corresponds to a purchase price of approximately USD 16.4 billion. Varian’s Board of Directors unanimously approved the agreement and recommends to the Varian shareholders also to approve the agreement. The acquisition of Varian is expected to close in the first half of calendar year 2021, with closing being subject to approval by Varian shareholders, receipt of regulatory approvals and satisfaction of other customary closing conditions. Since 2012, Siemens Healthineers and Varian have been working together successfully in the strategic “EnVision” partnership to shape the future of cancer treatment, combining Varian’s innovative therapeutic systems and Siemens Healthineers leading imaging technology. This transaction builds on this long-standing partnership to develop improved cancer therapy solutions – from imaging for treatment planning to focused radiation therapy – for efficient workflow and effective, personalized treatment. ]]> https://biospectrumindia.com/news/57/16939/roches-actemra-drug-fails-in-ph-iii-covacta-trial-for-covid-19.html https://biospectrumindia.com/news/57/16939/roches-actemra-drug-fails-in-ph-iii-covacta-trial-for-covid-19.html Thu, 30 Jul 2020 10:00:00 +0530 Swiss firm Roche has announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal. The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services. “People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic." In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. There are also a number of independent trials of Actemra/RoActemra in this setting. Actemra/RoActemra has not previously been studied in, nor approved for, COVID-19 associated pneumonia. ]]> https://biospectrumindia.com/news/57/16931/piramal-pharma-solutions-announces-integrated-development-programme-with-bolt-biotherapeutics.html https://biospectrumindia.com/news/57/16931/piramal-pharma-solutions-announces-integrated-development-programme-with-bolt-biotherapeutics.html Wed, 29 Jul 2020 10:00:00 +0530 Piramal Pharma Solutions, a leading contract development and manufacturing organization (CDMO), has announced that it is providing US based Bolt Biotherapeutics (Bolt) with the supply of both the BDC-1001 ISAC drug substance and the drug product for Bolt’s ongoing Phase 1/2 clinical study in cancer patients. The Piramal Pharma Solutions (PPS) team is applying its integrated drug development model to Bolt’s BDC-1001 for the treatment of patients with HER2-expressed solid tumors. The program encompasses formulation development and ISAC development and manufacture at PPS’ Grangemouth, UK site. The drug substance is then processed into lyophilized, sterile fill-finish vials at PPS’s Lexington, KY, U.S. site. This seamless integration across two PPS sites, which shortens delivery timelines and expedites distribution to clinic, is an example of PPS’ patient-centric philosophy. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, “Bolt’s technology platform has demonstrated significant, positive data in preclinical models, including the development of immunological memory against tumors, and is now in a human clinical trial. The manufacturing of ISACs utilizes essentially the same process as antibody drug conjugate (ADC) manufacturing, enabling us to capitalize on our deep expertise in this space. Our ability to produce these novel ISACs and package them for clinical trials in one efficient, integrated process compresses the timeline of the development of Bolt’s drug. We remain committed to our patient-centric approach and are proud to partner with an industry-leader like Bolt to help reduce the burden of disease on patients.” Nathan Ihle, VP CMC & Quality for Bolt Biotherapeutics, added, “Bolt is a leader in ISAC technology, and our partnership with Piramal Pharma Solutions is important to bring our technology to the clinic.  Piramal’s experience in the manufacture of commercial ADCs provides Bolt with a reliable partner for the development of BDC-1001.” The first cycle of drug substance to drug product manufacturing has been successfully completed through PPS’ integrated program. Additional cycles are in progress, as are further developments that will benefit future indications and new clinical programs. ]]> https://biospectrumindia.com/news/57/16896/piramal-critical-care-partners-with-medivant-healthcare.html https://biospectrumindia.com/news/57/16896/piramal-critical-care-partners-with-medivant-healthcare.html Fri, 24 Jul 2020 08:05:00 +0530 US based Piramal Critical Care (PCC), a business unit of Piramal Enterprises Limited, has announced a strategic partnership with US-based pharmaceutical outsourcing facility, Medivant Healthcare, to help address the severe shortage of injectable drugs in hospitals across the United States. Piramal Critical Care has a marketing and sales team with a strong footprint across the United States, serving nearly all hospitals and surgical facilities nationwide. Through this partnership, PCC and Medivant Healthcare will work together to distribute single-dose injectable drugs in approved states for COVID-19 patients that have fallen dangerously short in supply.  Peter DeYoung, Chief Executive Officer, Piramal Critical Care said, “In the last few months with the disruption caused by the pandemic, we have observed that there has been an acute shortage of certain key injectable drugs in the US. Our partnership with Medivant Healthcare will leverage our robust nationwide US marketing and distribution capabilities that will enable supply of single-dose injectable products to critical and sensitive markets for immediate use.”         "We are happy to enter an important partnership with Piramal Critical Care amidst a global healthcare crisis,” said Founder and Director of Medivant Healthcare, Viraj Gandhi. “Coupling our focus on producing critical shortage medications with PCC's extensive market reach, I am confident that together we will play an integral role in helping hospitals across the country alleviate these acute drug shortages.” ]]> https://biospectrumindia.com/news/57/16858/novartis-introduces-novel-medicine-portfolio-for-covid-19.html https://biospectrumindia.com/news/57/16858/novartis-introduces-novel-medicine-portfolio-for-covid-19.html Fri, 17 Jul 2020 06:50:00 +0530 Swiss firm Novartis has announced a new initiative to help patients in low-income and lower-middle-income countries (LIC; LMIC) access affordable medicines to treat the major symptoms of COVID-19 – a critical need in the absence of a vaccine or curative treatment. Inflammation and respiratory problems linked to COVID-19 can cause severe medical complications and can lead to death in some people, putting immense strain on fragile healthcare systems. The Novartis COVID-19 portfolio includes 15 medicines from its Sandoz division for gastro-intestinal illness, acute respiratory symptoms, pneumonia as well as septic shock. The medicines were chosen based on clinical relevance and availability to ensure demand can be met globally. The medicines will be made available to governments, Non-Governmental Organizations (NGOs) and other institutional customers in up to 79 eligible countries at zero-profit to support financially-strained healthcare systems. Countries will have the flexibility to select the medicines in the portfolio that meet their healthcare needs. Eligible countries must be included on the World Bank’s list of LICs & LMICs. The following medicines are included in the Novartis COVID-19 Response Portfolio: Amoxicillin, Ceftriaxone, Clarithromycin, Colchicine, Dexamethasone, Dobutamine, Fluconazole, Heparin, Levofloxacin, Loperamide, Pantoprazole, Prednisone, Prednisolone, Salbutamol, Vancomycin. ]]> https://biospectrumindia.com/news/57/16851/iqvia-teams-up-with-astrazeneca-to-support-covid-19-vaccine-development.html https://biospectrumindia.com/news/57/16851/iqvia-teams-up-with-astrazeneca-to-support-covid-19-vaccine-development.html Thu, 16 Jul 2020 05:30:00 +0530 Leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry IQVIA has announced its collaboration with AstraZeneca to accelerate development of a potential new vaccine for COVID-19. This joint initiative is part of the U.S. government’s recently announced Operation Warp Speed project. Operation Warp Speed is part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The specific IQVIA and AstraZeneca collaboration will drive faster delivery of clinical studies in the U.S. aimed at demonstrating efficacy of AstraZeneca’s potential COVID-19 vaccine, AZD1222. This initiative includes an expansive subject study, which is expected to begin enrolling participants this summer and will leverage IQVIA’s Virtual Trial solutions including Study Hub. ]]> https://biospectrumindia.com/news/57/16767/avantor-expands-life-sciences-innovation-center-to-address-bioprocessing-needs.html https://biospectrumindia.com/news/57/16767/avantor-expands-life-sciences-innovation-center-to-address-bioprocessing-needs.html Wed, 01 Jul 2020 00:00:00 +0530 Avantor, Inc., a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, has announced the expansion of the company's Bridgewater, N.J. (USA) innovation center. Located close to biotech companies, the site now has nearly double the laboratory and support space. Bioprocessing efficiency that doesn't compromise quality continues to be a top priority for the biopharma industry. At the same time, it's critical to meet increasingly stringent global regulatory standards. "Innovation is about solving customer problems in a rapidly progressing biotechnology environment using contemporary technologies and thinking," said Dr. Ger Brophy, Executive Vice President, Biopharma Production at Avantor. "We collaborate with our customers from their initial discovery and development activities through scale-up and commercialization. Our solutions support industry downward cost pressure by emphasizing supply chain efficiency and improving production process performance."  Avantor's expanded innovation center enhances the Company's R&D support for customized product and bioprocess development, and custom cell and gene therapy reagent manufacturing to support customers' therapeutic products that are developed for advancements in personalized medicine. The site capabilities support new bioprocessing products designed to help minimize risk of contamination and variability for cell and gene therapy (C&GT), monoclonal antibodies (mAbs) and vaccines, including high purity products, single-use solutions and small volume cGMP reagents in single use bags. The site developed Avantor's recently launched novel J.T.Baker® BAKERBOND® PROchievA™ recombinant protein A resin for purifying monoclonal antibodies (mAbs) and other complex molecules. Monoclonal antibodies (mAbs) are used in a wide variety of clinical indications, including asthma, cancer, Crohn's disease, and rheumatoid arthritis, and most recently being tested for use as a treatment for COVID-19 according to the National Institutes for Health (NIH).  The Bridgewater innovation center expansion follows the December 2019 opening of Avantor's innovation and customer support center in Shanghai, China. ]]> https://biospectrumindia.com/news/57/16672/fda-revokes-eua-for-chloroquine-hydroxychloroquine.html https://biospectrumindia.com/news/57/16672/fda-revokes-eua-for-chloroquine-hydroxychloroquine.html Tue, 16 Jun 2020 10:00:00 +0530 The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. The agency determined that the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. This is the statutory standard for issuance of an EUA. The Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services originally requested the EUA covering chloroquine and hydroxychloroquine, and the FDA granted the EUA on March 28, 2020 based on the science and data available at the time. Today, in consultation with the FDA, BARDA sent a letter to the FDA requesting revocation of the EUA based on up to date science and data. Recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit. ]]> https://biospectrumindia.com/news/57/16654/lupin-plushcare-expand-access-to-bacterial-vaginosis-treatment-.html https://biospectrumindia.com/news/57/16654/lupin-plushcare-expand-access-to-bacterial-vaginosis-treatment-.html Fri, 12 Jun 2020 00:00:00 +0530 Lupin Pharmaceuticals Inc., the U.S. based wholly-owned subsidiary of Lupin Limited (Lupin), and PlushCare, a leading virtual doctor's appointment service, have announced an agreement to allow treatment for bacterial vaginosis (BV) in adult women, via the PlushCare virtual platform. PlushCare enables patients to easily book a virtual doctor's appointment, discuss symptoms, receive a prescription for lab testing and treatment, if necessary. Bacterial vaginosis is the most common vaginal infection in the U.S. affecting more than 20 million women between the ages of 14 and 49 annually. Symptoms of BV include an unpleasant or fishy odor, a thin milky greyish-white discharge, or excessive discharge, and sometimes an itching, burning sensation or irritation. However, some women may have no symptoms. BV is treated with a prescription antibiotic, and if untreated, is associated with an increased risk of pelvic inflammatory disease, HIV, and other sexually transmitted infections. "As we navigate through these unprecedented times, we are committed to helping women access treatment, information and resources without delay, in order to maintain their health," said Jon Stelzmiller, President – Specialty, Lupin Pharmaceuticals, Inc. "This partnership allows women suffering from BV the ability to speak to a doctor about their symptoms and potentially get a treatment without leaving their home or delaying their treatment." "With the current healthcare landscape, more people are turning to telehealth than we've ever seen before," said Ryan McQuaid, CEO and Co-Founder of PlushCare. "We are thrilled that Lupin Pharmaceuticals has chosen to partner with us to help women gain access to BV treatment with greater ease." PlushCare is a virtual health platform offering affordable medical services to patients in all 50 states. Having treated over 225,000 patients and diagnosed over 3,500 medical conditions, PlushCare is changing the medical landscape and offering affordable and accessible healthcare to all. ]]> https://biospectrumindia.com/news/57/16563/breakthrough-in-3d-printing-at-high-resolution.html https://biospectrumindia.com/news/57/16563/breakthrough-in-3d-printing-at-high-resolution.html Thu, 28 May 2020 00:00:00 +0530 Manufacturing of cm-sized test specimens for material characterization according to ISO standards has now been achieved for the first time with a technology that allows 3D-printing a feature size of 200 nanometers. The innovation leader for high precision 2-Photon Polymerization (2PP) 3D-Printing, UpNano GmbH, succeeded in printing test specimens from their specific photopolymer on their state-of-the-art NanoOne-printer in sizes and shapes necessary for ISO tests. This achievement is the result of a productive collaboration with the TU Wien (Austria). Previously it was considered impossible to print specimens at the (large) size necessary for ISO tests with a photopolymer and a 2PP 3D-printer that at the same time is able to achieve a resolution in the sub-micrometer range. The proprietary adaptive resolution technology of UpNano in combination with a powerful laser makes this now possible and thus 3D-printing of nm-sized parts using materials characterized according to ISO for industry and academia.High-resolution 3D-printing allows the production of smaller and more precise parts than any traditional manufacturing processes. However, as the potential of this technology becomes more and more apparent, industries as well as research institutions throughout the world demand for reliable information on the qualities of the large number of different materials used for the various printing technologies. This often proves difficult as most standard test methods for material specifications require specimens much larger than high-resolution 3D-printers are able to produce. Now the technology leader for 2-Photon Polymerization (2PP) 3D-printing, UpNano GmbH (Vienna, Austria) succeeded in manufacturing test specimens in the required cm-range with its NanoOne-printer that allows nm-resolution as well. “The lack of standardized material specifications is a serious obstacle for using high-performance 3D-printing in an industrial setting. Decentralized production processes of global industries and warranty legislations are based on standards and norms. If your material or device does not fit in this finely honed system, it might be good for prototypes – but not for series production”, emphasizes Bernhard Küenburg, CEO, the importance of the progress made by UpNano. By addressing this requirement of the technical industry, the company strengthens its position as innovation leader in the emerging market for high-performance 3D-printing – a position gained by selling the fastest 2PP 3D-printing system that offers up to a hundred times faster throughput for short production cycles than other systems. PRINTING LIVING CELLSThe capabilities of the NanOne-system do not only meet requirements of technical industry but of research institutions, too. Just recently UpNano sold a complete system to the MedUni Vienna (Austria). Here the system will be used for various purposes in research. The possibility of printing delicate structures needed by biomedical research such as scaffolds, membranes or microchannels is facilitated by the so called UpBio photopolymer. This special resin permits 2 PP 3D-printing in the presence of living embedded cells and thus is ideal for biomedical research.By attending to the needs of industry and research alike, UpNano continues to push the possibilities and capabilities of 2PP 3D printing further and further. Focused in-house research in cooperation with the TU Wien as well as listening closely to the needs of industry will further strengthen the position of the innovation leader in the market. ]]> https://biospectrumindia.com/news/57/16483/roche-brings-blood-gas-digital-solution-for-covid-19.html https://biospectrumindia.com/news/57/16483/roche-brings-blood-gas-digital-solution-for-covid-19.html Tue, 19 May 2020 06:10:00 +0530 Swiss firm Roche has announced the CE mark availability of Roche v-TAC, a new digital diagnostic solution that allows clinicians to obtain results for arterial blood gas values from patients with respiratory or metabolic abnormalities via a simpler, less invasive venous puncture through the use of a digital algorithm.Blood gas analysis is typically used in hospital point of care (POC) settings, where quick and accurate results are needed. This includes emergency rooms, intensive care units and operating rooms. The analysis provides clinicians with information about a patient’s pulmonary function and acid‐base status, both of which are essential to make a diagnosis, provide treatment and monitor progress.A traditional blood gas test requires the collection of an arterial blood sample, which can be a painful experience for the patient since most arteries lie deeper in the tissue than veins and have a thicker wall to be punctured. This procedure is usually carried out by medical doctors or specially-trained staff. Through the Roche v-TAC digital solution, staff without specific training to draw arterial blood samples are now able to withdraw a venous blood sample instead and digitally convert these values into arterial blood gas values, which can help free up specialist healthcare staff to other tasks. Roche’s v-TAC is fully integrated for use with Roche’s cobas b 123 POC and cobas b 221 systems using the Roche cobas infinity POC solution.“In an emergency situation such as the COVID-19 pandemic, Roche v-TAC could also help healthcare professionals to assess disease severity faster in patients and closely monitor potential deterioration in patients with respiratory compromise,” said Thomas Schinecker, CEO Roche Diagnostics. “Digital tools based on clinical algorithms like Roche v-TAC can help improve and simplify delivery of care in emergency situations faster and where it is most needed.”Roche acquired the v-TAC technology at the end of March with the acquisition of Obi Medical Aps, a privately-held company based in Hadsund, Denmark that focuses on developing disruptive blood gas testing technology. ]]> https://biospectrumindia.com/news/57/16474/boehringer-ingelheim-expanding-immuno-oncology-portfolio.html https://biospectrumindia.com/news/57/16474/boehringer-ingelheim-expanding-immuno-oncology-portfolio.html Sat, 16 May 2020 20:00:00 +0530 German firm Boehringer Ingelheim has announced the acquisition of Canada based Northern Biologics Inc., a wholly owned subsidiary of Northern LP. By acquiring this entity, which focuses on therapeutic antibodies targeting the tumor microenvironment, Boehringer Ingelheim is now positioned at the forefront of the stromal biology space - an emerging area in cancer immunology. The seller will retain the Northern Biologics name and its subsidiaries will continue to drive certain preclinical efforts on one of the programs, while Boehringer Ingelheim will be responsible for clinical, regulatory and commercial development of the acquired programs.  The total transaction includes an upfront payment, milestones and other consideration payments. The first program, now in late preclinical development, is an antibody inhibitor of Periostin, a secreted matricellular protein overexpressed in the immunosuppressive stroma microenvironment of many solid tumor types. Targeting these stromal cells can help turn previously ‘cold’ tumors – non-reactive, immunologically inactive tumors – to ‘hot’ tumors – those that are susceptible or accessible to host immune system attack. The antibody program targeting Periostin has emerged as a promising therapy to overcome stromal mechanisms of immune exclusion and suppression.  The second program targets a key regulator of myeloid cells that is important for enhancing anti-tumor T-cell function. Targeting myeloid cells is a focus area of research and clinical development for Boehringer Ingelheim and the acquired program offers combination opportunities across Boehringer Ingelheim’s portfolio. “This acquisition provides Boehringer Ingelheim with two complementary assets to our existing cancer immunology portfolio and supports our strategy to target ‘cold’ tumors with synergistic combination approaches,” said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim. “Driving innovation in tumor stroma and myeloid cell biology is yet another example of how we are ‘Taking Cancer On’ by exploring first-in-class approaches to provide the best treatment options for cancer patients.”  “We are grateful for this relationship with Boehringer Ingelheim, which accelerates these assets into the clinic,” said Philip Vickers, Ph.D., President and CEO of Northern Biologics. “I am proud of our team, which discovered and advanced these novel compounds in the field of tumor stroma and myeloid cell biology.” Northern Biologics retains rights to its lead asset, MSC-1, an anti-LIF 1 antibody that recently successfully completed Phase 1 clinical trials.  This acquisition positions Boehringer Ingelheim as a leader in the field of stromal targeting biology and, along with a series of strategic acquisitions and collaborations over the past two years, further strengthens the company’s broad and diverse oncology pipeline. By combining its world-class, in-house research and development with that of highly innovative biotechnology companies, Boehringer Ingelheim is developing innovative cancer immunology therapies and accelerating the delivery of the next generation of cancer treatments. ]]> https://biospectrumindia.com/news/57/16466/childhood-vaccines-reduce-antibiotic-consumption-in-lmics.html https://biospectrumindia.com/news/57/16466/childhood-vaccines-reduce-antibiotic-consumption-in-lmics.html Fri, 15 May 2020 16:50:00 +0530 Researchers at CDDEP, Berkeley, and Imperial College London assessed the impact of PCVs and rotavirus vaccines on antibiotic consumption among children in low- and middle-income countries. Antimicrobial resistance (AMR) poses a serious threat to the health and economic well-being of countries worldwide. This burden disproportionately impacts low- and middle-income countries (LMICs) where antibiotic overuse exists alongside lack of access to such drugs. Acute respiratory infection (ARI) and diarrhea are the leading causes of antibiotic use in LMICs, where a lack of diagnostic tools may lead to inappropriate antibiotic prescriptions based on suspicion.  Vaccines have been hypothesized to reduce the burden of AMR by preventing infections that lead to antibiotic consumption, although evidence assessing this relationship is lacking. Researchers at CDDEP, University of California, and Imperial College London assessed the impact of vaccines recently implemented in the World Health Organization’s Expanded Programme on Immunization on antibiotic consumption among children under five in LMICs. They focused on the effect of the pneumococcal conjugate vaccines (PCVs) 10 and 13 and live attenuated rotavirus vaccines to prevent the main causes of ARI and diarrhea, respectively. The researchers used data from large-scale household surveys to quantify the incidence of antibiotic consumption among children prevented by PCV10/13 and rotavirus vaccines by calculating the following: The incidence of antibiotic treatment for ARI and diarrhea among children in LMICs The effectiveness of the PCV and rotavirus vaccines in preventing antibiotic use associated with ARI and diarrhea The proportion of antibiotic-treated ARI and diarrhea cases attributable to vaccine-serotype S. pneumoniae and rotavirus, respectively The study found that PCVs and the rotavirus vaccine are associated with a 19.7 percent (95% confidence interval, 3.4–43.4 percent) and 11.4 percent (4.0–18.6 percent) reduction in cases of antibiotic-treated ARI and diarrhea, respectively, among children 24-59 months old. Translated to India, this represents a major reduction in the number of infections. The vaccines prevent an estimated 23.8 million and 13.6 million cases of antibiotic-treated ARI and diarrhea per year among children in LMICs under current vaccination coverage levels. Universal coverage of these vaccines could prevent an additional 40 million cases of antibiotic-treated illnesses. Results of this study indicate that vaccines against S. pneumoniae and rotavirus significantly reduce antibiotic consumption among children in LMICs, and support vaccination as a global strategy to combat AMR. Ramanan Laxminarayan, senior author and CDDEP director said, “Despite the current attention on Covid-19, the longer-term infectious disease threat that India faces, is on antibiotic resistance.  This study, the first of its kind, shows that scaling up the PCV and rotavirus vaccines are among the most effective methods to reduce antibiotic consumption in a country like India.” ]]> https://biospectrumindia.com/news/57/16465/local-epidemiology-should-guide-focused-action-in-new-normal-covid-19-world-who.html https://biospectrumindia.com/news/57/16465/local-epidemiology-should-guide-focused-action-in-new-normal-covid-19-world-who.html Fri, 15 May 2020 16:40:00 +0530 Amid rising cases of COVID-19 and as countries in WHO South-East Asia Region ease lockdowns in a graded manner, WHO has announced careful assessment of local epidemiology should guide future actions to combat the virus. Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia said, “Countries in the Region must continue to take evidence-informed action and conduct careful risk assessments while winding back public health and social measures. The focus should be on local epidemiology of COVID-19, to identify hot-spots and clusters, and the capacity of systems and responders to find, isolate and care for cases, and quarantine contacts.” The Regional Director who held a virtual technical briefing meeting with senior health officials of 11 Member countries for the forthcoming virtual 73rd World Health Assembly session, said that despite the Region being the first to get an importation of COVID-19 on 13 January in Thailand, early and aggressive measures by member countries, including unprecedented physical distancing measures, have helped keep the number of cases low as compared to other parts of the world. With countries now preparing to transition towards a “new normal” in which social and economic life can function, continued whole-of-government and whole-of-society approach would be critical, said Dr Khetrapal Singh. As of this morning the Region has approximately 122,000 cases and 4,000 deaths due to COVID-19. Countries in the Region are in various transmission scenarios and the cases are increasing.  In every transmission scenario, the core public health measures remain – rapidly detect, test, isolate, care and trace contacts, the Regional Director said, adding that moving forward we need to scale up these measures. Prone to natural disasters, the Region have been prioritizing strengthening emergency response capacities as a flagship programme since 2014. In September 2019 member countries adopted Delhi Declaration on Emergency Preparedness in the South-East Asia Region reaffirming their continued commitment to disaster risk reduction through multi-hazard approach to emergency preparedness. The declaration called for “four I’s”: identify risks; invest in people and systems for risk management; implement plans and inter-link sectors and networks. “The declaration was timely and we are seeing this approach put to use across the Region,” she said. The Region with one-fourth of the global population and disproportionate disease burden, however, continues to be vulnerable in view of high population densities, mega-urban slums, migrant groups, socio-economic drivers impacting compliance to physical and social distancing, in addition to the global shortage of essential medicines and commodities. In the coming period all efforts should be made to control and suppress spread of COVID-19, strengthen and maintain health services, and support each other to stay safe, healthy and well. “There can be no illusions: We are in this for the long haul,” Dr Khetrapal Singh said. ]]> https://biospectrumindia.com/news/57/16361/moderna-inks-pact-with-lonza-to-manufacture-covid-19-vaccine.html https://biospectrumindia.com/news/57/16361/moderna-inks-pact-with-lonza-to-manufacture-covid-19-vaccine.html Mon, 04 May 2020 05:00:00 +0530 US based Moderna, Inc., a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, and Lonza Ltd. have announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future. Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza U.S. in July 2020. Over time, the parties intend to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide assuming the currently expected dose of 50 µg. The manufacturing facilities at Lonza complement Moderna’s ongoing U.S. manufacturing efforts, which continue to ramp up to prepare for the further clinical development and commercialization of mRNA-1273. On April 27, 2020, Moderna  announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Phase 2 and late stage studies of mRNA-1273 if supported by safety data from the Phase 1 study.  Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each subject will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. The company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Participants will be followed through 12 months after the second vaccination. ]]> https://biospectrumindia.com/news/57/16359/research-claims-smokers-less-vulnerable-to-coronavirus.html https://biospectrumindia.com/news/57/16359/research-claims-smokers-less-vulnerable-to-coronavirus.html Fri, 01 May 2020 17:55:00 +0530 A review of scientific studies has added more evidence to the claim that people who smoke might have a lower risk of becoming seriously ill with COVID-19. University College London academics looked at 28 papers and found the proportions of smokers among hospital patients were 'lower than expected'. One public health professor said there was 'something weird going on with smoking and coronavirus' and experts are struggling to explain the connection. One of the studies showed that in the UK the proportion of smokers among COVID-19 patients was just five per cent, a third of the national rate of 14.4 per cent. Another found in France the rate was four times lower. In China, a study noted 3.8 per cent of patients were smokers - despite more than half of the population regularly smoking cigarettes. When smokers do get diagnosed with the virus, however, they appear to be more likely to get so sick that they need ventilation, two studies in the review showed. Researchers admit that hospitals are probably not recording patients' smoking status properly, potentially because they are too busy, patients are too sick to answer, or because people lie in their answers. But they are struggling to knock down mounting evidence suggesting an apparent protective effect given by cigarettes, which one expert admitted was 'weird'. A review of five early studies on the topic last month made the exact same conclusions - that smokers may avoid serious infection, but their outlook is worse if they do. Twenty-two of the studies were conducted in China, three in the US, one in South Korea, one in France and one was an international study using mostly UK data.  Only three of them split smoking status into three parts - current, former and never smokers. The other 25 only reported current and former smoking status, but there were questions around how many of the rest had never smoked, and how many had missing data. Notwithstanding these uncertainties, compared with national prevalence estimates, recorded current and former smoking rates in the included studies were generally lower than expected. Data from the US suggests that smokers appear to be less likely to test positive for SARS-CoV-2 compared with never smokers. Rather than this reflecting likelihood of catching the virus in the first place, it is more likely to point to someone's risk of becoming so ill they have to go to hospital. Most of the countries involved in the studies did almost all of their testing in hospitals. But the researchers noted that smokers were more likely to be tested, possibly because their symptoms, like a cough, are more obvious due to their habit. 'We would therefore caution against drawing any conclusion as to whether smokers are at increased risk of SARS-CoV-2 infection at this early stage,' the UCL team said. Two high quality studies provided zero evidence that the 657 current or former smokers with the virus were at a higher risk of ending up in hospital. But among 1,370 people hospitalised across two other studies, smokers were 43 per cent more likely to see their disease progress to become severe than those who had never smoked. Three studies reported death rates from COVID-19 but there 'did not appear to be a notable difference' between smokers and non-smokers. However, the studies 'did not explicitly state never smoking status', the authors said. They implied that patients who died may have smoked in the past, but this was not clearly recorded by a doctor. The authors concluded there is a lack of evidence that meets a high standard to definitely say whether or not smokers are at higher risk of catching the coronavirus, or having poor outcomes. Commenting on the matter, Linda Bauld, a professor of public health at the University of Edinburgh, said 'there's something weird going on with smoking and coronavirus'. She told Good Morning Britain: 'We know for decades that smoking is linked to a higher risk of developing respiratory conditions and also people who smoke have poorer outcomes. 'And we've still got around seven million smokers in the UK, [the] leading preventable cause of death. 'However, my colleagues at UCL... what they’ve found is there are surprisingly few smokers in those studies who’ve developed coronavirus. 'In one French study, four times as many non-smokers got the virus and developed COVID-19 compared to smokers.  'There is a potential biological explanation for this.' Professor Bauld said the way the virus enters the body may be blocked by effects of nicotine - the addictive compound found in tobacco. The coronavirus enters cells inside the body via structures called ACE-2 receptors, which coat the surface of some cells, including in the airways and lungs. The numbers of ACE-2 receptors someone has are thought to vary depending on genetics and some evidence suggests that they are higher in smokers. This could, in theory, put them at a higher risk of contracting the coronavirus. However, the virus is known to cause lung damage by depleting the numbers of ACE-2 receptors, so the fact that smoking increases them could reverse the effect and prevent harm to the lungs. On the other hand, other studies show that nicotine reduces the action of the ACE-2 receptor, suggesting smokers are less likely to catch the virus in the first place. Professor Bauld said, 'It's plausible that smokers are less likely to develop the condition potentially because of nicotine. Importantly in that UCL review where smokers did develop COVID-19, their outcomes are far worse.' A leading infectious disease expert at University College London, Professor Francois Balloux, has also previously said there is 'bizarrely strong' evidence smoking may be protective. What did the studies from each country show? The studies conducted in hospitals in China showed that 3.8 to 17.6 per cent of COVID-19 patients were current smokers and fewer than five per cent were former smokers. However, 2018 data shows more than half the population of the country are current smokers (50.5 per cent of men and 2.1 per cent of women). And almost one in 10 of non-smokers in China are former smokers (8.4 per cent of men and 0.8 per of women). In the US studies, 1.3 to 27.2 per cent were current smokers, in contrast to a smoking prevalence of 13.8 per cent in 2018. And 2.3 to 30.6 per cent were former smokers, compared with the 20.9 per cent of former smokers across the states. In the South Korean study, 18.5 per cent were current smokers, which almost matches the smoking prevalence of 19.3 per cent in 2016. In the included study conducted in France, 7.1 per cent were current smokers, 6.1 per cent of whom were hospitalised. But much higher smoking rates are recorded in the population -  32 per cent. However the results were different for former smokers, of which there are 31.4 per cent in France. A much higher 59.1 per cent of COVID-19 patients were former smokers. In the international study with participants predominantly from the UK in a hospital setting, five per cent were current or former smokers. This compares with a current and former smoking prevalence of 14.4 and 25.8 per cent in England in 2018, 'suggesting a lower than expected proportion of current and former smokers in the included study'.  Typically, smokers are at a heightened risk of infection because the tiny hairs inside the airways and lungs, which help move pathogens and mucus away, are often damaged by the toxic chemicals in cigarette smoke. In theory, this would put smokers at a disadvantage if they catch coronavirus, considering the disease leaves patients unable to get enough oxygen into the bloodstream due to lung inflammation. Research has shown smokers do face a greater risk of suffering complications - but others suggested they were less likely to be infected in the first place. That was the finding of the first large review of evidence by a team led by Harvard's Dr Constantine Vardavas, Greece, published in the journal Tobacco Induced Diseases. The team reviewed five studies in March and said so far say the proof smoking raises the risk of coronavirus is limited, after finding as little as 1.4 per cent of hospitalised patients were smokers. The group of experts even admitted warnings made by health chiefs were based mainly on assumptions, given the known infection risks of smoking. A study published earlier this month by scientists in New York and Athens looked at 13 Chinese studies that had registered smoking as a precondition and found that the number of smokers across the whole sample of 5,300 patients was 6.5 per cent. It's an astonishingly small number in country where half of all men still smoke. Another study, by America's Centers for Disease Control of over 7,000 people who tested positive for coronavirus, found that just 1.3 per cent of them were smokers - against the 14 per cent of all Americans that the CDC says smoke. The study also found that the smokers stood no greater chance of ending up in hospital or an ICU. Governments in both the UK and US urge people to stop smoking to protect themselves from the virus as a matter of precaution, while scientists admit there is no clear proof cigarettes can worsen the disease. Recently, world-famous artist David Hockney wrote a letter to the Daily Mail saying: 'I used to joke that being a smoker in Malibu was the equivalent of being a non-smoker in Pasadena. They used to have very bad pollution there. 'Could it not be that smokers have developed an immune system to this virus? With all these figures coming out, it’s beginning to look like that to me.'  The British artist, now 82 and living in France, adds 'I'm serious' and has in the past revealed he's smoked for more than 60 years but still considers himself healthy. Meanwhile, a British NHS doctor claimed today that Prime Minister Boris Johnson was so severely affected by coronavirus because he is 'significantly' overweight. Consultant cardiologist Dr Aseem Malhotra said there is a ten-fold risk of death from the disease - which has so far killed more than 20,000 Britons - if patients are obese. He pointed out that other 'slimmer' members of the Cabinet - like Health Secretary Matt Hancock - recovered much more quickly and were not hospitalised. Other top Government officials and advisers who have recovered from the virus include Chief Medical Officer Chris Whitty, Chief Adviser Dominic Cummings and Health Minister Nadine Dorries.   ]]> https://biospectrumindia.com/news/57/16295/who-releases-technical-specifications-for-bp-measuring-devices.html https://biospectrumindia.com/news/57/16295/who-releases-technical-specifications-for-bp-measuring-devices.html Thu, 23 Apr 2020 15:30:00 +0530 Hypertension is the leading modifiable risk factor for serious diseases such as cardiovascular disease (stroke and ischemic heart disease), pre-eclampsia and eclampsia (a major killer of pregnant women and a cause of poor fetal growth and stillbirth) and chronic kidney disease. Globally, over one billion people have hypertension and the problem is compounded in India with one in three adults having hypertension. The risk of complications and deaths due to COVID-19 are significantly higher among those with comorbid conditions such as cardiovascular conditions and diabetes. Accurate blood pressure measurement is essential to identify and properly manage individuals with hypertension, many who are hypertensive are not aware of their condition hence labelled a silent killer. Hypertension is a significant marker of other diseases like chronic kidney disease and diabetes, responsible for co-morbidities that is the cause of death among several COVID-19 patients worldwide. Lack of access to accurate, affordable BP devices is a significant barrier to proper medical care, particularly in low-resource settings. There is also a frequent concern about the accuracy of automated BP devices that have not been validated which is more worrisome given the fact that people with significant co-morbidities at high risk of COVD-19 must accurately monitor their BP at home. According to studies, 70 per cent of readings from home blood pressure monitors are unacceptably inaccurate, which could have serious implications for people relying on them to make informed health decisions. Recently, there has been a move to regulate the digital thermometer industry which are now required to come with quality assurance certificates.   The World Health Organization (WHO) has now developed technical specifications for Blood Pressure measuring devices, which was released worldwide. The document updates WHO’s 2005 guidance on blood pressure measuring devices (BPMDs). It also responds to concern about the lack of accurate, good-quality devices, especially in low-and middle-income countries (LMIC) through technical consultation and expert review. The focus of the publication is on automated non-invasive blood pressure measuring devices with cuff, including characteristics, regulatory requirements and standards, calibration as well as maintenance. It also provides guidance on procurement, decontamination and decommissioning. Additional elements on accurate measurement of BP and training for personnel are included. Hopefully, these specifications can now guide the industry as well as the consumers to select and use the right digital blood pressure equipment for at home monitoring. Oommen John from The George Institute India, who was involved in the development of these WHO technical specifications, said “Given the COVID-19 situation these specifications are extremely timely as many with cardiovascular and other comorbidities are required to self-monitor at home. Health workers, clinicians and the general population are likely to benefit from this resource, as it may improve their understanding of BP devices and their capacity to measure BP accurately.   ]]> https://biospectrumindia.com/news/57/16240/bill-melinda-gates-foundation-expands-commitment-to-covid-19-response.html https://biospectrumindia.com/news/57/16240/bill-melinda-gates-foundation-expands-commitment-to-covid-19-response.html Fri, 17 Apr 2020 07:15:00 +0530 The Bill & Melinda Gates Foundation has announced an expansion of its funding for the global response to COVID-19. The increase includes an additional $150 million of grant funding plus a commitment to leverage the resources of the foundation’s Strategic Investment Fund, which could be deployed to catalyze the rapid procurement of essential medical supplies and help life sciences companies secure financing to produce COVID-19 products.  In announcing the funding, the foundation called on world leaders to unite in a global response to COVID-19 to ensure equitable access to diagnostics, treatments, and vaccines. Melinda Gates, Gates Foundation, co-chair said, “It is increasingly clear that the world’s response to this pandemic will not be effective unless it is also equitable. We have a responsibility to meet this global crisis with global solidarity. In addition to contributing to the development of diagnostics, therapeutics, and vaccines, these funds will support efforts against COVID-19 in low-and-middle-income countries, where local leaders and healthcare workers are doing heroic work to protect vulnerable communities and slow the spread of the disease.” The foundation’s new $150 million commitment will fund the development of diagnostics, therapeutics, and vaccines, as well as new efforts to provide partners in Africa and South Asia with resources to scale their COVID-19 detection, treatment, and isolation efforts. The foundation will also leverage a portion of its $2.5 billion Strategic Investment Fund, which uses a suite of financial tools to address market failures and incentivize private enterprise to develop affordable and accessible health products. These funds, which can include equity investments, loans, and volume guarantees, will be used to help health systems in low- and middle-income countries (LMICs) facilitate the rapid procurement of personal protective equipment for health care workers, COVID-19 diagnostics, oxygen therapeutics, and other essential medical supplies.  Any financial returns generated by the Strategic Investment Fund are re-invested in Gates Foundation philanthropic programs.  The funding announced today builds on the $100 million the foundation has committed to date to support the global response, as well as $5 million in resources to support public health agencies and frontline response organizations in the greater Seattle region. Initial foundation funding has helped to kick-start the search for COVID-19 diagnostics, therapeutics, and vaccines; enhanced virus detection capacity in Africa; and contributed to the response in China. The foundation has also directed its programmatic technical expertise to support multilateral, national, and sub-national responses to the pandemic. Bill Gates, foundation co-chair said, “COVID-19 doesn’t obey border laws. Even if most countries succeed in slowing the disease over the next few months, the virus could return if the pandemic remains severe enough elsewhere. The world community must understand that so long as COVID-19 is somewhere, we need to act as if it were everywhere. Beating this pandemic will require an unprecedented level of international funding and cooperation.”  While there is not yet global consensus on the total resources required to turn back COVID-19, the figure is more than any one contributor will bear. A coordinated, international effort bringing together all sectors will be required to mobilize the billions in funding needed in the months ahead. Institutions such as the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, The Vaccine Alliance are in place to coordinate the development and delivery of COVID-19 vaccines, but they require an influx of new resources to do so. Other organizations such as the World Health Organization (WHO), national governments, and private companies will need to be involved in funding the at-risk manufacturing of vaccine candidates and deciding how to ensure equitable access to essential products for populations worldwide. Mark Suzman, foundation CEO said, “This pandemic has unleashed an extraordinary philanthropic response. While significant, it is still only one small part of what must be a coordinated effort to beat this global crisis. Philanthropy cannot—and should not—supplant the public and private sectors. What philanthropy is good at is testing out ideas that might not otherwise get tried, so governments and businesses can then take on the successful ones. With all sectors working together, we can avoid the worst-case scenarios of human, economic, and social costs.” In announcing its new $150 million commitment, the foundation identified four priority areas for investment: Accelerating Virus Detection  The foundation will provide partners in sub-Saharan Africa and South Asia with funding to scale their COVID-19 detection, treatment, and isolation efforts. In some countries, this will include leveraging emergency operations centers normally deployed to support polio eradication and malaria elimination efforts toward COVID-19 detection.   Protecting the Most Vulnerable   Foundation funding will help partners in sub-Saharan Africa and South Asia pilot different approaches to physical distancing and infection suppression in settings where stay-at-home policies and other physical distancing strategies may not be practical. The goal will be to identify infection suppression strategies that can be effectively sustained over time with minimal social and economic disruption. A key focus will be building on lessons learned from two decades of experience in implementing infectious disease prevention programs, specifically the importance of community-designed and community-led engagement efforts.  The foundation is also considering gender equality issues in its response, and it will support research into the differential health, economic, and social impacts of the pandemic on women and girls in LMICs. This will help to inform the foundation’s short-, medium-, and long-term policy response to the pandemic and global policy responses. This effort will build on the foundation’s existing work to improve gender data by designing and implementing gender-specific metrics and surveys to capture data that reflects the experiences of women and girls.  Minimizing Social and Economic Impact    The foundation will provide non-medical funding to help LMICs strengthen social and economic support for people who are living in extreme poverty or who are at risk of falling back into extreme poverty due to the COVID-19 pandemic. Sub-Saharan Africa and South Asia together account for 85 percent of the 629 million people around the world who live on less than $1.90 per day, and past pandemics have had a disproportionate impact on people who cannot afford adequate nutrition, safe sanitation, and quality housing. People living in extreme poverty are also less likely to be able to practice physical distancing because they cannot afford to stop working.  The foundation will work with partners to help expand access to social payment systems to communities that are most at risk of serious social and economic disruption due to public health measures undertaken to suppress COVID-19 transmission.  Develop Products for a Sustained Response  The foundation will continue to invest in efforts to accelerate the development of diagnostics, therapeutics, and vaccines for the COVID-19 response while working with governments, the private sector, and multilateral institutions to ensure scaled manufacturing and the equitable procurement and distribution of these products as they become available. This work will include efforts to develop affordable and accessible point-of-care diagnostics, as well as support for the development of treatments and vaccines whose production can be quickly scaled once clinical trials have demonstrated their safety and efficacy. The foundation has committed to working with governments, CEPI, and the private sector to help provide financing for the at-risk enhancement of vaccine manufacturing capacity. This will allow the production of vaccine candidates so that global vaccine supply can be quickly scaled once clinical trial results are available.  The foundation will work with national governments and international organizations such as the WHO; UNICEF; Gavi; and the Global Fund to Fight AIDS, Tuberculosis and Malaria to ensure that LMICs have equitable access to essential commodities and to ensure that supply and distribution chains are well prepared to facilitate their rapid and widespread delivery to Gavi- and Global Fund-eligible countries.     ]]> https://biospectrumindia.com/news/57/16210/unitedhealth-group-commits-10-million-for-covid-19-international-response.html https://biospectrumindia.com/news/57/16210/unitedhealth-group-commits-10-million-for-covid-19-international-response.html Mon, 13 Apr 2020 15:00:00 +0530 UnitedHealth Group will contribute an initial $10 million to fight the COVID-19 pandemic internationally in countries where its UnitedHealthcare and Optum businesses operate, including in Brazil, Chile, Colombia, India, Ireland, Peru, Philippines and Portugal. The funding will support those most directly impacted by the public health emergency, including health care workers, seniors and people experiencing food insecurity or homelessness, while also expanding access to care in underserved communities. Dave Wichmann, chief executive officer of UnitedHealth Group said, “COVID-19 is a global health emergency and UnitedHealth Group is committed to ensuring the safety and well-being of people around the world. This additional investment of $10 million will support that effort and builds on our commitment to deploy our in-country resources, deep clinical expertise, and our compassionate team to support those in need at this unprecedented time.” UnitedHealth Group has developed partnerships with leading non-governmental organizations, universities and public health systems in each country. The funding will provide vital support for each country’s unique and most pressing needs, such as: Addressing food insecurity and funding health care and hygiene supports for vulnerable individuals and families. Helping expand local health care system capacity to treat COVID-19 patients through equipment, supplies and hospital beds. Purchasing protective equipment and safety kits for health care workers and other front-line responders. “We are working across the international communities to make resources available quickly and efficiently in an effort to fight COVID-19 and provide support for those most impacted by this global health crisis,” Wichmann said. The details of the country-specific partnerships will be announced soon.   ]]> https://biospectrumindia.com/news/57/16207/sanofi-to-donate-100m-doses-of-hcq-across-50-countries.html https://biospectrumindia.com/news/57/16207/sanofi-to-donate-100m-doses-of-hcq-across-50-countries.html Mon, 13 Apr 2020 05:05:00 +0530 Sanofi has committed to donating 100 million doses of hydroxychloroquine (HCQ) to 50 countries around the world, and has begun to progressively deliver the medicine to authorities that have requested it. In this global health emergency, Sanofi stands ready to assist as many countries as possible, starting with countries where its medicine is registered for current approved indications as well as countries where there are no hydroxychloroquine suppliers or countries with underserved populations. Since the beginning of the COVID-19 crisis, Sanofi has received a growing number of requests from local governments around the world. The company is regularly evaluating its increasing supply capacity and re-assessing how best to help those countries in the most ethical way. Sanofi’s priority is to ensure supply continuity for patients treated under the current approved indications of the medicine, notably including lupus and rheumatoid arthritis, while working hard to supply governments wishing to increase stocks in the hope that it may be an effective treatment of COVID-19. Sanofi will continue to donate the medicine to governments and hospital institutions if ongoing clinical studies demonstrate its efficacy and safety in COVID-19 patients. Sanofi has already doubled its incremental production capacity (on top of the usual production for current indications) across its eight hydroxychloroquine manufacturing sites worldwide and is on track to quadruple it by the summer. Sanofi is calling for coordination among the entire hydroxychloroquine chain worldwide to ensure the continued supply of the medicine if proven to be a well-tolerated and effective treatment in COVID-19 patients. ]]> https://biospectrumindia.com/news/57/16179/global-leaders-issue-g20-call-to-take-action-for-covid-19.html https://biospectrumindia.com/news/57/16179/global-leaders-issue-g20-call-to-take-action-for-covid-19.html Thu, 09 Apr 2020 14:35:00 +0530 A 165-strong international group including 92 former Presidents and Prime Ministers, along with current economic and health leaders in the developed and developing world have come together to demand the creation of a G20 executive task force and an immediate global pledging conference which would approve and co-ordinate a multi-billion dollar coronavirus fighting fund. In an open letter addressed to G20 leaders the group - which wants both to speed up the search for a vaccine, cure and treatments and revive the global economy - urges global collaboration and commitment to funding ‘far beyond the current capacity of our existing international institutions’. "The economic emergency will not be resolved until the health emergency is addressed: the health emergency will not end simply by conquering the disease in one country alone but by ensuring recovery from COVID-19 in all countries,” the statement says. The plea is for agreement within days for: $8 billion to rapidly hasten the global effort for vaccines, cure and treatment; $35 billion to support health systems, from ventilators to test kits and protective equipment for health workers; And $150 billion for developing countries to fight the medical and economic crisis, prevent a second wave of the disease flowing back into countries as they come out of the first wave. This means waiving debt interest payments for the poorest countries, including $44billion due this year from Africa. A $500- $600billion issue of additional resources by the IMF in the form of special drawing rights is proposed. The letter also urges the co-ordination of fiscal stimuli to avoid a recession becoming a depression. While welcoming the G20’s first communique on the Covid-19 crisis, the 165-strong group are pressing the G20 to speed up an action plan. The group states, "All health systems – even the most sophisticated and best funded – are buckling under the pressures of the virus. Yet if we do nothing as the disease spreads in poorer African, Asian and Latin American cities which have little testing equipment, hardly any ventilators, and few medical supplies; and where social distancing and even washing hands are difficult to achieve, Covid-19 will persist there – and re-emerge to hit the rest of the world with further rounds that will prolong the crisis. World leaders must immediately agree to commit $8 billion – as set out by the Global Preparedness Monitoring Board – to fill the most urgent gaps in the COVID-19 response. This includes $1billion this year for WHO, $3 billion for vaccines and $2.25 billion for therapeutics.” “Instead of each country, or state or province within it, competing for a share of the existing capacity, with the risk of rapidly-increasing prices, we should also be vastly increasing capacity by supporting the WHO in coordinating the global production and procurement of medical supplies, such as testing kits, personal protection equipment, and ITU technology to meet fully the worldwide demand. We will also need to stockpile and distribute essential equipment. $35 billion will be required, as highlighted by WHO, to support countries with weaker health systems and especially vulnerable populations, including the provision of vital medical supplies, surge support to the national health workforce (70% of whom in many countries are underpaid women) and strengthening national resilience and preparedness.” “According to WHO, almost 30% of countries have no COVID-19 national preparedness response plans and only half have a national infection prevention and control program. Health systems in lower income countries will struggle to cope; even the most optimistic estimates from Imperial College London suggest there will be 900,000 deaths in Asia and 300,000 in Africa. We propose convening a global pledging conference – its purpose supported by a G20 Executive Task Force - to commit resources to meeting these emergency global health needs.” On the Global Economic outlook, the group propose a range of measures and state: “Much has been done by national governments to counter the downward slide of their economies. But a global economic problem requires a global economic response. Our aim should be to prevent a liquidity crisis turning into a solvency crisis, and a global recession becoming a global depression. To ensure this, better coordinated fiscal, monetary, central bank, and anti-protectionist initiatives are needed. The ambitious fiscal stimuli of some countries will be all-the-more effective if more strongly complemented by all countries in a position to do so. The long-term solution is a radical rethink of global public health and a refashioning – together with proper resourcing – of the entwined global health and financial architecture.” “The UN, the G20 and interested partners should work together to co-ordinate further action.”   ]]> https://biospectrumindia.com/news/57/16175/epivax-gaia-vaccine-foundation-bring-hope-for-developing-countries.html https://biospectrumindia.com/news/57/16175/epivax-gaia-vaccine-foundation-bring-hope-for-developing-countries.html Thu, 09 Apr 2020 06:10:00 +0530 US based EpiVax, Inc., is using advanced computational tools to accelerate a COVID-19 vaccine candidate (EPV-CoV19) for healthcare workers (HCW) into clinical trials in 6 months. EpiVax has announced its partnership with GAIA Vaccine Foundation (GVF) to crowd-source funds for the project and its pledge to make a free license available to developing countries who qualify, in the context of this partnership. EPV-CoV19 is a peptide-based, epitope-driven vaccine that can be rapidly and safely produced in most countries. Applying EpiVax's expertise enabled the selection of sequences representing all circulating SARS-CoV-2 genomes that will drive a T cell-mediated immune response, providing HCW with immune system "body armor", reducing their risk of morbidity and mortality. EPV-CoV19 will enter US clinical trials once funds have been raised ($1.75M). GVF, a 501(c)(3) nonprofit organization, will enable private citizens and foundations to contribute to development of EPV-CoV19. GVF's mission is to reduce incidence of infectious diseases that disproportionately affect the under-served and promote the development of globally relevant, accessible vaccines that can be distributed on a not-for-profit basis in the developing world.  Annie De Groot, MD, EpiVax CEO/CSO, states "The soul of each company will be revealed during this crisis. Personally, I do not believe this is the time to become a billionaire. Each of us should do what we do best to reduce the impact of COVID-19 globally." As it is the mission of EpiVax to "improve human health everywhere", the company has granted GVF a cost-free, royalty-free license to the EPV-CoV19 design for use in countries that can produce and test the vaccine candidate on the Least Developed Countries list published by the United Nations. Collaborators and a clinical trial site in West Africa have been identified. ]]> https://biospectrumindia.com/news/57/16154/luminex-receives-fda-eua-for-aries-sars-cov-2-assay.html https://biospectrumindia.com/news/57/16154/luminex-receives-fda-eua-for-aries-sars-cov-2-assay.html Wed, 08 Apr 2020 08:00:00 +0530 US based Luminex Corporation has announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its ARIES® SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19. The assay runs on the ARIES® System, an FDA-cleared, sample-to-answer, automated, on-demand molecular diagnostic platform. The system is capable of running up to 144 tests per day, requiring no specialty training and minimal human interaction.  "The ARIES® SARS-CoV-2 Assay will allow hospital professionals to determine the appropriate course of treatment for patients suspected of having COVID-19 within approximately two hours," said Nachum "Homi" Shamir, President and CEO of Luminex. "We are grateful to the FDA for this Emergency Use Authorization, which allows us to bring another cost-effective SARS-CoV-2 test from Luminex to labs and patients in dire need of quick, accurate results. We are scaling up production of this assay over the next three weeks to support hundreds of labs across the US and the rest of the globe. These labs are already operating the ARIES® System and should be able to get up and running very quickly as we make this test broadly available." Luminex also launched the NxTAG® CoV Extended Panel last week after receiving an EUA from the US FDA and Medical Device Authorization for importation or sale for Health Canada. The panel is a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2 in as many as 96 samples in approximately four hours. To provide a more complete picture of a patient's respiratory health, the NxTAG CoV Extended Panel can also be run in parallel with the NxTAG Respiratory Pathogen Panel. Luminex is actively supporting laboratories in the US, Asia, and Europe with their testing, and the company has expanded its manufacturing capacity to produce up to 200,000 ARIES® SARS-CoV-2 tests per month, in addition to 300,000 NxTAG tests per month, with the majority of this capacity focused on SARS-CoV-2. ]]> https://biospectrumindia.com/news/57/16149/countries-in-who-south-east-asia-region-need-1-9-million-more-nurses-world-health-day.html https://biospectrumindia.com/news/57/16149/countries-in-who-south-east-asia-region-need-1-9-million-more-nurses-world-health-day.html Tue, 07 Apr 2020 18:15:00 +0530 Lauding tireless efforts being made by frontline health workers in the ongoing pandemic, the World Health Organization said that countries in South-East Asia Region need to redouble efforts to strengthen and expand their nurses and midwives’ cadre by 1.9 million to achieve health for all by 2030. “Nurses and midwives are central to quality health services for all, for preventing illness, promoting health throughout the life-course, caring for mothers, newborns and children to giving life-saving immunizations, health advice, and looking after older people. We must redouble our efforts to ensure the nursing and midwifery workforce has the strength, skills and support to meet all people’s health needs,” said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia, on the occasion of the World Health Day. The theme of the World Health Day, which marks the foundation of World Health Organization, is support and strengthen the nursing and midwifery workforce. In 2015 WHO South-East Asia embarked on a Decade for Health Workforce Strengthening aimed at overcoming shortages and skill-gaps in the Region’s health workforce.  Improving nursing and midwifery education, deployment and rural retention has been a top priority. By 2018 the Region had 3.5 million nurses and midwives – 18 per 10 000 population - up from 2.9 million in 2014, a ratio of 16 per 10 000 population. The regional average is still far below the global average of 37 nurses per 10 000 population, and the required minimum of 40 nurses by 10 000 population.  By 2030 the Region will need as many as 1.9 million more nurses and midwives. To fill this gap, the first ever State of the World’s Nursing Report, released today, highlights key areas that countries need to focus on. “We need to increase the number of nurses and improve nursing education; we need to improve the number of jobs for nurses, their quality and distribution in rural and marginalized areas; and we need to enhance leadership, management and the assignment of specialized roles for nurses,” Dr Khetrapal Singh added. Progress on each of these priorities will help countries strengthen services for maternal and child health among other needs, while also positioning them to better respond to non-communicable diseases, to provide adequate intensive care services, and to meet the health needs of older people. “The global outbreak of COVID-19 emphasizes how crucial nurses are to health security, and WHO takes this opportunity to thank them for their service in these challenging times,” the Regional Director said. The year 2020 is being celebrated as the International Year of the Nurse and the Midwife, as it marks the 200th birth anniversary of Florence Nightingale. Calling upon countries to sustain and accelerate progress in this vital area, Dr Khetrapal Singh said, “WHO reiterates its commitment to supporting all countries in the Region to strengthen their nursing and midwifery workforce. Together we can achieve universal health coverage and advance the equity agenda. Health for all at all ages is possible. We must make it happen”. ]]> https://biospectrumindia.com/news/57/16121/who-calls-for-stronger-whole-of-society-approach-in-south-east-asia-region.html https://biospectrumindia.com/news/57/16121/who-calls-for-stronger-whole-of-society-approach-in-south-east-asia-region.html Fri, 03 Apr 2020 13:30:00 +0530 Amidst rapid spread of COVID19 and continuing challenges, the World Health Organization has emphasized on a stronger whole of society and whole of government effort in South-East Asia Region to prevent a long-haul with the pandemic and avert further loss of precious human and other resources. Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia said, “A more comprehensive approach is needed with communities at the center of our response. Most importantly, communities need to be engaged and empowered to take appropriate decisions and measures. The onus must be on each one. At this stage, everyone needs to contribute to minimize health as well as socio-economic impact of the pandemic.” In recent days and weeks, countries in the Region have taken difficult decisions including implementation of unprecedented physical distancing measures to arrest the virus spread. Nearly 1.5 billion people - in Bangladesh, India, Myanmar, Nepal, Sri Lanka and Thailand together - are currently experiencing lockdowns. Supported by communities, we should start to see impact of these measures in the coming weeks. Simultaneously, this is also an opportunity for countries to enhance capacities of their health systems. As physical distancing measures take effect and capacities are built, whatever the transmission scenario, with the right approach the virus can be contained. In areas where community transmission occurs, it can be suppressed and controlled, the Regional Director said. “Every case, cluster and evidence of community transmission would need to be aggressively responded to. Basic public health measures such as active case detection, isolation, testing, treatment and contact tracing are among our most powerful tools. A strong surveillance is   needed to assess and guide evidence-based measures,” Dr Khetrapal Singh added The Regional Director held a virtual meeting with health ministers of the Region to review the challenges. Most countries highlighted the need for essential medical equipment, testing kits, personal protective equipment for health workers and enhancing health systems capacities, specially to respond to community transmission. The Regional Director said WHO will continue to work with the Pandemic Supply Chain Network to ensure all at-risk and critically affected countries are supported. “These shortages are a global problem, and one that will have a significant impact on the response. If we cannot protect health workers, and are unable to adequately test, we will be fighting with one arm tied,” she added. The Regional Director commended countries in the Region for participating in the WHO Solidarity Trial. India, Indonesia and Thailand have signed up for the multi-country trial, which will compare the safety and effectiveness of four different drugs or drug combinations against COVID-19. “It is a historic undertaking that will dramatically reduce the time needed to generate robust evidence about what drugs are effective in treating COVID-19. The more countries that join, the faster we will have the results. I urge all countries to sign up,” Dr Khetrapal Singh said, adding that WHO would soon be launching a second protocol for the Solidarity Trial that will help establish incidence and prevalence of infection and the future behavior of the virus. ]]> https://biospectrumindia.com/news/57/16110/siemens-opens-am-network-for-healthcare-providers-medical-designers.html https://biospectrumindia.com/news/57/16110/siemens-opens-am-network-for-healthcare-providers-medical-designers.html Thu, 02 Apr 2020 15:40:00 +0530 In response to the ongoing global health crisis caused by the outbreak of the COVID-19 virus, Siemens is making its Additive Manufacturing (AM) Network along with its 3D printers, available to the global medical community to speed design and production of medical components. The AM Network connects users, designers and 3D-print service providers to enable faster and less complicated production of spare parts for machines like ventilators. The Siemens AM network is available globally and covers the entire value chain – from upload and simulation to checking the design up to the printing process and associated services. Doctors, hospitals and organizations in need of medical devices as well as designers and service providers with medically certified printing capacities can register for free access to the Siemens AM Network. Klaus Helmrich, Member of the Managing Board of Siemens AG and CEO Siemens Digital Industries said, “Having worked on Additive Manufacturing for years, we offer AM solutions along the entire value chain and can print 3D parts quickly according to acute demands. To help fight COVID-19, we have opened our AM Network for hospitals and other health institutions needing spare medical parts to efficiently manage their design and printing requests.” Siemens’ designers and engineers are a part of the AM Network so they can answer design requests and help convert designs into printable files. Afterwards, these components can be printed via medically certified 3D printers of partner companies that are also part of the AM Network. In addition to numerous 3D printers from partner companies, Siemens’ 3D printing machines are also connected to the network and if suitable, will also be used to locally print components and spare parts for medical devices. Printing capacities from additional service providers can easily be added to the AM Network.   ]]> https://biospectrumindia.com/news/57/16086/covid-19-therapeutics-accelerator-awards-grants-worth-20-m-.html https://biospectrumindia.com/news/57/16086/covid-19-therapeutics-accelerator-awards-grants-worth-20-m-.html Wed, 01 Apr 2020 11:35:00 +0530 The partners in the COVID-19 Therapeutics Accelerator announced grants of $20 million to three institutions—the University of Washington, University of Oxford, and La Jolla Institute for Immunology—to fund clinical trials in order to identify highly potent immunotherapies for the COVID-19 pandemic. These grants mark the first investments to come from the COVID-19 Therapeutics Accelerator, a large-scale initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed the development of and access to therapies for COVID-19. Currently, there are no broad-spectrum antivirals or immunotherapies available to prevent or treat COVID-19. “These grants to leading institutions in their fields will advance our understanding of how existing drugs and antibodies can contribute to addressing the pandemic we’re facing around the world,” said Mark Suzman, chief executive officer of the Bill & Melinda Gates Foundation. “These initial investments through the COVID-19 Therapeutics Accelerator will bring rigor to the study of these potential solutions. The way forward will be informed by sound science and shared data.” In addition, newly announced funding from government and philanthropic donors has added to the Accelerator’s initial funding. The Chan Zuckerberg Initiative committed $25 million and the U.K. government committed £40 million last week. The additional funds will allow the Accelerator to continue making grants to study repurposed drugs and investigate biological compounds for activity against COVID-19. More funding is needed to move promising therapies through development and scale-up.  Studying repurposed drugs to prevent infection Two of the newly announced trials will fund an investigation of two well-established drugs, hydroxychloroquine and chloroquine, that have known antiviral properties. These drugs have been used to treat malaria and a variety of rheumatological conditions for more than 50 years. The trials aim to determine whether the drugs are effective as pre- and post-exposure preventive therapy for COVID-19. While these drugs both show initial promise, rigorous scientific evidence is needed to make decisions on how, where and within which populations to use them in this pandemic. The University of Washington will conduct a multi-site clinical trial in Western Washington and the New York City area, in collaboration with New York University’s School of Medicine, investigating whether hydroxychloroquine can effectively prevent COVID-19 in people already exposed to the infection. The trial will enroll up to 2,000 asymptomatic men and women who are close contacts of persons with confirmed or pending COVID-19 diagnoses. Participants will be randomly assigned to take hydroxychloroquine or a placebo over two weeks, and samples will be collected and tested daily to confirm new COVID-19 infections across the two groups. Sandoz, a Novartis division, has donated the hydroxychloroquine doses needed to conduct the study. Participant enrollment will begin in April, and results will be available in late 2020. The Mahidol Oxford Tropical Medicine Research Unit (MORU) will lead a placebo-controlled prophylaxis study of chloroquine and hydroxychloroquine in preventing COVID-19 in at-risk health care workers, frontline staff, and other high-risk groups. At least 40,000 participants in Asia and Europe will be randomized to receive either chloroquine (East Asian countries), hydroxychloroquine (United Kingdom and Europe), or a matched film-coated placebo as daily prophylaxis for three months. The one-year project, known as COPCOV, aims to determine definitively whether these drugs can prevent COVID-19 and thus protect the vital health care workforce. Participant enrollment will begin in April and initial results will be available by the end of the year. Nick Cammack, COVID-19 Therapeutics Accelerator Lead at Wellcome, said: “Investment in research is the world's only exit strategy from COVID-19. Drugs, vaccines, and diagnostics are vital to saving lives, to ending this pandemic, and to preventing it from happening again. Now is the time to evaluate whether existing drugs will prove to be safe and effective. We urge others to join us in this collective global effort. Investing now, at scale, in the COVID-19 Therapeutics Accelerator is vital if we are to change the course of this pandemic.”  Advancing immunological therapies In addition to funding drug trials, the Accelerator will provide $1.73 million to the La Jolla Institute for Immunology to establish a Coronavirus Immunotherapy Consortium, known as CoVIC. The effort will bring together scientists from around the world and enable them to share and evaluate candidate antibodies side by side in a blinded, multidisciplinary analysis to identify ideal therapeutic combinations. Antibody therapies can be used to protect frontline health care workers, contacts, and others who are exposed, as well as treat those who have already become sick. “Today’s grants are an important next step in the Therapeutic Accelerator’s commitment to identifying and scaling treatments to combat COVID-19,” said Mike Froman, vice chairman of Mastercard. “In order to provide therapeutic solutions to this global pandemic, particularly for those most vulnerable, we need to speed up the research and development process through a collaborative funding effort by the private sector, philanthropic organizations, and governments. We welcome the participation of additional organizations that can contribute the resources needed to help bring an end to this crisis.”  About the COVID-19 Therapeutics Accelerator The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed-up the response to the COVID-19 epidemic by identifying, assessing, developing, and scaling up treatments. The partners are committed to equitable access, including making products available and affordable in low-resource settings. The COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer-term. ]]> https://biospectrumindia.com/news/57/16019/international-surgical-guidelines-launched-to-reduce-ssi-amr.html https://biospectrumindia.com/news/57/16019/international-surgical-guidelines-launched-to-reduce-ssi-amr.html Wed, 25 Mar 2020 11:20:00 +0530 An international collaboration funded by the NIHR led by the University of Birmingham sets out nine essential recommendations that should be implemented as a priority across all hospitals world-wide in the fight against Surgical Site Infection (SSI). SSI is the most common complication following abdominal surgery, affecting 9% of patients in high-income countries and 17% of patients in low- and middle-income countries (LMICs) - causing patients to experience pain and delays return to normal activities such as work. At least 4·2 million people worldwide die within 30 days of surgery each year, and half of these deaths occur in LMICs. This number of postoperative deaths accounts for 7·7% of all deaths globally, making it the third greatest contributor to deaths, after ischaemic heart disease and stroke. More people die within 30 days of surgery annually than from all causes related to HIV, malaria, and tuberculosis combined (2·97 million deaths). It is estimated that failure to improve surgical care will cost the world economy $12.3 trillion in lost GDP by 2030. Additional SSI-related health costs can cause financial hardship, particularly for the most vulnerable patients in LMICs. SSI is associated with a three-fold increase in the risk of death after surgery. Treatment of SSI is increasingly challenging due to the rise of antibiotic resistance, which occurs in up to 46% of LMIC patients. This places a strong focus on preventing SSI from occurring in the first place Published in the British Journal of Surgery, the new Global Surgery Guideline for the Prevention of Surgical Site Infection will support surgeons in putting into practice key interventions that are proven to reduce the SSI risk. Expert surgeons representing 14 countries across Africa, Europe, Latin America, and South Asia identified nine evidence-based interventions which can be feasibly implemented worldwide at low cost. Aneel Bhangu, Consultant Surgeon and Senior Lecturer at the NIHR Global Health Research Unit on Global Surgery at the University of Birmingham commented, “We’ve estimated that around 20 million patients develop surgical site infections worldwide each year following abdominal surgery, including 14.7 million LMIC patients. “The Global Surgery Guideline for the Prevention of Surgical Site Infection has identified practical steps that all hospitals should urgently take to both reduce avoidable infections and the spread of antimicrobial resistance”, he added. Dr. Adewale Adisa, Senior Lecturer in Surgery at the Obafemi Awolowo University in Ile-Ife, Nigeria and co-lead author commented: “High rates of SSI and antimicrobial resistance are a real worry for surgeons, particularly in LMICs. Although guidelines for prevention of SSI have previously been published, they were developed in high income countries with little thought for the specific needs of LMIC patients. Many of their recommendations were impractical for resource-limited hospitals, and few LMIC surgeons put them in to practice. This is the first guideline to have been led by LMIC surgeons and I believe our recommendations can be implemented immediately to benefit all patients across the world.” The recommendations encourage medical professionals to boost patient safety by: Ensuring patients have had a full body wash with clean water and soap before operation. Selecting antibiotic prophylaxis according to published antibiotic prescribing guidelines. Administering antibiotic prophylaxis to all patients undergoing clean-contaminated, contaminated or dirty surgery. Administering antibiotic prophylaxis intravenously within 60 minutes before skin incision. Administering a repeat dose of antibiotic prophylaxis if the duration of operation is longer than the half-life of the antibiotic given. Not routinely continuing prophylactic antibiotics beyond 24 hours after operation. Ensuring scrub teams decontaminate their hands before surgery using antiseptic surgical solution. Preparing the skin at the surgical site immediately before incision, using antiseptic preparation Providing supplemental oxygen during surgery under general anaesthetic In addition, a further three ‘desirable’ recommendations are made in the guideline. It is recognised that worldwide some hospitals may lack the necessary resources to immediately implement these interventions, in which case they should plan strategies to introduce these interventions in the future.   ]]> https://biospectrumindia.com/news/57/16014/schrdinger-announces-expanded-collaboration-with-astrazeneca.html https://biospectrumindia.com/news/57/16014/schrdinger-announces-expanded-collaboration-with-astrazeneca.html Tue, 24 Mar 2020 09:05:00 +0530 Schrödinger, operator of a physics-based software platform for the discovery of high-quality, novel molecules for therapeutics and materials, has announced an expanded collaboration with AstraZeneca.  It focuses on the further development of a modeling solution for biologicals in order to accelerate the development of therapeutic candidates based on antibodies and proteins. The multi-year agreement will continue the existing collaboration in which AstraZeneca is driving research into small-molecule drugs with Schrödinger's computer platform.  The new collaboration aims to improve Schrödinger's Free Energy Perturbation (FEP +) technology to optimize key properties of biologicals such as affinity and selectivity, with a particular focus on binding affinity. ]]> https://biospectrumindia.com/news/57/15997/india-ramps-up-efforts-to-contain-the-spread-of-novel-coronavirus.html https://biospectrumindia.com/news/57/15997/india-ramps-up-efforts-to-contain-the-spread-of-novel-coronavirus.html Sun, 22 Mar 2020 00:00:00 +0530 Situation update As of 21 March 2020 (4:45 PM), a total of 283 COVID-19 cases (244 Indians and 39 foreign nationals) have been reported in 22 states/union territories. These include 22 who have been cured/discharged, 1 who has migrated and 4 reported deaths. Hospital isolation of all confirmed cases, tracing and home quarantine of the contacts is ongoing. Government response The Prime Minister's Office, Group of Ministers, Ministry of Health & Family Welfare (MoHFW) and Cabinet Secretary are closely monitoring the COVID-19 situation. The government has invoked powers under The Epidemic Diseases Act, 1897 to enhance preparedness and containment of the virus. With COVID-19 being declared a notified disaster, the State Disaster Response Fund, constituted under Section 48 (1) (a) of the Disaster Management Act, 2005, is now available with state governments for response measures. Central ministries along with states/UTs have taken urgent steps to strengthen community surveillance, quarantine facilities, isolation wards, and ensure availability of adequate personal protective equipment (PPE), trained manpower and rapid response teams for management of COVID-19. Addressing the nation, the Prime Minister, Mr Narendra Modi has urged for  resolve and restraint and adopting social distancing. He has also asked fellow citizens to follow 'Janta curfew' (voluntary self-isolation) on Sunday, 22 March 2020 from 7:00 AM to 9:00 PM. In a new advisory, apart from other prevention measures, the government has banned all international flights from entering India for a week starting 22 March 2020. Travel of passengers from Afghanistan, Philippines, Malaysia to India has been prohibited. All passengers coming from European Union (27 countries), European Free Trade Association (4 countries), Turkey and United Kingdom have also been prohibited from entering India.  These are temporary measures and shall remain in force till 31 March 2020. The earlier visa restrictions also remain in force. Universal Health Screening continues at all points of entry. WHO Country Office for India supportWHO Country Office for India (WCO) has been working closely with MoHFW, on preparedness and response measures for COVID-19, including disease surveillance, laboratory and research protocols, risk communications, training on infection prevention and control (IPC) and cluster containment plan, surveillance and tracking of travellers.  "We welcome Prime Minister's call for a Janta curfew and adopting social distancing. Effective implementation of the strategy  will go a long way in controlling the spread of the virus. Along with hand-hygiene, coughing and sneezing in one's sleeves prevents transmission. These measures, together  with social distancing can be effective in containing transmission. Even as we maintain social distancing, it is equally vital to stand together in solidarity to overcome this challenge," says Dr Henk Bekedam, WHO Representative to India. ]]> https://biospectrumindia.com/news/57/15977/who-un-launch-covid-19-solidarity-response-fund-.html https://biospectrumindia.com/news/57/15977/who-un-launch-covid-19-solidarity-response-fund-.html Thu, 19 Mar 2020 10:10:00 +0530 WHO, UN Foundation and partners have launched first-of-its-kind COVID-19 Solidarity Response Fund. A new coronavirus disease (COVID-19) Solidarity Response Fund will raise money from a wide range of donors to support the work of the World Health Organization (WHO) and partners to help countries respond to the COVID-19 pandemic. The fund, the first-of-its-kind, enables private individuals, corporations and institutions anywhere in the world to come together to directly contribute to global response efforts, and has been created by the United Nations Foundation and the Swiss Philanthropy Foundation, together with WHO.    Funds will go towards actions outlined in the COVID-19 Strategic Preparedness and Response Plan to enable all countries – particularly those most vulnerable and at-risk, and with the weakest health systems – to prepare for and respond to the COVID-19 crisis including rapidly detecting cases, stopping transmission of the virus, and caring for those affected. WHO and its partners are seeking financing for protective equipment for frontline health workers; to equip diagnostic laboratories; improve surveillance and data collection; establish and maintain intensive care units; strengthen supply chains; accelerate research and development of vaccines and therapeutics;  and take other critical steps to scale up the public health response to the pandemic. The COVID-19 Solidarity Response Fund is hosted by two foundations, the UN Foundation (registered in the United States) and the Swiss Philanthropy Foundation (registered in Switzerland). Both foundations have established relationships with the World Health Organization, allowing for efficient transfer of financial resources to enable COVID-19 response efforts.   ]]> https://biospectrumindia.com/news/57/15980/moderna-begins-ph-1-study-for-covid-19-vaccine.html https://biospectrumindia.com/news/57/15980/moderna-begins-ph-1-study-for-covid-19-vaccine.html Wed, 18 Mar 2020 10:30:00 +0530 US based Moderna, Inc., a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, has announced that the first participant has been dosed in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application. mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH. Manufacture of the first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). The Phase 1 study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein. The Company is actively preparing for a potential Phase 2 study under its own IND to build on data from the ongoing Phase 1 study being conducted by the NIH. In order to continue to progress this potential vaccine during the ongoing global public health emergency, Moderna intends to work with the FDA and other government and non-government organizations to be ready for a Phase 2 and any subsequent trials. ]]> https://biospectrumindia.com/news/57/15965/pfizer-outlines-five-point-plan-to-battle-covid-19.html https://biospectrumindia.com/news/57/15965/pfizer-outlines-five-point-plan-to-battle-covid-19.html Tue, 17 Mar 2020 06:10:00 +0530 Pfizer has issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19. Dr Albert Bourla, Chairman and CEO, made the following statement: “In this troubling time, Pfizer is committed to doing all we can to respond to the COVID-19 pandemic. Many companies, including Pfizer, are working to develop antiviral therapies to help infected patients fight this emerging virus as well as new vaccines to prevent infection and halt the further spread of this disease. Pfizer is working to advance our own potential antiviral therapies and is engaged with BioNTech on a potential mRNA coronavirus vaccine. We are committed to working as one team across the industry to harness our scientific expertise, technical skills andmanufacturing capabilities to combat this evolving crisis.” Pfizer is making five promises that will help scientists more rapidly bring forward therapies and vaccines to protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crises. Sharing tools and insights: Pfizer is committed to making the vital tools available on an open-source platform to the broader scientific community and to sharing the data and learnings gained with other companies in real-time to rapidly advance therapies and vaccines to patients. Marshalling our people: Pfizer has created a SWAT team of our leading virologists, biologists, chemists, clinicians, epidemiologists, vaccine experts, pharmaceutical scientists and other key experts to focus solely on addressing this pandemic. Applying our drug development expertise: Pfizer is committed to sharing clinical development and regulatory expertise to support the most promising candidates these companies bring forward. Offering our manufacturing capabilities: Pfizer is committed to using any excess manufacturing capacity and to potentially shifting production to support others in rapidly getting these life-saving breakthroughs into the hands of patients as quickly as possible. Improving future rapid response: Pfizer is reaching out to federal agencies including NIH, NIAID and CDC to build a cross-industry rapid response team of scientists, clinicians and technicians able to move into action immediately when future epidemics surface. ]]> https://biospectrumindia.com/news/57/15937/bill-melinda-gates-foundation-wellcome-mastercard-collaborate-for-covid-19-therapies-.html https://biospectrumindia.com/news/57/15937/bill-melinda-gates-foundation-wellcome-mastercard-collaborate-for-covid-19-therapies-.html Wed, 11 Mar 2020 14:25:00 +0530 The Bill & Melinda Gates Foundation, Wellcome, and Mastercard have committed up to $125 million in seed funding to speed-up the response to the COVID-19 epidemic by identifying, assessing, developing, and scaling-up treatments. The partners are committed to equitable access, including making products available and affordable in low-resource settings. The COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer-term. Currently there are no broad-spectrum antivirals or immunotherapies available for the fight against emerging pathogens, and none approved for use on COVID-19. The Gates Foundation and Welcome are each contributing up to $50 million, and the Mastercard Impact Fund has committed up to $25 million to catalyze the initial work of the accelerator. The Gates Foundation’s funding is part of its $100 million commitment to the COVID-19 response announced last month. Mark Suzman, chief executive officer of the Bill & Melinda Gates Foundation said, “Viruses like COVID-19 spread rapidly, but the development of vaccines and treatments to stop them moves slowly. If we want to make the world safe from outbreaks like COVID-19, particularly for those most vulnerable, then we need to find a way to make research and development move faster. That requires governments, private enterprise, and philanthropic organizations to act quickly to fund R&D.” The COVID-19 Therapeutics Accelerator will work with the World Health Organization, government and private sector funders and organizations, as well as the global regulatory and policy-setting institutions. The Accelerator will have an end-to-end focus, from drug pipeline development through manufacturing and scale-up. By sharing research, coordinating investments, and pooling resources, these efforts can help to accelerate research. This kind of collaboration was a key lesson from the 2014 Ebola outbreak. By providing fast and flexible funding at key stages of the development process, the Accelerator will de-risk the pathway for new drugs and biologics for COVID-19 and future epidemic threats, ensuring access in lower-resource countries. The COVID-19 Therapeutics Accelerator will operate jointly as an initiative of the funders, drawing on expertise from inside and outside their organizations. The Accelerator will pursue several aspects of the development cycle to streamline the pathway from candidate product to clinical assessment, use, and manufacturing. To identify candidate compounds, the Accelerator will take a three-pronged approach: testing approved drugs for activity against COVID-19, screening libraries of thousands of compounds with confirmed safety data and considering new investigational compounds and monoclonal antibodies. Drugs or monoclonal antibodies that pass initial screening would then be developed by an industry partner. The biotech and pharmaceutical industries will be critical partners, bringing their compound libraries and clinical data to the collaboration and lending commercialization and other expertise that will be required to scale up successful drugs and monoclonal antibodies. In parallel to the development of the COVID-19 drug pipeline, the Accelerator will work with regulators to align criteria and develop manufacturing capacity with industry. An accelerated pathway to bringing effective treatments to patients is around one year for products that have current regulatory approval or candidates with existing clinical data. The timeline would be longer for compounds further upstream in the pipeline that have limited existing clinical data. Dr. Jeremy Farrar, director of Wellcome said, “This virus is an unprecedented global threat, and one for which we must propel international partnerships to develop treatments, rapid diagnostics, and vaccines. Science is moving at a phenomenal pace against COVID-19, but to get ahead of this epidemic we need greater investment and to ensure research co-ordination. The Therapeutics Accelerator will allow us to do this for potential treatments with support for research, development, assessment, and manufacturing. COVID-19 is an extremely challenging virus, but we’ve proved that through collaborating across borders we can tackle emerging infectious diseases. We must strive to strengthen efforts in the face of COVID-19, and in doing so, continue to make sure advances are accessible and affordable to all. Investing now, at scale, at risk and as a collective global effort is vital if we are to change the course of this epidemic. We welcome others to join us in this effort.” Mike Froman, vice chairman of Mastercard said, “We’re proud to join this crucial effort to combat COVID-19 in furtherance of our commitment to inclusive growth. This global challenge not only represents a risk to the health and safety of populations all over the world, but also poses a potential disruption to the economic vitality of millions of people, businesses, and organizations worldwide. Our experience with financial inclusion shows us the importance of building a network of parties who bring not only their capital, but complementary assets and skill sets to the table, and we welcome other partners concerned about inclusive growth to join this effort.”  While antiviral drugs are approved to lessen the severity of seasonal flu and treat HIV, among other viral diseases, none have demonstrated efficacy against the current epidemic. One reason for the lack of effective treatments is that products may not have an immediate market, which can slow or prevent their research and commercial development. The COVID-19 Therapeutics Accelerator is designed to help by bringing together resources and expertise to lower the financial and technical risk for academia, biotech, and pharmaceutical companies, while ensuring that these products are accessible and affordable to people in low-resource settings. The expertise of pharmaceutical companies will be critical in identifying, researching, and commercializing successful drugs.   ]]> https://biospectrumindia.com/news/57/15894/gilead-to-acquire-forty-seven-for-4-9-b.html https://biospectrumindia.com/news/57/15894/gilead-to-acquire-forty-seven-for-4-9-b.html Wed, 04 Mar 2020 09:05:00 +0530 Gilead Sciences, Inc. and Forty Seven, Inc. announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash. The transaction, which values Forty Seven at approximately $4.9 billion, was unanimously approved by both the Gilead and Forty Seven Boards of Directors and is anticipated to close during the second quarter of 2020, subject to regulatory approvals and other customary closing conditions. Through the addition of Forty Seven’s investigational lead product candidate, magrolimab, the acquisition will strengthen Gilead’s immuno-oncology research and development portfolio. Magrolimab is a monoclonal antibody in clinical development for the treatment of several cancers for which new, transformative medicines are urgently needed, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). The investigational therapy targets CD47, a “do not eat me” signal that allows cancer cells to avoid destruction thereby permitting the patient’s own innate immune system to engulf and eradicate those cancer cells. Forty Seven presented promising results of a Phase 1b study of magrolimab in patients with MDS and AML at the American Society of Hematology meeting in December 2019. Magrolimab has the potential to be a first-in-class therapy. “This agreement builds on Gilead’s presence in immuno-oncology and adds significant potential to our clinical pipeline,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Magrolimab complements our existing work in hematology, adding a non-cell therapy program that complements Kite’s pipeline of cell therapies for hematological cancers. With a profile that lends itself to combination therapies, magrolimab could potentially have transformative benefits for a range of tumor types. We are looking forward to working with the highly experienced team at Forty Seven to help patients with some of the most challenging forms of cancer.” “This is an exciting day for patients who may one day benefit from future anti-CD47 therapies and other immuno-oncology treatments based on our research and an exciting time for Forty Seven as this allows us to achieve our vision of helping patients defeat their cancer,” commented Mark McCamish, MD, PhD, President and Chief Executive Officer of Forty Seven. “We are pleased to join Gilead and believe that by combining our scientific expertise with Gilead’s strength in developing treatments that modify the immune system, we will be able to more rapidly advance our therapies.” Magrolimab Forty Seven is initially studying magrolimab in patients with MDS and AML. Additional studies are ongoing in non-Hodgkin lymphoma (NHL) and solid tumors. Magrolimab has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of MDS and AML, and for the treatment of relapsed or refractory DLBCL and follicular lymphoma, two forms of B-cell NHL. Magrolimab has also been granted Orphan Drug designation by the FDA for the treatment of MDS and AML and by the European Medicines Agency for the treatment of AML. More than 400 patients have received the compound to date through clinical trials. Ongoing Phase 1b Clinical Trial In December 2019, Forty Seven presented promising results of a Phase 1b trial evaluating magrolimab in combination with azacitidine in untreated patients with higher risk MDS and untreated patients with AML, who are ineligible for induction chemotherapy. This has led to the initiation of a potential registrational cohort in MDS. All patients received a 1 mg/kg priming dose of magrolimab, coupled with intrapatient dose escalation to mitigate on-target anemia. Patients were then treated with full doses of azacitidine and magrolimab maintenance doses of 30 mg/kg weekly. As of the data cutoff of November 18, 2019, 62 patients had been treated with the combination in the Phase 1b portion of the trial, including 35 patients with MDS and 27 patients with AML. Clinical Activity Data As of the data cutoff, 46 patients were evaluable for response assessment, including 24 patients with untreated higher-risk MDS and 22 patients with untreated AML, who were ineligible for induction chemotherapy. In higher-risk MDS, the overall response rate (ORR) was 92 percent, with 12 patients (50 percent) achieving a complete response (CR), eight patients (33 percent) achieving a marrow CR and two patients (8 percent) achieving hematologic improvement. Two patients (8 percent) had stable disease. In untreated AML, the ORR was 64 percent, with nine patients (41 percent) achieving a CR, three patients (14 percent) achieving a CR with complete blood count recovery (CRi) and one patient (5 percent) achieving a morphologic leukemia-free state (MLFS). Seven patients (32 percent) had stable disease and one patient (5 percent) had progressive disease. The median time to response among MDS and AML patients treated with the combination was 1.9 months. Median duration of response and median overall survival have not been reached for either MDS or AML patients, with a median follow-up of 6.4 months (range 2.0 to 14.4 months) for MDS and 8.8 months (range 1.9 to 16.9 months) for AML.  Safety Data As of the data cutoff, the combination of magrolimab and azacitidine was well-tolerated, with no evidence of increased toxicities compared to azacitidine alone. Adverse events (AEs) were consistent with prior clinical experience. No deaths were observed in the first 60 days on combination treatment and only one patient out of 62 (1.6 percent) discontinued treatment due to a treatment-related AE. ]]> https://biospectrumindia.com/news/57/15893/pdcline-pharma-announces-the-administration-of-a-first-patient-with-its-therapeutic-cancer-vaccine-candidate-pdclung01.html https://biospectrumindia.com/news/57/15893/pdcline-pharma-announces-the-administration-of-a-first-patient-with-its-therapeutic-cancer-vaccine-candidate-pdclung01.html Tue, 03 Mar 2020 15:05:00 +0530 PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, announces that the first patient was dosed with its innovative medicinal product candidate PDC*lung01 in a phase I/II trial in non-small cell lung cancer (NSCLC). This patient is under the supervision of Dr. Anne Sibille, principal investigator for the Liege University Hospital (Belgium). The objectives of the phase I/II trial (PDC-LUNG-101) are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate, PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC. A total of 62 evaluable HLA-A*02:01 positive NSCLC patients are expected in three clinical centers in Belgium and six in France. PDC*lung01 is a cell suspension of a mix, in the same proportion, of seven active agents made of irradiated human plasmacytoïd dendritic cells (PDC*line) loaded separately with a distinct synthetic human leukocyte antigen serotype-restricted peptide (HLA-A*02:01) encoded by a tumour antigen. PDC*line is a potent professional antigen-presenting cell that is able to prime and boost the antitumor cytotoxic CD8+ T-cells in the patient’s immune system. “We are delighted to have achieved this first important milestone in the clinical development of PDC*line Pharma with our lead cancer vaccine candidate,” said Eric Halioua, president and CEO of PDC*line Pharma. “Based on preclinical studies there is a strong rationale for developing PDC*lung01 in this indication and we are currently exploring a number of additional indications, where our technology may provide potential benefit for patients.”“I’m very pleased to start patient dosing in the PDC*line Pharma phase I/II trial at our clinical center,” said Dr. Anne Sibille, principal investigator for the Liege University Hospital.“PDC*lung01 is an innovation in the field of cancer vaccines that appears particularly suitable for the treatment of NSCLC patients, an area where there is still a high unmet medical need,” said Dr. Channa Debruyne, medical director of PDC*line Pharma. ]]> https://biospectrumindia.com/news/57/15889/merck-partners-with-amcm-for-3d-printing-of-tablets.html https://biospectrumindia.com/news/57/15889/merck-partners-with-amcm-for-3d-printing-of-tablets.html Tue, 03 Mar 2020 09:05:00 +0530 Merck, a leading science and technology company and AMCM, Starnberg, Germany, have announced a cooperation agreement on the 3D printing of tablets. A MCM offers customized additive manufacturing solutions and is a sister company of 3D printing worldmarket leader EOS. The cooperation targets GMP-conform (Good Manufacturing Practice) tablet formulation development and production for clinical trials in a first step and later also commercial manufacturing services. Through this partnership, a novel, simplified process in clinical development of drugs can be enabled by using powder bed fusion methods, whereby a laser melts and fuses powder together layer by layer. In addition, 3D printing allows for API (active pharmaceutical development) formulation to be scalable while avoiding costly reformulations throughout the entire pharmaceutical development and commercial production processes. As a result tablet manufacturing can become faster and cheaper. Beyond the aforementioned objectives, the vision is to allow flexible and sustainable local tablet production according to specific market requirements as well as adaptation to patient needs. Next-generation tablet manufacturing through 3D printing is a project in the Innovation Center at Merck headquarters in Darmstadt, Germany. Here, project teams work on developing and upscaling ideas to create new businesses between and beyond the three Merck business sectors of Healthcare, Life Science and Performance Materials. ]]> https://biospectrumindia.com/news/57/15898/biospectrum-announces-industry-winners-of-excellence-awards-2020.html https://biospectrumindia.com/news/57/15898/biospectrum-announces-industry-winners-of-excellence-awards-2020.html Tue, 03 Mar 2020 00:00:00 +0530 BioSpectrum Excellence Awards 2020 ( INDIA ) Dear Industry Stalwarts, BioSpectrum India is excited to announce the return of BioSpectrum Excellence Awards 2020 India , taking place on March 27, 2020, The Lalit Ashok, Bangalore The Most Sought-After & Much Talked About Annual Awards Night To Felicitate The Stalwarts Of Indian Biotechnology & Health Science Industry. March 27, 2020, The Lalit Ashok, Bangalore We want you to join us on this journey.BioSpectrum is organizing its annual Biotech Industry Awards Nite to honor the achievers of the Indian Biotechnology industry. It is a "must-attend" event for the industry leaders in India, so reserve your place today to be part of the  much awaited industry show .   BioSpectrum Industry Awards: India's Top Biotech companies are honored. The winners will be the Top companies of the Industry selected in BioSpectrum industry survey held in Year 2019. -  BioSpectrum Industry Ranking Awards        I - Biopharma section Top MNC biopharma company - Novo Nordisk India Pvt Ltd, Bengaluru Top Indian biopharma company – Serum Institute of India, Pune        II - Diagnostics section Top Indian medtech company (Indian) – Transasia Bio Medicals Ltd., Mumbai          III - Bio services section TOP CDMO company -Piramal Pharma Solutions, Mumbai  TOP CRMO company - Syngene International Ltd, Bengaluru  TOP CRAMS company - Suven Life Sciences Ltd, Hyderabad  Top CLRO Company - Veeda Clinical Research Limited, Ahmedabad  TOP CRISP company - Anthem Biosciences Private Limited, Bengaluru           IV - Biosupplier section  Top biosupplier (MNC) - Waters India Pvt Ltd, Bengaluru Top biosupplier (Distributor) - DSS Imagetech Pvt. Ltd., New Delhi Top analytical instruments company (MNC) - Thermo Fisher Scientific India Pvt. Ltd., Mumbai  Top analytical instruments company (Distributor) - DSS Imagetech Pvt. Ltd., New Delhi             V - Industrial enzymes section Top industrial enzyme company (Indian) - Rossari Biotech Ltd, Mumbai  Top MNC industrial enzyme company (MNC) - Novozymes South Asia Private Limited, Bengaluru                      VI – Bio Incubator section Top Bioincubator in public sector – Bangalore Bioinnovation Centre, Bengaluru, Karnataka Top Bioincubator in private sector – KIIT Technology Business Incubator, Bhubneswar, Odisha    VII Editor’s Choice Awards ( BioSpectrum Awards )  Bio Supplier Industry Leader Award - Dr. G. M Warke, Founder & CMD, Hi Media Innovation in CRO sector in India – TCG Lifesciences Pvt. Ltd,  "Digital Media Disruptors" in Biotech & Life Science - Thermo Fisher Scientific Top Innovator for Biologics Packaging & Delivery  - West Pharma BioSpectrum Jury Awards will be disclosed on the same days !  Watch the space for more updates ! For further details, please feel free to contact Best regards, Ankit KankarManager - Product & Strategic CommunicationsE: ankit.kankar@mmactiv.com  HandHeld : +91 9579069369www.biospectrumindia.com/bsi-awards   ]]> https://biospectrumindia.com/news/57/15879/boehringer-ingelheim-collaborates-with-trutino-biosciences.html https://biospectrumindia.com/news/57/15879/boehringer-ingelheim-collaborates-with-trutino-biosciences.html Mon, 02 Mar 2020 09:25:00 +0530 Boehringer Ingelheim and Trutino Biosciences announced they have entered into a research collaboration and worldwide licensing agreement based on Trutino’s innovative On-Demand-Cytokine (ODC) platform. Under the terms of strategic alliance, Boehringer Ingelheim gains access to Trutino’s ODC platform technology for the generation and development of up to three new ODC candidates. This new collaboration combines Boehringer Ingelheim’s long-term strategy to provide first-in-class, breakthrough therapies for cancer patients with Trutino’s unique knowledge and expertise in increasing the safety and efficacy of cytokine therapies.  “Developing a strong and innovative cytokine therapeutic program as an additional component of our cancer immunology portfolio, demonstrates how we are ‘Taking Cancer On,’ and provides a high potential combination partner for our existing cancer vaccine, oncolytic virus, T cell engager and myeloid-targeting therapeutics portfolio,” said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim. “We are very pleased to partner with Trutino and harness the potential of their innovative scientific platform to develop treatment breakthroughs that will transform the lives of cancer patients.” Trutino’s ODC platform masks the activity of cytokines until they reach the tumor site and become fully activated, sparing systemic exposure and potentially leading to a higher margin of safety and greater efficacy than conventional cytokine treatments. Trutino will generate the new ODC molecules and carry out preclinical validation, handing over development to Boehringer Ingelheim for late pre-clinical testing through the rest of development.  “We are excited to embark on this partnership with Boehringer Ingelheim, a leader in cancer immunology, to advance cytokine therapeutic options that address the unmet medical needs of patients worldwide,” said Phillip Kim, Ph.D., MBA, Founder and CEO of Trutino Biosciences. “Boehringer Ingelheim has a deep commitment to innovative scientific approaches and is a leader in bringing novel cancer therapies to market. This global partnership validates the broad potential of our proprietary ODC platform to create safer and more effective cytokine therapies that can be delivered systemically and activated locally. Together, we can rapidly develop a new generation of cytokine therapies to address critical unmet need in oncology.” Trutino’s clinical potential was initially recognized by Boehringer Ingelheim through its grass roots programs, including the ‘BI Innovation Prize,’ where the ODC platform technology was an early-stage standout in the 2019 program held in San Diego. Launched in 2015, the grass roots programs comprise of ‘BI Office Hours,’ ‘BI Academy’ and the ‘BI Innovation Prize.’ Through Office Hours, Boehringer Ingelheim has provided over 200 early-stage companies in the life-sciences community with mentoring and direct access to relevant expertise and industry perspective from senior leaders within the company. In partnership with BioLabs in Boston, New York and San Diego, Boehringer Ingelheim has awarded numerous entrepreneurs with free lab space through the ‘Golden Ticket’ program. As a company dedicated to improving health and quality of life, these programs give Boehringer Ingelheim the opportunity to lend expertise to the innovation community and offer guidance around the science to help enable ideas to deliver the next breakthroughs. The partnership with Trutino will strengthen Boehringer Ingelheim’s next generation immune oncology portfolio, which combines cancer vaccines, oncolytic viruses, T Cell engagers and myeloid targeting platforms with the aim of making “cold” tumors that are invisible to the immune system “hot” to rally the immune system against the tumor. Under the terms of the agreement, Boehringer Ingelheim will provide an upfront payment, near-term pre-clinical milestone payments and clinical, regulatory and commercial milestone payments, including royalties on future product sales. ]]> https://biospectrumindia.com/news/57/15853/fda-approves-roches-bla-for-combination-treatment-of-breast-cancer.html https://biospectrumindia.com/news/57/15853/fda-approves-roches-bla-for-combination-treatment-of-breast-cancer.html Wed, 26 Feb 2020 00:00:00 +0530 Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.“For more than two decades, our medicines have redefined the standard of care for people with HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s acceptance builds upon our commitment by potentially offering patients a faster way to administer Perjeta and Herceptin. We’re working with the FDA to bring this treatment option to patients as quickly as possible.”SC administration of the FDC takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.1 This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.2,3,4The FeDeriCa study met its primary endpoint, with SC administration of the FDC showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough) when compared to IV administration of Perjeta. A secondary endpoint of non-inferior Ctrough of Herceptin was also met. A non-inferiority endpoint was chosen for the study to ensure that people were receiving sufficient dosing with Perjeta and Herceptin as compared to the established IV doses at the same treatment intervals. In addition, rates of total pathological complete response (pCR), another secondary endpoint, were comparable between the treatment arms. The safety profile of the FDC in combination with chemotherapy was comparable to that of IV administration of Perjeta plus Herceptin and chemotherapy and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhoea and anaemia.1In previous studies of other SC formulations, SC administration has been shown to be strongly preferred by the majority of patients compared to IV administration of the same medicine, with the most common reason being that administration required less time in the clinic.5,6 In the PHranceSCa study, Roche is currently investigating patient preference for SC administration of the FDC compared to standard IV administration of Perjeta and Herceptin in people with HER2-positive early breast cancer (eBC).7 Interim results of this phase II study will be presented at a future medical meeting. ]]> https://biospectrumindia.com/news/57/15842/france-pledges-100-m-for-who-academy.html https://biospectrumindia.com/news/57/15842/france-pledges-100-m-for-who-academy.html Tue, 25 Feb 2020 10:00:00 +0530 France’s Minister for Europe and Foreign Affairs, Jean-Yves Le Drian, and Dr Tedros Adhanom Ghebreyesus,  Director-General of WHO met at the Permanent Mission of France to the United Nations in Geneva to discuss the WHO Academy, which will be the world’s largest and most innovative lifelong learning platform in global health. The WHO Academy aims to reach millions of people worldwide, offering high-tech learning environments at a “hub” in Lyon with “spokes” in the six WHO regions. The Academy will provide learning opportunities for leaders, educators, researchers, health workers, WHO staff and the broader public, and will deliver high quality, multilingual learning, both online and in-person, alongside a cutting-edge simulation centre for health emergencies. The discussion follows a Declaration of Intent signed by Emmanuel Macron, President of the French Republic and Dr Tedros on 11 June 2019, and a pledge by France in the amount of US$ 100 million (€ 90 million) to WHO to support the creation of the WHO Academy, which will be established as an internal division within WHO. By propelling and strengthening digital innovations and lifelong learning opportunities around the world, the WHO Academy will play an instrumental role towards achieving WHO’s triple billion goal by 2023 and the health Sustainable Development Goals: 1 billion more people will benefit from universal health coverage; 1 billion more will be better protected in health emergencies, and 1 billion more will enjoy improved health and wellbeing. ]]> https://biospectrumindia.com/news/57/15833/advanced-bionics-initiates-corrective-action-of-hires-ultra-and-3d-cochlear-implant.html https://biospectrumindia.com/news/57/15833/advanced-bionics-initiates-corrective-action-of-hires-ultra-and-3d-cochlear-implant.html Mon, 24 Feb 2020 10:35:00 +0530 US based Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 3D cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients. AB’s priority is to ensure that all cochlear implant recipients and health care providers have the information they need to understand this situation and that they receive the necessary support. Existing recipients of HiRes Ultra and Ultra 3D may continue to use their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or other health care provider. In addition, we will begin the notification process for device recipients worldwide, where allowed, to make them aware of the potential issue. This voluntary action is being taken in an abundance of caution in response to recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of the more than 16,000 recipients of these implants, less than 0.5% have been explanted for this reason. Please note that this device-related issue may manifest in performance degradation that could require revision surgery. The only potential for patient harm are the risks associated with a surgery.  AB has identified factors that contribute to the clinical symptoms leading to explant and hearing performance degradation. This information will be provided to health care professionals and recipients in geographies that allow. As of February 11th, in the small number of cases that have been explanted,fluid ingress at the electrode has occurred leading to interruption of stimulation. The hermetic seal of the implant case has been shown to be intact. In our efforts to continually improve our products and in response to early reports of this issue AB has developed several improvements to the device to address the issue (new version). AB has received regulatory approval from the FDA in the US and TÜV SÜD in Europe for these improvements. AB is in the process of submitting these improvements to additional global regulatory agencies. AB plans to distribute products in these geographies as soon as approvals are obtained. AB will continue to distribute the HiRes 90K Advantage cochlear implant as well as the new version of HiRes Ultra and Ultra 3D based on market availability. Previous generations of AB cochlear implants and external sound processors and accessories are not included in the scope of this voluntary field action. AB’s primary concern is the safety and hearing performance of our recipients as well as the reliability of our products. AB continues to take all necessary corrective and preventative efforts to address this unforeseen occurrence. ]]> https://biospectrumindia.com/news/57/15826/taro-pharmaceuticals-issues-recall-of-phenytoin-oral-suspension.html https://biospectrumindia.com/news/57/15826/taro-pharmaceuticals-issues-recall-of-phenytoin-oral-suspension.html Fri, 21 Feb 2020 09:15:00 +0530 Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and is packaged in amber plastic bottles with an inner seal and a white child proof closure, and each bottle contains 237 mL. The reason for the recall is that product from these two lots of Phenytoin Oral Suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. This recall is being conducted with the knowledge of the FDA. The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening status epilepticus requiring immediate emergency room treatment. To date, Taro has not received any adverse event reports related to this recall. The two (2) lots that are being recalled are as follows: Lot #:   Expiration Date: 327874   December 2020 327876   December 2020 Each bottle is labeled to indicate the name of the product, Phenytoin Oral Suspension USP, 125 mg/5 mL and the NDC #51672-4069-1 (see image of container label below). Lot 327874 was distributed to wholesale distributors, long-term care providers, a repackager and mail order customers in the U.S. market between May 3 and July 5, 2019. Lot 327876 was distributed to wholesale distributors, long-term care providers and mail order customers in the U.S. market between July 1 and August 21, 2019. These customers may have further distributed these lots to retail pharmacies for prescription dispensing to patients who were prescribed Phenytoin Oral Suspension. Taro is notifying its distributors and retail customers by phone, e-mail, and letters via U.S. Mail and is arranging for return of any containers or quantities of Phenytoin Oral Suspension Lots # 327874 and 327876 (both with an expiration date of December 2020). Retail customers that have any quantities of these two (2) lots which are being recalled, should stop distribution and return any unsold units to their wholesaler. Consumers with questions regarding this recall can contact Taro by calling 1-866-705-1553 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 am and 7:00 pm, U.S. Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. ]]> https://biospectrumindia.com/news/57/15816/nimble-announces-collaboration-with-genentech.html https://biospectrumindia.com/news/57/15816/nimble-announces-collaboration-with-genentech.html Thu, 20 Feb 2020 15:50:00 +0530 Nimble Therapeutics, Inc. has announced a multi-year collaboration with Genentech, a member of the Roche Group, to accelerate discovery and development of novel peptide-based medicines for targets across a range of diseases. The collaboration will leverage Nimble's proprietary peptide synthesis, screening and optimization platform, chemical diversity, and integrated suite of assays to enable faster discovery and optimization of promising compounds for intracellular and extracellular targets. "We are excited to collaborate with a world class and well-respected organization such as Genentech to identify novel peptide therapeutics," said Jigar Patel, Ph.D., Chief Executive Officer of Nimble Therapeutics. "This partnership combines the strengths of our two organizations to potentially bring new medicines to patients." Under the terms of the agreement, Nimble will receive an undisclosed upfront payment and will be eligible for downstream milestone payments and royalties. ]]> https://biospectrumindia.com/news/57/15815/hummingbird-bioscience-announces-agreement-with-mycenax-biotech.html https://biospectrumindia.com/news/57/15815/hummingbird-bioscience-announces-agreement-with-mycenax-biotech.html Thu, 20 Feb 2020 15:40:00 +0530 Hummingbird Bioscience, an innovative biotherapeutics company pioneering the discovery of new breakthrough antibody therapeutics for difficult-to-treat conditions, today announced it has signed an agreement with Mycenax Biotech for the production of material for the Phase 1 clinical trial of its HMBD-002 program which is anticipated to commence in the second half of 2020. HMBD-002 is an anti-VISTA antibody developed for solid tumors that are unresponsive to existing treatments. VISTA is a new and important target for cancer as it strongly suppresses the activation of the body's anti-tumor immune response. The presence of VISTA cells is frequently associated with the emergence of tumors and resistance to current cancer immunotherapies. HMBD-002 uniquely blocks VISTA's activation, turning off the signal that keeps immune cells dormant. Critically, unlike other investigational anti-VISTA agents, HMBD-002 does not remove VISTA expressing cells from the body, thus allowing many of these cells to become active tumor-killing cells. Pre-clinical studies have shown that HMBD-002 can strongly inhibit tumor growth, both as a monotherapy and even more potently when combined with anti-PD(L)1 treatment.[1],[2]  "We are very pleased to be working with Mycenax, a pioneering provider of high-quality biologics, for the production of our anti-VISTA antibody, HMBD-002. This contract takes us one step closer to realizing the goal of more effective immunotherapies for a broader population of individuals with cancer," said Dr Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder, Hummingbird Bioscience. "We think HMBD-002 has great therapeutic potential and we are honored and excited to work with Hummingbird Bioscience on this project. We are committed to providing professional and customized service to facilitate the progress of the project. We are optimistic that, with our expertise and capability in CMC and production, HMBD-002 will be able to enter clinical trials and show therapeutic benefits soon," said Dr Pei-Jiun Chen, CEO and President of Mycenax. Further terms of the agreement were not disclosed. Following completion of manufacturing in Texas, an Investigational New Drug application will be submitted to the FDA to commence clinical trial. The development of HMBD-002 into the clinic is supported by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT). ]]> https://biospectrumindia.com/news/57/15812/sanofi-to-advance-novel-coronavirus-vaccine.html https://biospectrumindia.com/news/57/15812/sanofi-to-advance-novel-coronavirus-vaccine.html Thu, 20 Feb 2020 11:10:00 +0530 Sanofi Pasteur, the vaccines global business unit of Sanofi, will leverage previous development work for a SARS vaccine which may unlock a fast path forward for developing a COVID-19 vaccine. Sanofi will collaborate with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, expanding the company’s long-standing partnership with BARDA.  COVID-19 belongs to a family of coronaviruses that can cause respiratory disease. In late 2002, the SARS (severe acute respiratory syndrome) coronavirus emerged and then largely disappeared by 2004. Sanofi plans to further investigate an advanced pre-clinical SARS vaccine candidate that could protect against COVID-19.  “Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate,” said David Loew, Global Head of Vaccines at Sanofi. “While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak Sanofi will use its recombinant DNA platform to produce a 2019 novel coronavirus vaccine candidate.  The recombinant technology produces an exact genetic match to proteins found on the surface of the virus. The DNA sequence encoding this antigen will be combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product, and used to rapidly produce large quantities of the coronavirus antigen which will be formulated to stimulate the immune system to protect against the virus.  “Emerging global health threats like the 2019 novel coronavirus require a rapid response,” said BARDA Director Rick A. Bright, Ph.D.  “By expanding our partnership with Sanofi Pasteur and leveraging a licensed recombinant vaccine platform, we hope to speed development of a vaccine candidate to protect against a new virus.” In non-clinical studies, the SARS vaccine candidate was immunogenic and afforded partial protection as assessed in animal challenge models. This development work by Protein Sciences (acquired by Sanofi in 2017) provides a head start in expediting a COVID-19 vaccine. Additionally, since there is a licensed vaccine based on this platform this will allow for research and materials to be produced relatively quickly for clinical testing. Sanofi’s platform also has the potential to manufacture large quantities of the vaccine candidate. This agreement with BARDA marks another milestone in Sanofi’s ongoing contributions to help fight public health threats.  Sanofi continues to actively explore potential opportunities where the company’s deep vaccine experience and innovative technologies may contribute to addressing the coronavirus public health situation, including sharing Sanofi’s vaccine research and development experience with the Coalition for Epidemic Preparedness Innovations.   In December 2019, Sanofi also entered into an agreement with BARDA to establish state of the art facilities in the U.S. for the sustainable production of an adjuvanted recombinant vaccine for use in the event of an influenza pandemic and based on the same technology platform that will be used for the COVID-19 program. ]]> https://biospectrumindia.com/news/57/15807/merck-foundation-meets-the-first-lady-of-angola-to-discuss-their-programs.html https://biospectrumindia.com/news/57/15807/merck-foundation-meets-the-first-lady-of-angola-to-discuss-their-programs.html Wed, 19 Feb 2020 00:00:00 +0530 Merck Foundation, the philanthropic arm of Merck KGaA Germany underscored their long-term commitment to build healthcare capacity and empower women during a high-level meeting held between Merck Foundation CEO, Dr. Rasha Kelej and The First Lady of Angola, H.E. ANA DIAS LOURENÇO. Dr. Rasha Kelej, CEO of Merck Foundation explained, “It gave me great honor to meet the First Lady of Angola, H.E. ANA DIAS LOURENÇO last week to discuss with them the long-term partnership to empower women and girls in education. I was very inspired with the passion the First Lady has to motivate and empower girls to complete their education and reach their potential. I am looking forward to work closely with her to tailor our program “Educating Linda” for Angola.”H.E. ANA DIAS LOURENÇO, The First Lady of Angola shared “It is great initiative by Merck Foundation to empower women by improving their access to information, knowledge and through capacity building. We welcome the initiatives for Merck Foundation to our country.Moreover, I had a fruitful discussion with the Minister of Health of Angola, Hon. Dr. Silvia Lutucuta to kickoff partnership between Merck Foundation and Ministry of Health with the aim to provide specialty training in the fields of Cancer care, Fertility care and Diabetes care across Angola.” “We are excited to partner with Merck Foundation and are happy with their strong commitment and will provide all the required support for the efficient execution of their programs in the country,” said Hon. Dr. Silvia Lutucuta. Dr. Rasha Kelej also visited Agostinho Neto University in Luanda and met Prof. Nicolau Santos, Dean, School of Medicine along with his academic staff and Medical Undergraduate and Post graduates students to explore their challenges and needs to improve access to equitable and quality healthcare solutions in Angola. “I am happy and excited to announce to them the first online diabetes management master program in Portuguese Language which is specially developed for African Portuguese speaking countries Angola and Mozambique. Merck Foundation is making history again. I am so proud of our work and impact in Africa” concluded Dr. Rasha Kelej. ]]> https://biospectrumindia.com/news/57/15792/takeda-presents-new-clinical-trail-study-for-active-crohns-disease.html https://biospectrumindia.com/news/57/15792/takeda-presents-new-clinical-trail-study-for-active-crohns-disease.html Mon, 17 Feb 2020 00:00:00 +0530 Takeda Pharmaceutical Company Limited today announced results from the phase 3 VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab (Entyvio®) for use during maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD). The study evaluated patients who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy at weeks 0 and 2.1 The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008]),** meeting the study’s primary endpoint.1 These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria.  “The VISIBLE 2 study showed that the investigational subcutaneous formulation of vedolizumab helped patients with moderately to severely active Crohn’s disease achieve clinical remission at week 52, after first responding to induction therapy with intravenous vedolizumab,” said Séverine Vermeire, MD PhD, Head of the Department of Chronic Diseases & Metabolism at the KU Leuven and Honorary Member of ECCO. “These results suggest that the investigational subcutaneous formulation of gut-selective vedolizumab can provide a new treatment modality for patients who might prefer a therapy that can be self-administered outside of the hospital setting.”  Results for the following secondary endpoints were also presented at the congress. The enhanced clinical response*** rate was 52.0% (n=143/275) in patients receiving vedolizumab SC versus 44.8% (n=60/134) in patients on placebo at week 52.1 The difference between the treatment groups was not statistically significant, and consequently statistical testing for the remaining secondary endpoints was not performed. Among patients receiving corticosteroid treatment at baseline, the corticosteroid-free clinical remission† rate at week 52 was 45.3% (n=43/95) in patients who received therapy with vedolizumab SC versus 18.2% (n=8/44) who received placebo.1 The study enrolled patients who were naïve to treatment with anti-tumor necrosis factor-alpha (anti-TNFα) therapy, as well as those with previous experience of anti-TNFα therapy. Of the anti-TNFα-naïve patients, 48.6% (n=52/107) vs. 42.9% (n=27/63) were the clinical remissionǂ rates at week 52 in the vedolizumab SC and placebo arms, respectively.1  Patients received vedolizumab SC injections beginning at week 6 and every 2 weeks up to week 50, with an evaluation of the primary endpoint at week 52.1,2 The safety findings for vedolizumab SC were in line with the known safety profile of vedolizumab IV in patients with CD.1 Serious infections, malignancy, and liver injury were experienced by fewer than or equal to 5% of patients in both treatment groups.1 Anti-vedolizumab antibodies were detected in 2.5% of patients treated with vedolizumab SC, of whom approximately half developed neutralizing antibodies.1 Fewer than 3% of patients treated with vedolizumab SC reported injection-site reactions.1  “These data indicate that the investigational subcutaneous formulation of vedolizumab seems to have a similar safety profile to the intravenous formulation,” said William Sandborn, MD, Director of the Inflammatory Bowel Disease Center at the University of California, San Diego. “If approved, subcutaneous vedolizumab, together with the intravenous formulation, could provide more choice to patients in how they receive their therapy, helping to meet their individual needs and preferences.”  The investigational subcutaneous formulation of vedolizumab has been submitted for regulatory review with a number of key regulatory authorities worldwide. About Crohn’s DiseaseCrohn’s disease (CD) is one of the most common forms of inflammatory bowel disease (IBD).5 CD is a chronic, relapsing, remitting, inflammatory condition of the gastrointestinal (GI) tract which can progress over time.6 CD can affect any part of the GI tract from mouth to anus and can affect the entire thickness of the bowel wall.7 The condition commonly presents with symptoms of abdominal pain, diarrhea, and weight loss.6 The cause of CD is not fully understood; however, recent research suggests hereditary, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to CD.8,9   About Entyvio® (vedolizumab)Vedolizumab is a gut-selective biologic and is approved as an intravenous (IV) formulation.10,11 It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).12 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.13 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.12 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD).12,14,15 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.12 ]]> https://biospectrumindia.com/news/57/15779/carmelina-subgroup-analysis-supports-long-term-cardiovascular-and-renal-safety-of-linagliptin.html https://biospectrumindia.com/news/57/15779/carmelina-subgroup-analysis-supports-long-term-cardiovascular-and-renal-safety-of-linagliptin.html Thu, 13 Feb 2020 16:20:00 +0530 Boehringer Ingelheim have announced the results of a subgroup analysis of the CARMELINA trial which demonstrate that linagliptin did not increase the risk of adverse cardiovascular events or hypoglycemia compared with placebo in older people with type 2 diabetes. The findings have been published in the Diabetes Obesity and Metabolism journal. Population aging has shifted the epidemiology of diabetes towards older age.  Currently, approximately 136 million of the estimated 463 million people with diabetes are aged over 65 years.  However, despite the high prevalence, older patients have historically been underrepresented in clinical trials of glucose-lowering drugs. The recent CARMELINA cardiovascular outcome trial enrolled people aged 18 years and older with no maximum age restriction.  The prespecified CARMELINA  subgroup analysis evaluated clinical outcomes and adverse events with the main findings grouped into the following predefined age categories: <65, 65 to <75, and ≥75 years. “This subset analysis shines a spotlight on the older population living with type 2 diabetes. These individuals can be frail, have a high rate of comorbidities and can be on multidrug regimens, all of which present a challenge for their glucose management,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “As the older population also has the highest incidence of type 2 diabetes of any age group, this analysis will be invaluable in helping clinicians manage the treatment of this patient group, previously underrepresented in clinical studies.” Linagliptin did not increase the risk of adverse kidney outcomes, cardiovascular events or hospitalization for heart failure compared with placebo across age groups. The incidence of adverse events, including hypoglycemia, increased with age but was similar with linagliptin and placebo despite HbA1c reduction with linagliptin. Linagliptin improved glycemic control compared with placebo in all age groups. “Their advanced age, combined with established cardiovascular and/or kidney disease, means the older population of CARMELINA was comprised of high-risk individuals with type 2 diabetes,” continued Dr. Jamal. “The results should reassure healthcare professionals that linagliptin is suitable for a wide patient population to improve glycemic control whilst ensuring cardiovascular and ren ]]> https://biospectrumindia.com/news/57/15775/gene-corrected-stem-cell-therapy-to-treat-cystic-fibrosis-development-at-stanford-university.html https://biospectrumindia.com/news/57/15775/gene-corrected-stem-cell-therapy-to-treat-cystic-fibrosis-development-at-stanford-university.html Thu, 13 Feb 2020 11:00:00 +0530 A team of researchers at Stanford University has used the gene editing tool commonly known as CRISPR to repair the gene that causes cystic fibrosis in airway stem cells, which they say is a critical step to develop a gene therapy for the disorder. The researchers showed that the repaired airway stem cells could give rise to other airway cells and could produce functional cystic fibrosis transmembrane conductance regulator protein, which is faulty in cystic fibrosis patients. The study represents a proof of concept for the repair of genes that cause airway disorders. A study describing these results was published online in Cell Stem Cell on December 12, 2019. Postdoctoral scholar Sriram Vaidyanathan, PhD is the first co-lead author and Matthew Porteus, MD, PhD, professor of pediatrics is the lead co-senior author. Other co-lead authors include Ameen Salahudeen, MD, PhD, Zachary Sellers, MD, PhD, Dawn Bravo PhD. Other co-senior authors include Tushar Desai, MD, Jayakar Nayak, MD, PhD and Calvin Kuo MD,PhD.  A devastating childhood disease: Cystic fibrosis affects about 75,000-100,000 people globally. CF patients suffer from chronic lung infections that eventually cause lung failure and death. In addition, patients may also suffer from problems in several other organs. CF patients have an average life expectancy of about 40 years. CF is a fatal disease caused by mutations in a single gene (the cystic fibrosis transmembrane conductance regulator (CFTR)). The CFTR gene encodes an ion channel that transports chloride in cells that express the gene. In CF patients, the channel is non-functional and chloride transport is blocked. This results in a build-up of thick mucus in the airways and also results in damage to other organs such as the pancreas. The quest for a cure: Gene therapy has been attempted to treat several genetic diseases such as sickle cell disease and thalassemia over the past two decades with some individual successes. The discovery of CRISPR enabled the precise manipulation of genes and made it feasible to develop gene therapies for many more diseases. CRISPR was most readily applied to develop cures for blood disorders such as sickle cell disease because of our increased familiarity with blood stem cells and our ability to readily culture and transplant them into patients. Indeed, the first clinical trials to test the use of CRISPR to treat sickle cell disease, a blood disorder, have already started even though the technology is relatively new. Although CF was one of the first diseases for which gene therapy was attempted, attempts have been unsuccessful so far. The development of CRISPR renewed hopes for a gene therapy for CF. The application of CRISPR to treat lung disorders such as CF was challenging because methods to apply CRISPR to effectively edit airway stem cells had not been developed. The team consisting of Dr. Vaidyanathan, Dr. Porteus and colleagues have developed a method to correct one CF causing mutation (DF508) which affects over 70% of patients in the US and Europe. This publication describes the correction of a commonly observed CF causing mutation with efficiencies over >40% in airway stem cells. This is over a 100-fold improvement over previous work correcting the same mutations in other cell types and makes it possible to correct CF causing mutations in a clinically applicable manner. Further work is necessary to perfect the transplantation of edited airway stem cells in the airways to develop a durable treatment for CF. Not just a disease that affects Caucasians: In addition to Dr. Vaidyanathan, another co-first author and two of the co-corresponding authors leading this work are people of Indian origin. However, CF is not widely recognized as a disease that affects Indians. CF has been described in Indian patients previously.2,3 However, the exact number of CF patients in India is still unknown and the mutations that affect them are also not well characterized. It is likely that India has the largest number of CF patients in the world. It is also likely that most of them are undiagnosed and die before the age of 5. One study quantified the presence of CF in people of Indian origin in Canada and estimated the prevalence to be 1 in 9200 compared to 1 in 6600 among the general population between the ages of 0-14 years.4 In fact, Dr. Vaidyanathan has come across patients at Stanford University who received a diagnosis for CF after significant delay. In some cases, CF was even deemed unlikely because the patients were not of European origin. This is rather unfortunate because the quality of life and life expectancy of CF patients can be significantly improved if treatment is started early in life. This new gene therapy approach thus holds the promise to treat CF patients globally once a method to transplant airway stem cells is optimized. ]]> https://biospectrumindia.com/news/57/15767/pathios-therapeutics-appoints-dr-tobias-bopp-to-scientific-advisory-board.html https://biospectrumindia.com/news/57/15767/pathios-therapeutics-appoints-dr-tobias-bopp-to-scientific-advisory-board.html Wed, 12 Feb 2020 12:30:00 +0530 UK based Pathios Therapeutics Limited ("Pathios"), an innovative biotech company focused on the development of first-in-class therapies for cancer and autoimmune diseases, today announced that it has appointed Dr. Tobias Bopp, a leading academic and pioneer in the study of the influence of acidosis on tumour immunology, as the foundational member of its Scientific Advisory Board. Dr Bopp is the Professor of Molecular Immunology and Director of the Institute of Immunology at the University Medical Center of the Johannes Gutenberg University, Mainz, Germany. His work across several areas of immunology and cancer immunotherapy has led to over 150 peer-reviewed publications. He has received numerous awards and honours, is spokesperson of the Research Center of Immunotherapy, Mainz and a member of the advisory board of the Comprehensive Cancer Center (CCC) and the University Cancer Center (UCT), Mainz, and a Faculty Member of the German Cancer Consortium (DKTK).Recent seminal work from Dr. Bopp’s laboratory, published in Nature Immunology, demonstrated that the acidic microenvironment that is typical of many aggressive tumours signals to local innate immune cells called tumour-associated macrophages to bias their characteristics toward an immunosuppressive, tumour-permissive phenotype. This signalling occurs through activation of the pH-sensing G protein-coupled receptor, GPR65, on the surface of these cells. Pathios’ comprehensive and fully integrated drug discovery programme is aimed at the discovery and development of small molecule modulators of GPR65 for benefit in both cancer and autoimmune diseases. Pathios believes that Dr. Bopp will provide invaluable insights to help accelerate these programmes.Stuart Hughes, Chief Executive Officer of Pathios: "We are delighted to appoint Dr. Tobias Bopp as the first member of our Scientific Advisory Board. His track record and credentials in the field of tumour immunology are exemplary. In particular, his ground-breaking work demonstrating how the acidic tumour microenvironment impacts local immune cells has laid the foundation for a potentially whole new class of cancer immunotherapy agents that target GPR65 signalling. We believe that Dr. Bopp will be a vital part of ensuring that Pathios’ drug discovery efforts deliver on their therapeutic promise, bringing to bear a wealth of knowledge around both the preclinical and clinical aspects of GPR65."Tom McCarthy, Executive Chairman and Co-Founder: "We have long been aware of and admired Dr. Bopp’s important work relating tumour acidity to immune cell function in cancer and are thrilled that he has agreed to join Pathios as a key scientific strategic advisor. We anticipate that he will have a key role to play in guiding and influencing many of our important R&D decisions."Tobias Bopp, formative Scientific Advisory Board member: "I’m very much looking forward to working with the Pathios team and helping them as they progress their drug discovery efforts around GPR65. The company is making excellent progress toward generating a drug that targets this important receptor and has laid an excellent foundation for translating basic science into a therapy that may ultimately benefit many people suffering from cancer." ]]> https://biospectrumindia.com/news/57/15762/2020-ai-for-good-global-summit-to-scale-ai-powered-problem-solving-for-global-impact.html https://biospectrumindia.com/news/57/15762/2020-ai-for-good-global-summit-to-scale-ai-powered-problem-solving-for-global-impact.html Wed, 12 Feb 2020 10:55:00 +0530 Fourth edition of 2020 AI for Good Global Summit will be happening in Geneva from 4-8 May 2020. It will continue to connect AI innovators with public and private-sector decision-makers in the interests of stimulating the discovery and delivery of 'AI for Good' solutions for all. Ten years remain to achieve the United Nations Sustainable Development Goals (SDGs). Leaders in AI and humanitarian action will convene at the 2020 AI for Good Global Summit with strong intent to ensure that 'AI for Good' solutions achieve a scale matching that of the ambitions captured by the SDGs. The 2020 summit is co-organized by the International Telecommunication Union (ITU) – the United Nations specialized agency for information and communication technologies (ICTs) – and the XPRIZE Foundation, in partnership with Switzerland, the Association for Computing Machinery (ACM) and a wide variety of sister United Nations agencies. The AI for Good Global Summit is the leading United Nations platform for inclusive dialogue on AI. The summit identifies practical applications of AI to accelerate progress towards the SDGs and builds collaboration to assist these applications in achieving global impact. The 2017 summit marked the beginning of a global dialogue on the potential of AI to act as a force for good. The action-oriented 2018 and 2019 summits gave rise to numerous 'AI for Good' projects including an 'AI for Health' Focus Group led by ITU and the World Health Organization, an ITU Focus Group on 'AI for Autonomous and Assisted Driving', and an open framework for collaboration in 'AI Commons'. The pursuit of global impact will be the defining feature of the 2020 summit. Houlin Zhao, ITU Secretary-General said, “Three editions of the AI for Good Global Summit have recognized the significance of the leap from AI promise to global impact. We see renewed resolve within the AI for Good community to create the conditions necessary to make this leap and accelerate progress towards the achievement of the SDGs.” Anousheh Ansari, XPRIZE CEO said, “With only 10 years remaining to achieve the United Nations SDGs, AI is sure to be an invaluable technology to accomplish these critical goals that are designed to ensure a more sustainable and equitable future for all. At XPRIZE, our mission is to facilitate radical breakthroughs for the benefit of humanity, and our ongoing collaboration on the AI for Good Global Summit is one way we hope to accelerate safe and ethical development of AI and machine learning technology.” The summit attracts a unique cross-section of AI experts from industry and academia, global business leaders, Heads of UN agencies, ICT ministers, non-governmental organizations, civil society and artists. The summit is designed to generate 'AI for Good' projects able to be enacted in the near term, guided by the summit's multi-stakeholder and inter-disciplinary audience. It also aims to ensure trusted, safe and inclusive development of AI technologies and equitable access to their benefits. The 2020 summit will generate AI breakthroughs in climate and environmental action, the elimination of hunger, gender equality, healthcare, smart and safe mobility, the preservation of cultural heritage and the protection of access to trustworthy information. An 'AI Innovation Factory' will showcase new 'AI for Good' ideas, crowd-sourced AI challenges and promising AI startups. A 'partner day' will offer potential AI adopters an audience with leading AI experts and educators. It will also feature innovations at the cutting edge of AI research and development, such as RoboCup football matches, the AWS Deep Racer autonomous driving challenge, an AI gymnastics judge for the Tokyo Olympics, avatar prototypes, robot chefs, and AI-powered solutions to assist persons with disabilities. Summit attendees can also look forward to AI-inspired performances from ground-breaking artists and musicians. Over 100 speakers are expected to be the part of this summit.     ]]> https://biospectrumindia.com/news/57/15764/who-and-find-formalize-strategic-collaboration-to-drive-universal-access-to-essential-diagnostics.html https://biospectrumindia.com/news/57/15764/who-and-find-formalize-strategic-collaboration-to-drive-universal-access-to-essential-diagnostics.html Wed, 12 Feb 2020 00:00:00 +0530 The World Health Organization (WHO) and the Foundation for Innovative New Diagnostics (FIND) announced today that a memorandum of understanding has been signed by the two organizations to formalize a strategic collaboration that will strengthen diagnosis in resource-poor countries by closing major diagnostic gaps at country level and bolstering disease surveillance that will inform public health initiatives and enhance outbreak preparedness and response. “This collaboration is an inspiring development that will take us a long way towards ensuring access to diagnostics to all who need them,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “Global health challenges such as the ongoing novel coronavirus (2019-nCoV) outbreak demonstrates that without these essential elements of health systems, we cannot hope to promote health, keep the world safe, and serve the vulnerable. I look forward to working closely with FIND to determine what countries need and to forge a path to deliver these innovations so that no one is left behind.” Diagnosis is a driver of patient, financial and health systems impact, and a critical enabler of universal health coverage, but it is also the weakest link in the care cascade. This is especially true in primary healthcare settings in low- and middle-income countries. A unique and unprecedented opportunity exists to expand the role and impact of diagnostics to fully realize their potential to address major health security threats and evolving disease burdens through technological and digital advances. FIND has been an active partner with WHO since 2008 and a WHO Collaborating Centre since 2014, acting in the areas of laboratory strengthening and diagnostic technology evaluation. This expanded collaboration will put in place the building blocks necessary to enable transformative change in a move toward a country-led diagnostics alliance. Initial workstreams will focus on demand-driven access to essential diagnostics and the development of national Essential Diagnostics Lists, alongside collection of data that assist the scale up of diagnostics to support low- and middle-income countries on their paths to universal health coverage. “Each and every person has the right to a quality, timely diagnosis,” said Catharina Boehme, CEO of FIND. “Comprehensive diagnostic services underpin functional and efficient health systems not only to manage day-to-day healthcare needs, but also to ensure new disease outbreaks can be spotted and contained quickly. Working closely with WHO as part of a country-led alliance, we will strive to ensure that low- and middle-income countries have what they need to develop their own comprehensive, data-driven diagnostic strategies that enable universal health coverage and empower disease surveillance. Our ambition is that all patients, providers and decision-makers have access to the diagnostic solutions needed for optimal health outcomes.” ]]> https://biospectrumindia.com/news/57/15761/hygienas-ensure-touch-receives-performance-tested-methodsm-certification-from-the-aoac-ri.html https://biospectrumindia.com/news/57/15761/hygienas-ensure-touch-receives-performance-tested-methodsm-certification-from-the-aoac-ri.html Tue, 11 Feb 2020 17:35:00 +0530 Hygiena’s UltraSnap ATP Test received Performance Tested MethodSM certification from the AOAC-RI on the new EnSURE Touch luminometer, demonstrating the system's sensitivity, reliability and robust operation. The certification is a modification of Hygiena’s existing AOAC-RI certification of the UltraSnap using the EnSURE luminometer.Data submitted to the AOAC demonstrates the system to have a high level of sensitivity with a limit of detection of 1.28 femtomoles of ATP and high degree of consistency and accuracy.The EnSURE Touch is a next-generation ATP monitoring system that also collects, analyzes and reports data from multiple quality tests such as, water quality, indicator microorganisms, and process indicators (residual enzyme activity). The system provides a multi-functional tool for monitoring quality and safety parameter in food safety, healthcare and other industries.Hygiena UltraSnap system has consistently outperformed other ATP systems when data from other independent reports are compared.“We are delighted that our newest luminometer, the EnSURE Touch, has been certified and independently shown to perform as well as the EnSURE ATP monitor,” said Martin Easter, Chief Scientific Officer at Hygiena. “The EnSURE Touch not only represents a major improvement for ATP hygiene monitoring systems but has additional applications for the rapid detection of other contaminants.” ]]> https://biospectrumindia.com/news/57/15752/reform-biologics-collaborates-with-milliporesigma.html https://biospectrumindia.com/news/57/15752/reform-biologics-collaborates-with-milliporesigma.html Tue, 11 Feb 2020 10:35:00 +0530 US based ReForm Biologics LLC, a pharmaceutical technology company developing innovative platforms to improve biologic formulations and MilliporeSigma have announced a global license agreement and collaboration to commercialize proprietary ReForm excipients used in biotherapeutic formulations. The Life Science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. Under the agreement, MilliporeSigma and ReForm Biologics will conduct research, development and qualification of ReForm Biologics’ excipients for pharmaceutical use. MilliporeSigma will fund the research and development and be responsible for global commercialization, GMP manufacturing, and sale of ReForm Biologics’ excipients to MilliporeSigma’s customers for use in biologic formulations. ReForm Biologics will receive revenues from MilliporeSigma for sublicensing ReForm Biologics’ technology to MilliporeSigma’s customers in biologic formulations. ]]> https://biospectrumindia.com/news/57/15749/sona-develops-rapid-screening-test-for-coronavirus.html https://biospectrumindia.com/news/57/15749/sona-develops-rapid-screening-test-for-coronavirus.html Tue, 11 Feb 2020 09:55:00 +0530 Canada based Sona Nanotech Inc.  is deploying its proprietary nanotechnology in the development of a rapid screening test for the current Coronavirus, “nCoV19”. Sona is developing a quick-response lateral-flow test to screen patients for the nCoV19 virus. When completed, the test is expected to produce results in 5-15 minutes and is anticipated to cost less than $50. There is currently no lateral flow test specific to the nCoV19 strain of the Coronavirus, which was first detected in Wuhan, Hubei Province, China and continues to spread across the globe. Sona will integrate its proprietary nanorod technology into a disposable lateral flow test platform (similar to pregnancy tests that can be administered without skilled technicians or additional laboratory equipment) for use as a screening tool to help triage individuals. Currently, the majority of testing completed for the nCoV19 virus utilizes molecular based technology (PCR), a testing platform that; typically costs more than $200 per test, frequently takes 2-4 hours to produce results, and requires specialized laboratory equipment and skilled technicians to operate. In comparison, lateral flow assays provide results between 5-15 minutes and can be administered by a layperson. “Screening tests are critical tools in dealing with rapidly evolving and large-scale out-breaks that tax the health care system, like this novel Coronavirus,” says Darren Rowles, CEO, Sona Nanotech. Screening tests rapidly identify at-risk patients, which allows the medical community to focus its resources on the patients that need help the most. “Lateral flow tests previously developed with Sona’s proprietary nanorods have demonstrated industry-leading test sensitivity levels compared to other particles,” continues Rowles. “The higher the test sensitivity, the more accurately a lateral-flow screening test will identify patients as ‘at-risk’ or ‘not at risk’.” Sona is in continuing discussions with several companies and organizations relating to the development of the nCov19 Coronavirus and expects to provide additional updates on Sona’s test development in the coming days.  ]]> https://biospectrumindia.com/news/57/15732/biomotiv-and-bms-launch-anteros-pharmaceuticals.html https://biospectrumindia.com/news/57/15732/biomotiv-and-bms-launch-anteros-pharmaceuticals.html Fri, 07 Feb 2020 06:10:00 +0530 US based BioMotiv, drug development accelerator associated with The Harrington Project for discovery and development, that advances breakthrough discoveries from research institutions into therapeutics, and Bristol-Myers Squibb Company has announced the launch of Anteros Pharmaceuticals, a biotechnology company focused on developing a new class of drugs for fibrotic and other inflammatory diseases. The intellectual property behind Anteros was first developed by Yale University and in-licensed by Bristol-Myers Squibb and subsequently assigned to Anteros. Under the terms of the partnership, Bristol-Myers Squibb will contribute the IP, data, and reagents for a series of small molecules against an undisclosed mechanism, and BioMotiv, through the formation of Anteros Pharmaceuticals, working in close partnership with Yale, will be solely responsible for research and development. Once Anteros nominates a pre-clinical candidate, Bristol-Myers Squibb has the option to acquire the company from BioMotiv under pre-agreed terms. Satish Jindal, Ph.D., BioMotiv’s CEO said, “Anteros Pharmaceuticals is the first of several companies that BioMotiv and Bristol-Myers Squibb intend to form under the Strategic Partnership Agreement. Anteros will focus on refining a new class of drug candidates for inflammatory diseases, where currently there are no real answers to multiple diseases that afflict millions of patients. Our broader mission is to translate novel discoveries into breakthrough therapies for patients in need, forming companies such as Anteros to achieve this goal.” Rupert Vessey, Executive Vice President, Research & Early Development, Bristol-Myers Squibb said, “Bristol-Myers Squibb is committed to partnering with innovative collaborators like BioMotiv, which expand our reach and capabilities in early stage research. These types of partnerships also enable us to progress the transformational research being performed at leading academic institutions such as Yale and effectively translate those discoveries into new therapies for patients,” said. “We look forward to our continued collaboration with BioMotiv and to the scientific advancements driven by Anteros.” This is the first company BioMotiv and Bristol-Myers Squibb have launched since executing their Strategic Partnership Agreement, as previously announced in September 2019.   ]]> https://biospectrumindia.com/news/57/15721/who-spells-out-need-to-step-up-cancer-services.html https://biospectrumindia.com/news/57/15721/who-spells-out-need-to-step-up-cancer-services.html Wed, 05 Feb 2020 10:30:00 +0530 The World Health Organization (WHO) spells out the need to step up cancer services in low and middle-income countries. WHO warns that, if current trends continue, the world will see a 60% increase in cancer cases over the next two decades. The greatest increase (an estimated 81%) in new cases will occur in low- and middle-income countries, where survival rates are currently lowest. This is largely because these countries have had to focus limited health resources on combating infectious diseases and improving maternal and child health, while health services are not equipped to prevent, diagnose and treat cancers. In 2019, more than 90% of high-income countries reported that comprehensive treatment services for cancer were available in the public health system compared to less than 15% of low-income countries. “This is a wake-up call to all of us to tackle the unacceptable inequalities between cancer services in rich and poor countries,” says Dr Ren Minghui, Assistant Director-General, Universal Health Coverage/ Communicable and Noncommunicable Diseases, World Health Organization. “If people have access to primary care and referral systems then cancer can be detected early, treated effectively and cured. Cancer should not be a death sentence for anyone, anywhere.” WHO highlights a wide range of proven interventions to prevent new cancer cases. These include controlling tobacco use (responsible for 25% of cancer deaths), vaccinating against hepatitis B to prevent liver cancer, eliminating cervical cancer by vaccinating against HPV, screening and treatment, implementing high-impact cancer management interventions that bring value for money and ensuring access to palliative care including pain relief. ]]> https://biospectrumindia.com/news/57/15728/perkinelmer-unveils-advanced-drug-discovery-and-disease-research-solutions.html https://biospectrumindia.com/news/57/15728/perkinelmer-unveils-advanced-drug-discovery-and-disease-research-solutions.html Wed, 05 Feb 2020 00:00:00 +0530 PerkinElmer, Inc., a global leader committed to innovating for a healthier world,  introduced new workstations and a high content screening system at SLAS2020 International Conference and Exhibition, being held on January 27–29, at Booth #929 at the San Diego Convention Center, San Diego, California. These technologies automate workflows so that disease research and drug discovery professionals can improve productivity, increase reproducibility, and garner key insights. PerkinElmer highlights these new systems, along with several key offerings from its comprehensive portfolio of instruments and reagents at SLAS2020:   JANUS® G3 Blood iQ™ Workstation: for biobanking workflows, it offers front end reformatting of plasma and buffy coat layers from centrifuged blood tubes, enabling highly reproducible, downstream genetic analysis. Sciclone® G3 NGSx HT Workstation: helps simplify the miniaturization of NGS library prep. Coupled with a new NEXTFLEX® Rapid XP DNA-seq kit, this library preparation workflow is designed to enable researchers to increase their NGS throughput while decreasing their cost per reaction. Opera Phenix® Plus High Content Screening System: for fast response analysis of physiologically relevant model systems, this enhancement to PerkinElmer’s high content imaging platform adds fast frame rate image capture for assays such as cardiomyocyte beat rate monitoring. It also offers an optional liquid handling module to enable assays like Ca2+ flux, important to the study of neurological diseases such as Alzheimer’s, Huntington’s and Parkinson’s. Designed to drive more relevant testing earlier in the drug discovery process, the Opera Phenix Plus system can also be used with two cell cultures, primary cells, 3D organoids, spheroids and microtissues. PerkinElmer is showcasing additional technologies that enable disease research and life sciences: LabChip® GX Touch™ Nucleic Acid Analyzer; explorer™ G3 Integrated Workstations; MuviCyte™ Live-Cell Imaging Kit; VICTOR® Nivo™ Multimode Microplate Reader; EnVision® Multimode Plate Reader; and EnSight™ Multimode Plate Reader. SLAS attendees learn about PerkinElmer’s industry-leading no-wash assay technologies including the Alpha, LANCE® Ultra™ and HTRF® assays.  The Alpha CETSA® assays combine PerkinElmer’s Alpha and Pelago Biosciences' Cellular Thermal Shift assays (CETSA®), which enable the assessment of target engagement in cell-based assays and generate more physiologically-relevant results. These products are for research use only. Not for use in diagnostic procedures.  “Advancing disease research and bringing new drugs to market quickly is often supported by innovative testing and analysis solutions that deliver fast, more accurate and reproducible results and novel insights,” said Alan Fletcher, VP/GM, Life Sciences at PerkinElmer. “These new offerings will help scientists and technicians meet key needs across critical lab workflows as they leverage our robust portfolio, spanning from instruments and software, plate readers and integrated workstations, to assays, reagents and services.”   PerkinElmer’s experts delivered the following presentations at SLAS2020: “The Importance of Sample Management in Precision Medicine: A High-Throughput Biobanking Workflow Solution”, “An Automated Deep-Learning Workflow for Analyzing HCS Screens”, “Technical and Workflow Considerations for cfDNA Applications”, “Taking the Guesswork Out of NGS Library Prep Reaction Miniaturization” ]]> https://biospectrumindia.com/news/57/15709/cepi-gsk-to-develop-vaccine-for-2019-ncov-virus.html https://biospectrumindia.com/news/57/15709/cepi-gsk-to-develop-vaccine-for-2019-ncov-virus.html Tue, 04 Feb 2020 00:00:00 +0530 CEPI, the Coalition for Epidemic Preparedness Innovations, and GSK have announced a new collaboration aimed at helping the global effort to develop a vaccine for the 2019-nCoV virus. In this new move, GSK will make its established pandemic vaccine adjuvant platform technology available to enhance the development of an effective vaccine against 2019-nCoV. GSK is a leader in the development of innovative vaccines using different adjuvant systems. An adjuvant is added to some vaccines to enhance the immune response, thereby creating a stronger and longer-lasting immunity against infections than the vaccine alone. The use of an adjuvant is of particular importance in a pandemic situation since it can reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and made available to more people. Dr Richard Hatchett, CEO, CEPI commented:“Gaining access to GSK’s world-leading adjuvant technology is a huge step forward in developing a vaccine against the novel coronavirus 2019-nCoV. Coupling GSK’s adjuvant systems with the pioneering platform technology we are funding has the potential to make more vaccine available more rapidly – by decreasing the dose of vaccine antigen required to protect each individual. This “antigen-sparing” effect makes a given supply of vaccine go farther, increasing the number of people who can benefit.” Thomas Breuer, Chief Medical Officer, GSK Vaccines, commented:“As a leader in science and innovation, we believe we can help to contribute to the fight against 2019-nCOV with one of our advanced vaccine adjuvant systems. Our adjuvant technology has previously been used successfully in the pandemic flu setting. It enables using only small quantities of the vaccine antigen which allows the production of more doses of the vaccine – a crucial advantage in a pandemic.” CEPI will coordinate engagements between GSK and entities funded by CEPI who are interested in testing their vaccine platform with GSK’s adjuvant technology to develop effective vaccines against 2019-nCoV. The first agreement to formalize this arrangement has been signed between GSK and the University of Queensland, Australia, which entered a partnering agreement with CEPI in January 2019 to develop a “molecular clamp” vaccine platform, intended to enable targeted and rapid vaccine production against multiple viral pathogens. CEPI has extended this funding to work on a 2019-nCoV virus vaccine candidate, and access to the GSK adjuvant technology will now support this early stage research. Roger Connor, President, GSK Vaccines, added:“At GSK we believe in the value CEPI can bring to responding to outbreaks like 2019-nCOV. We are proud to contribute to cutting edge research from scientists at the University of Queensland, and we are open to working with other partners, who have a promising vaccine platform that could be used together with our adjuvant.” Prof Peter Høj, Vice-Chancellor, The University of Queensland, added:“The research team at The University of Queensland are progressing a 2019-nCoV vaccine program and the availability of the GSK adjuvant will enable us to carry out important pre-clinical experiments designed to assess vaccine effectiveness.” This announcement complements 4 prior CEPI programmes of work relating to 2019-nCoV vaccine development already announced by CEPI, in partnership with: CureVac; Inovio; The University of Queensland; and Moderna, Inc. and the U.S. National Institute of Allergy and Infectious Diseases. These partnerships seek to improve the scientific understanding of the novel coronavirus, and to develop vaccines against it. These programmes will leverage rapid response platforms already supported by CEPI with the aim of advancing 2019-nCoV vaccine candidates into clinical testing as quickly as possible. In addition, CEPI launched a new call for proposals to rapidly develop and manufacture already proven vaccine technology that can be used against the new coronavirus. The call is rolling and open until February. Both CEPI and GSK are committed to principles of equitable access and will work together in this collaboration to ensure that this principle governs the development, use and access of any 2019-nCoV vaccine developed through the collaboration. ]]> https://biospectrumindia.com/news/57/15705/how-astronauts-will-make-their-own-drugs-in-space.html https://biospectrumindia.com/news/57/15705/how-astronauts-will-make-their-own-drugs-in-space.html Mon, 03 Feb 2020 12:00:00 +0530 NASA’s Translational Research Institute for Space Health (TRISH) has funded innovative projects seeking to better protect astronauts' health during deep space missions of three years or more. Two of the six projects focus on ‘just-in-time’ medications, which allow drugs to be manufactured on-demand and on-board the spacecraft – a necessity given that most commercially available medicines have shelf lives of two years or less. GlobalData’s pharmaceutical technology writer Allie Nawrat looks at two on-demand medication projects. Nawrat says: “Two of these on-demand medications projects recently received two-year funding from TRISH. The first is from the Massachusetts Institute of Technology (MIT) and creates just-in-time medications from gastric resident microbial systems, the second from the University of California, Davis (UC Davis) involves genetically modifying and growing lettuces to produce associated drugs. “MIT’s project is led by David H Koch Institute professor Robert Langer and involves a gastric resident device called the ‘mother machine’. The drug delivery device is ingested by astronauts in the same manner as an oral drug, it then resides in their stomach for a specific period and gradually releases the drug it manufactures into their body. “Langer’s proof of concept will involve using bacterium, such as E. Coli, to produce three medications – caffeine, melatonin and acetaminophen – within the device. These are all over-the-counter medications and are used to treat conditions such as headaches and other minor pains, as well as sleep disorders. It is hoped that this device’s capacity would be expanded to a broader range of conditions in the future. “The synthetic biology project led by UC Davis’ Karen McDonald is based around genetically modifying lettuce so the plants can produce certain medications. Astronauts would grow the lettuce on the spacecraft, like is currently done on the International Space Station. The general concept is that if you need a medicine, the next time you grow a lettuce, you will grow it from seeds containing one of three genes – granulocyte-colony stimulating factor (GCSF), granulocyte macrophage colony stimulating factor (GMCSF) and parathyroid hormone (PTH) – and the lettuce will produce the medications you need. “GCSF and GMCSF would be particularly useful in space as they increase the number of blood cells in the patients; on earth GCSF-based drugs are used to increase the number of certain blood cells before chemotherapy or a stem cell transplant, while GMCSF-based drugs are used after chemotherapy or transplants to support white blood cell recovery. Therefore, drugs created from these genes could be useful in preventing the slowing of the cardiovascular system and changes in the immune system that occur from long-term weightlessness.” ]]> https://biospectrumindia.com/news/57/15680/microsoft-invests-40m-to-initiate-ai-for-health-.html https://biospectrumindia.com/news/57/15680/microsoft-invests-40m-to-initiate-ai-for-health-.html Thu, 30 Jan 2020 13:30:00 +0530 The health of people and communities around the world has been improving over time. For example, the steep decline in child and maternal mortality is a key indicator of positive momentum. However, progress has not been equal across the globe, and there is a great need to focus on societal issues such as reducing health inequity and improving access to care for underserved populations. While researchers work to unlock life-saving discoveries and develop new approaches to pressing health issues, advancements in technology can help accelerate and scale new solutions. That is why Microsoft is launching AI for Health, a new $40 million, five-year program to empower researchers and organizations with AI to improve the health of people and communities around the world. The program is underpinned with a strong foundation of privacy, security and ethics, and was developed in collaboration with leading health experts who are driving important medical initiatives. AI for Health is the fifth Microsoft AI for Good program, a $165 million initiative to empower researchers, nonprofits and organizations with advanced technologies to help unlock solutions to the biggest challenges facing society today. The AI for Health initiative will focus on three key areas: Quest for discovery. Accelerating medical research to advance prevention, diagnoses and treatment of diseases Global health insights. Increasing our shared understanding of mortality and longevity to protect against global health crises Health equity. Reducing health inequity and improving access to care for underserved populations “AI for Health is a philanthropic initiative that complements our broader work in Microsoft Healthcare,” wrote Microsoft’s John Kahan, Chief Data Analytics Officer in a blog post announcing the new program. “We will support specific nonprofits and academic collaboration with Microsoft’s leading data scientists, access to best-in-class AI tools and cloud computing, and select cash grants.” John Kahan said in statement that, “I am honored to lead AI for Health as part of my mission at Microsoft to fuse AI and data to address the world’s greatest challenges. As a tech company, it is our responsibility to ensure that organizations working on the most pressing societal issues have access to our latest AI technology and the expertise of our technical talent.” ]]> https://biospectrumindia.com/news/57/15663/astrazeneca-sells-hypertension-drugs-for-350m-to-atnahs.html https://biospectrumindia.com/news/57/15663/astrazeneca-sells-hypertension-drugs-for-350m-to-atnahs.html Wed, 29 Jan 2020 10:00:00 +0530 AstraZeneca has agreed to sell the global commercial rights to Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination) to UK based Atnahs Pharma (Atnahs). The agreement excludes the rights in the US and India, which were previously divested, and in Japan, which will be retained by AstraZeneca. The medicines, used primarily to treat hypertension, have lost their patent protection globally. Ruud Dobber, Executive Vice President, BioPharmaceuticals, said: “These are important established medicines, and the divestment to Atnahs ensures they will continue to be available to patients. This transaction supports our strategy to realise value from our portfolio of non-core mature brands, enabling further investment in new medicines.” AstraZeneca will continue to manufacture and supply Inderal, Tenormin, Tenoretic, Zestril and Zestoretic to Atnahs during a transition period. Financial considerations Atnahs will make an upfront payment of $350m to AstraZeneca. AstraZeneca may also receive future sales-contingent payments of up to $40m between 2020 and 2022. Income arising from the upfront and future payments will be reported in AstraZeneca’s financial statements within Other Operating Income & Expense. In 2018, Inderal, Tenormin, Tenoretic, Zestril and Zestoretic generated annual sales of $132m in the markets covered by this agreement. The divestment is expected to complete in the first quarter of 2020, subject to customary closing conditions and regulatory clearances. ]]> https://biospectrumindia.com/news/57/15665/noxopharm-to-bring-potential-transformative-drug-in-cancer-treatment-space.html https://biospectrumindia.com/news/57/15665/noxopharm-to-bring-potential-transformative-drug-in-cancer-treatment-space.html Wed, 29 Jan 2020 00:00:00 +0530 Headquartered in Australia, Noxopharm Limited (ASX: NOX) is a clinical-stage drug development company that has been in the limelight for its potential industry disruptive and revolutionary cancer therapy in late-stage prostate cancer where no life-extending therapies currently exist.With around 14 million new cases of cancer diagnosed worldwide each year, approximately 7 million patients are believed to possibly receive benefits from radiotherapy. Noxopharm is targeting this potential market opportunity with an objective to bring onboard its first-to-market, versatile, well-tolerated, effective enhancer of radiotherapy - Veyonda® which aims to restore the ability of the body’s immune system to fight and eradicate cancer.Noxopharm has developed a well-reasoned commercial strategy - the successful launch of Veyonda® into the market if possible, in the safest, quick and least expensive way, eyeing global level collaborations and research-oriented programs. Noxopharm has the vision to become a major drug discovery and drug development company, strongly underpinned by the encouraging outcomes from its DARRT-1 and LuPIN trials, primarily focused on prostate cancer. Noxopharm is further pushing the boundaries to explore cancer via strategically planned new studies that are in the research and development pipeline, including a potential brain cancer treatment drug program and an early cancer stem cell drug program.Noxopharm marked its 3rd Anniversary on the ASX (Australian Securities Exchange) in 2019. It is all set to step onto the international stage with its DARRT-2 trial in planning, presenting its clinical data at various conferences, while proactively engaging with U.S based clinicians for study development.Noxopharm also initiated its engagement with the US FDA through the IND process, which is a regulatory requirement to carry out clinical studies in the US. Moreover, the Company has lodged 6 patent families around Veyonda® and has received funding in excess of $A30 million through capital raising programs over the past three and a half years since its public listing.Noxopharm’s clinical and scientific teams, executive management and Board of Directors have been the backbone to its success so far. The Company has established a strong alliance with prominent experts in the prostate cancer field from both Australia and U.S., providing expert guidance on the clinical development of Veyonda® and the prospects to further build on these vital relationships and potential collaborations along the way to market approval. ]]> https://biospectrumindia.com/news/57/15655/merck-invests-250m-in-biotech-development-facility-in-switzerland.html https://biospectrumindia.com/news/57/15655/merck-invests-250m-in-biotech-development-facility-in-switzerland.html Mon, 27 Jan 2020 23:00:00 +0530 Merck, a leading science and technology company, announced an investment of US$250 million in a new facility in Corsier-sur-Vevey, Switzerland the Merck Biotech Development Center dedicated to biotech development and manufacturing for clinical studies. Driven by the growth of the Healthcare business sector R&D pipeline, this investment will help to sustainably secure capacity and high agility to deliver clinical trial material in a cost-effective way, contribute to accelerated development timelines of new biological entities, and address the increasing manufacturing complexity of the next generations of biotech compounds. This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines, said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck, at the groundbreaking ceremony for the new facility held today. Our investment in this biotech development facility in Switzerland is strongly related to the growth and progression of our Healthcare pipeline, and our confidence in its future potential,said Bel Garijo, Member of the Executive Board of Merck and CEO Healthcare. Located near Merck's current biotech commercial manufacturing site in Corsier-sur-Vevey, Switzerland, the Biotech Development Center will bridge together research and manufacturing. The facility will consist of a building providing a total of 15,700 square meters of development space bringing together a cross-functional team of approximately 250 employees spread across different sites today, responsible for advancing Merck's biotech R&D pipeline by ensuring that Merck's next generation of biotech therapies are available for clinical trials on time, on quality and on quantity. Equipped with the most advanced digital solutions and highest technological standards, including continuous manufacturing and laboratory automation, the Biotech Development Center will offer a flexible-by-design infrastructure to readily adapt to emerging needs and technology evolution, as well as open workspaces enabling collaboration, creativity and innovation. Everything will be designed to comply with the highest international standards of quality, environment, health and safety. Sustainable features in the new building will include an abundance of natural light, a highly efficient energy management, as well as an architectural design integrated into the landscape following the contours of the slope and preserving biodiversity with special habitats promoting wildlife and protected flora. The Biotech Development Center will showcase Merck's science and technology across its three business sectors, including Life Sciences process solutions for clinical manufacturing and pilot plant operations, as well as Performance Materials eyrise dynamic liquid crystal windows as part of the highly efficient energy management of the building. The construction of the building is expected to be completed in 2021 and the Biotech Development Center is anticipated to be fully operational by the end of 2022 following validation by regulatory authorities. The Biotech Development Center adds to recent investments aiming to further increase Merck's capacities in the research, development and manufacturing of medicines, such as the expansions of the R&D facility of Billerica, United States, of the biotech manufacturing site of Aubonne, Switzerland, and of the pharma manufacturing site of Darmstadt, Germany. With the existing sites of Corsier-sur-Vevey and Aubonne and the future Biotech Development Center, Switzerland further confirms its position as Merck's prime hub for the manufacturing and development of biotech medicines. Merck has invested more than one billion Swiss francs in Switzerland over the past ten years, reflecting the strategic importance of the country, where it employs more than 2,400 employees across 9 locations. ]]> https://biospectrumindia.com/news/57/15646/sungen-camber-launches-generic-bentyl-injection-in-us-market.html https://biospectrumindia.com/news/57/15646/sungen-camber-launches-generic-bentyl-injection-in-us-market.html Mon, 27 Jan 2020 11:50:00 +0530 US based SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products. SunGen has business partnerships with many North American, European and Asian-based generic pharmaceutical companies to develop, manufacture, and sell several pharmaceutical products around the world. SunGen Pharma has announced the U.S. launch and commercial shipment of generic version of Bentyl® (Dicyclomine) Injection, in collaboration with Camber Pharmaceuticals, a part of the Hetero Group of companies in Hyderabad, India which will be SunGen's distribution and marketing partner. Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) is a sterile injectable in a 2ml-vial. Dicyclomine is used to treat with severe irritable bowel syndrome and bowel spasms. Dicyclomine injection had total U.S. sales of $17 million for year of 2018 according to IQVIA. Isaac Liu, Ph.D., Co-CEO of SunGen, stated, "We are proud to add Dicyclomine to our growing portfolio of more than 40 specialty products. The launch of Dicyclomine Injection demonstrates our strong development and partnership capabilities. SunGen continues to expand its product development portfolio and has secured nine ANDA approvals and has an additional six filed with the FDA. We have also acquired or exclusively in licensed five ANDAs. We look forward to collaborating further to bring specialty pharmaceutical drugs to the markets around the world." Arun Nataraj, Ph.D., Camber's Vice-President of Business Development, commented, "Camber has had a remarkable track record of launching oral solid and oral liquid ANDA products successfully in the US marketplace. Now with the launch of our first injectable product, Camber is transitioning into the more complex generics space. We plan to launch more injectable products in 2020 as part of our growth and product diversification strategy." ]]> https://biospectrumindia.com/news/57/15631/researchers-reveal-influenza-vaccines-may-treat-cancer.html https://biospectrumindia.com/news/57/15631/researchers-reveal-influenza-vaccines-may-treat-cancer.html Fri, 24 Jan 2020 12:55:00 +0530 Physicians and scientists at Rush University Medical Center, Chicago have found that injecting tumors with influenza vaccines, including some FDA-approved seasonal flu shots, turns cold tumors to hot, a discovery that could lead to an immunotherapy to treat cancer. Inactivated flu vaccines can make tumors hot Currently, some immunotherapies utilize live pathogens (disease-causing organisms) as cancer treatments, but these treatments only have shown lasting effects in a limited number of patients and cancer types. "We wanted to understand how our strong immune responses against pathogens like influenza and their components could improve our much weaker immune response against some tumors," said Andrew Zloza, MD, PhD, assistant professor in Rush Medical College's Department of Internal Medicine and senior author of the study. Drawing on a National Cancer Institute database, researchers found that people who had lung cancer and hospitalization for a lung infection from influenza at the same time lived longer than those who had lung cancer with no influenza. They found a similar outcome in mice with tumors and influenza infection in the lung. "However, there are many factors we do not understand about live infections, and this effect does not repeat in tumors where influenza infections do not naturally occur, like skin," said Zloza. To find an alternative to the limitations of live infection, researchers inactivated the influenza virus, essentially creating a flu vaccine. They found that direct injection of this vaccine into the skin melanoma of the mice resulted in the tumors either growing slower or shrinking. The injection made the tumor hot by increasing the proportion of a type of immune-stimulating cells (called dendritic cells) in the tumor, leading to an increase in a type of cells known as CD8+ T cells, which recognize and kill tumor cells. Importantly, injecting a skin melanoma tumor on one side of the body not only resulted in the reduced growth of that tumor, but also in reduced growth of a second skin tumor on the other side of the same mouse that was not injected. The study authors note that they observed similar systemic outcomes in a mouse model of metastatic triple-negative breast cancer, in which both primary tumor growth and the natural spread of the breast tumor to the lungs were reduced after injection only into the primary tumor. "Based on this result, we hope that in patients, injecting one tumor with an influenza vaccine with lead to immune responses in their other tumors as well," Zloza said. FDA-approved flu shots also reduced tumor growth "Our successes with a flu vaccine that we created made us wonder if seasonal flu vaccines that are already FDA-approved could be repurposed as treatments for cancer," Zloza said. "Since these have been used in millions of people and have already been shown to be safe, we thought using flu shots to treat cancer could be brought to patients quickly." The researchers found that injection of such flu shots also resulted in reduction of tumor growth. To determine if similar results could be obtained with tumors from patients, the researchers developed a mouse model, which they call AIR-PDX. To create this model, they implant a piece of tumor and immune cells from a patient with cancer into a mouse that does not have a functioning immune system of its own - which prevents the mouse from rejecting the implanted cells. "Such transplant allows us to utilize patient-grade drugs in a living system. This is as close as we can get to testing something ahead of a clinical trial," Zloza said. The researchers used a patient's lung tumor and a melanoma metastasis in AIR-PDX models. They found that putting the flu shot in these patient-derived tumors causes them to shrink, while untreated tumors continued to grow. Influenza vaccines can be combined with immunotherapy Since new treatments are often compared to or combined with current frontline therapies for cancer, the researchers used immune checkpoint inhibitors in their studies. Immune checkpoint inhibition "releases the brakes" on immune cells so that they can fight the tumor. The researchers found that flu vaccines can reduce tumor growth when used alone, whether or not the tumor is responsive to checkpoint inhibitor therapy. When they combined the flu vaccine with a checkpoint inhibitor together, an even a greater reduction in tumor growth occurred. "These results propose that eventually both patients who respond and who do not respond to other immunotherapies might benefit from the injection of influenza vaccines into the tumor, and it may increase the small proportion of patients that are now long-term responders to immunotherapies," Zloza said. Not all effective flu vaccines work on cancer Five different influenza shots for the 2017-2018 flu season were used in this research. Four were effective in achieving the same results in fighting tumors. One flu shot with a synthetic adjuvant (an immune modifier) had no antitumor effect, and maintained other cells (called regulatory B cells or Bregs) that suppress an immune response. When the adjuvant was removed from the vaccine, it became effective. Similarly, when the B cells were removed, the vaccine also then became effective. That all five vaccines provided protection from flu infection, but one was ineffective in reducing tumor growth "demonstrates a disconnect between the principals of immune responses needed to fight pathogens versus tumors," Zloza said. "It also highlights the need for additional consideration regarding what adjuvants are included in immunotherapies and which vaccines could be used to treat cancer." Flu vaccine's FDA approval may speed clinical trials "Since humans and mice are about 95% genetically identical, the hope is that this approach will work in patients. The next step planned is to conduct clinical trials to test various factors," Zloza said. Clinical trials on average require four phases and can take between eight to 10 years to complete, but because the seasonal influenza vaccine is FDA-approved, the clinical trials for this study might be significantly shorter. "Although we are currently studying the use of other vaccines as well, the seasonal flu shot is safe and recommended for most people over 6 months of age, including most patients with cancer," Zloza said. "This is why we chose to start with it." "The flu shot is inexpensive and it has a quick translatability since it is an FDA-approved drug that we are repurposing," Zloza continued. Jochen Reiser, MD, PhD, professor in Rush Medical College, chairperson of the Department of Internal Medicine and a co-author of the study adds: "Turning one own's immune system against cancer using something as available and simple as a flu shot may help certain patients with cancer in the near future, instead of within a decade." ]]> https://biospectrumindia.com/news/57/15630/cepi-grants-9m-to-inovio-to-develop-coronavirus-vaccine-.html https://biospectrumindia.com/news/57/15630/cepi-grants-9m-to-inovio-to-develop-coronavirus-vaccine-.html Fri, 24 Jan 2020 12:10:00 +0530 Inovio Pharmaceuticals, USA has announced the Coalition for Epidemic Preparedness Innovations (CEPI) has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV). This initial CEPI funding will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI previously awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever and Middle East Respiratory Syndrome (MERS), also caused by a coronavirus. Inovio's participation in this developing effort is based on the ideal suitability of its DNA medicine platform to rapidly develop a vaccine against an emerging virus with pandemic potential, proven vaccine development capabilities and a strong track record of rapidly generating promising countermeasures against previous pandemic threats. Inovio was the first to advance its vaccine (INO-4700) against MERS-CoV, a related coronavirus, into evaluation in humans. Inovio is currently preparing to initiate a Phase 2 vaccine trial for INO-4700 in the Middle East where most MERS viral outbreaks have occurred. In a recently published paper in Lancet Infectious Diseases, Inovio's Phase 1 study of its MERS-CoV vaccine demonstrated it was well tolerated and furthermore induced high levels of antibody responses in roughly 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants. Durable antibody responses to INO-4700 were also maintained through 60 weeks following dosing. Richard Hatchett, CEPI's CEO, said, "Given the rapid global spread of the 2019-nCoV virus the world needs to act quickly and in unity to tackle this disease. Our intention with this work is to leverage our work with Inovio on the MERS coronavirus and rapid response platform to speed up vaccine development." Dr. J. Joseph Kim, Inovio's President & CEO said, "We're extremely honored to expand our partnership with CEPI to tackle this new threat to global public health. Our DNA medicine platform represents the best modern day approach to combatting emerging pandemics. We have already demonstrated positive clinical outcomes with our vaccine against MERS-CoV, another coronavirus. Importantly, following the Zika viral infection outbreak, Inovio and our partners developed a vaccine that went from bench to human testing in just seven months – the fastest vaccine development on record in recent decades. We believe we can further improve upon this accelerated timeline to meet the current challenge of the emerging coronavirus 2019-nCoV." Inovio's collaborators in this coronavirus vaccine development include the Wistar Institute, VGXI, a fully owned subsidiary of GeneOne Life Science and Twist Bioscience. ]]> https://biospectrumindia.com/news/57/15634/uk-to-create-digital-twin-of-human-heart.html https://biospectrumindia.com/news/57/15634/uk-to-create-digital-twin-of-human-heart.html Fri, 24 Jan 2020 12:00:00 +0530 A ‘digital twin’ of the human cardiovascular system will be developed for the first time by researchers at the University of Sheffield, UK. The ambitious project aims to transform how doctors diagnose and treat cardiovascular disease, giving patients real-time support to monitor their health alongside care from their doctor. The ‘Enhancing Cardiac Care Through Extensive Sensing’ (ECHOES) project will bring together international academic and industrial partners, to develop accessible wearable technology that can be used to capture the experiences, symptoms and cardiovascular data of an individual during their daily life. The University of Sheffield is a major partner in a research consortium of experts in cardiovascular medicine, science, engineering and computer science, that will develop this next generation health technology. Artificial intelligence and machine learning techniques will analyse the data alongside genetic and healthcare data, creating a digital twin of a patient’s heart to transform the diagnosis, monitoring and treatment of heart and circulatory diseases; leading to better patient outcomes and more effective treatment. ECHOES was announced as one of the four shortlisted international research projects competing for a single £30 million funding award from the British Heart Foundation’s Big Beat Challenge; a global initiative to galvanise researchers and inspire the development of transformational solutions to tackle the world’s biggest killer. ECHOES was chosen as a finalist due to its ‘radical’ approach to cardiovascular research and the clear benefit it could bring to patients. ]]> https://biospectrumindia.com/news/57/15628/evotec-indivumed-enter-into-second-joint-drug-discovery-program.html https://biospectrumindia.com/news/57/15628/evotec-indivumed-enter-into-second-joint-drug-discovery-program.html Fri, 24 Jan 2020 10:00:00 +0530 GErman firms Evotec SE and Indivumed GmbH have announced that the companies have entered into a new research collaboration to discover and develop first-in-class therapeutics for the treatment of non-small cell lung cancer ("NSCLC"). The final goal of this precision medicine collaboration is to deliver highly effective treatments for NSCLC patients. The collaboration will combine Evotec's proprietary bioinformatics analysis platform "PanHunter," as well as its small molecule and antibody discovery platforms, with the NSCLC cohort of Indivumed's true multi-omics cancer database "IndivuType," and its advanced analytics and AI capabilities. This agreement follows the successful progress of the companies' previous joint drug discovery program in the field of colorectal cancer, which was first announced in April 2019 and identified several novel drug targets by September 2019 that will be used in the development of new treatments for the disease. Working together, both parties will jointly invest in data analysis, target identification, validation and subsequent drug discovery. Evotec will be responsible for subsequent partnering of the programs and the platform. Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented, "We are excited to add this new discovery program to our successful precision medicine collaboration with Indivumed. We are confident that combining the highly complementary strengths of our companies will generate innovative drug candidates for clearly defined patient populations within non-small cell lung cancer who urgently need effective treatments." "We are delighted by this new collaboration with Evotec," said Prof. Dr Hartmut Juhl, CEO of Indivumed. "The fast and successful development of our previous joint colorectal cancer program has led to this new agreement, less than twelve months after the first one. Together we will discover and develop novel drugs for the treatment of NSCLC, using as a starting point our IndivuType multi-omics platform." Indivumed's focus on generating comprehensive high-quality oncology patient data is complementary to Evotec's capabilities in multi-omics data analysis and novel platforms for the generation of first-in-class and clearly differentiated small molecule and antibody therapies. No financial details of the agreement were disclosed.  ]]> https://biospectrumindia.com/news/57/15627/astrazeneca-to-support-unicef-with-12-5m-grant.html https://biospectrumindia.com/news/57/15627/astrazeneca-to-support-unicef-with-12-5m-grant.html Thu, 23 Jan 2020 16:05:00 +0530 AstraZeneca has announced that it will support UNICEF with a $12.5 million grant to support programming which will reach more than five million young people, train 1,000 youth advocates, and positively shape public policy around the world, over the next six years. The announcement follows AstraZeneca’s decision in October 2019 to continue to fund its Young Health Programme to 2025 with an overall commitment of $35m (£28m). The AstraZeneca Young Health Programme will work with UNICEF and other partners to raise awareness of the risks and effects of non-communicable diseases (NCDs) such as cardiovascular disease, preventable cancers and mental health conditions among young people and key decision-makers. The World Health Organisation (WHO) identifies NCDs as the number one cause of death worldwide1 and found that 70% of premature deaths from NCDs can be linked back to behaviours that first appear in adolescence. Similarly, the World Economic Forum (WEF) has predicted that NCDs will cost the worldwide economy more than $47 trillion in lost productivity and wages by 20303. Pascal Soriot, Chief Executive Officer said: “We believe in the power of young people to change the trajectory of the staggering burden of disease we face today, all over the world. Improving the health outcomes of future generations is a critical part of developing strong and stable healthcare systems, which in turn support sustainable markets and the economic prosperity of nations.” Since its launch in 2010, the Young Health Programme has reached more than 3.5 million young people across six continents and trained more than 50,000 peer educators. Gary Stahl, Director, UNICEF Private Fundraising and Partnerships, said: “The health and futures of young people must not be compromised by unhealthy lifestyles and behaviours. I am happy that UNICEF is joining a coalition of committed partners with the support of AstraZeneca to bring attention to NCDs which are now the world’s biggest killers. The burden of these diseases is closely linked to socio-economic factors and more work needs to be done on delivering the right messages through the right channels in countries to encourage healthy behaviours.” The other allies in the Young Health Programme are founding partner, and community-based programming lead, Plan International, youth engagement and development lead One Young World, and more than 30 other non-profit partners around the world, all working to improve health outcomes for young people through thoughtful programming, research and youth engagement activities. The Young Health Programme Since 2010 the Young Health Programme has reached over three million young people, through a mix of programmes, advocacy and research activities designed to increase awareness and understanding of NCD prevention. These have ranged over 24 countries and six continents from Australia to Zambia. Programmes range from one-to-one mentoring in Sweden, to long-running community-based behaviour change programmes involving hundreds of thousands of young people in Brazil and India. The methods may vary, but the drive is always the same – to help young people to lead longer, happier and healthier lives.   ]]> https://biospectrumindia.com/news/57/15626/advanced-biomatrix-acquires-hystem-for-rd-market.html https://biospectrumindia.com/news/57/15626/advanced-biomatrix-acquires-hystem-for-rd-market.html Thu, 23 Jan 2020 12:35:00 +0530 Advanced BioMatrix has acquired the HyStem® line of products from Lineage Cell Therapeutics – previously BioTime/ESI Bio/Glycosan. HyStem® kits are based on innovative thiolated hyaluronic acid technology. With HyStem®, researchers can create customizable 3D hydrogels for culturing cells whose natural environment is rich in hyaluronic acid. This acquisition includes the transfer of technology, intellectual property, know-how and assets for the manufacturing and sale of HyStem® products for research and development purposes. ABM and LTC are working closely together to ensure an efficient and seamless handover of the manufacturing, testing and distribution of products to users of the HyStem® products. ABM began providing and distributing HyStem® products on October 1, 2019. ABM plans to manufacture and supply the full product line including HyStem®, HyStem-C® and HyStem-HP® kits, as well as the individual kit components in bulk format. According to David Bagley, President of Advanced BioMatrix, “the HyStem® family of hyaluronan-based hydrogels is highly complementary and fits perfectly into our catalog of innovative 3D matrices and hydrogels. This acquisition will further strengthen the Advanced BioMatrix position as an industry leader in extracellular matrices and provide a broader range of high-quality products to our customers. We are eager to work with each of our existing and new customers to ensure unparalleled level of product quality and supply." HyStem® products have contributed to hundreds of breakthrough publications. In order to help continue the success of HyStem® products, Advanced BioMatrix is implementing the following: Production of HyStem® products in state-of-the-art manufacturing facility and cleanrooms. More rigorous quality control testing - rheology, viscosity and additional quality control tests on each batch of material to measure and control the consistency of HyStem® hydrogels. Stringent manufacturing protocols and specifications to ensure product lot-to-lot consistency. Provide a Certificate of Analysis for each batch of product. Utilization of the Advanced BioMatrix extensive distribution networks to minimize international shipping delays. ]]> https://biospectrumindia.com/news/57/15625/roches-risdiplam-meets-primary-endpoint-in-firefish-trial-.html https://biospectrumindia.com/news/57/15625/roches-risdiplam-meets-primary-endpoint-in-firefish-trial-.html Thu, 23 Jan 2020 12:15:00 +0530 Roche has announced positive topline results from the pivotal Part 2 of the FIREFISH study, evaluating risdiplam in infants aged 1-7 months with Type 1 spinal muscular atrophy (SMA). The primary outcome measure of the study was the proportion of infants sitting without support for at least five seconds at 12-months of treatment, assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Safety for risdiplam in the FIREFISH study was consistent with its known safety profile and no new safety signals were identified. To date, more than 400 patients have been treated with risdiplam across all studies, with no treatment related safety findings leading to study withdrawal in any risdiplam trial. “This large, global trial confirms the efficacy of risdiplam in an advanced and difficult-to-treat population, including many infants whose disease had already progressed significantly before starting treatment,” said Levi Garraway, M.D., Ph. D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are very encouraged by these results and we look forward to sharing them with regulators. We also thank the entire SMA community for their continued partnership.” Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier, designed to increase and sustain SMN protein levels throughout the central nervous system and in peripheral tissues. Roche leads the clinical development of risdiplam as part of a collaboration with the SMA Foundation and PTC Therapeutics. Data from the FIREFISH study will be presented at an upcoming medical congress. Risdiplam is being studied in a broad clinical trial programme in SMA, with patients ranging from birth to 60 years old, and includes patients previously treated with SMA-targeting therapies. The clinical trial population represents the broad real-world spectrum of people living with this disease with the aim of ensuring access for all appropriate patients. On November 11 2019, Roche announced positive results from Part-2 of SUNFISH, a study evaluating the efficacy and safety of risdiplam in people aged 2-25 years with Type 2 or 3 SMA. Also in November 2019, the U.S Food and Drug Administration granted Priority Review for risdiplam with a decision for approval by May 24, 2020.   ]]> https://biospectrumindia.com/news/57/15620/iqvia-features-in-fortunes-most-admired-company-list.html https://biospectrumindia.com/news/57/15620/iqvia-features-in-fortunes-most-admired-company-list.html Thu, 23 Jan 2020 10:00:00 +0530 IQVIA Holdings Inc. has been named to FORTUNE magazine’s “World’s Most Admired Companies” list. IQVIA has received this distinction every year, since its inception, following the merger between IMS Health and Quintiles in 2016. IQVIA is recognized in FORTUNE’s Healthcare: Pharmacy and Other Services category with high marks regarding efficient use of corporate assets, management quality, effectiveness in conducting business globally, and long-term investment value. “IQVIA is privileged to be on FORTUNE’s list of the World’s Most Admired Companies for the third consecutive year. This honor reinforces and recognizes the innovation and drive of our 65,000 employees around the world. Their work supports clients, providers, payers, and patients who benefit from our transformative advances in analytics and technology to improve healthcare outcomes,” said IQVIA Chairman and CEO Ari Bousbib. FORTUNE’s World's Most Admired Companies list is the definitive report card on corporate reputation. Since 1997, FORTUNE has identified, selected and ranked the World’s Most Admired Companies, identifying the business practices that make these companies highly regarded among their peers. Most Admired Company Survey Methodology FORTUNE collaborated with Korn Ferry on this survey of corporate reputation. They began with a universe of about 1,500 organizations comprising the 1,000 largest U.S. companies ranked by revenue, along with non-U.S. companies from FORTUNE’s Global 500 database that have revenues of $10 billion or more. The list was then winnowed to the highest-revenue companies within each industry, a total of 680 across 30 countries, and the top-rated companies were picked from that pool. To determine the best-regarded companies spanning 52 industries, Korn Ferry asked executives, directors, and analysts to rate enterprises within their own industry on nine criteria, from investment value and quality of management and products to social responsibility and ability to attract talent. A company’s score had to rank in the top half of its industry peer group to be listed. ]]> https://biospectrumindia.com/news/57/15614/fda-approves-tepezzatm-to-treat-thyroid-eye-disease.html https://biospectrumindia.com/news/57/15614/fda-approves-tepezzatm-to-treat-thyroid-eye-disease.html Wed, 22 Jan 2020 14:25:00 +0530 Ireland headquartered Horizon Therapeutics plc has announced that the U.S. Food and Drug Administration (FDA) has approved TEPEZZATM (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). TEPEZZA is the first and only FDA-approved medicine for the treatment of TED, a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation and facial disfigurement. TEPEZZA is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions. “Today is a great day for people living with Thyroid Eye Disease, a rare, vision-threatening disease that previously had no FDA-approved treatment options,” said Timothy Walbert, chairman, president and chief executive officer, Horizon. “The TED community has gone far too long without an FDA-approved therapy, and we are grateful to the people living with TED and physicians who partnered with us on the clinical development program that led to today’s approval of TEPEZZA. This also marks the early approval of Horizon’s first Biologics License Application – a key step in our evolution to an innovation-focused biopharma company, developing new medicines for debilitating diseases with few or no treatment options.” The FDA approval of TEPEZZA comes ahead of the Prescription Drug User Fee Act (PDUFA) goal date of March 8, 2020. The medicine received Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA. “The FDA approval of TEPEZZA is momentous for the TED community and has the potential to change the treatment paradigm for TED – providing new hope for people who are living with this horrible, vision-threatening disease,” said Raymond Douglas, M.D., Ph.D., director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center and co-principal investigator of the TEPEZZA Phase 3 confirmatory clinical trial. “Today’s news brings forward a medicine for patients that targets the underlying biology of the disease and has been shown to significantly improve eye bulging and double vision, which are the most debilitating aspects of the disease.” “TEPEZZA is a much-needed breakthrough for a community of people who have historically had to struggle in pain as their symptoms progress – risking permanent damage to their eyes and making it extremely difficult to go about their daily lives,” said Jeff Todd, president and chief executive officer, Prevent Blindness. “This approval is meaningful to our organization because we are committed to helping patients with vision impairment and those who are at significant risk.” Horizon will conduct a post-marketing study to evaluate safety in a larger patient population as was discussed at the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) FDA Advisory Committee meeting on December 13, 2019, where the committee voted unanimously (12-0) that TEPEZZA demonstrated a positive benefit risk profile. This study will also evaluate retreatment rates relative to how long patients receive the medicine. As a result of the FDA approval of TEPEZZA, Horizon will make approximately $105 million in milestone payments during the first half of 2020. ]]> https://biospectrumindia.com/news/57/15612/inotrem-collaborates-with-roche-for-septic-shock-diagnosis.html https://biospectrumindia.com/news/57/15612/inotrem-collaborates-with-roche-for-septic-shock-diagnosis.html Wed, 22 Jan 2020 11:50:00 +0530 French firm Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway with potential applications for acute and chronic inflammatory syndromes, has announced that it has entered a worldwide licensing agreement with Roche Diagnostics for the commercialization of a mechanism-based companion diagnostic test using a soluble plasma protein (sTREM-1). This agreement consolidates existing ties between Roche Diagnostics and Inotrem who are jointly developing since 2017 an in vitro assay for measurement of sTREM-1 in plasma samples of septic shock patients. Measurement of sTREM-1 in blood provides a valuable indicator for the severity and outcome prediction of septic shock patients. Inotrem has recently initiated its Phase IIb study in septic shock patients (ASTONISH trial) and enrolled its first patient. The study aims at demonstrating efficacy of its lead compound, nangibotide, and bring a clinically relevant proof of clinical activity in septic shock patients. This study also intends to confirm the value of soluble TREM-1 as a potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment. ]]> https://biospectrumindia.com/news/57/15608/microvention-announces-fda-premarket-approval-of-new-flow-diverter-.html https://biospectrumindia.com/news/57/15608/microvention-announces-fda-premarket-approval-of-new-flow-diverter-.html Wed, 22 Jan 2020 11:20:00 +0530 MicroVention, Inc., a U.S. based subsidiary of Terumo and a global neurovascular company announced the FDA Premarket Approval (PMA) for the FRED™ (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms. The FRED™ device is the first flow diverter in the U.S. to use a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion. The unique interwoven nitinol design of the FRED™ device allows for smooth delivery to the target aneurysm, as well as reliable opening and vessel wall apposition, resulting in high treatment durability. Dr. Cameron McDougall, Director of Endovascular Neurosurgery and Professor of Neurosurgery at The Johns Hopkins Hospital, and primary investigator for the FRED™ pivotal trial said, “The FRED™ device represents a step forward in flow diversion technology with the inclusion of the lowest profile delivery platform in the U.S. This advancement will allow physicians to more easily access and treat wide-necked or fusiform aneurysms. The pivotal study shows that a single FRED™ device is safe and effective for use in a variety of aneurysm sizes and locations and expands treatment options for patients.” Irina Kulinets, PhD, Sr. WW Vice President of Regulatory Affairs, Clinical Research & Quality at MicroVention said, "With our 3rd PMA approval by the Food and Drug Administration in 18 months, MicroVention is proud to introduce the FRED™ flow diversion device to the United States. The FRED™ device helps address a need for a clinically proven flow diverter with simplified delivery. MicroVention is dedicated to the development of novel technologies that improve patient outcomes and quality of life. We are excited to bring the FRED™ device to patients in the U.S. who will benefit from treatment." The FRED™ device has been CE marked since 2013, safely used in nearly 20,000 procedures, and published in numerous clinical studies around the world. The FRED™ device pivotal study adds new evidence to the large existing body of global clinical data, further demonstrating the safety and effectiveness of the device. ]]> https://biospectrumindia.com/news/57/15607/european-commission-approves-roches-polivy-for-people-with-previously-treated-aggressive-lymphoma.html https://biospectrumindia.com/news/57/15607/european-commission-approves-roches-polivy-for-people-with-previously-treated-aggressive-lymphoma.html Wed, 22 Jan 2020 00:00:00 +0530 Roche today announced that the European Commission has granted conditional marketing authorisation for Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant. “With this approval, people in the EU with relapsed or refractory diffuse large B-cell lymphoma will have the opportunity to benefit from this new Polivy combination,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “For patients battling this aggressive disease, the prognosis is poor and few treatments are available. We are proud to bring this first-in-class treatment option to those who need it most.” The conditional approval is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a haematopoietic stem cell transplant. Results of the study showed that 40% of people treated with Polivy plus BR achieved a complete response (n=16/40), meaning no cancer could be detected at the time of assessment, compared to 17.5% (n=7/40) with BR alone. Complete response rates were assessed by an independent review committee. The study also showed that OS more than doubled, with a median of 12.4 months in the Polivy arm vs. 4.7 months in the BR alone arm (HR=0.42). Furthermore, patients treated with Polivy plus BR showed a longer time between first response to treatment and disease worsening than those receiving BR alone (investigator assessed median duration of response: 10.3 months vs. 4.1 months; HR=0.44). The most commonly reported adverse events in people treated with Polivy in combination with BR included anaemia, thrombocytopenia, neutropenia, fatigue, diarrhoea, nausea, and pyrexia. Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. Today’s conditional EU approval follows the US Food and Drug Administration’s (FDA) accelerated approval of Polivy in combination with BR for the treatment of people with R/R DLBCL who have received at least two prior therapies, in June 2019. Polivy was granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of people with R/R DLBCL in 2017, the first PRIME designation for a Roche medicine. Additional submissions of the GO29365 data to health authorities around the world are ongoing with the goal of bringing this new treatment option to more patients as soon as possible. ]]> https://biospectrumindia.com/news/57/15596/seekyo-raises-800k-from-french-tech-seed-fund.html https://biospectrumindia.com/news/57/15596/seekyo-raises-800k-from-french-tech-seed-fund.html Tue, 21 Jan 2020 12:15:00 +0530 France based Seekyo, a privately-owned biotech start-up specializing in the development of the next generation of chemotherapies, announces that it has completed a seed round of fundraising to the value of €800k ($889K). The funds will allow the company to accelerate the development of its flagship drug candidate, before launching a new fundraising round that will address clinical trials. For this round, Seekyo benefited from the support of investors and of the French Tech Seed Fund, which is intended to give leverage to private investment in technology companies less than three years old. Its round table was based on a fundraising of €400,000 ($445K) from a pool of investors from the BAdGE, INVESTESSOR and SYNERGENCE business angel networks, reinforced by a €150,000 ($167K) European Investment Fund (EIF) Investment Initiation Loan. The French Tech Seed Fund, managed by Bpifrance, the French Public Investment Bank, completed the fundraising by providing €250,000 ($278K) in convertible bonds. This additional funding is a direct result of the labeling of Seekyo by the French Tech Seed Paris-Saclay consortium. The French biotechnology company was co-founded in 2018 by Oury Chetboun and Prof Sébastien Papot (CNRS/University of Poitiers, France). Seekyo develops a drug candidate that can specifically target solid tumors (pancreas, lung, triple negative breast, colon, head and neck). Based on its patented molecular platform, the drug is transported in an innocuous manner in the form of therapeutic vectors that detect the tumor and trigger its anticancer activity only in malignant tissues. The drug is activated in the tumor microenvironment via an extracellular and highly specific enzymatic cleavage. This increases the effectiveness of anticancer drugs, while considerably reducing their adverse effects. In 2018, the total number of new cases of cancer worldwide was estimated to be 18.1 million. It is also estimated that one in two men and one in three women will develop cancer before the age of 85. The total number of cancer-related deaths worldwide in 2018 was nearly 10 million (source: World Health Organization). More than 40% of cancers are solid tumors for which chemotherapy is one of the main forms of treatment. This relies on the use of drugs to eliminate cancer cells. Unfortunately, chemotherapy attacks not only cancer cells, but also healthy ones, causing significant adverse effects to patients. Drugs on the market or in development seek to be more selective in their targeting, such as Antibody Drug Conjugates (ADC). However, they have already demonstrated their own limitations in the treatment of solid tumors, including low tissue penetration and cancer cells heterogeneity. The chemotherapy drugs developed by Seekyo constitute an alternative to ADCs. Seekyo has already conducted preclinical studies with its drug candidate SKY01, with very promising results. The company also develops a pipeline of early stage drug candidates based on its molecular platform. “SKY01 is a therapeutic vector carrying a powerful cytotoxic agent that can be activated in the tumor microenvironment via an extracellular and highly specific enzymatic cleavage. With this, Seekyo positions itself as an alternative to the already identified limitations of treatments, such as ADCs, including targeting the tumor microenvironment without using monoclonal antibodies,” said Prof Sebastien Papot, CSO and co-founder of Seekyo. “We are very happy to support Seekyo which is embarking on a promising development with high technological intensity,” said Mame Dieye, regional director at Bpifrance Poitiers. “We are very pleased to have attracted new financial partners to push forward the development of our company and our drug candidate,” said Oury Chetboun, CEO of Seekyo. “The funds will allow us to consolidate the promising results in mice by conducting toxicology and pharmacokinetics tests. We are also preparing a new round of fundraising in 2020 to conduct regulatory preclinical trials, with the goal of entering human clinical trials within 24 months.” ]]> https://biospectrumindia.com/news/57/15582/civica-collaborates-with-thermo-fisher.html https://biospectrumindia.com/news/57/15582/civica-collaborates-with-thermo-fisher.html Mon, 20 Jan 2020 10:05:00 +0530 US based drug manufacturer Civica Rx (Civica, Inc.) has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications with Civica as the owner of the regulatory pathway. By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug shortages in the future. This partnership has an initial seven-year term and represents a key component of Civica’s manufacturing strategy. By partnering with Thermo Fisher, Civica will begin to build its internal pipeline of medications for use in emergency and critical care in the United States. To date, Civica has worked with multiple quality drug manufacturers that already have U.S. FDA approved manufacturing facilities and capacity to produce Civica labeled drugs in an effort to get shortage medications to market immediately. “We are thrilled to enter into a partnership with a world class organization that is dedicated to helping Civica serve patients,” said Martin VanTrieste, Civica’s President and CEO. “The Thermo Fisher team is known for top manufacturing talent, supply reliability, product quality and innovation. We look forward to working with them to develop and produce Civica medicines.” “We thank Civica for their confidence in our team and capabilities and welcome this opportunity to work with them to help mitigate the risk of drug shortages in the U.S.,” said Mike Shafer, President of Thermo Fisher’s Pharma Services business. “Together we will be able to deliver medicines to the market sooner to the patients who are waiting.” Initially the Thermo Fisher collaboration will focus on nine critical medications that have been in short supply or where the drug supply chain is fragile because there are too few manufacturers making these drugs. Civica’s hospital-led drug selection and medical trends advisory committees helped prioritize these medications for Civica’s Research & Development efforts. Civica was founded in 2018 by leading US hospital systems concerned about generic drug shortages and philanthropic organizations passionate about improving healthcare. To date, nearly 50 health systems are Civica members, representing more than 1,200 US hospitals and over 30 percent of all licensed US hospital beds. Civica currently has 18 medications in production and/or shipped for use in hospitals across the country. ]]> https://biospectrumindia.com/news/57/15574/agilent-assists-in-eczema-research-in-the-uk.html https://biospectrumindia.com/news/57/15574/agilent-assists-in-eczema-research-in-the-uk.html Fri, 17 Jan 2020 06:00:00 +0530 Agilent Technologies Inc. is collaborating with researchers at two UK universities who are looking into the risk factors for atopic eczema (also known as atopic dermatitis), a chronic skin condition that affects one in five children and one in 12 adults. The aim of the collaboration is to help the medical community diagnose the condition early and to administer the best possible treatment. To that end, UK researchers at the University of Sheffield and the University of Manchester are conducting a study to follow a group of 175 babies during their first year of life to see how skin matures, and identify which babies are most at risk of developing eczema. Underpinning the study is the researcher’s use of Agilent’s specialized Fourier-transform infrared (FTIR) spectroscopy technology. Agilent has developed a prototype sampling approach that enables researchers to work non-invasively, and with speed and accuracy. This technology, built around Agilent’s 4300 Handheld FTIR, is already being used in studies for direct skin measurements, where it provides higher-quality data more reliably when compared to prior methods. Agilent is currently considering making the new sampling device available so that others working in skin research can take advantage of its unique capabilities. The early identification of high-risk babies creates an opportunity to prevent eczema developing—and could also potentially be used to prevent the development of other inflammatory skin disorders. ]]> https://biospectrumindia.com/news/57/15565/scientists-breach-brain-barriers-to-attack-tumors.html https://biospectrumindia.com/news/57/15565/scientists-breach-brain-barriers-to-attack-tumors.html Thu, 16 Jan 2020 13:30:00 +0530 The brain is a sort of fortress, equipped with barriers designed to keep out dangerous pathogens. But protection comes at a cost: These barriers interfere with the immune system when faced with dire threats such glioblastoma, a deadly brain tumor for which there are few effective treatments. Yale researchers have found a novel way to circumvent the brain's natural defenses when they're counterproductive by slipping immune system rescuers through the fortresses' drainage system. "People had thought there was very little the immune system could do to combat brain tumors," said senior corresponding author Akiko Iwasaki. "There has been no way for glioblastoma patients to benefit from immunotherapy." Iwasaki is the Waldemar Von Zedtwitz Professor of Immunobiology and professor of molecular, cellular, and developmental biology and an investigator for the Howard Hughes Medical Institute in the US. While the brain itself has no direct way for disposing of cellular waste, tiny vessels lining the interior of the skull collect tissue waste and dispose of it through the body's lymphatic system, which filters toxins and waste from the body. It is this disposal system that researchers exploited in the new study. These vessels form shortly after birth, spurred in part by the gene known as vascular endothelial growth factor C, or VEGF-C. Yale's Jean-Leon Thomas, associate professor of neurology at Yale and senior co-corresponding author of the paper, wondered whether VEGF-C might increase immune response if lymphatic drainage was increased. And lead author Eric Song, a student working in Iwasaki's lab, wanted to see if VEGF-C could specifically be used to increase the immune system's surveillance of glioblastoma tumors. Together, the team investigated whether introducing VEGF-C through this drainage system would specifically target brain tumors. The team introduced VEGF C into the cerebrospinal fluid of mice with glioblastoma and observed an increased level of T cell response to tumors in the brain. When combined with immune system checkpoint inhibitors commonly used in immunotherapy, the VEGF-C treatment significantly extended survival of the mice. In other words, the introduction of VEGF-C, in conjunction with cancer immunotherapy drugs, was apparently sufficient to target brain tumors. "These results are remarkable," Iwasaki said. "We would like to bring this treatment to glioblastoma patients. The prognosis with current therapies of surgery and chemotherapy is still so bleak." The study was primarily funded by the Howard Hughes Medical Institute and the National Institutes of Health. Other Yale authors are Tianyang Mao, Huiping Dong, Ligia Simoes,Braga Boisserand, and Marcus Bosenberg. Salli Antila and Kari Alitalo of the University of Helsinki are also authors. ]]> https://biospectrumindia.com/news/57/15563/sygnature-discovery-hires-new-senior-management-team.html https://biospectrumindia.com/news/57/15563/sygnature-discovery-hires-new-senior-management-team.html Thu, 16 Jan 2020 12:40:00 +0530 UK based company Sygnature Discovery has further strengthened its DMPK (drug metabolism and pharmacokinetics) capabilities, with the addition of new senior scientists to the management team.   Clive Dilworth has been recruited as Director of DMPK. He replaces Tim Schulz-Utermoehl, who had been heading up the DMPK team on a part-time basis alongside his work with several biotech start-ups, on which he is now going to focus on full time.Dilworth joins from a management role at the Alderley Park life science campus, where he provided strategic and scientific guidance for start-ups and CROs at the site. Prior to this, he spent 20 years working in DMPK roles at various CROs, most recently Cyprotex and Evotec. He has a PhD in toxicology from the London School of Pharmacy.Another recent recruit to the DMPK team is Robert Kime, who joined Sygnature as Associate Director of DMPK in November, and reports to Dilworth. He was recruited from the mid-sized pharma company Grünenthal, where he was Associate Scientific Director. Before that, he had roles at CROs including Quintiles.Kime brings important client-side experience to the team. ‘Having run drug discovery projects within a pharma company using an integrated approach, I understand what a client needs from a CRO,’ Kime says. ‘My experience on both sides of the fence gives me an insight into client thinking, and what they need from us to be reassured we can do the job for them.’In addition to Dilworth and Kime, Sally Lee has joined Sygnature Discovery as a Principal Scientist bringing over 20 years of DMPK experience in both assay and Project Management roles. In her previous position at AMR (AntiMicrobial Resistance) Centre, she coordinated DMPK requests for novel antimicrobials targeting the threat of antibiotic resistance.Sygnature’s DMPK team now numbers 37, with a group of 24 in the Nottingham labs and a further 13 in Alderley Park. Further expansion is planned this year in order to meet the growing global demand for Sygnature’s DMPK capabilities.‘As well as adding new skills and techniques to our DMPK portfolio, we are strengthening the expertise we already have,’ Dilworth says. ‘Our presence in both Nottingham and Alderley Park gives our clients access to a large pool of talented scientists and capabilities. We aim to expand the DMPK groups in both sites to provide our clients with a harmonised and efficient service.’ ]]> https://biospectrumindia.com/news/57/15569/bosch-packaging-technology-is-now-syntegon.html https://biospectrumindia.com/news/57/15569/bosch-packaging-technology-is-now-syntegon.html Thu, 16 Jan 2020 00:00:00 +0530 Syntegon Technology is the new name among the market leaders in the processing and packaging industry. Known as Bosch Packaging Technology until late 2019, the former Bosch division today presented itself as an independent enterprise at the company headquarters in Waiblingen (Germany). Syntegon Technology’s business focus is on intelligent and sustainable technologies for the pharmaceutical and food industries. Extending the service range is a priority for the company. Syntegon Technology employs 6,100 people at more than 30 locations worldwide. It posted 1.3 billion euros in sales in 2019. Bosch disclosed its plans to sell the packaging machinery division to a newly incorporated entity managed by CVC Capital Partners, a leading private equity and investment advisory firm, in July 2019. The transaction was completed according to plan, with the company gaining full independence at the turn of the year. Transaction wrapped up on schedule as business development remains stable The sale of Bosch Packaging Technology was completed on January 2, 2020, as envisioned. Bosch had announced in June 2018 that it intended to sell its packaging division, finding a buyer a year later in CVC Capital Partners (CVC). Bosch Packaging Technology then expanded its headquarters in Waiblingen, Germany, augmenting it with new departments required for the switch. Business developments remained stable in the interim, bucking the trend in the sluggish machine engineering sector. Sales in 2019 came to 1.3 billion euros, matching the previous year’s figure. The new owner, CVC, aims to vigorously develop the company as a whole and expand intra-group synergies. Commenting on the closing of the sale, Marc Strobel, a partner at CVC Capital Partners said, “CVC is delighted to see the transaction completed on schedule. Syntegon Technology has a strong presence in many market segments, great technological know-how, and innovative power. We want to build on these strengths jointly with management and the entire workforce.”  Into the future with a new brand “Processing and packaging technology for a better life!” This is Syntegon’s mission statement. The company is determined to improve the lives of consumers and patients with intelligent and sustainable processing and packaging solutions. A new corporate brand was developed over the past few months. The name Syntegon stands for synergy, technology, and focus on the future. The new corporate colour green underscores the importance of sustainability and health. The square in the newly designed logo symbolizes a package as well as packaging technology’s ability to protect products. The entire workforce will celebrate the independent company’s launch with management on January 16, 2020. The ceremony at the Waiblingen headquarters, broadcasted live around the world, will be followed by events held at the individual locations. Syntegon Technology will share the news with its business partners today. Chairman of the Executive Board Dr Stefan König takes this opportunity to send an emphatic message: “We are building on 150 years of experience and the 64,000 machines deployed by our customers, and pursuing new avenues of business. Now, more than ever before, we are working on intelligent and sustainable technologies and embracing the collaboration with our business partners in the true spirit of partnership.”  Greater flexibility and focus on caring partnerships This newly gained independence enables Syntegon Technology to be even more flexible. And newly added departments at the headquarters such as Purchasing and IT shorten the distances between in-house units and facilitating interaction with customers and suppliers. Whereas the company had been part of a large corporation with diverse divisions, it can now create a business framework that is an even better fit for the industry. This new setup will enable the company to enhance its profile as a leading processing and packaging company. Syntegon Technology aims to set new priorities for services. Impelled by the spirit of partnership with its customers, the company is striving to improve its processes. One goal is to reduce response times to customer enquiries; another is to further increase the availability of service technicians. Syntegon Technology is also investing in a customer and technology centre at its Waiblingen headquarters. The processing and packaging technology company collaborates with global corporations and regional market leaders and is determined to offer even more attractive services for medium-sized enterprises and startups.  Intelligent and sustainable technologies Syntegon Technology has intensified its efforts to develop intelligent and sustainable technologies. Drawing on a deep well of experience in developing and integrating software solutions, the company uses connected components as well as components enhanced with artificial intelligence to this end. It puts a premium on ensuring sophisticated technologies are simple to use. The greater goal is to collect and evaluate data to avoid machine downtime, maximize product quality, and optimize overall plant efficiency. The enterprise is pursuing two approaches to produce sustainable packaging – one is to use mono materials rather than conventional multilayer films, and the other is to use paper packaging as an alternative to plastic. Syntegon Technology supports its customers on the path to a sustainable future with material testing, machine applications, and innovative packaging designed to meet the requirements of products, transport modes, and regional circumstances. The company has also significantly reduced its machines’ energy consumption. ]]> https://biospectrumindia.com/news/57/15551/takeda-to-outline-progress-at-the-38th-annual-j-p-morgan-healthcare-conference.html https://biospectrumindia.com/news/57/15551/takeda-to-outline-progress-at-the-38th-annual-j-p-morgan-healthcare-conference.html Wed, 15 Jan 2020 10:25:00 +0530 Takeda Pharmaceutical Company Limited will provide an update on the progress of its business transformation and priorities today at the 38th Annual J.P. Morgan Healthcare Conference. President and Chief Executive Officer, Christophe Weber, will share details on Takeda’s portfolio and pipeline strategy, financial outlook, and ongoing sustainability efforts, including its newly established commitment to carbon neutrality across its value chain. “Last year was an important and successful year for Takeda as we accelerated our transformation to become a leading global biopharmaceutical company,” said Mr. Weber. “Our commitment to bringing better health and a brighter future to patients worldwide continues as we expand our global brands and advance our next-generation pipeline, driving sustainable growth. We also recognize that supporting our patients means we must commit to work on behalf of the broader global community – and one way to do this is by accelerating our environmental efforts.” Commercial Strategy and Innovative Pipeline As highlighted at its recent R&D Investor Day event in November 2019, Takeda continues to generate significant opportunities through new indications and geographic expansion of its 14 global brands. By cultivating the best science through its research and development engine, comprised of internal capabilities and external partnerships, Takeda is quickly advancing a steady stream of next-generation therapies designed to provide transformative or curative potential for targeted populations with high unmet medical needs in its core therapeutic areas of oncology, rare diseases, neuroscience and gastroenterology. Over the next several years, Takeda’s pipeline is projected to deliver value with a focus on the potential launches of 12 unique new molecular entities (NMEs) in 14 indications, which represent best-in-class or first-in-class therapies to advance patient standard of care, and that have the potential to deliver more than $10 billion (USD) in aggregate peak sales. Takeda is confident in its ability to execute in the near-term and achieve sustainable growth through 2024 and beyond, with its portfolio of 14 global brands and additional anticipated product launches intended to fuel its growth trajectory while its next-generation platforms mature.  Additional Highlights include: ~40 NME clinical stage assets; 17 NMEs in Phase 2 and Phase 3 ≥15 potential new launches within the next five years in China 8 potential best-in-class/first-in-class NMEs in pivotal studies ~50% of pipeline with orphan drug designation Diversified modalities in research, including cell and gene therapies, small molecules and biologics Financial Strength Takeda is committed to maintaining investment grade credit ratings and remains on track towards its target of 2x Net Debt/adjusted EBITDA ratio within the fiscal years ending March 2022 to March 2024, with rapid de-leveraging driven by strong cash flow and proceeds from non-core asset divestitures. In the first six months of FY19, Takeda reduced its Net Debt/adjusted EBITDA ratio from 4.7x to 3.9x. In addition, four non-core asset divestitures were announced that, together with other potential divestments, are expected to reach $10 billion (USD). Through expected cost synergies from the acquisition of Shire that are expected to reach a run rate of approximately $2 billion (USD) annually and operating expenditure efficiencies, Takeda is also driving towards its target of a mid-30% underlying core operating profit margin within the fiscal years ending March 2022 through March 2024. Takeda remains committed to shareholder returns with a well-established dividend policy of 180 yen per share annually. Values-Driven Commitment to ESG (Environment, Social, Governance) Recognizing that climate change poses a risk to human health, including the spread of infectious diseases, Takeda has made environmental efforts a priority. To date, Takeda has met and exceeded its previously established 2020 environmental goals ahead of schedule, including reducing its CO2 emissions by 33.7% compared to 2005 levels. Furthering the Company’s commitment to the environment, today Takeda will unveil its new 2040 targets to achieve carbon neutrality across its value chain. Takeda intends to do this by eliminating all greenhouse gas (GHG) emissions from its operations (Scopes 1 and 2), working with its suppliers to significantly reduce their emissions (Scope 3), and addressing remaining Scope 3 emissions through verified carbon offsets. Beginning with FY19 GHG emissions, the Company commits to carbon neutrality (Scopes 1, 2, and 3) through the purchase of renewable energy and verified carbon offsets, while simultaneously working to reduce emissions from its operations and suppliers. In addition to Takeda’s environmental efforts, its overall commitment to ESG – including the Access to Medicines Strategy and Global Corporate Social Responsibility (CSR) Program – has been recognized by multiple benchmark ESG indices. Since 2014, Takeda has risen 15 spots to No. 5 in the latest Access to Medicines Index, which measures commitment and achievements in the field of patient access to medicine and treatment globally. Takeda is proud to have provided access to innovative and potentially life-saving treatments to more than 125,000 patients. In addition, its CSR Program has committed over $100 million (USD) to organizations that work to prevent diseases and improve health outcomes around the world. Takeda is proud that employees are engaged and select the organizations that the CSR Program supports. Takeda’s 2019 Sustainable Value Report provides additional details on the its commitment to ESG. ]]> https://biospectrumindia.com/news/57/15544/biomed-x-commences-schizophrenia-research-program-with-bi.html https://biospectrumindia.com/news/57/15544/biomed-x-commences-schizophrenia-research-program-with-bi.html Wed, 15 Jan 2020 06:00:00 +0530 BioMed X has announced the start of a new joint research group in collaboration with Boehringer Ingelheim at the BioMed X Innovation Center in Heidelberg. The aim of the new research project is to investigate myelination deficits of the adolescent brain in connection with the development of schizophrenia. Psychiatric disorders such as schizophrenia emerge as consequence of abnormal brain development and maturation. During adolescence, the brain is reorganized for mature function by processes such as cortical myelination, dendritic arborization, synaptic pruning, and circuit plasticity. Particularly in schizophrenia, there is evidence that genetic, epigenetic and environmental factors negatively affect the balanced functional maturation during adolescence and cumulatively increase the risk for developing symptoms. The new group supported by Boehringer Ingelheim will specifically investigate the myelination deficits, which have been observed in the brains of schizophrenia patients. The innovative approach includes the development of in vitro and in vivo platforms to study oligodendrocyte development and myelination. The goal of the project is to identify novel extrinsic (neuronal) and intrinsic (oligodendrocytic) factors affecting myelination as potential new targets for the prevention of schizophrenia in high-risk individuals. “We are excited to further extend our collaboration with Boehringer Ingelheim”, said Christian Tidona, founder and Managing Director of BioMed X. “This is already our fourth joint research group with Boehringer Ingelheim and our second in the field of psychiatric diseases. The new project will significantly extend our expertise and capabilities in the field of neurosciences.” ]]> https://biospectrumindia.com/news/57/15553/genscript-biotech-global-forum-highlights-advances-in-cell-and-gene-therapy-and-opportunities-in-china.html https://biospectrumindia.com/news/57/15553/genscript-biotech-global-forum-highlights-advances-in-cell-and-gene-therapy-and-opportunities-in-china.html Wed, 15 Jan 2020 00:00:00 +0530  GenScript Biotech Corp., a leading global biotechnology group and a pioneer in the field of gene synthesis, today held its inaugural "Global Forum on Cell & Gene Therapy and the Booming China Market," during the JP Morgan Healthcare Conference week, attracting hundreds of industry leaders, investors and others to address the challenges and opportunities in this innovative field. "As an industry, we are on the brink of achieving some extraordinary breakthroughs in cell and gene therapy for cancer and other diseases," said GenScript Biotech CEO Frank Zhang, PhD. "Four gene and cell therapies have recently been approved by the FDA, bringing new hope to patients, and this is only the beginning. Our vision is to make cancer a chronic or curable disease rather than a deadly one, and to transform the treatment of cancer, autoimmune and other diseases by leveraging the advantages of cell and gene therapy." While significant advances are being made, the Forum also tackled some of the more pressing challenges, such as mitigating treatment side effects, improving treatment efficacy in solid tumors and scaling up manufacturing. Panelists from Kite Pharma, GE Healthcare Life Sciences, Ziopharm Oncology, Oxford Biomedica, Genethon, CARsgen Therapeutics, J&J Innovation Asia Pacific, the American Society of Gene & Cell Therapy, Loncar Investment, Lilly Asia Ventures, and many others participated in the event. In the U.S. alone, the U.S. Food and Drug Administration is expected to approve 40-60 cell and gene therapies by 2030. During a panel discussion focused on regulatory issues, experts considered what regulators will need to do to keep up with the rapid pace of innovation, the new hospital-based regulatory pathway in China, how to ensure quality through the manufacturing process, and the challenges and opportunities that come with regulatory harmonization among different countries. China continues to attract significant attention from industry and investors and is poised to grow even more. During his welcoming remarks, Zhang noted China's emergence as a global economic leader, with a projected $1.1 trillion spend on healthcare this year, as well as the growing disease burden in China. By 2030, an estimated 4.3 million Chinese will be diagnosed with one of the 14 major cancers, according to research from IMS Health. Panelists addressed issues such as the amount of capital required to achieve scale in China, and advantages of the market in China. "The drug development business is changing rapidly and China is at the fore in a number of ways," Zhang said. "Biotech and pharma companies do not need or desire to have the infrastructure to scale their drugs through commercialization. With lower costs, China is a natural place for companies to contract out costly development and manufacturing to organizations that have the expertise and experience to collaborate with them through the entire discovery to development lifecycle." For its part, GenScript has put significant resources into its Contract Development and Manufacturing Organization (CDMO) business to meet the increasing demand. In 2018, the company officially launched its biologics CDMO segment, and last year opened a new GMP compliant biologics research center. GenScript is also leading the way in cell therapy through its antibody discovery service and plasmid and virus production capabilities. ]]> https://biospectrumindia.com/news/57/15554/probiogen-and-lava-therapeutics-sign-agreement-for-novel-bispecific-molecule.html https://biospectrumindia.com/news/57/15554/probiogen-and-lava-therapeutics-sign-agreement-for-novel-bispecific-molecule.html Wed, 15 Jan 2020 00:00:00 +0530 ProBioGen AG and Lava Therapeutics B.V. announced the closing of a cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate. Founded in 2016, Lava Therapeutics works on the development of antibody formats for the successful retrieval and activation of the body’s own immune system to effectively kill cancer cells in the tumour microenvironment. Under the agreement and using its CHO.RiGHT™ expression platform, including its recently launched DirectedLuck Transposase technology for generation of stable high-titer cell lines, ProBioGen will conduct cell line development of a γδ T-cell engaging bispecific antibody format. With subsequent process development and GMP manufacturing, this project depicts another full-service program conducted at ProBioGen. “We like to get our hands on novel protein formats”, said ProBioGen’s Chief Executive Officer Dr. Wieland Wolf, “and we are very much looking forward conducting this project together with Lava Therapeutics.” “Solving the manufacturing requirements early in drug development is a key element to enabling the future success of a program”, commented Steve Hurly, Chief Executive Officer at Lava Therapeutics. “With ProBioGen, we found a scientific-driven partner with a proven development platform and a dedicated analytical panel for challenging bispecific antibody formats.” ]]> https://biospectrumindia.com/news/57/15539/biolog-id-llc-partners-with-lifeserve-blood-center-to-implement-blood-product-inventory-management-ecosystem.html https://biospectrumindia.com/news/57/15539/biolog-id-llc-partners-with-lifeserve-blood-center-to-implement-blood-product-inventory-management-ecosystem.html Tue, 14 Jan 2020 10:00:00 +0530 Biolog-id LLC, a world leader in connected solutions for blood and other high-value health products, announced today that LiveServe Blood Center, the leading provider of blood products in Iowa, Nebraska, and South Dakota, will implement Biolog-id’s cutting-edge technology solution in its blood supply chain. The technology solution provides real-time visibility into blood product location and movement, providing actionable data to streamline inventory and improve efficiencies to maximize return on donation. Patients, donors, and staff across LifeServe’s enterprise will benefit from the actionable insights provided by a digitally visible supply chain.  “LifeServe Blood Center is the perfect partner for Biolog-id. They embrace change and innovation. They are constantly seeking new ways to deploy technology to reduce costs, improve quality, and impact patient outcomes,” said Patrick Conway, Director of Sales Biolog-id LLC. “Biolog-id’s unique solution combines hardware, software, consumables and data analytics is a great platform to help deliver those desired results.”  “Our partnership with Biolog-id LLC builds on our heritage of continuously innovating and improving to address the changing needs of patients, hospitals, and donors to ensure the sustainability of our blood supply,” said Stacy Sime, CEO of Lifeserve Blood Center. “By providing us rich, real-time insights about our blood inventory, the technology ecosystem we are deploying has the opportunity to provide our organization, our hospitals and the patients who receive life-saving blood, multiple channels of value.”  “There is a crucial need to evolve processes in healthcare to achieve higher levels of efficiency and scale, yielding positive results across the healthcare industry,” said Troy L. Hilsenroth, CEO Biolog-id LLC. “Our goal is to facilitate this evolution in an effort to provide everyone with effective, reliable products and services that meet the highest standards of quality and have adaptability for future uses.” ]]> https://biospectrumindia.com/news/57/15540/exonate-janssen-to-develop-new-eye-drop.html https://biospectrumindia.com/news/57/15540/exonate-janssen-to-develop-new-eye-drop.html Tue, 14 Jan 2020 06:00:00 +0530 Exonate, a privately held, early stage, biotech company spun out of the University of Nottingham, has announced that it has entered into a strategic collaboration agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Through the collaboration, Exonate will work with Janssen Research & Development, LLC scientists to develop an eye drop treatment for retinal vascular diseases such as wet AMD and DMO by using mRNA targeted therapies. Exonate has developed small molecules that inhibit the production of pro-angiogenic vascular endothelial growth factor (VEGF) through the selective inhibition of serine/threonine-protein kinase (SRPK1)-mediated VEGF splicing. The agreement was facilitated by Johnson & Johnson Innovation. Commenting on the announcement, Dr. Catherine Beech CEO of Exonate, said: "I am absolutely delighted to enter this strategic collaboration with Janssen, we are looking forward to successfully developing a novel treatment for retinal neovascular diseases." ]]> https://biospectrumindia.com/news/57/15529/indapta-lonza-announce-strategic-partnership.html https://biospectrumindia.com/news/57/15529/indapta-lonza-announce-strategic-partnership.html Mon, 13 Jan 2020 10:45:00 +0530 Indapta Therapeutics, Inc., a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic G-NK (FcRγ-deficient Natural Killer) cell therapy to treat multiple cancers, and Lonza have announced a strategic partnership. Indapta also announced its founding leadership team and scientific advisors. Under the terms of the agreement, Lonza will manufacture Indapta’s off-the-shelf, allogeneic G-NK cell therapy under current good manufacturing practices (cGMP) for use in clinical studies. Indapta will leverage Lonza’s process development capabilities and expertise to ensure a robust, reproducible and scalable cGMP process. Process development and manufacturing will take place in Lonza's state-of-the-art cell and gene therapy manufacturing facility in Houston. “We believe our first-in-class, off-the-shelf, allogeneic G-NK cell therapy will drive the next critical phase in the evolution of cancer therapies following CAR T-cell therapies,” said Guy DiPierro, founder and chief executive officer of Indapta Therapeutics. “Current autologous CAR T-cell therapies have proven efficacy in various hematologic cancers but have been beset with serious clinical and manufacturing challenges. By providing an off-the-shelf solution with our G-NK cell therapy, we can eliminate the need for a patient-specific therapy. Additionally, because our investigational cell therapies are not engineered, they are likely to be more effective, less costly and have a simpler regulatory pathway.” ]]> https://biospectrumindia.com/news/57/15530/nbe-therapeutics-closes-a-22m-series-c-financing-round.html https://biospectrumindia.com/news/57/15530/nbe-therapeutics-closes-a-22m-series-c-financing-round.html Mon, 13 Jan 2020 05:00:00 +0530 NBE-Therapeutics AG announces the closing of a USD 22M Series C financing round, led by its existing shareholders Boehringer Ingelheim Venture Fund and the PPF Group and with participation from all private shareholders. The funds will enable NBE to advance the development of the lead asset NBE-002 through early clinical trials and to further strengthen the development team, management and board of the company. NBE-Therapeutics’ best in class iADCTM platform creates highly potent and safe immune-stimulatory ADCs with an anthracycline payload, inducing a long-lasting immunological anti-tumour effect. It has shown unprecedented preclinical efficacy, as well as safety in multiple pipeline programs. The GLP tox study for the lead program NBE-002 against the ROR1 target has been successfully completed, supporting the initiation of a first in man study. GMP manufacturing of the clinical batch has also been successfully completed. The first-in-human study with NBE-002 is expected to commence by mid-2020, focusing on triple-negative breast cancer and lung cancer, as well as including other solid cancer indications and lymphomas. Dr. Ulf Grawunder, CEO and founder of NBE-Therapeutics commented “We are very proud of our achievements in developing NBE-002 toward IND filing. This has been recognized by our existing shareholders who, with this financing, show their continued commitment to NBE-Therapeutics. This financing will enable us to further develop our lead asset NBE-002 into the clinic and take the next step in our goal to create valuable treatments for cancer patients. We highly value the trust our current shareholders have placed in both our technology platform and lead ADC program, through which we have been able to develop highly effective oncology treatments”. “NBE Therapeutics has progressed nicely over the last few years and is now entering its next phase, becoming a leading clinical-stage ADC company” mentions Dr Jens Hennecke, board member of NBE and representative of the PPF Group. “The broad support by existing shareholders in this financing round is a testimony to the great promise of NBE’s NBE-002 in becoming a leading cancer treatment in the future.” Dr Detlev Mennerich, board member of NBE and Director at BIVF further comments: “BIVF is very happy to further support NBE-Therapeutics, being one of the early investors in the company. NBE has been able to develop an ADC platform that overcomes all historical challenges in the field and is now ready to generate a clinical precedent by showing superiority over other ADC strategies, which would then allow full leverage of the underlying iADC technology.” ]]> https://biospectrumindia.com/news/57/15526/medlever-and-raysearch-announce-interoperability-agreement.html https://biospectrumindia.com/news/57/15526/medlever-and-raysearch-announce-interoperability-agreement.html Fri, 10 Jan 2020 14:50:00 +0530 MedLever announced that it has signed an agreement with RaySearch Laboratories to develop interoperability and advance workflow automation solutions in cancer care.  The interoperability will support streamlined task management and simplify clinical workflow between RayStation, RayCare and the MedLever Platform. Founder and CEO of RaySearch, Johan Löf, says: "RaySearch and MedLever share the vision of simplified workflows, improved interoperability and more efficient ways of organizing data for oncology centers. This agreement promotes an ecosystem with fewer data silos and greater degrees of transparency that improve clinician satisfaction and patient care." MedLever is dedicated to seamless interoperability and giving customers the choice of selecting the best information systems, planning and delivery technology options to meet their needs and the needs of their patients.  With MedLever solutions, clinics have workflow automation tools to prepare for alternative payment models and value-based care as novel reimbursement approaches grow in popularity throughout the world. "MedLever workflow automation solutions have helped physicians and staff manages care workflow for thousands of patients over the three years since the product first entered clinical use.  Our work with RaySearch will further enable innovations in efficiency improvements that benefit the patient, provider/health system and payor," said Jacob Philip, founder and CEO of MedLever.  ]]> https://biospectrumindia.com/news/57/15521/blueprint-medicines-wins-fda-approval-of-ayvakit-to-treat-gist.html https://biospectrumindia.com/news/57/15521/blueprint-medicines-wins-fda-approval-of-ayvakit-to-treat-gist.html Fri, 10 Jan 2020 11:20:00 +0530 Blueprint Medicines Corporation, a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, has announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT is the first precision therapy approved to treat a genomically defined population of patients with GIST. The FDA granted a full approval to AYVAKIT based on efficacy results from the Phase 1 NAVIGATOR clinical trial, as well as combined safety results from multiple clinical trials for avapritinib. In patients with PDGFRA exon 18 mutant GIST, AYVAKIT had an overall response rate (ORR) of 84 percent (95% CI: 69%, 93%), and a median duration of response (DOR) was not reached. Blueprint Medicines plans to make AYVAKIT available in the U.S. within a week. GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. Approximately 6 percent of patients with newly diagnosed GIST have PDGFRA exon 18 mutations. The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies. A retrospective study showed that when these patients were treated with imatinib, they had an ORR of 0 percent. Blueprint Medicines is dedicated to helping patients with PDGFRA exon 18 mutant GIST access treatment with AYVAKIT and providing robust support throughout their treatment journey. As part of this commitment, Blueprint Medicines is introducing YourBlueprint™, a patient support program that offers access and affordability solutions for individuals receiving AYVAKIT. ]]> https://biospectrumindia.com/news/57/15516/biomed-x-merck-start-new-research-program-in-autoimmune-diseases-.html https://biospectrumindia.com/news/57/15516/biomed-x-merck-start-new-research-program-in-autoimmune-diseases-.html Thu, 09 Jan 2020 16:35:00 +0530 BioMed X has announced the start of a new joint research group in collaboration with Merck. With this new group, BioMed X and Merck extend their ongoing collaboration to a total of six joint research projects at the BioMed X Innovation Center in Heidelberg, Germany. The new project will focus on the role of the intestinal epithelial barrier in the development and exacerbation of autoimmune diseases such as systemic lupus erythematosus (SLE) and multiple sclerosis (MS). Loss of intestinal barrier function is correlated with several autoimmune diseases. The main objective of the new group supported by Merck is to understand the molecular mechanisms of the interactions between intestinal epithelial barrier and immune cells in autoimmune diseases, in particular the interactions between dendritic cells and intestinal enterocytes. Studies will involve the use of conventional and high-throughput metagenomics, generation of intestinal organoids from murine and human subjects, isolation of immune cells and establishing a three dimensional in-vitro co-culture model to observe interactions of the intestinal epithelial barrier with immune cells. The goal of the project is to identify novel biomarkers and new therapeutic targets for the treatment of intestinal barrier loss to prevent the development and progression of autoimmune diseases. ]]> https://biospectrumindia.com/news/57/15510/schrdinger-bayer-focus-on-accelerating-drug-discovery.html https://biospectrumindia.com/news/57/15510/schrdinger-bayer-focus-on-accelerating-drug-discovery.html Thu, 09 Jan 2020 10:55:00 +0530 Schrödinger and Bayer have announced a five-year technology alliance to develop a de novo comprehensive design solution with the goal of accelerating the discovery of innovative and high-quality drugs quality.  The technology should make it possible to list, select and rate billions of virtual compounds, synthetically feasible, and promoting the identification and optimization of potential new candidate therapies. Under the terms of the agreement, Schrödinger is expected to receive around EUR 10 million. The de novo design software will be equipped with Schrödinger's molecular design technology, which is based on physics-based modeling and augmented by machine learning, and proprietary in silico models by Bayer predicting absorption, distribution, metabolism, excretion, toxicity of compounds and chemical synthesizability. The new software will be based on Schrödinger's enterprise computing solution, LiveDesign, and will aim to rapidly design large numbers of molecules and predict their properties. "Underlining our efforts in digital transformation across our entire value chain, our collaboration with Schrödinger aims to exploit advanced methods based on physics and machine learning capabilities in order to optimize the discovery of viable drug candidates, "says Dr. Karl Ziegelbauer, head of open innovation and digital technology in the pharmaceutical division of Bayer AG. "The new co-developed technological solution aims to create new horizons for the therapeutic discovery of tomorrow, with the ultimate goal of bringing benefits to patients." "We admire Bayer's passion for innovation and its commitment to using cutting-edge technology to meet global health challenges," says Ramy Farid, CEO of Schrödinger, Ph.D. "Our goals are reflected in our mission , and we are proud to make this vision a reality through this collaboration. The de novo design solution , which builds on the complementary strengths of Schrödinger and Bayer, promises to accelerate the discovery of innovative drugs that respond to important unmet needs. " ]]> https://biospectrumindia.com/news/57/15511/schrdinger-bayer-focus-on-accelerating-drug-discovery.html https://biospectrumindia.com/news/57/15511/schrdinger-bayer-focus-on-accelerating-drug-discovery.html Thu, 09 Jan 2020 10:55:00 +0530 Schrödinger and Bayer have announced a five-year technology alliance to develop a de novo comprehensive design solution with the goal of accelerating the discovery of innovative and high-quality drugs quality.  The technology should make it possible to list, select and rate billions of virtual compounds, synthetically feasible, and promoting the identification and optimization of potential new candidate therapies. Under the terms of the agreement, Schrödinger is expected to receive around EUR 10 million. The de novo design software will be equipped with Schrödinger's molecular design technology, which is based on physics-based modeling and augmented by machine learning, and proprietary in silico models by Bayer predicting absorption, distribution, metabolism, excretion, toxicity of compounds and chemical synthesizability. The new software will be based on Schrödinger's enterprise computing solution, LiveDesign, and will aim to rapidly design large numbers of molecules and predict their properties. "Underlining our efforts in digital transformation across our entire value chain, our collaboration with Schrödinger aims to exploit advanced methods based on physics and machine learning capabilities in order to optimize the discovery of viable drug candidates, "says Dr. Karl Ziegelbauer, head of open innovation and digital technology in the pharmaceutical division of Bayer AG. "The new co-developed technological solution aims to create new horizons for the therapeutic discovery of tomorrow, with the ultimate goal of bringing benefits to patients." "We admire Bayer's passion for innovation and its commitment to using cutting-edge technology to meet global health challenges," says Ramy Farid, CEO of Schrödinger, Ph.D. "Our goals are reflected in our mission , and we are proud to make this vision a reality through this collaboration. The de novo design solution , which builds on the complementary strengths of Schrödinger and Bayer, promises to accelerate the discovery of innovative drugs that respond to important unmet needs. " ]]> https://biospectrumindia.com/news/57/15500/lannett-launches-venlafaxine-er-tablets-and-lidocaine-topical-solution-4.html https://biospectrumindia.com/news/57/15500/lannett-launches-venlafaxine-er-tablets-and-lidocaine-topical-solution-4.html Wed, 08 Jan 2020 15:50:00 +0530 Lannett Company, Inc. has commenced marketing Venlafaxine Extended Release (ER) Tablets, 150 mg and 225 mg, USP, and Lidocaine Topical Solution 4%. The estimated IQVIA market values of Venlafaxine ER Tablets, 150 mg and 225 mg, USP, and Lidocaine Topical Solution 4% are approximately $150 million and $17 million, respectively, for the 12 months ending November 2019, although actual generic market values are expected to be lower. "Both Venlafaxine ER Tablets and Lidocaine Topical Solution 4% are solid additions to our offering and add to our recent wave of product launches," said Tim Crew, chief executive officer of Lannett.  "Venlafaxine ER is a partnered product and the Lidocaine Topical Solution 4% is a product we acquired in May 2018 from a subsidiary of Endo International plc." ]]> https://biospectrumindia.com/news/57/15499/probiogen-inks-next-commercial-glymaxx-license-with-roche.html https://biospectrumindia.com/news/57/15499/probiogen-inks-next-commercial-glymaxx-license-with-roche.html Wed, 08 Jan 2020 15:40:00 +0530 ProBioGen AG has signed a commercial license agreement with Roche for applying ProBioGen’s proprietary GlymaxX® technology to boost the antibody’s ADCC anti-tumor activity. The GlymaxX® technology for production of afucosylated proteins is universally applicable, simple and potent. The unique advantage of the GlymaxX® technology is that a single GlymaxX® modified cell line is sufficient to produce both, completely fucosylated or afucosylated antibodies and those with an intermediate defined fuscosylation level. The technology can easily be integrated in newly developed or already existing cell lines of different origins. ]]> https://biospectrumindia.com/news/57/15492/mina-therapeutics-announces-research-collaboration-with-astrazeneca-.html https://biospectrumindia.com/news/57/15492/mina-therapeutics-announces-research-collaboration-with-astrazeneca-.html Wed, 08 Jan 2020 06:00:00 +0530 UK based MiNA Therapeutics has announced the initiation of a research collaboration with AstraZeneca to evaluate small activating RNA ("saRNA") molecules in metabolic diseases. The collaboration combines MiNA's leading expertise in the discovery and development of saRNA therapeutics with AstraZeneca's experience in identifying and bringing breakthrough treatments to patients with metabolic diseases. Robert Habib, CEO of MiNA said, “Many metabolic diseases lack sufficient treatment options to help patients manage their disease and to treat the underlying causes to improve patient outcomes. This is an exciting opportunity for us to collaborate with AstraZeneca, a global leader in the discovery and development of prescription medicines to treat metabolic diseases that may lead to therapeutic advances for a large number of patients globally. We continue to evaluate the potential of saRNA therapeutics in a variety of indications, in parallel with advancing our proprietary programs in cancer.” Under the terms of the agreement MiNA and AstraZeneca will conduct in vitro and in vivo studies that may enable the future development of saRNA therapeutics to treat metabolic diseases through biological pathways not addressable by conventional treatment strategies. Shalini Andersson, Chief Scientist, New Modalities, Discovery Sciences, R&D, AstraZeneca said, “saRNA molecules are a novel therapeutic modality that upregulate genes and have the potential to access disease-relevant targets that cannot be addressed efficiently with other approaches. We look forward to working with MiNA to investigate the potential of saRNAs further.” Upon completion of these studies, AstraZeneca will have the option to negotiate a license agreement to further develop saRNA molecules that activate an undisclosed gene target identified by AstraZeneca. No further details about the collaboration have been disclosed.   ]]> https://biospectrumindia.com/news/57/15502/probiogen-inks-next-commercial-glymaxx-license-with-roche.html https://biospectrumindia.com/news/57/15502/probiogen-inks-next-commercial-glymaxx-license-with-roche.html Wed, 08 Jan 2020 00:00:00 +0530 ProBioGen AG has signed a commercial license agreement with Roche for applying ProBioGen’s proprietary GlymaxX® technology to boost the antibody’s ADCC anti-tumour activity. The GlymaxX® technology for production of afucosylated proteins is universally applicable, simple and potent. The unique advantage of the GlymaxX® technology is that a single GlymaxX® modified cell line is sufficient to produce both, completely fucosylated or afucosylated antibodies and those with an intermediate defined fuscosylation level. The technology can easily be integrated into newly developed or already existing cell lines of different origins. ProBioGen is a premier, Berlin-based specialist for developing and manufacturing complex therapeutic glycoproteins. Combining both state-of-the-art development platforms, based on ProBioGen’s CHO.RiGHTTM expression and manufacturing platform, together with intelligent product-specific technologies, yields biologics with optimized properties. ]]> https://biospectrumindia.com/news/57/15493/merck-strengthens-crispr-cas9-strategic-alliance-with-genoway.html https://biospectrumindia.com/news/57/15493/merck-strengthens-crispr-cas9-strategic-alliance-with-genoway.html Tue, 07 Jan 2020 17:20:00 +0530 genOway, a leading company in the development of genetically modified research models, has announced an important milestone in expanding its strategic alliance with Merck, a leading science company and technology and genome editing. In December 2018, genOway acquired the exclusive rights of the founding portfolio of Merck's CRISPR / Cas9 in the rodent field (all applications involving rodent or animal cells). Today, the two companies have further strengthened their collaboration by signing an additional license that grants genOway non-exclusive rights to commercialize the development and use of all other animal cell models for their clients' internal research, as well as to Commercial exploitation. Both Merck and genOway have identified research fields where they can combine their respective technologies and experience in order to develop and validate new products and solutions related to CRISPR / Cas9. Merck's patented CRISPR integration technology is a solid starting point through which innovation can be developed and promoted.   ]]> https://biospectrumindia.com/news/57/15488/polyganics-achieves-ce-mark-certification-for-liqoseal.html https://biospectrumindia.com/news/57/15488/polyganics-achieves-ce-mark-certification-for-liqoseal.html Tue, 07 Jan 2020 14:10:00 +0530 Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, announced today that it has obtained CE marking for LIQOSEAL®, its easy-to-use and innovative dural sealant patch, and will launch the device in Europe with immediate effect. Approval of the CE mark is based on outstanding data from Polyganics’ ENCASE I clinical trial, evaluating the safety and performance of LIQOSEAL® in reducing cerebrospinal fluid (CSF) leakage after elective cranial surgery. 3-month follow-up results showed the absence of CSF leakage, as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgery. Initially, Polyganics will commercialize LIQOSEAL® in selected European countries with renowned distribution partners which have extensive experience in neurosurgical products. During 2020, the Company will then grow its network with the addition of multiple distributors throughout Europe. Polyganics is also preparing to launch LIQOSEAL® in selected non-European countries. In addition, arrangements are well underway for the start of ENCASE II, a randomized controlled trial, which will enable the Company to submit the patch for pre-market approval to the US Food and Drug Administration. Rudy Mareel, CEO of Polyganics, commented: “CSF leakage remains a devastating complication of neurosurgical procedures and represents a significant patient burden with high associated cost. The CE approval of this product is testament to the strength and quality of the clinical data from ENCASE I, showing that LIQOSEAL® establishes effective and enduring watertight dural closure. This is a key milestone in our journey to deliver our dural sealant patch to surgeons and patients in Europe and ultimately worldwide.”   ]]> https://biospectrumindia.com/reports-white-papers/57/15484/global-cancer-immunotherapy-to-hit-115-bn-by-2023-.html https://biospectrumindia.com/reports-white-papers/57/15484/global-cancer-immunotherapy-to-hit-115-bn-by-2023-.html Tue, 07 Jan 2020 11:40:00 +0530 Immunotherapy is forecast to become the oncology treatment of choice by 2026 with an estimated 60% of previously treated cancer patients likely to adopt immunotherapy in this timeframe. Multiple treatment lines, combination therapy and the opportunity for repeat treatment are likely to accelerate fast growth. Cancer immunotherapy also expands into multiple indications and our analysis indicates that key immunotherapies including anti-PD-1 drugs, dendritic cell vaccines, T-cell therapies and cancer vaccines are all driving the market. The rising incidence and prevalence of numerous cancers globally is a significant accelerator of growth. This is due to more sensitive early detection techniques, higher patient awareness and a growing aging population. Furthermore, the FDA's pro-science attitude will accelerate development and regulatory approval for these drugs. To that end, the cancer immunotherapy market is forecast to hit $115 billion by 2023. Overall strong growth rates are expected due to a significant unmet need and increasing trends of hematological cancers.  Prior to the launching of Yervoy, the five-year survival rate for patients with early stage melanoma was 98%; but the five-year survival rate for late-stage melanoma was just 16%. Yervoy has been reported to have a survival rate of 25% when tested alone. When tested as part of a combination therapy treatment with Bristol's nivolumab, the two-year survival rates rose to 88% for patients with late-stage cancer. Increase in patient survival rates brought about by cancer immunotherapy treatment is similar to that seen when bone marrow transplantation changed our conception on how blood cancer was treated. Other key therapeutic players in this market include Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), Ibrance (palbociclib) the newly approved Bavencio (avelumab) and Imfinzi (durvalumab) and of course the first CAR-T therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel). Opdivo (nivolumab) from BMS is one of the most exciting agents in the immunotherapy space, and is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer. It was given a fast-track approval on December 22, 2014. The majority of immune-oncology agents are anti-programmed death-1 (PD-1) monoclonal antibodies, which will certainly guide the market over the coming years. Projects that currently are valuable include combined immunotherapies on our knowledge of CD137 and PD-1/PDL1 mechanisms.  A study on a novel effector activating monoclonal antibody known as IMAB362 for the treatment of solid cancers is also exciting. Other projects comparing CAR-T cell effectiveness against T-cells that target CD19 or mesothelin are interesting in a preclinical setting. Of course, Novartis gained the first CAR-T FDA approval for Kymriah (tisagenlecleucel, CTL019), in August 2017, for children and young adults with B-cell ALL. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval. This is a major boost for the global and US immunotherapy, and gene therapy markets.  What Are CAR-T Therapies? How Will They Impact the Market? CAR T (chimeric antigen receptor T) cells are engineered specificity using antibody fragments directed to the tumor cell, and also T-cell CD8/CD3 plasma membrane proteins that elicit specific activity towards the tumor cell, via intracellular signaling pathways. To date publications have revealed a number of effective intracellular molecules in the engineered T cell including CD28, 4-1BB (CD137) and CD3 zeta. These engineered T cells have numerous advantages including: Intracellular domain can be modified to increase efficacy and durability of CAR-T CAR-T are still subject to the same regulatory and tolerogenic constraints of natural T cells, including checkpoints, Treg, MDSC CAR-T can be engineered to express cytokines and chemokines that further enhance function and migration Can be modified to express suicide genes that limit CAR-T population if toxicity occurs To date, the main challenges associated with CAR T therapy include manufacturing, regulations, pricing and toxicity in patients. Currently there are over 100 recruiting CAR-T clinical trials globally, mainly in the US, China and Europe. To date a number of CAR T Cells (autologous/allogeneic) trials are demonstrating clinical benefit to patients, but others have demonstrated toxicity such as cytokine release syndrome. In July 2017, an FDA advisory panel determined that the benefits of CAR T outperform the risks.  Kymriah (tisagenlecleucel) by Novartis is indicated to treat children and young adults with acute leukemia and performed well in the ELIANA trial. The FDA's Oncologic Drugs Advisory Committee (ODAC) recommended this agent for approval and became the first CAR-T cell therapy on the US market. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval.  The CAR-T industry is addressing unmet needs in specific relapsed cancers, and trials have indicated that some patients show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity. The main players within the CAR-T market are Novartis, Juno Therapeutics, Kite Pharma and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies. From now on, Kelly Scientific forecasts that CAR T therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR-T therapy ahead. However, recent deaths in the Juno ROCKET trial are creating questions amongst investors. How will the CAR T space influence the total immunotherapy industry going forward? This comprehensive report scrutinizes the total market and provides cutting-edge insights and analysis.  Within the cancer therapeutics space, which today is worth over $100 billion globally, immunotherapeutic drugs have gained worldwide acceptance. This is because they are targeted therapeutics that have high specificity for cancer cells. Today, cancer immunotherapy drugs have captured nearly 50% of the overall oncology drugs market, generating about $75 billion in 2019 alone and are forecast to surpass $115 billion in 2023. ]]> https://biospectrumindia.com/news/57/15481/merck-forms-strategic-oncology-link-with-taiho-astex.html https://biospectrumindia.com/news/57/15481/merck-forms-strategic-oncology-link-with-taiho-astex.html Tue, 07 Jan 2020 06:30:00 +0530 Merck, known as MSD outside the United States and Canada, has announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd., and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer. Under the terms of the agreement, Merck, Taiho and Astex will combine preclinical candidates and their data with knowledge and expertise from their respective research programs. In exchange for providing Merck an exclusive global license to their small molecule inhibitor candidates, Taiho and Astex will receive an aggregate upfront payment of $50 million and will be eligible to receive approximately $2.5 billion contingent upon the achievement of preclinical, clinical, regulatory and sales milestones for multiple products arising from the agreement, as well as tiered royalties on sales. Merck will fund research and development and will be responsible for commercialization of products globally. Taiho has retained co-commercialization rights in Japan and an option to promote in specific areas of South East Asia. KRAS is among the most frequently mutated oncogenes in cancer. It is estimated to occur in more than 90% of pancreatic cancers and approximately 20% of non-small cell lung cancers (NSCLC) and is associated with poorer outcomes. ]]> https://biospectrumindia.com/news/57/15491/velabs-therapeutics-receives-exclusive-licence-for-development-of-therapeutic-antibodies-.html https://biospectrumindia.com/news/57/15491/velabs-therapeutics-receives-exclusive-licence-for-development-of-therapeutic-antibodies-.html Tue, 07 Jan 2020 00:10:00 +0530 Velabs Therapeutics, a biotech company focused on the rapid screening of functional therapeutic antibodies announced that it has entered into an exclusive licence agreement with alytas therapeutics GmbH (alytas), for the development and commercialization of alytas’ antibodies in the field of senescence, related degenerative processes and pathologies. Velabs Therapeutics, a young start-up company of the European Molecular Biology Laboratory (EMBL), is a pioneer of microfluidic technology for the screening of antibodies with modulatory function on complex signalling proteins such as GPCRs, ion channels or other regulatory proteins. The current active investor is Xlife Sciences, a Swiss company focusing on the development of promising life science technologies. Velabs offers its screening know-how and capacities for pharmaceutical collaborations worldwide. In addition to existing partnerships, Velabs is currently building its own pipeline of therapeutic antibody candidates for further development. Recently, the company has started to develop antibody-based senolytics, a class of drugs designed to prevent cell and tissue degeneration that can occur during the aging process by eliminating so-called “senescent cells.” alytas specializes in the research of fat metabolism in connection with obesity. Its program is based on several proprietary protein epitopes with high relevance for the immunological regulation of excess adipocytes and has already been conceptually confirmed in vitro and in vivo. In a previous strategic partnership, alytas and Velabs co-developed different sets of preclinical antibodies for a novel immune-based obesity treatment. The current licence will allow Velabs to exclusively develop these antibodies against senescence related degenerative processes. Both indications, obesity and senescence, together with their associated comorbidities, are conditions with unmet medical need and enormous market potential. Christoph Antz, Managing Director of Velabs, states: "We are pleased to have entered this licence agreement with alytas, which will allow us to develop a completely new treatment against ageing related decline of body functions. We are confident that this new approach has the potential to open new ways towards less associated deteriorations, higher degrees of vitality and better health conditions during human ageing process, thus increasing quality of life at older age and reducing the burden of age-related diseases and complaints. Velabs’ know-how in the generation and preclinical validation of functional antibodies will be instrumental in developing a first mover antibody-based therapy for the preventive delay of senescence associated body decline.” ]]> https://biospectrumindia.com/news/57/15479/molina-acquires-nextlevel-health-partners.html https://biospectrumindia.com/news/57/15479/molina-acquires-nextlevel-health-partners.html Mon, 06 Jan 2020 16:55:00 +0530 Molina Healthcare has entered into a definitive agreement to acquire all of the capital stock of NextLevel Health Partners, Inc., a Medicaid managed care organization. As part of the transaction, Molina will assume the right to serve approximately 50,000 Medicaid and Managed Long-Term Services and Supports (MLTSS) members in Illinois’ Cook County. The purchase price of approximately $50 million, net of certain tax benefits, will be funded through Molina’s available cash. Subject to regulatory approvals and the satisfaction of other customary conditions, the closing of the transaction is expected to occur in early 2020. NextLevel Health’s estimated premium revenue for the full year 2019 is approximately $270 million. “We are delighted to expand our presence in Illinois as the state’s higher acuity populations skew toward Molina’s strengths,” said Pam Sanborn, president of Molina Healthcare of Illinois. “Acquiring NextLevel Health increases our footprint in the state of Illinois, enables us to scale our existing business platform, and provides additional operating cost leverage. The existing base of acquired assets also provides Molina with expansion opportunities for our Medicare-Medicaid Plan (MMP) and Marketplace offerings.” "NextLevel Health’s community-based approach combines a culturally sensitive lens and the recognition of social determinants of health to provide Medicaid members access to quality care,” said Dr. Cheryl Whitaker, CEO of NextLevel Health Partners, Inc. “We are proud to join Molina and continue to positively impact our communities.” Centerview Partners LLC acted as financial advisor for Molina and Sheppard Mullin acted as legal advisor. ]]> https://biospectrumindia.com/news/57/15475/ebb-therapeutics-to-launch-wearable-technology-for-sleeplessness.html https://biospectrumindia.com/news/57/15475/ebb-therapeutics-to-launch-wearable-technology-for-sleeplessness.html Mon, 06 Jan 2020 16:20:00 +0530 Ebb Therapeutics is on a mission to make an impact in both the professional healthcare and consumer sleep markets. At CES 2020 (Booth # 43824/Sands Expo, January 7-10, Las Vegas, NV), the sleep tech company will debut a wearable sleep device with proprietary technology that targets the root cause of sleeplessness: a racing, or overactive, mind.  THE RESEARCH Founder and Chief Medical Officer Dr. Eric Nofzinger spent 35 years studying the brain mechanisms of healthy sleep. Studies suggest that reduction in metabolic activity in the frontal cortex (the thinking part of the brain) is key to the restorative properties of sleep. Meanwhile, higher-than-normal activity when the body is at rest leads to hyperarousal, which is often associated with clinical complaints of not being able to turn off one's mind when trying to sleep. While Director of the Sleep Neuroimaging Research Program at the University of Pittsburgh School of Medicine, Dr. Nofzinger discovered that when the forehead is cooled, brain activity decreases and the mind can relax. This finding inspired Ebb. "Sleeplessness is an epidemic. More than ever, people are struggling with being able to 'turn off' their minds in order to get to sleep," said Dr. Nofzinger. "Lack of sleep can have a dire effect on one's ability to function mentally, emotionally and physically, so it is critical that we keep innovating in this space in order to offer safe, drug-free solutions that work." THE PRODUCT AND TECHNOLOGY Ebb is the first and only sleep solution that uses precise cooling, called PrecisionCool™ Technology, to reduce metabolic activity in the frontal cortex. A scientifically-engineered, fluid-filled headband softly wraps around the head and cools the forehead using an intelligent cooling algorithm in order to maintain an optimal temperature range over the course of the night. As brain activity declines, the mind calms and the user is able to fall into a deeper, more restorative sleep. The device hits the consumer market after several years of research and fundraising. At the end of 2016, the company closed a $38 million Series B round led by KKR & Co. LP. (Other investors included Versant Ventures, Arboretum Ventures, and Partner Ventures.) These investments allowed the company to conduct the type of studies and clinical tests needed to perfect the technology, and build a first-class team, which includes former executives from Respironics, a leader in sleep and respiratory markets that was acquired by Philips in 2008 for $5 billion. At the show, the startup will also tease another innovation, set to hit the market in late 2020: a second-generation device with similar cooling technology that is battery-powered and portable, for consumers with busy, on-the-go lifestyles. ]]> https://biospectrumindia.com/news/57/15474/biostage-gives-update-on-fda-investigational-nda-for-cellspan-esophageal-implant.html https://biospectrumindia.com/news/57/15474/biostage-gives-update-on-fda-investigational-nda-for-cellspan-esophageal-implant.html Mon, 06 Jan 2020 15:25:00 +0530 Biostage, a bioengineering company developing next-generation esophageal implants, received the anticipated formal response from the U.S. Food and Drug Administration (FDA) related to the Company's Investigational New Drug (IND) application for the Cellspan Esophageal Implant (CEI).  This anticipated letter, received December 26th, details specific questions and clarifications that will enable Biostage to complete and submit its formal reply. Biostage received a preliminary communication from the FDA on November 27th, allowing the Company to begin preparing its responses.  "Our R&D team is expeditiously finalizing our responses," said Jim McGorry, CEO of Biostage. "Prior to receiving approval to begin testing human subjects for a first-in-human trial, multiple rounds of communication with the FDA are anticipated and routine. Entering the clinic is our greatest priority and we will provide an update as soon we receive approval from the FDA." The FDA noted in its letter that it will inform Biostage of its decision within 30 days of the Company's submission of its formal response. ]]> https://biospectrumindia.com/news/57/15473/nih-study-reveals-how-to-improve-tb-vaccine-efficacy.html https://biospectrumindia.com/news/57/15473/nih-study-reveals-how-to-improve-tb-vaccine-efficacy.html Mon, 06 Jan 2020 10:25:00 +0530 Researchers from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and their colleagues have shown that simply changing the dose and route of administration from intradermal (ID) to intravenous (IV) greatly increases the vaccine’s ability to protect rhesus macaques from infection following exposure to Mycobacterium tuberculosis (Mtb), the bacterium that causes TB. The findings provide a new understanding of the mechanisms of BCG-elicited protection against tuberculosis infection and disease. In addition, the findings support investigation of IV BCG administration in clinical trials to determine whether this route improves its effectiveness in teens and adults. To control Mtb infection and prevent clinical disease, a TB vaccine must elicit strong, sustained responses from the immune system’s T cells, specifically those in the lungs. However, the standard, ID, route of BCG administration may not generate enough of these critical cells in the lungs. The NIAID researchers and their colleagues hypothesized that administration of BCG by IV or aerosol (AE) routes would overcome this hurdle and thus confer substantially better protection from infection and/or disease in rhesus macaques following challenge with virulent Mtb. In their study, groups of animals received the BGC vaccine by ID, AE or IV routes. The scientists assessed immune responses in blood and in fluid drawn from the lungs for a 24-week period following vaccination. IV BCG vaccination resulted in the highest durable levels of T cells in the blood and lungs. Six months after vaccination, the researchers exposed groups of vaccinated rhesus macaques (immunized via ID, AE or IV routes) and a group of unvaccinated macaques to a virulent strain of Mtb by introducing the bacteria directly into the animals’ lungs. They then tracked the infection and disease development over three months. Nine out of 10 animals vaccinated with IV BCG were highly protected; six showed no detectable infection in any tissue tested and three had only very low counts of Mtb bacteria in lung tissue. All unvaccinated animals and those immunized via ID or AE routes showed signs of significantly greater infection. The investigators concluded that IV BCG conferred an unprecedented degree of protection in an animal model of severe TB and “represents a major step forward in the field of TB vaccine research.” ]]> https://biospectrumindia.com/news/57/15460/hardy-diagnostics-unveils-utm-product-line.html https://biospectrumindia.com/news/57/15460/hardy-diagnostics-unveils-utm-product-line.html Thu, 02 Jan 2020 15:35:00 +0530 Universal Transport Medium (UTM) ® is an FDA-cleared collection and transport system suitable for collection, transport, maintenance and long-term freeze storage of clinical specimens containing viruses, chlamydia, mycoplasma and ureaplasma organisms. The transport medium comes in a plastic, screw-cap tube and maintains organism viability for 48 hours at room or refrigerated temperature. UTM® has been tested and validated in full compliance with CLSI M40-A2: Quality Control of Microbiological Transport System Standard. UTM® has been used successfully for Rapid Antigen Testing, DFA, Viral Culture and for Molecular-Based Assays. The unique media formulation includes antibiotics to inhibit bacterial and fungal growth, without affecting viruses, chlamydia, mycoplasma or ureaplasma. HealthLink UTM®, which is distributed by Hardy Diagnostics, was developed and is manufactured by COPAN. COPAN (which stands for Collection and Preservation for Analysis) was founded in 1979 by the late Giorgio Triva in Mantua, Italy. Since its beginning, COPAN has focused on developing technological innovations in preanalytics. COPAN's vertically integrated approach to manufacturing allows complete control over the entire process, allowing consistent production of quality products. Today, COPAN supplies hundreds of millions of bacteriology transport swabs, transfer pipets, calibrated plastic inoculation loops, UTM® viral transport systems and Flocked Swabs worldwide. "We're incredibly proud to be able to offer the full line of HealthLink UTM® products to our customers," says Christopher Catani, Vice President and Director of Sales and Marketing at Hardy. "COPAN is an excellent partner and we expect high demand for these products because of the aggressive flu season predicted by the CDC."  ]]> https://biospectrumindia.com/news/57/15458/lilly-commences-ph-3-trial-in-ret-mutant-mtc.html https://biospectrumindia.com/news/57/15458/lilly-commences-ph-3-trial-in-ret-mutant-mtc.html Thu, 02 Jan 2020 12:45:00 +0530 Eli Lilly and Company has announced the opening of the LIBRETTO-531 clinical trial [NCT04211337] for selpercatinib, also known as LOXO-292, for treatment-naïve RET-mutant medullary thyroid cancer (MTC) patients. This is the second Phase 3 trial to open for selpercatinib, a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. Enrolled trial participants will be randomized to receive either selpercatinib or physician's choice of cabozantinib or vandetanib as initial treatment of their advanced or metastatic RET-mutant MTC. "Approximately 60 percent of people with medullary thyroid cancer have an activating RET point mutation, yet the current therapeutic options are not ideal for many patients," said Lori Wirth, MD, medical director of the Center for Head and Neck Cancer, Massachusetts General Hospital Cancer Center. "This Phase 3 trial of selpercatinib in patients with advanced or metastatic RET-mutant MTC seeks to confirm a new standard of care that we hope will provide a more effective treatment option for this patient population." "While medullary thyroid cancer is rare, the occurrence of RET mutations in MTC is high," said Gary Bloom, executive director for ThyCa: Thyroid Cancer Survivors' Association, Inc. "For that reason, we are very excited about the opening of this Phase 3 trial because it shows promise for patients with advanced and metastatic RET-mutant MTC. Due to new treatment options, it is imperative that MTC patients discuss with their medical doctors if and when they should undergo genomic testing of their tumors. This will ensure that people with RET tissue mutations have access to potential treatments and clinical trials such as this one for selpercatinib." ]]> https://biospectrumindia.com/news/57/15451/janssen-completes-acquisition-of-investigational-bermekimab-from-xbiotech-inc-.html https://biospectrumindia.com/news/57/15451/janssen-completes-acquisition-of-investigational-bermekimab-from-xbiotech-inc-.html Wed, 01 Jan 2020 14:45:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson announced  the completion of the acquisition of all rights to the investigational compound bermekimab, which has multiple dermatological indications, along with certain employees, from XBiotech Inc., for $750 million.  Should Janssen pursue bermekimab indications outside of dermatology, XBiotech may be eligible to receive additional payments upon the receipt of certain commercialization authorizations. Janssen Research & Development, LLC will develop bermekimab. The agreement was executed through Janssen Biotech, Inc. The transaction will be accounted for as a business combination. Bermekimab is an anti-IL-1alpha monoclonal antibody (mAb) in Phase 2 development for the treatment of atopic dermatitis and hidradenitis suppurativa.  It is the only antibody targeting IL-1a currently in clinical development and has the potential for superior efficacy and safety compared to the current standard of care. "Adding bermekimab to our pipeline and portfolio builds on our legacy in immuno-dermatology, while expanding our reach to two additional disease areas with immense unmet need: atopic dermatitis and hidradenitis suppurativa," said David M. Lee, M.D., Ph.D., Immunology Therapeutic Area Head, Janssen Research & Development, LLC. "We're passionate about identifying and pursuing the best, most exciting science for the benefit of patients – and in particular, new mechanisms of action, with the potential to reach patients coping with diseases that have few or no options," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "As the only anti-IL1a in clinical development, bermekimab fits this approach perfectly." ]]> https://biospectrumindia.com/news/57/15447/fda-approves-first-generics-of-eliquis.html https://biospectrumindia.com/news/57/15447/fda-approves-first-generics-of-eliquis.html Wed, 01 Jan 2020 10:00:00 +0530 The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy. Apixaban will be dispensed with a Medication Guide for patients that provides instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding. The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc.   ]]> https://biospectrumindia.com/news/57/15446/astrazeneca-mercks-lynparza-gets-fda-nod-to-treat-pancreatic-cancer.html https://biospectrumindia.com/news/57/15446/astrazeneca-mercks-lynparza-gets-fda-nod-to-treat-pancreatic-cancer.html Tue, 31 Dec 2019 12:35:00 +0530 AstraZeneca and MSD have announced that Lynparza (olaparib) has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza. The approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee (ODAC) on 17 December for Lynparza in this indication, and was based on results from the pivotal Phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting. Results showed a statistically significant and clinically meaningful improvement in progression-free survival, where Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo. The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials. The Pancreatic Cancer Action Network (PanCAN) is a US-based organisation that supports and advocates on behalf of the patients, caregivers and communities affected by pancreatic cancer. ]]> https://biospectrumindia.com/reports-white-papers/57/15445/persistent-organic-pollutants-in-maternal-blood-linked-to-smaller-fetal-size.html https://biospectrumindia.com/reports-white-papers/57/15445/persistent-organic-pollutants-in-maternal-blood-linked-to-smaller-fetal-size.html Mon, 30 Dec 2019 23:50:00 +0530 Pregnant women exposed to persistent organic pollutants, or POPs, had slightly smaller fetuses than women who haven't been exposed to these chemicals, according to an analysis of ultrasound scans by researchers at the National Institutes of Health and other institutions. The researchers also found that the women in their study had lower levels of POPs than women in the 2003-2004 U.S. Health and Nutrition Survey, the most recent comprehensive study of these compounds in U.S. pregnant women. The latest findings suggest that the chemicals, which are no longer produced in the United States but persist in the environment, may have lasting health effects even at low levels. The study appears in JAMA Pediatrics and was conducted by Pauline Mendola, Ph.D., an investigator in the Epidemiology Branch at NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, and colleagues. Persistent organic pollutants are chemicals once used in agriculture, disease control, manufacturing, and industrial processes. They include the pesticide DDT and dioxin, a byproduct of herbicide production and paper bleaching. POPs are slow to break down, may persist in water and air, and may be passed through the food chain. Their health effects vary, but some compounds have been linked to reproductive disorders and a higher risk of birth defects. Earlier studies of the potential effects of POP exposure during pregnancy have produced conflicting results. According to the authors, most of these studies looked at infant birth weight and length, measures that could suggest impaired fetal growth but could also indicate genetic factors that lead to smaller birth size and weight. Moreover, previous studies have investigated POPs as individual chemicals, but people typically are exposed to a mix of these compounds. "The differences we found in fetal growth measures may be more sensitive indicators, compared to birth size, of the potential effects of these compounds," said Dr. Mendola. "Even at low levels, there is evidence of a possible effect on fetal growth." In the current study, researchers analyzed records, stored blood samples, and a series of ultrasound scans taken from weeks 16-40 of 2,284 pregnant women enrolled in the NICHD Fetal Growth Study from 2009 to 2013. The blood samples were tested for the presence of 76 POPs soon after the women began the study. The POP levels in each woman's blood were listed as percentiles, with the highest levels set at 100 and the lowest at 1. The researchers then compared growth measurements of head circumference, abdominal circumference, and femur (thigh bone) length of the fetuses of women in the 75th percentile to those of women in the 25th percentile. They found that, compared to fetuses in the 25th percentile of exposure to organochlorine pesticides, the fetuses of women with exposure in the 75th percentile had the most widespread growth reductions, with head circumference reduced by an average of 4.7 mm, abdominal circumference reduced by 3.5 mm, and femur length reduced by 0.6 mm. High levels of dioxin-like polychlorinated biphenyls were associated with an average head circumference reduction of 6.4 mm and an abdominal circumference reduction of 2.4 mm. High levels of polybrominated diphenyl ethers—flame-retardant chemicals used in furniture, electronics and other consumer products—were associated with an average abdominal circumference reduction of 2.4 mm and an average femur length reduction of 0.5 mm. ]]> https://biospectrumindia.com/news/57/15437/medigate-and-cerner-to-advance-medical-device-security.html https://biospectrumindia.com/news/57/15437/medigate-and-cerner-to-advance-medical-device-security.html Mon, 30 Dec 2019 11:00:00 +0530 Medigate, a dedicated medical device security and asset management solution in the US, has announced it’s joining forces with Cerner Corporation, a global health care technology company, to make it easier for healthcare organizations to establish and maintain strong network security, manage medical device security risks and keep operations intact. For clients that choose to implement Medigate’s medical device security and asset management, Cerner’s team of cybersecurity experts will be equipped to help accurately inventory IoT and IoMT environments and support creation of effective clinical-based policies that help protect all connected devices and reduce the risk of cyberattacks. Cerner will also offer remediation services to stifle attacks, supporting organizations to get back on track in the event of a cyberattack. Together, Medigate and Cerner will provide hospitals and health systems with in-depth visibility into its security with continuous, unobtrusive monitoring of network activity to create a current, detailed medical and IoT device inventory. The in-depth visibility the Medigate solution delivers, coupled with the deep expertise Cerner offers, makes it easy to identify potential security risks and support an appropriate response to effectively protect the integrity and privacy of the clinical network. The platform also supports pre-emptive measures, supporting appropriate remediation to mitigate threats and keep the delivery of patient care safe. ]]> https://biospectrumindia.com/news/57/15428/genscript-initiates-precision-mutant-library-services-.html https://biospectrumindia.com/news/57/15428/genscript-initiates-precision-mutant-library-services-.html Fri, 27 Dec 2019 10:25:00 +0530 GenScript, the world's leading gene synthesis provider has announced the launch of its Precision Mutant Library Services for the drug development, industrial chemical and synthetic biology markets. The service overcomes the challenges of traditional library construction methods, saving researchers valuable screening time, expediting drug discovery and reducing costs. Mutant libraries are powerful, high-throughput tools for optimizing protein structure and function. However, traditional methods for library construction, including error-prone PCR or degenerate methods, suffer from limited control over codon usage and poor variant representation. These limitations require researchers to perform multiple rounds of screening to capture the entire variation of the library. The new Precision Mutant Library Services utilizes GenScript's proprietary semiconductor oligo synthesis technology to deliver precise control over each synthesized variant. The result is a more diverse and fully covered mutant library with unbiased distribution. "GenScript was able to create a mutant library that had 100 percent coverage of all expected variants before and after viral packaging, and excluded variants that contained amino acids that I did not want present at these sites," said Susan Butler, a PhD student in Junghae Suh's Synthetic Virology Lab at Rice University who was working to create a library of mutant caspids for adeno-associated vectors. "Having a library with only the variants that I wanted to test was able to reduce my screening efforts and maximize my time in finding my optimal viral vector sequence." GenScript's patented semiconductor technology-based platform uses CMOS technology to construct integrated circuit chips, providing electronic control over oligonucleotide synthesis and allowing precise control of the composition and proportions of amino acids at one or multiple variant sites in a single protein. Although degenerate NNK and NNS libraries have proved economical, scientists waste valuable screening time due to the poor representation of variants and desired amino acids at certain positions. "GenScript's Precision Mutant Library Services is a significant advancement over existing technologies and is as reliable as your iPhone," said Dr. Cedric Wu, senior director of research and development. "Researchers now have a new tool for developing better, safer drugs faster, and for many applications in the industrial chemical and synthetic biology markets." GenScript's Precision Mutant Library Services include site-saturation mutagenesis, saturation scanning mutagenesis, or combinatorial mutagenesis libraries. Saturation mutagenesis libraries provide the ability to screen mutations located at several sites within a protein sequence or across the total sequence space. Each position is mutated to all 19 non-wild-type amino acids. Combinatorial mutagenesis libraries involve mutating multiple positions simultaneously across specific target regions of a protein and exploring all possible combinations of mutations. ]]> https://biospectrumindia.com/news/57/15426/jj-receives-usfda-crl-for-investigational-long-acting-hiv-regimen.html https://biospectrumindia.com/news/57/15426/jj-receives-usfda-crl-for-investigational-long-acting-hiv-regimen.html Fri, 27 Dec 2019 09:25:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare's (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV's cabotegravir and Janssen's rilpivirine for the treatment of HIV-1 infection in adults. The regimen was co-developed as part of a collaboration between Janssen and ViiV. The reasons given in the CRL relate to Chemistry, Manufacturing and Controls (CMC).  There have been no reported safety issues related to CMC, and the CRL does not relate to the clinical safety data submitted as part of the package. Janssen will work closely with ViiV and the FDA to determine the appropriate next steps for this New Drug Application. "We believe the once-monthly, long-acting regimen represents an important therapeutic advance for those living with HIV," said Brian Woodfall, M.D., Global Head, Development, Infectious Diseases, Janssen Biopharma, Inc. "We will continue to collaborate with our partners and the FDA to fully understand the requirements needed to support U.S. approval as we continue in our efforts to change the course of the HIV epidemic." The HIV LA regimen is an investigational product and not currently approved anywhere in the world. It is a combination of rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company, with the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare.   ]]> https://biospectrumindia.com/news/57/15412/pfizer-licenses-theravances-jak-inhibitors-for-skin-conditions.html https://biospectrumindia.com/news/57/15412/pfizer-licenses-theravances-jak-inhibitors-for-skin-conditions.html Tue, 24 Dec 2019 13:50:00 +0530 Theravance Biopharma Ireland Limited, a subsidiary of Theravance Biopharma, and Pfizer have announced that the companies have entered into a global license agreement for Theravance Biopharma's preclinical program for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitors that can be rapidly metabolized. The compounds in this program target validated pro-inflammatory pathways and are specifically designed to possess skin-selective activity with minimal systemic exposure. Under the terms of the agreement, Theravance Biopharma will receive an upfront cash payment of $10 million and will be eligible to receive up to an additional $240 million in development and sales milestone payments from Pfizer. In addition, Theravance Biopharma will be eligible to receive royalties on worldwide net sales of any potential products emerging from the program.  "We believe that this global agreement with Pfizer provides further validation of our unique expertise in the discovery and development of innovative, organ-selective JAK inhibitors. As a clear global leader in the field of JAK inhibition, Pfizer is ideally positioned to advance this program and unlock its therapeutic potential," said Rick E Winningham, chief executive officer of Theravance Biopharma.  "Theravance Biopharma's skin-targeted JAK inhibitor program will nicely complement Pfizer's portfolio of preclinical and clinical-stage molecules, which have unique selectivity profiles and are matched to conditions in which we believe they have the greatest potential to address unmet need," said Michael Vincent, chief scientific officer, Inflammation & Immunology, Pfizer. "Topical JAK inhibitors that can be rapidly metabolized have potential to reach more patients with mild-to-moderate skin conditions, for whom treatment is currently limited." ]]> https://biospectrumindia.com/news/57/15411/fda-approves-first-generics-of-blood-thinner-eliquis.html https://biospectrumindia.com/news/57/15411/fda-approves-first-generics-of-blood-thinner-eliquis.html Tue, 24 Dec 2019 13:15:00 +0530 The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy. "Today's approvals of the first generics of apixaban are an example of how the FDA's generic drug program improves access to lower-cost, safe and high-quality medicines," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing." Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA's Drug Competition Action Plan and the agency's efforts to help increase patient access to more affordable medicines. For at-risk patients, such as those with, or at risk for, DVT, or nonvalvular atrial fibrillation, the risk of stroke related to blood clots forming in the body and traveling to the brain is a serious concern. Atrial fibrillation is a heart rhythm problem that can potentially cause such blood clots. According to the Centers for Disease Control and Prevention, it is estimated that between 2.7 and 6.1 million people in the U.S. have atrial fibrillation. Many of these individuals use anticoagulants or anti-clotting drugs to reduce that risk. The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc. ]]> https://biospectrumindia.com/news/57/15399/roche-enters-into-licensing-agreement-with-sarepta-therapeutics-.html https://biospectrumindia.com/news/57/15399/roche-enters-into-licensing-agreement-with-sarepta-therapeutics-.html Mon, 23 Dec 2019 12:25:00 +0530 Roche and Sarepta Therapeutics, have announced the signing of a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin),  Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the United States. Under the terms of the agreement, Sarepta will receive an upfront payment of $750million in cash and $400million in equity. In addition, Sarepta is eligible to receive regulatory and sales milestones, and royalties on net sales. Roche and Sarepta will equally share global development expenses. This collaboration demonstrates Roche's commitment to gene therapy and its transformational potential for patients. It combines Roche’s global reach, commercial presence and regulatory expertise with Sarepta’s gene therapy candidate for DMD to accelerate access to SRP-9001 for patients outside the United States. DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. SRP-9001, currently in clinical development for DMD, is designed to deliver the microdystrophin-encoding gene directly to the muscle tissue for the targeted production of the microdystrophin protein. As part of the agreement, Roche also obtains an option to acquire ex-U.S. rights to certain future DMD-specific programs from Sarepta, in exchange for separate milestone and royalty considerations, and cost sharing. The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions. The parties anticipate that the agreement will close in the first quarter of 2020. ]]> https://biospectrumindia.com/news/57/15390/innovation-and-regulatory-harmonisation-to-drive-indian-pharma-in-2020.html https://biospectrumindia.com/news/57/15390/innovation-and-regulatory-harmonisation-to-drive-indian-pharma-in-2020.html Fri, 20 Dec 2019 00:00:00 +0530 Mumbai, 18 December 2019: CPhI & P-MEC India 2019 – organised by Informa Markets – recently closed its doors to over 45,000 visitors and 1,600+ exhibitors from 44 countries, making it the largest pharmaceutical trade show in South Asia. Mirroring the event’s success, India is set for rapid growth in 2020 according to the recent CPhI Annual Report Pharma Index.  Cara Turner, Brand Director at Informa, said: “CPhI & P-MEC India is emblematic of the performance of the Indian pharmaceutical industry, which has made fantastic progress in the last 12 months. With remarkable results seen in the 2019 CPhI Pharma Index serving as its backdrop, this year’s exhibition welcomed a record-breaking number of attendees to New Delhi.  Now in its 13th year, three days of CPhI & P-MEC India staged a breadth of informative content sessions, with pharma experts from across the entire supply chain sharing their knowledge. One key trend to emerge was the continued goal of aligning India to Western regulatory standards, which experts suggest will help the country sustain significant increases in exports if harmonization of regulations continues.  Innovation was another major talking point, with the widespread view that the current lack of innovation could potentially be one drag factor for India in the near future. Pharma experts discussed a number of proposed ideas for boosting innovation, including government investments in research initiatives and talent to form an ‘Innovation Hub’, as well as shifting manufacturing towards biologics development. In fact, raising regulatory standards and enhancing innovation are two crucial milestones the country must reach if the market is to achieve its ‘Vision 2030’ aspiration, which could result in a market valued at $130bn by the end of the next decade1.  There was huge interest in the latest machinery driven by the expanding production base in India, as well as continued efforts to lower production costs and adapt equipment to the evolving drugs pipeline. In response, P-MEC India was larger than any previous year, with cutting edge manufacturers displaying the newest commercial machinery and technologies on the market. Investing in the right technologies has become an integral part of industry efforts to prepare for the next wave of growth.  In its 4th consecutive year, India Pharma Week hosted a plethora of initiatives spanning over five days, giving executives the chance to engage in thought-provoking discussions about how to propel the country’s pharmaceutical market forward. Notably, the CEO roundtable saw pharma leaders explore the benefits of Indian companies tapping into the Chinese and Russian markets. For example, the Russian government provided a number of cost-saving incentives that Indian pharma could capitalise on2.  This year’s Women in Pharma Summit – a platform where women in the industry can give accounts of their personal experiences and success stories – proved to be a major triumph. It included a celebration of contributions made by some of pharma’s brightest female stalwarts, as well as progressive approaches to better shaping a future-fit industry.  The Pre-Connect Congress event brought together stakeholders from all aspects of the pharma supply chain to discuss the key drivers in Indian pharma for the upcoming year. On top of the aforementioned ‘improving regulatory compliance’ and ‘innovation’ topics, the implications of Pharma 4.0 and Artificial Intelligence were discussed, as well as the benefits of companies diversifying their generics portfolios.  Finally, the India Pharma Awards saw winners spanning 18 categories and all aspects of the supply chain. Notable victors include Syngene, who won the ‘Excellence in Contract Research & Manufacturing’ award, as well as Biocon, who were bestowed the prestigious ‘Company of the Year’ award.  Rahul Deshpande, Group Director at Informa commented, “The event never fails to educate visitors on the latest trends to emerge in Indian pharma, including new innovation initiatives and rapidly advancing harmonization efforts – it’s a really buoyant time across pharma in India. Already, we are excited to return to Delhi next year, as we anticipate both Indian pharma and CPhI & P-MEC India to be hugely successful in 2020.”  CPhI & P-MEC India 2020 will take place at the India Expo Centre next November (25-27), with all market indicates pointing to an extremely prosperous few years ahead. ]]> https://biospectrumindia.com/news/57/15373/nccn-publishes-new-pediatric-cancer-guidelines-.html https://biospectrumindia.com/news/57/15373/nccn-publishes-new-pediatric-cancer-guidelines-.html Thu, 19 Dec 2019 12:15:00 +0530 National Comprehensive Cancer Network® (NCCN®) published new guidelines for treating children, adolescents and young adults with pediatric aggressive mature B-cell lymphomas, including Burkitt lymphoma and diffuses large B-cell lymphoma. NCCN published the first pediatric NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) earlier this year that addressed Acute Lymphoblastic Leukemia. These new pediatric guidelines—with more to follow—further NCCN's efforts to improve quality of care and outcomes for children with cancer worldwide. Historically, most children with cancer in the United States have been included on active clinical trials, with clear protocols in place to standardize treatment and maximize response, while addressing potential toxicities. However, improved cure rates and decreased research funding have resulted in more patients being treated outside of clinical trials, where treatment guidelines are lacking. The new NCCN Guidelines® are intended to fill the void and make sure management is provided in the best possible manner to improve both short- and long-term outcomes.  Furthermore, globally (especially in resource-constrained settings) many patients do not have access to oncologists who specialize in pediatric cancers, making guidelines highly relevant for these situations. Non-Hodgkin lymphoma is responsible for approximately 5% of all cancers in children age 14 and younger and 7% of all cancers for adolescents between 15 and 19 years old. Major supportive care concerns include disease-associated infections, renal dysfunction, bowel obstruction, treatment-related tumor lysis syndrome, neurotoxicity, and mucositis.2 "Over the course of my career, one of the successes I have witnessed is the improvement in treatment outcomes for children, adolescents, and young adults with aggressive mature B-cell lymphomas. These previously fatal diseases can now be cured in almost all cases, thanks to decades of cooperative international research into how to optimize the way we approach treatment and supportive care," explained Kimberly J. Davies, MD, Medical Director of Dana-Farber's Pediatric Oncology Clinic at Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Chair of the NCCN Guidelines Panel for Pediatric Aggressive Mature B-Cell Lymphomas. "Treatments for these lymphomas are intensive and complicated, but when applied appropriately and with good supportive care, they have high curative potential. The NCCN Guidelines have been developed by experts in the field to share decision-making recommendations with all pediatric oncologists for the best treatment of these lymphomas." "These new recommendations from NCCN represent one of the first guidelines developed specifically for the care of pediatric cancer patients," said Matthew Barth, MD, Roswell Park Comprehensive Cancer Center, Vice-Chair of the NCCN Guidelines Panel for Pediatric Aggressive Mature B-Cell Lymphomas. "Based on evidence from recent clinical trials, we are now achieving unprecedented success in treating children with aggressive mature B-cell non-Hodgkin lymphomas, including Burkitt lymphoma and diffuse large B-cell lymphoma, and we want to make sure that providers around the world have access to these best practices. This resource will help guide treatment decisions for providers treating pediatric, adolescent, and select young adult patients—for whom recommended regimens depart significantly from the recommendations for older adults—while also providing guidance on appropriate supportive care, which has also played a major role in improving survival outcomes in childhood B-cell lymphomas." "Together with the new NCCN Guidelines for Pediatric Acute Lymphoblastic Leukemia, these NCCN Guidelines for Pediatric Aggressive Mature B-Cell Lymphomas begin the exciting expansion of the widely-used NCCN Guidelines into pediatric diseases," added Alexandra E. Kovach, MD, Vanderbilt-Ingram Cancer Center, Member of the NCCN Guidelines Panel for Pediatric Aggressive Mature B-Cell Lymphomas. "The goal of these guidelines is to provide oncologists, pathologists, general practitioners, and students with a comprehensive yet concise and user-friendly guide to modern diagnosis, staging, treatment and management of pediatric Burkitt lymphoma and diffuse large B-cell lymphoma, and to illustrate how management differs from how these diseases are handled in adult patients." Up next, NCCN plans to adapt these guidelines into NCCN Harmonized Guidelines™ for Sub-Saharan Africa, which take into account specific regional concerns and potential resource limitations. The organization will also continue expanding into pediatric recommendations with upcoming NCCN Guidelines for Wilms Tumor and Pediatric Hodgkin Lymphoma. Recently, NCCN also published new supportive care guidelines detailing best practices in the lead-up and after-effects of stem-cell transplantation, and significantly updated the NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. ]]> https://biospectrumindia.com/news/57/15372/ec-approves-roches-kadcyla-to-treat-her2-positive-early-breast-cancer.html https://biospectrumindia.com/news/57/15372/ec-approves-roches-kadcyla-to-treat-her2-positive-early-breast-cancer.html Thu, 19 Dec 2019 11:45:00 +0530 Roche has announced that the European Commission has approved Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. “Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This approval of Kadcyla will allow many more women with HER2-positive early breast cancer to be given a transformative treatment that may cut the risk of their disease returning or progressing." The goal of neoadjuvant treatment is to shrink tumours in order to help improve surgical outcomes. Adjuvant treatment aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.1 People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease. The approval of Kadcyla in Europe is based on results from the phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.001) compared to Herceptin® (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%. The safety profile of Kadcyla was consistent with that observed in previous studies. The impact of adjuvant treatment with Kadcyla has already been seen in the US where thousands of women are already being given this treatment following US Food and Drug Administration approval in May. Kadcyla in this setting is now approved in 27 countries worldwide and the use of Kadcyla in eBC has been recommended by multiple treatment guidelines, including those from the St Gallen International Breast Cancer Conference, the AGO and the NCCN. ]]> https://biospectrumindia.com/news/57/15361/roche-acquires-spark-therapeutics-to-strengthen-presence-in-gene-therapy.html https://biospectrumindia.com/news/57/15361/roche-acquires-spark-therapeutics-to-strengthen-presence-in-gene-therapy.html Wed, 18 Dec 2019 10:55:00 +0530 Roche and Spark Therapeutics, Inc. have announced the completion of the acquisition following the receipt of regulatory approval from all government authorities required by the merger agreement. Commenting on this important step forward, Severin Schwan, CEO of Roche, said, “We are excited about this important milestone because we believe that together, Roche and Spark will be able to significantly improve the lives of patients through innovative gene therapies. This acquisition supports our long-lasting commitment to bringing transformational therapies and innovative approaches to people around the world with serious diseases.” Spark Therapeutics, based in Philadelphia, Pennsylvania, is a fully integrated, commercial company committed to discovering, developing and delivering gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases. Spark Therapeutics will continue to operate as an independent company within the Roche Group. “Today ushers in a new and promising era in the development of genetic medicines for patients and families living with inherited diseases and beyond,” said Jeffrey D. Marrazzo, co-founder and CEO of Spark Therapeutics. “Spark and Roche share an ethos of imagining the unimaginable. Together, we have the potential to change the future of medicine and deliver the medicines of tomorrow today. We couldn’t be more thrilled about what’s next.” ]]> https://biospectrumindia.com/news/57/15363/eli-lilly-enters-into-alliance-with-dexcom.html https://biospectrumindia.com/news/57/15363/eli-lilly-enters-into-alliance-with-dexcom.html Wed, 18 Dec 2019 07:30:00 +0530 Eli Lilly and Company has announced a global commercialization agreement to integrate DexCom, Inc. products into Lilly's personalized diabetes management system, currently in development to advance the treatment of diabetes. Under the terms of the non-exclusive agreement, Lilly will use Dexcom's continuous glucose monitoring (CGM) devices in both the pen- and pump-based platforms of the system being designed to help improve diabetes management. The agreement with Dexcom builds on Lilly's efforts to provide a comprehensive system that integrates connected insulin delivery devices, software and analysis to equip people with type 1 and type 2 diabetes and their healthcare providers with personalized information and guidance to help simplify management of their diabetes. "Even with all of the advances in diabetes technology, insulin therapy is still overwhelming and complex," said Mike Mason, senior vice president, Connected Care and Insulins, Lilly Diabetes. "We're excited to include Dexcom's technology in the solutions we deliver to people with diabetes to help improve health outcomes by delivering actionable insights in one connected system. As we integrate our expertise and insights with those from our partners, like Dexcom, we are aiming to not only transform the way we develop and deliver medicine, but to transform how people manage their diabetes." The personalized diabetes management system being developed will include both pen- and pump-based platforms. The goal of the pen-based platform is to integrate personalized data from a prefilled, disposable insulin pen with data from glucose-sensing technologies into a compatible software application. Personalized data is transferred from the pen via an optional attachment. The goal of the pump-based platform, which is a hybrid-closed loop system, is to use integrated devices – an insulin pump, continuous glucose monitor and a dedicated handheld controller or smartphone application that controls the system – to automate insulin dosing. "CGMs provide people with diabetes and their healthcare team with important real-time data that can help alleviate the burden of diabetes management, including overall glucose level trends and information on time spent in target blood glucose range," said Rick Doubleday, executive vice president and chief commercial officer of Dexcom. "We're looking forward to expanding our collaboration with Lilly as we integrate our technology into their system and believe it will help reduce some of the complexity that can come from managing diabetes every day." ]]> https://biospectrumindia.com/news/57/15357/pfizer-astellas-get-usfda-nod-for-prostate-cancer-therapy-xtandi.html https://biospectrumindia.com/news/57/15357/pfizer-astellas-get-usfda-nod-for-prostate-cancer-therapy-xtandi.html Tue, 17 Dec 2019 15:50:00 +0530 Pfizer Inc. and Astellas Pharma Inc. have announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). In 2019, it is estimated that just over 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone. With this approval, XTANDI is now the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC. The approval is based on results from ARCHES, a randomized Phase 3 study which evaluated 1,150 men with mCSPC and met its primary endpoint of radiographic progression-free survival (rPFS). “Men with metastatic castration-sensitive prostate cancer face complex treatment decisions and it is critical for physicians and patients to have as much information as possible when deciding on all of the options available,” said Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Cancer Biology, Director of Research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers and lead investigator of ARCHES. “The research supporting the FDA approval and updated treatment guidelines provide physicians and patients with compelling evidence to consider enzalutamide as a treatment option for men with this disease.”  “XTANDI has been established as a standard of care for men with castration-resistant prostate cancer and has been prescribed to more than 420,000 patients worldwide since it was first approved in 2012,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas. “This approval in metastatic castration-sensitive prostate cancer means physicians can now offer XTANDI to men earlier in their advanced prostate cancer treatment journey.” “Today’s approval adds to over a decade of global clinical research aimed at better understanding the potential benefit of XTANDI for men with advanced prostate cancer,” said Andy Schmeltz, Global President, Pfizer Oncology. “The FDA approval marks continued progress to help meet the needs of patients, including men living with metastatic castration-sensitive prostate cancer.” ]]> https://biospectrumindia.com/news/57/15356/roche-to-complete-spark-acquisition-deal.html https://biospectrumindia.com/news/57/15356/roche-to-complete-spark-acquisition-deal.html Tue, 17 Dec 2019 15:05:00 +0530 Roche and Spark Therapeutics, Inc. have announced that the UK Competition and Markets Authority has unconditionally cleared Roche’s pending acquisition of Spark pursuant to its previously announced tender offer to purchase all of the outstanding shares of common stock (the “Shares”) of Spark for USD 114.50 per Share, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 7, 2019 (as it may be amended and supplemented from time to time, the “Offer”). The offering period of the Offer is scheduled to expire at 5:00 p.m., New York City time, on Monday, December 16, 2019, unless it is extended further under the circumstances set forth in the Agreement and Plan of Merger, dated as of February 22, 2019, by and among Roche Holdings, Inc., 022019 Merger Subsidiary, Inc., and Spark. Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and received, and not validly withdrawn, a majority of the outstanding Spark Shares. ]]> https://biospectrumindia.com/news/57/15336/mkea-announces-strategic-equity-investment-of-7-5-mn-by-j-j.html https://biospectrumindia.com/news/57/15336/mkea-announces-strategic-equity-investment-of-7-5-mn-by-j-j.html Mon, 16 Dec 2019 15:10:00 +0530 Mauna Kea Technologies (MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, has announced a strategic equity investment of 7.5 million euro by Johnson & Johnson Innovation – JJDC, Inc. (JJDC). Pursuant to the agreement, JJDC, the strategic venture capital arm of Johnson & Johnson, will subscribe to 5,357,142 new ordinary MKEA shares for €1.40 per share, representing a total equity value of 7.5 million euro. “We are very proud to announce a strategic equity investment agreement with Johnson & Johnson Innovation – JJDC, Inc.,” said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. “This agreement represents a significant strategic inflection point for Mauna Kea Technologies, particularly in that it provides a capital infusion that will help us execute our strategic growth initiatives.” Mr. Gershon continued: “This strategic investment will advance our collaboration with the Lung Cancer Initiative at Johnson & Johnson, which is working to develop new diagnostic and therapeutic approaches for this disease with significant unmet need. Our Cellvizio platform and AQ-Flex™ 19 Confocal Miniprobe™ (nCLE) is designed to be used through existing bronchoscopes, transbronchial needles and other bronchoscopic accessories, which makes it a viable option for use with the new emerging robotic and existing advanced navigation platforms.” Transaction Summary JJDC will invest in the share capital of the Company an amount of 7.5 million euro, in consideration for 5,357,142 new ordinary shares, corresponding to an issue price per ordinary share equal to approximately €1.40. The new ordinary shares will be fungible with the existing shares of the Company. JJDC will own approximately 17.5% of the total ordinary shares outstanding following this transaction. JJDC will not have any board representation rights. As part of the investment, JJDC agreed to customary lock up and stand still obligations for a period of 12 months. Pursuant to an agreement entered into as part of the investment, Mauna Kea has granted, for 24 months, to JJDC and its affiliates, a right of first refusal with respect to a transaction (other than change of control of Mauna Kea) on its pCLE (probe CLE) or nCLE (needle CLE) variants for use in endoluminal robotic procedures for lung applications and to the application of machine learning and artificial intelligence for lung applications. Mauna Kea has also granted, for 24 months, to JJDC and its affiliates, a right of first negotiation with respect to a transaction (other than change of control of Mauna Kea) on its pCLE (probe CLE) or nCLE (needle CLE) variants for use in endoluminal robotic procedures for GI and urology applications. The closing of the transaction is expected to occur on December 19, 2019. ]]> https://biospectrumindia.com/news/57/15335/paragon-28-launches-unique-option-for-failed-sci.html https://biospectrumindia.com/news/57/15335/paragon-28-launches-unique-option-for-failed-sci.html Mon, 16 Dec 2019 11:55:00 +0530 Paragon 28, an orthopedic foot and ankle Company has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient. The AVITRAC™ MTP Revision System was created to provide an option when revising a failed Synthetic Cartilage Implant (SCI) to MTP arthrodesis. The system contains grafts in three different size options (Ø9 mm, Ø11 mm, Ø13 mm) to address the void left in the head of the metatarsal upon removal of an SCI implant. Sterile packaged reamers are included that are true to size in order to properly prepare the void for introduction of the AVITRAC™ graft. AVITRAC™ is the only aseptically processed allograft solution available on the market to address SCI revisions. Gamma irradiation and bleaching are avoided during processing to maintain the structural integrity and osteoinductivity of the graft. These strict tissue handling guidelines ensure the highest quality allograft is provided for these revisions. ]]> https://biospectrumindia.com/news/57/15309/icer-issues-final-report-for-add-on-therapies-to-treat-type-2-diabetes.html https://biospectrumindia.com/news/57/15309/icer-issues-final-report-for-add-on-therapies-to-treat-type-2-diabetes.html Wed, 11 Dec 2019 16:35:00 +0530 The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of oral semaglutide (Rybelsus® Novo Nordisk), a GLP-1 receptor agonist for the treatment of Type 2 diabetes mellitus (T2DM). This new therapy is an oral version of the injectable Ozempic® (Novo Nordisk), which was approved by the FDA in 2017. For this analysis, adding oral semaglutide was compared to background therapy with metformin alone, and to three competitors for add-on therapy: liraglutide (Victoza®, Novo Nordisk), sitagliptin (Januvia®, Merck), and empagliflozin (Jardiance®, Boehringer Ingelheim). ICER’s report on these therapies was reviewed at the November 2019 public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), one of ICER’s three independent evidence appraisal committees. During the meeting, CEPAC members unanimously voted that the evidence was adequate to demonstrate that adding oral semaglutide to ongoing background therapy provides a positive net health benefit, and that this benefit is superior to that provided by adding sitagliptin. However, a majority of the CEPAC found that the evidence did not adequately demonstrate that the net health benefit of adding oral semaglutide was superior to that of adding liraglutide, nor did the evidence adequately distinguish the net health benefit of adding oral semaglutide from that provided by adding empagliflozin. During their deliberation, panel members also weighed the therapies’ other benefits and contextual considerations. Noting that diabetes represents a particularly high lifetime burden of illness, the panel members voted that the oral version of semaglutide offers reduced complexity compared to injectable liraglutide, and this reduced complexity may significantly improve patient outcomes. Given the available evidence on comparative effectiveness and incremental cost-effectiveness, and considering other benefits, disadvantages, and contextual considerations, the CEPAC panel voted that oral semaglutide provides “intermediate” long-term value for money. When compared to background therapy alone, oral semaglutide’s annual estimated net price of $6,103 falls within ICER’s value-based price benchmark range of $6,000-$6,400 per year. However, oral semaglutide is unlikely to reach commonly cited thresholds compared with empagliflozin. ICER’s value-based price benchmarks suggest a price range, net of any discounts and rebates, that aligns fairly with a treatment’s added benefits for patients over their lifetime. The ranges reflect commonly cited cost-effectiveness thresholds between $100,000 and $150,000 per Quality-Adjusted Life Year (QALY) gained. Prices at or below these thresholds help ensure that the health benefits gained by patients using new treatments are not outweighed by health losses due to long-term cost pressures that lead individuals to abandon care or lose health insurance. To reach thresholds of between $100,000 and $150,000 per life year gained, oral semaglutide would need to be priced between $6,400-$7,100 per year. Key Policy Recommendations   Following the voting session, a policy roundtable of experts — including clinicians, patient advocates, and representatives from manufacturers and payers — convened to discuss the implications of the evidence for policy and practice. Key recommendations stemming from the roundtable discussion include: Manufacturers with new diabetes agents should seize the opportunity to come to market with a lower list price to benefit patients. To provide high quality head-to-head evidence on the comparative effectiveness of emerging treatment options for patients with diabetes, manufacturers should look to the example set by the PIONEER trials of oral semaglutide. As the treatment options for T2DM continue to evolve, primary care providers should make themselves aware of the updated clinical guidelines to ensure that all treating clinicians know how to identify the varying risks and benefits of different agents for particular subpopulations. Given the high rate of gastrointestinal side effects with oral semaglutide, real-world evidence on adherence should be studied and reported. ]]> https://biospectrumindia.com/news/57/15301/abbvie-scripps-research-to-develop-new-therapeutics-range.html https://biospectrumindia.com/news/57/15301/abbvie-scripps-research-to-develop-new-therapeutics-range.html Wed, 11 Dec 2019 07:05:00 +0530 AbbVie, a research-based global biopharmaceutical company and Scripps Research, an international leader in non-profit biomedical research and drug discovery, have announced a collaboration to develop new therapies for a range of diseases, including in the therapeutic areas of oncology, immunology, neurology and fibrosis. "Based on our strong switchable CAR-T alliance launched in 2018, we feel the expanded relationship with AbbVie represents a robust path forward for some of our programs, complementing a diverse ecosystem of innovation we've created over the past several years at Scripps to advance life-changing therapies," says Peter Schultz, Ph.D., chief executive officer, Scripps Research and Calibr, its drug discovery division. In addition to programs initially named in the collaboration from preclinical to IND stages of development, Scripps Research will present to AbbVie a certain number of preclinical programs of mutual interest per year for consideration to be included in the collaboration. Scripps and AbbVie will also work together in parallel to advance CD3 bispecifics against oncology targets nominated by AbbVie. Under the terms of the license agreement, Scripps Research will continue to conduct pre-clinical research and development activities and, in some cases, Phase 1 clinical trials with AbbVie having an exclusive option to further develop and commercialize. Upon AbbVie's decision to exercise its option to a given program, Scripps Research is eligible to receive additional payments from AbbVie, including option exercise fees, success-based development and commercial milestone payments, as well as tiered royalties. AbbVie will make an undisclosed upfront payment, as well as a near-term milestone payment upon achievement of certain success criteria. "The best way to develop transformational medicines is through collaborations that bring together the brightest minds," says Mohit Trikha, Ph.D., vice president and head of oncology early development, AbbVie. "This partnership with Scripps Research will collaboratively advance next generation programs, build stronger relationships with proven and emerging scientific leaders, and most importantly help us advance novel medicines for patients. We are eager to partner with Scripps on these assets as they enter the clinic over the next few years as Scripps has one of the strongest track records of any academic institution when it comes to advancing novel medicines for patients." ]]> https://biospectrumindia.com/news/57/15296/gedmatch-collaborates-with-genomics-firm-verogen.html https://biospectrumindia.com/news/57/15296/gedmatch-collaborates-with-genomics-firm-verogen.html Tue, 10 Dec 2019 11:10:00 +0530 US based GEDmatch, a pioneer in consumer genealogy has joined with forensic genomics firm Verogen, Inc. in a move that allows the company to ensure ongoing privacy protections and enhance the customer experience for users of its website. “Verogen understands our philosophy and shares the vision of GEDmatch, which has always been about using science to connect people” “I am confident that we have found an ideal partner for GEDmatch,” said founder Curtis Rogers. “Verogen understands our philosophy and shares the vision of GEDmatch, which has always been about using science to connect people,” Rogers said. “Verogen is able to support our growth while staying true to our roots.” GEDmatch allows users to upload genetic profiles created by other genealogy sites in order to expand the search for familial links. GEDmatch’s database currently has more than 1.3 million customer profiles and is gaining as many as 1,000 new users every day. In the coming months, GEDmatch users will begin to see improvements to the website, such as an enhanced homepage that offers increased functionality, Verogen CEO Brett Williams said. Verogen will also bolster the GEDmatch platform, resulting in increased stability and optimal searchability. These back-end changes won’t disrupt the experience for users and, in fact, will make searching the database easier, Williams said. GEDmatch’s terms of service will not change with respect to the use, purposes of processing, and disclosures of user data, Williams confirmed. The website gives users a choice to opt-in to allow law enforcement to search uploaded files as a tool to solve violent crimes. Among the successes of this technology is work by public safety officials who used GEDmatch to apprehend accused Golden State Killer Joseph DeAngelo, a notorious serial killer who terrorized California and evaded police for decades until his arrest in 2018. As many as 70 violent crimes have been solved as a result of genealogy searches. “Never before have we as a society had the opportunity to serve as a molecular eyewitness, enabling law enforcement to solve violent crimes efficiently and with certainty,” Williams said. “Still, our users have the absolute right to choose whether they want to share their information with law enforcement by opting in,” Williams said. “We are steadfast in our commitment to protecting users’ privacy and will fight any future attempts to access data of those who have not opted in.” Added Rogers: “Our number one priority is our customers. We are and always have been a genealogy site whose goal is to help people find answers they’re looking for about themselves and their families. As we grow, we want to enhance the customer experience by making the site more user-friendly and by ensuring data is protected. Verogen can help us do that.” Under terms of the deal, Rogers will retain a key role focused on the primary mission of GEDmatch, which is providing tools to help amateur and professional researchers and genealogists. ]]> https://biospectrumindia.com/news/57/15294/ipro-creates-kidney-disease-management-tools.html https://biospectrumindia.com/news/57/15294/ipro-creates-kidney-disease-management-tools.html Tue, 10 Dec 2019 10:30:00 +0530 IPRO software developers and quality improvement professionals have created exciting new technologies that will enhance data-driven management of chronic kidney disease (CKD) by physicians, patients and care partners. IPRO's intuitive and freely-available mobile applications interface with the federal government's massive "Blue Button 2.0 Initiative," which permits access to and analysis of up to four years of given patient's entire Medicare claims history. IPRO's CKD Screening App guides physicians in identifying patient CKD risk, selecting appropriate lab tests for diagnosis and making disease staging determination. The CKD Screening App also offers a "Conversation Starter" that helps clinicians initiate difficult conversations with patients and care partners regarding CKD as a serious clinical condition. IPRO's patient-facing Kidney Choices mobile app has two tracks; one that facilitates access to CKD related claims history for lab tests, clinician visits , drug dispensing, and other pertinent information via Medicare Blue Button 2.0, while the other offers easy-to-understand explanations of advanced kidney disease treatment options including hemodialysis, peritoneal dialysis, kidney transplant and conservative care. Patients can access and customize a series of questions to ask healthcare providers. "These physician-facing and patient-facing CKD management mobile apps represent a quantum leap in developing innovative resources that expand data-driven decision-making while better educating patients on difficult treatment options," according to Clare B. Bradley, MD, MPH, IPRO's Senior Vice President and Chief Medical Officer. "I congratulate IPRO on being an early champion in the effort to create intuitive, online resources that a patient can access from a tablet or a cell phone," according to Ken D Teasley of the Patient Advisory Council (PAC).  "I don't think there's any question that this is the wave of the quality improvement future."  A HIPAA-compliant health data organization, IPRO is a non-profit organization that works with government agencies, providers and consumers to implement innovative programs that bring policy ideas to life. For more than 35 years IPRO has made creative use of clinical expertise, emerging technology and data solutions to make the healthcare system work better. ]]> https://biospectrumindia.com/news/57/15292/healx-boehringer-ingelheim-to-treat-rare-neuro-diseases.html https://biospectrumindia.com/news/57/15292/healx-boehringer-ingelheim-to-treat-rare-neuro-diseases.html Tue, 10 Dec 2019 07:10:00 +0530 UK based Healx Ltd., the AI-powered biotechnology company focused on developing breakthrough treatments for rare diseases has entered into an agreement with Boehringer Ingelheim to identify indications related to rare neurological diseases. The project will leverage Healx’s comprehensive AI-based drug discovery platform, Healnet, and expertise in rare diseases and pharmacology, to identify potential new indications for assets from Boehringer Ingelheim’s pipeline. Healx will use their data analysis and technological capabilities to assist Boehringer Ingelheim’s efforts in prioritising selected indications for further research. Their AI platform, which draws upon the most comprehensive knowledge graph of rare disease data to intelligently predict and match treatments to rare diseases, will play a key part in the collaborative effort. In addition, Healx has significant experience in the area of rare neurological disorders, such as Fragile X syndrome as well as Pitt-Hopkins syndrome. The company’s AI-based drug discovery platform (Healnet) has proven success in that it identified eight repurposing drug candidates with potential benefits for Fragile X syndrome, which were not considered for the condition prior to Healx’s involvement. As a result, several candidates have demonstrated efficacy in vivo and one candidate is now progressing toward a Phase 2a trial. In another project, carried out in collaboration with the Pitt Hopkins Research Foundation, Healnet was successfully used to investigate, predict and progress novel treatment options for the ultra-rare neurodevelopmental disorder Pitt-Hopkins syndrome. Dr Tim Guilliams, Founder and CEO of Healx, commented: “Healx is dedicated to transforming the lives of rare disease patients by intelligently matching and developing potential drug treatments to their conditions. We believe that sophisticated technologies, such as AI and machine learning methods, will be fundamental to any drug discovery and development project in the future. “The project with Boehringer Ingelheim presents an opportunity for further innovation in identifying rare disease candidates for patients whose medical needs are not currently met. Harnessing BI’s expertise for drug development, especially in rare neurological conditions, in combination with our AI-powered drug discovery platform, will enable faster identification of potential new treatments.” More than 7,000 rare diseases have been identified to date (diseases affecting fewer than 1 in 2,000 people), with 250 new rare diseases classified annually. Collectively, this impacts over 400 million individuals worldwide with less than 5% of these rare diseases having approved treatments. There is therefore a substantial unmet medical need1. Healx’s mission is to use its AI platform, deep pharmacological expertise and extensive patient engagement to improve the quality of life and care for patients with rare diseases. Its business model is to develop its own pipeline of proprietary drug candidates, as well as to work in partnership with a range of organisations to explore novel pharmacological routes and indication expansion opportunities. The project with Boehringer Ingelheim adds to Healx’s portfolio of agreements and collaborations with pharmaceutical and biotechnology companies, academia, clinical institutes and rare disease charities since its foundation in 2014.   ]]> https://biospectrumindia.com/news/57/15289/bayer-forms-strategic-partnership-with-capgemini.html https://biospectrumindia.com/news/57/15289/bayer-forms-strategic-partnership-with-capgemini.html Mon, 09 Dec 2019 12:55:00 +0530 French firm Capgemini has announced a six-year agreement with Bayer AG, the German global enterprise with core competencies in the Life Science fields of health care and agriculture, to transform its IT landscape and to further accelerate the digitalization of the organization. As part of the new agreement, Capgemini will deliver a wide range of transformational services, including Bayer’s IT infrastructure Cloud transformation; run Enterprise Resource Planning (ERP) and Business Intelligence/Analytics domains management and transformation, as well as the Service Integration of Bayer’s entire new supplier eco-system.  Following a competitive tender process, Capgemini was selected as a lead partner, for its ability to enable large and complex transformations at scale, its proven track record in agility and flexibility, organizational change management, and robust and reliable delivery. Specific services within the agreement, that draw upon the end to end capabilities of the Group, include ERP; Business Intelligence and Analytics; Automation; global IT Infrastructure including public Cloud transformation; Unified Communications and end to end Service Integration.  “Major IT companies like Capgemini are able to realize scale effects and have an innovative power that we want to benefit from. We will focus our internal IT competencies on generating value for our businesses in the Life Science industry by providing differentiating solutions in an increasingly digital world,” said Daniel Hartert, Chief Information Officer at Bayer. “Our longterm partnership and deep commitment to Bayer has resulted in us being able to take our collaboration to the next level with this landmark deal that draws on capabilities from across the Group. We are now looking forward to delivering a cloud-first strategy at Bayer to support the business in achieving its strategic goals and Bayer’s 2022 transformation plan,” said Olivier Sevillia, CEO of the Europe Strategic Business Unit at Capgemini and Member of the Group Executive Board. The new agreement is due to commence on January 1, 2020, with several hundred team members from Bayer due to join Capgemini, to build their careers and growth opportunities.     ]]> https://biospectrumindia.com/news/57/15285/jj-acquires-investigational-bermekimab-from-xbiotech.html https://biospectrumindia.com/news/57/15285/jj-acquires-investigational-bermekimab-from-xbiotech.html Mon, 09 Dec 2019 11:25:00 +0530 Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, has entered a definitive agreement to acquire all rights to the investigational compound bermekimab from XBiotech Inc. Bermekimab is an anti-IL-1alpha monoclonal antibody (mAb) in Phase 2 development for the treatment of atopic dermatitis and hidradenitis suppurativa. It is the only antibody targeting IL-1a currently in clinical development and has the potential for superior efficacy and safety compared to the current standard of care. "Janssen is a world leader in immunology, and we are particularly proud of our long legacy of helping patients with dermatological disease, including psoriasis," said David M. Lee, M.D., Ph.D., Immunology Therapeutic Area Head, Janssen Research & Development, LLC. "The acquisition of bermekimab allows us to build on our expertise in immuno-dermatology, while expanding to atopic dermatitis and hidradenitis suppurativa, immune-mediated disease areas that have incredible unmet need." Under terms of the agreement, Janssen will assume responsibility for the clinical program, working closely with XBiotech as it completes the ongoing Phase 2 studies in atopic dermatitis and hidradenitis suppurativa. Janssen will pay XBiotech a purchase price of $750 million for the rights to bermekimab; should Janssen pursue bermekimab indications outside of dermatology, XBiotech may be eligible to receive additional payments upon the receipt of certain commercialization authorizations.  "This is an important step to enhancing our ability to help patients, leveraging our decades-long heritage and deep expertise in immunology," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development. "It's that heritage that drives us to seek the best solutions from within our own laboratories as well as from the exciting and innovative work happening in companies like XBiotech." The transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, and is expected to close shortly after HSR approval. ]]> https://biospectrumindia.com/news/57/15274/fda-launches-app-to-report-novel-uses-of-existing-medicines-.html https://biospectrumindia.com/news/57/15274/fda-launches-app-to-report-novel-uses-of-existing-medicines-.html Mon, 09 Dec 2019 06:30:00 +0530 The U.S. Food and Drug Administration has announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH). “The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats and infections caused by antimicrobial-resistant organisms. When health care professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organized and analyzed much faster, making it easier to spot promising new uses for existing drugs,” said Amy Abernethy, M.D., Ph.D., FDA Principal Deputy Commissioner. “Our hope is that this app will serve as a connector among major treatment centers, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster.”   The repository captures clinical outcomes when drugs are used for new indications, in new populations, in new doses or in new combinations. Health care professionals generally may choose to prescribe or use a legally marketed human drug or medical device for an unapproved or uncleared use when they judge that the unapproved use is medically appropriate for an individual patient. The systematic collection of real-world experience in the app will help identify drug candidates for additional study, encourage further drug development, and may serve as a resource for practitioners making individual patient treatment decisions in the absence of established safe and effective options. Repurposing approved drugs for new clinical indications can potentially offer an efficient drug-development pathway for treatments of diseases and conditions that have few or no therapeutic options. “The potential importance of new therapeutic opportunities from repurposing drugs can’t be understated,” said NCATS Director Christopher P. Austin, M.D. “The CURE ID platform exemplifies how collaborative efforts can spark innovations that benefit patients. This new platform harnesses the power of crowdsourcing to help gather medical observations in the field and help identify potentially effective treatments for diseases.” The app works by collecting a simple case report form from caregivers about their experience using an approved product for an unapproved use. Health care professionals can browse from a collection of cases that have already been documented, including successful and unsuccessful treatments, in addition to viewing relevant clinical trials and those open to enrollment at clinicaltrials.gov. App users can also participate in a treatment discussion forum where they can engage with fellow providers globally. The FDA plans to reach out to health care providers in various disciplines, including infectious and tropical diseases, to encourage them to use the app.   The full launch of the app follows the release of several pilot versions after an initial innovation award was received from the U.S. Department of Health & Human Services IDEA Lab in April 2015. During the pilots, extensive user-testing was conducted in India (2015 and 2017) and South Africa (2016). Additional feedback was also collected from users in the U.S., Europe and Peru. The updated app that launched today includes the addition of a newsfeed, an improved search feature with data from 325 different infectious diseases and syndromes to choose from, and the inclusion of nearly 1,500 initial cases from clinicians and the published literature and over 18,000 clinical trials.  ]]> https://biospectrumindia.com/news/57/15283/amazon-web-services-collaborates-with-novartis-.html https://biospectrumindia.com/news/57/15283/amazon-web-services-collaborates-with-novartis-.html Fri, 06 Dec 2019 18:15:00 +0530 Amazon Web Services has announced a multi-year strategic collaboration with Novartis to reimagine this pharmaceutical company’s core pharmaceutical manufacturing, supply chain, and delivery operations using AWS’s portfolio of cloud services. This enterprise-wide data and analytics platform is expected to form the foundation for custom solutions powered by AWS AI and ML services to help drive agility, innovation, and cost efficiencies across Novartis global business processes and systems. Core to this collaboration is the creation of Novartis ‘Insight Centers’ that provide real-time visibility across its network of manufacturing operations and distribution centers. Building on the success of its trial operations center SENSE, these ‘Insight Centers’ can enable manufacturing and planning teams to better forecast and track production lines, detect potential bottlenecks and then make adjustment recommendations to improve accuracy. Using AWS, Novartis can collect inventory, quality, and production data across its network and apply AWS Internet of Things (IoT), analytics, and machine learning (ML) services to gain greater visibility and help drive efficiencies. By centralizing this data, Novartis data scientists can also experiment with new optimization models to help ramp up the production of innovative, personalized treatments that are more complex to make. In addition, Novartis plans to use AWS IoT services to augment and improve visual inspections of its manufacturing sites by generating images that can be analyzed using computer vision algorithms to monitor for risks to manufacturing production, such as unplanned downtime or delayed orders. With this real-time data, Novartis associates can be better equipped to make data-based decisions that help ensure medicines are efficiently produced and distributed to nearly 1 billion patients in 155 countries around the world. Bertrand Bodson, Chief Digital Officer at Novartis said, “I’m really proud of how the teams are working together on the ground to bring Amazon-like user experiences to our associates. There is a lot we can learn from the AWS team, and while manufacturing is a great starting place, we’re keen to also explore where else we can apply this technology. Using data science and digital technologies to reimagine the way we manufacture medicines is not only at the heart of our transformation, but also core to our ambition to bring innovative medicines to patients faster.” Mike Clayville, Vice President, Worldwide Commercial Sales at AWS said, “We are excited about this collaboration, bringing together AWS’s unmatched portfolio of services with deep Novartis expertise in the way they manufacture pharmaceuticals and the way they approach supply chain processes. AWS’s security, scalability, and highly reliable infrastructure can help Novartis advance its technical operations with greater agility and customer-orientation, and potentially reducing the time it takes to bring innovative medicines to patients.”   ]]> https://biospectrumindia.com/news/57/15278/dubai-health-authority-signs-mou-with-vps-healthcare.html https://biospectrumindia.com/news/57/15278/dubai-health-authority-signs-mou-with-vps-healthcare.html Fri, 06 Dec 2019 14:10:00 +0530 Dubai Health Authority and UAE based VPS Healthcare signed a memorandum of understanding (MoU) to strengthen cooperation and partnership and exchange experiences. His Excellency Humaid Al Qutami, Director General of the DHA and Dr Shamsheer Vayalil, Chairman and Managing Director of VPS Healthcare signed the MoU. The MoU aims to facilitate knowledge transfer and collaboration in key healthcare areas The Dubai Health Authority delegation is currently on an official visit to India and is meeting leading healthcare institutions across Kerala, Bangalore and Mumbai. Commenting on the MoU, Al Qutami said, “We aim to provide highest quality super specialized care to our patients and visitors and we work with leading healthcare organizations across the world to help us achieve this vision. This MoU provides us with an opportunity to collaborate in key healthcare fields.” Dr. Shamsheer Vayalil, Chairman and Managing director of VPS Healthcare said, “VPS healthcare has a deep-rooted connect with the UAE and we are committed to collaborate in the healthcare sector with the ultimate goal of providing high quality healthcare.” In Kerala, the Dubai Health Authority delegation headed by Humaid Al Qutami had visited VPS Lakeshore Hospital and Research Centre. Al Qutami was received by Dr Shajir Gaffar, Group Director, VPS Healthcare and SK Abdulla, CEO of VPS Lakeshore. S K Abdulla, CEO of the hospital presented an overview of the specialties available especially the organ transplant facilities and the Liver Care Institute. He highlighted the state-of-the-art techniques the hospital has adopted, the high-quality expertise they have and the importance of multi-disciplinary care in dealing with complex surgeries such as pediatric cancer cases and rarest-of-the-rare tumour cases.   ]]> https://biospectrumindia.com/news/57/15276/screen-therapeutics-partners-with-immunaccel-for-immuno-oncology-drug-development-.html https://biospectrumindia.com/news/57/15276/screen-therapeutics-partners-with-immunaccel-for-immuno-oncology-drug-development-.html Fri, 06 Dec 2019 12:55:00 +0530 Screen Therapeutics LLC has formed a partnership with Immunaccel to focus on the discovery and development of next generation cancer immunotherapies.Screen Therapeutics will combine its immunology expertise, capabilities and know-how together with Immunaccel's IP, know-how and proprietary cell lines to discover next generation cancer therapies targeting stromal interactions in the tumor microenvironment. This transaction is also part of a broader strategy for Immunaccel to leverage its intellectual property (IP) and know-how in developing human relevant translational platforms. Underlying the company's programs is a combination of proprietary ex vivo 3D platforms and well characterized human cell lines that enable the simulation of the tumor microenvironment. Screen Therapeutics will leverage these platforms to study the tumor stromal barriers that affect T cell activity and migration of immune cells in tumors. "With approximately 30-40% of patients not responding to current immunotherapies, it is important to study the stromal factors that contribute to this phenomenon. Together with advanced imaging and complimentary technology platforms, we aim to simulate the various tumor immune microenvironments ex vivo, which will allow us to dissect the cross talk between immune cells, stromal cells and tumors with the goal of identifying novel targets and biomarkers," said Tonya Webb PhD, scientific co-founder on Screen Therapeutics.  "Since our inception, our mission has been to research, develop and advance synergistic translational research platforms to accelerate preclinical development timelines and advance innovative drug candidates into clinical trials," said Vik Subbu, Managing Partner of Equidis Ventures and CEO of Immunaccel. "The applications of ex vivo 3D platforms in cancer drug discovery have tremendous potential in providing human physiological relevance in identifying novel drug targets and biomarkers," he added. ]]> https://biospectrumindia.com/news/57/15261/malaria-on-the-decline-in-who-south-east-asia-region-who.html https://biospectrumindia.com/news/57/15261/malaria-on-the-decline-in-who-south-east-asia-region-who.html Wed, 04 Dec 2019 15:45:00 +0530 As WHO South-East Asia Region continues to register a steep decline in malaria incidence, the World Health Organization reiterated accelerated concerted efforts by member countries to achieve zero malaria by 2030. Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia said, “There is a strong commitment to eliminate malaria in the Region, reflected in the commendable intense efforts and progress being made by member countries.  This momentum needs to be sustained and further accelerated to prevent, rapidly detect and treat malaria, to benefit everyone, everywhere.” As per the World Malaria Report released, in 2018 WHO South-East Asia Region had an estimated 8 million cases and 11 600 malaria deaths – 69% and 70% less as compared with 2010. This is the largest decline among all six WHO Regions. Two countries in the Region - Maldives and Sri Lanka – have been certified malaria free, and two more, Timor-Leste and Bhutan, are close to elimination target. Despite being the highest burden country of the Region, India reduced its reported cases by half as compared with 2017. Bangladesh and Thailand also reported substantial decline in reported cases. All countries in the Region are on target to achieve a more than 40% reduction in case incidence by 2020, and all have strategic plans for malaria elimination by 2030. However, despite progress, an estimated 1.61 billion people in the Region continue to remain at risk of malaria with the disease being endemic in 9 countries. “We need to intensify efforts, particularly at the sub-national and grassroots levels, with multi-sectoral collaboration, to strengthen surveillance and reach the most vulnerable and marginalized communities,” the Regional Director said. Better implementation of treatment regimens, to effectively manage drug resistance and relapsing disease, needs to be focused upon, she said. We also need to further strengthen cross-border collaboration as malaria free countries would always remain at risk of importation from neighboring endemic countries. Joint efforts to rapidly detect and respond to importations and prevent and protect vulnerable communities along the borders is vital in our drive to achieve zero malaria and protect everyone everywhere, the Regional Director said. The WHO South-East Asia Region, home to one-fourth of the world’s population, has been prioritizing malaria elimination. Member countries adopted a ‘Ministerial Declaration on Accelerating and Sustaining Malaria Elimination in the South-East Asia Region’ in November 2017, reaffirming their commitment and emphasizing the need for new funding and technologies to keep up the momentum to end malaria by 2030. This was followed by a Call to Action adopted by countries of Greater Mekong Sub-region (GMS) May 2018. The Six GMS member countries, two from WHO South East Asia Region – Myanmar and Thailand –  have stepped up collaboration to address resistance of malaria parasites to antimalarial drugs, including artemisinin, by eliminating malaria altogether from the Mekong by 2030. The progress and challenges in malaria elimination are periodically reviewed by member countries. In September 2018, all member countries renewed their commitment and once again resolved to end the scourge of this life-threatening disease. ]]> https://biospectrumindia.com/news/57/15259/astrazeneca-to-sell-rights-of-anti-psychotic-drug-to-cheplapharm-.html https://biospectrumindia.com/news/57/15259/astrazeneca-to-sell-rights-of-anti-psychotic-drug-to-cheplapharm-.html Wed, 04 Dec 2019 11:10:00 +0530 AstraZeneca, a global, science-led biopharmaceutical company has agreed to sell the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the US and Canada to Cheplapharm Arzneimittel GmbH (Cheplapharm).  Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in the US and Canada. Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “This divestment supports our strategy of reducing the number of mature medicines to enable reinvestment in our main therapy areas. Cheplapharm recently agreed to acquire the commercial rights to Seroquel and Seroquel XR in most European markets and Russia from AstraZeneca and this new agreement will help ensure continued patient access to this important established medicine in North America as well.” AstraZeneca will continue to manufacture and supply Seroquel and Seroquel XR to Cheplapharm during a transition period. Cheplapharm will make an upfront payment of $35m to AstraZeneca and may also make future sales-contingent payments of up to $6m. ]]> https://biospectrumindia.com/news/57/15250/philips-introduces-next-gen-enterprise-imaging-solution.html https://biospectrumindia.com/news/57/15250/philips-introduces-next-gen-enterprise-imaging-solution.html Tue, 03 Dec 2019 13:25:00 +0530 Royal Philips, a global leader in health technology, introduced its next-generation enterprise imaging solution. The introduction follows several years of strategic investments in R&D and complementary acquisitions, resulting in a suite of integrated products that deliver a comprehensive platform designed to connect clinical capabilities and optimize workflows around every step in the patient’s journey. The new solution is being unveiled at the 2019 Radiological Society of North America (RSNA) Annual Meeting. “Our new solution seamlessly embeds intelligence at every step of each operational workflow and disease pathway, providing the foundation for advanced enterprise imaging today and the fully integrated precision diagnosis platform of tomorrow,” said Calum Cunningham, general manager Enterprise Diagnostic Informatics at Philips. “The solution will enable patients, clinicians and hospital administrators to fully harness the power of information and translate it into actionable insights – a critical next step to advance the healthcare enterprise.” At RSNA 2019, Philips is highlighting its patient-centered approach to a precision diagnosis and treatment selection. By demonstrating advanced clinical and operational capabilities, embedded with AI and analytics, Philips simplifies and enhances workflows across the entire enterprise imaging network, including image acquisition, viewing and data interpretation, and diagnostic patient management workflows. The new enterprise imaging solution supports hospitals and imaging centers as they seek to connect and optimize performance, improving the patient experience, health outcomes, and staff experience, while lowering the cost of care. It includes: An integrated offering that provides support throughout the patient journey: Even before they reach the hospital, Philips’ diagnostic patient management application orchestrates and streamlines patient interactions with their health system before and after procedures, maximizing engagement while helping to improve operational efficiency. Workflow management automates scheduling flexibility, tracks patient results efficiently and enables the most urgent studies to be automatically delivered together with advanced reporting to the most qualified radiologists. Image sharing and interoperability to support shared decision making: In any healthcare environment, seamless, securely managed access to data and efficient workflow is critical. The solution includes a vendor-neutral, zero-footprint enterprise viewer and a secure web portal to provide patient access to relevant clinical information. In addition, Philips Forcare Interoperability allows systems, departments and stakeholders to communicate with each other and exchange data, seamlessly linking information from different sources. Comprehensive diagnostic solutions and advanced visualization: The solution provides comprehensive solutions for radiology, cardiology, neurology, pathology, oncology, and breast imaging, alongside comprehensive advanced visualization and quantification software and interactive multimedia reporting including EMR, RIS and PACS integration. Operational insights to improve productivity: Philips’ Enterprise Operational Informatics offering is built to support structural optimization of the operational performance of imaging departments. The suite includes a broad range of applications, both user-focused and cloud-based, providing insights into operations and performance across vendor neutral modalities. In addition, it includes clinical analytics to enable a more proactive care model, providing business-critical information and a secure remote connection. Clinical repository for archiving and storage: The solution’s clinical repository includes a vendor neutral archive, smart lifecycle management to provide storage and access beyond individual episodes of care, and an acquisition portal to capture images across departments, modalities and file formats. Integrated AI applications across the imaging workflow: The solution’s IntelliSpace AI Workflow Suite enables healthcare providers to seamlessly integrate AI applications into the imaging workflow. The comprehensive solution provides a full suite of applications for integration and centralized workflow management of AI algorithms, delivering structured results wherever they’re needed across the healthcare enterprise. ]]> https://biospectrumindia.com/news/57/15240/ge-healthcare-brings-novel-solution-for-mammography.html https://biospectrumindia.com/news/57/15240/ge-healthcare-brings-novel-solution-for-mammography.html Mon, 02 Dec 2019 11:00:00 +0530 To help empower clinicians and patients in their fight against breast cancer, GE Healthcare has introduced Serena Bright™ (Not available for sale in the United States), the healthcare industry’s first contrast-enhanced mammography solution for biopsy.  Interventional and biopsy procedures are a necessary step in most breast cancer diagnoses. Previously, for lesions not seen on mammography or ultrasound, contrast-enhanced biopsy was typically performed with breast MR, which can be more time-consuming, uncomfortable and costly for patients. With Serena Bright, breast biopsy exams can now be done with the same mammography equipment and in the same room as the screening or diagnostic mammogram. This can help save time, lessen costs and ultimately help improve the patient experience.  “This new mammography-guided biopsy technique offers an alternative to MR-guided breast biopsy, which can improve the patient experience and allow us to get answers to patients faster,” says Dr. Corinne Balleyguier, Head of Medical Imaging at Gustave Roussy in France. “We are proud to be the first in the world to be able to offer this technology to our patients and believe this will have a significant impact on breast imaging capabilities.”   Key to this revolutionary change in breast care is GE Healthcare’s SenoBright™ HD Contrast Enhanced Spectral Mammography (CESM), a diagnostic imaging tool that can detect malignant lesions not seen on mammography or ultrasound in certain cases. By highlighting areas of unusual blood flow to help localize lesions that need to be biopsied, CESM biopsy – Serena Bright – helps improve radiologists’ diagnostic confidence with the ultimate goal of getting answers to patients as quickly as possible.   “This novel approach has the potential to be a more affordable and faster alternative to MR-guided biopsy for suspect findings seen in CESM,” says Dr. Rodrigo Alcantara, Head of Breast Imaging Section at Hospital del Mar in Spain. “Our initial findings have been incredibly successful in reliably targeting enhancing lesions to ultimately find cancer earlier.”  ]]> https://biospectrumindia.com/news/57/15229/elsevier-acquires-creator-of-3d-anatomy-technology.html https://biospectrumindia.com/news/57/15229/elsevier-acquires-creator-of-3d-anatomy-technology.html Fri, 29 Nov 2019 10:45:00 +0530 Elsevier, a global information analytics business specializing in science and health, and part of RELX, has acquired 3D4Medical, the global anatomy education company headquartered in Dublin, Ireland. 3D4Medical created Complete Anatomy, the world's most advanced 3D anatomy platform, revolutionizing how students, educators, health professionals and patients understand and interact with anatomy. With outstanding technology and design that pushes the boundaries of how people learn using advanced 3D visualization tools, Complete Anatomy has garnered more than a million registered users at more than 300 of the world's top universities.   "When we started 3D4Medical, we wanted to disrupt the way anatomy was taught and learned," said John Moore, Founder of 3D4Medical. "Our advanced and proprietary technology and content are available on the devices used by a new generation of students. Together with Elsevier, a global leader in medical content, we look forward to this new and exciting chapter." 3D4Medical's Complete Anatomy has won an Apple Design & Innovation Award and was selected as the "Best of the Year" on multiple occasions on Apple's App Store, also reaching the top spot in the Microsoft Store. 3D4Medical has also been a winner of the US-Ireland Research Innovation Awards. Elsevier is a global leader in anatomy education and content, with world leading brands including Netter's Atlas of Human Anatomy, Gray's Anatomy, Sobotta Atlas of Human Anatomy and McMinn & Abrahams' Clinical Atlas of Human Anatomy. More than 30 percent of medical doctors learn anatomy from these brands. This acquisition brings a world class 3D technology platform to complement these brands and will further strengthen Elsevier's health education offerings, improving learning outcomes for health students and professionals. "We are looking forward to accelerating our medical education offerings with the addition of 3D4Medical," said Jan Herzhoff, Managing Director, Health Education, Elsevier. "With 3D4Medical's advanced technology and brilliant content, we hope to bring this 3D anatomy platform to more learners, educators and professionals. We see 3D4Medical as a perfect extension of our ClinicalKey and ClinicalKey for Students platforms. We are pleased to welcome 3D4Medical to Elsevier and look forward to serving those global audiences dedicated to advancing the understanding of anatomy." ]]> https://biospectrumindia.com/news/57/15223/fda-grants-priority-review-to-roches-risdiplam-for-sma.html https://biospectrumindia.com/news/57/15223/fda-grants-priority-review-to-roches-risdiplam-for-sma.html Thu, 28 Nov 2019 16:30:00 +0530 Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier for SMA. Risdiplam is designed to increase and sustain SMN protein levels both throughout the central nervous system and peripheral tissues of the body. The FDA is expected to make a decision on approval by May 24, 2020. “The FIREFISH and SUNFISH trials were designed to represent the real world spectrum of people living with SMA and include many people previously underrepresented in clinical trials,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to working closely with the FDA to explore broad access to risdiplam for all individuals in the community who might benefit.” If approved, risdiplam, an orally administered liquid, would be the first at-home administered medicine for people living with SMA. In addition to the studies included in the NDA submission, risdiplam is being studied in a broad clinical trial programme in SMA, with patients ranging from newborns to 60 years old, and includes patients previously treated with SMA therapies. Roche leads the clinical development of risdiplam as part of collaboration with the SMA Foundation and PTC Therapeutics, and would commercialize the medicine in the United States if approved. Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Previously, the FDA also granted Orphan Drug Designation for risdiplam in January 2017, followed by Fast Track Designation in April 2017. ]]> https://biospectrumindia.com/news/57/15208/lonza-collaborates-with-dinaqor-ag-to-advance-gene-therapy-programs-.html https://biospectrumindia.com/news/57/15208/lonza-collaborates-with-dinaqor-ag-to-advance-gene-therapy-programs-.html Wed, 27 Nov 2019 11:05:00 +0530 Lonza and DiNAQOR AG, a global gene therapy platform company, have announced a strategic collaboration to advance DiNAQOR's preclinical programs for the treatment of cardiac myosin-binding protein-C (MYBPC3) cardiomyopathies, a genetic condition that can result in heart failure. Under the terms of the collaboration, Lonza will provide DiNAQOR preclinical, clinical and commercial production support for the company's lead preclinical program DiNA-001, an adeno-associated virus (AAV) gene therapy program for patients with MYBPC3-linked cardiomyopathy. Lonza's state-of-the-art cell-and-gene-therapy manufacturing facility in Houston, TX (US) will handle all product supply for DiNA-001. Through this partnership, DiNAQOR will be able to leverage Lonza's extensive, dedicated teams and laboratories for viral-vector process-development, located in Houston (US). In addition to its cardiac gene therapy platform, DiNAQOR is also developing a local-regional delivery system for the heart. This will allow the company to route gene therapy directly to the cardiac muscle maximizing biodistribution and transduction of the cardiomyocytes. This approach will look to minimize potential adverse effects of systemic gene therapy delivery. Cardiomyopathy is a disease of the heart muscle that can lead to heart failure. Approximately 50% of all cardiomyopathies are caused by a single-gene or monogenic defect. There are 1.7 million people in the European Union and the United States currently affected by a monogenic cardiomyopathy, 300,000 of these individuals have a defect in the MYBPC3 gene. There is currently no cure for patients living with genetic cardiomyopathies.   ]]> https://biospectrumindia.com/news/57/15194/novartis-to-acquire-the-medicines-company-for-9-7-b.html https://biospectrumindia.com/news/57/15194/novartis-to-acquire-the-medicines-company-for-9-7-b.html Tue, 26 Nov 2019 06:00:00 +0530 Novartis has announced that it has entered into an agreement and plan of merger with The Medicines Company (MDCO) to acquire the US-based biopharmaceutical company for USD 85.00 per share in cash, valuing the company at approximately USD 9.7 billion on a fully diluted equity basis. The offer price represents a premium of approximately 41% over The Medicines Company’s 30-day (to November 22, 2019) volume weighted average price of USD 60.33 and approximately 24% premium over The Medicines Company’s closing share price of USD 68.55 on November 22, 2019 which represented a fully diluted equity value of approximately USD 7.7 billion when including the impact of outstanding stock options and convertible debt. The transaction has been unanimously approved by the Boards of Directors of both companies. Novartis CEO Vas Narasimhan said: “We are excited about entering into an agreement to acquire The Medicines Company as inclisiran is a potentially transformational medicine that reimagines the treatment of atherosclerotic heart disease and familial hypercholesterolemia. With tens of millions of patients at higher risk of cardiovascular events from high LDL-C, we believe that inclisiran could contribute significantly to improved patient outcomes and help healthcare systems address the leading global cause of death. The prospect of bringing inclisiran to patients also fits with our overall strategy to transform Novartis into a focused medicines company and adds an investigational therapy with the potential to be a significant driver of Novartis’ growth in the medium to long term.” The transaction is expected to close in the first quarter of 2020, subject to the satisfaction or waiver of all closing conditions. Until closing, Novartis and The Medicines Company will continue to operate as separate and independent companies. Under the terms of the agreement and plan of merger, Novartis will, through a subsidiary, commence a tender offer to purchase all outstanding shares of The Medicines Company for USD 85.00 per share in cash.  Following completion of the tender offer, Novartis expects to merge the acquiring subsidiary with The Medicines Company, resulting in The Medicines Company becoming an indirect wholly-owned subsidiary of Novartis. The transaction is subject to customary closing conditions, including antitrust clearance. Novartis plans to finance the transaction through available cash and short- and long-term borrowings.   ]]> https://biospectrumindia.com/news/57/15198/alkermes-completes-acquisition-of-rodin-therapeutics.html https://biospectrumindia.com/news/57/15198/alkermes-completes-acquisition-of-rodin-therapeutics.html Mon, 25 Nov 2019 17:55:00 +0530 Ireland based Alkermes plc has completed its previously announced acquisition of Rodin Therapeutics, Inc. (Rodin), a privately held biopharmaceutical company. This transaction builds on Alkermes' experience in central nervous system (CNS) diseases and expands Alkermes' CNS development efforts into a wide range of neurodegenerative disorders.  Rodin has been working to develop first-in-class, orally-available, brain-permeable therapeutics for synaptopathies by designing molecules that target specific histone deacetylase (HDAC) complexes. This novel approach is designed to reactivate neuronal gene expression, strengthen existing synapses and promote the creation of new synapses, while minimizing known HDAC class-based hematologic safety concerns. Synaptic dysfunction is a pathological feature in many neurodegenerative and neuropsychiatric diseases, and synaptic loss correlates closely with cognitive decline. At the closing of the transaction, Alkermes made an upfront cash payment of $100 million (subject to customary adjustments) to Rodin's former security holders.  Under the terms of the definitive agreement between Alkermes and Rodin, and subject to the conditions and adjustments set forth therein, Rodin's former security holders are eligible to receive future payments of up to $850 million upon achievement by Rodin's development candidates of certain specified clinical and regulatory milestones, and attainment of certain sales thresholds.  ]]> https://biospectrumindia.com/news/57/15184/cns-pharma-acquires-brain-cancer-drug-rights-from-houston-pharma.html https://biospectrumindia.com/news/57/15184/cns-pharma-acquires-brain-cancer-drug-rights-from-houston-pharma.html Fri, 22 Nov 2019 13:40:00 +0530 CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, completed an agreement with Houston Pharmaceuticals, Inc. ("HPI") to obtain the rights to a worldwide, exclusive royalty-bearing, license for the chemical compound commonly known as Berubicin. CNS' licensing agreement with HPI grants the Company the exclusive right to develop certain patented chemical compounds for use in the treatment of cancer globally. In its agreement with HPI, the Company acquired multiple U.S. patents for Berubicin. CNS intends to apply for orphan drug status for Berubicin with the FDA for the treatment of malignant glioma. "We believe our acquisition of the rights to Berubicin represents an important milestone in our pursuit to develop therapies for the treatment of glioblastoma, a type of brain cancer which is currently considered incurable," stated CEO of CNS, John M. Climaco, Esq. "Our agreement with HPI expands our IP protection and provides us with developmental protection worldwide while we seek orphan drug status. We are excited to continue the clinical development of Berubicin and believe its promising tolerability and efficacy results are a testament to its therapeutic potential as a novel anthracycline agent." ]]> https://biospectrumindia.com/news/57/15183/cholesterol-lowering-drugs-may-cut-risk-of-lethal-prostate-cancer.html https://biospectrumindia.com/news/57/15183/cholesterol-lowering-drugs-may-cut-risk-of-lethal-prostate-cancer.html Fri, 22 Nov 2019 13:05:00 +0530 New research led by Queen’s University Belfast has found that men who are on statins, medicine used to lower blood cholesterol, may have a reduced risk of developing a more lethal form of prostate cancer. The study was carried out by researchers at Queen’s University Belfast, Trinity College Dublin and the Dana-Farber/Harvard Cancer Center. Statins are drugs that are often used to help lower cholesterol levels and can reduce the risk of heart attack, stroke and heart disease. Previous studies have suggested that statins could have a role in slowing down the growth of different types of cancers. This research specifically looked at ways statins might affect prostate cancer. The researchers discovered that there were no differences in the overall rates of prostate cancer among men who were prescribed statins. However, men who had taken statin medicines had a 24% reduced risk of developing a more lethal type of prostate cancer when compared to men who were not. Lead author Dr Emma Allott, from the Centre for Cancer Research and Cell Biology and the Institute for Global Food Security at Queen’s University Belfast, said: “Some prostate cancers are slow growing and will not affect the man over the course of his lifetime, but others are aggressive and often deadly. My work is to understand the biology driving these different types of prostate cancer in order to reduce the number of men who develop this lethal form of the disease. “By studying a large group of men who had been monitored for 24 years, we were able to see the link between statin use and the prevention of lethal prostate cancer. We then looked at tissue samples from some of these men to try and understand why the statin use was having this impact. “Although the findings are at an early stage, we were able to see that statin use may affect inflammation and immunity levels in the prostates of some men as well as having an effect on the characteristics of the tumour itself. Our findings are in agreement with some of the known biology of statins but are the first to observe these effects in prostate cancer.” The research was funded by an international research fellowship awarded to Dr Allott by the Irish Cancer Society. Dr Allott worked in collaboration with colleagues in Ireland, Northern Ireland and the US to analyse data from a study funded by the U.S. National Cancer Institute. Dr Robert O’Connor, Head of Research at the Irish Cancer Society, said: “Dr Allott is part of the next generation of prostate cancer research leaders, whose work is making a significant contribution to our knowledge and understanding of this challenging disease.  While we are not recommending that men start taking statins unless prescribed to do so, this study provides us with building blocks to further explore how statins could be used to combat aggressive prostate cancer in the future.” ]]> https://biospectrumindia.com/news/57/15176/bristol-myers-squibb-completes-acquisition-of-celgene.html https://biospectrumindia.com/news/57/15176/bristol-myers-squibb-completes-acquisition-of-celgene.html Thu, 21 Nov 2019 22:30:00 +0530 Bristol-Myers Squibb Company has announced that it has completed its acquisition of Celgene Corporation following the receipt of regulatory approval from all government authorities required by the merger agreement and, as announced on April 12, 2019, approval by Bristol-Myers Squibb and Celgene stockholders. Upon completion of the acquisition, pursuant to the terms of the merger agreement, Celgene became a wholly owned subsidiary of Bristol-Myers Squibb. Under the terms of the merger, Celgene shareholders received for each share, 1.00 share of Bristol-Myers Squibb common stock, $50.00 in cash without interest and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a payment of $9.00 in cash if certain future regulatory milestones are achieved. Celgene common stock ceased trading as of the close of trading today. On November 21, 2019, newly issued Bristol-Myers Squibb shares and CVRs will commence trading on the New York Stock Exchange, with the CVRs trading under the symbol “BMYRT.” “This is an exciting day for Bristol-Myers Squibb as we bring together the leading science, innovative medicines and incredible talent of Bristol-Myers Squibb and Celgene to create a leading biopharma company,” said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. “With our leading franchises in oncology, hematology, immunology and cardiovascular disease, and one of the most diverse and promising pipelines in the industry, I know we will deliver on our vision of transforming patients’ lives through science. I am excited about the opportunities for our current employees and the new colleagues that we welcome to the Company as we work together to deliver innovative medicines to patients.” Since announcing the transaction on January 3, 2019, there have been a number of tangible advancements toward delivering on the key value drivers for the merger, including: further progress relating to the patent estate for REVLIMID®, the U.S. Food and Drug Administration (FDA) approval of INREBIC® (fedratinib) for the treatment of certain forms of myelofibrosis, the U.S. FDA approval of REBLOZYL® (luspatercept-aamt) for the treatment of anemia in certain adult patients with beta thalassemia, and regulatory filings of luspatercept and ozanimod in the U.S. and Europe. The Company has also made substantial progress toward the planning of a successful integration ]]> https://biospectrumindia.com/news/57/15169/mc2-therapeuticss-wynzora-cream-gets-fda-nod-to-treat-plaque-psoriasis.html https://biospectrumindia.com/news/57/15169/mc2-therapeuticss-wynzora-cream-gets-fda-nod-to-treat-plaque-psoriasis.html Thu, 21 Nov 2019 14:50:00 +0530 MC2 Therapeutics, an emerging pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Wynzora™ Cream. MC2 Therapeutics is seeking marketing approval for Wynzora™ Cream for the treatment of plaque psoriasis. The FDA has set July 20th, 2020 as the Prescription Drug User Fee Act (PDUFA) action date. MC2 Therapeutics’ NDA for Wynzora™ Cream is comprised of extensive quality, non-clinical and clinical data. Specifically, data from the pivotal phase 3 trial demonstrated that Wynzora™ Cream treatment has a substantial and statistically significantly greater efficacy compared to Taclonex® Topical Suspension (“Taclonex®”) based on treatment success defined as a minimum two-point decrease in the Physician Global Assessment (PGA) score to clear or almost clear disease (40.1% versus 24.0%, p < 0.0001). “We are very proud of the overall clinical profile of Wynzora™ Cream and look forward to continuing our interaction with the FDA during the NDA review”, said Jesper J. Lange, President & CEO of MC2 Therapeutics and added “In parallel we will continue our efforts to ensure widespread patient access to Wynzora™ Cream pending approval”.   ]]> https://biospectrumindia.com/news/57/15168/azeria-therapeutics-announces-32-0-m-series-b-financing.html https://biospectrumindia.com/news/57/15168/azeria-therapeutics-announces-32-0-m-series-b-financing.html Thu, 21 Nov 2019 14:20:00 +0530 Azeria Therapeutics (Azeria), a newly formed pioneer factor drug discovery company, has announced a £32 million Series B financing in which Syncona has committed £29.5 million alongside existing investor the CRT Pioneer Fund. Azeria was originally founded in 2017 by Sixth Element Capital, manager of the CRT Pioneer Fund and Cancer Research UK's Commercial Partnerships team with the aim of building a world class pioneer factor oncology company, developing breakthrough treatments for hormone resistant breast cancer patients. It was based on the work of leading expert in the field, Professor Jason Carroll at the Cancer Research UK Cambridge Institute, University of Cambridge, UK, whose scientific insights have led to a new approach to target FOXA1 driven cancer.     FOXA1 is an essential pioneer factor which has been shown to be pivotal in the tumour growth, progression and maintenance of oestrogen receptor positive luminal breast cancer. This is an area of significant unmet patient need where approximately 30 per cent of patients progress to late stage endocrine resistant disease and where there is potential for new treatments to have significant impacts for patients not addressed by existing therapeutics. Extensive target validation and drug discovery work to date supports the lead programme, with a plan to take the programme into the clinic over the course of the Series B funding. Azeria is seeking to develop the programme to commercialisation and to explore a pipeline of further programmes in oncology.  Azeria received initial investment of £5.5 million in Series A financing from the CRT Pioneer Fund, which focuses on early stage investments in highly innovative oncology programmes. Syncona is the largest investor in the CRT Pioneer Fund and will now participate directly in the next stage of growth and development. Magda Jonikas and Martin Murphy of Syncona will now join the Board of Azeria.  ]]> https://biospectrumindia.com/news/57/15161/fda-approves-pfizers-biosimilar-for-multiple-inflammatory-conditions.html https://biospectrumindia.com/news/57/15161/fda-approves-pfizers-biosimilar-for-multiple-inflammatory-conditions.html Wed, 20 Nov 2019 12:35:00 +0530 Pfizer Inc. has announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab), for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. For full details of indications please see the approved label. “Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” said Richard Blackburn, Global President, Pfizer Inflammation and Immunology. “Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients.” The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of ABRILADA to the reference product. This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety and immunogenicity of ABRILADA and found no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis. Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to drive cost savings for healthcare systems. With more than 10 years of global in-market experience and eight approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. Pfizer is working to make ABRILADA available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie. Our current plans are to launch in 2023. We will provide further updates as the date approaches. ]]> https://biospectrumindia.com/news/57/15160/royal-philips-philips-foundation-join-forces-to-fight-childhood-pneumonia.html https://biospectrumindia.com/news/57/15160/royal-philips-philips-foundation-join-forces-to-fight-childhood-pneumonia.html Wed, 20 Nov 2019 12:00:00 +0530 Royal Philips a global leader in health technology, and the Philips Foundation, with its mission to reduce healthcare inequality by providing access to quality healthcare for disadvantaged communities, have announced the achievements of a year-long program of collaborations to reduce infant mortality rates for childhood pneumonia, a disease that currently claims the lives of around 800,000 under-five-year-olds a year– equivalent to one every 39 seconds.  Combining the volunteering activities of Philips’ 80,000 employees, local stakeholder engagement, accessible and affordable technology, and the scale-up capabilities of international NGOs, this childhood pneumonia program exemplifies the Philips Foundation’s commitment to drive and support initiatives that deliver long-term system change and achieve lasting impact. During the past 12 months, the program is estimated to have created access to better care for more than 700,000 people, in countries as widespread as Afghanistan, Ethiopia, Nicaragua, Malawi and India. The mission of the Philips Foundation is to reduce healthcare inequality by providing access to quality healthcare for disadvantaged communities. “The mission of the Philips Foundation is to reduce healthcare inequality by providing access to quality healthcare for disadvantaged communities,” said Ronald de Jong, Chairman of the Philips Foundation Board. “Focusing our year-long volunteering efforts on a single global healthcare issue that disproportionately affects disadvantaged communities, created a multiplier effect, supporting ways to overcome the challenges, and ensuring long-term impact.” Examples of the supported and initiated activities of the Philips Foundation over the past 12 months, conducted through global partnerships, local projects and support of social entrepreneurs, are listed below:   Save the Children and ZMQ in India – VISHWAAS (Breath of Hope) project: This program is aimed at developing and proving a low-cost innovative approach in India for the prevention, diagnosis and treatment of childhood pneumonia, including an app-based solution to improve awareness of the means of prevention and care-seeking practices in affected communities.  Partnership with Ashoka Fellow Hilmi Quraishi, ZMQ – the MIRA Channel project on childhood pneumonia: This project addresses the knowledge gap in childhood pneumonia through a series of short digital stories embedded in a larger ‘Maternal & Child Health’ mobile-based platform called MIRA.  The Malaria Consortium BREATHE (Breath REcognition Aid to Health Experts) project: This study aims to assess the reliability of a video annotation tool for counting respiratory rate, which has the potential to be used as a new reference standard for measuring the performance of new automated respiratory rate diagnostic aids to support the diagnosis of pneumonia in children under five in low resource settings.  ]]> https://biospectrumindia.com/news/57/15154/sio2-receives-strategic-investment-from-world-drug-leader-.html https://biospectrumindia.com/news/57/15154/sio2-receives-strategic-investment-from-world-drug-leader-.html Tue, 19 Nov 2019 15:20:00 +0530 SiO2 Medical Products has announced a strategic investment by Novartis to explore and possibly use its materials science in packaging technology across multiple products. SiO2 containers are formed of a molded plastic body with a thin layer of glass on the inner side. With SiO2's patented technology, several possible benefits are expected: improved packaging (low particles, silicone oil and tungsten free, no delamination, glass-like oxygen barrier, tighter dimensional control, no breakage); innovative material science technology to achieve possible improved standards of quality and safety for biological products. As health authorities are becoming more rigid about particulate contamination, especially in ophthalmic products, SiO2 technology offers a unique platform to help meet this requirement; and possible operational savings related to better dimensional control, allowing for more precise handling, filling, inspection, interface with mechanisms (eg auto injectors) and dosing. It is hoped that after the first successful use in ophthalmology, the technology can be extended to several products. SiO2, a privately held material science company, manufactures precision molded cyclic olefin (COP) polymer primary drug containers with a thin, transparent, silicon-based nano-coating system and silica. This innovative coating system uniquely combines the durability and dimensional consistency of plastics with the oxygen barrier properties, low extractables and pH stability of glass, ie quartz. "We thank our investors Novartis and MPM Capital and look forward to collaborating with Novartis on various uses of our materials science technology," said Lawrence Ganti , Commercial Director. "Novartis shares our vision of advancing technology for better patient outcomes. We believe this collaboration is one of the first of its kind, where using advanced material science in drug delivery can help improve life." patients, "said Dr. Robert Pangborn , retired director of research and development at Dow Chemical Corp., and Dr. Bob Langer , professor at MIT , in a joint statement., both leaders of the SiO2 Scientific Council and with the collaboration of the world's leading scientists. "SiO2's leadership, coupled with Novartis' collaboration, positions the organization for success," said Tony Rosenberg , MPM Capital's executive partner and board director of SiO2. "SiO2's innovative surface coating technology for primary drug packaging has the potential to facilitate the innovation of numerous products throughout the development cycle through to final market introduction." ]]> https://biospectrumindia.com/news/57/15151/sgd-pharma-launches-digital-tool-for-compliance.html https://biospectrumindia.com/news/57/15151/sgd-pharma-launches-digital-tool-for-compliance.html Tue, 19 Nov 2019 12:30:00 +0530 Resulting from a development project between SGD Pharma Quality and Marketing departments, this new digital tool makes it possible to identify non-compliances that may be discovered during an incoming inspection or during on-line inspection at client’s side. The SGD Pharma App is a testament to our commitment to continuous improvement. It also demonstrates transparency in working with customers toward the mutual objective of safeguarding patient health. As a leader in molded glass pharmaceutical packaging for the healthcare sector, SGD Pharma makes product quality an essential part of its mission. The SGD Pharma App aims at optimizing and harmonizing exchanges with quality controllers and technical staff by making it easier to identify non-compliances that could be present in molded glass bottles intended for pharmaceutical use. Available for free from the Apple Store and the Play Store, it only takes a few clicks for users to create their account and have unlimited access to a 2D visual compilation of the most frequently encountered forms of non-compliance. Users can refine their searches by administration method (parenteral, oral or nasal), by location or non-compliance types corresponding to various effects on the patients or on filling lines (critical, major or cosmetic). Once a non-compliance has been identified, the user then accesses a dedicated page including a visual, a definition, the type of non-compliance and its associated acceptable quality level (AQL) in conjunction with the international standard ISO 2859-1. As an added benefit, the SGD Pharma standards are then cross-referenced with the two quality benchmarks recognized and accepted by the Pharmaceutical industry: technical report 43 from the Parenteral Drug Association (PDA) and the list of molded glass container non-compliances from Edito-Cantor-Verlag (ECV). According to Quentin Ritter, Quality Project Manager at SGD Pharma: “This application project was initiated in response to our customers’ increasing demand for glass non-conformities training. It is crucial for them to be able to identify and recognize non-conformities quickly in order to improve inspection processes and make the right decision.” The application is intuitive and comprehensive and offers reliable practical information. "The mission of SGD Pharma,” adds Emmanuel Lepitre, Head of Development and Quality, “is to improve safety for the end user. SGD Pharma App answers to the growing zero tolerance trend, including cosmetic quality, by hospital staff. With this application, open to all professionals in the industry, designed upstream with its customers in mind, SGD Pharma aims to support the Pharmaceutical Industry to protect patient health." ]]> https://biospectrumindia.com/news/57/15149/mylan-and-pfizer-to-form-new-company-viatris-.html https://biospectrumindia.com/news/57/15149/mylan-and-pfizer-to-form-new-company-viatris-.html Tue, 19 Nov 2019 12:00:00 +0530 Mylan N.V. and Pfizer Inc. have announced the name of the new company to be formed by the planned combination of Mylan and Upjohn, a division of Pfizer, will be Viatris (pronounced 'viǝ-trīs). Deriving its name from Latin, Viatris embodies the new company's goal of providing a path—"VIA"—to three—"TRIS"—core goals: expanding access to medicines, leading by innovating to meet patient needs, and being a trusted partner for the healthcare community worldwide. "We wanted a name that would differentiate our new company and clearly explain how we will be a champion for global health," said Robert J. Coury, who will serve as Executive Chairman of the new company, as previously announced. "We are creating a company unlike any other – a company focused on building a more hopeful and sustainable healthcare journey, empowering patients to live healthier at every stage of life." "The name Viatris communicates the strength of our companies' combined heritage and our shared goal to provide the highest-quality medicines to the most patients possible," said Michael Goettler, Group President, Upjohn, who will serve as Chief Executive Officer of Viatris, as previously announced. "We have an opportunity to deliver better health, better care and better value for patients and partners around the world." Formed through a combination of two highly complementary businesses, Viatris will unite Upjohn's strong leadership position in China and emerging markets with Mylan's significant presence in the U.S. and Europe, allowing the new company to have a meaningfully expanded geographic reach for Viatris' broad product portfolio and future pipeline. It is expected that in the coming months, shareholders of Mylan will vote on the proposed combination of Mylan and Upjohn. More information regarding Viatris, including the company's full executive management team, board of directors, stock symbol, and logo will be available at a later date. Customers and patients will continue to be served by the Mylan and Upjohn brands for the near future. The new name will be effective upon closing of the combination, which is expected to occur in mid-2020. The two companies will continue to operate as independent, separate organizations until close. ]]> https://biospectrumindia.com/news/57/15132/novartis-to-provide-innovative-medicines-to-ssa.html https://biospectrumindia.com/news/57/15132/novartis-to-provide-innovative-medicines-to-ssa.html Mon, 18 Nov 2019 08:00:00 +0530 Novartis announced a new strategy to broaden patient reach and availability of its portfolio of medicines in sub-Saharan Africa (SSA), which is home to the largest underserved patient population in the world. Novartis also aspires to be the partner of choice for governments and NGOs to strengthen healthcare systems across Africa. “We are deeply committed to improving access to medicines around the world,” says Vas Narasimhan, CEO of Novartis. “Building on our longstanding efforts to improving health in Africa, including on malaria and sickle cell disease, we’re taking a comprehensive approach to ensuring patients in sub-Saharan Africa, regardless of income, have access to our portfolio of medicines.” As part of the new strategy, Novartis will pivot the current organizational focus in SSA from financial metrics such as sales performance and profits, to metrics that drive access to innovative medicines and strengthen health systems in the region. A new organizational unit will bring together the expertise and portfolio of our Sandoz Division, the Novartis Pharmaceuticals and Oncology business units comprising our Innovative Medicines Division and Novartis Social Business. Racey Muchilwa is appointed Head of Global Health SSA, contributing her strong knowledge of the healthcare system and patient needs in the region. The SSA unit aims to maximize patient reach across the full income pyramid by focusing on tiered pricing models, competitiveness in tenders and scaling social business models as well as affordability strategies. Novartis also will work to increase its clinical trial capabilities, and accelerate regulatory and administrative processes in the region to shorten the time between the development, approval and ultimately access to new medicines for patients across SSA. Novartis has a long-standing commitment to helping improve health of people in Africa. This includes communicable diseases such as malaria and leprosy as well as non-communicable diseases such as sickle cell disease (SCD), cardiovascular disease and cancer. Novartis has contributed nearly 900 million courses of malaria treatment at no-profit to patients in malaria-endemic countries, including more than 380 million doses of our pediatric formulation.  Novartis is also pioneering research and development with clinical trials, utilizing novel biologic molecules and deploying new technologies to provide the benefits of cutting-edge innovation to the region. Most recently, the company announced a broad public-private partnership with the government of Ghana to tackle sickle cell disease, including access to available medicine, clinical research and use of digital technologies to achieve global standards of care. ]]> https://biospectrumindia.com/news/57/15133/bayer-dewpoint-to-research-new-treatments-for-cv-and-gynecological-diseases.html https://biospectrumindia.com/news/57/15133/bayer-dewpoint-to-research-new-treatments-for-cv-and-gynecological-diseases.html Fri, 15 Nov 2019 16:10:00 +0530 Bayer and Dewpoint Therapeutics, a biotechnology company with sites in Boston and Dresden, Germany, have announced an option, research and license agreement worth up to USD 100 million. The partnership will leverage Dewpoint’s proprietary platform for biomolecular condensates and Bayer’s small molecule compound library to develop new treatments for cardiovascular (CV) and gynecological diseases. Today, around 80 percent of the human proteome is still considered to be beyond the reach of small molecules, which make up more than 80 percent of all marketed therapeutic drugs. The emerging paradigm of biomolecular condensates is expanding the traditional drug target space for small molecules by unveiling new targets and new approaches to previously intractable targets. Many proteins act as part of complexes in biomolecular condensates, droplet-like membraneless organelles that form dynamically to carry out a wide variety of functions in cells. Though condensates were first observed more than 100 years ago, they have historically been understudied because they are difficult to analyze with traditional drug discovery methods such as protein crystallography and biochemical activity assays. Now, a new wave of research into condensates could provide new insights into cellular function and disease. Under the terms of the agreement, Bayer will gain the option to exclusively license a specified number of novel therapeutics derived from the research activities. Bayer will contribute with its small molecule compound library and R&D capabilities including high throughput screening and medicinal chemistry. As part of this partnership, Bayer and Dewpoint will broaden Dewpoint's presence in Germany, and foster local capabilities to translate the emerging science into new medicines. The collaboration follows Bayer's participation in Dewpoint's January 2019 Series A financing round through the Leaps by Bayer unit. The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.   ]]> https://biospectrumindia.com/news/57/15129/fujifilm-invests-55-m-to-expand-gene-therapy-development-services.html https://biospectrumindia.com/news/57/15129/fujifilm-invests-55-m-to-expand-gene-therapy-development-services.html Fri, 15 Nov 2019 11:40:00 +0530 FUJIFILM Diosynth Biotechnologies (FDB), a leading global biologics Contract Development and Manufacturing Organization (CDMO) has announced the expansion of its gene therapy services with the addition of dedicated process and analytical development laboratories. As a part of a capital investment of approximately 13 billion yen (approx. $120 million USD) in the gene therapy field by FUJIFILM corporation, an investment of approximately $55 million USD will be made to establish a new Gene Therapy Innovation Center adjacent to FDB's existing state-of-the-art cGMP gene therapy manufacturing facility in College Station, Texas and forms part of the company's strategy to meet the growing demands in the Viral Gene Therapy Market.  The gene therapy market forecast for CDMOs is expected to grow to $1.7Bn by 2025. The Gene Therapy Innovation Center will be approximately 60,000 square feet and will house state-of-the-art upstream, downstream and analytical development technologies.  The facility will be operational in the fall of 2021. "We are very much aware of the incredible growth in such an important therapeutic space," said Martin Meeson, President and COO of FUJIFILM Diosynth Biotechnologies, US.  "We know that we need to invest now, in technology, assets and people in order to achieve a market leadership position. The expansion through the construction of the Gene Therapy Innovation Center demonstrates our ongoing commitment for growth." FDB's main goals behind this new strategy are to provide leading, future proofed end-to-end gene therapy solutions, from pre-clinical to commercial launch. This follows an earlier announcement made by FDB to introduce its gene therapy fill finish services. "We expect to break ground in the first quarter of 2020," said Gerry Farrell, COO at FUJIFILM Diosynth Biotechnologies, Texas, "this new facility will triple our gene therapy development capabilities and will add approximately 100 jobs to our Texas Campus." Gene Therapy remains a strategic investment area for Fujifilm. ]]> https://biospectrumindia.com/news/57/15128/who-launches-first-ever-insulin-prequalification-programme.html https://biospectrumindia.com/news/57/15128/who-launches-first-ever-insulin-prequalification-programme.html Fri, 15 Nov 2019 11:35:00 +0530 The World Health Organization (WHO) has announced the start of a pilot programme to prequalify human insulin to increase treatment for diabetes in low- and middle-income countries. The decision is part of a series of steps WHO will take to address the growing diabetes burden in all regions. About 65 million people with type 2 diabetes need insulin, but only half of them are able to access it, largely due to high prices.  All people with type 1 diabetes need insulin to survive. “Diabetes is on the rise globally, and rising faster in low-income countries,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Too many people who need insulin encounter financial hardship in accessing it, or go without it and risk their lives. WHO’s prequalification initiative for insulin is a vital step towards ensuring everyone who needs this life-saving product can access it.”   Insulin prequalification can lead to lower prices WHO prequalification of insulin is expected to boost access by increasing the flow of quality-assured products on the international market, providing countries with greater choice and patients with lower prices. Insulin was discovered as a treatment for diabetes almost 100 years ago and has been on WHO’s List of Essential Medicines since it was published in 1977. Despite an ample supply, insulin prices are currently a barrier to treatment in most low- and middle-income countries. Three manufacturers control most of the global market for insulin, setting prices that are prohibitive for many people and countries.   Access to insulin a challenge in many countries Data collected by WHO in 2016-2019 from 24 countries on four continents showed that human insulin was available only in 61% of health facilities and analogue insulins in 13%.  The data showed that a month’s supply of insulin would cost a worker in Accra, Ghana, the equivalent of 5.5 days of pay per month, or 22% of his/her earnings. In wealthy countries, people often have to ration insulin, which can be deadly for people who do not get the right quantity of the medicine. People with type 1 diabetes need insulin for survival and to maintain their blood glucose at levels to reduce the risk of common complications such as blindness and kidney failure. People with type 2 diabetes need insulin for controlling blood glucose levels to avoid complications when oral medicines become less effective as the illness progresses. Insulin prequalification is one of a number of steps WHO will take in the coming year to address the diabetes burden. Plans are underway to update diabetes treatment guidelines, devise price reduction strategies for analogues and improve delivery systems and access to diagnostics. WHO also works with countries to promote healthier diets and physical activity to lower people’s risk of developing type 2 diabetes. ]]> https://biospectrumindia.com/news/57/15114/philips-launches-first-clinical-product-for-aiding-cognitive-assessment-.html https://biospectrumindia.com/news/57/15114/philips-launches-first-clinical-product-for-aiding-cognitive-assessment-.html Thu, 14 Nov 2019 14:35:00 +0530 Royal Philips, a global leader in health technology has announced the U.S. debut of its new cognitive assessment platform IntelliSpace Cognition. Leveraging the power of artificial intelligence (AI) and Philips’ cloud-based HealthSuite Digital Platform, IntelliSpace Cognition provides healthcare professionals with a powerful aid for assessing cognitive impairment.    IntelliSpace Cognition automates and enhances well-established neuropsychological tests, offering new insights for clinicians treating patients with debilitating neurological conditions. It provides direct access to detailed information about a patient’s cognition while also providing quantitative longitudinal data to aid in assessing disease progression and treatment efficacy.  “While dealing with the rising tide of neurological disease remains a great challenge, our solution will facilitate robust and reliable cognitive assessment with greater efficiency and scale than traditional methods,” said Jeroen Tas, Chief Innovation & Strategy Officer at Philips. “Combining this with imaging-based diagnostics we aim to offer care providers more meaningful insights into the health of their patients and potentially open up new possibilities for treatment in the future.”  The number of neuropsychologists able to perform an assessment is limited and coupled with a rise in the number of patients suffering from neurological conditions, there is a need for new innovative solutions. A rapid and reliable method for neurologists to better assess cognition and select those that would benefit from seeing a neuropsychologist would alleviate pressure on this part of the healthcare system. Results from a study conducted by Philips support interest in new solutions to address these issues. Ninety-two percent of neurologists indicated that the IntelliSpace Cognition concept would be appealing to use within their practice. Philips has invested in collecting insights from both neurologists and neuropsychologists in order to design IntelliSpace Cognition in an iterative manner and ensure it fits into the majority of existing workflows. IntelliSpace Cognition was developed under a quality management system for medical devices and has undergone rigorous usability testing and a monitored clinical trial has been performed to validate the digital cognitive tests and collect normative data from healthy individuals that reflect the U.S. population. The Philips study found that 80% of neurologists said they would feel confident using IntelliSpace Cognition because Philips has collected normative data to provide peer comparisons to a healthy group. In the typical workflow, illustrated in this video, a patient performs various tests on a tablet under minimal supervision of an assistant with audio prompts to guide in tasks such as drawing a clock, joining numbered dots or remembering a sequence of numbers. The results of the tests are then communicated to IntelliSpace Cognition’s cloud-based computing platform, where advanced validated algorithms perform analytics to present the clinician with the results. IntelliSpace Cognition is just one part of an expanding neurology IT portfolio of Philips which includes, neuroimaging, high density EEG and now digital cognitive assessment.  IntelliSpace Cognition will initially be commercially available only in the U.S.  ]]> https://biospectrumindia.com/news/57/15103/gsks-nucala-reduces-flares-of-hypereosinophilic-syndrome-hes-patients.html https://biospectrumindia.com/news/57/15103/gsks-nucala-reduces-flares-of-hypereosinophilic-syndrome-hes-patients.html Wed, 13 Nov 2019 14:50:00 +0530 GlaxoSmithKline plc (GSK) has announced positive results from the pivotal study of Nucala (mepolizumab) in the treatment of patients living with Hypereosinophilic Syndrome (HES), making it the first treatment to demonstrate a reduction in flares for this rare disease. The phase 3 study met its primary endpoint, demonstrating a statistically significant result with 50% fewer patients experiencing a HES flare (worsening of symptoms or eosinophil threshold requiring an escalation in therapy) when treated with mepolizumab, compared to placebo, when added to standard of care treatment over the 32-week study period (56% vs 28%; p=0.002). Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “Mepolizumab has the potential to change the treatment landscape for patients with HES which is a complex and debilitating disease with limited therapeutic options today.” Secondary endpoints from the study were also statistically significant and supported the primary endpoint, showing: Risk of first HES flare over the study period was 66% lower for patients treated with mepolizumab compared to placebo (hazard ratio 0.34; 95% CI 0.18, 0.67). There was a 66% reduction in the annualised rate of HES flares versus placebo (rate ratio 0.34; 95% CI 0.19, 0.63). Fatigue scores improved in mepolizumab compared to placebo (p=0.036). The safety results in the study were consistent with the known profile of mepolizumab. Dr Gerald Gleich, MD, allergist, immunologist and HES expert, University of Utah, said: “Mepolizumab is thought to work by reducing blood eosinophil levels and evidence suggests it has potential as a targeted treatment option for a range of inflammatory diseases driven by raised eosinophils. These data are very promising and should provide hope for patients affected by this rare, life-threatening condition caused by eosinophilic inflammation”. Based on these data, GSK plans to progress regulatory submissions in 2020. ]]> https://biospectrumindia.com/news/57/15097/ivac-launches-10th-annual-pneumonia-and-diarrhea-progress-report-card.html https://biospectrumindia.com/news/57/15097/ivac-launches-10th-annual-pneumonia-and-diarrhea-progress-report-card.html Tue, 12 Nov 2019 15:10:00 +0530 The 10th annual Pneumonia and Diarrhea Progress Report Card has been launched by International Vaccine Access Center and highlights increases in immunization coverage—but a universal failure to meet targets across 23 countries with the greatest burden of disease. A report card finds health systems are falling short of ensuring the world’s most vulnerable children have access to prevention and treatment services in the 23 countries that together account for 75% of global pneumonia and diarrhea deaths in children under five. Globally, pneumonia and diarrhea led to nearly one of every four deaths in children under five years of age in 2017. The report describes progress in fighting pneumonia and diarrhea in countries with the highest absolute number of deaths and for, the first time, in countries with the highest rates of deaths from these illnesses. It also analyzes how effectively countries are delivering 10 key interventions—breastfeeding, vaccination, access to care, use of antibiotics, oral rehydration solution (ORS), and zinc supplementation—to help protect against, prevent and treat pneumonia and diarrhea. These measures are proven to help prevent death due to these illnesses and could help achieve the UN’s Sustainable Development Goal target of reducing under-five mortality to at least as low as 25 per 1,000 live births by 2030. The Pneumonia and Diarrhea Progress Report, issued annually for a decade, finds as in past years that immunization coverage—the most frequently updated indicators in the report—generally makes up the highest scores. Use of exclusive breastfeeding continues to lag behind, as does access to treatment, particularly zinc supplements for diarrhea. Bill Moss, MD, MPH, Executive Director of IVAC and Professor in the Department of International Health said, “It’s critical to prevent children from becoming ill from pneumonia and diarrhea by ensuring universal coverage of immunization, so we’re pleased to see higher scores for immunization across many countries. However, newer vaccines such as rotavirus and pneumococcal vaccine are not yet reaching most children in these 23 countries, and access to treatments such as basic antibiotics and oral rehydration therapy is surprisingly low across most of the countries included.” Sixteen out of 23 countries assessed failed to meet the targets for any of 10 interventions to protect against and treat pneumonia and diarrhea, as outlined in the World Health Organization and UNICEF’s Integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhea (GAPPD). Three of the 23 countries met the 90% target coverage rate for at least four vaccines while one was able to attain 90% level of coverage for all four treatment measures. The report notes progress in Pakistan, which recently introduced rotavirus vaccine into its immunization program, as well as in Nigeria, Indonesia, Angola, and Côte d'Ivoire. Niger’s score dipped because of decreases in immunization coverage, although its coverage remained above other high-mortality countries, as many of them struggle with fragile governance, conflict, disease outbreaks, or natural disasters. Progress in India—which due in large part to its population was home to more under-five pneumonia and diarrhea deaths than any other country in 2017—has been mixed. Rollouts of rotavirus vaccines, beginning in 2016, and pneumococcal conjugate vaccine, beginning in 2017, helped India’s scores improve. India’s exclusive breastfeeding rate, at 55%, is among the highest of the 23 countries. However, the proportion of children receiving important treatments as with many other countries remains below targets. Half of children with diarrhea receive ORS and 20% receive zinc. The report card concludes that progress continues slowly with only a few of the 23 countries in the analysis positioned to meet GAPPD targets by 2025. The global community must increase investment and support countries in developing smart, sustainable strategies that close gaps and accelerate progress. Support for the report was provided by the Bill & Melinda Gates Foundation.   ]]> https://biospectrumindia.com/news/57/15085/avantor-nibrt-collaborate-to-advance-bioprocessing-.html https://biospectrumindia.com/news/57/15085/avantor-nibrt-collaborate-to-advance-bioprocessing-.html Mon, 11 Nov 2019 11:15:00 +0530 Avantor, Inc. and Ireland based National Institute of Bioprocessing Research and Training (NIBRT) have announced they are teaming up to address downstream bottlenecks in buffer preparation when producing monoclonal antibodies (mAbs). As part of the joint effort, Avantor® is providing in-line dilution systems for hands-on experience at NIBRT's prestigious training and research facility dedicated to supporting the global bioprocessing industry. Avantor's technology adds to NIBRT's full complement of bioprocessing capabilities. Dr. Ger Brophy, Executive Vice President, Biopharma Production for Avantor, said, "Demand for therapeutic biologics is increasing and this will require increased manufacturing productivity.  At the same time, there is significant pressure on the biopharma industry to reduce overall costs while ensuring that safety and quality are not compromised. This has resulted in initiatives to improve efficiency and increase flexibility in bioprocessing facilities. Buffer management is a key process step which is prime for optimization."  Buffers are a critical component when producing and purifying mAbs and are extensively used in upstream and downstream production.  Recent activities in upstream optimization have resulted in increasing production yields, which has now placed pressure on downstream purification resources. In addition, demand for multi-product facilities has placed a strain on capacity for traditional buffer preparation. Buffer management can help advance bioprocessing production by reducing downstream bottlenecks and costs. Avantor's collaboration with NIBRT will provide industry leading buffer management training to help mitigate downstream challenges, which will help new therapies to reach patients faster and more cost effectively. Dominic Carolan, NIBRT CEO, stated, "This collaboration further advances our mission of providing a world-class research and training center of excellence. Technicians and professionals will benefit from access to the latest bioprocessing production knowledge, technology and innovation in buffer management. We are delighted to be working closely with Avantor to support the biopharmaceutical industry." ]]> https://biospectrumindia.com/news/57/15082/fda-approves-reblozyl-to-treat-anemia-.html https://biospectrumindia.com/news/57/15082/fda-approves-reblozyl-to-treat-anemia-.html Mon, 11 Nov 2019 09:45:00 +0530 Celgene Corporation and Acceleron Pharma Inc. have announced the U.S. Food and Drug Administration (FDA) has approved REBLOZYL® (luspatercept-aamt) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. REBLOZYL is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy which works by regulating late-stage red blood cell maturation to help patients reduce their RBC transfusion burden. “Today’s approval is an important milestone and underscores our continued commitment to patients with hematology disorders,” said Nadim Ahmed, President, Global Hematology and Oncology for Celgene. “There are very limited options for patients living with anemia due to beta thalassemia who are dependent on long term red blood cell transfusions. We are pleased to make REBLOZYL available as a new therapy for these patients to help address their anemia, a significant clinical complication of beta thalassemia.” “We’re thrilled that Acceleron’s first approved medicine is one with the potential to help patients with beta thalassemia, who have been in need of new treatments for this lifelong disease,” said Habib Dable, President and Chief Executive Officer of Acceleron. “We are enormously grateful to the patients, families and caregivers who participated in and supported our research. Their contributions have been essential in helping to ensure that REBLOZYL would emerge successfully from our longstanding collaboration with Celgene.” The approval of REBLOZYL for beta thalassemia, which received a Priority Review designation from the FDA, is based on results from the pivotal, Phase 3, randomized, double-blind, placebo-controlled, multicenter BELIEVE trial evaluating the safety and efficacy of REBLOZYL for the treatment of anemia in adult patients with beta thalassemia who require regular RBC transfusions (defined as 6-20 RBC units per 24 weeks, with no transfusion-free period greater than 35 days during that period). REBLOZYL is anticipated to be available 1 week following the FDA approval. ]]> https://biospectrumindia.com/news/57/15079/abcam-brickbio-to-include-conjugation-ready-sites-into-recombinant-antibodies-.html https://biospectrumindia.com/news/57/15079/abcam-brickbio-to-include-conjugation-ready-sites-into-recombinant-antibodies-.html Fri, 08 Nov 2019 16:20:00 +0530 Abcam plc, a global innovator in life science reagents and tools, is pleased to announce a strategic partnership with BrickBio, experts in site-specific protein modification and a Tiger Gene portfolio company, covering the use of BrickBio's proprietary platform for introducing conjugation-ready sites into antibodies and other proteins in both mammalian and bacterial expression systems. Under the partnership, Abcam will have exclusive rights to the platform for the creation of novel conjugation-ready recombinant products for the research tools market, as well as rights to commercialize the platform across its recombinant antibody and protein portfolio for diagnostic use.  In addition, Abcam will make a financial investment in BrickBio and work together with the BrickBio team to further industrialize the platform.  BrickBio's platform provides an unparalleled ability to site-selectively modify proteins in a broad range of eukaryotic and bacterial cell lines. Using a proprietary engineered tRNA synthetase/tRNA pair, the platform can readily incorporate unnatural amino acids that can then be coupled to a second molecule for labeling or other research applications, or to create protein-conjugate therapeutics including Antibody-Drug-Conjugates (ADCs).    ]]> https://biospectrumindia.com/news/57/15078/mallinckrodt-completes-sale-of-biovectra-for-250-million.html https://biospectrumindia.com/news/57/15078/mallinckrodt-completes-sale-of-biovectra-for-250-million.html Fri, 08 Nov 2019 16:10:00 +0530 Mallinckrodt plc a global biopharmaceutical company has completed the sale of its wholly owned subsidiary BioVectra Inc. to an affiliate of H.I.G. Capital, a leading global private equity investment firm. The terms of the transaction were updated since initial announcement, with total consideration of up to $250 million including an upfront payment of $135 million and contingent consideration of $115 million based on the long-term performance of the business. "This transaction marks an advancement of Mallinckrodt's strategic focus on branded, high-growth biopharmaceuticals," said Mark Trudeau, President and Chief Executive Officer.  "While we recognize the longer-term growth potential of BioVectra, we believe this company will best achieve its potential under H.I.G. Capital, and we are confident that this sale will enable us to participate financially in the future success of the business." ]]> https://biospectrumindia.com/news/57/15072/abbott-discovers-new-strain-of-hiv.html https://biospectrumindia.com/news/57/15072/abbott-discovers-new-strain-of-hiv.html Fri, 08 Nov 2019 10:25:00 +0530 Abbott has announced that a team of its scientists identified a new subtype of the human immunodeficiency virus (HIV), called HIV-1 Group M, subtype L. The findings, published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS), show the role next-generation genome sequencing is playing in helping researchers stay one step ahead of mutating viruses and avoiding new pandemics. Since the beginning of the global AIDS pandemic, 75 million people have been infected with HIV and 37.9 million people today are living with the virus. "In an increasingly connected world, we can no longer think of viruses being contained to one location. This discovery reminds us that to end the HIV pandemic, we must continue to outthink this continuously changing virus and use the latest advancements in technology and resources to monitor its evolution”, said Carole McArthur, Ph.D., M.D., professor in the departments of oral and craniofacial sciences, University of Missouri — Kansas City, and one of the study authors. This research marks the first time a new subtype of "Group M" HIV virus has been identified since guidelines for classifying new strains of HIV were established in 2000. Group M viruses are responsible for the global pandemic, which can be traced back to the Democratic Republic of Congo (DRC) in Sub-Saharan Africa. The science behind genetic sequencing to discover new viruses To determine whether an unusual virus is in fact a new HIV subtype, three cases must be discovered independently. The first two samples of this subtype were discovered in DRC in the 1980s and the 1990s. The third, collected in 2001, was difficult to sequence at that time because of the amount of virus in the sample and the existing technology. Today, next-generation sequencing technology allows researchers to build an entire genome at higher speeds and lower costs. In order to utilize this technology, Abbott scientists had to develop and apply new techniques to help narrow in on the virus portion of the sample to fully sequence and complete the genome. "Identifying new viruses such as this one is like searching for a needle in a haystack," said Mary Rodgers, Ph.D., a principal scientist and head of the Global Viral Surveillance Program, Diagnostics, Abbott, and one of the study authors. "By advancing our techniques and using next generation sequencing technology, we are pulling the needle out with a magnet. This scientific discovery can help us ensure we are stopping new pandemics in their tracks”, she added. Twenty-five years of tracking mutating viruses around the world  Abbott created its Global Viral Surveillance Program 25 years ago to monitor HIV and hepatitis viruses and identify mutations to ensure the company's diagnostic tests remain up to date. As part of this research, Abbott scientists confirmed that its core and molecular laboratory diagnostic tests can detect this new HIV strain. In partnership with blood centers, hospitals and academic institutions around the world, Abbott has collected more than 78,000 samples containing HIV and hepatitis viruses from 45 countries, identified and characterized more than 5,000 strains, and published 125 research papers to date to help the scientific community learn more about these viruses.   ]]> https://biospectrumindia.com/news/57/15064/coherus-to-market-bioeqs-biosimilar-to-lucentis.html https://biospectrumindia.com/news/57/15064/coherus-to-market-bioeqs-biosimilar-to-lucentis.html Thu, 07 Nov 2019 09:55:00 +0530 Bioeq IP AG has announced that it signed a license and development agreement with Coherus BioSciences, Inc., under which Coherus will exclusively market and distribute Bioeq's biosimilar candidate to Lucentis® (ranibizumab) in the United States (U.S.) Bioeq will retain responsibility for filing of the Biologics License Application (BLA) with the U.S. Food and Drug Administration in Q4 2019 and for subsequent product supply. Coherus plans to launch the product in 2021. Commenting on the agreement, Hannes Teissl, Board Member at Bioeq, said, "We are proud of having secured Coherus as our partner of choice for the U.S. This agreement is an important milestone in bringing a more affordable, highly effective treatment option for retinopathies, including age-related macular degeneration, to U.S. patients." According to the terms of the agreement, Bioeq will receive upfront, regulatory and launch milestone payments as well as shared profits. Commenting on future plans, Nicola Mikulcik, Board Member at Bioeq, said, "Starting in 2020, Bioeq will also be in a position to offer rights for its biosimilar ranibizumab to marketing and distribution partners outside the U.S. ]]> https://biospectrumindia.com/news/57/15059/scirhom-kicks-off-antibody-development-program-to-treat-autoimmune-diseases.html https://biospectrumindia.com/news/57/15059/scirhom-kicks-off-antibody-development-program-to-treat-autoimmune-diseases.html Wed, 06 Nov 2019 13:25:00 +0530 SciRhom GmbH, a therapeutic antibody company, has announced the development of first-in-class antibodies against iRhom2, a key modulator of several major pro-inflammatory signaling pathways, including TNF-alpha signaling. Based on a decade of cutting-edge bench research and the completion of a challenging, yet ultimately successful antibody campaign, SciRhom is now in the unique position to pursue the development of monoclonal antibodies against iRhom2 for the treatment of major autoimmune diseases. iRhom2 is a protein that controls the tumor necrosis factor-alpha-convertase (TACE; also known as ADAM17), a set of molecular scissors that activates several crucial signaling pathways, including TNF-alpha (tumor necrosis factor-alpha) and other disease-related signaling. Blocking TACE, however, raises major concerns about side effects, as TACE-deficient patients show severe skin and intestinal defects. In contrast, antibodies against iRhom2 would have the unique advantage over TACE-targeted therapies of simultaneously blocking several TACE-dependent disease-associated pro-inflammatory pathways without causing lesions in the skin and intestinal barrier. Moreover, antibodies against iRhom2 are expected to be superior over anti-TNF-alpha biologics due to their ability to interfere with other important pro-inflammatory pathways. This concept has been validated using iRhom2 knockout mice, which are normal and healthy, but are protected from Rheumatoid Arthritis (RA) and glomerulonephritis caused by Systemic Lupus Erythematosus. These proof-of-concept studies were primarily conducted by Professor Dr. Carl Blobel, co-founder of SciRhom and pioneer of the TACE/ADAM17 field, and his colleague, Professor Dr. Jane Salmon. Prof. Blobel is Program Director of the Arthritis and Tissue Degeneration Program at Hospital for Special Surgery (HSS) in New York, USA, one of the world’s top-ranking academic medical centers in Rheumatology and musculoskeletal health. From these promising results, SciRhom has identified iRhom2-specific antibodies that block TNF-alpha release by TACE and is currently advancing the preclinical development of its first-in-class anti-iRhom2 antibodies towards IND-enabling studies. SciRhom was founded and is led by a highly experienced management team with an excellent track record in antibody drug development that consists of Dr. Jens Ruhe, co-founder of U3 Pharma and former Director R&D at U3 Pharma / Daiichi Sankyo and Dr. Matthias Schneider, previously Preclinical Head of the Patritumab lead program at U3 Pharma / Daiichi Sankyo. In addition to Professor Dr. Carl Blobel, the co-founders of SciRhom are Professor Dr. Axel Ullrich, biotech pioneer, former Director at the Max Planck Institute of Biochemistry and recent recipient of the prestigious Lasker Award, Dr. Andreas Jenne, serial biotech entrepreneur, and HSS. To date, SciRhom has secured about EUR 7 million in seed funding from the High-Tech Gruenderfonds (HTGF), HSS and private investors.   ]]> https://biospectrumindia.com/news/57/15049/beigene-announces-global-strategic-oncology-collaboration-with-amgen.html https://biospectrumindia.com/news/57/15049/beigene-announces-global-strategic-oncology-collaboration-with-amgen.html Tue, 05 Nov 2019 14:05:00 +0530 BeiGene, Ltd.  and Amgen have announced a global strategic oncology collaboration for the commercialization and development in China of Amgen’s XGEVA® (denosumab), KYPROLIS® (carfilzomib), and BLINCYTO® (blinatumomab), and the joint global development of 20 oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China. In connection with the collaboration, Amgen will purchase a 20.5% stake in BeiGene for approximately $2.7 billion in cash at $174.85 per American Depositary Share (ADS). “Through this collaboration, Amgen, a true biotech pioneer and leader in our industry, has recognized the transformative potential of BeiGene’s unique clinical development capabilities to accelerate global drug development. We are thrilled to join forces with Amgen to realize the development and commercialization of this broad oncology pipeline with the aim of benefitting patients around the world,” said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene. “In addition, this alliance expands the portfolio available to our market-leading China commercial team, led by Dr. Xiaobin Wu, with the potential to bring as many as eight internally discovered and in-licensed innovative treatments to cancer patients by the end of 2020.” “This strategic collaboration with BeiGene will enable Amgen to serve significantly more patients by expanding our reach in the world’s most populous country. We’ve chosen an innovative strategic collaborator that can offer commercial and clinical reach with global quality standards,” said Robert A. Bradway, Amgen’s chairman and chief executive officer. “Cancer is a leading cause of death in China and will only become a more pressing public health issue as the Chinese population ages. We look forward to working with BeiGene to make a meaningful difference in the lives of millions of cancer patients in China and around the world.” Key elements of the collaboration include: Commercialization of Approved Products in China: Under the agreement, BeiGene will commercialize XGEVA, KYPROLIS and BLINCYTO in China for five or seven years, during which time the parties will equally share profits and losses. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained; and XGEVA (denosumab) was approved in China in 2019 for patients with giant cell tumor of the bone and is in development for prevention of skeletal-related events in cancer patients with bone metastases. KYPROLIS (carfilzomib) is in late-stage development in China for patients with multiple myeloma, and BLINCYTO (blinatumomab) is in late-stage development in China as a treatment for adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). Global Clinical Development: BeiGene has agreed to jointly develop 20 Amgen oncology pipeline assets globally, which include targeted small-molecule agents such as AMG 510, a first-in-class investigational KRAS G12C inhibitor, as well as BiTE® (Bispecific T cell Engager) antibodies, for solid and hematologic malignancies; Amgen and BeiGene will co-fund global development costs, with BeiGene contributing up to $1.25 billion worth of development services and cash over the term of the collaboration. BeiGene is entitled to receive royalties from global sales of each product outside of China, with the exception of AMG 510; For each pipeline asset that is approved in China, BeiGene will receive commercial rights for seven years from approval, during which time the parties will share equally in profits and losses. BeiGene is also entitled to receive royalties from sales in China for five years after the seven-year commercial term; and BeiGene will also have the right to retain approximately one of every three approved pipeline assets, up to a total of six, other than AMG 510, for commercialization in China, during which time the parties will share in profits and losses.  Amgen has agreed to purchase approximately $2.7 billion of BeiGene ordinary shares, at a price of $174.85 per ADS, a 36% premium to BeiGene’s 30-day volume-weighted average share price as of October 30, 2019. Amgen will receive one seat on BeiGene’s Board of Directors. ]]> https://biospectrumindia.com/news/57/15048/sanofi-declares-positive-results-from-phase-3-trial-for-toujeo-.html https://biospectrumindia.com/news/57/15048/sanofi-declares-positive-results-from-phase-3-trial-for-toujeo-.html Tue, 05 Nov 2019 13:45:00 +0530 Children and adolescents (aged 6 to 17 years) living with type 1 diabetes achieved comparable reduction in average blood sugar (HbA1c) and similar risk of low blood sugar events with Toujeo® (insulin glargine 300 Units/mL) compared to insulin glargine 100 Units/mL (Gla-100), according to results presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts. “We know that living with type 1 diabetes means dealing with highs and lows in blood sugar, which are worrying and present substantial challenges for young people,” said Prof. Dr. Thomas Danne, Director of the Department of General Pediatrics and Endocrinology/Diabetology at the Children's Hospital on the Bult, Hannover Medical School, Germany. “In addition to the trial demonstrating safety and efficacy, the percentage of patients with severe hypoglycemia, and the percentage with hyperglycemia with ketosis, were numerically lower with Toujeo.” The trial, EDITION JUNIOR, is the first randomized, controlled trial comparing Toujeo vs Gla-100 in this group of patients. The study met its primary endpoint with comparable reductions in average blood sugar over 6 months with both treatments and similar risk of low blood sugar events (hypoglycemia). The percentages of patients who experienced severe hypoglycemia and who experienced high blood sugar (hyperglycemia) with ketosis were numerically lower with Toujeo. As these are serious short-term complications, these findings are clinically important for people with type 1 diabetes. Based on these data, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on October 17, recommending expanding the current indication for Toujeo in the Europe Union for the treatment of diabetes mellitus in adolescents and children (6 years and older). “Across the globe, between 50 and 80 percent of young people living with type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5%,” said Dietmar Berger, Global Head of Development at Sanofi. “By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease.” The European Commission will make a final decision on this additional indication in the coming months.   ]]> https://biospectrumindia.com/news/57/15043/scanwell-health-launches-smartphone-enabled-test-and-treatment-service-for-uti.html https://biospectrumindia.com/news/57/15043/scanwell-health-launches-smartphone-enabled-test-and-treatment-service-for-uti.html Tue, 05 Nov 2019 11:00:00 +0530 Scanwell Health, a modern diagnostics company has announced that its at-home smartphone-enabled test and treatment service for Urinary Tract Infections (UTIs) is now available in all 50 states. Through a partnership with Lemonaid Health, a telehealth company that enables patients to quickly, safely and inexpensively receive care online, people across the country can now diagnose UTIs using Scanwell’s test and app, then receive immediate treatment from a Lemonaid physician or nurse practitioner. Scanwell’s UTI test is the only FDA-cleared urine testing app available over-the-counter without a prescription. In addition, the company also announced that it has raised $3.5M of seed funding from investors including Founders Fund, Mayfield, DCM, Version One, Y Combinator and Joe Montana’s Liquid 2 Ventures. The proceeds of the financing will be used to support the national launch, develop new diagnostics, and hire additional team members. Stephen Chen, founder and CEO of Scanwell Health said, “This funding from an incredible group of investors, together with the national launch of our test and app, are exciting milestones that will allow us to realize our vision of making reliable, convenient at-home testing available to millions of people. Our partnership with Lemonaid is only the beginning. We have a number of additional diagnostic tests in the pipeline that have the potential to change the way we diagnose and treat infections and monitor chronic diseases. We look forward to working with additional partners to bring these tests to people across the country.” Using the Scanwell test kit and the Scanwell iOS or Android app, people can quickly and accurately determine whether they have a high concentration of leukocytes and nitrites in their urine, indicating that they could have a UTI. Scanwell’s test provides a result in as little as two minutes, with the same diagnostic accuracy as a urinalysis performed in a clinic. If the user has signs of a UTI they are directly connected with Lemonaid’s virtual team of physicians and nurse practitioners, who can prescribe antibiotics if needed. Davis Liu, M.D., Chief Clinical Officer of Lemonaid Health said, “UTIs are a common, painful medical condition prompting 10 million doctor visits in the United States each year. We are committed to providing the very best in patient care. Scanwell Health’s innovative at-home UTI test will help our clinicians treat more people by providing patients a convenient, fast way to provide clinically reliable diagnostic information to their online doctor.” Jack Jeng, M.D., Chief Medical Officer of Scanwell Health said, "Before Scanwell Health, virtual visits for UTIs relied on patient-reported symptoms for diagnosis. Recent studies suggest that this approach results in 30-50% of cases being treated inappropriately with antibiotics. With the growing threat of antibiotic resistance and the call for improved antibiotic stewardship, clinicians are now more judicious in how we treat common infections like UTIs." Scanwell Health’s UTI test was conceived by founder, Stephen Chen, based on his experience developing Petnostics, an at-home urine testing solution to detect and monitor health conditions in dogs and cats.   ]]> https://biospectrumindia.com/news/57/15033/astrazeneca-divests-rights-to-seroquel-and-seroquel-xr-.html https://biospectrumindia.com/news/57/15033/astrazeneca-divests-rights-to-seroquel-and-seroquel-xr-.html Mon, 04 Nov 2019 11:55:00 +0530 AstraZeneca has agreed the sale and licence of the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Cheplapharm Arzneimittel GmbH (Cheplapharm). Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in Europe and Russia. Ruud Dobber, Executive Vice President, Biopharmaceuticals, said: “Seroquel is an important established medicine and this agreement with Cheplapharm will help ensure continued patient access. It forms part of our strategy of reducing the portfolio of mature medicines to enable reinvestment in our main therapy areas.” AstraZeneca will continue to manufacture and supply Seroquel and Seroquel XR to Cheplapharm during a transition period. Pursuant to Listing Rule 10.4.1R (notification of class 2 transactions), the gross book value of assets subject to the divestment as at 31 December 2018 was nil. In the year to 31 December 2018, the aggregate pre-tax profits attributable to Seroquel and Seroquel XR in the relevant territories were $86m. The consideration will be paid in cash and the proceeds used for general corporate purposes. Financial considerations Cheplapharm will make an upfront payment of $178m to AstraZeneca and may also make future sales-contingent payments of up to $61m. Income arising from the upfront and future payments will be reported in AstraZeneca’s financial statements within Other Operating Income & Expense. In 2018, Seroquel generated annual product sales of $47m in the markets covered by this agreement, while Seroquel XR generated $61m. The agreement does not impact the Company’s financial guidance for 2019. The transaction is expected to complete in the fourth quarter of 2019, subject to customary closing conditions and regulatory clearances. ]]> https://biospectrumindia.com/news/57/15032/gsks-biologic-treatment-gets-ec-approval-to-treat-children-with-lupus.html https://biospectrumindia.com/news/57/15032/gsks-biologic-treatment-gets-ec-approval-to-treat-children-with-lupus.html Mon, 04 Nov 2019 11:35:00 +0530 GlaxoSmithKline plc has announced that the European Commission has adopted a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta (belimumab) as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity. Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK said: “Children with lupus typically have more severe disease and earlier onset of organ damage than adults, but until now their treatment options have been limited. This approval means that for the first time in Europe these children can be treated with a biologic therapy specifically developed and approved for their disease.” Alain Cornet, General Secretary of Lupus Europe, a charity supporting people with lupus in Europe, commented: “This decision is great news for the lupus community in Europe and particularly for young people affected and their supportive families, that so much need new therapeutic options. We are thankful to the many patients who, by taking part in clinical trials, made such progress possible.”                                            There are estimated to be between 3,000 and 6,000 children aged five to 17 years old with systemic lupus erythematosus in the European Union. In children this disease is associated with more rapid accrual of damage and has a higher degree of morbidity compared with systemic lupus erythematosus in adult populations.[2,3] This approval by the European Commission follows recent approvals in the US and Japan, all supported by data from PLUTO, a post-approval commitment study.   ]]> https://biospectrumindia.com/news/57/15031/gsk-candidate-vaccine-shows-protection-against-active-tb.html https://biospectrumindia.com/news/57/15031/gsk-candidate-vaccine-shows-protection-against-active-tb.html Mon, 04 Nov 2019 11:20:00 +0530 GSK and IAVI reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease (TB) in HIV-negative adults with latent TB infection. These results demonstrate an overall vaccine efficacy of 50% during the three years after vaccination. The candidate vaccine has an acceptable safety and reactogenicity profile. The final results are consistent with the primary analysis done after two years of follow-up and published in New England Journal of Medicine in September 2018. TB is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.5 million attributed deaths in 2018[3]. It is estimated that one-quarter of the global population has latent TB infection, of whom approximately 10% will develop active pulmonary TB disease. Currently, multi-drug resistant strains of TB are emerging and spreading globally, and the only available TB vaccine, BCG, does not provide proven and consistent protection in adults in TB-endemic countries. Without a more effective vaccine, it will not be possible to achieve the World Health Organization target of decreasing the number of new cases by 90% and the number of TB deaths by 95% between 2015 and 2035. Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines, said: “These results demonstrate that for the first time in almost a century, the global community potentially has a new tool to help provide protection against TB. I want to thank our scientists for their dedicated effort and scientific innovation in developing this impactful vaccine candidate in partnership with IAVI and other key organisations.”    The trial was conducted in TB-endemic regions (Kenya, South Africa and Zambia) and involved 3,573 HIV-negative adults between the ages of 18 and 50 years. Participants who received two doses of either M72/AS01E or placebo 30 days apart were followed for three years to detect evidence of pulmonary tuberculosis disease. In the final analysis, 13 participants in the vaccine group developed active pulmonary tuberculosis compared to 26 participants in the placebo group. Among participants who received the vaccine, an increased M72-specific immune response was sustained through three years.   Dr. Mark Feinberg, President and CEO of IAVI, said: “These final results show that M72/AS01E could be an important tool in the fight against pulmonary tuberculosis. While additional trials need to be conducted to confirm these findings in other populations, we have never before seen a vaccine that provides protection in adults who are already infected with the bacteria that cause tuberculosis.”   ]]> https://biospectrumindia.com/news/57/15027/chil-raises-us2-3-million-in-pre-series-a-funding-set-for-further-expansion-in-india.html https://biospectrumindia.com/news/57/15027/chil-raises-us2-3-million-in-pre-series-a-funding-set-for-further-expansion-in-india.html Fri, 01 Nov 2019 15:20:00 +0530 Child Health Imprints (CHIL), the Singapore-based company focusing on neonatal-clinical care improvement has announced that it has raised US$2.4 million in Pre-Series A funding. The round was led by HealthXCapital, with participation from Enterprise SG and other HNIs.  According to the 2018 World Health Organisation’s report, nearly 15 million infants are born preterm annually, of which close to 1 million die due to preterm birth-related complications. More than 60% of preterm births take place in Asia and Africa. Prematurity, infections, delay in treatment, skilled manpower shortage and human-based errors are the major causes of neonatal deaths. Better data integration amongst multiple devices (patient monitor, ventilator, blood gas machines, infusion pumps) and ElectroMagnetic Resonance adoption in NICU, along with unified neonatal workflow practices need to be urgently adopted to tackle the rising neonatal births across the world. CHIL develops and applies informational and computational technologies including IoT, AI, and predictive analysis; to improve early diagnosis of critical diseases, and overall quality of neonatal intensive care units across the world. The solution aggregates and integrates neonate’s vital data, bedside clinical observations and laboratory results, leverages deep learning methodologies to analyse the data in medically comprehensive formats and is available to clinicians for improvised decision making. CHIL founders Harpreet Singh and Ravneet Kaur, faced similar challenges when their twins were born preterm and one of them passed away within a week of birth due to NEC (necrotizing enterocolitis). Their personal struggle, helped them understand the urgency of transforming NICUs, and led them to build the solution comprising bedside IoT based device - NEO, that inter-operates with various medical devices used in NICU. NEO aggregates data in a vendor-agnostic manner offering temporal (longitudinal) data of the infant’s stay in the NICU that reduces manual charting effort of nurses. The solution also provides bedside tablet-based interface to ensure prospective data entry supported by AI-based iNICU analytics engine that infers millions of data-points persisted in time-series representation. By leveraging clinical rules and deep learning-based disease-specific (respiratory distress, sepsis, bronchopulmonary dysplasia) analytical models, iNICU assists the neonatologists in focussing on neonatal care and identifying early onset of diseases. Harpreet Singh said, “Our aim is to improve neonatal safety across countries with high neonatal mortality rate. The company will also develop inroads into more advanced neonatal ecosystems to bring their best clinical practices to other markets across the world.” Ravneet Kaur stated, “Regulatory compliance and peer-reviewed publications to document the efficacy of iNICU platform in reducing medical errors in the NICU will be the next strategic step of our expansion. This is why we couldn’t be more thrilled to have some of the best strategic partners in HealthXCapital and Enterprise Singapore, who are equally passionate to build the next phase of CHIL.”  Presently, CHIL is running in 25 NICUs across top tier hospitals in India including Apollo Hospitals (Apollo Cradle in 4 key cities) and Sir Gangaram Hospital (New Delhi) amongst others.  The startup is set for further expansion in India, Indonesia, Japan, South Korea, Gulf Cooperation Council and the ASEAN region shortly.  Seemant Jauhari, Managing Partner of HealthXCapital said, “HealthXCapital is proud to be a part of an exciting journey which shall enable a new model for Neonatal care to be offered remotely by the best available neonatologists present in cities to multiple paediatric clinics located in distant areas. The clinical decision support and predictive analytics based on real time data showcases the power of digital health disrupting traditional models of care delivery.” Ted Tan, Deputy CEO, Enterprise Singapore, praised Child Health Imprint's progress to date, saying, “CHIL is rapidly becoming one of the most crucial and significant technology platforms in Asia.”  The team is backed by some of the world’s top neonatologists, such as Dr. Yao Sun ( UCSF Benioff Children's Hospital) , Dr. Jonathan Palma (Lucile Packard Children's Hospital, Stanford), Dr. Satish Saluja (Gangaram Hospital) and Dr. Su Jin Cho (EWHA Womans University School of Medicine , Seoul).      ]]> https://biospectrumindia.com/news/57/15026/tetrascience-secures-investment-from-series-a-round.html https://biospectrumindia.com/news/57/15026/tetrascience-secures-investment-from-series-a-round.html Fri, 01 Nov 2019 12:20:00 +0530 TetraScience, developers of the industry's first cloud-based data integration platform for life sciences R&D, has secured a strategic investment from Waters Corporation, the world's leading specialty measurement company. Waters Corporation joins a roster of leading venture investors in TetraScience's $8M series A round of financing including Floodgate Capital, First Round Capital, Underscore VC, Founder Collective, and Y Combinator. "We are honored by this vote of confidence from a renowned industry leader," said Siping (Spin) Wang, Co-Founder and CEO of TetraScience. "Waters Corporation brings to the table over 60 years of experience in high value analytical technologies, scientific expertise, and a global footprint. We look forward to working together to transform the future of R&D." Wang (EECS M.S., MIT) co-founded TetraScience with Salvatore Salvo (Metamaterials Ph.D., University of Naples) to solve the challenges in deriving value from scientific data that they experienced first-hand as researchers. With life sciences R&D becoming increasingly data-driven, and operationally complex due to evolving models for distributed scientific research, Wang and Salvo recognized the need for new data integration infrastructure to power transformational changes in drug discovery. Tetrascience's cloud-based platform enables easier collection, normalization and centralization of R&D data, expediting development timelines and allowing scientists to make better informed and earlier decisions. Demand for the solution has been staggering, with 70+ leading pharmaceutical and biotech companies using TetraScience's platform. "We believe that dynamic, young companies like TetraScience have an enabling role to play in advancing the way the scientific community collects, shares and analyzes R&D data," said Alan Millar, Sr. Director of Corporate Development for Waters Corporation.  "Waters is excited to support TetraScience via this investment." TetraScience will use this funding to expand its commercial team, supporting a growing list of global customers and partners. ]]> https://biospectrumindia.com/news/57/15025/medcerts-launches-partnerships-with-national-retail-pharmacies.html https://biospectrumindia.com/news/57/15025/medcerts-launches-partnerships-with-national-retail-pharmacies.html Fri, 01 Nov 2019 11:50:00 +0530 MedCerts, a provider of online career certification training, has added to its national pharmacy partnerships with the additions of Kroger, Walmart and Albertsons Companies. Students enrolled in MedCerts Pharmacy Technician program can now complete their local externship at one of these national retail pharmacy chains along with our existing externship partners, CVS and Walgreens. The retail partners will provide the hands-on experience required for students to finish the program and sit for their certification exam. With the current demand for certified pharmacy technicians, this program is a great way for retail pharmacies to connect with trained, local pharmacy technician students. The MedCerts ASHP Pharmacy Technician Program features 28 weeks of educational learning, followed by a required 8 weeks of hands-on externship training. The partnerships with national pharmacy chains allow more MedCerts students to have an externship location close to them. "We are excited to be the first online education provider to secure a relationship with now five of the major pharmacy retailers," said Jason Aubrey, CEO of MedCerts. "As part of our ongoing commitment to our students, we will continue to connect our students with national employer partners in high-growth, high-demand industries." The MedCerts Pharmacy Technician program is committed to helping students grow academically and take the smart steps into their new careers. It starts with a unique learning experience that combines video lecture and demonstration. Guided by our subject matter experts, students are able to gain hands-on experience offline through proctored skill-building exercises and lab simulations they perform at home.  The opportunity for students to apply their knowledge in the pharmacy environment through externships at retail pharmacies gives students a more solid foundation and prepares them to pass the certification exam. The new MedCerts partnerships with Kroger, Walmart, and Albertsons Companies will create additional opportunities to gain on-the-job experience and open doors for future career opportunities in this high-demand industry. ]]> https://biospectrumindia.com/news/57/15023/pegasystems-enhances-healthcare-management-for-patients.html https://biospectrumindia.com/news/57/15023/pegasystems-enhances-healthcare-management-for-patients.html Thu, 31 Oct 2019 23:00:00 +0530 Pegasystems Inc., the software company empowering digital transformation at the world’s leading enterprises, has announced enhancements to Pega Care Management that improve transparency and care effectiveness between payers and providers for optimal patient care. These updates help ensure patients receive the most personalized engagement and care during every interaction within their healthcare network.  The U.S. healthcare industry is entering a new era of healthcare consumerism, with patients more involved than ever before in their healthcare decisions. The industry is now shifting to a more human-centric model of care built on powerful and accessible technology, proactive engagement, open markets, and transparency. However, many healthcare organizations are struggling to keep pace, causing patients to switch providers in search of more responsive care. Pega Care Management, part of the Pega InfinityTM suite of digital transformation solutions, now offers the following features to optimize patient engagement across the care continuum: Improved delivery of personalized, proactive care: While historically, payers and providers did not have full access to each other’s data, Pega Care Management now enables organizations to view the application through a payer or provider mode to access data such as demographics, claims, and authorization data, as well as clinical profiles with vitals, labs, medications, and history. This allows departments within an organization to access different views to fully understand patient context and provide the best care and service possible. Data and workflows automatically adjust based on the user with compliant, role-specific guidance, goals, task alerts, potential issues, and interventions. Additionally, users can access fully integrated marketing outreach and engagement strategies within the application, which provide next-best-action recommendations for patients.   Easier creation and delivery of tailored care plans: Pega Care Management now offers easier reusability of clinical content, common workflows, policies, and procedures to expedite the creation of compliant, personalized care plans. Content is intelligently applied across business units, channels, and geographies, improving coordination and work routing across teams for interventions, escalations, tasks, alerts, and goal management. Pega has also extended its content library to include even more information for patients, such as clinically appropriate educational materials, organizational policies, and community program information.   Maximized business agility: Pega Care Management provides a number of new capabilities to help make organizations more nimble, such as: Automated authorizations and pre-authorizations, correspondence, alert generation, notifications, and interventions that streamline care tasks and interactions; Low-code visual tools that enable seamless collaboration between business and IT, enabling business users to rapidly develop and customize standardized care plans and workflows with minimal IT assistance; Robotic automation capabilities that assist clinical staff with non-clinical tasks such as gathering data from external party websites used for clinical decision making, while automatically pulling regulatory information for optimal care.   Pega Care Management is a unified platform that enables care teams to deliver innovative, patient-centric programs across case, disease, utilization, and wellness management. The solution optimizes care planning, engagement, communications, operations, and reporting to deliver the highest quality, most cost-effective management possible. Pega works with many of the largest global healthcare and life sciences companies to help them achieve their digital transformation and one-to-one engagement goals.   ]]> https://biospectrumindia.com/news/57/15007/who-signs-mou-with-igba-to-promote-access-of-medicines-.html https://biospectrumindia.com/news/57/15007/who-signs-mou-with-igba-to-promote-access-of-medicines-.html Thu, 31 Oct 2019 10:00:00 +0530 Full access to medicines is hampered by a variety of factors. Two important barriers are high prices and regulatory issues such as long lag times in bringing medicines to market. To address these issues, Dr Tedros Adhanom Ghebreyesus, WHO Director-General, and Jim Keon, Chair of the International Generic and Biosimilar Medicines Association (IGBA) has signed a memorandum of understanding (MoU). The new agreement is an important step in WHO’s drive towards universal health coverage by underscoring the importance of generic and biosimilar medicines to increasing access to affordable, quality treatment. WHO is an active supporter of expanding use of generic medicines: The vast majority of the products in the WHO Essential Medicines List are generic. WHO’s prequalification programme – which assesses the quality of priority medicines supplied by UN agencies and other organizations in low-income countries – has prioritized generic medicines as a way to treat more people with the funds available; around 70% of the medicines it prequalifies are generic. A recent independent study by McKinsey estimated WHO prequalification saves the world up to US$ 590 million every year. Every $ 1 invested in WHO Prequalification has a return in terms of savings of between $ 30-40. WHO has also supported use of and access to generics through normative guidelines. Implementation of WHO guidance on interchangeability of generic medicines is further supported by the WHO List of International Comparators, which provides information on reference products for clinical trials into bioequivalence – i.e. whether two different products achieve the same results. Another tool is the WHO Biowaiver List which describes generic medicines that are eligible for a waiver from such studies. Regional and national regulatory normative guidance aligned with WHO guidance has now paved the way for the approval of many biosimilars with regulators. Last year, the Organization launched a pilot prequalification project for biosimilars for two anti-cancer drugs: rituximab and trastuzumab. In parallel, WHO is working to increase reliance between regulatory authorities to facilitate registration of generics and biosimilars, thereby getting the products to patients quicker. The new agreement between WHO and IGBA highlights the role of the pharmaceutical Industry in helping WHO maintain tools that can facilitate registration of generic and biosimilar medicines. It will facilitate cooperation between the two organizations to reduce the burden of clinical trials for biosimilars, speeding up registration and increasing access. It is an important first step towards increased collaboration with the generic and biosimilar industry for long-lasting impact on access to health products and progress towards universal health coverage.   ]]> https://biospectrumindia.com/news/57/15006/who-expert-panel-on-digital-health-meets-for-first-time.html https://biospectrumindia.com/news/57/15006/who-expert-panel-on-digital-health-meets-for-first-time.html Wed, 30 Oct 2019 15:15:00 +0530 WHO is convening global experts to help shape the Organization’s roadmap to advance the digital health ecosystem. The WHO Digital Health Technical Advisory Group met for the first time this week to discuss topics ranging from data governance, to ethical and equitable use of digital technologies, to helping communities benefit from proven and cost-effective digital health solutions. Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, “All governments are facing increasing demands to provide health services to their citizens, and many digital technologies offer solutions to help meet these needs. But countries require confidence in what works. The action plan agreed today focuses our efforts on helping the world benefit from digital health technologies and solutions while safeguarding the misuse of people’s data and protecting their health.” The two-day meeting at WHO’s headquarters in Geneva led to an agreed action plan to focus the expert group’s activities and priorities over the next two years. Meeting focused on better defining WHOs role in supporting global digital transformation. Topics included: Developing a global framework for WHO to validate, implement and scale up digital health technology and solutions. Recommendations for safe and ethical use of digital technologies to strengthen national health systems by improving quality and coverage of care, increasing access to health information. Advice on advocacy and partnership models to accelerate use of digital health capabilities in countries to achieve better health outcomes. Advice on emerging digital health technologies with global reach and impact, so no one is left behind. Steve Davis, Advisory group co-chair & president and chief executive officer of global health non-profit PATH, said the new plan provides direction to help WHO maximize the potential of the digital health landscape and chart future trends, tools and opportunities. “The WHO continues to demonstrate its strong commitment to harnessing the power of digital technologies and data to address the world’s most pressing health challenges through the launch of this new Digital Health Technical Advisory Group. I am honored to be co-chairing this group that brings together diverse experts from government, civil society, technology innovators, and NGOs. We are committed to working with the WHO to identify sustainable and scalable digital and data tools and approaches that meet global health needs”, he added. Bernardo Mariano, director of WHO’s Department of Digital health and Innovation, said: “Digital technologies can play a powerful role in improving the health of people worldwide. WHO’s goal is to ensure digital technologies for health are safe and that proven tools reach everyone, everywhere. Digital health can help expand primary health care, allow health workers to fight resurgent or new diseases and ensure people can benefit from the transformation in digital health. What we call ‘digital health’ today will be, in future, known simply as the way we deliver health services in the digital age.” Technical advisory group members will meet regularly over the coming year to implement their work plan in support of WHO’s digital health agenda. Representing the public, private and social sectors, the experts will provide insights, guidance, feedback, and new opportunities for WHO as it helps drive digital health transformation in countries and globally. Members come from a wide array of digital health fields, including artificial intelligence, virtual and augmented reality, biomedical innovation, robotic surgery, and wearable technologies; also represented are experts in health and wellness, ethics, governance, security, economics and law.      ]]> https://biospectrumindia.com/news/57/14986/fda-approves-breakthrough-therapy-for-cystic-fibrosis.html https://biospectrumindia.com/news/57/14986/fda-approves-breakthrough-therapy-for-cystic-fibrosis.html Thu, 24 Oct 2019 14:25:00 +0530 The U.S. Food and Drug Administration has approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population. "At the FDA, we're consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today's landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy," said acting FDA Commissioner Ned Sharpless, M.D. "In the past few years, we have seen remarkable breakthroughs in therapies to treat cystic fibrosis and improve patients' quality of life, yet many subgroups of cystic fibrosis patients did not have approved treatment options. That's why we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance today's approval in the most efficient manner possible, while also adhering to our high standards. The FDA remains committed to advancing novel treatment options for areas of unmet patient need, particularly for diseases affecting children." Cystic fibrosis, a rare, progressive, life-threatening disease, results in the formation of thick mucus that builds up in the lungs, digestive tract, and other parts of the body. It leads to severe respiratory and digestive problems as well as other complications such as infections and diabetes. Cystic fibrosis is caused by a defective protein that results from mutations in the CFTR gene. While there are approximately 2,000 known mutations of the CFTR gene, the most common mutation is the F508del mutation. Trikafta is a combination of three drugs that target the defective CFTR protein. It helps the protein made by the CFTR gene mutation function more effectively. Currently available therapies that target the defective protein are treatment options for some patients with cystic fibrosis, but many patients have mutations that are ineligible for treatment. Trikafta is the first approved treatment that is effective for cystic fibrosis patients 12 years and older with at least one F508del mutation, which affects 90% of the population with cystic fibrosis or roughly 27,000 people in the United States. The FDA granted this application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Trikafta also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. Drugs approved under expedited programs are held to the same approval standards as other FDA approvals. Because of Trikafta's benefit to the cystic fibrosis community, the FDA reviewed and approved Trikafta in approximately three months, ahead of the March 19, 2020 review goal date. The approval of Trikafta was granted to Vertex Pharmaceuticals Incorporated, which will receive a Rare Pediatric Disease Priority Review Voucher for developing this therapy. ]]> https://biospectrumindia.com/news/57/14982/bioinvent-signs-manufacturing-agreement-with-cancer-research-uk.html https://biospectrumindia.com/news/57/14982/bioinvent-signs-manufacturing-agreement-with-cancer-research-uk.html Wed, 23 Oct 2019 17:35:00 +0530 BioInvent International AB has concluded a production agreement with Cancer Research UK, the world's largest independent funder of cancer research, for the production of Hummingbird Bioscience's anti-HER3 antibody drug HMBD-001 for use within a clinical partnership formed between Cancer Research UK and Hummingbird Bioscience to test the agent in a phase I trial. Under the agreement, which is expected to generate revenue of approximately SEK 30 million (~$3 million), mostly in 2020, BioInvent will provide HMBD-001 to Cancer Research UK. It includes process, analytical and formulation development, process scale up and manufacturing of toxicology and clinical grade material in 200- and 1,000-liters scale. "We are very pleased to have concluded an agreement to provide this service to Cancer Research UK and are looking forward to producing Hummingbird's drug candidate for clinical trials. The fact that BioInvent has its own production facility gives us added flexibility, meaning we can develop our proprietary immuno-oncology programs more efficiently, and also generate revenue from our services to help fund our pipeline," says Martin Welschof, CEO of BioInvent. Dr Nigel Blackburn, Cancer Research UK's director of drug development, says: "We are delighted to be partnering with BioInvent who will produce Hummingbird Bioscience's anti-HER3 antibody, ready to be tested in clinical trials. Our clinical development partnerships fast track promising new treatments like this through one of the most difficult stages of drug development, benefitting people with cancer much sooner." Cancer Research UK's Centre for Drug Development entered into a partnership with Hummingbird Bioscience to manufacture clinical grade anti-HER3 antibody and conduct a Phase I clinical trial to evaluate drug safety, toxicity and efficacy. HMBD-001 is the only anti-HER3 antibody in development that binds to the most critical region involved in HER3 activation, turning off this signal completely. If successful, this new antibody could be used in the treatment of multiple cancers and be effective against drug resistant cancers.   ]]> https://biospectrumindia.com/news/57/14981/viz-ai-raises-50-mn-to-bring-ai-powered-synchronized-stroke-care-.html https://biospectrumindia.com/news/57/14981/viz-ai-raises-50-mn-to-bring-ai-powered-synchronized-stroke-care-.html Wed, 23 Oct 2019 17:20:00 +0530 Viz.ai, the developer of the first synchronized healthcare software (Viz) using artificial intelligence (AI), has announced a $50 million Series B funding. The funding round was led by Greenoaks with participation from Threshold Ventures, CRV along with existing investors GV and Kleiner Perkins. Viz.ai has emerged as one of the most exciting and fastest growing healthcare companies in the artificial intelligence (AI) space. It was recently named by Forbes as one of “America’s Most Promising Artificial Intelligence Companies.” Through the De Novo FDA pathway, Viz.ai introduced the concept of computer-aided triage software; Viz uses deep learning algorithms to identify a suspected large vessel occlusion, a particularly disabling type of stroke, in a CT scan and alerts the stroke team specialist. This happens in minutes. By alerting the right doctor at the right time and synchronizing care, Viz has the potential to significantly reduce the time to treatment and greatly increase a patient’s chances of a good outcome. “Viz.ai’s mission is to improve access to lifesaving treatments. In stroke, by saving time for the hospital system, we can achieve significant cost savings for the payer and most importantly, improved outcomes for the patient. This round of funding will enable us to expand the benefits of Synchronized Care to more disease states and geographies, democratizing the quality of health care globally,” said Chris Mansi, CEO of Viz.ai. Viz.ai’s acute ischemic stroke software is now available in over 300 hospitals across the U.S. “Viz.ai shortens time to treatment, increases the number of patients able to receive lifesaving therapy, and allows us to provide the best care for our patients. With stroke being the number one cause of long-term disability, every minute counts! Viz.ai is reducing the impact of this devastating disease and saving lives,” said J Mocco1, MD, Professor and Vice Chair of the Department of Neurosurgery, Mount Sinai Health System. Viz.ai is positioned to make a big impact on healthcare as a whole by curating the exponentially expanding healthcare data and making it immediately actionable for medical providers. “We see Viz.ai as the future of how healthcare is delivered. With rising costs and more focus on value-based care, there needs to be an emphasis on delivering the highest quality care in the shortest amount of time while reducing costs,” said Neil Shah of Greenoaks. ]]> https://biospectrumindia.com/news/57/14966/gsk-divests-two-vaccines-to-bavarian-nordic.html https://biospectrumindia.com/news/57/14966/gsk-divests-two-vaccines-to-bavarian-nordic.html Wed, 23 Oct 2019 10:00:00 +0530 GlaxoSmithKline has announced the divestment of travel vaccines Rabipur (tradename Rabavert in the US) for the prevention of rabies, and Encepur for the prevention of tick-borne encephalitis, to Bavarian Nordic. The decision to divest these brands, acquired from Novartis in 2015 as part of the acquisition of its vaccines business, supports GSK’s strategic intent to increase focus and reinvest in growth assets, innovation and a simplified supply chain in its vaccines business.  Roger Connor, President, Global Vaccines at GSK, said: “This agreement with Bavarian Nordic will enable us to commit greater resources to our key growth assets and to our R&D pipeline, while also ensuring the continued supply of these important and successful vaccines.”  GSK will receive an upfront payment of approximately EUR301 million (£259m) and will also receive milestone payments of EUR495 million and additional proceeds from the sale of inventory over the course of the supply arrangements for a total consideration of up to EUR 955m. The value of inventory at the anticipated closing date is estimated to be EUR 159 million.  EUR 25m (£22m) of the total consideration is conditional upon future sales performance of the two vaccines. To ensure supply continuity both vaccines will continue to be manufactured primarily at GSK’s Marburg site in Germany until full production is transferred to Bavarian Nordic. The staged technology transfer is expected to commence in Q1 2020 with completion anticipated within 5 years.  The transaction is expected to close by the end of 2019 and is conditional upon anti-trust approval as well as approval of Bavarian Nordic’s rights issue by its shareholders. Rabipur is a well-established life-saving vaccine with 30 years of market experience supported by extensive clinical and safety evidence and WHO pre-qualification. It is indicated both in persons bitten by suspect animals and non-immune subjects at risk of rabies. Encepur is indicated for active immunization of high-risk populations against tick-borne encephalitis (TBE). It has unique dosing flexibility supported by proven efficacy and long-term persistence data.   ]]> https://biospectrumindia.com/news/57/14965/smithnephew-announces-change-of-ceo.html https://biospectrumindia.com/news/57/14965/smithnephew-announces-change-of-ceo.html Tue, 22 Oct 2019 12:20:00 +0530 Smith+Nephew has announced that Namal Nawana will step down from the Board and his position as Chief Executive Officer (CEO) by mutual agreement on 31 October 2019 to pursue other opportunities outside of the UK. The Board has announced that Roland Diggelmann has been appointed as the Company’s new CEO and will take on his new responsibilities on 1 November 2019. Namal will be employed and provide advice and assistance to Roland in his new role until 31 December 2019 to help ensure a smooth transition. Roland joined Smith+Nephew’s Board as a Non-Executive Director in March 2018, since when he has gained deep insight into the Company and its management team. His career has been spent in medical technology, most recently as CEO of Roche Diagnostics. Prior to his 11-year career at Roche Diagnostics, Roland spent 12 years in the orthopaedics sector, serving in strategy and leadership roles at Sulzer Orthopedics and Zimmer, now Zimmer Biomet. Roberto Quarta, Chairman of Smith+Nephew said, “On behalf of the Board, I am delighted to welcome Roland Diggelmann as Smith+Nephew’s incoming CEO. I am certain that Roland’s leadership qualities, combined with his excellent track record of delivering results in an innovation-led business, his deep expertise in the medical devices industry, and his knowledge of Smith+Nephew, make him the right person to build on the Company’s success into the future.” "During his time with Smith+Nephew, Namal has substantially transformed the business with a new strategy, purpose and culture, and renewed commitment to innovation, returning it to an improved growth trajectory. I would like to thank Namal for his leadership and many contributions to the Company, our employees, customers and stakeholders.” Roland Diggelmann said, “I am honoured to have been asked to lead Smith+Nephew at an exciting time for the business. As Non-Executive Director I have seen first-hand the strength of the Group’s people and its portfolio of leading technologies. I look forward to playing my part in shaping the future of the company and driving the next stage of growth.” Namal Nawana said, “There is clear momentum behind our strategy laid out last year, underlined by the Company’s performance generated by our team during 2019. I am proud to be leaving Smith+Nephew in a strong position for the next phase of its development.”  With immediate effect, Roland will cease to be a Non-Executive Director and steps down from the Audit Committee and Culture and Compliance Committee of the Board.   ]]> https://biospectrumindia.com/news/57/14952/universal-health-coverage-passes-key-global-milestone.html https://biospectrumindia.com/news/57/14952/universal-health-coverage-passes-key-global-milestone.html Mon, 21 Oct 2019 12:25:00 +0530 The World Health Organization has recently welcomed a new Inter-Parliamentary Union (IPU) Resolution on achieving Universal Health Coverage (UHC) by 2030. The resolution, adopted at the IPU Assembly in Belgrade, Serbia, comes one month after heads of state agreed a high-level United Nations Political Declaration on UHC in New York. UHC is increasingly regarded as a cornerstone for sustainable global development as leaders and communities acknowledge that health is both a human right and essential to economic growth. “Universal health coverage is a political choice. Last month, the world’s leaders signalled their readiness to make that choice.  Now it’s time to turn those commitments into health results,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. He added: “Parliamentarians have a vital role to play in making this happen. Because it’s parliamentarians who pass laws and allocate funding. It’s parliaments who, keep government accountable for the commitments it’s made and who forge  the partnerships that help countries make universal health coverage a reality.” Today’s Resolution calls on parliaments and parliamentarians to “take all possible measures to achieve UHC”, stressing the need for robust legal frameworks and the need to allocate adequate resources. Like the UN declaration, it highlights the importance of assuring strong primary health care – the provision of essential health services at the community level –  and strengthening health systems. It also emphasizes the role strong health systems and services play in assuring global health security. Only when  the most vulnerable groups can obtain health care, can a country protect its people and ensure that outbreaks do not turn into epidemics.The resolution includes a strong focus on women, children and adolescent health including sexual and reproductive health as a key component of UHC. The Resolution ends with a request to WHO to work with the IPU and other partners to support the implementation of the resolution at the global, regional and country levels and to monitor progress. “The resolution highlights the power of the collaboration between IPU and WHO, and builds on the Memorandum of Understanding we both signed in October 2018,” added Dr Tedros. ]]> https://biospectrumindia.com/news/57/14944/concept-medical-gets-ce-certification-for-their-magictouch-products.html https://biospectrumindia.com/news/57/14944/concept-medical-gets-ce-certification-for-their-magictouch-products.html Fri, 18 Oct 2019 12:35:00 +0530 Concept Medical B.V. has announced that, they have received the CE certification for their MagicTouch group of products. The CE certified products/brands are as listed below: MagicTouch – PTA (Sirolimus Coated PTA Balloon Catheter) for peripheral arterial disease MagicTouch – ED (Sirolimus Coated Balloon Catheter) for Erectile Dysfunction MagicTouch – AVF (Sirolimus Coated PTA Balloon Catheter) for Arterio-Venous Fistula and Graft MagicTouch – PTA is the only commercially available and CE certified Sirolimus coated balloon catheter for peripheral arterial diseases. Percutaneous transluminal angioplasty (PTA) is a procedure that can open a blocked blood vessel using a small catheter, with a "balloon" at one end. Currently accepted procedure is, to use drug delivery devices to deliver drugs that inhibit the inflammatory and proliferative pathways that lead to restenosis. Sirolimus is widely accepted as a drug of choice for such purpose. Several studies have demonstrated that Erectile Dysfunction (ED) is increasingly prevalent with age. Approximately 40% of men are affected by the age of 40 years and nearly 70% of men are affected by the age of 70 years. MagicTouch ED is the only CE certified commercially available Sirolimus coated balloon catheter in the world for the therapeutic management of Erectile Dysfunction. An arteriovenous fistula (AVF) is a connection created surgically (also called as a native fistula) between an artery and a vein so as to expand the bore of the vein. An AV fistula causes extra pressure and extra blood to flow into the vein, making it grow large and strong (maturing of the AVF). The larger vein provides easy, reliable access to blood vessels. Without this kind of access, regular hemodialysis sessions would not be possible. Untreated veins cannot withstand repeated needle insertions, because they would collapse the way a straw collapses under strong suction. Arteriovenous graft (AVG), is another method for connecting an artery and a vein and is made by surgically suturing an external tube, made of a biomaterial, between the two vessels. Common complications of AVF and AVG are an infection, stenosis of the fistula, thrombosis, aneurysm, and limb ischemia. PTA tackles the complications of AVF and AVG. Concept Medical will now intensify its efforts to market and promote their products in all of Europe and other relevant markets that accept the CE certification for marketing authorization.   ]]> https://biospectrumindia.com/news/57/14932/ge-healthcare-to-develop-one-stop-breast-cancer-diagnostic-center.html https://biospectrumindia.com/news/57/14932/ge-healthcare-to-develop-one-stop-breast-cancer-diagnostic-center.html Thu, 17 Oct 2019 15:00:00 +0530 GE Healthcare and Premier Inc. have announced a collaboration to develop a model to bring a same-day breast cancer diagnosis and treatment model to the United States. A similar model has already proven effective at the Gustave Roussy Cancer Campus in France. Launched in 2004, the One-Stop Clinic at the Gustave Roussy Institute in France offers a coordinated patient journey from the initial appointment through diagnosis and treatment plan in one place, on one day and with one team. With a multimodality approach that includes the GE Healthcare Senographe Pristina™ mammography system, SenoBright™ Contrast Enhanced Spectral Mammography (CESM) and biopsy, the program has proven to be successful, with an 80 percent patient satisfaction rating. To support the effort, Premier conducted a Rapid Evidence Review, one of the first comprehensive evaluations of expedited diagnosis for patients with breast cancer. Based on the results of the first phase of the collaboration, GE Healthcare and Premier will next evaluate the potential and merits associated with adopting the One-Stop Clinic model in the United States. The companies have convened an advisory board to provide insight on the One-Stop Clinic model, as well as guidance and counsel on best approaches to redesign it for the U.S. market. ]]> https://biospectrumindia.com/news/57/14929/minoryx-therapeutics-gets-odd-for-cns-disease-drug.html https://biospectrumindia.com/news/57/14929/minoryx-therapeutics-gets-odd-for-cns-disease-drug.html Thu, 17 Oct 2019 14:20:00 +0530 Minoryx Therapeutics, a company that specializes in the development of innovative treatments for orphan Central Nervous System (CNS) diseases, has announces that its lead drug candidate, leriglitazone (MIN-102), has been granted Orphan Drug Designation in Friedreich’s Ataxia by the US Food and Drug Administration (FDA).   Friedreich’s Ataxia is a severe, rare, genetic neurodegenerative disease characterized by loss of coordination and muscle strength. The disease results from frataxin deficiency leading to mitochondrial dysfunction. Patients today rely solely on symptomatic treatments to manage their disease. Friedreich’s Ataxia affects one in 40,000 people globally and has an onset in people aged between five and 18 years old.   Leriglitazone (MIN-102) is a novel, brain penetrant, orally bioavailable and selective PPAR gamma agonist that engages the target receptor within the central nervous system. The disease-modifying potential and unique mode-of-action of leriglitazone have been demonstrated in multiple preclinical CNS disease models showing that it has an anti-oxidant, anti-inflammatory and neuroprotective effect. Leriglitazone improves mitochondrial function and biogenesis, promotes remyelination, ameliorates lipid metabolism and delays progression of neurological disability. Leriglitazone is currently in late-stage clinical development in adrenomyeloneuropathy and Friedreich’s Ataxia.   “Orphan Drug Designation by the FDA for Friedreich’s Ataxia is yet another important milestone for the company. It is recognition of the disease-modifying potential of leriglitazone and of our commitment to changing the lives of patients suffering from severe orphan diseases with high unmet medical needs,” said Marc Martinell, CEO of Minoryx. “We recently completed enrollment in the Phase 2 study of leriglitazone in Friedreich’s Ataxia and the pivotal study in patients with adrenomyeloneuropathy is progressing as planned. We are looking forward to reporting the topline data for both studies in late 2020.” ]]> https://biospectrumindia.com/news/57/14928/novant-health-partners-tyto-care-for-unique-digital-health-offerings.html https://biospectrumindia.com/news/57/14928/novant-health-partners-tyto-care-for-unique-digital-health-offerings.html Thu, 17 Oct 2019 13:55:00 +0530 Novant Health, an integrated healthcare system has announced its strategic partnership with Tyto Care, the healthcare industry's first all-in-one modular device and telehealth platform for on-demand, remote medical exams. With this partnership, patients will have access to standard virtual visits, as well as the ability to utilize the TytoHome examination device, available for purchase later this fall, to augment virtual visits with comprehensive physical exams. Patients in North Carolina will be connected exclusively via the Tyto Care platform to a Novant Health provider anytime, anywhere.   "Novant Health is committed to creating a digital health experience that connects a person's entire health journey and delivers a personalized experience through a comprehensive virtual venue of care," said Dr. Hank Capps, senior vice president and chief digital health and engagement officer for Novant Health. "By integrating Tyto Care's end-to-end telehealth offering into our digital health care delivery platform, we're expanding our remarkable patient experience with game-changing technology. This partnership will empower consumers to receive high-quality care, on their terms, while delivering a seamless experience that combines information and relationship continuity across their care journey." TytoHome is a handheld, modular examination device used by patients that allows clinicians to perform comprehensive physical exams virtually. Providers will leverage video, augmented reality, advanced sensors and machine learning to examine the heart, lungs, skin, ears, throat and abdomen. Tyto devices will also measure body temperature and heart rate and have the capability to connect via Bluetooth to other devices that measure blood pressure, oxygen saturation and weight. These virtual visits represent the next generation of primary and specialty care that delivers an unmatched level of quality, safety and convenience. "We are thrilled that Novant Health has chosen to partner with us to help expand their digital health offering," said Dedi Gilad, CEO and co-founder of Tyto Care. "Tyto Care is enabling Novant Health to provide the telehealth experience people desire in today's on-demand world, allowing for more comprehensive diagnoses and treatment whether they're at work, at home or on the go."    The strategic partnership comes on the heels of Novant Health's announcement of a new digital health and engagement business division. "Novant Health's partnership with Tyto Care further shows our commitment to digital health and expanding access to care," said Angela Yochem, executive vice president and chief digital and technology officer for Novant Health. "We are always looking for ways to make the health care experience simpler, more convenient and more affordable. This partnership embraces technology to help parents get care for their sick children no matter the time – or enable an older adult who has difficulty getting out of the house to be seen virtually for minor health issues. Novant Health is excited to expand how we use technology to help our patients." ]]> https://biospectrumindia.com/news/57/14927/roche-reports-strong-sales-growth-in-2019.html https://biospectrumindia.com/news/57/14927/roche-reports-strong-sales-growth-in-2019.html Thu, 17 Oct 2019 13:10:00 +0530 Commenting on the Group’s results, Roche CEO Severin Schwan said: “The uptake of our newly introduced medicines is very strong. We are successfully entering new disease areas and providing important new treatment options to serve more patients with severe conditions. Based on the strong demand for our new medicines and continued progress of our product pipeline we have raised the outlook for 2019 and I am confident that we will continue to grow beyond this year.” Sales are now expected to grow in the high-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to further increase its dividend in Swiss francs. In the first nine months of 2019, Group sales rose 10% to CHF 46.1 billion. Sales in the Pharmaceuticals Division increased 12% to CHF 36.6 billion. Key growth drivers were the multiple sclerosis medicine Ocrevus, the new haemophilia medicine Hemlibra and cancer medicines Tecentriq, Perjeta and Avastin. The strong uptake of newly introduced medicines more than offset lower sales of Herceptin and of MabThera/Rituxan. In the US, sales increased 14%, led by Ocrevus, Hemlibra, Tecentriq, Kadcyla, Perjeta and Avastin. Ocrevus sales were driven by both new and returning patient demand. In Europe (-1%), sales were affected by the competition from biosimilars for Herceptin (-44%) and MabThera/Rituxan (-33%). This decline was almost offset by the strong growth of Ocrevus, Perjeta, Tecentriq, Alecensa and Hemlibra. In Japan, sales increased 11%, driven by recently launched products, including Hemlibra, Perjeta and Tecentriq. The growth in Japan was partially offset by lower sales of MabThera/Rituxan (-46%) driven by biosimilar competition. In the International region sales grew 20%, mainly driven by significantly increased numbers of patients benefitting from Roche cancer drugs in China with strong sales of Herceptin, Avastin and MabThera/Rituxan as well as the uptake of Perjeta and Alecensa. Diagnostics Division sales increased 4% to CHF 9.5 billion. The business area Centralised and Point of Care Solutions (+5%) was the main contributor, with growth driven by the immunodiagnostics business. Growth was reported in Asia-Pacific (+9%), EMEA2 (+3%) and Latin America (+9%). In North America sales declined 1%. In February 2019, Roche announced that it had entered into a definitive merger agreement to fully acquire Spark Therapeutics, Inc. (‘Spark Therapeutics’). Regulatory review of the transaction is ongoing, and the parties are actively working with the US and UK authorities to facilitate that process. Closing of the transaction is expected until the end of this year. ]]> https://biospectrumindia.com/news/57/14925/alexion-to-acquire-achillion.html https://biospectrumindia.com/news/57/14925/alexion-to-acquire-achillion.html Thu, 17 Oct 2019 12:30:00 +0530 Alexion Pharmaceuticals, Inc.  and Achillion Pharmaceuticals, Inc. have entered into a definitive agreement for Alexion to acquire Achillion, a clinical-stage biopharmaceutical company focused on the development of oral small molecule Factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases, such as paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy (C3G). Achillion currently has two clinical-stage medicines in development, including danicopan (ACH-4471) in Phase 2 and ACH-5228 in Phase 1. “Alexion has demonstrated the transformative impact that inhibiting C5 can have on multiple rare and devastating diseases. However, we believe this is just the beginning of what’s possible with complement inhibition,” said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. “Targeting a different part of the complement system – the alternative pathway – by inhibiting Factor D production addresses uncontrolled complement activation further upstream in the complement cascade, and importantly, leaves the rest of the complement system intact, which is critical in maintaining the body’s ability to fight infection. We believe this approach has the opportunity to help patients with diseases not currently addressed through C5 inhibition. We look forward to applying our nearly three decades of complement and development expertise to unlock the potential of oral Factor D inhibitors and bring these benefits to patients.” “We have established great momentum – discovering and advancing several small molecules into clinical development that have the potential to treat immune-related diseases associated with the alternative pathway of the complement system,” said Joe Truitt, President and Chief Executive Officer at Achillion. “Having already demonstrated proof-of-concept and proof-of-mechanism with our lead candidate, danicopan (ACH-4471), in PNH and C3G, respectively, we believe there is significant opportunity for Factor D inhibition in the treatment of other diseases as well. Alexion is an established leader in developing medicines for complement-mediated diseases, and we look forward to working together to accelerate our objective of bringing novel therapies to patients as quickly as possible and ensuring that the broad promise of this approach is fully realized. We thank our employees, investigators and partners for their incredible work and commitment.” Transaction Details The initial consideration of approximately $930 million, or $6.30 per share of Achillion common stock, will be funded with cash on hand. As part of the acquisition, Alexion will also be acquiring the cash currently on Achillion’s balance sheet. As of September 30, 2019, this was approximately $230 million; the actual amount will be determined as of the transaction close. The transaction includes the potential for additional consideration in the form of non-tradeable contingent value rights (CVRs), which will be paid to Achillion shareholders if certain clinical and regulatory milestones are achieved within specified periods. These include $1.00 per share for the U.S. FDA approval of danicopan and $1.00 per share for ACH-5228 Phase 3 initiation. Alexion’s acquisition of Achillion is subject to the approval of Achillion shareholders and satisfaction of customary closing conditions and approval from relevant regulatory agencies, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. Pending these approvals, the transaction is expected to close in the first half of 2020. ]]> https://biospectrumindia.com/news/57/14920/u-s-fda-approves-bayers-rivaroxaban-to-help-prevent-blood-clots.html https://biospectrumindia.com/news/57/14920/u-s-fda-approves-bayers-rivaroxaban-to-help-prevent-blood-clots.html Wed, 16 Oct 2019 14:20:00 +0530 Bayer AG and its development partner Janssen Research & Development have announced that the U.S. Food and Drug Administration (FDA) has approved rivaroxaban (Xarelto™) for the prevention of venous thromboembolism (VTE), or blood clots, in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding. The approval is based on data from the Phase III MAGELLAN trial, and supported by the data from the MARINER trial. These trials evaluated rivaroxaban for the prevention of VTE in acutely ill medical patients during hospitalization and immediately following discharge. “With this new approval, rivaroxaban as an oral-only option now has the potential to change how acutely ill medical patients in the US are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, M.D., Professor of Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, New York, NY. “The Phase 3 clinical studies in this high-risk patient group show us that rivaroxaban at the 10mg dose is an effective option with a well-established safety profile to help prevent blood clots, which can be fatal in this population.” “Acutely ill” is a broad term used to describe people who are hospitalized for serious, yet common, medical conditions such as heart failure, infectious diseases or ischemic stroke. More than seven million Americans are hospitalized with acute medical illnesses each year. These patients are at increased risk of VTE for some three months after hospital discharge, with 80 percent of events happening within the first six weeks. Although VTE is largely preventable, guidelines currently recommend acutely ill medical patients receive anticoagulants, typically injectable agents, in the hospital to protect them from VTE, but advise against routine anticoagulant use after leaving the hospital. However, research has shown that many acutely ill medical patients refuse treatment with injectable anticoagulants out of fear, discomfort, anxiety or inconvenience. ]]> https://biospectrumindia.com/news/57/14918/diamedica-gets-fda-nod-to-initiate-clinical-trial-of-dm199-for-ckd.html https://biospectrumindia.com/news/57/14918/diamedica-gets-fda-nod-to-initiate-clinical-trial-of-dm199-for-ckd.html Wed, 16 Oct 2019 12:20:00 +0530 DiaMedica Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Phase II clinical trial protocol for the treatment of Chronic Kidney Disease (CKD). The Phase II trial is designed to assess the safety and efficacy of DM199 in the treatment of CKD in two cohorts: patients with CKD caused by IgA nephropathy (IgAN) and hypertensive African American patients with CKD. DiaMedica intends to initiate participant enrollment in the next few weeks. “Based upon the Company’s previously announced Phase Ib results demonstrating early signals in both estimated glomerular filtration rate (eGFR) and albuminuria improvement, which were consistent with published clinical data using porcine-derived KLK1 in Asia for CKD, we are cautiously optimistic about the potential for DM199 to provide a safe and effective new treatment option for individuals suffering from CKD,” said Rick Pauls, DiaMedica’s President and CEO. “We are looking forward to working with patients and physicians to evaluate the potential of DM199.” DM199 is a recombinant (synthetic) form of the human serine protease kallikrein (KLK1). The KLK1 protein plays an important role in the regulation of a variety of physiological processes in the kidneys, including blood flow, inflammation, fibrosis and oxidative stress. The Company believes that DM199 may restore KLK1 levels, enabling the natural physiologic process of the body to selectively release bradykinin-mediated nitric oxide, prostaglandins (PGE2 and PGI2-cAMP) and other anti-inflammatory mediators in the kidneys, which in turn may work synergistically to improve renal blood flow (dilating both afferent & efferent arterioles) and reduce inflammation, oxidative stress and fibrosis. The Company also believes that DM199 may play a role in restoring the body’s ability to naturally regulate the function of the epithelial sodium channel (ENaC), which controls sodium levels in the body. This Phase II study is a multi-center, open-label investigation of approximately 60 participants with CKD, who will be enrolled in two cohorts, and will be conducted in the United States at up to 10 sites. The study will be focused on participants with CKD caused by IgAN and non-diabetic, hypertensive African American participants with CKD. African Americans are at greater risk for CKD than Caucasians, and African Americans who have the APOL1 gene mutation are at an even higher risk. The study is designed to capture APOL1 gene mutation as an exploratory biomarker. The study will evaluate two dose levels of DM199 within each cohort. Study participants will receive DM199 by subcutaneous injection twice weekly for 95 days. The primary study endpoints include safety, tolerability, blood pressure and kidney function, which will be evaluated by changes from base line in eGFR and albuminuria, as measured by the urinary albumin to creatinine ratio (UACR). ]]> https://biospectrumindia.com/news/57/14910/imaginab-inks-pact-with-three-global-pharma-companies.html https://biospectrumindia.com/news/57/14910/imaginab-inks-pact-with-three-global-pharma-companies.html Wed, 16 Oct 2019 07:25:00 +0530 ImaginAb, Inc., a leading clinical-stage immuno-oncology imaging company has announced the signing of a multi-party collaboration agreement with AstraZeneca, Pfizer Inc. and Takeda Pharmaceutical Company Limited (Takeda) focused on furthering the clinical development of ImaginAb’s CD8 ImmunoPET technology. Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient. Under the terms of the agreement, the collaborators will help guide a current ImaginAb-sponsored clinical trial that aims to evaluate the utility and value of CD8 ImmunoPET in immuno-oncology drug development. In return, the collaborators will gain early access to clinical and imaging data and collectively contribute to the post-trial data analysis. Commenting on the agreement, Ian Wilson, Chief Executive Officer of ImaginAb, said: “One of our key objectives is to streamline the clinical development of next-generation cancer immunotherapies so that ultimately cancer patients have access to the best possible treatments. We believe that working with global leaders in immuno-oncology will help us further develop CD8 ImmunoPET as a pharmacodynamic marker for use in drug development and, in the future, as a diagnostic and predictive test for use in hospitals.” Chris Arendt, Head of the Oncology Drug Discovery Unit at Takeda, said: “We are excited to participate in this pre-competitive alliance, which brings together a rich network of expertise and resources to develop and evaluate an imaging tracer for CD8+ T cells. The ability to track, both spatially and temporally, immune responses associated with novel immuno-oncology therapies and relate these to anti-tumor responses in patients has the potential to deepen our understanding of the cancer immunity cycle and how it can be leveraged for curative intent, which is the primary focus of our oncology research efforts at Takeda.” ]]> https://biospectrumindia.com/news/57/14911/pneumagen-reveals-preclinical-proof-of-concept-in-oncology-for-neumonco.html https://biospectrumindia.com/news/57/14911/pneumagen-reveals-preclinical-proof-of-concept-in-oncology-for-neumonco.html Tue, 15 Oct 2019 15:35:00 +0530 Pneumagen Ltd, focused on treating infectious disease and oncology by targeting the human glycome, has announced promising in vivo data in oncology from a novel Carbohydrate Binding Module (mCBM) generated from its proprietary GlycoTarge™ platform. The study results demonstrate that Pneumagen’s oncology targeted mCBMs, known as Neumonco™, significantly inhibits tumour growth in an orthotopic mouse xenograft model of human ovarian cancer. In this study Neumonco was administered intraperitoneally into mice for the first time and tumour growth was measured using bioluminescence imaging. Results demonstrated tolerability and efficacy, yielding a statistically significant inhibition in tumour mass compared to the control group. In vitro data has previously demonstrated that mCBMs target cancer cells directly, reducing cancer cell proliferation, migration, and altering metabolism. Pneumagen’s platform technology, GlycoTarge, has generated a portfolio of engineered oligomers of monomeric carbohydrate binding modules (CBMs), derived from carbohydrate-active enzymes. These CBMs are genetically linked in tandem, with a trimerisation domain, resulting in multivalent proteins (mCBMs) with greatly increased binding affinities for their respective glycan targets. Pneumagen is utilising this technology for a universal treatment of respiratory tract infections (RTIs) but has now shown this platform has direct utility in the emerging and exciting area of novel glycan-targeted cancer therapeutics. Douglas Thomson, CEO of Pneumagen, said: “We are very excited by these results from our first in vivo oncology study demonstrating the efficacy of our platform. We now intend to progress our lead Neumonco candidate to the next stage of development as well as extending further the GlycoTarge platform in cancer.” Pneumagens’ oncology research has been funded in part by a SMART: SCOTLAND grant from  Scottish Enterprise.  SMART:SCOTLAND awards aim to support ambitious R&D projects by SMEs based in Scotland. ]]> https://biospectrumindia.com/news/57/14905/sta-to-sell-sarcoma-drug-in-australia-new-zealand-and-se-asia.html https://biospectrumindia.com/news/57/14905/sta-to-sell-sarcoma-drug-in-australia-new-zealand-and-se-asia.html Tue, 15 Oct 2019 12:00:00 +0530 Under the terms of the agreement, STA will provide the marine-derived compound YONDELIS (trabectedin) to patients throughout Australia, New Zealand and in South East Asia under exclusive license from Spanish company PharmaMar. YONDELIS – which has been shown to improve progression-free survival when used as second-line therapy for patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS)  – is already approved and has been available to patients in the United States since 2015, and in Europe since 2007. Until now, it has not been available in Australia and New Zealand, although it is currently provided to patients in Singapore, Malaysia and Brunei via a previous pharmaceutical arrangement. Former product licensee Janssen will continue to distribute YONDELIS in Singapore, Malaysia and Brunei until marketing authorisation is formally transferred to STA. Announcing the new deal, STA Chief Executive Officer Mr Carlo Montagner said some Australian patients and their doctors had previously sought to access YONDELIS from international sources, at great difficulty and expense. Specialised Therapeutics will now seek formal regulatory approval to market YONDELIS in Australia from the Therapeutic Goods Administration (TGA) and subsequent reimbursement via the Pharmaceutical Benefits Scheme (PBS). In the interim, a Special Access Program will be opened on November 1 to ensure YONDELIS is available at the earliest opportunity to eligible patients. PharmaMar President, José María Fernández Sousa-Faro, commented: "This new license arrangement is the third we have struck with STA, and is a strong endorsement of their capabilities in these key marketing regions of Australia, New Zealand and South-East Asia. ]]> https://biospectrumindia.com/news/57/14901/biolife-solutions-wins-three-new-patents-.html https://biospectrumindia.com/news/57/14901/biolife-solutions-wins-three-new-patents-.html Mon, 14 Oct 2019 17:50:00 +0530 BioLife Solutions, a leading developer and supplier of best-in-class bioproduction tools for cell and gene therapies has announced three new patents for inventions related to cryopreservation, thawing and cold chain transport technologies. The new patents awarded to BioLife include: European Patent: Apparatuses and Compositions for Cryopreservation of Cellular Monolayers  This patent includes claims related to facilitating bulk freezing of adherent cells in multi-well plates for use in high-throughput drug screening processes. United States Patent: Systems, Devices and Methods for Automated Sample Thawing This patent covers the core technologies used in the ThawSTAR® automated thawing products, which BioLife obtained in the acquisition of Astero Bio in April 2019. United States Patent: Insulated Storage and Transport System This patent covers core technologies used in the evo® cloud-connected precision thermal shipping containers, which BioLife obtained in the acquisition of SAVSU Technologies in August 2019. Mike Rice, BioLife Solutions CEO, remarked, "We have a remarkably strong team of inventors who are experts in the fields of cryopreservation, storage and transport, and thawing of biologic material; specifically, for cell and gene therapies targeting the leading causes of disabilities and death. Our scientific team has several additional pending patents covering novel features of our best-in-class portfolio of bioproduction tools. We look forward to providing a continuous stream of innovative solutions to the high growth cell and gene therapy market." ]]> https://biospectrumindia.com/news/57/14897/bluebird-bio-and-novo-nordisk-enter-into-research-agreement-.html https://biospectrumindia.com/news/57/14897/bluebird-bio-and-novo-nordisk-enter-into-research-agreement-.html Mon, 14 Oct 2019 12:40:00 +0530 bluebird bio and Novo Nordisk have announced that they have entered into a three-year research collaboration to jointly develop next-generation in vivo genome editing treatments for genetic diseases, including haemophilia. During the three-year research collaboration, bluebird and Novo Nordisk will focus on identifying a development gene therapy candidate with the ambition of offering people with haemophilia A, a lifetime free of factor replacement therapy. The research collaboration will utilise bluebird bio’s proprietary mRNA-based megaTAL™ technology that has the potential to provide a highly specific and efficient way to silence, edit or insert genetic components. Aligned with Novo Nordisk’s haemophilia portfolio, the research collaboration will initially focus on correcting FVIII-clotting factor deficiency, with the potential to explore additional therapeutic targets. Marcus Schindler, senior vice president for Global Drug Discovery in Novo Nordisk said, “We are pleased to announce our collaboration with bluebird whose demonstrated capabilities in gene therapy will enable the next-generation of innovative products to make a significant impact on patients’ lives. This important research collaboration aimed at addressing genetic diseases at the DNA level reflects Novo Nordisk’s enduring commitment and dedication to inventing disease-modifying medicines that can truly change the lives of people living with haemophilia and other genetic diseases.” Philip Gregory, D. Phil, chief scientific officer, bluebird bio said, “bluebird has made tremendous progress on enabling an in vivo gene editing platform based on our megaTAL technology, including important advances in high-quality mRNA production and purification. We believe this technology has the potential to create a highly differentiated approach to the treatment of many severe genetic diseases. Moreover, we are thrilled to be able to combine this new platform technology with Novo Nordisk’s deep expertise in haemophilia research and therapeutics. We believe this collaboration will move us toward our shared goal of recoding the treatment paradigm and substantially reduce the burden of disease for patients with factor VIII deficiency.” MegaTALs are a single-chain fusion enzyme that combines the natural DNA cleaving processes of Homing Endonucleases (HEs) with the DNA binding region of transcription activator-like (TAL) effectors. TALs are easily engineered proteins that recognize specific DNA sequences. This protein fusion architecture allows the generation of extremely active and highly specific and compact nucleases that are compatible with all current viral and non-viral cell delivery methods. For people with haemophilia, bleeds often occur in the joints, particularly knees and ankles. Bleeds can also occur in the muscles, soft tissues, gastrointestinal tract or even the brain. Trauma, major surgery, tooth extractions or other minor surgical interventions require medical supervision to manage the associated bleeding. Without treatment, bleeds are painful and can cause lasting damages and lead to impaired mobility.   ]]> https://biospectrumindia.com/news/57/14895/nih-to-address-growing-tickborne-diseases-threat.html https://biospectrumindia.com/news/57/14895/nih-to-address-growing-tickborne-diseases-threat.html Mon, 14 Oct 2019 12:10:00 +0530 The incidence of reported cases of tickborne diseases in the United States has significantly increased in recent years. It is expected to continue to grow as tick species expand their geographical reach and new tick-transmitted pathogens emerge, raising the potential for serious human illness and death. A new strategic research plan from the National Institutes of Health aims to build on — and accelerate — new and existing research initiatives to improve scientific understanding of ticks and the pathogens they may transmit and to develop the necessary tools and strategies to better diagnose, prevent and treat tickborne diseases. The new NIH Strategic Plan for Tickborne Disease Research focuses on five scientific priorities for advancing research and development over the next five years. First, the plan calls for improving fundamental knowledge of tickborne diseases, including the biology of tickborne pathogens; how they are transmitted to humans, evade the immune system, and spread within the body. This area also includes determining the cause of persistent symptoms in some people infected with tickborne diseases, such as Lyme disease, and furthering the understanding of how tick-derived factors contribute to the establishment and severity of disease. Second, the plan calls for improving detection and diagnosis of tickborne diseases by developing rapid diagnostic tests that can detect a pathogen both early and late in infection and distinguish between active and past infections. Third, NIH will support the development of diagnostics capable of predicting treatment success and identifying human biomarkers of infection and persistent symptoms. The new plan also prioritizes the acceleration of research designed to prevent tickborne disease infection, including vaccines, and immune-based treatments, as well as strategies to reduce the transmission of tickborne pathogens to animal populations that serve as hosts. Fourth, the plan focuses on research to develop new treatments for tickborne diseases and techniques to reduce disease complications. Fifth, the plan prioritizes the development of tools and resources to advance tickborne disease research by improving scientists’ access to biological samples, tickborne disease genetic data, and supporting preclinical development of promising products. NIH intends to expand collaborations across its institutes and centers to promote a multidisciplinary approach to tickborne disease research, answer complex biological questions and encourage the application of state-of-the-art technologies used successfully in a range of scientific disciplines. The new NIH strategic plan builds on the activities of the Department of Health and Human Services Tick-Borne Diseases Working Group, which issued a 2018 report to Congress outlining research recommendations. NIH sought input from the research and medical communities, patient advocacy groups, pharmaceutical industry, and the general public in developing this strategic plan. ]]> https://biospectrumindia.com/news/57/14889/fda-permits-to-market-first-rapid-ebola-virus-antigens-diagnostic-test-.html https://biospectrumindia.com/news/57/14889/fda-permits-to-market-first-rapid-ebola-virus-antigens-diagnostic-test-.html Fri, 11 Oct 2019 14:20:00 +0530 The U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. "Today's marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the U.S. Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo (DRC)," said Acting FDA Commissioner Ned Sharpless, M.D. "The current outbreak in the DRC has already killed thousands and the outbreaks in West Africa that began in 2014 tragically killed more than 11,000. Investigational vaccines and therapeutics have shown promising results, but one of the most important tools in stopping these outbreaks is quickly diagnosing patients and supporting safe and dignified burials. This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving. Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials." The FDA has authorized a number of diagnostic tests for EVD under the EUA pathway to assist with the public health response. Today's marketing authorization of the first EVD presumptive rapid diagnostic test for Ebola virus antigens through the De Novo review pathway reflects the ongoing collaboration between the U.S. Government and test developers to gather additional data on EUA products. For the OraQuick Ebola Test submission, the FDA reviewed data from multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak and from a variety of analytical studies. Based on these data, the FDA determined that general and special controls were necessary to provide a reasonable assurance of the safety and effectiveness of the OraQuick Ebola Test when intended to identify antigens associated with Ebola virus in blood from symptomatic patients and oral fluid of cadavers. The OraQuick Ebola Test was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this marketing authorization, the FDA is establishing criteria, called special controls, that determine the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to identify Ebola virus antigens. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device. The OraQuick Ebola Test was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency's review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients. The FDA granted marketing authorization of the OraQuick Ebola Test to OraSure Technologies, Inc.   ]]> https://biospectrumindia.com/news/57/14886/bayer-launches-lifehub-uk-focused-on-ai-for-drug-discovery-.html https://biospectrumindia.com/news/57/14886/bayer-launches-lifehub-uk-focused-on-ai-for-drug-discovery-.html Fri, 11 Oct 2019 12:40:00 +0530 Bayer has launched LifeHub UK to accelerate and optimize disease detection and data-driven drug discovery by developing artificial-intelligence-enabled imaging solutions. The new hub is the seventh pillar of Bayer’s global network of LifeHubs designed to accelerate the co-exploration and development of pioneering solutions to solve global challenges in health and nutrition. Kemal Malik, Bayer Board Member for Innovation, said: “We are delighted to launch LifeHub UK. We firmly believe that artificial intelligence has transformative potential for healthcare which can lead to enhancements in prediction, prevention and personalized treatments.” Monika Lessl, Head of Corporate Innovation, R&D and Societal Engagement at Bayer, added: “Today’s global challenges in health and nutrition are too large for one single company to tackle alone. This is why our Open Innovation strategy is rooted in a newly-designed global network of LifeHubs which boast offerings from partnering and incubation programs to world-class venturing activities.” AI-enabled imaging solutions in focus at LifeHub UK As a first step, Bayer’s LifeHub UK will focus on the development of AI-enabled radiology solutions by building on its longstanding knowledge and expertise in the medical imaging field. Clinical AI company Sensyne Health – after sealing a collaboration agreement with Bayer earlier this year – is one of the first companies to move into LifeHub UK. In addition to the already-established collaboration, both parties intend to conduct joint R&D activities for the development of AI-enabled imaging solutions. Olaf Weber, Head of Radiology R&D at Bayer, today welcomed the opportunities that LifeHub UK will open up, saying: “Bayer is looking forward to bringing its knowledge and expertise in medical imaging within radiology into joint development activities with our partners at LifeHub UK.” He added that main intention was to develop digital solutions that deliver patient benefits through improved diagnoses that in turn can enable earlier disease management and interventions. The new LifeHub is based in Reading’s Green Park – at the heart of the Thames Valley – which boasts more than 45,000 tech-related jobs and contributes around 12 billion pound to UK annual digital technology revenues. According to “Tech Nation 2019” the UK is today the world’s third biggest market for AI investment – following the US and China – with funding rising six-fold since 2014. LifeHubs offer touch points for innovators from all over the world as cornerstone of Open Innovation strategy Bayer’s network of LifeHubs strives to springboard solutions at the intersection of health and nutrition by exploring promising leads through collaboration with customers and entrepreneurs. As such, the brightest minds within and beyond Bayer are invited to incubate solutions, technologies and pilot new business models through alliances that explore cutting-edge technologies. The six other LifeHubs are located at the global innovation hotspots of Berlin, Boston, California, Lyon, Singapore and Tokyo/Osaka. Each site boasts an individual focus field, leveraging the strength of its location: Boston, for example, focuses on close collaboration with entrepreneurs and students from the Massachusetts Institute of Technology (MIT) and Harvard University environment. Another important focus of Bayer’s Boston-related activities lies on pharma science partnerships with the Broad Institute. LifeHubs Berlin and California meanwhile combine a so-called “CoLaborator” lab space with various R&D and digital health opportunities that tap into the cities’ startup environment. LifeHubs Japan and Singapore focus on Pharma research collaborations while Lyon offers CropScience partnerships. Bayer’s Open Innovation opportunities also include G4A (formerly entitled Grants4Apps) program, which provide start-ups with holistic offerings including incubation space, funding and mentoring. Bayer’s collaborative innovation ecosystem is completed by highly-ambitious venture activities. This is leveraged through the initiative “Leaps by Bayer” which co-founds new biotech start-up companies that work on groundbreaking innovations using cutting-edge technologies like genome editing and stem cell therapy. Since 2015, Leaps by Bayer has invested almost USD 1 bn (incl. committed funds) into six Leaps joint ventures – including Casebia, BlueRock Therapeutics and JoynBio – as well as a few smaller collaborations. ]]> https://biospectrumindia.com/news/57/14873/clinigen-launches-managed-access-program-for-progenics-pharmaceuticals-.html https://biospectrumindia.com/news/57/14873/clinigen-launches-managed-access-program-for-progenics-pharmaceuticals-.html Thu, 10 Oct 2019 12:45:00 +0530 Clinigen Group plc, the global pharmaceutical and Services Company, has launched a Managed Access Program for Progenics Pharmaceuticals, Inc., an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, to provide AZEDRA® (iobenguane I 131) via a global Managed Access Program, outside the United States. AZEDRA, a high-specific-activity radiotherapeutic agent, is approved in the United States for the treatment of adult and pediatric patients 12 years and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. AZEDRA is not approved for use outside of the United States. Pheochromocytomas and paragangliomas are ultra-rare adrenal gland tumors, with approximately 55,000 new cases each year world-wide. Over a quarter of cases are genetically linked; the tumors frequently secrete high levels of hormones that can lead to life-threatening high blood pressure, heart failure, and stroke. The prognosis after diagnosis of metastatic pheochromocytoma or paraganglioma is highly variable, with 5-year survival rate estimates as low as 12%. James Winterman, Senior Vice President, Unlicensed Medicines, Clinigen, said:  “Clinigen’s new partnership with Progenics aligns with our mission to deliver the right medicine to the right patient at the right time. Through our global infrastructure and expertise in the supply of unlicensed medicines, eligible patients with pheochromocytomas and paragangliomas will now be able to gain access to this new medicine.”   ]]> https://biospectrumindia.com/news/57/14868/gsk-and-lyell-immunopharma-to-develop-new-cancer-cell-therapies.html https://biospectrumindia.com/news/57/14868/gsk-and-lyell-immunopharma-to-develop-new-cancer-cell-therapies.html Thu, 10 Oct 2019 10:00:00 +0530 GlaxoSmithKline plc has announced a five-year collaboration with Lyell Immunopharma, a San Francisco biotechnology company, to develop new technologies to improve cell therapies for cancer patients. The collaboration will apply Lyell’s technologies to further strengthen GSK’s cell therapy pipeline, including GSK3377794, which targets the NY-ESO-1 antigen that is expressed across multiple cancer types. To date, two cell therapies have been approved for blood-borne cancers, but engineered T cells have not yet delivered strong clinical activity in common solid tumours.  Improving the “fitness” of T cells and delaying the onset of T cell exhaustion could help engineered T cell therapies become more effective. Combining GSK’s strong cell and gene therapy programmes with Lyell’s technologies may allow the joint research team to maximise the activity and specificity of cell therapies in solid tumour cancers, where there is a high unmet medical need. Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK said: “We are witnessing significant scientific innovation in cell and gene therapies, transforming the treatment of some blood-borne cancers, but patients with solid tumours are in need of equally effective treatments.  Applying Lyell’s novel approach to counter T cell exhaustion and working with world class scientists, such as Rick Klausner and his impressive team, increases our probability of delivering the next generation of cancer cell therapies for patients with solid tumours.” Lyell is exploring several approaches to improving T cell function and increasing T cell “fitness” to enhance initial response rates in solid tumour cancers and to prevent relapses due to loss of T cell functionality. As Lyell addresses inhibition of T cells by the tumour in a fundamental way, there is an opportunity that these technologies can be used as a platform for multiple new cell and gene therapies that can be applied across a broad range of rare and prevalent solid cancers. Dr. Rick Klausner, founder and CEO, Lyell Immunopharma said: “Our approach is to tackle three of the most significant barriers to T cell efficacy in solid tumours. We are redefining the ways we prepare patient cells to be made into therapies, modulating cells’ functionality so that they maintain activity in the tumour microenvironment, and establishing methods of control to achieve specificity and safety for solid tumour-directed cell therapies.” Lyell has a scientific management team with a long history in the field of immune cell therapy. Rick Klausner is the former head of the National Cancer Institute (NCI) and co-founder of Juno Therapeutics, and whose lab discovered the molecular engine behind T cell receptor and CAR signalling; Stan Riddell, co-founder and the Head of R&D, co-founder of Juno whose pioneering work over three decades at Fred Hutchinson Cancer Research Center has helped to define the parameters of successful adoptive cell therapy; Nick Restifo, EVP of Science, whose research over 25 years at the NCI defined the properties of the T cells capable of therapeutic efficacy in cancer; and Margo Roberts, CSO, whose work in adoptive T cell therapy includes serving as CSO of Yescarta® maker Kite Pharma, administering the first CAR T cell into patients in 1993, and demonstrating the role of co-stimulation in T cells for effective CARs. Next generation engineering that leverages Lyell technologies could further enhance the benefit/risk profile of GSK’s lead programme and other cell therapies in GSK’s pipeline. GSK3377794 uses genetically engineered autologous T cells and is currently in Phase 2, on an accelerated development path. The collaboration will also build on GSK’s world-leading manufacturing platform and expertise for cell and gene therapy that delivered the world’s first approved ex vivo gene therapy (Strimvelis) for ADA-SCID in 2016. GSK has granted patents and pending patent applications related to its stable cell line technology (SCLT) and has a long-standing collaboration with Miltenyi Biotec to improve quality and scale of output to meet the needs of larger patient populations. Lyell co-founders also include Crystal Mackall, M.D., who has pioneered work on T cell exhaustion, and David Baker, Ph.D., Director of the University of Washington Institute for Protein Design, whose novel approaches to protein engineering provide technologies to enable enhanced precision, control and safety in cell-based therapies. ]]> https://biospectrumindia.com/news/57/14859/researchers-find-way-to-assess-prostate-cancer-aggressiveness.html https://biospectrumindia.com/news/57/14859/researchers-find-way-to-assess-prostate-cancer-aggressiveness.html Wed, 09 Oct 2019 12:25:00 +0530 Researchers from Queen’s University Belfast have discovered a new way to predict the aggressiveness and future behaviour of prostate cancers. The new method uses images from computed tomography (CT) scans that are routinely collected from all patients. The images are then analysed by a computer to extract hundreds of features, termed ‘radiomic features’, which have the potential to uncover disease characteristics that fail to be seen by the naked eye. This technique could complement traditional assessment methods and may help clinicians to make more informed personalised treatment decisions for men with prostate cancer. In the long run, it may reduce or even replace the need for traditional invasive biopsies. Prostate cancer is one of the most common forms of cancer, but the behaviour of an individual cancer is extremely variable.  While some tumours metastasize rapidly, others can remain harmlessly localised in the prostate gland for years. Dr Suneil Jain, Principal Investigator from the Centre for Cancer Research & Cell Biology at Queen's University Belfast, said: “To predict the risk represented by a given tumour, ‘Gleason scores’ are typically assigned based on how a sample of the tumour appears under the microscope compared with normal prostate tissue. Patients are then classified as low, medium, or high risk depending on their Gleason score, level of prostate specific antigen (PSA) in the blood, and on size of the tumour and whether it has spread to other parts of the body.” The research team used CT scans for 342 prostate-cancer patients acquired as a routine care prior to radiotherapy treatment. Focusing on the prostate gland, the researchers then extracted and analysed over 500 radiomic features from each image. These features, along with the Gleason score and risk group classification for each patient, were used to ‘train’ a computer to be able to discriminate between patients in low- and high-risk groups, and between those with low and high Gleason score. CT-based classification models proved able to discriminate between patients from different Gleason score and risk groups. The system was especially competent at distinguishing between patients in low- and high-risk groups, and between those with low and high Gleason score. Dr Sarah Osman, Lead Investigator and Postdoctoral Research Fellow at Queen's University Belfast and the Belfast Health and Social Care Trust, explained: “This is the first CT-based radiomics investigation for this treatment site and it is showing very promising results. Although the present study will not revolutionize prostate cancer treatment by itself, it shows what could be possible in the future. We are building on collaborations with other institutes to provide datasets to validate our exciting findings and take this discovery forward.” Professor Philippe Lambin from the Maastricht University and one of the co-inventors of Radiomics added: “Typically, there isn’t a huge amount of quantitative data in radiology reports. With the radiomics revolution, we need to look at medical images not just as pictures, but as quantitative data potentially useful for trials and routine care.”  Professor Ian Young, Chief Scientific Advisor to the Department of Health in Northern Ireland and Director of HSC R&D said: “Cancer is a major cause of morbidity and mortality. By supporting research like this, we can ensure that patients have access to the most innovative cancer treatments, and the best preventive strategies can be put in place.” Dr Matthew Hobbs, Deputy Director of Research at Prostate Cancer UK said: “We’re delighted to see more results coming out of the Prostate Cancer UK and Movember funded Centre of Excellence. “This new work suggests that we may be able to use a CT scan to assess how aggressive a cancer will be. The next step will be to compare this to other imaging techniques, and to assess how well it performs when biopsies are informed by multiparametric MRI scans, which is now standard practice. It will also be important to understand how well this technique predicts outcomes in the longer term for men with localised disease.” The research was supported by the Belfast-Manchester Movember Centre of Excellence, Prostate Cancer UK, and the Health and Social Care Research and Development Division of the Public Health Agency. ]]> https://biospectrumindia.com/news/57/14857/4d-pharma-with-msd-to-develop-live-biotherapeutics-for-vaccines.html https://biospectrumindia.com/news/57/14857/4d-pharma-with-msd-to-develop-live-biotherapeutics-for-vaccines.html Wed, 09 Oct 2019 09:00:00 +0530 4D pharma plc, a UK based pharmaceutical company leading the development of Live Biotherapeutics, has announced that the Company has entered into a research collaboration and option to license agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics (LBPs) for vaccines. Under the terms of the agreement 4D's proprietary MicroRx® platform will be paired with MSD's expertise in the development and commercialisation of novel vaccines, to discover and develop LBPs as vaccines in up to three undisclosed indications. 4D has the right, subject to certain conditions, to cause MSD to purchase $5 million in ordinary shares in 4D during the first 12 months of the collaboration. In addition to an upfront cash payment, for each indication, 4D will be eligible to receive up to $347.5 million in option exercise and development and regulatory milestone payments, plus tiered royalties on annual net sales of any licensed products derived from the collaboration. MSD will be responsible for development, manufacturing and commercialisation following the exercise of any of its exclusive options. ]]> https://biospectrumindia.com/news/57/14848/nordic-nanovector-signs-global-clinical-and-commercial-agreement-with-itm.html https://biospectrumindia.com/news/57/14848/nordic-nanovector-signs-global-clinical-and-commercial-agreement-with-itm.html Mon, 07 Oct 2019 16:45:00 +0530 Nordic Nanovector ASA has signed a long-term global supply agreement with a subsidiary of ITM Isotopen Technologien München AG (ITM), Isotope Technologies Garching GmbH (ITG) to ensure the supply of high quality, no-carrier-added (n.c.a.) Lutetium-177, a key component of Betalutin® (177Lu-lilotomab-satetraxetan) for R&D, clinical and commercial uses. ITM, a biotechnology and radiopharmaceutical group of companies and world-leader in the development and production of radiopharmaceuticals and radionuclides for the targeted treatment of cancers as well as for diagnostics, has been supplying n.c.a. Lutetium-177 (EndolucinBeta®) to Nordic Nanovector since 2010. Marco Renoldi, Chief Operating Officer at Nordic Nanovector, said: "We are pleased to extend our collaboration with a long-time and reliable partner such as ITM. This global supply agreement is a key milestone in the implementation of our CMC (Chemistry, Manufacturing and Controls) strategy for gaining regulatory approval for Betalutin® and its subsequent commercial rollout, as it provides certainty of continued supply of n.c.a. Lutetium-177 during clinical development as well as after launch. The agreement with ITM, alongside other manufacturing supply and development agreements in place with specialist manufacturers at all stages of the manufacturing and supply chain for Betalutin® strengthens our confidence in the ability to deliver a reliable and sustainable supply chain in support of the launch of our lead asset." Steffen Schuster, CEO of ITM, added: "Nordic Nanovector is one of our longstanding partners and we are delighted that Nordic Nanovector has reaffirmed their confidence through this long-term supply agreement for EndolucinBeta®. In addition to the development of our own pipeline, we have once again been able to gain a strategic partner for the development of targeted radiopharmaceuticals in Precision Oncology, thereby making a significant contribution to advancing a promising treatment option for difficult-to-treat cancers. With our manufacturing facilities around the world and our unrivaled logistics network, we feel well equipped to reliably meet our partners' needs and to enter into further strategic relationships." ]]> https://biospectrumindia.com/news/57/14845/jj-commits-500-m-investment-to-eliminate-of-hiv-and-tb.html https://biospectrumindia.com/news/57/14845/jj-commits-500-m-investment-to-eliminate-of-hiv-and-tb.html Mon, 07 Oct 2019 16:25:00 +0530 Johnson & Johnson has committed to ensuring more than $500 million is dedicated to world class research & development and delivery programs over the next four years to accelerate global efforts to eliminate HIV and tuberculosis (TB) by 2030.  As one of the world's largest healthcare companies, Johnson & Johnson is deeply engaged in global health innovation, working closely with governments and strategic partners to improve the health and well-being of more people in more places around the world. "No single institution can tackle the historic challenge of eliminating an infectious disease," said Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.  "By advancing our technologies, uniting our best scientists and leveraging decades of experience in HIV and TB, we're optimistic that we can make a significant contribution to the global effort." Building on a strong track record set by its Janssen Pharmaceutical Companies in the areas of HIV and TB and Johnson & Johnson's existing Health for Humanity 2020 Goals, Johnson & Johnson will dedicate a team of world-class researchers who will leverage our scientific resources to accelerate the discovery, development and delivery of next generation medicines and vaccines to complement investments being made by governments. This investment in innovation has the potential to positively impact the day-to-day lives of millions of people affected by both HIV and TB and maximize the efficiency of country investments in health over the long-term.  In doing so, these efforts will also support the achievement of the United Nations Sustainable Development Goal 3 targets when combined with other global programs. HIV The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) have been committed to the fight against HIV for more than 25 years. Over this time, the Company has introduced eight transformational HIV medicines – including three antiviral agents and five combination products developed in partnership – which have helped to transform HIV/AIDS from a death sentence  into a chronic, manageable disease, allowing millions of people living with HIV to lead near normal lives. "Although HIV is now considered a chronic and manageable condition, people living with HIV still face a lifetime of taking daily pills.  We therefore must continue to advance important innovations to help them," said Johan Van Hoof, MD, Global Therapeutic Area Head, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica NV. "The global challenge remains immense. With 37 million people around the world living with HIV – and nearly two million people newly-infected each year – we cannot treat ourselves out of the HIV epidemic. Our ultimate goal must be to find a preventive vaccine for HIV." As part of the $500 million investment, Janssen will continue to advance an investigational mosaic-based vaccine regimen to prevent HIV together with a consortium of partners.  An ongoing efficacy trial (Imbokodo) in 2,600 women in Southern Africa is fully enrolled. A second efficacy trial (Mosaico) is about to commence in North America, South America and Europe with 3,800 men who have sex with men and transgender individuals. In partnership with ViiV Healthcare, Janssen is also investigating a long-acting injectable HIV treatment regimen that could be administered to patients once every two months.  This regimen, if approved, could potentially reduce HIV treatment for some patients to just twelve or even six injection visits per year to keep the virus under control, instead of a daily oral treatment taken 365 times per year Tuberculosis In 2012, Janssen introduced bedaquiline, which was the first TB medicine with a novel mechanism of action in nearly half a century. Since then, the Company has provided more than 145,000 courses of treatment for multidrug-resistant TB (MDR-TB) patients in 131 countries, including through a four-year donation program that operated in the 2015-2019 period in partnership with the U.S. Agency for International Development and JSC Pharmstandard. At the United Nations High-Level Meeting on Tuberculosis in September 2018, Johnson & Johnson announced a comprehensive 10-year initiative to support ending the TB epidemic by 2030, which builds on our current Health for Humanity 2020 TB Goal.  With the goal of saving an estimated 1.8 million lives and preventing 12 million new TB infections in the next decade, Johnson & Johnson is working with partners to improve detection of undiagnosed cases of TB, broaden access to bedaquiline, and accelerate research & development (R&D) to discover next-generation TB treatments. ]]> https://biospectrumindia.com/news/57/14844/noble-prize-in-medicine-2019-for-us-uk-scientists.html https://biospectrumindia.com/news/57/14844/noble-prize-in-medicine-2019-for-us-uk-scientists.html Mon, 07 Oct 2019 00:00:00 +0530 The Nobel Prize in Physiology or Medicine for 2019 has been jointly awarded to three winners, William G. Kaelin Jr., Peter J. Ratcliffe and Gregg L. Semenza, for their work in discovering how cells sense and adapt to oxygen availability. The Nobel Assembly announced the prize at the Karolinska Institute in Stockholm on October 07. The three winners were awarded for their discoveries of "how cells sense and adapt to oxygen and availability". Their work is relevant to everything from pregnancy to cancer, as oxygen levels are vital to sustaining animal life. US based researchers William Kaelin and Gregg Semenza shared the prize equally with Peter Ratcliffe, who is from Britain.   The nobel prize is awarded each year to the person or group deemed to have made an outstanding discovery within the domains of life sciences and medicine.       (Source : Public Domain)  ]]> https://biospectrumindia.com/news/57/14840/certara-launches-basecase-data-studio.html https://biospectrumindia.com/news/57/14840/certara-launches-basecase-data-studio.html Fri, 04 Oct 2019 16:35:00 +0530 Certara®, the global model-informed drug development and decision support leader, today announced the launch of BaseCase Data Studio, the newest product for its BaseCase value communications platform. Certara’s BaseCase platform enables pharmaceutical and medtech clients to build interactive, data-driven mobile apps using real-world data sources, such as healthcare claims, costs, quality, outcomes, and population data to demonstrate the value of specific drugs or devices during cost discussions with payers, providers and healthcare professionals (HCPs). With the addition of BaseCase Data Studio, those clients can now also perform sophisticated statistical modeling and data analyses live on their mobile apps during those meetings. “Due to rising healthcare costs, payers, providers and healthcare professionals are increasingly turning to evidence-based medicine and are seeking to gain meaningful insights from the huge volumes of available healthcare data to enable them to make the best value-based decisions regarding new drugs and devices,” said Thomas Kerbusch, PhD, President of Certara Strategic Consulting. “Using BaseCase Data Studio, our clients can now conduct the requisite analyses in real time and accurately predict a range of outcomes, thus supporting their value messages with evidence-based claims.” The programming language R is widely used by modelers, statisticians and data scientists in the life science industry. Much of the pharmacometrics, health economics and outcomes research, and epidemiology modeling, which is central to Certara’s staff and customers’ work, is performed in R. Data Studio unlocks the power of those advanced models in value communication. The commonly used R packages heemod and deSolve are supported by BaseCase Data Studio “out-of-the-box.” Using BaseCase Data Studio, Certara’s clients can create mobile tools that generate simulations (including Markov chains and discrete event simulation) and budget impact models; conduct meta-analyses; perform multi-criteria decision, cost-effectiveness, health-related quality of life and probabilistic sensitivity analyses. “As with all the other BaseCase personalized, interactive mobile tools, Data Studio provides centralized content management and streamlined global deployment, ensuring that updated content is distributed to all client devices in all markets simultaneously. As a result, their staff always has the most current material. Data Studio also has built-in version control so that clients can release or roll-back resources as required to maintain compliance,” said BaseCase Senior Vice President Seamus Nestor. By employing R, BaseCase Data Studio permits the use of more complex formulas than Excel. It is also a very flexible tool, allowing clients to combine script outputs with spreadsheet formulas so their data can be processed and presented in whatever form they require. The script inputs and outputs can also be linked to BaseCase’s presentation layer to create especially powerful interactive tools. To ensure all security needs are met, BaseCase Data Studio employs a strict ACL permissions system, password-protected accounts, and industry-standard encryption. Founded in 2007, and acquired by Certara in January 2018, BaseCase is a software as a service (SaaS) and value communication company that has been developing interactive mobile apps for the pharmaceutical and medical device industries for more than a decade. ]]> https://biospectrumindia.com/news/57/14834/nih-researchers-create-new-viral-vector-for-treating-sickle-cell-disease.html https://biospectrumindia.com/news/57/14834/nih-researchers-create-new-viral-vector-for-treating-sickle-cell-disease.html Fri, 04 Oct 2019 14:20:00 +0530 Researchers at the National Institutes of Health have developed a new and improved viral vector—a virus-based vehicle that delivers therapeutic genes—for use in gene therapy for sickle cell disease. In advanced lab tests using animal models, the new vector was up to 10 times more efficient at incorporating corrective genes into bone marrow stem cells than the conventional vectors currently used, and it had a carrying capacity of up to six times higher, the researchers report. The development of the vector could make gene therapy for sickle cell disease much more effective and pave the way for wider use of it as a curative approach for the painful, life-threatening blood disorder. Sickle cell disease affects about 100,000 people in the United States and millions worldwide. “Our new vector is an important breakthrough in the field of gene therapy for sickle cell disease,” said study senior author John Tisdale, M.D., chief of the Cellular and Molecular Therapeutic Branch at the National Heart, Lung, and Blood Institute (NHLBI). “It’s the new kid on the block and represents a substantial improvement in our ability to produce high capacity, high efficiency vectors for treating this devastating disorder.” Researchers have used virus-based vehicles for years in gene therapy experiments, where they have been very effective at delivering therapeutic genes to bone marrow stem cells in the lab before returning them to the body. But there’s always room for improvement in their design in order to optimize effectiveness, Tisdale noted. He compared the new virus-based vehicle to a new and improved car that is also far easier and cheaper for the factory to produce. The study was supported by the NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both part of the NIH. It was published online today in Nature Communications. Sickle cell disease is an inherited blood disorder caused by a mutation, or misspelling, in the beta-globin gene (or β-globin gene). This mutation causes hemoglobin, the main ingredient of blood cells, to produce sickle-shaped cells that can stick to the walls of blood vessels, causing blockage, pain, anemia, organ damage, and early death. With gene therapy, doctors modify the patient’s bone marrow hematopoietic (blood-producing) stem cells in the lab by adding a normal copy of the beta-globin gene through the use of a viral vector. They then reinfuse the modified stem cells into the patient to produce normal, disc-shaped red blood cells. For the past 30 years, researchers have been designing these beta-globin vectors in a reverse structural orientation, meaning the therapeutic genes incorporated into the virus are translated, or “read,” from right to left by the viral vector-making machinery — much like reading an English sentence backwards. The reason for the reverse orientation is the sensitive expression of a key molecular component of the vector called intron 2. This segment is required for high-level beta-globin gene expression but gets clipped out during the normal vector preparation process if it is left in the natural, forward direction. Gene therapy trials using reverse-oriented vectors for sickle cell disease and beta-thalassemia have largely been encouraging, the researchers said, but this complicated gene translation process has made vector preparation and gene-transfer efficiency more difficult.   About 10 years ago, Tisdale and Naoya Uchida, M.D., Ph.D., a staff scientist in his lab, searched for an improved delivery vehicle — like designing a better car — and decided to undertake a radical redesign of the beta-globin vector. They came up with a unique work-around design that left intron 2 intact and created the new forward-oriented beta-globin vector. In contrast to the old vector, the gene sequence, or “message,” of the new beta-globin vector is read from left to right — like reading a normal sentence — making the gene translation approach less complicated, Tisdale explained. The researchers tested the new vectors in mice and monkeys and compared the results to reverse-oriented vectors. They found that the new vectors could transfer a much higher viral load — up to six times more therapeutic beta-globin genes than the conventional vectors — and had four to 10 times higher transduction efficiency, a measure of the ability to incorporate corrective genes into repopulating bone marrow cells. The new vectors also showed a capacity for longevity, remaining in place four years after transplantation. Researchers also found that they could be produced in much higher amounts than the conventional vectors, potentially saving time and lowering costs associated with large-scale vector production. “Our lab has been working on improving beta-globin vectors for almost a decade…and finally decided to try something radically different—and it worked,” Tisdale said. “These findings bring us closer to a curative gene therapy approach for hemoglobin disorders.” The new vector, for which the NIH holds the patent, still needs to undergo clinical testing in humans. Already an estimated 27 people with sickle cell disease have undergone experimental gene therapy using conventional vectors. Through its Cure Sickle Cell Initiative, NIH is working to accelerate the development of these and other new genetic therapies, including gene editing, with the goal of finding a cure for the disease. The initiative is part of NIH’s larger multi-pronged approach to reducing the burden of blood disorders. People with sickle cell disease can visit clinicaltrials.gov to find a clinical trial that is actively enrolling. ]]> https://biospectrumindia.com/news/57/14832/univercells-receives-eur-20m-financing-to-accelerate-vaccine-portfolio-.html https://biospectrumindia.com/news/57/14832/univercells-receives-eur-20m-financing-to-accelerate-vaccine-portfolio-.html Fri, 04 Oct 2019 12:35:00 +0530 The European Investment Bank (EIB) and Univercells S.A have signed a EUR 20 million loan agreement to support the development of a portfolio of four essential and undersupplied vaccines to be delivered at an affordable price. The portfolio – including polio, measles and rubella, and rabies vaccines – requires significant investment in process development through to clinical and regulatory validation. In funding Univercells, the EIB is aiming to promote the delivery of such vaccines, increasing their availability for diseases with high unmet medical needs. The fight against infectious diseases is of high policy relevance for the European Union and for the EIB, its financing arm. While infectious diseases are already amongst the leading causes of death worldwide, the emergence of resistant pathogens is on the rise and anti-microbial resistance is therefore expected to become the leading cause of death by the middle of this century. At the same time there is little investment in drugs and vaccines to fight infectious diseases and a limited number of players in the field. Univercells recently introduced its NevoLine biomanufacturing platform capable of delivering large quantities of vaccines at a fraction of the traditional cost. With the support of the EIB, the company will leverage the technology to pursue its mission and make four global health vaccines more available and affordable to all. This EIB venture debt financing is backed by the “InnovFin – EU-finance for innovators” programme, a joint European Commission and EIB Group initiative funded by Horizon 2020, the EU’s research and innovation programme. More specifically, the “InnovFin – Infectious Diseases Finance Facility” (IDFF) targets the development of innovative vaccines, drugs, medical devices and novel research infrastructures for combatting infectious diseases. Through this support from InnovFin IDFF, the EIB can provide stable long-term funding with a flexible repayment and interest structure, limiting the cash outflow from the company and thereby enabling it to focus on investing in innovation and growth.  Univercells has also benefited from InnovFin Advisory, one of the InnovFin tools, which identified the company as innovative and provided it with advice to improve its access to finance. ]]> https://biospectrumindia.com/news/57/14830/who-launches-digital-app-to-improve-care-for-older-people.html https://biospectrumindia.com/news/57/14830/who-launches-digital-app-to-improve-care-for-older-people.html Fri, 04 Oct 2019 12:05:00 +0530 The World Health Organization (WHO) is launching a package of tools, including a digital application to help health and social workers provide better care for older people. The innovative interactive digital application known as WHO ICOPE Handbook App provides practical guidance to address priority conditions including mobility limitations, malnutrition, vision and hearing loss, cognitive decline, depressive symptoms and social care and support. Used in conjunction with a package of tools including a new handbook, the app will accelerate training of health and social workers to better address the diverse needs of older people.   Dr Anshu Banerjee, director of the department of Maternal, new-born, child and adolescent health and ageing at WHO said, “It is essential that services for older people are included in universal health care packages. At the same time there needs to be good coordination between the health and social services to provide optimal care when needed. The new package of tools supports healthy ageing with a person-centred and coordinated model of care.” The world’s population is ageing at a fast pace. By 2050 one in five people will be over 60. The number of aged over 80 is projected to triple from 143 million in 2019 to 426 million in 2050. While every older person is different physical and mental capacity tend to decline with increasing age.   Dr Islene Araujo de Carvalho, group lead on ageing and integrated care at WHO said, “Such innovation will enable older people to continue doing the things they value and prevent them from social isolation and care dependency. Intervening close to where older people live, with active participation of the community and older persons themselves, is essential for a personalized care plan.” The Integrated Care for Older People package of tools is the result of two years of extensive consultations with leading experts and stakeholders including civil society representatives.   The 2030 Agenda and the Sustainable Development Goals recognize that development will only be achievable if it is inclusive of people of all ages. Empowering older persons and enabling their full participation and social inclusion in good health are ways to reduce inequalities.     ]]> https://biospectrumindia.com/news/57/14831/multilateral-agencies-launch-a-joint-plan-to-boost-global-health-goals.html https://biospectrumindia.com/news/57/14831/multilateral-agencies-launch-a-joint-plan-to-boost-global-health-goals.html Fri, 04 Oct 2019 10:00:00 +0530 Recently at the United Nations General Assembly, 12 multilateral agencies launched a joint plan to better support countries over the next 10 years to accelerate progress towards the health-related Sustainable Development Goals (SDGs). Developed over 18 months, Stronger Collaboration, Better Health: Global Action Plan for Healthy Lives and Well-being for All outlines how a dozen multilateral health, development and humanitarian agencies will collaborate to be more efficient and provide more streamlined support to countries to deliver universal health coverage and achieve the health-related SDG targets. Healthy people are essential for sustainable development and for ending poverty, promoting peaceful and inclusive societies as well as protecting the environment. Over the last few decades, significant gains have been made in key areas of health, but the 2030 targets will not be met without redoubled efforts. Dr Tedros Adhanom Ghebreyesus, Director-General of WHO said, “The plan is called, ‘Stronger Collaboration, Better Health’ for a reason. Although collaboration is the path, impact is the destination.  The release of this plan is the beginning, not the end, of that path.” Universal health coverage is key to meeting the health-related goals and addressing health inequities. If trends continue, up to 5 billion of the world’s population will not be covered by essential health services in 2030, as highlighted in the Universal Health Coverage: Global Monitoring Report, released last week by WHO. To leave no one behind, countries need to address health inequities. Improved collaboration and coordination can help countries tackle complex health challenges and bring innovative solutions. Together, the 12 agencies contribute nearly one-third of all development assistance to health.  Under the Global Action Plan, the agencies commit to strengthening their collaboration to: Engage with countries better to identify priorities, plan and implement together; Accelerate progress in countries through joint actions under 7 accelerator themes, which represent common challenges for many countries and where the agencies’ mandates, expertise and resources offer solutions, namely: 1) Primary health care 2) Sustainable health financing 3) Community and civil society engagement 4) Determinants of health 5) Innovative programming in fragile and vulnerable settings and for disease outbreak responses 6) Research and development, innovation and access, and 7) Data and digital health. They will also work together to advance gender equality and support the delivery of global public goods; Align by harmonizing their operational and financial strategies and policies in support of countries to increase efficiency and reduce the burden on countries; and Account, by reviewing progress and learning together to enhance shared accountability. Governments are setting priorities, developing implementation plans and intensifying efforts to achieve the health-related SDG targets. Demand from countries for the Global Action Plan is growing. Upendra Yadav, Deputy Prime Minister of Nepal said, “Achieving the health-related SDG goals is key for Nepal. Strengthening primary health care and enhancing data utilization for evidence-based planning and decision-making are two accelerators that will help bring us closer to achieving the SDG goals.” Through the Global Action Plan, the agencies will help countries deliver on international commitments in addition to the SDGs, such as those made in Astana on primary health care and at the UN General Assembly High-level Meeting on Universal Health Coverage this week in New York. Coordinated by WHO, the Global Action Plan for Healthy Lives and Well-being for All, is in response to a call from Germany, Ghana and Norway, with support from the United Nations Secretary-General, Antonio Guterres, for more effective collaboration and coordination among global health organizations to achieve the health-related SDGs.   The 12 signatory agencies to the plan are Gavi, The GFF, the Global Fund, UNAIDS, UNDP, UNFPA, UNICEF, UNITAID, UN Women, World Bank Group, WFP and WHO.    ]]> https://biospectrumindia.com/news/57/14824/novo-nordisk-partners-noom-around-digital-health-to-help-obese-people.html https://biospectrumindia.com/news/57/14824/novo-nordisk-partners-noom-around-digital-health-to-help-obese-people.html Thu, 03 Oct 2019 11:45:00 +0530 Novo Nordisk, a global healthcare company, and Noom, a leading behaviour change company, have announced collaboration on digital health solutions focusing on weight management and education, with the aim of improving the lives of people living with obesity. The collaboration follows a successful 8-month pilot that combined Noom's proven, science-backed behaviour change programmes with Novo Nordisk's more than 95 years of experience in helping people living with chronic diseases. This collaboration, as one of many ways Novo Nordisk is partnering to improve care, will make solutions for behaviour change and education available to people with obesity in the US. "We are passionate about improving the lives of people with obesity and finding new solutions to support respectful and complete care, which includes lifestyle change and medical management," said Camilla Sylvest, Novo Nordisk executive vice president, Commercial Strategy & Corporate Affairs. "We believe that the combination of Noom's services, with Novo Nordisk's offerings to support people with obesity, will help educate and empower people with obesity to lose weight, keep it off – and live healthy lives." Noom's solutions seek to understand individual motivations and obstacles and use cutting-edge technology, including artificial intelligence, behavioural coaching by over 1,000 personal health coaches, data and wellness insights, to guide people towards sustainable change. "Sustainable change can't happen in a vacuum, and those living with obesity who want to manage their weight are in need of personalised human coaching to help them change their habits, so they can lose weight for good," said Saeju Jeong, CEO and co-founder of Noom. "We've worked with the Novo Nordisk team for over a year and have engaged with over 4,000 people with obesity. We're enthused by the exciting feedback and know that by jointly testing and refining what works, we will continue to deliver much-needed, sustainable solutions and support, as part of a scientific, insight-driven treatment plan." ]]> https://biospectrumindia.com/news/57/14818/astrazeneca-divests-rights-for-losec-to-cheplapharm.html https://biospectrumindia.com/news/57/14818/astrazeneca-divests-rights-for-losec-to-cheplapharm.html Thu, 03 Oct 2019 11:00:00 +0530 AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arzneimittel GmbH (Cheplapharm). The divestment includes medicines containing omeprazole marketed by AstraZeneca or its collaborators under the Acimax, Antra, Mepral, Mopral, Omepral and Zoltum medicine names. Ruud Dobber, Executive Vice President, BioPharmaceuticals, said: “This agreement forms part of our strategy of reducing the portfolio of mature medicines to enable reinvestment in our main therapy areas, accelerating the number of innovative new medicines for patients with high unmet medical need. We already have an excellent relationship with Cheplapharm, and their strong European presence and global distribution network will help ensure continued patient access to Losec.” AstraZeneca will continue to manufacture and supply Losec and its associated medicines and commercialise the medicine in markets where it still holds the rights. Financial considerations Cheplapharm will pay AstraZeneca approximately $243 million on completion of the agreement, plus sales-contingent milestones of up to $33 million in 2021 and 2022. Income arising from the upfront payment will be reported in the Company’s financial statements in 2019 as Other Operating Income. In 2018, Losec sales in the countries covered by this agreement were $98 million, the majority of which were in Emerging Markets. The agreement does not change the Company’s financial guidance for 2019. As there were no closing considerations to the transaction, the agreement became effective upon signing ]]> https://biospectrumindia.com/news/57/14809/nih-forms-collaborative-influenza-vaccine-research-network.html https://biospectrumindia.com/news/57/14809/nih-forms-collaborative-influenza-vaccine-research-network.html Tue, 01 Oct 2019 13:55:00 +0530 The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has initiated the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, a new network of research centers that will work together in a coordinated, multidisciplinary effort to develop more durable, broadly protective and longer-lasting influenza vaccines. NIAID will provide up to approximately $51 million in total first-year funding for the program, which is designed to support the CIVICs program centers over seven years. “To more effectively fight influenza on a global scale, we need better influenza vaccines that are more broadly protective,” said NIAID Director Anthony S. Fauci, M.D. “With the CIVICs program we hope to encourage an exchange of ideas, technology and scientific results across multiple institutions to facilitate a more efficient and coordinated approach to novel influenza vaccine development.” Seasonal influenza causes hundreds of thousands of hospitalizations and tens of thousands of deaths in the United States each year, according to the Centers for Disease Control and Prevention. While current seasonal influenza vaccines are widely available and provide important public health benefit, they could be improved. Notably, they do not always protect against all strains of circulating influenza viruses. Each year, months ahead of the flu season, scientists must make their best prediction as to which circulating viruses will be dominant. New seasonal influenza vaccines must be manufactured, distributed and administered to keep up with constantly evolving influenza viruses. This process can be slow, and if a drifted seasonal influenza virus emerges, that can impact the effectiveness of the vaccine against that virus. The relatively long timeline for vaccine production and the rapidly changing nature of influenza viruses poses a unique and difficult public health challenge for these reasons. The CIVICs network will develop so-called universal influenza vaccines, which could provide longer-lasting protection than current vaccines and against a wider variety of influenza viruses. The CIVICs centers will conduct multidisciplinary research that supports the development of vaccine candidates through testing in preclinical studies, clinical trials and human challenge studies. The CIVICs network also will explore approaches to improve seasonal influenza vaccines, such as by testing alternative vaccine platforms or incorporating new adjuvants (substances added to vaccines to boost immunity). These advances could substantially reduce influenza hospitalizations and deaths in the future. The CIVICs program will include three Vaccine Centers, one Vaccine Manufacturing and Toxicology Core, two Clinical Cores, and one Statistical, Data Management, and Coordination Center (SDMCC). The Vaccine Centers will focus on designing novel vaccine candidates and delivery platforms with an emphasis on cross-protective vaccine strategies that could be used in healthy adults as well as populations at high risk for the most serious outcomes of influenza, such as children, older adults, and pregnant women. The Vaccine Centers also will focus on new ways to study influenza viruses and the human immune response to them through computer modeling, animal models and human challenge trials. The most promising candidate vaccines will advance to clinical trials conducted by the Clinical Cores. Vaccine candidates will first be evaluated for safety and immunogenicity in small Phase 1 clinical trials conducted among healthy adult participants. Successful vaccine candidates may eventually be advanced to larger Phase 2 clinical trials in healthy adults, or in specific age groups or at-risk populations. The Vaccine Manufacturing and Toxicology Core will work with the Vaccine Centers to develop and manufacture the vaccine candidates for clinical testing. ]]> https://biospectrumindia.com/news/57/14798/medicure-acquires-full-us-ownership-of-zypitamag.html https://biospectrumindia.com/news/57/14798/medicure-acquires-full-us-ownership-of-zypitamag.html Mon, 30 Sep 2019 17:15:00 +0530 Medicure Inc. a cardiovascular pharmaceutical company, is pleased to announce that through its subsidiary, Medicure International Inc., it has acquired the ownership of ZYPITAMAGTM (pitavastatin) tablets, from Cadila Healthcare Ltd., India ("Zydus") for US and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5,000,000 and U.S. $2,000,000 in deferred payments to be made over the next four years, as well as contingent payments on achievement of milestones and royalties related to net sales. Medicure previously had acquired U.S. marketing rights with a profit-sharing arrangement. With this acquisition Medicure retains all profits, with full control of marketing and pricing negotiation. ZYPITAMAGTM is a HMG-CoA reductase inhibitor indicated for adult patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet, to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) (see additional safety information provided below). ZYPITAMAGTM was approved in 2017 by the U.S. Food and Drug Administration for sale and marketing in the United States and was launched by Medicure in the second quarter of 2018 through a license agreement it had entered into with Zydus. "This acquisition of ZYPITAMAGTM fits well with Medicure's mission of being a significant cardiovascular company focused on the U.S. market," commented Medicure's CEO, Dr. Albert D. Friesen.  "We look forward to growing the ZYPITAMAGTM brand as part of our portfolio of cardiovascular products." ]]> https://biospectrumindia.com/news/57/14797/sobi-to-acquire-dova-pharma-expands-haematology-platform.html https://biospectrumindia.com/news/57/14797/sobi-to-acquire-dova-pharma-expands-haematology-platform.html Mon, 30 Sep 2019 17:05:00 +0530 Swedish Orphan Biovitrum AB (SOBI) has announced a definitive agreement to acquire Dova Pharmaceuticals, by means of a tender offer. The consideration consists of an upfront payment of USD 27.50 per share in cash and, one non-tradeable Contingent Value Right (CVR). The CVR entitles Dova shareholders to an additional USD 1.50 per share upon approval of Doptelet® for use in Chemotherapy-Induced Thrombocytopenia (CIT) by the US Food and Drug Administration (FDA). The upfront cash component of the offer represents a premium of 36 per cent based on Dova's most recent closing price of USD 20.19. The transaction is valued at up to USD 915 million (approximately SEK 9.0 billion) on a fully diluted basis. The acquisition of Dova provides Sobi with Doptelet (avatrombopag), a differentiated on-market product in Chronic Immune Thrombocytopenia (ITP), a well established and growing market, for Chronic Liver Disease (CLD) and an ongoing phase 3 trial in Chemotherapy Induced Thrombocytopenia (CIT) The acquisition of Dova will broaden the scope of Sobi's product portfolio into haematology and enhance Sobi's commercial presence in the United States Doptelet will further diversify Sobi's revenue base adding a new growth driver Sobi will leverage its expertise and existing infrastructure in haematology to grow Doptelet across its indications by expanding patient access outside the US. The current TPO market is estimated at USD 2.0 billion and represents an attractive commercial opportunity. Doptelet's recent launch in ITP in the US is a first step to capturing significant market share in the mid-term. In addition, Doptelet has the potential to become the first-to-market drug to treat CIT. "The cadence of upcoming launches and approvals across indications and regions that Doptelet provides, enables us to further accelerate growth in our haematology franchise", said Guido Oelkers CEO and President at Sobi. "There is a large unmet medical need within thrombocytopenia and for us this is a great opportunity to be able to give patients access to new and improved treatments. Furthermore, we are excited to welcome the 125 professionals from Dova who will greatly strengthen Sobi's haematology infrastructure and broaden our value chain in the US." ]]> https://biospectrumindia.com/news/57/14785/new-nih-program-provides-treatment-for-inherited-blood-and-immune-diseases.html https://biospectrumindia.com/news/57/14785/new-nih-program-provides-treatment-for-inherited-blood-and-immune-diseases.html Fri, 27 Sep 2019 16:45:00 +0530 People with inherited diseases of the blood and immune system can now receive treatment at the National Institutes of Health Clinical Center through a new, streamlined program that integrates expertise from many medical specialties and related basic science disciplines. Immunologists, transplant specialists, geneticists and hematologists from across NIH are collaborating in the Blood and Immune Deficiency–Cellular Therapy Program (BID–CTP). These physicians will deliver state-of-the-art and experimental care to people with rare blood and immune system diseases through a unified approach to assessing, treating and monitoring patients and the centralized tracking of treatment outcomes. The initiative spans four NIH institutes: the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Human Genome Research Institute and the National Heart, Lung and Blood Institute (NHLBI). Theresa Jerussi, PA-C, of the NIH Clinical Center is chief operating officer of the program.    “The BID–CTP has the potential to accelerate progress in the treatment of people with genetic diseases of the blood and immune system, which can be debilitating and even life-threatening,” said NIAID Director Anthony S. Fauci. “The close clinical and scientific collaboration within this program aims to foster advances that improve the lives of patients with these diseases.” Inherited diseases of the immune system are known as primary immune deficiency diseases, or PIDDs. NIH physicians have a strong track record of successfully treating PIDDs. They have developed several therapies and have discovered previously unrecognized PIDDs. Now, people with any one of hundreds of different PIDDs can enroll in the BID–CTP, and a single, multi-specialty team including both immunologists and transplant experts will oversee their treatment and care. In addition, basic scientists and clinicians are collaborating on detailed molecular and cellular assessments of the extent to which treatment restores each patient’s immune function. Multidisciplinary teams are studying issues that transcend individual PIDDs, such as the detection and management of infections, to improve patient safety and treatment outcomes. New diseases are continually being added to the program, which includes sickle cell disease, a group of inherited blood disorders for which NIH has a successful gene therapy program.  It is anticipated that the BID–CTP will become a strong component of the Primary Immune Deficiency Treatment Consortium, an NIH-supported network of 42 centers in North America with the goal of improving health outcomes of patients with rare, life-threatening, inherited disorders of the immune system. NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.  ]]> https://biospectrumindia.com/news/57/14780/bactiguard-inks-global-license-pact-with-zimmer-biomet.html https://biospectrumindia.com/news/57/14780/bactiguard-inks-global-license-pact-with-zimmer-biomet.html Fri, 27 Sep 2019 15:00:00 +0530 Stockholm headquartered Bactiguard has entered into an exclusive, global license agreement for orthopedic trauma implants with US based Zimmer Biomet. The agreement includes an upfront license fee of USD 3 million payable at signing, additional contingent payments of USD 2 million, based on U.S. regulatory clearance and royalties on net sales following commercialization. "Our new, global partnership has the potential of expanding Bactiguard's current license business significantly and making a substantial contribution to our license revenues, both in the near term and in a longer perspective. It also confirms the value of the Bactiguard technology in a new application and global context, which makes me both happy and proud," says Christian Kinch, CEO. Orthopedic trauma implants with Bactiguard's infection preventive technology were CE marked in December 2018 and will be used as a reference in the process of obtaining regulatory clearance. According to the Orthopaedic Industry Annual Report®, the global orthopedics market was valued at USD 51 billion in 2018, where the orthopedic trauma segment accounted for 14 percent of those sales. In 2018, Zimmer Biomet generated net sales of close to USD 8 billion. ]]> https://biospectrumindia.com/news/57/14778/nih-to-accelerate-progress-in-tb-vaccine-development.html https://biospectrumindia.com/news/57/14778/nih-to-accelerate-progress-in-tb-vaccine-development.html Fri, 27 Sep 2019 10:50:00 +0530 The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded $30 million in first-year funding to establish new centers for immunology research to accelerate progress in tuberculosis (TB) vaccine development. New and improved TB vaccines are badly needed. Over the past 200 years, TB has claimed the lives of more than 1 billion people—more deaths than from malaria, influenza, smallpox, HIV/AIDS, cholera and plague combined. TB is the world’s leading infectious cause of death and remains a major global health concern. TB is caused by the bacterium Mycobacterium tuberculosis (Mtb), which spreads from person to person through airborne transmission. Nearly one-quarter of the world’s population has latent Mtb infection, meaning they carry the bacteria in an inactive form but are not ill and do not transmit Mtb to others. People with latent TB have a 5 to 10% lifetime risk of developing active TB disease. The probability of developing active TB is considerably higher in those who are immunocompromised. The new contract awards establish and provide up to seven years of support for three Immune Mechanisms of Protection Against Mycobacterium tuberculosis (IMPAc-TB) Centers to elucidate the immune responses needed to protect against Mtb infection. A better understanding of TB immunology is critical to guide the design and development of new and improved TB vaccines, and aligns with the goals of the NIAID Strategic Plan for Tuberculosis Research. Existing BCG vaccines provide some protection to infants and young children against disseminated TB disease, in which the infection has spread to multiple organs. However, these vaccines do not prevent lung infections or provide long-term protection against Mtb infection. The IMPAc-TB program aims to develop a comprehensive understanding of the immune responses required to prevent initial infection with Mtb, establishment of latent infection, and transition to active TB disease. To accomplish these objectives, multi-disciplinary research teams will analyze immune responses against Mtb, as well as immune responses elicited by promising vaccine candidates, in animal models and humans. Other aims of the IMPAc-TB program include understanding the effects of co-infections such as HIV on immune responses to Mtb infection or TB vaccination and improving the value of animal models in predicting Mtb vaccine efficacy in humans.   The following three institutions were awarded the new contracts: Harvard T.H. Chan School of Public Health, BostonPrincipal investigators: Sarah Fortune, M.D. (Harvard); Henry Boom, M.D. (Case Western Reserve University, Cleveland); JoAnne Flynn, Ph.D. (University of Pittsburgh)            Infectious Disease Research Institute (IDRI), SeattlePrincipal investigator: Rhea Coler, Ph.D. Seattle Children’s HospitalPrincipal investigator: Kevin Urdahl, M.D., Ph.D. ]]> https://biospectrumindia.com/news/57/14765/bayer-bwh-mgh-open-joint-lab-for-research-.html https://biospectrumindia.com/news/57/14765/bayer-bwh-mgh-open-joint-lab-for-research-.html Thu, 26 Sep 2019 10:00:00 +0530 Bayer and Partners HealthCare’s founding members Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) have announced the launch of a joint lab to research new drug candidates to treat chronic lung diseases. The joint lab will host scientists from all three parties and Bayer is investing more than $30 million to fund joint research projects over the next five years. Chronic lung disease is a broad term for a number of diseases of the airways and other structures of the lung, including chronic obstructive pulmonary disease (COPD). About 65 million people suffer from COPD and 3 million die from it each year, making it the third leading cause of death worldwide. Within the framework of this new collaboration, four leading experts will combine their expertise in the search for new treatment options for patients who suffer from chronic lung diseases: Edwin Silverman, MD, PhD, Chief of the Channing Division of Network Medicine at BWH, Bruce Levy, MD, Chief of Pulmonary and Critical Care Medicine at BWH, Benjamin Medoff, MD, Chief of Pulmonary and Critical Care at MGH, Markus Koch, PhD, Head of Preclinical Research, Lung Diseases at Bayer. “This strategic collaboration complements our in-house research and will bring us closer to providing life-changing treatment options for patients living with chronic lung diseases,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceuticals Division and Head of Research and Development. “The joint lab concept continues to be an innovative model for collaboration between academia and industry, enabling novel approaches to drug discovery.” “We strongly believe that this model will significantly accelerate the pace of discovery toward the goal of getting new therapies from the lab to patients safely and efficiently,” said Paul Anderson, MD, PhD, SVP and Chief Academic Officer, Brigham and Women’s Hospital. “This collaboration provides the opportunity to integrate novel findings directly into the drug development pipeline, thus speeding up the time to move a new treatment into the clinic.” Scientists will work side-by-side, combining Bayer’s capabilities in drug discovery and development with the complementary clinical expertise, understanding of disease mechanisms, data analysis capabilities and insights from leading physician scientists of Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH). The lab, located at Brigham and Women’s Hospital, will see more than 20 people from all three organizations work in combined teams. The rights to the research findings will be shared equally between the organizations. ]]> https://biospectrumindia.com/news/57/14766/vitrakvi-receives-first-tumor-agnostic-approval-in-eu.html https://biospectrumindia.com/news/57/14766/vitrakvi-receives-first-tumor-agnostic-approval-in-eu.html Wed, 25 Sep 2019 15:25:00 +0530 Bayer has announced that the European Commission has granted marketing authorization in the European Union (EU) for the precision oncology treatment Vitrakvi® (larotrectinib). The drug is indicated for the treatment of adult and pediatric patients with solid tumors that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.  Vitrakvi, a first-in-class oral TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, is the first treatment in the EU to receive a tumor-agnostic indication. Vitrakvi has demonstrated high response rates and durable responses in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. It is already approved in the U.S., Brazil and Canada. “With this first-ever tumor-agnostic approval in the EU, physicians in Europe now have the option to replace less tailored treatment approaches with a precision oncology treatment exclusively designed to treat tumors that have an NTRK gene fusion – a rare cancer which affects both children and adults and occurs in varying frequencies across various tumor types,” said Prof. Jesus Garcia-Foncillas, Director of the University Cancer Institute and the Department of Oncology at the University Hospital “Fundacion Jimenez Diaz” and Professor of Oncology at the Autonomous University of Madrid, Director of the Translational Oncology Division at the Health Research Institute FJD-UAM and Coordinator of the Comprehensive Cancer Program of four University Hospitals in Madrid. “Existing therapies commonly used to treat TRK fusion cancer patients such as chemotherapy or immuno-oncology therapies have shown limited efficacy, and may have significant side effects. With Vitrakvi, we have seen rapid, robust and durable responses with a consistent and manageable safety profile in patients with TRK fusion cancer, regardless of the age of the patient or where in the body the tumor is located.” TRK fusion cancer is rare overall, affecting no more than a few thousand patients across Europe annually. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.  Larotrectinib, an oral, highly selective TRK inhibitor, was investigated in clinical trials across 29 different histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, soft tissue sarcomas, salivary gland and infantile fibrosarcoma. The compound has shown efficacy in primary CNS tumors as well as patients with brain metastases, across age or tumor histology. “The approval of Vitrakvi® in the EU, a first-of-its-kind treatment exclusively designed for adults and children with TRK fusion cancer, represents a meaningful advancement in the fight against cancer, as it treats the oncogenic driver that causes tumor spread and growth, rather than where the tumor originates in the body,” said Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. “Cancer care is currently undergoing a paradigm shift and as this new era of precision oncology treatment unfolds, we are continuing our effort of delivering innovative medicines such as Vitrakvi, which can provide value to patients and their treating physicians around the world.” “As researchers learn more about tumor genomics, precision oncology treatments that directly address the genomic abnormality driving tumor growth become increasingly relevant for patients. We now have the tools to move beyond a one-size fits all treatment approach,” said Marcia K. Horn, President and CEO of ICAN, the International Cancer Advocacy Network. “We welcome the approval of Vitrakvi for patients with TRK fusion cancer in the EU, which also underscores the importance of implementing consistent, widespread high quality molecular testing into the clinical practice to identify more patients through genomic insights and ultimately benefit their care.” ]]> https://biospectrumindia.com/news/57/14756/abbvie-to-present-new-and-updated-data-from-22-abstracts.html https://biospectrumindia.com/news/57/14756/abbvie-to-present-new-and-updated-data-from-22-abstracts.html Tue, 24 Sep 2019 13:35:00 +0530 AbbVie , a research-based global biopharmaceutical company, has announced experts in the neuroscience field will present results from two late-breaking abstracts, including final data from the Phase 1b study evaluating the safety and tolerability of the investigational medicine ABBV-951 in patients with advanced Parkinson's disease (PD), and data from the real-world DUOGLOBE study, evaluating the effect of DUODOPA® (levodopa/carbidopa intestinal gel) in patients with advanced Parkinson's disease. In total, 22 abstracts featuring new and updated data evaluating AbbVie's neuroscience portfolio and pipeline will be presented at the 2019 International Congress of Parkinson's Disease and Movement Disorders®, September 22-26 in Nice, France. The Phase 1b study evaluating ABBV-951 was designed to determine the safety and tolerability of ABBV-951, an investigational solution of levodopa/carbidopa delivered through continuous subcutaneous infusion (CSCI) in patients with advanced Parkinson's disease. A Phase 3 study evaluating the safety and tolerability of ABBV-951 (NCT-03781167) CSCI over 24 hours per day is currently enrolling patients. The design of the Phase 3 study will be presented as a poster at the congress. The multinational, real-world observational study, DUOGLOBE, was designed to evaluate the effect of DUODOPA on motor symptoms/motor complications (including "off" time and dyskinesia), quality of life (QoL) and caregiver burden, in patients with advanced PD who were treated with DUODOPA in routine clinical practice. Duodopa is indicated for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. "Our research presented at the congress demonstrates our longstanding commitment to developing and delivering science that will make a difference in the lives of people with Parkinson's disease and other neurodegenerative conditions," said Michael Gold, M.D., vice president, neuroscience development, AbbVie. "We are excited to share this latest data with leading researchers around the world as we take a few steps closer to potentially providing patients with much needed additional treatment options." Other data presentations include the pharmacokinetics of ABBV-951, the impact of progressive supranuclear palsy (PSP) on healthcare resource utilization and PSP caregivers, and several studies examining DUODOPA in advanced PD patients in a variety of clinical and real-world settings, including its impact on motor symptoms when using wearable sensors, its utilization in patients being treated with add-on therapies, and in patients with non-motor symptoms. Abstracts demonstrating the prevalence, impact and burden of PD will also be presented.  ]]> https://biospectrumindia.com/news/57/14753/mercks-pifeltro-and-delstrigo-get-fda-permission-to-treat-hiv-1-.html https://biospectrumindia.com/news/57/14753/mercks-pifeltro-and-delstrigo-get-fda-permission-to-treat-hiv-1-.html Tue, 24 Sep 2019 12:00:00 +0530 Merck has announced that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO™ (in combination with other antiretroviral agents) and DELSTRIGO™ (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to PIFELTRO or the individual components of DELSTRIGO. PIFELTRO (doravirine, 100 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral agents. DELSTRIGO is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). DELSTRIGO contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B virus (HBV) infection. DELSTRIGO and PIFELTRO do not cure HIV-1 infection or AIDS. PIFELTRO and DELSTRIGO were approved in the United States on August 30, 2018 for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history.  “Thanks to developments in HIV science, more treatment options are becoming available to address the medical needs of people living with HIV,” said Dr. Princy Kumar, Chief, Division of Infectious Diseases and Tropical Medicine at MedStar Georgetown University Hospital and Professor of Medicine and Microbiology, Georgetown University School of Medicine, Washington, D.C. “The expanded indications offer certain people with HIV-1 infection, and their doctors, the choice to switch their current antiretroviral therapy to DELSTRIGO or PIFELTRO in combination with other antiretroviral agents.” “Today’s approvals provide doravirine treatment options for people living with HIV-1 who are virally suppressed, reflecting Merck’s continued commitment to research and development of HIV treatments,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, Global Clinical Development, Merck Research Laboratories. “We are thankful to the researchers and HIV community for their collaboration that made this possible.” ]]> https://biospectrumindia.com/news/57/14736/boehringer-ingelheim-puts-focus-on-novel-therapies-for-retinal-diseases.html https://biospectrumindia.com/news/57/14736/boehringer-ingelheim-puts-focus-on-novel-therapies-for-retinal-diseases.html Tue, 24 Sep 2019 10:00:00 +0530 German player Boehringer Ingelheim and US based Inflammasome Therapeutics Inc. (Inflammasome) have announced that they have entered into a co-development and license agreement to develop up to three therapies for patients with retinal diseases. By combining Inflammasome’s unique intravitreal (IVT) drug delivery technologies with Boehringer Ingelheim’s compounds from its retinal disease pipeline portfolio, Boehringer Ingelheim aims to develop novel therapies for retinal diseases. Boehringer Ingelheim takes a holistic approach in the development of novel retinal disease therapies, targeting key mechanisms in the pathogenesis of retinal diseases. The company has built a comprehensive pipeline portfolio of next generation therapy approaches in various stages of development up to Phase 2 in macular degeneration, diabetic retinal diseases and beyond. Inflammasome’s novel delivery technology using a long-acting degradable IVT implant complements this portfolio. Inflammasome is entitled to receive up to $160 million in up-front, research and development support and milestone gated development payments as well as tiered royalties based on future commercial sales of developed products and other milestones due on commercialization. ]]> https://biospectrumindia.com/news/57/14747/biomed-x-completes-research-collaboration-with-roche.html https://biospectrumindia.com/news/57/14747/biomed-x-completes-research-collaboration-with-roche.html Mon, 23 Sep 2019 18:25:00 +0530 BioMed X has announced the completion of their first research collaboration project with Roche Diagnostics in the field of nanomaterial-based biosensors for near patient testing. BioMed X successfully achieved the proof of principle for a new sensor platform allowing the analysis of several different parameters from blood samples with one single device. The project was initiated in 2015 as a call for application using BioMed X’s proprietary crowd sourcing platform for project proposals. As a result of an international innovation challenge, a team of early-career researchers from five different countries worked in Heidelberg on the design of a field effect transistor-based multimodal sensing platform for proteins, blood gases and electrolytes, metabolites and enzymes with a single-use disposable material for point-of-care diagnostics. “We offer fully equipped state-of-the-art research labs and a lot of support, so our scientist can allocate their full attention to the scientific project.” says Dr. Christian Tidona, founder and Managing Director of BioMed X. “As we are very well connected within the regional life science cluster in Heidelberg, we have access to the research infrastructure of local institutions. For this particular project, we initiated a collaboration with InnovationLab in Heidelberg, to use their clean room facilities for the design and fabrication of our sensors.” The team successfully demonstrated the first highly sensitive label-free detection of thyroid-stimulating hormone (TSH) in undiluted human serum on a new FET sensor design based on gold and graphene. A fundamental limit to previous sensor designs, known as Debye screening, was overcome by specific modification of the sensor surfaces. Meanwhile the sensor design has been further refined and the goal was met to show proof-of-principle for the multimodal sensing platform allowing detection of multiple analytes from whole human blood samples. Following BioMed X’s strategy, the intellectual property (IP) and know-how has been transferred to Roche Diagnostics for further development. ]]> https://biospectrumindia.com/news/57/14739/countries-must-invest-at-least-1-more-of-gdp-on-primary-health-care-to-eliminate-coverage-gaps-who.html https://biospectrumindia.com/news/57/14739/countries-must-invest-at-least-1-more-of-gdp-on-primary-health-care-to-eliminate-coverage-gaps-who.html Mon, 23 Sep 2019 11:20:00 +0530 Countries must increase spending on primary healthcare by at least 1% of their gross domestic product (GDP) if the world is to close glaring coverage gaps and meet health targets agreed in 2015, said a new report from the World Health Organization and partners on the eve of a UN General Assembly high-level meeting on Universal Health Coverage. They must also intensify efforts to expand services countrywide The world will need to double health coverage between now and 2030, according to the Universal Health Coverage Monitoring Report. It warns that if current trends continue, up to 5 billion people will still be unable to access health care in 2030 – the deadline world leaders have set for achieving universal health coverage. Most of those people are poor and already disadvantaged. Primary health care key to health for all Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, “If we are really serious about achieving universal health coverage and improving people’s lives, we must get serious about primary health care. That means providing essential health services like immunization, antenatal care, healthy lifestyle advice as close to home as possible – and making sure people do not have to pay for this care out of their own pockets.” Investing an additional USD200 billion a year on scaling up primary health care across low and middle-income countries would potentially save 60 million lives, increase average life expectancy by 3.7 years by 2030, and contribute significantly to socio-economic development. It would represent about 3% increase on the USD7.5 trillion already spent on health globally each year. Most of that funding would come from countries themselves. The report says that most countries can scale up primary health care using domestic resources – either by increasing public spending on health in general, or by reallocating spending towards primary health care – or by doing both.  At present, most countries are underinvesting in primary health care. But for the poorest countries, including many affected by conflict, this may not be feasible. These countries will continue to require assistance from outside. This funding must be carefully targeted to result in a lasting improvement to health systems and services – via a systematic strengthening of primary health care countrywide. Accelerate scale-up of services Countries must also renew efforts to scale up service coverage countrywide. Although coverage has increased steadily since 2000, progress has slowed down in recent years. Most increases have occurred in lower income countries, but these countries are still lagging behind. The biggest health service gaps are in the poorest countries and those affected by conflict. Henrietta Fore, UNICEF Executive Director said, “Too many women and children continue to die from easily preventable and treatable causes simply because they can’t get the care they need to survive. By working with communities to provide primary health care to the poorest and the most vulnerable, we can reach the last mile and save millions of lives.” Coverage is generally lower in rural areas than in towns. The report cites lack of health infrastructure, shortages of health workers, weak supply systems, and poor-quality care leading to low trust among communities as major obstacles to achieving UHC. Natalia Kanem, Executive Director of UNFPA said, “Improving and expanding primary health care in all regions is key. It’s the best way to ensure people can obtain services to cover the majority of their health needs from pre-birth throughout their lives.” Dr. Muhammad Pate, Global Director, Health, Nutrition, and Population at the World Bank said, “The goal of universal health coverage will remain elusive unless countries take urgent steps to protect people from falling into poverty to pay for essential health care. Expanding access to quality primary health care services will save more lives and keep health care costs affordable.” Angel Gurria, Secretary General of the OECD said, “It’s shocking to see a growing proportion of the population struggling to make ends meet because they are paying too much for their own health, even in advanced economies. The only places where this is not happening is in countries that invest more and more effectively in health.” More people are suffering the consequences of paying for services out of their own pockets than 15 years ago. About 925 million people spend more than 10% of their household income on healthcare; 200 million people spend more than 25% of their income on health. And impoverishment due to paying for health care increased except among the extremely poor.     ]]> https://biospectrumindia.com/news/57/14729/vbi-vaccines-announces-pricing-of-35m-public-offering.html https://biospectrumindia.com/news/57/14729/vbi-vaccines-announces-pricing-of-35m-public-offering.html Fri, 20 Sep 2019 16:10:00 +0530 VBI Vaccines Inc., a US based commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, has announced the pricing of its previously announced underwritten public offering of 70,000,000 common shares, at a public offering price of US$0.50 per share. VBI also granted the underwriters a 30-day option to purchase up to an additional 10,500,000 common shares at US$0.50 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately US$35 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about September 23, 2019, subject to satisfaction of customary closing conditions. Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as joint book-running managers, and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc., is acting as lead manager for the underwritten public offering. VBI intends to use the net proceeds from the offering to progress its pipeline programs including the completion of the global CONSTANT Phase 3 lot-to-lot consistency study, regulatory submissions, and pre-commercialization activities for Sci-B-Vac®, a trivalent hepatitis B vaccine, and for the continued clinical development of VBI-1901, a vaccine immunotherapeutic candidate for recurrent glioblastoma (GBM); VBI-2601, an immunotherapeutic candidate for chronic hepatitis B infection; and VBI-1501, a cytomegalovirus (CMV) vaccine candidate. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures. ]]> https://biospectrumindia.com/news/57/14725/inovio-receives-nih-funding-to-combat-antimicrobial-resistant-infection.html https://biospectrumindia.com/news/57/14725/inovio-receives-nih-funding-to-combat-antimicrobial-resistant-infection.html Fri, 20 Sep 2019 13:05:00 +0530 Inovio Pharmaceuticals has announced that the company and its collaborator The Wistar Institute have received a $4.6 million National Institutes of Health (NIH) grant in support of innovative research to tackle antimicrobial resistance (AMR) employing Inovio's DNA-encoded monoclonal antibodies (dMAb®) platform. Inovio is advancing a ground-breaking approach to combat multidrug-resistant infections based on Inovio's dMAbs. In a recent study, Inovio developed a targeted dMAb approach for AMR and demonstrated that these dMAbs can effectively control multidrug-resistant infection in animal models. The U.S. Centers for Disease Control and Prevention estimates that resistance to antibiotics causes 2 million illnesses and 23,000 deaths a year in the United States. Estimates of the impact of antimicrobial resistance on the U.S. economy include $20 billion in direct health-care costs, with additional indirect costs as high as $25 billion a year. Earlier this year, Inovio initiated the first human study of its dMAb product (INO-A002) to treat and prevent Zika virus infection. In addition to demonstrating safety and tolerability, this Zika study marks a major step towards the development of a broad range of Inovio's dMAb platform targeting cancer, infectious diseases, and inflammatory diseases. When delivered directly into the body, the genetic instructions provided by the designed synthetic antibody gene sequence instruct the body's cells to become the factory which manufactures the therapeutic antibody (dMAb) products, enabling a major leap in antibody technology. This $4.6 million NIH grant will support additional pre-clinical studies with the ultimate goal of initiating clinical development for its dMAb technology against antimicrobial-resistant infections. Inovio and its collaborators have developed dMAb technology by designing synthetic genetic sequences encoding functional monoclonal antibodies into an optimized DNA platform. These gene sequences are administered in vivo to be expressed locally at the site of injection. The recipient receives a gene-encoded blueprint instructing their cells to produce the encoded monoclonal antibody specifically targeting the bacteria. Inovio's dMAbs can be developed simply and quickly and are produced directly in the patient, dramatically lowering production timeline and costs associated with the manufacturing of conventional antibodies; furthermore, DNA plasmids encoding for antibodies do not require expensive cold chain storage and are suitable for delivery in combinations. Traditional monoclonal antibodies represent the largest segment of pharmaceutical markets today, accounting for more than $100 billion in sales each year, with treatments spanning cancer, infectious diseases, inflammation, and cardiovascular diseases. With its synthetic design and in-patient production, dMAb products represent a disruptive entrant to this important class of pharmaceuticals. Inovio and its collaborators have already received over $60 million in non-dilutive grant funding to advance its dMAb platform in the last few years. There is a significant interest in dMAb as a disruptive entrant to a highly valuable overall monoclonal antibody market as well as its unique applicability for rapid responses against emerging global infectious disease threats. ]]> https://biospectrumindia.com/news/57/14715/fda-grants-fast-track-designation-for-farxiga-in-heart-failure.html https://biospectrumindia.com/news/57/14715/fda-grants-fast-track-designation-for-farxiga-in-heart-failure.html Thu, 19 Sep 2019 16:55:00 +0530 AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The FDA’s Fast Track programme is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Heart failure affects approximately 64 million people worldwide, and about half will die within five years of diagnosis. This Fast Track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients.” The Fast Track designation is based on two Phase III trials, DAPA-HF and DELIVER, which investigated the role of Farxiga in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively. Farxiga is currently approved as a monotherapy and as part of combination therapy to improve glycaemic control in adults with type-2 diabetes (T2D). In August 2019 the FDA granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease. ]]> https://biospectrumindia.com/news/57/14714/astrazeneca-amends-collaboration-with-ironwood-for-linzess-.html https://biospectrumindia.com/news/57/14714/astrazeneca-amends-collaboration-with-ironwood-for-linzess-.html Thu, 19 Sep 2019 16:00:00 +0530 AstraZeneca has amended its collaboration agreement with Ironwood Pharmaceuticals, Inc. (Ironwood) in China mainland for Linzess* (linaclotide), a first-in-class new treatment for patients with irritable bowel syndrome with constipation (IBS-C). IBS-C is characterised by symptoms of abdominal pain and constipation, is a chronic and prevalent functional gastrointestinal disorder in China and there are currently few treatment options for this condition. The amended agreement gives AstraZeneca sole responsibility for developing, manufacturing and commercialising Linzess in China mainland, China Hong Kong and China Macau. Ironwood will no longer be involved in the research and development or the commercialisation of Linzess; it will also transfer manufacturing responsibility to AstraZeneca. The two companies first entered into a collaboration to co-develop and co-commercialise Linzess in 2012. Under the original collaboration agreement, AstraZeneca and Ironwood were jointly responsible for strategic oversight of the development and commercialisation of Linzess in China, while AstraZeneca had primary responsibility for local operational execution. Linzess was approved by the National Medical Products Administration for adults with IBS-C in January 2019 in China, where it is expected to be launched in 2019. ]]> https://biospectrumindia.com/news/57/14711/eu-who-join-forces-to-promote-benefits-of-vaccines.html https://biospectrumindia.com/news/57/14711/eu-who-join-forces-to-promote-benefits-of-vaccines.html Thu, 19 Sep 2019 13:55:00 +0530 The European Commission and the World Health Organization (WHO) recently co-hosted the world's first Global Vaccination Summit in Brussels. The aim is to accelerate global action to stop the spread of vaccine-preventable diseases, and advocate against the spread of vaccine misinformation worldwide. Jean-Claude Juncker, President of the European Commission, said: “It is inexcusable that in a world as developed as ours, there are still children dying of diseases that should have been eradicated long ago. Worse, we have the solution in our hands but it is not being put to full use. Vaccination already prevents 2-3 million deaths a year and could prevent a further 1.5 million if global vaccination coverage improved. Today's summit is an opportunity to address this gap. The Commission will continue to work with the EU's Member States in their national efforts and with our partners here today. This is a global challenge we must tackle together, and now.” Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said: “After many years of progress, we are at a critical turning point. Measles is resurging, and 1 in 10 children continues to miss out on essential childhood vaccines,” said Dr Tedros, “We can and must get back on track. We will only do this by ensuring everyone can benefit from the power of vaccines – and if governments and partners invest in immunization as a right for all, and a social good. Now is the time to step up efforts to support vaccination as a core part of health for all.” Opening the summit, President Juncker and Dr Tedros called for an urgent intensification of efforts to stop the spread of vaccine-preventable diseases such as measles. In the past 3 years, 7 countries, including 4 in the European region, have lost their measles elimination status. New outbreaks are the direct result of gaps in vaccination coverage, including amongst teenagers and adults who were never fully vaccinated. To tackle vaccination gaps effectively, the summit addressed the multiple barriers to vaccination, including rights, regulations and accessibility, availability, quality and convenience of vaccination services; social and cultural norms, values and support; individual motivation, attitudes, and knowledge and skills. The European Commission and the World Health Organization also urged for strong support of GAVI, the Global Vaccine Alliance. GAVI plays a critical role in achieving the global vaccine goals in the world's least-resourced countries. New models and opportunities for stepping up vaccine development are also on the Global Vaccination Summit agenda, as well as ways to ensure that immunisation is a public health priority and a universal right. ]]> https://biospectrumindia.com/news/57/14704/askbio-acquires-assets-from-rovermed-biosciences.html https://biospectrumindia.com/news/57/14704/askbio-acquires-assets-from-rovermed-biosciences.html Wed, 18 Sep 2019 14:30:00 +0530 Asklepios BioPharmaceutical (AskBio), a fully integrated Adeno-Associated Virus (AAV) gene therapy platform company focused on providing curative therapeutics for genetic disorders, has acquired the technology assets of RoverMed BioSciences. RoverMed developed nanotechnology cargo delivery of therapeutics into the nucleus of diseased cells without affecting healthy cells. Under the terms of the agreement, AskBio will integrate the company's technology and assume all assets of RoverMed.  Consistent with AskBio's focus on meeting the challenges of gene therapy head-on, RoverMed's nanocapsule technology carries large or small molecules, naked DNA and/or viral particles across biological barriers and into the nuclei of the targeted cells, no matter where they are located in the body. This non-viral nanotechnology can potentially achieve unequalled delivery efficiency and precision targeting, as well as repeat administration to reach and treat diseases from inside the cell. "The addition of RoverMed technology provides us with another means for delivering therapeutic molecules, including large or small molecules, to increase stability and specificity and could enable entire new tissues and diseases to be reachable," said Sheila Mikhail, CEO of AskBio. "We continue to explore new technologies and expand therapeutic innovation to ensure that effective gene therapies for genetic disorders can be accessible to patients in need across the globe without limits." AskBio's integrated gene therapy platform includes an expansive capsid library, scaled Pro10™ manufacturing and new delivery methods to accelerate and lower the cost of end-to-end gene therapy processes and support its portfolio of curative therapeutics. ]]> https://biospectrumindia.com/news/57/14702/mylan-expands-oncology-portfolio-with-launch-of-generic-faslodex-injection.html https://biospectrumindia.com/news/57/14702/mylan-expands-oncology-portfolio-with-launch-of-generic-faslodex-injection.html Wed, 18 Sep 2019 13:00:00 +0530 Mylan N.V. has announced the U.S. launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, a generic version of AstraZeneca's Faslodex® Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used to treat certain types of advanced breast cancer in women who have experienced menopause as monotherapy and in advanced or metastatic breast cancer in combination with other products. "Mylan's launch of Fulvestrant Injection represents an important addition to our growing oncology portfolio and, more importantly, expands the available treatment options for women who are facing advanced or metastatic stages of breast cancer," said Mylan President Rajiv Malik. "The launch also reinforces our scientific expertise in bringing to market complex products, like injectables, which further enhances our institutional business and exemplifies our continued commitment to expanding access to medicine." Mylan is dedicated to supporting patients at every stage of cancer care with more than 50 oncology supportive care, therapeutic and diagnostic products in the U.S. Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, had U.S. sales of approximately $550 million for the 12 months ending June 30, 2019, according to IQVIA. Currently, Mylan has 151 ANDAs pending FDA approval representing approximately $88.4 billion in annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $59.2 billion in annual brand sales, for the 12 months ending June 30, 2019, according to IQVIA. Fulvestrant Injection is a prescription medicine used to treat women with: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), who have gone through menopause, in combination with ribociclib as their first endocrine therapy or after their cancer has progressed while on prior endocrine therapy HR-positive, HER2-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib whose disease has progressed after endocrine therapy ]]> https://biospectrumindia.com/news/57/14691/ppf-expands-investment-in-healthcare-sector.html https://biospectrumindia.com/news/57/14691/ppf-expands-investment-in-healthcare-sector.html Tue, 17 Sep 2019 15:55:00 +0530 PPF has announced the acquisition of a 19.2% stake in Autolus Therapeutics plc, a leader in next-generation T cell programming technologies. The shares were acquired in the market through NASDAQ. Autolus Therapeutics plc (“Autolus”) is a leader in T cell programming technologies and is developing a pipeline of next generation T cell therapies targeting both hematological cancers and solid tumors. Focused on the development of precisely targeted, controlled and highly active CAR-T cell products, Autolus aims to provide T cell therapies with very favorable safety profile and enhanced clinical efficacy to better recognize cancer cells, break down their defense mechanisms, and attack and kill these cells. The lead program AUTO1 is expected to enter a pivotal phase II study in patients with adult relapsed or refractory acute B lymphocytic leukemia (“adult ALL”) later this year with an anticipated filing for marketing authorization in 2021. With the investment into Autolus, PPF Group N.V. (“PPF”) significantly increased its commitment to the healthcare sector. Next to Autolus, PPF’s majority-owned biotechnology company SOTIO a.s. (“SOTIO”) is aiming to become a fully-integrated oncology specialty pharma company. Together with SOTIO, PPF have built a biotechnology portfolio through in-house research and development, investments, acquisitions and in licensing of products with companies like NBE-Therapeutics, Cellestia Biotech, Cytune Pharma or Lead Discovery Center. SOTIO is developing its proprietary dendritic cell-based cell therapy platform DCVAC and has a significant manufacturing and regulatory expertise in the domain of cellular therapies.  SOTIO also recently initiated a Phase I/Ib clinical trial with its interleukin-15 superagonist SO-C101. ]]> https://biospectrumindia.com/news/57/14683/bio-techne-attains-iso-certification-for-fbs-manufacturing-facility.html https://biospectrumindia.com/news/57/14683/bio-techne-attains-iso-certification-for-fbs-manufacturing-facility.html Tue, 17 Sep 2019 12:25:00 +0530 Bio-Techne Corporation has attained ISO 9001:2015 certification at its fetal bovine serum (FBS) and specialty media manufacturing facility in Flowery Branch, Georgia. ISO 9001:2015 is an international Business Quality Management System standard that is recognized globally as an indicator of quality excellence. This certification demonstrates Bio-Techne's commitment for providing high-quality serum and media that aligns with the quality excellence standards preferred by biotech, biopharmaceutical and pharmaceutical companies as well as academic researchers. In January 2018, Bio-Techne acquired Atlanta Biologicals, a leading provider of FBS, base media and cell culture supplements for academic research and development. Since the acquisition, Bio-Techne has invested heavily in quality systems and certifications for serum and cell culture products produced at the Atlanta Biologicals facility. This includes ISO9001:2015 certification, as well as an USDA APHIS (Animal Health and Plant Inspection Services)-certified manufacturing process for Optima FBS. By pursuing and successfully obtaining ISO and USDA APHIS certifications, Bio-Techne solidifies its commitment to supporting the serum needs of high-quality research, development and manufacturing. ]]> https://biospectrumindia.com/news/57/14674/nih-partners-with-apple-harvard-to-study-womens-health.html https://biospectrumindia.com/news/57/14674/nih-partners-with-apple-harvard-to-study-womens-health.html Mon, 16 Sep 2019 11:40:00 +0530 The National Institutes of Health (NIH), Apple, and the Harvard T. H. Chan School of Public Health announced their research partnership for a major long-term study of women’s health. The collaboration will permit researchers to study conditions including pregnancy, infertility, polycystic ovary syndrome (PCOS), menopausal transition, and osteoporosis. Apple’s new Research App will help users participate in the study and will be a free download in the App Store later this year. The intention is to improve women’s health by identifying the factors that impact women from around the country. This new study will connect academic medical institutions, healthcare organizations, and Apple products with the goal of contributing to medical science and helping to create the next generation of innovative health software.  The National Institute of Environmental Health Sciences (NIEHS), the NIH institute involved in the partnership, has several of the world’s leading scientists on women’s health and population studies. NIEHS will provide expert advice and data analysis for the Apple Women’s Health Study. ]]> https://biospectrumindia.com/news/57/14662/mayo-clinic-partners-with-google-for-healthcare-innovation.html https://biospectrumindia.com/news/57/14662/mayo-clinic-partners-with-google-for-healthcare-innovation.html Fri, 13 Sep 2019 09:00:00 +0530 Mayo Clinic and Google has announced a ten year strategic partnership recently to redefine how health care is delivered and accelerate the pace of health care innovation through digital technologies. Mayo Clinic selected Google Cloud to be the cornerstone of its digital transformation. Mayo will use advanced cloud computing, data analytics, machine learning and artificial intelligence (AI) to redefine health care delivery, bringing together global providers and consumers to make health care better. Gianrico Farrugia, M.D., president and CEO of Mayo Clinic said, "Data-driven medical innovation is growing exponentially, and our partnership with Google will help us lead the digital transformation in health care. It will empower us to solve some of the most complex medical problems; better anticipate the needs of people we serve; and meet them when, where and how they need us. We will share our knowledge and expertise globally while caring for people locally and always do it with a human touch." The extensive collaboration will combine the world-class clinical knowledge and expertise from Mayo Clinic with the industry-leading digital technology and data security expertise from Google to develop solutions for people who want medicine to deliver on the promise of scientific and technological advances. With the help of Google, Mayo Clinic will transform the way it advances virtual care with AI-enabled digital diagnostics. Mayo also will leverage Google technology to boost its ability to conduct medical research. Through this partnership, Mayo Clinic will be able to develop and deploy new machine learning models designed to improve treatment precision and clinical outcomes of diseases. Sundar Pichai, CEO, Google said, "We're proud to partner with the Mayo Clinic in its mission to bring the best health care to every patient. Health care is one of the most important fields that technology will help transform over the next decade, and it's a major area of investment for Google. By pairing the Mayo Clinic's world-class clinical expertise with our capabilities in AI and cloud computing, we have an extraordinary opportunity to develop services that will significantly improve lives." Google Cloud will secure and store Mayo Clinic's data, while working with Mayo Clinic to apply AI and other cloud computing technologies to solve complex health care problems. However, Mayo Clinic will continue to control access and use of its patient data by using Google's cloud technologies. Mayo Clinic will specifically authorize the use of data in projects to create new health care insights and solutions in conjunction with partners, including Google. Mayo Clinic will manage access to all data using rigorous long-standing institutional controls. Christopher Ross, chief information officer, Mayo Clinic said, "With one of the most robust sources of clinical insights in the world, Mayo Clinic is well-positioned to lead digital transformation in health care. Our partnership will propel a multitude of AI projects currently spearheaded by our scientists and physicians, and will provide technology tools to unlock the value of data and deliver answers at a scale much greater than today." Thomas Kurian, CEO, Google Cloud said, "As health care embraces digital innovation, management and analysis of complex data will become increasingly important. We are thrilled that Mayo Clinic has selected Google Cloud as the bedrock of its digital transformation. We look forward to helping the renowned medical center transform health care to serve patients around the world." Under the partnership, Google also will open a new office in Rochester, where its engineers will work side by side with Mayo Clinic researchers, physicians, and information technology staff and data scientists, to apply advanced computing techniques to health care problems.   ]]> https://biospectrumindia.com/news/57/14660/apple-announces-three-groundbreaking-health-studies.html https://biospectrumindia.com/news/57/14660/apple-announces-three-groundbreaking-health-studies.html Thu, 12 Sep 2019 12:00:00 +0530 Apple has announced three unprecedented medical studies, in partnership with leading academic and research institutions that will reach more participants than has ever been possible. The studies will be available on the new Research app which democratises how medical research is conducted by bringing together academic medical institutions, healthcare organisations and the Apple products customers already make a part of their everyday life. Participants will contribute to potential medical discoveries and help create the next generation of innovative health products. The Research app will be available as a free download in the App Store later this year. Jeff Williams, Apple’s chief operating officer said, “With the Apple Heart Study, we found that we could positively impact medical research in ways that help patients today and that make contributions that will benefit future generations.” The studies include:  Apple Women’s Health Study: In partnership with Harvard T.H. Chan School of Public Health and the NIH’s National Institute of Environmental Health Sciences (NIEHS), Apple has created the first long-term study of this scale focused on menstrual cycles and gynecological conditions. This study will inform screening and risk assessment of conditions like polycystic ovary syndrome (PCOS), infertility, osteoporosis, pregnancy and menopausal transition. Apple Heart and Movement Study: Apple is partnering with Brigham and Women’s Hospital and the American Heart Association on a comprehensive study of how heart rate and mobility signals — like walking pace and flights of stairs climbed — relate to hospitalizations, falls, heart health and quality of life in order to promote healthy movement and improved cardiovascular health. Apple Hearing Study: Alongside the University of Michigan, Apple is examining factors that impact hearing health. The Apple Hearing Health Study is the first of its kind to collect data over time in order to understand how everyday sound exposure can impact hearing. The study data will also be shared with the World Health Organisation (WHO) as a contribution toward its Make Listening Safe initiative. Apple’s support of the medical research community began with the introduction of ResearchKit and CareKit, which expanded the pace and scale at which healthcare could be studied and provided. Apple used ResearchKit to create the Apple Heart Study, which was the largest study of its kind and illustrated the impact virtual, large-scale studies can have on medical research by examining atrial fibrillation to provide validation for the irregular rhythm notification feature on Apple Watch. Michelle A. Williams, a reproductive epidemiologist and dean of the faculty at the Harvard T.H. Chan School said, “Women make up half of the world’s population, yet even today there has been limited investment in studying their unique health needs. This study, unprecedented in scope, will greatly advance our understanding of the biological and social determinants of women’s health, and lead to better health outcomes.” Dale Sandler, Ph.D., chief of the NIEHS Epidemiology Branch said, “This is an exciting opportunity for NIEHS researchers to contribute to the study design and use the resulting data to answer novel questions, not only important to women of reproductive age, but to women of all ages.” Calum MacRae, the vice chair of Scientific Innovation for the Department of Medicine at Brigham and Women’s Hospital and associate professor of Medicine at Harvard Medical School said, “We are excited to be working with all the study participants and with Apple to identify the features of complex human physiology that lead to different outcomes in wellness or chronic disease, and to use this information to empower individuals to maximise their own health.” Nancy Brown, CEO of the American Heart Association said, “At the American Heart Association, we are a relentless force for a world of longer, healthier lives, and we are committed to educating and empowering people to be proactive in all areas of their heart health and general well-being. We believe that emerging technology solutions that seek to provide deeper health insights offer great potential in getting us there. We are collaborating with Apple and Brigham and Women’s Hospital on the Apple Heart and Movement Study to explore the correlation between a broad range of physical activities and a person’s overall heart health to ultimately understand risks and interventions to improve health.” DuBois Bowman, dean of the University Of Michigan School Of Public Health said, “We are excited about this unique opportunity to partner with Apple to determine how everyday activities affect our hearing. The information gleaned from this partnership will be critical for us to address the public health impact of various noise exposures on hearing loss in the United States.” Dr. Shelly Chadha, technical officer of Prevention of Deafness and Hearing Loss at the World Health Organisation said, “The World Health Organisation is pleased to note the announcement of the Apple Hearing Study which will contribute toward our Make Listening Safe initiative by improving our understanding of users’ listening behaviours. With over a billion young people who could be at risk of hearing loss due to unsafe listening, WHO is addressing this challenge through raising awareness and setting new standards for safe listening. The knowledge gained through this study will contribute to future public health action in this field.”   ]]> https://biospectrumindia.com/news/57/14635/novo-nordisk-to-launch-insulin-affordability-offerings-in-jan-2020.html https://biospectrumindia.com/news/57/14635/novo-nordisk-to-launch-insulin-affordability-offerings-in-jan-2020.html Tue, 10 Sep 2019 09:05:00 +0530 Novo Nordisk is expanding the company's affordability offering in the US beginning January 2, 2020. People with diabetes experience different issues and complexities that can't be covered by one solution. That's why the company continues to bring forth programs that will directly benefit even more people with diabetes – including those with insurance and those without – as we work toward much needed longer-term systemic reform.  Expanded affordability options available on January 2, 2020 The new offerings will include: $99.00 Cash Card Program for Analog Insulins: Allows people with diabetes to purchase up to three vials or two packs of FlexPen®/FlexTouch® pens of any combination of Novo Nordisk analog insulins (3000 – 3600 Units total depending on brands) for a flat cost of $99.00. Studies and clinical experience suggest that is an adequate supply to cover the monthly needs of most people with diabetes. This program is being made available from the Novo Nordisk US affiliate Novo Nordisk Inc. (NNI) NovoLog® and NovoLog® Mix Follow-On Brands (also known as an authorized generic): Follow-on brand versions of NovoLog® and NovoLog® Mix will be made available from the newly established Novo Nordisk US affiliate Novo Nordisk Pharma Inc. (NNPI) The follow-on brands will be priced at a 50 percent discount compared to the current list price of the branded versions. NovoLog® is Novo Nordisk's most widely prescribed insulin, used by approximately one million people with diabetes in the US.  ]]> https://biospectrumindia.com/news/57/14636/spepharm-ag-wins-case-against-eisai-.html https://biospectrumindia.com/news/57/14636/spepharm-ag-wins-case-against-eisai-.html Mon, 09 Sep 2019 13:50:00 +0530 SpePharm AG, a subsidiary of Norgine B.V., announced that the United States District Court for the District of Delaware ruled on 4th September 2019 in favour of SpePharm in its proceeding against Eisai Inc., upholding SpePharm's licensed rights for SALAGEN® (pilocarpine hydrochloride) through April 2026. Judge Richard Andrews upheld SpePharm's position, finding that SpePharm properly exercised its option to extend its license agreement in 49 countries. Eisai Inc. purported to give notice of its intent to terminate SpePharm AG's exclusive licensed rights for SALAGEN, a drug used to treat dry mouth caused by radiation therapy for head and neck cancer and to treat dry mouth and dry eyes in individuals with Sjögren's syndrome, and had entered into an agreement to sell global rights to SALAGEN to Advanz Pharma Corp. The Court's decision confirms that SpePharm retains its rights in 49 countries in Europe and the Commonwealth of Independent States through April 2026. Speaking on behalf of SpePharm, Peter Stein (CEO of Norgine) said, "We are gratified that the Court speedily agreed with SpePharm's position and upheld SpePharm's rights to continue commercialising SALAGEN for the benefit of patients. We are disappointed that we had to resort to legal action against Eisai, however, SpePharm will vigorously defend its rights through all appropriate means."   ]]> https://biospectrumindia.com/news/57/14622/nih-launches-search-for-neuroprotective-stroke-therapies.html https://biospectrumindia.com/news/57/14622/nih-launches-search-for-neuroprotective-stroke-therapies.html Mon, 09 Sep 2019 09:05:00 +0530 Recently the National Institutes of Health (NIH) called on researchers to make the standards and practices for conducting early stage, or preclinical, medical research on animals more like those used for clinical trials. To facilitate this change, NIH will fund a nationwide preclinical trial platform designed to systematically and efficiently test novel treatments for acute ischemic stroke in rodents. Seven labs will work together, as part of the Stroke Preclinical Assessment Network (SPAN), to employ rigorous, clinical research practices, like randomization and blinding, while assessing the effectiveness of six potential neuroprotective therapies in reducing ischemic brain injury. The funding estimate for the network is $4 million over three years. “Our primary goal is to identify the most promising treatments for testing in patients with clinical trials,” said Walter J. Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke which supports SPAN. “In the long term, we hope that this approach will increase the chance of success in pairing a brain saving treatment with the current practice of clot removal used to treat patients with potentially fatal or disabling stroke.” The term “preclinical” refers to an early stage of medical research in which scientists working in labs explore the causes of diseases and novel ideas for treatments, often by recreating or modeling diseases in animals such as mice and rats. Over the past few decades this type of research has expanded in all areas of medicine including stroke. Ischemic stroke, a leading cause of disability and the fifth leading cause of death in the United States, happens when an artery in the brain becomes blocked, often by clots, and blood flow is stopped. Strokes can leave survivors with a variety of challenges including partial paralysis of the face and limbs, pain and speech and thinking problems. Current treatments aim to remove clots either by dissolving them with injections of the blood thinner tissue plasminogen activator or by direct extraction from the blocked blood vessel. While both treatments help patients recover, preclinical studies have suggested that there are several therapies that could potentially protect the brain against damage that occurs prior to or during successful reopening of the blocked blood vessel. However, it is not known whether any of these therapies will work in humans and many industry-funded trials failed during the 1990s before effective clot removal became a common treatment. “While we’ve made lot of progress in helping patients recover from ischemic strokes, studies in the lab suggest we can do more,” said Patrick D. Lyden, M.D., the Carmen and Louis Warschaw Chair in Neurology at Cedars Sinai Medical Center, Los Angeles, and the principle investigator of the coordinating center of the SPAN trial. “Over the years several labs have shown that therapies used for other diseases could also be repurposed to help patients recover from an ischemic stroke attack." Recent studies have shown that most promising preclinical ideas for treating strokes and other diseases often cannot be replicated in other labs and fail when researchers try to test or translate them into treatment for humans. To address these concerns, NIH has worked with scientific journals on a project called Rigor and Reproducibility to make standards for publishing preclinical research results more like those used for clinical trials. “This SPAN trial will take the principles laid out in NIH’s Rigor and Reproducibility guidelines one step further,” said Francesca Bosetti, Ph.D., Pharm. D., program director, NINDS. “The network will use clinical trial practices and standards to search for the neuroprotective stroke therapies that have the greatest potential for working in humans.” Specifically, SPAN researchers will test the effectiveness of six therapies for protecting the brain before and during clot removal after an ischemic stroke. The therapies have been approved by the U.S. Food and Drug Administration for treating other diseases, such as cancer and multiple sclerosis. All the experiments will be performed on rodents using the transient middle cerebral occlusion model of ischemic stroke. The trial will follow several critical clinical research practices such as randomization of treatments, large test sizes, blinded analysis and attempts to reproduce results in other network labs. The results will help researchers decide whether any of these therapies should be examined with Phase II clinical trials, which test in patients the efficacy or expected biological effects of a new drug as well as the risk of harmful side effects. In the future, SPAN may conduct further trials on novel treatments for stroke patients. “These labs have produced a lot of great ideas and promising preliminary data. It is our duty to patients to develop a system that rigorously tests and translates those ideas more effectively from bench to the bedside,” said Dr. Koroshetz. ]]> https://biospectrumindia.com/news/57/14621/scientists-develop-potential-strategy-against-leukemia-drug-resistance.html https://biospectrumindia.com/news/57/14621/scientists-develop-potential-strategy-against-leukemia-drug-resistance.html Fri, 06 Sep 2019 14:40:00 +0530 Scientists from the National Institutes of Health and Cincinnati Children’s Hospital Medical Center have devised a potential treatment against a common type of leukemia that could have implications for many other types of cancer. The new approach takes aim at a way that cancer cells evade the effects of drugs, a process called adaptive resistance. The researchers, in a range of studies, identified a cellular pathway that allows a form of acute myeloid leukemia (AML), a deadly blood and bone marrow cancer, to elude the activity of a promising class of drugs. They then engineered a compound that appears to launch a two-pronged attack against the cancer. In several experiments, the compound blocked a mutant protein that causes the AML. At the same time, it halted the cancer cells’ ability to sidestep the compound’s effects. Co-corresponding authors Daniel Starczynowski, Ph.D., at Cincinnati Children’s, Craig Thomas, Ph.D., at NIH’s National Center for Advancing Translational Sciences (NCATS) and their colleagues wanted to better understand drug resistance in a form of AML caused by a mutant protein called FLT3. This form of AML accounts for roughly 25% of all newly diagnosed AML cases, and patients often have a poor prognosis. A more thorough understanding of the drug resistance process could help them find ways to improve therapy options. FLT3 belongs to a class of enzymes called kinases. Kinases are proteins that play a role in cell growth and proliferation. When kinases work overtime, they can cause some cancers. Drugs that block kinase activity have been effective in treating cancers. While many of these drugs work initially, often in combination with other therapies, cancer cells frequently find ways to bypass the drugs’ effects and begin growing again. For many patients, this drug resistance can be deadly. FLT3 is always turned on in these cancer cells, sending chemical signals for the cells to grow and divide. Scientists have designed drugs to block FLT3 activity, but the AML cells eventually find ways to get the growth signals elsewhere.  To find out how this happens, Starczynowski’s team treated FLT3-mutant cancer cells grown in the laboratory with an inhibitor drug. The drug initially killed many cancer cells. The scientists closely examined the AML cells that survived, including genes that were turned on and off in the resistant cells. They found that the leukemia cells were now getting chemical growth signals from different protein kinases through a system normally used by the immune system to respond to viruses and other invaders. Experiments on AML cells from patients treated with a FLT3 inhibitor showed similar results. “We think that these leukemia cells were under stress from the FLT3 inhibitor drug because it was blocking the growth signals they badly wanted,” Starczynowski said. “The cells found another way to get these signals through another route that compensated for this, a complex of the kinases IRAK1 and IRAK4, which are involved in the immune system.” To prove their theory, the scientists, in a series of experiments on leukemia cell models in the lab and cells from leukemia patients, showed that inhibiting FLT3 and IRAK1-IRAK4 activity at the same time was more toxic to cells relative to only inhibiting FLT3.  To prevent this drug resistance, the NCATS team worked to block the activity of FLT3 and the IRAK kinases with a single compound. Starting with an IRAK4 inhibitor, they developed a compound that was effective against all three protein kinases. These efforts led to a new compound, NCGC1481, that could effectively block the activity of the kinases in both human cancer cells in the lab and mouse models with cancer cells from patients. (NCGC is an acronym for the NCATS Chemical Genomics Center.) “NCGC1481 not only stops the cancer cells’ growth caused by the mutant protein, but also blocks the cancer’s escape route,” said first author Katelyn Melgar, Ph.D. “The result is a compound with superior activity in the models we tested.” The findings may be broadly applicable to many other cancers as well. “There is already evidence that this may be a general cancer resistance mechanism to protein kinase inhibitor drugs,” Starczynowski said. “In theory, the use of drugs that affect many kinases at once, along with other kinds of cancer therapies, could be effective treatments.” ]]> https://biospectrumindia.com/news/57/14615/merck-foundation-launches-five-year-initiative-to-reduce-disparities-in-hiv-care.html https://biospectrumindia.com/news/57/14615/merck-foundation-launches-five-year-initiative-to-reduce-disparities-in-hiv-care.html Fri, 06 Sep 2019 12:00:00 +0530 The Merck Foundation (the Foundation) has launched HIV Care Connect, a $7 million, five-year initiative to help reduce disparities in access to care and improve health outcomes for persons with HIV living in vulnerable and underserved Southeastern U.S. communities. While new cases of HIV are on the decline in the U.S., HIV continues to disproportionately affect certain populations and geographic regions of the country. According to the U.S. Centers for Disease Control and Prevention, over half of all people newly diagnosed with HIV live in the U.S. South, with approximately three quarters of them identifying as people of color. To help improve the delivery of HIV care and address persistent health disparities, HIV Care Connect will support community-based programs that promote linkage to and long-term engagement in HIV care as well as foster multisectoral approaches to address the many factors outside the health system that affect access to high-quality care. “We need to accelerate solutions that address the growing disparities in patients’ access to HIV care and health outcomes, and focus on communities that are most affected,” said Dr. Julie Louise Gerberding, executive vice president and chief patient officer at Merck. “Through HIV Care Connect, the Merck Foundation is helping to catalyze collaboration among organizations across the southeastern United States and improve care coordination among people most affected by HIV.” The Foundation has selected the following organizations as HIV Care Connect program grantees. Care Resource (Miami, FL) Medical Advocacy and Outreach (Montgomery, AL) University of Mississippi Medical Center (Jackson, MS) The University of Alabama at Birmingham will serve as the National Program Office for HIV Care Connect. In this capacity, it will support the program efforts of the grantee organizations and provide leadership in building a public-private partnership to reduce disparities in HIV care. “We believe the HIV Care Connect initiative has the potential to be transformative in our region,” said Michael Mugavero, MD, MHSc, professor of medicine, University of Alabama at Birmingham (UAB) and co-director, UAB Center for AIDS Research. “The program will serve as a catalyst in advancing the objectives of the National HIV/AIDS Strategy and the Ending the HIV Epidemic Federal initiative.” HIV Care Connect program grantees will implement multifaceted, evidence-based programs to: Improve linkage to and retention in high-quality HIV care for populations most affected by HIV Build sustainable collaborations between the health care sector and other sectors to address barriers related to the social determinants of health Engage the community in program development to ensure that interventions are effectively tailored to address local needs Improve health outcomes for persons living with HIV, particularly in underserved communities The Foundation will support an independent evaluation to assess the impact of the HIV Care Connect initiative and its programs. A key goal will be to identify and promote best practices for improving the delivery of HIV care among vulnerable and underserved U.S. communities. Improving Access to Care Merck is committed to discovering smart, sustainable ways to expand global access to health care and, through the Merck Foundation, supports innovative partnerships and approaches to improve the health of vulnerable and underserved populations. The new HIV Care Connect initiative follows other investments by the Foundation to reduce health disparities and improve access to high-quality health care, such as the $16 million, five-year initiative Bridging the Gap in Diabetes Care. ]]> https://biospectrumindia.com/news/57/14611/vertex-pharma-to-acquire-semma-for-950-million-.html https://biospectrumindia.com/news/57/14611/vertex-pharma-to-acquire-semma-for-950-million-.html Thu, 05 Sep 2019 12:30:00 +0530 Vertex Pharmaceuticals Incorporated has entered into a definitive agreement under which Vertex will acquire Semma Therapeutics, a privately held biotechnology company pioneering the use of stem cell-derived human islets as a potentially curative treatment for type 1 diabetes, for $950 million in cash. Semma has demonstrated a differentiated approach to treat type 1 diabetes, a serious disease affecting over one million people in the United States alone. Semma has made two major scientific advances: the ability to produce large quantities of functional human pancreatic beta cells that restore insulin secretion and ameliorate hypoglycemia in animal models and a novel device that encapsulates and protects these cells from the immune system, enabling durable implantation without the need for ongoing immunosuppressive therapy.  “This acquisition aligns perfectly with our strategy of investing in scientific innovation to create transformative medicines for people with serious diseases in specialty markets,” said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex. “We are excited to work with the talented scientists at Semma to build on their significant progress toward providing effective and potentially curative cell therapy options for people living with type 1 diabetes. We see a substantial opportunity to transform the treatment paradigm for type 1 diabetes, a specialty disease cared for by endocrinologists, both by advancing the development and manufacturing of the cells themselves, as well as through the highly innovative cell/device combination.” “The therapeutic approach pioneered by Semma has the potential to address the causal human biology of type 1 diabetes, a serious disease inadequately controlled by existing therapies. Unlike insulin injections and insulin pumps, islet cell transplantation can provide physiologic regulation of blood glucose thereby potentially ameliorating or preventing both the hyperglycemic and hypoglycemic episodes associated with the current standards of care,” said David Altshuler, M.D., Ph.D., Executive Vice President, Global Research and Chief Scientific Officer of Vertex. “Their compelling proof-of-concept data in animals demonstrates the opportunity to develop transformative and potentially curative therapies to treat people with type 1 diabetes. In addition, the acquisition of Semma continues to expand the Vertex toolbox of cutting edge technologies and capabilities, and bolsters our team of leading scientists.”   ]]> https://biospectrumindia.com/news/57/14603/biocity-to-back-promising-self-care-venture-invests-in-maxwellia.html https://biospectrumindia.com/news/57/14603/biocity-to-back-promising-self-care-venture-invests-in-maxwellia.html Wed, 04 Sep 2019 15:05:00 +0530 BioCity, the pioneering life science incubator and business collective has invested in Maxwellia. The world’s first prescription (Rx) to Over the Counter (OTC) switch incubator, Maxwellia’s novel approach converts prescription drugs into versions that can be purchased without prescription from pharmacies and supermarkets; a process known as ‘switching’. As growing pressure and budget constraints are put upon the NHS, self-care, within therapeutics has been recognised as a future Public Health priority. Securing a GP appointment can be difficult with many not seeking treatment for manageable conditions because they do not want to ‘bother the Doctor’. The creation of new OTC products potentially enables quicker therapeutic outcomes for many, who may not previously have sought treatment. For the NHS, the shift towards self-care also supports the wider public health issues by freeing-up GP’s time. The consumer healthcare market is currently estimated at £2.6 billion in the UK and is growing, with nearly half of all UK adults needing help to self-care for treatable conditions2. The funding round was partially completed via the BioCity angel investment platform, in which BioCity co-invests alongside a collective of business angels. The investment will be used to support three innovative products in the areas of women’s health and healthy lifestyle that are currently in the pipeline at different stages, two of which are undergoing the approval process with the Medicines and Healthcare products Regulatory Agency (MHRA). Maxwellia, now based at Alderley Park, is the latest graduate to have gone on to successfully secure funding from BioCity and the angel investor collective. Specialists in early stage life science investments, BioCity has added several promising ventures to the portfolio since the beginning of the year and is quickly becoming a leading investor within the life sciences. BioCity investment analyst, Dr. Imelda Juniarsih said “Maxwellia are spearheading the move towards self-care therapeutics, their potential impact is vast. “By providing consumers with quicker, wider and more convenient access to medicines and reducing the burden felt by the NHS, Maxwellia could support and accelerate the move towards self-care and provide early intervention opportunities for some long-term conditions in the UK. The Maxwellia team, led by Anna Maxwell, has both the skills and the expertise to deliver and reach their goal of creating the big OTC brands of the future.” Anna Maxwell, Maxwellia CEO and founder said: “We are delighted to have the support of the BioCity fund and the benefits of their mentorship in this important phase of Maxwellia’s journey towards the commercialisation of our first approved product.” ]]> https://biospectrumindia.com/news/57/14602/allergan-gets-fda-nod-for-juvderm-voluma-xc-.html https://biospectrumindia.com/news/57/14602/allergan-gets-fda-nod-for-juvderm-voluma-xc-.html Wed, 04 Sep 2019 14:50:00 +0530 Allergan plc has received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA® XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE™ cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21. A cannula is a thin, flexible tube with a rounded tip that can serve as an effective delivery system. Use of a cannula allows for injection of Juvéderm VOLUMA® XC in the cheek area. The TSK STERiGLIDE™ has a unique design compared to other cannulas available on the market and features a patented tip design with a near-tip delivery port for precise product placement. "As a physician, I have used the Juvéderm Collection of Fillers for 13 years, so I am thrilled that the FDA has approved the use of cannula with Juvéderm VOLUMA® XC for mid-face volume deficit. With this latest approval, I have another effective option to provide volume and contour in the mid-face area. I can tailor my treatment approach for each patient while safely providing the aesthetic outcomes they wish to achieve," says Dr. Dee Anna Glaser, a board-certified dermatologist in St. Louis and clinical trial investigator. "At Allergan, we are committed to driving innovation in medical aesthetics as well as providing best-in-class injector training to our customers," says Carrie Strom, Senior Vice President of U.S. Allergan Medical Aesthetics. "With this approval, Allergan will be able to educate on facial anatomy and injection techniques that will help healthcare providers administer treatment with Juvéderm VOLUMA® XC safely to achieve optimal patient satisfaction." A multicenter, split-face, investigator-blinded, non-inferiority study was performed to assess the safety and effectiveness of Juvéderm VOLUMA® XC for correction of age-related volume deficit in the mid-face with the use of a TSK STERiGLIDE™ cannula versus a needle. The 12-week study took place in seven sites across the U.S. with 60 subjects. All subjects completed the study. Results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection. Within the Juvéderm Collection of Fillers, this is the first approval for the use of cannula. Juvéderm VOLUMA® XC was first approved by the FDA in 2013 and is formulated with Allergan's proprietary VYCROSS® technology, which blends different molecular weights of hyaluronic acid, contributing to the gel's duration and is proven to last in the mid-face area for up to 24 months with optimal treatment. Juvéderm VOLUMA® XC is currently the best-selling Juvéderm product in the US. ]]> https://biospectrumindia.com/news/57/14598/sandoz-announces-global-deal-to-market-natalizumab-.html https://biospectrumindia.com/news/57/14598/sandoz-announces-global-deal-to-market-natalizumab-.html Wed, 04 Sep 2019 13:15:00 +0530 Sandoz, a Novartis division and a global leader in biosimilars, has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under the agreement, Polpharma Biologics will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. Sandoz will commercialize and distribute the medicine in all markets upon approval, through an exclusive global license. Other specific terms of the agreement are confidential. Polpharma Biologics is a European biopharmaceutical company with a fully integrated R&D and manufacturing footprint. Reference medicine natalizumab is a disease-modifying therapy (DMT) that was approved for use over 10 years ago, offering patients a valuable therapeutic option for treating RRMS. In addition to the personal burden of MS for patients and families, affordability is a significant challenge for MS medicines globally. A recent report highlighted affordability as the most common challenge affecting access to MS therapy in 46% of the 90 countries included[1]. Elsewhere it has been highlighted that providing access to DMTs for MS represents a considerable challenge for healthcare systems[3]. Sandoz continues to expand the biosimilars marketplace and is committed to help millions of patients access biologic medicines sustainably and affordably. The addition of proposed biosimilar natalizumab expands the Novartis/Sandoz portfolio across small molecules, complex generics, biosimilars, and innovator medicines enabling broad patient access to patented and off-patent medicines. In addition to entering complex and underserved areas such as MS, Sandoz is already helping patients in the areas of immunology, oncology and endocrinology. The division has a leading global portfolio with eight marketed biosimilars and a further 10+ in development. ]]> https://biospectrumindia.com/news/57/14591/robocath-raises-5m-for-cardiovascular-robotic-system.html https://biospectrumindia.com/news/57/14591/robocath-raises-5m-for-cardiovascular-robotic-system.html Tue, 03 Sep 2019 15:40:00 +0530 Robocath, a company that designs, develops and commercializes cardiovascular robotic systems for the treatment of vascular diseases, announces has raised €5 million ($5.5M) to support the rollout of its robotic platform in strategic European target markets. The company has also hired Lucien Goffart as CEO.   With twenty years of experience in interventional cardiology, Lucien Goffart has held a number of key positions in leading companies in the sector. He also has a strong track record of supporting international marketing of new products. His résumé notably includes a position as business unit manager for France at Boston Scientific, a post he occupied for the last four years, and his recent appointment as an executive board member at Electroducer, a French manufacturer of vascular devices.   Philippe Bencteux, founder & president of Robocath, said: “I’m delighted to welcome Lucien Goffart to the company at such a key moment for us with the commercial launch of our first robotic platform. His experience in the industry is undeniable. This appointment has been made at a particularly auspicious time, with our only direct competitor, Corindus Vascular Robotics, having been bought out by Siemens for $1.1 billion (€1bn). I would like to thank our longstanding shareholders, who have once again demonstrated their belief in us by raising this new capital. We are also grateful for the support shown by new shareholders.”   Lucien Goffart, CEO of Robocath, added: “It’s an honor for me to begin work today as CEO of Robocath. I’m impressed by the progress the company has made since it was founded and I’m excited to be working with such a young and dynamic team. R-One™ is a unique product that offers several advantages to physicians and, by extension, to patients. It has significant potential on the market, and I’m looking forward to starting clinical studies and writing a brand new page in the history of interventional cardiology.”   The €5 million ($5.5M) capital injection was provided by longstanding shareholders (GO CAPITAL, NCI, Normandie Participations, M Capital and Supernova Invest) and new funds (Caisse d’Epargne Normandie Innovation, Crédit Agricole Innove en Normandie and Unexo, a subsidiary of the Crédit Agricole group). The company previously raised €6.4 million ($7M) in 2017. This new injection will allow Robocath to lay the groundwork for rolling out the R-One™ robotic platform in a number of target European countries.   ]]> https://biospectrumindia.com/news/57/14585/who-launches-global-registry-on-human-genome-editing.html https://biospectrumindia.com/news/57/14585/who-launches-global-registry-on-human-genome-editing.html Tue, 03 Sep 2019 11:15:00 +0530 A WHO expert advisory committee has approved the first phase of a new global registry to track research on human genome editing. The 18-member committee also announced an online consultation on the governance of genome editing.   Addressing the second meeting of the committee on effective governance and oversight of human genome editing, Dr Tedros Adhanom Ghebreyesus, WHO’s Director-General, said, “Since our last meeting, some scientists have announced their wish to edit the genome of embryos and bring them to term. This illustrates how important our work is, and how urgent. New genome editing technologies hold great promise and hope for those who suffer from diseases we once thought untreatable. But some uses of these technologies also pose unique and unprecedented challenges – ethical, social, regulatory and technical.” Dr Tedros emphasized that countries should not allow any further work on human germline genome editing in human clinical applications until the technical and ethical implications have been properly considered. Accepting the recommendation of the Committee, WHO announced plans for an initial phase of the registry using the International Clinical Trials Registry Platform (ICTRP), a WHO entity. This phase will include somatic and germline clinical trials. In order to ensure that the registry is fit for purpose and transparent, the committee will engage with a broad range of stakeholders on how it will operate. The Committee called on all relevant research and development initiatives to register their trials. To enhance the development of a global governance framework for human genome editing, the Committee will undertake online consultations and in-person engagement.  WHO’s advisory committee on developing global standards for governance and oversight of human genome editing was announced by Dr Tedros in December 2018. ]]> https://biospectrumindia.com/news/57/14581/lindacare-partners-with-philips.html https://biospectrumindia.com/news/57/14581/lindacare-partners-with-philips.html Mon, 02 Sep 2019 11:00:00 +0530 LindaCare announced that it is collaborating with Philips to combine LindaCare's innovative OnePulse™ cloud-based solution for the remote monitoring of patients with cardiac implantable electronic devices (CIEDs) with the Philips IntelliSpace Cardiovascular informatics platform. The seamless combination of LindaCare's OnePulse™ solution with Philips IntelliSpace Cardiovascular allows clinicians to more easily access data from their patients' CIEDs remotely. This results in a more seamless overall workflow, including alert management and triaging, supporting more proactive care. OnePulse™ will be available on Philips IntelliSpace Cardiovascular platform later this year. "We are leading a revolution in remote patient monitoring," said Shahram Sharif, CEO and Founder of LindaCare.  "Our OnePulse™ solution integrates transmissions from implantable cardiac devices like no other, making them easily accessible to caregivers. By combining our OnePulse™ with the IntelliSpace Cardiovascular platform, together we are creating an industry-leading standard for CIED patient follow-up and care." "Monitoring and follow-up of cardiac arrhythmia patients with CIEDs can be often complex, with data trapped in different silos that need to be reviewed individually," said Calum Cunningham, Business Leader for Enterprise Diagnostic Informatics at Philips. "LindaCare's innovative OnePulse™ solution consolidates this data, and by incorporating OnePulse™ into our IntelliSpace Cardiovascular platform, caregivers can see this additional information as part of the broader cardiovascular history of each patient, allowing them to make the most appropriate treatment decisions for each patient." "This step is a significant achievement in our partnership with Philips creating value for both companies, as it accelerates our market access and brings our innovation to Philips' customers", said Shahram Sharif. The OnePulse™ platform aggregates data from cardiac electronic implantable devices across all manufacturers streamlining operational management of multitudes of patients.  The intuitive OnePulse™ dashboard makes transmissions from different implantable cardiac device manufacturers available on a single platform, providing efficient workflow automation and seamless integration with electronic patient records.  OnePulse™, in use in major hospitals across Europe and in the USA, aims at providing more efficient care for patients, ease of use for caregivers, and cost efficiency for health organization and administrators. Philips IntelliSpace Cardiovascular is a web-based image and workflow management platform which streamlines the workflow of cardiology departments and across hospitals by consolidating multi-modality images and data and enabling access to an open ecosystem of cardiovascular software applications.   ]]> https://biospectrumindia.com/news/57/14577/ec-approves-roches-tecentriq-in-combination-with-abraxane.html https://biospectrumindia.com/news/57/14577/ec-approves-roches-tecentriq-in-combination-with-abraxane.html Fri, 30 Aug 2019 15:50:00 +0530 Roche has announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease. Roche’s VENTANA PD-L1 (SP142) Assay is now CE marked and commercially available in the European Union as an aid for identifying patients with TNBC eligible for treatment with the Tecentriq combination. “For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great.” This approval is based on the results from the Phase III IMpassion130 study. Progression-free survival (PFS) results demonstrated a statistically significant benefit for Tecentriq in combination with nab-paclitaxel and showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 38% compared with nab-paclitaxel alone. The assessment of PD-L1 on tumour-infiltrating immune cells is essential for identifying the patients with TNBC benefiting from this Tecentriq combination. PD-L1 expression status in the IMpassion130 study was assessed by the VENTANA PD-L1 (SP142) assay. Currently, there are seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease. ]]> https://biospectrumindia.com/news/57/14558/ionis-licenses-hepatitis-b-program-to-gsk.html https://biospectrumindia.com/news/57/14558/ionis-licenses-hepatitis-b-program-to-gsk.html Wed, 28 Aug 2019 16:05:00 +0530 Ionis Pharmaceuticals, the leader in RNA-targeted therapeutics, announced that GSK exercised its option to license Ionis' antisense medicines for people with chronic hepatitis B virus (CHB) infection following positive Phase 2 results. CHB is a chronic viral infection of the liver that can lead to significant and potentially fatal health conditions, including cirrhosis, liver failure and liver cancer. Current treatments for patients with CHB provide low levels of hepatitis B virus S antigen seroclearance, leaving many patients without a treatment to achieve sustained disease remission. There are more than 200 million patients worldwide living with CHB. "By targeting the root cause of CHB-related liver disease, our antisense technology can potentially deliver a transformative medicine for people who suffer from chronic hepatitis B virus infection," said Brett P. Monia, chief operating officer at Ionis. "We believe GSK's development and commercialization expertise in infectious diseases makes them the ideal partner to help address this high unmet need." As a part of the licensing agreement, Ionis is eligible to receive license fees and milestone payments up to $262 million, including a $25 million license fee. In addition, Ionis is also eligible to receive tiered royalties in the low double digits on net sales. GSK is now responsible for all development, regulatory and commercialization activities and costs. This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act. Review of the full data package by Ionis and GSK is ongoing and the positive results from the Phase 2 program will be presented at an upcoming medical congress. ]]> https://biospectrumindia.com/news/57/14549/amgen-to-acquire-otezla-for-13-4-billion-.html https://biospectrumindia.com/news/57/14549/amgen-to-acquire-otezla-for-13-4-billion-.html Tue, 27 Aug 2019 17:00:00 +0530 Amgen has entered into an agreement with Celgene Corporation in connection with its previously announced merger with Bristol-Myers Squibb Company to acquire worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and certain related assets and liabilities, for $13.4 billionin cash, or approximately $11.2 billion, net of the present value of $2.2 billion in anticipated future cash tax benefits.  Amgen believes that the acquisition of Otezla offers many benefits including: A strong strategic fit with Amgen's long-standing expertise in psoriasis and inflammation A differentiated, oral therapy complementary to Amgen's existing inflammation franchise of innovative biologics and biosimilar products At least low double-digit Otezla sales growth, on average, over the next five years Acceleration of Amgen's near- and long-term revenue growth Immediate non-GAAP EPS accretion Intellectual Property exclusivity through at least 2028 in the U.S. Worldwide rights which fit well with Amgen's international presence and global expansion objectives Support of increased R&D investment in 2020 to advance Amgen's innovative pipeline of first-in-class molecules No interruption in deployment of Amgen's capital allocation priorities "The acquisition of Otezla offers a unique opportunity for Amgen to provide patients an innovative oral therapy for psoriasis and psoriatic arthritis that fits squarely within our portfolio and complements our Enbrel® and AMGEVITA®brands," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We will take advantage of our 20 years of experience in inflammatory disease to realize the full global potential of Otezla as an affordable option for patients with these serious, chronic inflammatory conditions." Otezla is the leading treatment in the post-topical, pre-biologic segment in its approved indications. Otezla is currently approved for three indications in the U.S.—the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adult patients with active psoriatic arthritis; and adult patients with oral ulcers associated with Behçet's Disease. Otezla is approved in more than 50 markets outside the U.S., including the European Union and Japan, and has patent exclusivity through at least 2028 in the U.S.  Sales of Otezla in 2018 were $1.6 billion driven by strong volume growth. Amgen has stated previously that it will focus on medicines that can deliver sustained, long-term volume driven growth and the Company believes there is a significant opportunity to grow Otezla through global expansion and new indications, with expectations for Otezla to realize at least low double-digit sales growth, on average, over the next five years. Strategic Benefits of the Transaction This transaction will advance Amgen's strategy in several ways:   Bringing Innovative Medicines to Patients -- The number of patients suffering from chronic inflammatory diseases is growing worldwide. Amgen is already a leader in this very large therapeutic category with Enbrel® (etanercept), a biologic medicine marketed by Amgen in the U.S. and Canada to treat several chronic inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe plaque psoriasis, and psoriatic arthritis (PsA). ENBREL and Otezla are complementary. ENBREL is most frequently prescribed to treat moderate-to-severe rheumatoid arthritis, while Otezla is positioned as a therapy of first-choice in patients with moderate-to-severe psoriasis who are not satisfied with topical therapies given its differentiated mechanism of action and established efficacy and safety profile. In PsA, Otezla is positioned for use in patients early in their disease and/or with moderate joint involvement. Additionally, studies are currently underway exploring potential new indications for Otezla, including mild-to-moderate psoriasis. Expanding Geographic Reach -- Otezla is approved in 54 countries, including major markets such as France, Germany and Japan. Amgen is well positioned to continue driving Otezla international sales growth. Investing for Long-Term Growth with Uninterrupted Capital Allocation Plans -- The transaction is expected to contribute to Amgen's near- and long-term revenue growth rate and will be immediately accretive from close to non-GAAP earnings per share growth, with acceleration thereafter. Amgen will finance the transaction with current balance sheet cash and expects to retain its investment grade credit rating. Additionally, Amgen's capital allocation priorities will remain unchanged as we invest to grow our business through internal investment and business development, maintain an optimal capital structure to minimize our Weighted Average Cost of Capital and continue to provide capital returns to shareholders through a growing dividend and continued share repurchases. The closing of the acquisition is contingent on Bristol-Myers Squibb entering into a consent decree with the Federal Trade Commission in connection with the pending Celgene merger, the closing of the pending merger with Celgene and the satisfaction of other customary closing conditions. The transaction is expected to close by the end of 2019. "Otezla represents an exciting opportunity to strengthen Amgen's presence in inflammation and continue Amgen'sgeographic expansion," said Bradway. "We are excited about the opportunity that Otezla represents for Amgen, for our shareholders, and for patients worldwide, and we look forward to welcoming those staff members who support Otezla to the Amgen family." ]]> https://biospectrumindia.com/news/57/14548/viralgen-receives-cgmp-certification-from-ema.html https://biospectrumindia.com/news/57/14548/viralgen-receives-cgmp-certification-from-ema.html Tue, 27 Aug 2019 16:55:00 +0530 Viralgen and AskBio announced that Viralgen has received Current Good Manufacturing Practices (cGMP) compliance accreditation and Pharmaceutical Laboratory authorization by the AEMPS (Spanish Agency for Medicines and Health Products) and certification from the European Medicines Agency (EMA). Viralgen is a leading contract development and manufacturing organization (CDMO) that specializes in developing, validating and manufacturing adeno-associated virus (AAV) gene therapies.  "We have gone from a bare concrete floor to a fully certified, world-class facility in less than two years," said Javier García, Viralgen's CEO. "The quality of our facility, scaled-up manufacturing processes, and this certification underscore our commitment to helping our clients develop safer and more effective therapies for genetic disease. We have an amazing facility and a highly skilled team focused on delivering technology that produces higher yields of rAAV vectors, ultimately contributing to lowering the cost of potentially life-saving therapeutics for patients in need." Adherence to the cGMP regulations guides the proper quality, monitoring, safety, efficacy and information accuracy of medicines and health products for manufacturing processes and facilities in the interest of protecting and promoting people's health. A key benefit of Viralgen's technology is the cGMP production of high-quality rAAV in large batches through a unique and robust manufacturing platform. AskBio, which owns 50 percent of Viralgen, has developed the world's foremost clinical stage gene therapy platform that includes an industry-leading proprietary cell line manufacturing process known as Pro10™. This allows Viralgen to scale cGMP manufacturing of rAAV vectors at levels that exceed what other CMOs can produce and enables flexible, scalable clinical manufacturing faster than current industry standards. According to Mr. García, Viralgen's current cGMP capacity is comprised of: Three independent, state-of-the-art cGMP production suites (>1800m2), providing the capability to continuously and simultaneously manufacture three different products 50L scale to supply toxicology/biodistribution studies with full support for research, toxicology and GMP production in parallel 50L, 250L and 500L single-use stirred-tank bioreactors for culture of suspension cells with a total capacity of 1,250 liters of dedicated AAV production In-house quality control labs for critical release assays Mr. García also noted that Viralgen plans to expand its current footprint with support for up to 2000L scale for commercial use by the end of 2021. This will enable full life cycle support and maximized flexibility to serve a wide range of AAV capsids for manufacturing potentially curative therapeutics ]]> https://biospectrumindia.com/news/57/14546/velabs-enters-into-a-screening-cooperation-with-chiome-bioscience-.html https://biospectrumindia.com/news/57/14546/velabs-enters-into-a-screening-cooperation-with-chiome-bioscience-.html Tue, 27 Aug 2019 15:50:00 +0530 Velabs Therapeutics (Velabs), specializing in the fast generation of functional therapeutic antibodies, announced that its cooperation with Chiome Bioscience, Inc., Tokyo, will be deepened, to jointly discover modulatory and functional antibodies for one of Chiome’s GPCR target genes. The collaboration will capitalize on Velabs’ microfluidics-based technology in the field of functional antibody screening. Under the terms of the agreement and after successful completion of an initial feasibility phase, Velabs will receive milestone payments upon the achievement of specific development and regulatory events. In addition, Velabs will also be eligible to receive tiered royalties and milestones on the worldwide sales of products that arise from the collaboration. Chiome Bioscience is a leading expert in the discovery and development of therapeutic antibodies for clinical applications with unmet medical need. The company has the exclusive license of the ADLib® antibody generation technology from RIKEN and has several preclinical and clinical development programs for its therapeutic antibodies. Velabs Therapeutics, a recent startup company of the European Molecular Biology Laboratory (EMBL) and financed by Swiss based Xlife Sciences Ltd., is a pioneer in microfluidic technology for screening of antibodies with modulatory function on complex signal proteins like GPCRs or ion channels. The high-throughput screening platform allows for testing millions of correctly paired fully natural IgGs from humans and mice for therapeutic effects, rather than just for binding. Results are obtained in only a fraction of the time required by other technologies. The company offers customized screening services for users worldwide. Besides carrying out service projects, Velabs is currently also establishing its own proprietary pipeline of therapeutic antibody candidates for further joint development with pharma partners.   ]]> https://biospectrumindia.com/reports-white-papers/57/14545/automatic-orbital-shakers-revenue-to-cross-us-435-mn-in-2019.html https://biospectrumindia.com/reports-white-papers/57/14545/automatic-orbital-shakers-revenue-to-cross-us-435-mn-in-2019.html Tue, 27 Aug 2019 15:35:00 +0530 The approximately US$ 572 million orbital shakers market is likely to demonstrate just-under 7% year on year expansion in 2019. As indicated by a recent market research report, the demand for orbital shakers will remain on a healthy growth trajectory over the next few years.  “With the flourishing laboratory automation industry, the sales of advanced technology laboratory systems are on a constant rise. The subsequently growing demand for orbital shakers is thus pushing the revenue prospects for orbital shakers in recent years. Significantly growing adoption of next-generation laboratory equipment, especially across developing regional markets, is predominantly driving the growth of orbital shakers market,” explains a senior market research analyst at the company. However, longer lifespan of orbital shakers, i.e. up to 10 years will remain the longstanding barrier to frequent adoption of orbital shakers, mentions the report. Widening Research Expanse Propels Application-specific NPD Healthcare, medicine, and life sciences industries are increasingly creating a positive outlook for R&D, which is translating into healthy revenue growth prospects for laboratory equipment such as orbital shakers or laboratory shakers. Besides lab and clinical research centers, orbital shakers find wide applicability in the industrial sector, reports research study. The application-specific demand for orbital shakers has been pushing product innovations based on the desired load, weight capacity, orbital range, and speed. Research laboratories are thus exploring the available alternatives in orbital shakers for an appropriate lab environment, creating attractive revenue generation opportunities for orbital shakers manufacturers. Automatic Orbital Shakers Remain Highly Favored for R&D The global sales of automatic orbital shakers are projected to exceed the valuation of US$ 435 million in 2019, of which more than 1/4th is estimated to be contributed by North America. The orbital shakers market in North America is forecast to remain the top consuming region and is anticipated at the highest yearly growth at around 8% in 2019. The report concludes that the ability of automatically operated orbital shakers to adjust the shaking speed according to the load continues to attract maximum sales potential. Researchers Fuel Sales of Experimental Equipment Moreover, the report projects global revenue of experimental equipment to be more than US$ 255 million, towards the end of 2019. Dramatically increasing number of research laboratories and lab experimental activities continues to be the key driving force behind the escalating sales of high-speed orbital shakers. The widening application base is likely to create strong growth prospects for orbital shakers market at a global level. Thermo Fisher Scientific Remains Global Leader Thermo Fisher Scientific, the leading player in orbital shakers landscape, currently accounts for more than 14% share of the global market revenue. Focusing on firming up the global footprint, the company is augmenting investments in R&D directed to new product launches for an extended and diverse offering portfolio. Thermo Fisher has already invested around 4% of its annual revenue in R&D activities, as indicated by the report. The company is currently strategizing collaborations and acquisitions, the latest of which include the deals with Patheon N.V., Phenom-World, and IntegenX Inc. Benchmark Scientific has been innovating its range of mini orbital shakers, and thermal and incubation shakers. Eppendorf Inc. on the other hand offers the widest range of premium range, high-performance orbital shakers. IKA-Works, another active competitor in the orbital shakers landscape, provides a selection of orbital shakers with a large LED display and the PID temperature control that allow the regulation of speed and time of shakers. The report indicates that a large number of manufacturers of orbital shakers are focusing on developing advanced products with incubation, display integration, RPM specificity, and temperature regulators. Launching such products is likely to enable companies to tap into new application areas and thereby penetrate into new markets.   ]]> https://biospectrumindia.com/news/57/14542/lehigh-valley-health-network-iks-health-announce-strategic-partnership.html https://biospectrumindia.com/news/57/14542/lehigh-valley-health-network-iks-health-announce-strategic-partnership.html Tue, 27 Aug 2019 12:40:00 +0530 Lehigh Valley Health Network (LVHN), has announced a new partnership with IKS Health, a premier healthcare solutions organization, to drive operational innovation and efficiencies, saving physicians’ time to focus on what matters most—delivering meaningful and high-quality patient care. The two organizations will collaborate to develop and perfect solutions to enrich and enhance healthcare delivery across the country, including addressing provider burden, meaningful patient engagement, care coordination, shrinking margins, and more. One of the largest health systems on the East Coast with more than 1,500 providers, LVHN has actively worked to address growing concerns around physician burnout. Together LVHN and IKS will leverage existing IKS technologies as well as develop new, cutting-edge solutions to tackle this and other healthcare industry challenges. “Although the healthcare industry faces a myriad of challenges, we’re meeting them head-on to support our physicians and patients,” said Dr. Michael Rossi, chief physician executive of LVHN and president of Lehigh Valley Physician Group (LVPG). “We are excited to partner with IKS to further identify and explore ways to truly drive innovation as we continue to provide exceptional care simultaneously with the interest in recruiting the best talent to the area.” As a first step in the partnership, 50 of LVHN’s providers will begin leveraging IKS’ Scribble technology solution by December 2019, the first group going live In June 2019. Scribble, an asynchronous virtual scribe solution, pairs physicians with a Virtual Physician Partner to deliver an accurate, comprehensive clinical note. This enables the physician to more fully engage with patients—freeing up schedules for more patient interaction or additional patient visits and decreasing documentation time, often saving physicians 1-2 hours per day. “Thoughtfully pairing human-in-the-loop technology that reduces physician administrative burden with clinical insight delivered at the point of care, will continue to play an instrumental role in transforming the healthcare industry; especially in improving the quality and cost of care,” said Sachin K. Gupta, founder and CEO of IKS Health. “We see our partnership with LVHN as an impactful opportunity to bring more meaning to the physician-patient relationship. LVHN's culture of excellence enabled with our solutions will help in furthering our mission of enabling large physician groups to deliver better, safer and more efficient care.” ]]> https://biospectrumindia.com/news/57/14539/boehringer-ingelheim-rejigs-board-members.html https://biospectrumindia.com/news/57/14539/boehringer-ingelheim-rejigs-board-members.html Tue, 27 Aug 2019 11:15:00 +0530 The research-driven pharmaceutical company Boehringer Ingelheim has announced changes in its Board of Managing Directors.  Allan Hillgrove, Member of the Board of Managing Directors responsible for the Human Pharma and the Biopharma business, will step down from the Board and retire at the end of this year after 37 committed and successful years within the corporation. The shareholders have decided to appoint Dr Carine Brouillon to the Board of Managing Directors, effective January 1st, 2020 as his successor. Since she joined Boehringer Ingelheim in 2018, Carine Brouillon has been leading the Therapeutic Areas for prescription medicines. Also at the end of this year, Dr Joachim Hasenmaier will retire and step down as member of the Board of Managing Directors and from his responsibility for the Animal Health business.  The shareholders have decided to appoint Jean Scheftsik de Szolnok as Member of the Board of Managing Directors and new Head of the Animal Health Business Unit, effective January 1st, 2020.  Also, Dr Andreas Neumann has decided to step down from the Board of Managing Directors at the end of September and will leave the corporation after more than eight years of dedicated work for the corporation. ]]> https://biospectrumindia.com/news/57/14580/essity-unicef-strengthen-collaboration-on-hygiene-issues.html https://biospectrumindia.com/news/57/14580/essity-unicef-strengthen-collaboration-on-hygiene-issues.html Fri, 23 Aug 2019 16:55:00 +0530 Essity and UNICEF in Mexico have entered into a new agreement to jointly promote awareness of the importance of good hand hygiene and to break the taboos around menstruation. Over the next three years, the collaboration will provide education to 4,000 pupils and 500 teachers in Mexico City and Chihuahua about attitudes and habits in connection with menstrual hygiene management and hand washing. The project is called Hygiene is our right, and highlights the rights of children and young people in relation to health, education and gender equality. The shortage of water and hygiene facilities in schools may contribute to higher absenteeism and poorer school results. According to UNICEF, 43% of girls and adolescents in Mexico point out that during their period they prefer to stay at home than go to school. A national survey shows that one in five schools lack adequate washrooms and 58% lack water.   "With Hygiene is our right we will work with breaking taboos surrounding menstruation and address issues around good hand hygiene, which will increase well-being and equality in schools and society. We will now continue to help improve hygiene routines among children and young people together with UNICEF in Mexico," says Joséphine Edwall Björklund, Senior Vice President, Communications at Essity.  Essity and its feminine care brand in Mexico, Saba, have collaborated with UNICEF in Mexico since 2016 to increase dialogue about menstruation and hygiene issues among young people in the country. This collaboration has reached 7.5 million people via various channels in Mexico. The Essity brands Saba and Tork are participating in the new collaboration.  ]]> https://biospectrumindia.com/news/57/14511/ew-healthcare-partners-raises-over-745-million-fund-2a.html https://biospectrumindia.com/news/57/14511/ew-healthcare-partners-raises-over-745-million-fund-2a.html Fri, 23 Aug 2019 11:10:00 +0530 EW Healthcare Partners ("EW" or the "Firm"), a growth equity firm that seeks to invest in fast-growing healthcare companies, announced it raised over $745 million in EW Healthcare Partners Fund 2a, L.P. (together with its parallel fund, "Fund 2"), the Firm's second dedicated growth equity fund. This raise was substantially above the $650M target and $200 millionabove the amount raised for Essex Woodlands Fund IX, L.P. ("Fund 1"). Following the strategy established in Fund 1, Fund 2a targets fast-growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. "We are committed to creating value for both our investors as well as our portfolio companies' shareholders and management teams. Fund 2's capital will be deployed with the goal of accelerating the revenue growth of burgeoning healthcare companies. We are primarily looking for middle-market companies, with revenues of $20 million to $200 million and the potential to grow at ~20% annual revenue growth rate for several years.  We believe our healthcare expertise and team of experienced operating partners and senior advisors provide us with the platform to attract and add value to the types of healthcare companies that Fund 2 is targeting," said Petri Vainio, Managing Director and Chairman of the Firm's Executive Committee. "Our approach is hands-on, long-term oriented, highly collaborative and focused on value creation," said Marty Sutter, Co-Founder and Chairman of the Firm's Investment Committee.  "Fund 1 successfully invested in several promising healthcare companies, and we look forward to endeavouring to build another portfolio of successful healthcare companies in Fund 2. Our goal is to provide capital that can drive revenue growth by expanding a sales force, expanding the geographic territory or countries where the products are sold, acquiring complementary products or companies, and/or developing and launching new products." EW HEALTHCARE PARTNERS SENIOR ADVISORS AND OPERATING PARTNERS The EW Healthcare Partners team includes a number of experienced healthcare executives who help identify, work with, and add value to our portfolio companies.  The executives with pharmaceutical experience include: Goran Ando, senior advisor and former Chairman of Novo Nordisk A/S; Lamberto Andreotti, senior advisor and former Chairman of Bristol-Myers Squibb Company; Tom Caskey, senior advisor and former President of the Merck Genome Research Institute; Bryan Morton, operating partner and former CEO and current Chairman of EUSA Pharma Ltd.; and Mike Warmuth, operating partner and former head of the Established Pharmaceuticals Division of Abbott Laboratories. The executives with medical device experience include: Olivier Bohuon, senior advisor and former CEO of Smith & Nephew plc; Bill Hawkins, senior advisor and former Chairman and CEO of Medtronic Inc.; Guido Neels, operating partner and former COO of Guidant Corporation; and Bob White, operating partner and former CEO of Entellus Medical, Inc. ]]> https://biospectrumindia.com/news/57/14509/jj-reports-positive-results-for-injectable-hiv-treatment-regimen.html https://biospectrumindia.com/news/57/14509/jj-reports-positive-results-for-injectable-hiv-treatment-regimen.html Thu, 22 Aug 2019 15:35:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced positive top-line results from the Phase 3 ATLAS-2M study of the investigational, long-acting two-drug injectable regimen of its rilpivirine and ViiV Healthcare's cabotegravir for the treatment of HIV. The study achieved its primary objective, showing that administering the long-acting (LA) injectable regimen of Janssen's rilpivirine and ViiV's cabotegravir every two months was as effective in maintaining viral suppression throughout the 48-week study period as monthly dosing in adults living with HIV-1 infection, whose viral load is suppressed and not resistant to rilpivirine or cabotegravir. Non-inferiority was measured by the proportion of participants with plasma HIV-RNA ≥ 50 copies per milliliter (c/mL) using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population). Overall safety, virologic response, and drug resistance results for the LA regimen were consistent with results from the Phase 3 ATLAS study1 The ATLAS-2M study is a Phase 3, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of the LA regimen administered every two months compared to the LA regimen administered monthly over a 48-week treatment period in 1,045 adults living with HIV-1.  The study is being conducted at research centers in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States. The LA regimen is being co-developed as a collaboration with ViiV Healthcare and has been submitted to regulatory authorities in the United States, Canada and Europe. A Priority Review Designation for the once-monthly injectable regimen was granted by the US FDA. ]]> https://biospectrumindia.com/news/57/14508/pfizer-invests-into-20-organizations-to-tackle-infectious-diseases.html https://biospectrumindia.com/news/57/14508/pfizer-invests-into-20-organizations-to-tackle-infectious-diseases.html Thu, 22 Aug 2019 15:25:00 +0530 The Pfizer Foundation announced today 20 grants to help non-governmental organizations (NGOs), non-profits and social enterprises address critical health challenges related to infectious diseases, including the increasing threat of antimicrobial resistance (AMR), in some of the world’s most vulnerable communities. Recipients of the one-year Global Health Innovation Grants (GHIG) include partners in 12 low- and middle-income countries, that will each receive US $100,000, for a total investment this year of US $2 million by The Pfizer Foundation.  “Mounting infectious disease outbreaks and the threat of large-scale antimicrobial resistance are increasingly becoming some of the most challenging global health needs of our time,” said Caroline Roan, President of The Pfizer Foundation. “We are dedicated to working with individuals and organizations in local communities as they rethink and scale innovative solutions to fight infectious diseases from the ground up, providing effective solutions to those patients most in need.” The Pfizer Foundation’s flagship GHIG program is managed in partnership with Innovations in Healthcare (IiH), a nonprofit organization hosted by Duke University. The GHIG program combines grant investments with technical support to help accelerate global health innovations by giving partners the autonomy to navigate the unique and fluid challenges they face in their local – and often last mile – communities. The Pfizer Foundation and IiH work together to analyze results from each partner program in order to build on key learnings and pivot approaches, when needed. Launched in 2016, the GHIG program has had incredible impact to date: 370,000 new patients have received care, 160,000 have been reached with screening and education, and 2,000 health workers have been trained. With the inclusion of this cohort of grants, total funding to date by the GHIG program totals $7.5 million. The 20 organizations included in this year’s cohort of grants each take a community-tailored approach to finding and scaling sustainable solutions to overcome infectious diseases. There is a strong focus across the grants on strengthening local healthcare systems and building capacity, including through primary healthcare delivery and the integration of innovative health technologies in low-resource settings. Examples include: The expansion of a clinical staff training program by Muso in Mali to support clinicians at government-run health centers to improve quality of care as it relates to infectious disease, maternal and child health and core clinical issues driving preventable deaths such as childhood pneumonia, malaria and maternal hemorrhage; The launch of UE LifeSciences’ new innovation cervAIcal, an artificial intelligence-enabled, hand-held, wireless mobile colposcope to aid health workers and healthcare providers in detecting precancerous lesions at the point of care in regions of India with limited infrastructure; and Group for Technical Assistance in Nepal will develop, implement and evaluate Global Learning in Anti-Microbial Resistance, an e-learning platform and web-based information repository containing curriculum to set up AMR programs in health facilities across the country, including opportunities for live communication and mentoring via webinars with health providers. This new GHIG cohort demonstrates Pfizer’s continued commitment to infectious disease and supports Pfizer’s ongoing efforts to reduce health disparities.   ]]> https://biospectrumindia.com/news/57/14505/conagen-acquires-production-platform-of-therapeutic-proteins.html https://biospectrumindia.com/news/57/14505/conagen-acquires-production-platform-of-therapeutic-proteins.html Thu, 22 Aug 2019 14:10:00 +0530 US based Conagen, a vertically integrated synthetic biology company, leader in bioengineering, has acquired a fermentation-based technology for the production of therapeutically useful glycoproteins. The acquisition includes several patents covering the platform and all associated tangible assets, establishing Conagen as a leading developer of active pharmaceutical ingredients. In addition to a suite of more than 10 already developed therapeutic glycoproteins, the host platform will be used by Conagen for development of both novel and generic drugs. Industrial fermentation typically employs microbes which can be cultured rapidly at the largest scales without cell disruption or losses in productivity.  Characteristics of these therapeutics, which include desirable glycostructures and other post-translational modifications, have limited their commercial production to fragile mammalian cell systems at relatively small scales.  "One of the most exciting features of this host organism is its ability to express glycoproteins harboring glycostructures which promote the desired immune cell functions.  This is a very unusual feature to find in a robustly fermentable microbe.  It is also advantaged by its ability to tolerate the engineering required to customize these glycostructures while preserving the microbe's robustness," said Vice President of Research and Development, Casey Lippmeier The platform will reduce costs, and the savings can be passed down to patients. This is important to the pharmaceutical industry which is under increasing pressure to reduce time and capital in developing drugs," said Oliver Yu, Ph.D., co-founder, and CEO of Conagen. The largest category of therapeutic glycoproteins is the blockbuster monoclonal antibodies upon which the entire $100 billion immunotherapy and antibody-drug conjugate market is based.  ]]> https://biospectrumindia.com/news/57/14504/denovomatrix-introduces-cultureware-serum-free-hmsc-mesenchymal-stem-cells.html https://biospectrumindia.com/news/57/14504/denovomatrix-introduces-cultureware-serum-free-hmsc-mesenchymal-stem-cells.html Thu, 22 Aug 2019 13:55:00 +0530 Due to their high accessibility and extensive beneficial properties, human Mesenchymal Stem Cells (hMSC) offer exciting promises in a plethora of applications in regenerative medicine, particularly in cell-based therapies. The major challenge of hMSC-based therapy is the large-scale expansion of cells in order to achieve the cell numbers necessary for therapeutic treatment. Currently, bovine-derived fetal calf serum and human plasma-derived fibronectin are commonly used in hMSC culture. These biological extracts frequently reduce experimental reproducibility, and represent a liability for manufacturers of hMSC. To increase lot-to-lot consistency and eliminate the risk of transmission of xenogenic infectious agents, defined cell culture conditions including media and extracellular matrix mimetic coatings are essential. denovoMATRIX has now introduced a ready-to-use coating composed of chemically defined components. The new product - termed myMATRIX MSC - promotes adhesion, proliferation and high viability of hMSC. According to the manufacturer, this novel surface supports long-term expansion of hMSCs over 10 passages and more than 25 population doublings. Furthermore, myMATRIX MSC enables expansion of hMSC in both serum-free and xeno-free media conditions.   ]]> https://biospectrumindia.com/news/57/14495/okyo-pharma-collaborates-with-prof-pedram-hamrah.html https://biospectrumindia.com/news/57/14495/okyo-pharma-collaborates-with-prof-pedram-hamrah.html Wed, 21 Aug 2019 17:30:00 +0530 OKYO Pharma Limited, a biotechnology company developing targeted drugs for inflammatory dry eye diseases and chronic pain, is pleased to announce a collaborative agreement with Pedram Hamrah, MD, Ophthalmology Scientist and Cornea Specialist at Tufts Medical Center, and Professor of Ophthalmology at Tufts University School of Medicine, Boston, MA, to evaluate proprietary lead compounds, targeting G-protein coupled receptors (“GPCRs”), as non-opioid analgesics. Based on our preclinical research, we have identified novel Bovine Adrenal Medulla (“Bam8”) analogs that have potential to ameliorate inflammation and neuropathic pain. The research collaboration with Dr. Hamrah is focused on evaluation of our lead compounds as non-opioid analgesics to suppress corneal neuropathic pain using a mouse ocular pain model recently developed in Dr. Hamrah’s laboratory at Tufts Medical Center, Boston. Dr. Hamrah is a prominent key opinion leader in Ocular Immunology, Inflammation and Ocular Pain. Recently, he was featured in The Wall Street Journal article on ‘When Routine Eye Surgery Leads to Debilitating Pain’.These collaborative studies will provide additional ‘Proof-of-Concept’ results for the Bam8 analogs as potential non-opioid analgesics. OKYO is focused on GPCR Technology Platform, a novel approach to develop innovative therapies for inflammatory dry eye diseases and chronic pain management. More than 40% of the drugs available in the global market target GPCRs. Large market potential and growth exists for GPCR targeted drugs for treating a wide variety of indications such as inflammation, oncology, cardiovascular diseases and inflammatory eye diseases including dry eye, uveitis and allergic conjunctivitis. In addition to non-opioid analgesics program, OKYO is also pursuing development of Chemerin receptor agonist that targets inflammatory pathways to treat dry eye syndrome, uveitis and allergic conjunctivitis. Previously, OKYO presented preclinical studies demonstrating anti-inflammatory activity of OKYO-0101, a Chemerin receptor agonist, to suppress dry eye symptoms in a mouse model and ocular safety in rabbits in a ‘Late Breaking Poster Session’ at the 14th Congress on Ocular Pharmacology and Therapeutics in New Orleans (March 2019)1. IND-enabling studies for both, Chemerin and Bam8 are ongoing at OKYO and we anticipate IND submission for Chemerin agonist for dry eye indication by Q4 2020 and Bam8 for ocular pain indication by Q2 2021. “Neuropathic corneal pain is a severe, chronic and debilitating disease,” said Dr. Hamrah. “No commercially available treatments are currently available for this condition, so we are excited about this collaboration to test new compounds in our pre-clinical model of this disease.” “Non-opioid strategies for chronic pain are central to solve the opioid public health crisis. We are thrilled to identify novel non-opioid GPCR agonists as lead candidates for IND-enabling studies, that have potential to ameliorate neuropathic pain” said Dr. Raj Patil, Senior Director R&D, OKYO Pharma Limited. ]]> https://biospectrumindia.com/news/57/14492/actify-launches-innovative-treatment-for-ptsd-mental-health-disorders.html https://biospectrumindia.com/news/57/14492/actify-launches-innovative-treatment-for-ptsd-mental-health-disorders.html Wed, 21 Aug 2019 16:25:00 +0530 Actify, a leader in innovative mental health treatment, is proud to support veteran care with the launch of Transcranial Magnetic Stimulation (TMS) in the State of Maryland. With the addition of TMS to the Baltimore and Potomac office locations, Actify is becoming a care provider within the TRICARE East military insurance network, making mental healthcare treatment more easily accessible for veterans. TMS is FDA-approved for treatment resistant depression, but may also be delivered off-label for OCD, PTSD, and anxiety; all common mental health issues that veterans face. "TMS is a well-tolerated, non-invasive treatment for depression that is offered in-office. TMS uses a MRI-strength magnetic coil to deliver a low-energy pulse to a targeted area of the brain, and is delivered consistently for four to six weeks to the patient, and then maintenance treatments are given as needed. Results are typically seen within the first two to three weeks," explained Steve Levine, M.D., internationally recognized interventional psychiatrist and Chief Medical Officer with Actify. "At Actify, we want to give back to veterans who have done their part for others. Now, it's our turn to do our part for them," said Kathy Kaluhiokalani, Actify's CEO. "We are enthusiastic to offer convenient insurance coverage through TRICARE East in both our Baltimore and Potomac offices. We look forward to educating Veterans about Actify and their mental healthcare treatment options, such as TMS." ]]> https://biospectrumindia.com/news/57/14485/lilly-launches-open-innovation-challenge-for-ibd.html https://biospectrumindia.com/news/57/14485/lilly-launches-open-innovation-challenge-for-ibd.html Wed, 21 Aug 2019 10:00:00 +0530 Eli Lilly and Company is launching an open innovation challenge to encourage individuals and teams across the U.S. to identify and submit pioneering digital health solutions aimed at transforming inflammatory bowel disease (IBD) care. The challenge, "Transforming IBD Care: Better disease monitoring, management, and care for people with inflammatory bowel disease," focuses on innovation in IBD monitoring, condition management or care enhancements. Divakar Ramakrishnan, Ph.D., chief digital officer at Lilly said, "Lilly is investing in digital solutions that can help empower people with chronic conditions, such as IBD, to better manage their own health. Innovation is happening everywhere, and this challenge is aimed at identifying bold ideas outside our walls and collaborating on ways to potentially deliver new solutions to those who need them most. Approximately 3 million Americans have reported being diagnosed with IBD, and Lilly is committed to tackling the challenge of this disease through science and innovation. We're looking for digital innovators to join us." The innovation challenge recently launched is a call for novel solutions that leverage today's most innovative technologies and systems — mobile apps, sensors and wearable, connected drug delivery devices, real-time monitoring, algorithms, digital games, etc. — to enhance care and improve health and wellbeing for those struggling with IBD.    ]]> https://biospectrumindia.com/news/57/14481/merck-receives-seven-additional-crispr-patents-.html https://biospectrumindia.com/news/57/14481/merck-receives-seven-additional-crispr-patents-.html Tue, 20 Aug 2019 11:30:00 +0530 Merck, a leading science and technology company has announced that the European, Israeli, South Korean and U.K. intellectual property offices have issued formal notices allowing seven additional Merck patent application claims covering CRISPR gene-editing technology, bringing the number of patents to 20 worldwide. "It is encouraging to see this important body of scientific work recognized with the grants of these latest CRISPR patents," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "Our ambition is to continue growing our CRISPR intellectual property portfolio with technologies such as paired Cas9 nickases, for reducing off-target effects, and proxy-CRISPR, which offers researchers more experimental options to accelerate drug development and access to new therapies." Details on Merck's latest CRISPR patent awards are as follows: European Patent Office — Patent allowances for: Vectors for CRISPR integration. The newly allowed claims cover vector compositions to support CRISPR delivery and expression in eukaryotic cells, including viral delivery methods broadly used in both cancer research (lentivirus) and human therapeutic applications (adeno-associated virus, or AAV). proxy-CRISPR technology, which provides access to modify difficult-to-reach genomic regions, expanding CRISPR design options. This approach also allows a reduction in off-target effects. Engineered Ribonucleic Acid (RNA)-guided endonuclease and protein- RNA complexes.        These two newly allowed claim sets cover compositions that can be used for gene knock-in and gene knock-out. Israeli IP Office — Patent allowance for: Paired Nickase technology, to reduce off-target effects. Paired nickases represent a significant step in increasing genome-editing safety. South Korean IP Office — Patent allowance for: Paired Nickase technology. U.K. (IP) Office — Patent allowance for: proxy-CRISPR technology. In addition to Europe, Israel, U.K. and South Korea, Merck has CRISPR-related patents in the following regions: U.S., Canada, Australia, China and Singapore. The company was awarded its first foundational patent in Australia covering CRISPR integration in 2017, and its first U.S. CRISPR patent for proxy-CRISPR in 2019. Earlier, Merck announced different CRISPR patents in Europe in 2017 and in South Korea and Israel in 2018. On July 18, 2019, Merck announced a CRISPR licensing framework with Broad Institute of MIT and Harvard to offer non-exclusive licenses to CRISPR IP under their respective control for use in commercial research and product development. This new framework aims to simplify and accelerate scientific access to CRISPR IP. On July 19, 2019, Merck filed a petition with the U.S. Patent and Trademark Office requesting an interference proceeding between CRISPR-Cas9 patents the company applied for in 2012 and patents that UC Berkeley has applied for or been awarded.   ]]> https://biospectrumindia.com/news/57/14480/boston-scientific-gets-fda-nod-for-imageready-mri-vercise-gevia-system.html https://biospectrumindia.com/news/57/14480/boston-scientific-gets-fda-nod-for-imageready-mri-vercise-gevia-system.html Tue, 20 Aug 2019 11:15:00 +0530 Boston Scientific Corporation announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™  Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI) environment.   This system, with the Vercise Cartesia™ Directional Lead, is designed to treat the symptoms of Parkinson's Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects. An estimated ten million people worldwide are affected by Parkinson's disease, causing symptoms such as shaking or tremors, muscle stiffness, and slowness of movement. DBS therapy helps patients with Parkinson's disease control their symptoms and improve their quality of life. This FDA approval allows patients to undergo a full-body MRI while benefiting from the latest advances in DBS therapy including directional stimulation and a longer-lasting rechargeable battery. Clinical evidence from the INTREPID study demonstrated that patients treated with the Vercise System sustained a 48% improvement in motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III scores over two years, which is favorable to previous published reports (25%, Follett, 2010). "When evaluating which DBS system is best for each of my patients, I always consider the immediate and long term needs my patient might have so that we can effectively address a patient's therapeutic needs even as their disease progresses," said Dr. Robert Gross, MBNA Bowman Endowed Chair in Neurosurgery & Professor Department of Neurosurgery at Emory University. "Customizable therapy, battery life, the size of the device, and access to MRI are factors patients should talk to their doctor about when they are considering deep brain stimulation." ]]> https://biospectrumindia.com/news/57/14477/boston-scientific-completes-acquisition-of-btg-.html https://biospectrumindia.com/news/57/14477/boston-scientific-completes-acquisition-of-btg-.html Tue, 20 Aug 2019 10:50:00 +0530 Boston Scientific Corporation, a global medical technology leader has announced the completion of its acquisition of BTG plc. pursuant to the previously announced scheme of arrangement. BTG develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases, as well as specialty pharmaceuticals. BTG has three key businesses, the largest of which is its highly-differentiated Interventional Medicine portfolio that encompasses interventional oncology therapeutic technologies for patients with liver and kidney cancers, as well as a vascular portfolio for treatment of deep vein thrombosis, pulmonary embolism, deep venous obstruction and superficial venous disease. In addition to the Interventional Medicine product lines, the BTG portfolio also includes a specialty pharmaceutical business comprised of acute care antidotes to treat overexposure to certain medications and toxins, and a licensing business that receives royalties related to BTG intellectual property and product license agreements. Upon the effectiveness of the scheme of arrangement, BTG became a wholly-owned subsidiary of Boston Scientific, and BTG shares no longer trade on the London Stock Exchange. Under the terms of the previously announced transaction, holders of BTG common shares will receive 840 pence in cash per share. Boston Scientific expects to complete the previously announced sale of its global embolic microspheres portfolio – comprised of Embozene®, Embozene TANDEM® and ONCOZENE™ brands – to Varian Medical Systems, Inc. in due course, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction.    In addition, the company is initiating a process to explore the divestiture of the royalty stream associated with BTG's Zytiga® licensing arrangements and anticipates closing this divestiture by the end of 2019. The transaction is expected to be immaterial to adjusted earnings per share in 2019 as a result of the BTG transaction closing later than originally anticipated, the divestiture of the Boston Scientific embolic microspheres portfolio, and the treatment of the licensing business as an asset for accounting purposes and its intended divestiture.  The transaction is expected to be four to five cents accretive in 2020 on an adjusted basis, and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be less accretive, or more dilutive as the case may be, due to amortization expense and acquisition-related net charges. ]]> https://biospectrumindia.com/news/57/14473/abbvie-seeks-fda-nod-for-elagolix.html https://biospectrumindia.com/news/57/14473/abbvie-seeks-fda-nod-for-elagolix.html Mon, 19 Aug 2019 15:15:00 +0530 AbbVie, a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. have announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elagolix, an investigational, oral gonadotropin-releasing hormone (GnRH) antagonist, for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids in women. Uterine fibroids are non-cancerous, hormonally-responsive muscle tissue tumors of the uterus.They can affect up to 70% of Caucasian women and up to 80% of African American women by age 50. Fibroids can be asymptomatic but, in some women, fibroids can cause symptoms, such as heavy menstrual bleeding (HMB), vaginal bleeding at times other than menstruation, and anemia. "This submission brings us closer to our goal of improving care for women who continue to struggle with the often disruptive effects of uterine fibroids," said Michael Severino, M.D., vice chairman and president, AbbVie. "If approved, this combination has the potential to offer women and their healthcare providers an additional oral medical treatment option." The NDA is supported by data from the elagolix Phase 3 uterine fibroid program, which evaluated nearly 800 premenopausal women with HMB associated with uterine fibroids in two pivotal studies (ELARIS UF-I and ELARIS UF-II) at approximately 100 sites in the U.S. and Canada. The replicate studies evaluated the safety, tolerability and efficacy of elagolix alone (300 mg twice daily, or BID) and in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg/norethindrone acetate 0.5 mg) in women with uterine fibroids for six months. An extension study permitted women to be treated for an additional six months. The primary endpoint assessed the reduction in HMB compared to placebo as measured by the alkaline hematin method, an objective measurement of total menstrual blood loss (MBL) based on quantification of menstrual blood collected on sanitary products. In both studies, elagolix in combination with add back therapy met the primary endpoint. The most frequent adverse events reported (≥ 5 percent) were hot flush, night sweats, nausea, headache and fatigue. Top-line results from these clinical studies were previously announced at the 47th American Association of Gynecologic Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology. Detailed results from the Phase 3 program will be published in a peer-reviewed medical journal later this year. Elagolix for the management of HMB associated with uterine fibroids is investigational and its safety and efficacy have not been evaluated by any regulatory authorities ]]> https://biospectrumindia.com/news/57/14472/abbvie-to-launch-rinvoq-to-treat-rheumatoid-arthritis.html https://biospectrumindia.com/news/57/14472/abbvie-to-launch-rinvoq-to-treat-rheumatoid-arthritis.html Mon, 19 Aug 2019 15:00:00 +0530 AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR). RINVOQ is expected to be available in the U.S. in late August 2019. The FDA approval of RINVOQ is supported by data from the SELECT program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies.2-6 The studies include assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate. RINVOQ is not indicated for methotrexate-naïve patients. "Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis," said Roy M. Fleischmann, M.D., primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas. "With this FDA approval, RINVOQ has the potential to help additional people living with RA achieve remission who have not yet reached this goal." Across the SELECT Phase 3 studies, RINVOQ met all primary and ranked secondary endpoints. "The discovery and development of RINVOQ is indicative of AbbVie's long-standing commitment to advancing the science for people living with immune-mediated conditions," said Michael Severino, M.D., vice chairman and president, AbbVie. "Today's FDA approval marks an important milestone in our pursuit to deliver innovative medicines that advance care for people living with rheumatoid arthritis." ]]> https://biospectrumindia.com/news/57/14461/regenerons-evinacumab-provides-efficacy-against-hofh.html https://biospectrumindia.com/news/57/14461/regenerons-evinacumab-provides-efficacy-against-hofh.html Fri, 16 Aug 2019 12:20:00 +0530 Regeneron Pharmaceuticals, Inc. announced positive pivotal Phase 3 results for evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholesterolemia (HoFH). Patients with HoFH have severely elevated levels of bad cholesterol (otherwise known as low-density lipoprotein cholesterol, or LDL cholesterol), and often experience early atherosclerotic disease, sometimes suffering cardiac events as early as their teenage years. On average, patients entered the trial with LDL cholesterol levels of 255 mg/dL, despite treatment with other lipid-lowering therapies, including maximally-tolerated statins, PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, ezetimibe, LDL apheresis and lomitapide. The trial met its primary endpoint, showing that adding evinacumab to other lipid-lowering therapies decreased LDL cholesterol by 49% on average, compared to lipid-lowering therapies alone. "Currently HoFH patients face limited choices in reducing their LDL cholesterol, including therapies that are time-consuming like LDL apheresis, or that may have side effect concerns. Despite recent therapeutic advances, there is still a significant unmet need to lower the LDL cholesterol of many patients with HoFH. On average, evinacumab reduced patients' LDL cholesterol in half and was generally well-tolerated in the trial," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "These results raise the potential that evinacumab may have value for other patients with severe, refractory hypercholesterolemia, where we have a trial ongoing." In 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for evinacumab for the treatment of hypercholesterolemia in patients with HoFH. Regeneron scientists discovered the angiopoietin gene family more than two decades ago. Human genetics research published in The New England Journal of Medicine in 2017 by scientists from the Regeneron Genetics Center found that patients whose ANGPTL3 gene did not function properly (called a "loss-of function mutation") have significantly lower levels of key blood lipids, including LDL cholesterol, and this is associated with a significantly lower risk of coronary artery disease. "People born with homozygous familial hypercholesterolemia – the rare and most severe form of FH – are in urgent need of additional therapies to lower life-threatening cholesterol levels. HoFH causes aggressive heart disease even in childhood, and today's treatments often are not enough for these individuals," said Katherine Wilemon, Founder and Chief Executive Officer, FH Foundation. "These evinacumab Phase 3 results bring hope to those who need it most. The FH Foundation is grateful to the researchers who advanced this science and the individuals who participated in this clinical trial." ]]> https://biospectrumindia.com/news/57/14458/harmony-biosciences-set-to-launch-excessive-daytime-sleepiness-drug.html https://biospectrumindia.com/news/57/14458/harmony-biosciences-set-to-launch-excessive-daytime-sleepiness-drug.html Fri, 16 Aug 2019 11:40:00 +0530 Harmony Biosciences, LLC (Harmony) has announced that the U.S. Food and Drug Administration (FDA) approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). “We are extremely proud to bring WAKIX to market for those living with narcolepsy, a chronic, debilitating, rare neurologic disorder,” said Harmony’s Chairman and Chief Executive Officer, John C. Jacobs. “At Harmony we share a vision to develop novel treatment options for people living with rare diseases, with a focus on those that affect the central nervous system. The approval of WAKIX strengthens our commitment to making that vision a reality.” WAKIX, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. WAKIX is administered orally once daily in the morning upon wakening. “The approval of WAKIX provides healthcare professionals managing people living with narcolepsy a new and important treatment option for their patients,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “Additionally, WAKIX is the only non-scheduled treatment option approved for adult patients with narcolepsy, and it offers an important benefit/risk profile to address the unmet medical need that exists in people living with narcolepsy.” WAKIX will be commercially available to healthcare professionals and appropriate patients in the U.S. in the fourth quarter of 2019. ]]> https://biospectrumindia.com/news/57/14457/fda-approves-new-drug-for-resistant-tb.html https://biospectrumindia.com/news/57/14457/fda-approves-new-drug-for-resistant-tb.html Fri, 16 Aug 2019 10:50:00 +0530 The U.S. Food and Drug Administration (FDA) has approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. Pretomanid in combination with bedaquiline and linezolid is approved for treating a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB. The FDA granted the approval of Pretomanid Tablets to The Global Alliance for TB Drug Development (TB Alliance). With this approval, The Global Alliance for TB Drug Development is awarded a Tropical Disease Priority Review Voucher in accordance with a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases. Pretomanid is the second drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, established by Congress under the 21st Century Cures Act to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.  Pretomanid also received the FDA’s Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. ]]> https://biospectrumindia.com/reports-white-papers/57/14445/home-care-dementia-geriatric-care-spur-high-sale-of-smart-pill-boxes-bottles.html https://biospectrumindia.com/reports-white-papers/57/14445/home-care-dementia-geriatric-care-spur-high-sale-of-smart-pill-boxes-bottles.html Wed, 14 Aug 2019 11:05:00 +0530 Sales of smart pill boxes and bottles are likely to reach around 800 thousand in 2019. According to an analytical research study, smart pill boxes and bottles market will remain a high growth-low volume landscape over the course of next few years. Over 43% of total sales will be accounted by smart pill boxes. The report envisages a higher rate of adoption for smart pill bottles. Almost 70% of adult patients are observed to discontinue or manipulate drug therapy, resulting in non-adherence to prescribed medication. The study opines that this directly adds to the economic burden on healthcare delivery system in form of emergency cases and hospitalization. Smart pill boxes and bottles are increasingly being perceived as a potential solution to such challenges posed by increased healthcare delivery costs. Significance of medication adherence continues to rise with increasing prevalence of chronic conditions, propelling demand for smart pill boxes and bottles. Dementia and geriatric care remain the key application areas of smart pill boxes and bottles, according to the report. More than 80% of sales is accounted by aging patients and dementia-afflicted population. Cancer management is likely to emerge lucrative in terms of applicability in coming years. With surging demand for high-quality healthcare delivery, senior care centers, hospitals, long-term care centers, and homecare settings are accelerating adoption of medication dispensers, thereby elevating the revenue growth of smart pill boxes and bottles market. Some of the leading companies are actively involved in the development of advanced technology medication dispensing devices with zero error risks during medication. Home care settings maintain the highest consumption share in smart pill boxes and bottles market that roughly equates 65% of total sales. Almost a fifth of smart pill boxes and bottles sold are installed at seniors care and assisted living centers. Study analysis indicates that long-term care centers are also creating promising market opportunities for smart pill boxes and bottles manufacturers and distributors. North America continues to reign supreme owing to early adoption of advanced technology enabled smart pill boxes and bottles, accounting for more than a third of the global market revenue. European market for smart pill boxes and bottles also represents a substantial volume share, majorly driven by German patients. South and East Asian regions are briskly developing high-potential markets for manufacturers and distributors of smart pill boxes and bottles, says the report. The vendor landscape of smart pill boxes and bottles market remains fairly consolidated and competitive, as Tier 1 manufacturers continue to account for a majority of share in the market in terms of volume. While dominance of Koninklijke Philips N.V., PharmRight Corporation & Livi, and AdhereTech prevails in smart pill boxes and bottles market, the report finds that the competition among these players is characterized by product innovation, new launches, and technological advancements. ]]> https://biospectrumindia.com/news/57/14442/jazz-pharma-acquires-cavion-in-a-312-5m-deal.html https://biospectrumindia.com/news/57/14442/jazz-pharma-acquires-cavion-in-a-312-5m-deal.html Tue, 13 Aug 2019 15:50:00 +0530 Jazz Pharmaceuticals plc has announced the acquisition of Cavion, Inc. through a merger with a Jazz subsidiary.  Under the terms of the agreement, the former Cavion shareholders receive an upfront payment of $52.5 million and have the potential to receive additional payments of up to $260.0 million upon the achievement of certain clinical, regulatory and commercial milestones, for a total potential consideration of $312.5 million.  Cavion, a clinical-stage biotechnology company and now a wholly-owned subsidiary of Jazz, creates therapies aimed at modulating the T-type calcium channel for the treatment of chronic and rare neurological diseases.  Cavion's lead molecule, CX-8998, has been evaluated in a Phase 2 randomized, placebo-controlled clinical study in patients with essential tremor.  The study demonstrated proof-of-concept, supporting continued development of CX-8998 as a potential treatment for essential tremor.   "We are excited to continue the development of Cavion's lead asset, CX-8998, a first-in-class small molecule, for the potential treatment of essential tremor, a prevalent and disabling movement disorder," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals.  "The acquisition of Cavion demonstrates our commitment to further diversify our pipeline and product portfolio with the addition of CX-8998, which has the potential to provide a meaningful treatment option to patients."   "Jazz shares Cavion's passion to develop differentiated therapies for patients," said Andrew Krouse, president and chief executive officer of Cavion, Inc.  "We believe that Jazz Pharmaceuticals' development and commercial expertise will help realize the value of CX-8998 as a treatment for patients with essential tremor."  ]]> https://biospectrumindia.com/news/57/14437/bayer-acquires-bluerock-therapeutics-to-strengthen-cell-therapy-portfolio.html https://biospectrumindia.com/news/57/14437/bayer-acquires-bluerock-therapeutics-to-strengthen-cell-therapy-portfolio.html Tue, 13 Aug 2019 15:00:00 +0530 Bayer AG and BlueRock Therapeutics have announced an agreement under which Bayer will fully acquire BlueRock Therapeutics, a privately held US-headquartered biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform. Following a 2016 joint venture with Versant Ventures to establish BlueRock Therapeutics, Bayer will acquire the remaining stake for approximately USD 240 million in cash to be paid upfront at closing and an additional USD 360 million payable upon achievement of pre-defined development milestones. With Bayer currently holding 40.8 percent stake, the investment corresponds to a total company value of BlueRock Therapeutics of approximately USD 1 billion. The closing of the transaction is expected during the third quarter of 2019. The convergence of cell biology and engineering has enabled an important new treatment modality for patients, with significant clinical benefit demonstrated in diseases previously deemed intractable. Especially for degenerative diseases where cell loss and low self-repair potential occur, such as cardiac muscle loss or degenerative neurological disorders, regenerative cell therapy offers unprecedented potential to have a significant benefit for patients. BlueRock Therapeutics' portfolio of cell therapies is currently focused on neurology, cardiology and immunology with a lead program in Parkinson's disease expected to enter the clinic by the end of 2019. Among neurodegenerative disorders, Parkinson's disease is the fastest growing in prevalence, disability and mortality. The primary and most debilitating symptom of Parkinson's disease is a progressive loss of motor control. Stem cell therapy could re-innervate the human brain and reverse degenerative disease, potentially restoring motor function to more than seven million of patients suffering from Parkinson's disease globally. In 2016, Bayer and founding investor Versant Ventures established BlueRock Therapeutics with a USD 225 Million Series A Financing as part of the Leaps by Bayer unit. Leaps is complementary to Bayer's divisional R&D approach and works on establishing new companies and investing in new early-stage technologies with breakthrough potential that have the potential to prevent or cure some of today's biggest health concerns. With this transaction, Bayer will own full rights to BlueRock Therapeutics' CELL+GENETM platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering and cell differentiation capabilities. In addition to its current focus, BlueRock Therapeutics' platform brings the opportunity to extend to other therapeutic areas beyond the current development programs. To preserve the entrepreneurial culture as an essential pillar for nurturing successful innovation, BlueRock Therapeutics' will remain an independent company, operating on an arm's-length basis. ]]> https://biospectrumindia.com/news/57/14436/harvard-merck-to-discover-new-immuno-oncology-targets.html https://biospectrumindia.com/news/57/14436/harvard-merck-to-discover-new-immuno-oncology-targets.html Tue, 13 Aug 2019 14:20:00 +0530 Harvard University and Merck are launching a collaboration that will provide significant research funding for up to four years to support immuno-oncology research led by Arlene Sharpe, MD, PhD, at Harvard Medical School (HMS). Sharpe, the George Fabyan Professor of Comparative Pathology and chair of the HMS Department of Immunology, will collaborate with researchers at Merck on a major project aiming to discover novel aspects of the immune system that may be targeted in future treatments for cancer. “This collaborative project aims to discover and validate novel regulators of immune responses,” said Dr. Sharpe. “Immunotherapies such as checkpoint inhibitors have revolutionized the treatment of cancer, but my lab is deeply interested in understanding why some patients do not respond or develop resistance to those interventions. My hope is that by defining mechanisms that inhibit immune responses to tumors, we will identify very important druggable targets and new approaches to improve cancer immunotherapy.” The funding will support the work of scientists in the lab of Dr. Sharpe, who is a renowned leader in the field of tumor immunology. She is a member of the National Academy of Sciences and the National Academy of Medicine, and the recipient of numerous awards including the Warren Alpert Foundation Prize in 2017 for her contributions to the discovery of the PD-1 pathway. “Crucial insights into patient responses and outcomes may be gained through the study of fundamental biological mechanisms,” said Isaac Kohlberg, Harvard’s Chief Technology Development Officer and Senior Associate Provost. “The complexity and promise of immuno-oncology presents a prime opportunity for Harvard’s top scientists to advance discovery through an academic-industry collaboration. Through this project, the Sharpe Lab is setting its sight on innovations that may contribute to dramatic improvements in patient care.” Under the agreement spearheaded by Harvard’s Office of Technology Development, Merck will have the option to negotiate an exclusive license to innovations arising from the research collaboration to develop these discoveries toward potential treatments for patients. “Collaboration with leading scientific groups is an integral part of Merck’s discovery strategy,” said Dr. Nick Haining, vice president for oncology discovery at Merck Research Laboratories. “We look forward to working with Dr. Sharpe’s team to investigate new ways to harness the immune system for therapeutic advances.” ]]> https://biospectrumindia.com/news/57/14427/myriad-to-seek-usfda-approval-of-brac-analysis-cdx-.html https://biospectrumindia.com/news/57/14427/myriad-to-seek-usfda-approval-of-brac-analysis-cdx-.html Mon, 12 Aug 2019 13:05:00 +0530 Myriad Genetics, Inc. a global leader in molecular diagnostics, has announced that the AstraZeneca/Merck Phase III PROfound study (NCT02987543) met its primary endpoint and demonstrated that men with metastatic castration-resistant prostate (mCRPC) cancer selected for BRCA1/2 or ATM gene mutations, a subpopulation of homologous recombination repair gene mutations, lived for longer time without disease progression when treated with Lynparza® (olaparib), a novel PARP inhibitor.  Myriad will file a supplementary Premarket Approval Application (sPMA) with the U.S. Food and Drug Administration (FDA) to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in mCRPC patients with germline BRCA mutations.  “The PROfound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics.  “This study is another example of Myriad’s commitment to help our pharmaceutical partners achieve and deliver precision medicine for people with cancer.” The topline results – announced earlier today by AstraZeneca and Merck – are the first reported clinical results from the PROfound study, which assessed the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.  The results demonstrated a statistically-significant and clinically-meaningful improvement of radiographic progression-free survival among patients selected for mutations in BRCA1/2 or ATM and were treated with olaparib.  “We congratulate AstraZeneca and Merck on the successful completion of the PROfound trial and look forward to expanding the population of people who can potentially benefit from testing with BRACAnalysis CDx,” said Nicole Lambert, president, Myriad Oncology.  “Importantly, this study is another example of Myriad’s commitment to leverage our portfolio of tumor and germline tests to develop and deliver precision medicine for people with cancer.” The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.  BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA.  Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing.  Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.  ]]> https://biospectrumindia.com/news/57/14426/diplomat-inks-exclusive-practice-based-infusion-contract-with-allergy-partners.html https://biospectrumindia.com/news/57/14426/diplomat-inks-exclusive-practice-based-infusion-contract-with-allergy-partners.html Mon, 12 Aug 2019 12:50:00 +0530 Diplomat Pharmacy, is pleased to announce an exclusive agreement between Diplomat and Allergy Partners, P.A., to manage in-office and in-home delivery and administration of infusion drugs and biologics. The agreement will cover treatments for primary immunodeficiency, alpha-1 antitrypsin deficiency, hereditary angioedema, and more. Allergy Partners is the nation's largest independent, single-specialty practice for allergic disease, asthma, and immunology. Their fast-growing national network consists of 161 providers across 128 locations and 20 states. The five-year agreement, which includes renewal provisions, should allow both organizations to leverage their consolidated purchase volume within the growing marketplace for allergy and immunology biologics. It also creates a unique and preeminent treatment platform for patients that supports both companies' core value of putting patients first. Under this management agreement, Diplomat will provide clinical oversight and staffing, nursing services, information technology, materials management, reimbursement, and certain finance and accounting services on behalf of Allergy Partners' 128 practice locations. The agreement includes the integration of both parties' information technology platforms to support close care coordination between Allergy Partners' physicians and the pharmacy and nursing service teams that Diplomat will be managing. ]]> https://biospectrumindia.com/news/57/14422/amgen-wins-patent-case-on-enbrel-etanercept.html https://biospectrumindia.com/news/57/14422/amgen-wins-patent-case-on-enbrel-etanercept.html Mon, 12 Aug 2019 10:50:00 +0530 Amgen has announced that the U.S. District Court for the District of New Jersey has ruled in Amgen's favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the patent infringement action in Federal Court against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (together, Sandoz). Before trial, Sandoz acknowledged that its biosimilar etanercept infringes seven patent claims in U.S. Patent Nos. 8,063,182 and 8,163,522. Trial proceeded only on Sandoz's challenges to validity of those claims. After careful consideration, the Court found that Sandoz had not met its burden to prove all seven asserted claims invalid. Immunex/Amgen and Sandoz have entered into an agreement with respect to a preliminary injunction regarding Sandoz's etanercept as set out in the Court's order of June 7, 2018. "We are pleased with today's decision recognizing the validity of these patents.  Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients," said Robert A. Bradway, chairman and chief executive officer at Amgen. ]]> https://biospectrumindia.com/news/57/14420/halix-starts-operational-production-with-new-cgmp-facility-in-q4-2019.html https://biospectrumindia.com/news/57/14420/halix-starts-operational-production-with-new-cgmp-facility-in-q4-2019.html Fri, 09 Aug 2019 17:05:00 +0530 HALIX, a contract development and manufacturing organization of clinical and commercial proteins and viral products, based in the Netherlands, announced that they have met their major milestone with the interim delivery of their new 6,700 m2 cGMP facility in Leiden Bio Science Park. Following one year of construction, HALIX has completed its new state-of-the-art cGMP facility for the development and production of biopharmaceutical drug substances. The new five-level production facility contains a state-of-the-art manufacturing line for viral vaccines and viral vectors and a separate protein manufacturing area with a capacity up to 1,000 Liter single-use bioreactors. In addition, lab space is available for process development, analytical development and quality control. All cleanroom areas have a unidirectional process flow and are designed to allow commercial manufacturing of biopharmaceuticals products. “This new facility offers our current and future clients capacity and flexibility for future expansion and will allow for cGMP manufacturing solutions for viral products, proteins, gene therapy and client-specific new technologies.” said Roland Hecht, HALIX Chief Customer Officer. Alex Huybens, HALIX Chief Operations Officer, further added “We are very pleased to have met this major milestone for our new manufacturing facility. We have made great progress under very aggressive timelines. After a construction time of just 12 months we are now able to start production of viral products and protein production will follow soon. This milestone aligns with our growth and expansion strategy that will enable us to accommodate the growing market demand as well as our clients’ demands”. ]]> https://biospectrumindia.com/news/57/14402/gsk-grants-exclusive-technology-license-to-sabin-for-ebola-vaccines-.html https://biospectrumindia.com/news/57/14402/gsk-grants-exclusive-technology-license-to-sabin-for-ebola-vaccines-.html Fri, 09 Aug 2019 10:00:00 +0530 GSK and the Sabin Vaccine Institute (Sabin) has announced exclusive agreements for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Ebola Zaire, Ebola Sudan and the closely related, but lesser known, Marburg virus. No licensed vaccines against these three viruses are currently available. All three cause hemorrhagic fever with subsequent death in an average of 50 percent of cases. More than 1,600 people have already died during the ongoing Ebola Zaire outbreak in the Democratic Republic of Congo (DRC), leading the World Health Organization (WHO) to recently declare it a Public Health Emergency of International Concern. Under the agreements between GSK and Sabin, Sabin has exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary ChAd3 platform, were further developed by GSK, including the Phase II development for the Ebola Zaire vaccine. Amy Finan, Sabin Chief Executive Officer commented, “As an organization committed to improving lives through immunization, Sabin is dedicated to preventing devastating outbreaks of the Ebola and Marburg viruses. Thanks to GSK’s longstanding engagement in global health, as well as its scientific expertise, the ChAd3 vaccine program is well positioned to be an effective weapon in the global community’s arsenal against Ebola. Sabin appreciates GSK’s years of work to advance the ChAd3 Ebola program and the productive partnership the two organizations have established. Sabin plans to continue the development and seek regulatory approval of Ebola and Marburg vaccines with our shared goal of making them available to the millions of people potentially at risk.” Thomas Breuer, Chief Medical Officer of GSK Vaccines, said: “These agreements with the Sabin Vaccine Institute are an important next step in the fight against Ebola and Marburg viruses. Enabling Sabin to build on the scientific progress GSK has delivered up to Phase II increases the likelihood these candidate vaccines may help prevent potential future outbreaks, and exemplifies GSK’s approach to global health vaccines which supports partners in taking forward our innovations in a sustainable way. I am proud of the work that our world-leading vaccines scientists at GSK have contributed so far to the development of these vaccine candidates, including the Ebola Zaire candidate vaccine which has demonstrated encouraging results in studies to date.” To further develop the ChAd3 Ebola and Marburg vaccines, Sabin has entered into a Research Collaboration Agreement with the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID). The ChAd3-based vaccines against Ebola Zaire, Ebola Sudan, and Marburg viruses have demonstrated a strong safety profile and encouraging immunogenicity results after being administered to more than 5,000 adults and 600 children, in 13 different clinical trials to date. Specifically, the majority of the clinical volunteers were tested using the ChAd3 Ebola Zaire vaccine. In addition to numerous Phase I trials, the Ebola Zaire vaccine has been tested in three Phase II trials in Africa; two trials were conducted by GSK and one was conducted by the Partnership for Research on Ebola Virus in Liberia (PREVAIL), a clinical research partnership between NIAID and the Liberian Ministry of Health. The Ebola Sudan vaccine has been evaluated in three Phase I trials in Africa and the United States as a bivalent formulation with Ebola Zaire and will be evaluated in an upcoming Phase I study as monovalent formulation. A Phase I study of the Marburg vaccine is ongoing in the United States.   ]]> https://biospectrumindia.com/news/57/14401/lilly-announces-leadership-changes.html https://biospectrumindia.com/news/57/14401/lilly-announces-leadership-changes.html Thu, 08 Aug 2019 13:25:00 +0530 Eli Lilly and Company has announced several leadership changes in the company's corporate business development, oncology R&D, and managed healthcare services organizations. Darren Carroll, senior vice president of corporate business development, will retire at the end of August after 22 years of service with the company. Carroll has led Lilly's corporate business development organization for nearly a decade, including the $8.1 billion acquisition of Loxo Oncology earlier this year, the largest acquisition in Lilly's history. In two related moves, Phil Johnson, senior vice president and treasurer, will assume additional duties overseeing merger & acquisition activity, while Heather Wasserman, Ph.D., has been promoted to vice president of corporate business development, with responsibility for business development transactions, emerging technologies and innovation, and venture capital. The company also announced that Levi Garraway, M.D., Ph.D., has resigned from his position as senior vice president of oncology research and early phase development in order to pursue other opportunities. Josh Bilenker, M.D., CEO of Loxo Oncology, a wholly owned subsidiary of Lilly, will lead oncology research and early phase development in the interim, in addition to his current responsibilities. In addition, Frank Cunningham has been promoted to senior vice president of managed healthcare services, in recognition of the critical role his organization plays in leading the company's interactions and negotiations with payer customers. Managed healthcare services works to ensure patients in the U.S. have broad access to Lilly medicines.   ]]> https://biospectrumindia.com/news/57/14398/bioivt-acquires-keystone-biologicals.html https://biospectrumindia.com/news/57/14398/bioivt-acquires-keystone-biologicals.html Thu, 08 Aug 2019 12:00:00 +0530 BioIVT, a global leading provider of research models and services for drug and diagnostic development has acquired Keystone Biologicals, Inc., a global supplier of disease-state plasma, sera and controls, located in Hatboro, PA. This acquisition will expand BioIVT’s disease-state portfolio both by volume and product range. “With the addition of Keystone Biologicals, BioIVT broadens its product offerings and better supports clients in the in vitrodiagnostic (IVD) market,” said BioIVT Chief Executive Officer Jeffrey Gatz. “This acquisition furthers our mission of becoming the partner of choice for both biopharmaceutical and diagnostic clients.” Keystone Biologicals provides a broad range of autoimmune, serology and virology, immunology, and tumor marker research samples. Its antibody positive cohorts include donors with infectious diseases such as hepatitis, herpes, syphilis and toxoplasmosis, and autoimmune diseases such as rheumatoid factor and systemic lupus. It also offers liquid-stable controls, standards and calibrators for use with stock or custom-produced diagnostic kits. In addition, Keystone Biologicals’ in-house laboratory enables it to characterize raw material using a variety of testing formats including the client’s own test kits. By using clients’ own assays, Keystone Biologicals can help ensure that clients do not spend time and money evaluating material that does not meet their study requirements. Financial details about this transaction were not disclosed. ]]> https://biospectrumindia.com/news/57/14392/la-biomed-to-develop-vaccine-against-deadly-superbug.html https://biospectrumindia.com/news/57/14392/la-biomed-to-develop-vaccine-against-deadly-superbug.html Wed, 07 Aug 2019 12:10:00 +0530 Researchers from the Los Angeles Biomedical Research Institute (LA BioMed) have taken a major step toward the creation of vaccine that could neutralize the culprit behind a growing public health crisis. Candida auris, a “superbug” that has caused hundreds of often fatal hospital-acquired infections in the United States in recent years, is resistant to common antifungal drugs. Almost half of those who contract C. auris die within the first three months, according to the Centers for Disease Control and Prevention. In a paper published August 5 in the PLoS Pathogens Journal, a team of scientists including Drs. Ashraf Ibrahim and Jack Edwards of LA BioMed detailed recent breakthrough experiments that successfully immunized mice against C. auris infection. The first-of-their-kind experiments can serve as a blueprint for the development of a vaccine that could prevent infections caused by C. auris in humans. Drs. Ibrahim, Edwards and their team performed studies that identified the presence of proteins in C. auris similar to a major protein in another fungus, Candida albicans, called Als3. In conjunction with LA BioMed spinoff company NovaDigm Therapeutics, they developed a vaccine, NDV-3A, based on certain characteristics of the Als3 protein that they used to successfully immunize mice against C. aurisinfection. The vaccine induced significant levels of immune responses and protected immunosuppressed mice from lethal C. auris infection compared with a control group not given the vaccine. Given that C. auris can be resistant to almost all anti-fungal drugs, a vaccine is likely the best way to combat this emerging and deadly pathogen.  “The potential for a vaccine for a drug-resistant fungus like C. auris can save both thousands of lives and billions of dollars in health care costs,” Ibrahim said.  “We are proud that our investigators are continuing our tradition of discoveries that will save many lives,” said David Meyer, PhD, President and CEO, LA BioMed. “Hospital-acquired infections are a growing problem affecting those least able to fight them. This type of highly impactful—and successful— research is what our institute is all about.” ]]> https://biospectrumindia.com/news/57/14387/merck-acquires-bssn-software-.html https://biospectrumindia.com/news/57/14387/merck-acquires-bssn-software-.html Tue, 06 Aug 2019 19:05:00 +0530 Merck, a leading science and technology company, has acquired BSSN Software, a Darmstadt, Germany-based laboratory Informatics Company that makes data more readily accessible for ease of integration, collaboration, analysis and long-term archiving. Financial details were not disclosed. “BSSN Software and the capabilities that it brings will allow Merck’s customers to better use and share their scientific data — the most important part of laboratory experiments,” said Jean-Charles Wirth, head of Applied Solutions at the Life Science business sector of Merck. “We acquired this company for commercial growth of the lab data management technology that BSSN provided for many years. This acquisition creates opportunity and gives Merck a unique position in this fast-paced market.”  BSSN Software is known for developing and marketing data management and integration software that unifies data from instruments and data systems and makes them available for analyzing, processing and sharing. It collects and converts scientific data from a broad range of more than 200 lab instrument models into a single, unified format. As a middleware offering, it facilitates communication and data flow between instruments and systems, such as laboratory information management systems, electronic lab notebooks and enterprise resource planning systems. The acquisition complements Merck’s efforts to support its customers’ digital transformation in the lab.  Since 2014, Merck has been working with BSSN Software, which primarily served pharmaceutical and food and beverage customers and provided services to facilitate standard laboratory efforts. BSSN Software was the first company to introduce to the market a complete AnIML implementation, an open standardized XML data format for storing and sharing of experiment data. With this acquisition, Merck is combining BSSN’s technology with its market access and laboratory domain knowledge to develop and commercialize an open and interoperable platform for laboratory data. Merck is committed to the continued development and support of the current BSSN Software product portfolio, its customers and partnerships, as well as an open ecosystem building on the AnIML standard and Standardization in Lab Automation. BSSN’s employees have joined Merck as part of its Applied Digital Lab Productivity Solutions team. ]]> https://biospectrumindia.com/news/57/14386/antikor-biopharma-essex-bio-technology-collaborate-for-cancer-treatment.html https://biospectrumindia.com/news/57/14386/antikor-biopharma-essex-bio-technology-collaborate-for-cancer-treatment.html Tue, 06 Aug 2019 18:55:00 +0530 UK based Biotechnology company Antikor Biopharma Ltd is pleased to announce that it has entered into an Investment Agreement for up to US$3,100,000 with Essex Bio-Investment, a wholly-owned subsidiary of Essex Bio-Technology Ltd (”EssexBio”), which will enable Antikor to consolidate and expand its position as a leading innovator in smaller-format conjugate therapies for solid tumours. Essex Bio-Technology is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic rb-bFGF (FGF-2), having five commercialised biologics marketed in China since 1998.The products of the Company and its 3rd party products are prescribed for the treatment of wound healing and diseases in Ophthalmology & Dermatology, which are marketed and sold through more than 6,300 hospitals and managed directly by its 42 regional sales offices in China. Mahendra Deonarain, Antikor’s CEO and visiting Reader in Antibody Technology at Imperial College London where Antikor has its roots, commented: “We believe wehave a platform that is tailored to make an impact in an area of major unmet medical need, and with EssexBio’s considerable commercial and clinical expertise, we now have the opportunity for translating the promised advantages of Antikor’s proprietary products into clinical benefit.” “We are excited to have established a strong alliance with Antikor”, said Malcolm Ngiam, President of Essex Bio-Investment, “Fragment-Drug Conjugate is an innovative approach with the potential to overcome many of the challenges faced by current treatment methods. The research and commercial partnership with Antikor is an important step towards developing first-in-class treatment for cancer.” Antikor’s novel technology platform will enrich Essex’s research pipeline and is aligned with EssexBio’s long-term research and commercial strategy. ]]> https://biospectrumindia.com/news/57/14384/cytena-to-sell-all-shares-to-cellink-for-30-25m-euros.html https://biospectrumindia.com/news/57/14384/cytena-to-sell-all-shares-to-cellink-for-30-25m-euros.html Tue, 06 Aug 2019 17:05:00 +0530 The owners of Cytena GmbH ("Cytena") have agreed to sell all Cytena shares to CELLINK AB ("CELLINK") for a purchase price of 30.25M euros ("acquisition"). Through CELLINK’s complimentary technology offering cytena sees great synergies that will support and accelerate future growth of Cytena. An extended product offering and a stronger global presence are just some of the benefits for our Cytena’s customers and partners. Background and motivation for the acquisition Through this strategic acquisition, CELLINK expands its technology portfolio, supporting further expansion into the pharmaceutical industry. CELLINK offers bioink, bioprinters, rapid dispensers and live cell imaging systems that enable creation and monitoring of human tissues and 3D cell culture models. Cytena’s single-cell dispensing platform enables pharmaceutical companies to develop antibodies and cell lines and offers a great complement to CELLINK’s 3D bioprinting technologies. The companies’ synergies enable greater market opportunities for Cytena’s and CELLINK’s product portfolio and global sales forces. The products are well-suited to be sold together to Cytena’s and CELLINK's existing customer base. Cytena’s technology platform allows dispensing of single cells, enabling researchers to isolate cells for cell line development and build microtissues faster and more reproducibly. Cytena’s products fit well within CELLINK's current product portfolio and will enhance the group’s product offering. Cytena’s products are most suitable for pharmaceutical companies, an area and market in which CELLINK has communicated interest in expanding further into. With this acquisition, CELLINK aims to increase market penetration in the pharmaceutical field. Cytena’s products are based on patented single-cell dispensing technologies, providing both protection and freedom to operate. The acquisition is in line with CELLINK’s commercial strategy, strengthening CELLINK’s product offering and providing a more complete 3D cell culturing solution. Cytena will remain under current entity and management post-transaction. ]]> https://biospectrumindia.com/news/57/14373/prudential-mydoc-launches-online-healthcare-services-in-asia.html https://biospectrumindia.com/news/57/14373/prudential-mydoc-launches-online-healthcare-services-in-asia.html Mon, 05 Aug 2019 15:00:00 +0530 Prudential Corporation Asia ("Prudential") has announced it will partner with telemedicine provider MyDoc to offer consumers access to value-added health services on their mobile phones, including doctor consultations, electronic prescriptions and electronic medical certificates. Prudential is a leading life insurer and asset manager in Asia with over 15 million customers and £151 billion in assets under management. Singapore-based MyDoc, founded in 2012, is a leading digital healthcare provider in Asia. MyDoc's services will be integrated into Pulse by Prudential, the first app of its kind in the region offering holistic health management to users. Pulse features self-help health and wellness tools, a symptom checker powered by Artificial Intelligence, and other value-added services. The Pulse app will launch in 11 markets across Asia, and can be downloaded for free. MyDoc offers patients a video consultation with a doctor through Pulse, as well as the option to book a face-to-face appointment. Electronic prescriptions, medicine delivery, electronic medical certificates and online records will be offered in selected markets as an additional service. MyDoc's panel of doctors and pharmacy partners are all selected using stringent standards. The consulting doctors are required to have at least three years of private practice experience, additional clinical and product training, and must pass test consultations prior to certification. Mr Nic Nicandrou, Chief Executive of Prudential Corporation Asia, said, "Prudential's partnership with MyDoc is in line with our commitment to make healthcare affordable and accessible to all. MyDoc's telemedicine services will be part of the full cycle of healthcare and wellness services on Pulse, from wellness tracking and symptom checking to online consultations and disease prevention. "By combining revolutionary health technology and the convenience of telemedicine, MyDoc and Prudential are helping to empower consumers to take control of their health, anytime, anywhere. Prudential will continue to bring the best health and wellness services to Pulse, in tandem with our local and regional partners." Dr Snehal Patel, CEO and co-Founder of MyDoc, said, "We are honoured and excited to be providing pioneering support to Prudential. As the leader in digital health innovations with over seven years of experience across Southeast Asia, MyDoc is uniquely positioned to deliver this important regional multi-year initiative to Prudential.  "As part of this groundbreaking project, MyDoc will help drive improved quality and better value healthcare across the region. We look forward to working with Prudential to improve the lives of their customers and over 600 million people in Southeast Asia." Access to physicians remains a challenge for many communities across Asia. According to World Health Organisation data, Southeast Asia has fewer physicians on average, at 6 for every 10,000 people, compared to developed economies such as Germany, which has 37.  With more than 2.8 billion people or 67% of Asia's population owning mobile phones, there is an opportunity for communities to take control of their own lives and their own health through digital healthcare. Using the digital services provided by Pulse and MyDoc, medical care, health monitoring and health management will be at peoples' fingertips. Market-specific details and launch dates for Pulse and MyDoc's telemedicine services will be announced in due course.  ]]> https://biospectrumindia.com/news/57/14370/essenlix-creates-smallest-lowest-cost-blood-count-device.html https://biospectrumindia.com/news/57/14370/essenlix-creates-smallest-lowest-cost-blood-count-device.html Mon, 05 Aug 2019 11:25:00 +0530 Essenlix Corporation, a US based premier provider of instant personal mobile health test solutions and a global leader in the application of nanotechnology, machine learning and advanced biology for health test, has announced the development of the world's smallest, simplest, and lowest-cost blood count device – iMOST-CBC (instant mobile self-test for complete blood count). Essenlix's iMOST is an instant personal, mobile, health self-testing platform that uses unique technology innovations. iMOST allows an individual to perform health tests easily, quickly, accurately, and affordably anywhere, anytime, with results in 60 seconds that can be sent immediately to a healthcare professional. With the potential to do various tests of different biomarkers in different body fluids with different biochemistries, the first application of iMOST will be iMOST-CBC. CBC or complete blood count is a vital sign of a person's health, and one of the most common but important lab tests. iMOST-CBC has gone through over four years of development and extensive laboratory tests and clinical trials. iMOST-CBC is currently only for research use, and has not yet been cleared by the FDA. ]]> https://biospectrumindia.com/news/57/14369/fujifilm-completes-acquisition-of-biogens-manufacturing-site-in-denmark.html https://biospectrumindia.com/news/57/14369/fujifilm-completes-acquisition-of-biogens-manufacturing-site-in-denmark.html Mon, 05 Aug 2019 11:10:00 +0530 FUJIFILM Corporation has announced that it has completed the acquisition of Biogen (Denmark) Manufacturing ApS, a large-scale biologics manufacturing site located in Hillerød near Copenhagen, Denmark (“Hillerød Manufacturing”) from Biogen. Fujifilm invested approximately US$890 million in cash for the transaction. With the closing of this transaction, the Hillerød Manufacturing site is now the fourth biopharmaceutical manufacturing site of FUJIFILM Diosynth Biotechnologies, a subsidiary of Fujifilm and a leading Contract Development and Manufacturing Organization (“CDMO”) with expertise in the development and manufacture of biologics and advanced therapies. Hillerød Manufacturing will change its name to FUJIFILM Diosynth Biotechnologies Denmark ApS once all regulatory procedures are complete. The new site consists of a campus hosting a large-scale production facility equipped with 6 x 15,000L bioreactors for the manufacture of cell culture derived biologics for clinical and commercial use. There are close to 800 employees in the Hillerød campus which also houses an assembly, labeling and packaging facility, quality control laboratories and warehouses. The products which were manufactured under Biogen at the site will continue to be supplied by Hillerød Manufacturing under Fujifilm ownership. Takatoshi Ishikawa, Executive Vice President, General Manager of Bio CDMO Division, FUJIFILM Corporation said, “Fujifilm's culture of innovation and its reputation of manufacturing excellence provides unique value to the bio CDMO industry. We will seek to continue to the further advancement of the pharmaceutical industry by serving our range of diverse customers' needs through combining resources of the Biogen (Denmark) Manufacturing ApS and Fujifilm” Steve Bagshaw, Chief Executive Officer of FUJIFILM Diosynth Biotechnologies said, “I am delighted to welcome the Biogen (Denmark) Manufacturing ApS team to the FUJIFILM Diosynth Biotechnologies family. For us this is more than an acquisition. It is fulfilling Fujifilm's mission and the vision to bring new value to society, through innovation and the creation of new technologies, products and services.” This acquisition demonstrates the clear focus of Fujifilm to deliver on its strategy, not only to increase production capacity significantly, but also to support projects from pre-clinical through to commercialization with best in class assets capable of delivering very small to very large production volumes. With its expertise in the process development, manufacture and aseptic filling for its full service CDMO approach, and the capability for a variety of biologics including recombinant proteins, monoclonal antibodies, viral vaccines and gene therapies, Fujifilm will continue to further expand the business and seeks to achieve 100 billion yen in sales in its Bio CDMO business by fiscal year ending March 2022.   ]]> https://biospectrumindia.com/news/57/14366/bayer-gets-eu-chmp-nod-for-precision-oncology-treatment-larotrectinib-.html https://biospectrumindia.com/news/57/14366/bayer-gets-eu-chmp-nod-for-precision-oncology-treatment-larotrectinib-.html Fri, 02 Aug 2019 15:30:00 +0530 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended Bayer’s precision oncology treatment larotrectinib for marketing authorization in the European Union (EU). The recommended indication is treatment of adult and pediatric patients with solid tumors that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options. The final decision of the European Commission on the marketing authorization is expected in the coming months. Larotrectinib, a first-in-class oral TRK inhibitor specifically developed to treat tumors that have an NTRK gene fusion, will be the first treatment to receive a tumor-agnostic indication in the EU. Larotrectinib is already approved in the U.S. as well as in Brazil and Canada.  The CHMP recommendation is based on pooled clinical trial data of 102 patients (93 patients from the primary analysis population and an additional 9 patients with primary central nervous [CNS] tumors) across the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial, showing a high response rate with durable and rapid responses for larotrectinib. TRK fusion cancer is rare overall, affecting no more than a few thousand patients across Europe annually. It affects both children and adults and occurs in varying frequencies across various tumor types. In clinical trials, larotrectinib was investigated across 29 different histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, soft tissue sarcomas, salivary gland and infantile fibrosarcoma. Larotrectinib is an oral, highly selective TRK inhibitor that targets TRK proteins that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body. Larotrectinib has shown efficacy in primary central nervous system (CNS) tumors as well as patients with brain metastases, across age or tumor histology. “This positive CHMP recommendation for the first-ever tumor agnostic indication in Europe marks an important step towards delivering a first-of -its -kind precision medicine for children and adults with TRK fusion cancer in Europe,” said Dr Scott Z Fields, Senior Vice President and Head of Oncology Development at Bayer. “Larotrectinib was specifically developed to treat patients with TRK fusion cancer, and has the potential to significantly improve treatment outcomes, regardless of tumor type or age. As researchers learn more about tumor genomics, it becomes all the more important to ensure broad access to genomic testing to allow patients that have the potential to benefit from precision medicines to be identified and treated, moving us beyond a one-size fits all therapeutic approach.” High quality NTRK testing is key to identifying those patients who are most likely to benefit from larotrectinib. Only specific tests can identify NTRK gene fusions or TRK fusion proteins. Immunohistochemistry (IHC) is a useful screening tool. However, IHC detects both the expression of the wildtype TRK protein as well as the TRK fusion protein; therefore, positive results need to be confirmed by more specific tests such as next-generation sequencing. Patients eligible for treatment with larotrectinib should be selected based on the presence of an NTRK gene fusion in their tumor. ]]> https://biospectrumindia.com/news/57/14365/usfda-approves-bayers-darolutamide-to-treat-prostate-cancer.html https://biospectrumindia.com/news/57/14365/usfda-approves-bayers-darolutamide-to-treat-prostate-cancer.html Fri, 02 Aug 2019 15:15:00 +0530 The U.S. Food and Drug Administration (FDA) has approved darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa®. The FDA approval is for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and is based on the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. The compound, which is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, was approved under the FDA Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions. The androgen receptor inhibitor has a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. “Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. “This approval marks an important new option for the prostate cancer community.” Prostate cancer that is treated with ADT but keeps progressing even when the amount of testosterone is reduced to very low levels in the body is known as castration-resistant prostate cancer (CRPC). In the U.S., over 73,000 men are estimated to have a CRPC diagnosis in 2019. About one-third of men with non-metastatic CRPC go on to develop metastases within two years. “With the approval of darolutamide, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC,,” said Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. “Bayer is proud to take this latest step forward in the nmCRPC treatment landscape. Darolutamide is the newest addition to our prostate cancer portfolio and reflects Bayer's commitment to finding treatments for men at different stages along the prostate cancer continuum.”  In the ARAMIS trial, overall survival (OS) and time to pain progression were additional secondary efficacy endpoints. A positive trend in OS was observed; OS data were not yet mature at the time of final MFS analysis. The MFS result was additionally supported by a delay in time to pain progression as compared to placebo plus ADT. All other secondary endpoints, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event, demonstrated a benefit in favor of darolutamide.  Preclinical studies showed that darolutamide has a lower blood-brain barrier penetration compared to other currently available AR inhibitors. A high concentration of these compounds in the central nervous system (CNS) may lead to undesired side effects. Bayer has filed for approval of the compound in the European Union (EU), Japan and with other health authorities.  ]]> https://biospectrumindia.com/news/57/14364/access-scientific-signs-sales-agreement-with-smiths-medical-.html https://biospectrumindia.com/news/57/14364/access-scientific-signs-sales-agreement-with-smiths-medical-.html Fri, 02 Aug 2019 15:00:00 +0530 Access Scientific, LLC, a leading provider of extended dwell and midline catheters, announced the signing of a sales agreement with Smiths Medical to sell the POWERWAND™ product line in the United States. The POWERWAND product line helps Smiths Medical extend their vascular access product portfolio into the extended dwell and midline catheter categories – the fastest growing devices within the vascular access device segment (valued at $1.6B). "With the growing emphasis on quality of care and the increased financial penalties associated with hospital acquired conditions (HACs), hospitals are seeking products that help them achieve better clinical outcomes and reduced costs. These outcomes include reduced catheter-related bloodstream infection rates, improved patient satisfaction and lower overall costs — this is why demand for our POWERWAND catheter products is at an all time high. Partnering with Smiths Medical allows us to reach a broader market, ultimately helping improve the lives of more patients," said Jeff Goble, Access Scientific's CEO. To expand marketing and sales of POWERWAND in association with the Smiths Medical relationship, Access Scientific has secured $20M in additional capital funding from existing shareholders and a new long term credit facility. This new funding allows Access to further invest in product development, increased production capacity and expanded sales & marketing efforts. ]]> https://biospectrumindia.com/news/57/14360/novo-nordisk-e-therapeutics-extend-type-2-diabetes-research-pact.html https://biospectrumindia.com/news/57/14360/novo-nordisk-e-therapeutics-extend-type-2-diabetes-research-pact.html Fri, 02 Aug 2019 11:10:00 +0530 UK based firm e-therapeutics has announced that it has signed an extension to its existing research collaboration with Novo Nordisk in the type 2 diabetes space. To date, the companies have been using e-therapeutics' proprietary Network-Driven Drug Discovery (NDD) platform to discover potentially novel biological mechanisms and therapeutic approaches for a specific area of type 2 diabetes. Under the amended agreement, e-therapeutics will now also use its new Genome-Associated Interaction Networks (GAINs) technology to analyse population genomics data from patients with type 2 diabetes. This is the first research agreement for e-therapeutics' new and novel functional genomics technology. The amendment extends the original contract by six months to June 2020 and will also allow further work to be performed using e-therapeutics' NDD technology. In addition, output from the GAINs collaboration can be included in any subsequent work and commercial agreement. Dr Ray Barlow, CEO at e-therapeutics, said: "We are very pleased that Novo Nordisk, a global leader in diabetes care and innovation, has chosen to extend our original agreement. In addition to extending the original contract, this marks the first deal on our new "GAINs" functional genomics technology in a hugely important disease area. We are really excited by the potential of GAINs to greatly improve the understanding of complex diseases, identify previously unknown disease processes and pathways and facilitate the discovery of new drugs. Over the last 20 years, the pharma industry has conducted many population genomics studies to understand the genetic basis of disease, most of which have met with limited success. Using GAINs, we are now able to interrogate genomics data from patients with complex, polygenic disease and shed new light on important and novel biological pathways for particular groups of patients. GAINs has potentially broad application in therapeutic, diagnostic and biomarker fields. We only began to market GAINs to the industry two months ago and are encouraged by the interest already shown." Other than the extension in term and additional payments, the terms and conditions of the original agreement remain in place. Novo Nordisk has the option to license relevant IP generated under the collaboration. Any future license would require mutual agreement of commercial terms.   ]]> https://biospectrumindia.com/news/57/14356/malaria-no-more-adds-two-leaders-to-its-board-.html https://biospectrumindia.com/news/57/14356/malaria-no-more-adds-two-leaders-to-its-board-.html Thu, 01 Aug 2019 17:45:00 +0530 Malaria No More has announced the appointment of Uday Shankar, Chairman of Star and Disney India and President of The Walt Disney Company’s Asia Pacific Unit, and Kathy Park, Managing Director at Goldman Sachs to its Board of Directors. Martin Edlund, CEO, Malaria No More said, “Malaria No More relies on the political, communications and technical savvy of our Board to pursue our mission to ensure no one dies of a mosquito bite. Uday and Kathy bring a wealth of expertise and influence that will help advance Malaria No More’s work to end one of the world’s oldest and deadliest diseases, and we’re grateful for their leadership and commitment.” Uday Shanka is a trained journalist and has helped to pioneer the development of the TV news ecosystem in India. He is a recognized leader in India’s and the Asia Pacific region’s media and entertainment industries for helping to scale new technologies while driving social change to fuel women’s empowerment and to promote progressive mindsets in India. His expertise will be instrumental as Malaria No More works with India’s Government to develop the first national mosquito-borne disease education campaign, and works with the State of Odisha – one of India’s highest malaria burden states that reduced malaria cases by more than 80% between 2017 and 2018 – to replicate its success in other high burden regions in India. Kathy Park at Goldman Sachs, Kathy Park is head of Fund & Private Capital Raising in the Americas, and has been a leader in developing innovative and bespoke financing and business solutions, particularly for alternative investment managers and financial institutions. Park has also championed women’s issues as a Board member of Susan G. Komen Greater NYC. To put the world on a path to eradicate malaria, funding will need to grow to more than $5 billion annually by 2025, according to the report titled From Aspiration to Action: What will it take to end malaria? Recent models in Africa and the Americas demonstrate that the tools of innovative finance can play a role in filling that gap and unlocking domestic resources for malaria and broader health issues. “Malaria disproportionately affects women, putting their lives at risk, threatening the health of their unborn children and hampering earning potential. This is a critical time to mobilize new resources to step up the fight to end malaria. Malaria No More’s work has contributed to the global effort that resulted in saving 7 million lives and preventing more than 1 billion malaria cases since 2000. I am honored to join my fellow board members who are committed to ending this preventable and treatable disease”, Park added. Malaria No More was co-founded by businessmen Ray Chambers, who currently serves as the WHO Ambassador for Global Strategy, and Peter Chernin, Founder and CEO of The Chernin Group. Chernin and Chris Combe, Chairman of Combe Incorporated, serve as Co-Chairs of the Board. The additions of Shankar and Park build on Malaria No More’s Board expansion in 2018, which saw the addition of visionary global leaders including Dick Costolo, former CEO of Twitter; Surya Mohapatra, former Chairman, President and CEO, Quest Diagnostics Incorporated; Kieran Murphy, President and CEO, GE Healthcare; and Rich Verma, former US Ambassador to India. Dr. Sanjeev Singh Gaikwad has been named as its India Country Director. Dr. Gaikwad brings a depth of experience in areas that align closely to Malaria No More’s focus in India, including in technical programs, national communications campaigns, and policy and advocacy work in Delhi and state capitals. He brings 30 years of global service to agencies such as the United States Agency for International Development (USAID), the United Kingdom’s Department for International Development (DFID), the German Corporation for International Cooperation (GIZ), FHI360 and most recently Abt Associates. “I look forward to leading Malaria No More India to support the Government of India and our partners in making malaria a disease of the past in India, just like India did with smallpox and polio. India has made great strides against this ancient disease, and now we must turbocharge our efforts to rally the political will, increase human engagement, harness data and adopt new innovations to end malaria for good in India”, Dr. Gaikwad added. To strengthen its work supporting India’s goal to be malaria-free by 2030, Malaria No More also expanded its India Country Team by hiring: Narendra Shekhar Behera, Odisha Research, Data Management and Metrics & Evaluation Manager; Bhesaja Kumar Choudhury, Odisha BCC and Public Relations Communications Manager; Manisha Gautam, Communications Lead; Susanta Jena, Office Assistant; and Ajit Samantray, Administrative Officer. In addition, Malaria No More recently hired Kate Hourihan, Graphic Designer, and Carrie Nichols, International Programs Manager, to work in its U.S. offices.   ]]> https://biospectrumindia.com/news/57/14353/novanta-completes-acquisition-of-arges.html https://biospectrumindia.com/news/57/14353/novanta-completes-acquisition-of-arges.html Thu, 01 Aug 2019 15:45:00 +0530 Novanta, a trusted technology partner to medical and advanced industrial equipment manufacturers has completed its acquisition of ARGES GmbH, based in Wackersdorf, Germany. ARGES develops and manufactures intelligent subsystems for positioning and deflecting laser beams. Through its Photonics Group, Novanta develops and manufactures lasers and laser beam steering solutions. “ARGES shares our passion for innovation and we are excited that they are now part of Novanta,” said Phil Martin, Novanta’s Group President, Photonics. “We can provide our OEM customers with expanded and compelling solutions for their challenging applications in advanced material processing, additive manufacturing, medical and many other fast-growing markets.” ]]> https://biospectrumindia.com/news/57/14350/fda-approves-new-monotherapy-indication-for-mercks-keytruda.html https://biospectrumindia.com/news/57/14350/fda-approves-new-monotherapy-indication-for-mercks-keytruda.html Thu, 01 Aug 2019 13:45:00 +0530 Merck known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. “Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With this approval, KEYTRUDA is now the first anti-PD-1 therapy approved for the treatment of previously-treated patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10), providing an important new monotherapy option for physicians and patients in the United States.” Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected This indication was also based on data from KEYNOTE-180, a multicenter, non-randomized, open-label trial that enrolled 121 patients with locally advanced or metastatic esophageal cancer who progressed on or after at least two prior systemic treatments for advanced disease. With the exception of the number of prior lines of treatment, the eligibility criteria were similar to and the dosage regimen identical to KEYNOTE-181. ]]> https://biospectrumindia.com/news/57/14347/who-endorsement-of-simpler-drug-treatment-for-blood-pressure-will-save-lives-george-institute-.html https://biospectrumindia.com/news/57/14347/who-endorsement-of-simpler-drug-treatment-for-blood-pressure-will-save-lives-george-institute-.html Thu, 01 Aug 2019 11:25:00 +0530 The George Institute for Global Health has announced that it welcomes the addition of fixed-dose combinations (FDCs) of blood pressure (BP) lowering drugs to the World Health Organization’s (WHO) Essential Medicines List (EML) in response to an application filed by Resolve to Save Lives (RTSL), an initiative of vital strategies, the George Institute and other partners. Adding FDCs of BP-lowering drugs to the EML is a critical step to improve the availability and affordability of these drugs, making it easier for the more than 1 billion people with high BP worldwide to regularly take the medicines they need to prevent early disability and death. FDCs, which combine two or more BP-lowering drugs that are commonly taken together into a single pill, has been proven to improve patients’ adherence to medication regimens and BP control rates. FDCs have important advantages for patients and health systems, including simpler dose schedules, decreased pill burden, reduced stockouts, easier task sharing, training, and supervision. Dr. Tom Frieden, President, and CEO of RTSL said, “High BP kills more people than all infectious diseases combined, but there are safe, effective, generic, low-cost medications that can prevent many of these deaths. FDCs have played an important role in improving BP control rates in many countries, and their inclusion in the WHO EML will encourage all health systems to prioritize these life-saving drugs.” Many countries use the WHO EML as a model, and the listing of FDC BP-lowering drugs in EML will promote broader global uptake. Resolve to Save Lives coordinated the application for BP lowering FDC’s inclusion in the 21st WHO EML with support from the Arnhold Institute for Global Health, the George Institute for Global Health, and the Young Professionals Chronic Disease Network. “Ensuring a supply of safe, effective medications for high BP and promoting patient-centered care through convenient medication regimens are both keys to improving BP control rates around the world. Having FDCs for hypertension on the WHO EML is a breakthrough for both of these proven strategies, and for getting these drugs to the people who need them, added Dr. Frieden.” Only one in every seven people who have high BP worldwide has it under control, even though high BP can be safely treated and managed with medication. “A major reason for poor control of BP globally is that most patients require two or more drugs to control their BP, yet many only receive one. Lack of adherence to drug therapy is another major risk factor and is worsened by the increased number of drugs. FDCs have the potential to address these factors” says Dr. Abdul Salam, Senior Research Fellow, The George Institute India. Many leading global organizations support increasing access to FDCs of BP-lowering medications, including the American Heart Association, European Society of Hypertension, International Society of Hypertension, Lancet Commission on Hypertension Group, Latin American Society on Hypertension, Resolve to Save Lives, World Heart Federation, World Hypertension League, and World Stroke Organization. Although specific FDCs are listed in the EML, countries can select similar medications of the same class. For example, many experts recommend that chlorthalidone be used in place of hydrochlorothiazide because of evidence that it is more effective in preventing cardiovascular events. Current availability of chlorthalidone is limited and prices are higher than hydrochlorothiazide, but that may change if chlorthalidone becomes more widely used. ]]> https://biospectrumindia.com/news/57/14346/usfda-approves-bayers-darolutamide-for-prostate-cancer.html https://biospectrumindia.com/news/57/14346/usfda-approves-bayers-darolutamide-for-prostate-cancer.html Thu, 01 Aug 2019 09:55:00 +0530 The U.S. Food and Drug Administration (FDA) has approved darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa®. The FDA approval is for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and is based on the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. The compound, which is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, was approved under the FDA Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions. The androgen receptor inhibitor has a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. Matthew Smith, Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center said, “Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy. This approval marks an important new option for the prostate cancer community.” Prostate cancer that is treated with ADT but keeps progressing even when the amount of testosterone is reduced to very low levels in the body is known as castration-resistant prostate cancer (CRPC). In the U.S., over 73,000 men are estimated to have a CRPC diagnosis in 2019. About one-third of men with non-metastatic CRPC go on to develop metastases within two years. Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit said, “With the approval of darolutamide, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC. Bayer is proud to take this latest step forward in the nmCRPC treatment landscape. Darolutamide is the newest addition to our prostate cancer portfolio and reflects Bayer's commitment to finding treatments for men at different stages along the prostate cancer continuum.”  In the ARAMIS trial, overall survival (OS) and time to pain progression were additional secondary efficacy endpoints. A positive trend in OS was observed; OS data were not yet mature at the time of final MFS analysis. The MFS result was additionally supported by a delay in time to pain progression as compared to placebo plus ADT. All other secondary endpoints, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event, demonstrated a benefit in favor of darolutamide. Bayer has filed for approval of the compound in the European Union (EU), Japan and with other health authorities.    ]]> https://biospectrumindia.com/news/57/14345/fda-clears-new-indications-for-existing-lyme-disease-tests-.html https://biospectrumindia.com/news/57/14345/fda-clears-new-indications-for-existing-lyme-disease-tests-.html Thu, 01 Aug 2019 09:00:00 +0530 The U.S. Food and Drug Administration recently cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.  Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health said, “Lyme disease can have a devastating impact on patients. With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients.” Lyme disease is caused by the bacteria Borrelia burgdorferi and is transmitted to humans through the bite of infected ticks. Typical symptoms include fever, headache, fatigue and skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart and the nervous system. In 2017, the last year for which the Centers for Disease Control and Prevention (CDC) has published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported to CDC, an increase of 17% from 2016. Laboratory diagnosis of Lyme disease has traditionally used a two-tier process for detecting the presence of antibodies against Borrelia burgdorferi in a patient’s blood. Antibodies are proteins present in the blood when the body is responding to a specific infection. In the previous two-tier approach, different types of tests were used (EIA and Western blots) to confirm a clinical diagnosis. The tests cleared today involve a modified approach that uses only EIA technology-based tests. The FDA reviewed data from clinical studies of the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgM Test System, and the ZEUS ELISA Borrelia burgdorferi IgG Test System that showed this alternative approach, referred to as a modified two-tier test, is as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi, the causative agent of Lyme disease, over current methods. CDC recommendations should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate. The enzyme immunoassay tests were reviewed through the premarket notification (510(k)) pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. The FDA granted clearance of the ZEUS ELISA enzyme immunoassay tests to ZEUS Scientific.   ]]> https://biospectrumindia.com/news/57/14341/pfizer-acquires-array-biopharma.html https://biospectrumindia.com/news/57/14341/pfizer-acquires-array-biopharma.html Wed, 31 Jul 2019 14:15:00 +0530 Pfizer Inc. has announced the successful completion of its acquisition of Array BioPharma Inc., advancing breakthrough science for the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. As Array becomes part of Pfizer, it brings an impressive existing portfolio that includes the approved combined use of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma, with significant potential for long-term growth via expansion into additional areas of unmet need. Additionally, BRAFTOVI and MEKTOVI are being investigated as a potential first-in-class combination for the treatment of BRAF-mutant metastatic colorectal cancer (mCRC), based on compelling interim results from the pivotal Phase 3 BEACON trial, setting the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer’s existing expertise in breast and prostate cancers. As Array’s colleagues become part of Pfizer, the company plans to maintain Array’s operations in Cambridge, Massachusetts and Morrisville, North Carolina, as well as Boulder, Colorado, which becomes part of Pfizer’s Oncology Research & Development network in addition to La Jolla, California and Pearl River, New York. The tender offer for all of the outstanding shares of Array expired at 6:01 p.m., Eastern Time, on July 29, 2019. Computershare Trust Company, N.A., the depository and paying agent for the tender offer, has advised Pfizer that as of the tender offer expiration, 171,905,358 shares of Array common stock were validly tendered, representing approximately 77.0% of the shares outstanding. All of the conditions of the offer have been satisfied and Pfizer and its subsidiary Arlington Acquisition Sub Inc. have accepted for payment for $48 per share in cash, without interest, subject to any required withholding taxes, all shares validly tendered and not validly withdrawn and will promptly pay for all such shares. Following its acceptance of the tendered shares, Pfizer completed its acquisition of Array through a second step merger of Arlington Acquisition Sub Inc. with and into Array. As a result of the merger, Array became a wholly owned subsidiary of Pfizer. In connection with the merger, all Array shares not validly tendered (other than shares held by Array, Pfizer, their respective subsidiaries and shareholders of Array who have perfected their statutory appraisal rights) have been cancelled and converted into the right to receive the same $48 in cash (without interest and less any applicable withholding taxes) as will be paid for all Array shares that were validly tendered and not validly withdrawn. Array common stock will cease to be traded on the Nasdaq Global Market. Pfizer expects the transaction to be dilutive to Pfizer’s Adjusted Diluted EPS by $0.04 in 2019, $0.04 -$0.05 in 2020, neutral in 2021 and accretive beginning in 2022, with additional accretion and growth anticipated thereafter. The company has updated its 2019 financial guidance based on a number of factors, including this acquisition. ]]> https://biospectrumindia.com/news/57/14329/hillrom-introduces-new-technology-in-fight-against-diabetic-retinopathy.html https://biospectrumindia.com/news/57/14329/hillrom-introduces-new-technology-in-fight-against-diabetic-retinopathy.html Tue, 30 Jul 2019 14:55:00 +0530 Hillrom announced that its latest innovation in vision screening and diagnostics with the introduction of the Welch Allyn® RetinaVue® 700 Imager handheld retinal camera, part of the RetinaVue® Care Delivery Model that enables remote ophthalmologists to diagnose diabetic retinopathy in patients with diabetes during routine primary care office visits. Diabetic retinopathy is the leading cause of blindness in working-age adults1. Hillrom President and CEO John Groetelaars said, "Our next-generation RetinaVue 700 Imager offers primary caregivers a simpler, faster and more cost-effective way to help customers achieve patient compliance with eye exams and help catch vision-threatening disease earlier. The new RetinaVue 700 Imager represents an exciting growth opportunity and an outstanding demonstration of our promise of Advancing Connected Care™." Hillrom's new Welch Allyn RetinaVue 700 Imager is the first handheld camera that is capable of capturing high-quality retinal images in a fully automated fashion in pupils as small as 2.5 millimeters2. With its 60-degree field of view and image-quality assessment algorithm, the new RetinaVue 700 Imager enables remote eye specialists to efficiently review up to 75% more retinal area compared to cameras with a standard 45-degree field of view. A new study3 demonstrates that image quality from the RetinaVue 700 Imager is as good as a leading large, automated non-mydriatic tabletop camera. Patient-data security is built in at every layer of the RetinaVue Care Delivery Model, including the RetinaVue 700 Imager device and Hillrom's HIPAA/HITECH-compliant RetinaVue Network, which features end-to-end encryption of data in transit and at rest, along with secure client-server authentication. The RetinaVue Network, hosted on Microsoft® Azure™ cloud, is independently verified for security, privacy and compliance controls. The new RetinaVue 700 device is Wi-Fi-enabled, providing mobility, and connects to major EMR systems to integrate seamlessly with clinical workflows and to enable best-practice reminder alerts for caregiver teams. Images are securely transferred to board-certified, state-licensed ophthalmologists and retina specialists at RetinaVue P.C., the first tele-ophthalmology provider to earn The Joint Commission's Gold Seal of Approval®, or to a preferred local eye care specialist, who return a complete diagnostic report to the primary care physician. The reports include retinal images, ICD 10 codes and a recommended referral/care plan, generally in one business day. ]]> https://biospectrumindia.com/news/57/14321/roche-expands-global-access-program-beyond-hiv.html https://biospectrumindia.com/news/57/14321/roche-expands-global-access-program-beyond-hiv.html Tue, 30 Jul 2019 11:10:00 +0530 Roche has announced that the Global Access Program is expanding beyond HIV, to include Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) for low and middle income country programs where the disease burden is the highest. The expansion of the Global Access Program highlights Roche’s commitment to improve access to cost-effective resources, implement scale-up programs, and contribute to the elimination of diseases in the regions with the greatest need. In 2014, Roche announced, the Global Access Program for increased access to HIV diagnostics. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including UNAIDS, CHAI, Unitaid, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Global Fund, and Center for Disease Control and Prevention (CDC), to establish programs that would go beyond providing diagnostic tests. In total, the Global Access Program now includes molecular diagnostics for HIV-1 viral load, HIV-1 and HIV-2 early infant diagnosis, the cobas® Plasma Separation Card - an innovative plasma collection device, MTB and MTB - RIF/INH, Hepatitis B and C, and Human Papillomavirus. All these assays run on the cobas®4800/6800/8800 platforms for various testing volume needs enabled by the cobas® Plasma Separation Card that transports samples from remote areas/sites to the central lab for further processing. ]]> https://biospectrumindia.com/news/57/14313/hikma-launches-cisplatin-injection.html https://biospectrumindia.com/news/57/14313/hikma-launches-cisplatin-injection.html Mon, 29 Jul 2019 14:55:00 +0530 Hikma Pharmaceuticals PLC the multinational pharmaceutical company, has launched Cisplatin Injection, 1mg/mL in 50mL and 100mL vials, in the United States through its US affiliate, Hikma Pharmaceuticals USA Inc. Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy. According to IQVIA, US sales of Cisplatin Injection, 1mg/mL in 50mL and 100mL, were approximately $5 million in the 12 months ending May 2019. ]]> https://biospectrumindia.com/news/57/14312/hikma-civica-to-reduce-generic-drug-shortages-in-the-us.html https://biospectrumindia.com/news/57/14312/hikma-civica-to-reduce-generic-drug-shortages-in-the-us.html Mon, 29 Jul 2019 12:25:00 +0530 Hikma Pharmaceuticals PLC,the multinational generic pharmaceutical company and Civica Rx (Civica, Inc.) have announced a five-year agreement to manufacture and supply Civica’s growing membership of US health systems with medications that are often in short supply in US hospitals. Under the agreement, Hikma will produce 14 essential sterile injectable medications for Civica as a private label distributor, using Hikma’s Abbreviated New Drug Applications (ANDAs) and Civica’s labeling and National Drug Code (NDC). These medicines are used daily by hospitals in emergency care, surgery, pain management and in treating hypertension.  The list of products included in the agreement will be publicly announced in the near future, and initial shipments are expected to begin before the end of 2019. Civica was founded in 2018 by leading US hospital systems concerned about generic drug shortages and philanthropic organisations passionate about improving healthcare. To date more than 30 health systems are Civica members, representing more than 900 US hospitals and approximately 30 percent of all licensed US hospital beds. Hikma is the third largest US supplier of generic injectable medicines with a growing portfolio of more than 100 injectable products. Today, one in every six generic injectable medicines used in US hospitals is a Hikma product. During the last three years, Hikma has launched more than 20 medications into US shortage situations and in 2016 the company received a Drug Shortage Assistance Award from the US Food and Drug Administration (FDA) for its role in preventing or alleviating drug shortages. ]]> https://biospectrumindia.com/news/57/14294/curza-gets-5-25m-funding-from-the-novo-holdings-.html https://biospectrumindia.com/news/57/14294/curza-gets-5-25m-funding-from-the-novo-holdings-.html Fri, 26 Jul 2019 14:25:00 +0530 Curza, a privately-held small-molecule drug development company focused on the discovery and development of novel therapeutics to address the high unmet need of multi-drug resistant bacterial infections, announced that it has received a $5,250,000 investment from the REPAIR Impact Fund and the proceeds will be used to advance the company's novel CZ-02 program, which targets multi-drug resistant (MDR) gram-negative infections. "Curza is very excited to be working with Novo Holdings.  Both companies have a strong commitment to bringing new antibiotics to the market to combat the growing threat of drug-resistant bacteria.  Novo's commitment to Curza allows the company to accelerate the development of a much needed novel class of antibiotics," said Ryan Davies, Curza's Chief Executive Officer. Aleks Engel, Director of the REPAIR Impact Fund, commented, "We are very pleased to be able to support Curza's efforts to advance truly novel science, which we believe will become critical new medicines in this area of high unmet need." Antibiotic-resistant superbugs pose a threat to global healthcare, with Gram-negative bacterial infections recognized as one of the most serious threats.  This partnership will help Curza to accelerate the development of it's new class of Gram-negative antibiotics, targeting the most difficult to kill drug-resistant bacteria.  With increasing resistance to frontline therapies, there is a critical need for developing new antibiotics.  Despite this necessity, very few therapies exist in the development pipeline of the pharmaceutical industry.  Curza and REPAIR's efforts will therefore address a critical unmet medical need. ]]> https://biospectrumindia.com/news/57/14292/allergan-voluntarily-recalls-biocell-textured-breast-implants-.html https://biospectrumindia.com/news/57/14292/allergan-voluntarily-recalls-biocell-textured-breast-implants-.html Fri, 26 Jul 2019 12:50:00 +0530 Allergan plc (NYSE: AGN) has announced a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).  BIOCELL® saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan. Allergan will provide additional information to customers about how to return unused products. Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns. Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.  This global recall does not affect Allergan's NATRELLE® smooth or MICROCELL® breast implants and tissue expanders. ]]> https://biospectrumindia.com/news/57/14300/are-you-up-to-date-with-the-new-laboratory-trends-in-2019.html https://biospectrumindia.com/news/57/14300/are-you-up-to-date-with-the-new-laboratory-trends-in-2019.html Fri, 26 Jul 2019 09:00:00 +0530 The medical laboratories market is growing rapidly in the Asia-Pacific region mainly due to the growing awareness about medical testing services, government support to improve the healthcare sector and the introduction of new and improved testing procedures by major market players in this region. The Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicines is a regional federation which includes members from seven countries in the Asia-Pacific region. This federation focuses on increasing awareness and improving patient conditions with respect to access to medical laboratories and other testing procedures. The trend has also been the same for all South East Asian countries where rapid urbanization is expected to grow from 36.7% in 2000 to 50.6% in 2025. In Thailand, the real GDP is 3.8%, which is 4.2% from the growth in private consumption and 2.0% from private investment. As a result, VNU Exhibitions Asia Pacific, the organizer of Thailand LAB INTERNATIONAL is trying to capture this market by boosting investment in Life Sciences & Medical Laboratory through the exhibition channel. Thailand LAB INTERNATIONAL 2019 is both an exhibition and conference platform for analytical laboratory equipment & technology. At the 9th edition, we have launched a new area called “Bio Investment Asia” which focuses on innovation and trends for Life Sciences & Biotechnology, Health Care & Wellness. The show will be held from 25 to 27 September 2019 at EH102-104, BITEC, Bangkok, Thailand. You will find the latest laboratory equipment and technology from over 250+ global brands around the world. Moreover, a variety of conferences covering many related laboratory industries will be held, such as updates on ISO/IEC 17025 for laboratory standards, food safety, and biopharmaceuticals; updates on current diseases (ASF, Dengue Fever); medical cannabis development, and standards in the medical & clinical laboratory and digital health. These will be important issues at the exhibition. 8 highlights of the exhibition include: Offering the complete “Platform for B2B Exhibition” for Laboratory Equipment in SEA Providing business opportunities with 250 companies from 15 countries and over 10,000 trade buyers and visitors from 40 countries Showcasing “Innovation and New LAB Technology Equipment” with more than 650 product brands from around the world Networking with selected industries, leaders and experts through the “Networking Night” function Offering a variety of conferences and seminars for academic, research and industrial purposes with over 60 sessions over 3 days Enjoying new business tools with the “Thailand LAB Event App” and the “Business Matching Program” Updates on trends in the “Life sciences & Biotechnology” sector with industry experts and leaders Complimentary air ticket & accommodation for international qualified buyers through the “Hosted Buyer Program” Pre-registration online is now open! Register to receive the following privileges: Free entry badge for “Open Seminars & Conferences” during the exhibition Free download of the “Digital Show Guide” Free access to “Online Business Matching” and Free download of the “Event Application” as your personal assistant and reminders about your meeting schedule during the exhibition Get a chance to win prizes in the “Lucky Draw” ]]> https://biospectrumindia.com/news/57/14282/kibow-to-develop-lbp-to-slow-dialysis-progression.html https://biospectrumindia.com/news/57/14282/kibow-to-develop-lbp-to-slow-dialysis-progression.html Thu, 25 Jul 2019 11:40:00 +0530 As a pioneer in the Enteric Dialysis® platform technology, Kibow® Biotech's mission has always been in conjunction with the standard care of therapy. The company's kidney health supplement product was developed to support normal kidney function which may help to slow the progression of kidney function in all stages of Chronic Kidney Disease (CKD) and potentially help a better outcome for dialysis patients worldwide. Kibow® Biotech Inc is proud to announce that throughout its 22 years of operation, the focus on supporting and maintaining healthy kidney function with probiotics/prebiotics to potentially delay the progression to dialysis is based on its enteric toxin reduction platform technology termed "Enteric Dialysis®". Since 2005, Kibow® has been a pioneer and leader in the presently marketed kidney health supplement product, Renadyl™*. Kibow® has been participating and exhibiting at various nephrology and medical professional annual meetings, like the American Society of Nephrology (ASN), National Kidney Foundation (NKF), American Association of Kidney Patients (AAKP), World Congress of Nephrology (WCN) and several other professional medical conferences since 2005. Kibow®Biotech's participation in these events is intended to educate nephrology and all other medical professionals about the emerging importance and crucial role of probiotics/prebiotics, gut-kidney connection, dysbiosis, and modulation of the Gut Microbiome with its innovative "Enteric Dialysis®" platform technology. Kibow® is committed to improving kidney health in patients with kidney problems, not only for Americans but in all countries worldwide. Although marketed and sold as a dietary supplement product, Renadyl™ is the first and only kidney health supplement developed and formulated based on clinical results that utilizes Kibow® Biotech's patented and revolutionary "Enteric Dialysis®" technology. Even before President Trump's announcement of an ambitious plan to change treatment for kidney disease in the United States, Kibow® Biotech has been taking steps to reach and improve more patients' lives by diversifying Renadyl™ from health supplement to a novel live biotherapeutic drug product (micro-organisms) and obtaining approval as a new drug product. As an FDA-approved human drug, Renadyl™ will be able to be marketed based on specific health benefit claims which should lead to greater acceptance by healthcare professionals.  It will also pave the way for its medical reimbursement and could result in lower co-payment cost – both from private insurers and federal Medicare/Medicaid authorities. In addition to maintaining normal kidney function and slowing the progression of kidney disease, the goal would be to delay the need for expensive, physically and mentally taxing dialysis therapy. As a LBP drug product, Renadyl™ may also be potentially useful in reducing the duration or frequency of dialysis with significantly improved quality of life and help save several billions of dollars spent not only in the USA but worldwide. ]]> https://biospectrumindia.com/news/57/14283/dassault-systmes-extends-collaboration-with-fda.html https://biospectrumindia.com/news/57/14283/dassault-systmes-extends-collaboration-with-fda.html Thu, 25 Jul 2019 11:40:00 +0530 Dassault Systèmes has announced the five-year extension of its collaboration with the U.S. Food and Drug Administration.  The 3DEXPERIENCE platform will be used to develop a new digital tool to enable more efficient regulatory review of cardiovascular and medical devices.  Researchers hope the first-of-its-kind process will increase industry innovation and pave the way for an efficient path for patients to access safe, effective new treatments for the world’s leading cause of death – heart disease. This second phase of their ongoing collaboration supports the 21st Century Cures Act, using virtual patients based on computational modeling and simulation to improve efficiency of clinical trials for new device designs.  A groundbreaking project with the Living Heart simulated 3D heart model will examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals.  This includes an in silico clinical trial aimed to reduce animal testing or the number of patients required while still ensuring safety and efficacy of the device is demonstrated.  The new digital process is intended to be more efficient and less expensive than current ones – whose delays and costs can impede patient access to novel treatments – without losing rigor or confidence in a device’s safety and efficacy.  The FDA has publicly recognized the public health benefits offered by modeling and simulation, and the potential for in silico clinical trials to safely advance medical products more efficiently, from preclinical studies through clinical trials to market.   ]]> https://biospectrumindia.com/news/57/14275/sanofi-signs-exclusive-deal-for-otc-rights-to-tamiflu.html https://biospectrumindia.com/news/57/14275/sanofi-signs-exclusive-deal-for-otc-rights-to-tamiflu.html Wed, 24 Jul 2019 13:55:00 +0530 Sanofi signed an agreement with Roche for the exclusive over-the-counter (OTC) rights to Tamiflu® for the prevention and treatment of influenza or flu in the US. Under the terms of the agreement, Sanofi will be responsible for leading FDA negotiations for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the US. Tamiflu is currently sold in the US by Genentech, a member of the Roche Group, for prescription use. “This is a strategic and important transaction for us as we strive to continually bring innovations to the market,” says Alan Main, Executive Vice President, Consumer Healthcare, Sanofi. “The US market is the largest OTC market in the world and a successful switch of Tamiflu to OTC would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market. Tamiflu will offer a significant public health benefit once switched by providing increased access to a safe and efficacious treatment for the prevention and treatment of flu. People would be able to either reduce their chances of getting the flu or, at the first signals, appropriately treat as early as possible during the crucial first 48 hours without having to wait for a doctor’s appointment.” Flu is a condition for which there is no effective OTC anti-viral treatment. Currently consumers are only able to treat flu symptoms with the available OTC products. Early treatment will help prevent unnecessary spread of the disease. According to the Centers for Disease Control and Prevention (CDC), over 31 million people in the US suffer from the flu in the US each year, but only about 7 million were treated with an effective product like Tamiflu in 2017. Under the agreement, in addition to leading the FDA negotiations, Sanofi will be responsible for leading the clinical program and funding all studies needed to support the OTC switch in the US in consultation with leading experts in the field. Roche will continue to market Tamiflu in the rest of the world. Sanofi will retain the rights to first negotiations for switch rights in other selected markets.  ]]> https://biospectrumindia.com/news/57/14254/yellow-wood-partners-to-acquire-dr-scholls-from-bayer.html https://biospectrumindia.com/news/57/14254/yellow-wood-partners-to-acquire-dr-scholls-from-bayer.html Tue, 23 Jul 2019 11:55:00 +0530 Yellow Wood Partners has entered into a definitive agreement to buy the Dr. Scholl’s™ business from Bayer for a purchase price of 585 million U.S. dollars.  Dr. Scholl’s™ is an iconic, one-of-a-kind brand, which is synonymous with foot care. The brand has an over 110 year heritage with unmatched brand equity in the foot care category and the #1 sales position in the most attractive segments – a true category leader. Dr. Scholl’s™ generated sales of 234 million U.S. dollars in 2018. With the acquisition of Dr. Scholl’s™, Yellow Wood Partners will create a stand-alone company in which it plans to invest in all aspects of the business to drive the growth and profitability of the brand to deliver value for all of its stakeholders. The divestiture enables Bayer to focus on building its core over-the-counter brands. Yellow Wood Partners will acquire the product rights to Dr. Scholl’s™ in the Americas and take over approximately 30 dedicated brand personnel in the United States and Canada, including Sales and Marketing, Research & Development and others. The transaction is expected to close in Q4 2019 subject to the satisfaction of customary closing conditions, including approval by the competition authorities. Citi and Sawaya Partners acted as financial advisors to Bayer, while Covington & Burling provided legal advice. Fried Frank acted as legal advisor to Yellow Wood. ]]> https://biospectrumindia.com/news/57/14251/who-recommends-dolutegravir-as-preferred-hiv-treatment-option-.html https://biospectrumindia.com/news/57/14251/who-recommends-dolutegravir-as-preferred-hiv-treatment-option-.html Tue, 23 Jul 2019 11:00:00 +0530 Based on new evidence assessing benefits and risks, the WHO recommends the use of the HIV drug dolutegravir (DTG) as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.   Initial studies had highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception. This potential safety concern was reported in May 2018 from a study in Botswana that found 4 cases of neural tube defects out of 426 women who became pregnant while taking DTG. Based on these preliminary findings, many countries advised pregnant women and women of childbearing potential to take efavirenz (EFV) instead. New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested. The guidelines group also considered mathematical models of the benefits and harms associated with the two drugs; the values and preferences of people living with HIV, as well as factors related to implementation of HIV programmes in different countries, and cost. DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%. ]]> https://biospectrumindia.com/news/57/14242/gilead-licenses-antiviral-research-programs-from-novartis.html https://biospectrumindia.com/news/57/14242/gilead-licenses-antiviral-research-programs-from-novartis.html Mon, 22 Jul 2019 11:50:00 +0530 Gilead Sciences, Inc. has announced today that it has licensed three preclinical antiviral programs from Novartis, including investigational agents with the potential to treat human rhinovirus, influenza and herpes viruses. Under the agreement, Gilead will acquire exclusive global rights to develop and commercialize novel small molecules against three undisclosed targets. Novartis will receive an upfront payment and is eligible to receive up to an additional $291 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on annual net sales. “Today’s announcement builds on Gilead’s heritage in antiviral research and development. We look forward to applying this expertise to advance the development of potential new treatments for viruses with limited therapeutic options,” said John McHutchison AO, MD, Gilead’s Chief Scientific Officer and Head of Research and Development. Gilead’s antiviral portfolio includes among the most widely used medicines for the treatment of HIV, hepatitis B and hepatitis C, as well as influenza infection. ]]> https://biospectrumindia.com/news/57/14232/transperfect-mds-offers-ai-solution-for-mdr-and-ivdr-content-compliance.html https://biospectrumindia.com/news/57/14232/transperfect-mds-offers-ai-solution-for-mdr-and-ivdr-content-compliance.html Fri, 19 Jul 2019 13:50:00 +0530 TransPerfect Medical Device Solutions (MDS), the world's largest provider of language services and process automation technology to the device industry has announced the division's certification to ISO 18587 for the application of artificial intelligence (AI) in medical device translation. TransPerfect's AI solutions are specifically designed to support the requirements of Medical Device Regulations (MDR) and In-vitro Diagnostics Regulations (IVDR) with special emphasis on labeling and post-market surveillance. AI-Enabled Services Solve MDR and IVDR Challenges  Industry-wide, the cost of implementing the EU's new MDR and IVDR requirements is estimated at nearly $20 billion. A significant portion of that cost is due to new content requirements. Says TransPerfect MDS President Marc Miller, "Two critical areas affected by MDR and IVDR are labeling – including translations – and post-market surveillance. The new regulations will create a substantial, permanent increase in the volume and velocity of content in both of these areas. The only practical way to address this increase is through automation and AI." Clients Seeing Positive Results from Implementing AI-Enabled Processes  Rainer Degener, Director of EMEA Customer Service at IBA Dosimetry, GmbH, commented, "What first attracted me to TransPerfect's AI solutions was the cost savings while maintaining the same level of translation quality. Now that we have successfully converted our process to AI, I'm happy to report we've realized 15% savings and 30% turnaround reduction with the same quality. Overall, my experience has been that the AI-supported process works even better than expected!" TransPerfect MDS helps manufacturers meet the daunting volume increases and turnaround challenges for labeling and post-market surveillance with structured content, process automation, and AI as part of its EnCompass Solution. In addition, TransPerfect's Rapid Prototyping Program enables device makers to build an evidence-based business case for management approval. The specialized division also recently introduced an AI portal for MDR and IVDR post-market surveillance to provide cost- and time-efficient translation of PMS data. Compatible with 30+ file formats, including scanned images and PDFs, the portal supports more than 40 languages and helps manufacturers manage the increased volumes and faster turnarounds required under MDR and IVDR. The division's certification to ISO 18587 ensures that processes and output for AI-enabled translation meet specific requirements and provides clients with confidence that AI technology has been implemented according to best practices to support quality and patient safety.     ]]> https://biospectrumindia.com/news/57/14229/boehringer-ingelheim-expands-idiopathic-pulmonary-fibrosis-pipeline.html https://biospectrumindia.com/news/57/14229/boehringer-ingelheim-expands-idiopathic-pulmonary-fibrosis-pipeline.html Fri, 19 Jul 2019 11:15:00 +0530 Boehringer Ingelheim and Bridge Biotherapeutics Inc. have announced that they are entering into a new collaboration and license agreement with the goal of developing Bridge Biotherapeutics’s autotaxin inhibitor BBT-877 for patients with fibrosing interstitial lung diseases, including IPF. BBT-877 is currently in Phase I clinical studies and is anticipated to enter Phase II testing within the next 12 months. Both companies will initially focus on developing the compound for the treatment of IPF, an area of high-unmet medical need and one of the key focus areas of Boehringer Ingelheim. Boehringer Ingelheim has developed OFEV®(nintedanib), an antifibrotic drug shown to slow disease progression by reducing lung function decline and currently approved for the treatment of IPF in more than 70 countries around the world including the US, the EU and Japan. Bridge Biotherapeutics will receive upfront and near term payments of EUR 45 million and is eligible to receive up to more than EUR 1.1billion in potential payments based upon the successful achievement of specified development, regulatory, and commercial milestones and staggered, up to double digit royalties. ]]> https://biospectrumindia.com/news/57/14224/merck-announces-crispr-license-framework-to-encourage-innovation.html https://biospectrumindia.com/news/57/14224/merck-announces-crispr-license-framework-to-encourage-innovation.html Thu, 18 Jul 2019 18:15:00 +0530 Merck, a leading science and technology company, and the Broad Institute of MIT and Harvard (Boston, Massachusetts) have announced an agreement to offer non-exclusive licenses to CRISPR intellectual property (IP) under their respective control for use in commercial research and product development. "Together with the Broad Institute, we are simplifying the path to licensing CRISPR technology, which will make it more widely available to the global research and discovery community," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "Through this agreement, we will make it easier for our customers to be successful in their research that shortens drug development timelines for previously untreatable diseases." Broad Institute and Merck share the goal of enabling all entities to apply the technology with a wider range of CRISPR tools. To streamline access for scientists, Broad Institute will offer licenses to Merck's and Broad Institute's CRISPR IP portfolios to potential licensees for internal research use and for commercial research tools and kits. Under the agreement, companies applying CRISPR in their research and development activities can license both sets of IP through Broad Institute. The framework is designed to allow other key patent holders to participate in the future — either through this framework or via a third-party patent pool or collaboration — to further streamline non-exclusive access to key CRISPR technology. "We believe that key CRISPR patent holders should come together to simplify and open up access, and this agreement is another example of a partnership that helps maximize and streamline access to these important scientific tools," said Issi Rozen, chief business officer of the Broad Institute. "Broad Institute already licenses CRISPR non-exclusively for all applications, with the exception of human therapeutics. We are actively working to ensure the widest and simplest possible access to key CRISPR intellectual property." The institutions worked together to develop a framework that (i) continues to provide non-exclusive access to Broad-controlled IP co-owned with its collaborators (including Harvard University, the Massachusetts Institute of Technology, New York Genome Center, New York University, The Rockefeller University, the University of Iowa Research Foundation, The University of Tokyo, the Whitehead Institute for Biomedical Research and others) and (ii) provides non-exclusive access to IP from Merck, with certain limitations specific to the Merck IP for creation of rodent models. Features of the licensing framework: Merck's IP for CRISPR technology, offered under the Sigma-Aldrich portfolio brand, will become available royalty-free to non-profit academic institutions, non-profit business communities and governmental agencies for their internal research, consistent with the Broad Institute's long-standing practice and requirements. Licenses follow Broad Institute's and Merck's ethical licensing considerations, which exclude certain CRISPR technology applications, such as any for clinical human germline editing. Each organization can continue offering licenses independently, outside of this framework. In addition to IP from Broad Institute and Merck, this licensing framework includes certain Broad IP co-owned with multiple other institutions: Harvard University, the Massachusetts Institute of Technology, The Rockefeller University, the University of Iowa Research Foundation, the University of Tokyo, the Whitehead Institute for Biomedical Research and others. Broad Institute and Merck have each developed guidelines that support research with genome editing under careful consideration of ethical and legal standards. The Broad Institute outlines "institutional policies on IP licensing" on its website. Merck has established an independent, external Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing, and has defined a clear operational position taking into account scientific and societal issues to inform promising therapeutic approaches for use in research and applications. ]]> https://biospectrumindia.com/news/57/14223/nextgen-healthcare-partners-with-appriss-health-.html https://biospectrumindia.com/news/57/14223/nextgen-healthcare-partners-with-appriss-health-.html Thu, 18 Jul 2019 17:10:00 +0530 NextGen Healthcare, the leading provider of ambulatory-focused technology solutions,has integrated Appriss Health prescription monitoring and tracking analytics into NextGen® Office, the company’s cloud-based, small practice electronic health record (EHR) solution. These enhanced capabilities enable providers to more effectively prescribe and dispense controlled substances. The technology also maximizes patient health and safety by checking state records for controlled substances prescribed by multiple providers for an individual patient, all within one system at the point of care. “The U.S. is experiencing an opioid epidemic that is devastating families,” said Rusty Frantz, Chief Executive Officer, NextGen Healthcare. “As a responsible healthcare information technology leader, we partnered with Appriss Health to ensure small practice providers using NextGen Office can more effectively identify, prevent and manage substance use disorder.” According to the National Center for Biotechnology Information, of U.S. residents abusing controlled substances, 20% source their supply from a prescriber and 2% from multiple doctors. With the integration of Appriss Health, NextGen Office now: • Connects providers with 40 prescription drug monitoring programs that contain comprehensive controlled substance dispensation information in those states and helps ensure proper prescribing • Provides comprehensive industry analytics to enable opioid stewardship strategies, identify patients at risk for adverse events, and facilitate early intervention and improved clinical outcomes • In some areas, alerts authorities to negative prescriber and patient behaviors for more timely and effective response The Appriss Health PMP Gateway platform is live in healthcare entities in 40 states and processes more than 50 million transactions per month in partnership with 130+ EHR and pharmacy management systems vendors. Friendswood Family Medicine, a community health center in Friendswood, Texas, has served many patients with a wide variety of needs—including those struggling with substance use disorders. Glenn Orsak, MD recognized that proper prescription management was needed to secure the best possible clinical outcomes for their patients. “Technology is a critical tool in providing quality care to our patients, and NextGen Office is our solution of choice. With the addition of smart prescription tracking, we now can identify patients with critical issues and have candid conversations while they are still sitting in the office. We can then successfully develop comprehensive care plans to better address the needs of the whole patient,” said Dr. Orsak. ]]> https://biospectrumindia.com/news/57/14222/biocity-and-oxford-ahsn-partner-to-accelerate-life-science-businesses-.html https://biospectrumindia.com/news/57/14222/biocity-and-oxford-ahsn-partner-to-accelerate-life-science-businesses-.html Thu, 18 Jul 2019 16:50:00 +0530 BioCity, a pioneering life science incubator and business collective, has announced a new strategic partnership with Oxford AHSN.  Working in partnership, the Oxford Academic Health Science Network and BioCity are launching a new Accelerator Programme in Berkshire and South Oxfordshire to catalyse growth in Thames Valley’s world-class health and life sciences cluster by supporting the development of start-ups, spin-outs and growth companies across the region’s research, clinical and commercial base. The announcement of a Berkshire and South Oxfordshire-based Accelerator marks a first for BioCity, who have until this point, operated outside the ‘golden triangle’. Seen as a key area for life sciences in the UK, the ‘golden triangle’ is an unofficial grouping of research universities located in Cambridge, Oxford, Milton Keynes, and London.  The strategic partnership between Oxford AHSN, who operate in the heart of the regional ecosystem, and BioCity, aims to strengthen collaboration and focus on scaling and sustaining the human and clinical impact of meaningful innovations.  The announcement further cements BioCity’s position as a leader in entrepreneur coaching within the life sciences. Using contemporary concepts and Lean Start-up methods, BioCity, who run entrepreneur coaching across their UK locations, also frequently deliver accelerators on behalf of industry partners, including Opportunity North East (ONE) in Aberdeen and The Biosphere, Newcastle. The BioCity Accelerator has a proven track record. To date, over one hundred science entrepreneurs have graduated from the coaching programme before successfully launching life science businesses, securing investment, both via and independent of the BioCity investment fund, and attracting industry recognition. Colin Roberts, BioCity venture development director, said, “This is a new geographic area for BioCity, we’re excited to discover some of the new ideas and work with new ventures on our first Accelerator in Oxfordshire and Berkshire.  “The strategic goals of Oxford AHSN are closely aligned with ours; together, we’ll be able to achieve our shared goal of supporting life science innovation at a regional level.” At the completion of taster workshops focused on commercialisation with a cohort of twelve entrepreneurs and start-ups, Paul Durrands, the Chief Operating Officer of the Oxford AHSN said, ‘‘In our pursuit to build a business case for change, our collaboration with delivery partners such as BioCity is already making a good impact’’.  The Oxford AHSN has a leading national and international health and life sciences cluster, home to a rich and diverse community of innovators, entrepreneurs, researchers and healthcare providers. The Oxford AHSN provides expert support along the entire health innovation pathway, from ideation, through prototype testing, system viability on to adoption. It fosters long term partnerships with industry, a culture of innovation in the NHS and economic growth, securing £123M of investment into the region to date. Highly sought after, entrepreneurs will be awarded a place on the Accelerator after first taking part in a pre-accelerator, held 02–04 September 2019. ]]> https://biospectrumindia.com/news/57/14221/nih-to-launch-hiv-vaccine-efficacy-trial-in-the-americas-and-europe.html https://biospectrumindia.com/news/57/14221/nih-to-launch-hiv-vaccine-efficacy-trial-in-the-americas-and-europe.html Thu, 18 Jul 2019 10:50:00 +0530 The National Institutes of Health (NIH) and partners have announced plans to conduct a Phase 3 HIV vaccine efficacy trial at multiple clinical research sites in North America, South America and Europe. The trial, called HPX3002/HVTN 706 or Mosaico, will assess whether an investigational vaccine regimen designed to induce immune responses against a variety of global HIV strains can safely and effectively prevent HIV acquisition among men who have sex with men and transgender people. A complementary study in women called HPX2008/HVTN 705 or Imbokodo that launched in 2017 in five southern African countries is ongoing. Mosaico is sponsored by Janssen Vaccines & Prevention, B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with funding support from NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The HIV Vaccine Trials Network (HVTN), headquartered at the Fred Hutchinson Cancer Research Center in Seattle, is facilitating the implementation of the study. Additional partners providing support include the U.S. Army Medical Research and Development Command (USAMRDC). The public-private partnership’s plans for Mosaico will be described in more detail at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City. This Phase 3 efficacy study will enroll 3,800 HIV-negative men and transgender people aged 18 to 60 years who have sex with men and/or transgender people. It is anticipated to open for enrollment at clinical research sites in the United States later this year. In addition, clinical research sites in Argentina, Brazil, Italy, Mexico, Peru, Poland and Spain will participate in the study. ]]> https://biospectrumindia.com/news/57/14215/abbvie-enhances-early-stage-oncology-pipeline-with-acquisition-of-mavupharma.html https://biospectrumindia.com/news/57/14215/abbvie-enhances-early-stage-oncology-pipeline-with-acquisition-of-mavupharma.html Wed, 17 Jul 2019 14:15:00 +0530 AbbVie has acquired Seattle-based Mavupharma, a privately held biopharmaceutical company focused on novel approaches to target the STING (STimulator of INterferon Genes) pathway for the treatment of cancer. STING pathway signaling plays an important role in the generation of an immune response directed at tumors, and enhancing STING signaling has shown promise in a variety of tumor models. STING pathway stimulation has the potential to increase the susceptibility of tumors and broaden treatment options for patients. "AbbVie's vision in oncology is to advance breakthrough areas of science leading to a strong pipeline of innovative cancer therapies," said Steve Davidsen, Ph.D., vice president of oncology discovery, AbbVie. "Mavupharma's platform has the potential to further our immuno-oncology portfolio and assist in the development of transformative medicines for patients." Mavupharma's lead clinical candidate is MAVU-104, a first-in-class, orally active, small molecule inhibitor of ENPP1, an enzyme involved in the regulation of the STING pathway. Inhibiting ENPP1 activity with MAVU-104 allows for highly controlled enhancement of STING signaling in tumors without the need for injections. "AbbVie has built a leadership position in oncology and their world-class capabilities will enable the accelerated development of our pipeline of STING modulators," said Michael Gallatin, Ph.D., former president and a co-founder of Mavupharma. "We made tremendous strides in developing our novel STING modulators and advancing MAVU-104 towards the clinic. We are confident in AbbVie's ability to continue to advance this exciting science for patients," added former chief scientific officer and co-founder Gregory Dietsch, Ph.D. Financial terms of the transaction were not disclosed.  ]]> https://biospectrumindia.com/news/57/14212/novartis-sickle-cell-disease-drug-gets-usfda-priority-review-status.html https://biospectrumindia.com/news/57/14212/novartis-sickle-cell-disease-drug-gets-usfda-priority-review-status.html Wed, 17 Jul 2019 12:10:00 +0530 Novartis has announced the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) and has granted Priority Review for its investigational sickle cell medicine crizanlizumab (SEG101). If FDA-approved, crizanlizumab is expected to represent the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in sickle cell disease. Novartis submitted the application for crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD) and was granted Breakthrough Therapy designation in December 2018. VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic life-threatening complications and death. VOCs also lead to significant health care utilization. They are the most common cause of emergency room visits and hospital admissions for SCD patients, with total medical costs exceeding $1.1 billion annually in the United States. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The designation is intended to shorten the FDA review period to six months from the standard ten months. "The FDA's decision to give crizanlizumab priority review reflects the impact that this medicine could have for the many thousands of US sickle cell adult patients who experience painful vaso-occlusive crises," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. "We are looking forward to the opportunity, if crizanlizumab is approved, to reimagine medicine in sickle cell disease for patients who live with this condition every day of their lives."  ]]> https://biospectrumindia.com/news/57/14211/menarini-silicon-biosystems-launches-vrnxt-volume-reduction-instrument.html https://biospectrumindia.com/news/57/14211/menarini-silicon-biosystems-launches-vrnxt-volume-reduction-instrument.html Wed, 17 Jul 2019 11:35:00 +0530 Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, announced that it will launch the new VRNxT(TM), a volume reduction instrument optimized to remove manual sample volume reduction steps in cellular biology workflows. By standardizing sample volume reduction, the VRNxT adds precision and accuracy to rare-cell and single-cell analysis, minimizing the loss of precious samples and increasing workflow throughput. While the VRNxT has been developed to standardize the DEPArray workflow, broader applications in volume reduction are possible. The VRNxT automated volume reduction instrument removes manual pipetting steps, reducing hands-on time up to 90% and eliminating operator variability. No specific skill sets or training are required for operation, thereby delivering user-independent results with high reproducibility and success, with 99% of single cells retained after volume reduction. "The instrument helped us to reduce our error rate and processing time," said Matija Snuderl, M.D., Department of Pathology Director, Molecular Pathology NYU Langone Health, who tested the new instrument in his laboratory. "We handle rare cell types isolated from FFPE specimens. With the VRNxT, we were able to lower the chance of error in the volume reduction step, which is especially important when single-cell samples are collected, and decrease the time required to process these samples."  The VRNxT uses rotational motion for sample volume reduction and can process up to four samples at once, decreasing the time required for sample preparation. Starting from any volume in a PCR tube, the VRNxT consistently reduces sample volume to approximately 12.5 μL in 25 seconds and approximately 2 μL in about eight seconds. The DEPArray System is the only image-based sorting and isolation platform that combines microfluidics with microelectronics and microscopy to isolate and manipulate individual rare cells with 100% precision. ]]> https://biospectrumindia.com/news/57/14200/jj-announces-ppp-for-investigational-prophylactic-hiv-vaccine.html https://biospectrumindia.com/news/57/14200/jj-announces-ppp-for-investigational-prophylactic-hiv-vaccine.html Wed, 17 Jul 2019 09:00:00 +0530 Johnson & Johnson has announced that Janssen Vaccines & Prevention B.V., one of its Janssen Pharmaceutical Companies, together with a consortium of global partners are preparing to launch Mosaico, the first large-scale Phase 3 efficacy study of Janssen’s investigational mosaic-based HIV-1 preventive vaccine. Janssen’s mosaic vaccine is designed as a global vaccine with the goal of preventing infections from the wide range of viral strains responsible for the HIV pandemic. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN) based at the Fred Hutchinson Cancer Research Center, and the U.S. Army Medical Research and Development Command (USAMRDC) are joining forces with Janssen to advance the potential global vaccine. The public-private partnership’s plans for Mosaico will be described in more detail at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City, along with new late-breaking data regarding the mosaic-based vaccine regimen to be studied in Mosaico. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson said, “Our vision at Johnson & Johnson is to develop a preventive vaccine that can be deployed anywhere, worldwide, to halt the HIV epidemic. No single organization can tackle this historic challenge alone. By working with our global partners and leveraging cutting-edge technologies, we are optimistic that we can achieve an HIV vaccine in our lifetime.” Mosaico (HPX3002/HVTN 706) will have a target enrollment of 3,800 individuals in eight countries across North America, South America and Europe. It is expected to commence later in 2019. Conducted at approximately 55 clinical sites worldwide, the study will evaluate Janssen’s mosaic-based HIV vaccine in men who have sex with men (MSM) and transgender people. “We are determined to develop a globally effective HIV vaccine to reduce the trajectory of the estimated 1.5 million new HIV infections that are occurring,” said Larry Corey M.D., Principal Investigator of the HVTN, virologist, and president and director emeritus at the Fred Hutchinson Cancer Research Center in Seattle. Johan Van Hoof, M.D., Global Therapeutic Area Head, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica NV said, “The search for a vaccine began the moment HIV was first identified over 35 years ago, but there have been many challenges along the way due to the unique properties of this virus, including its global genetic diversity. Janssen is committed to advancing clinical trials to help build an HIV-free future. With each new study we are working to optimize the mosaic-based vaccine regimen.” Mosaico will be the second, and largest, efficacy study for Janssen’s investigational HIV vaccine. The first efficacy study, the proof-of-concept Phase 2b clinical trial known as Imbokodo (HPX2008/HVTN 705), is currently evaluating a mosaic-based vaccine regimen in 2,600 young women (aged 18-35) across five southern African countries.   ]]> https://biospectrumindia.com/news/57/14206/pherecydes-pharma-and-bioaster-join-forces-to-treat-complicated-uti.html https://biospectrumindia.com/news/57/14206/pherecydes-pharma-and-bioaster-join-forces-to-treat-complicated-uti.html Tue, 16 Jul 2019 14:55:00 +0530 Pherecydes Pharma and BIOASTER, the French Technology Research Institute (TRI) for Microbiology and Infectious Diseases, announce the signing of a collaboration agreement. This project, called PhagUTI, is a unique opportunity for the partners to capitalize on BIOASTER’s unique expertise in pre-clinical models and the extensive experience of Pherecydes in the selection, characterization and production of bacteriophages. In the last few decades, antibiotics have turned life-threatening diseases into short-term disorders and have had a major positive impact on public health and the global economy. Today, however, this progress is under serious threat due to the rapidly increasing emergence of antibiotic resistance. The increasing threat of resistance to existing antibiotics has been the major driver in the renewed interest in bacteriophages treatment; phages being the natural predators of bacteria. E. coli is the main pathogen responsible for Urinary Tract Infections (UTI), in particular catheter-associated UTI (CAUTI) and Pyelonephritis. The objective of this project is to demonstrate the in vivo efficacy of phage therapy to treat urinary tract E. coli infections. “This project will be an important step forward for phage therapy and a new hope for patients,” commented Guy-Charles Fanneau de la Horie, CEO of Pherecydes Pharma. “We are looking forward to working with BIOASTER on this fascinating project.”  “This collaborative program illustrates BIOASTER’s ambition very well; bringing together partners’ complementary expertise for accelerating innovation towards new effective solutions for the patients,” said Nathalie Garçon, CEO & CSO of BIOASTER. “We are very proud to be part of this exciting project with Pherecydes that will generate new avenues for alternative treatments of multi-drug resistant bacterial infections.”   ]]> https://biospectrumindia.com/news/57/14203/chad-mirkin-wins-kabiller-prize-in-nanoscience-and-nanomedicine.html https://biospectrumindia.com/news/57/14203/chad-mirkin-wins-kabiller-prize-in-nanoscience-and-nanomedicine.html Tue, 16 Jul 2019 12:35:00 +0530 Exicure, a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs has announced Co-founder Chad A. Mirkin has been awarded the $250,000 Kabiller Prize in Nanoscience and Nanomedicine for discovering and developing spherical nucleic acids (SNAs). SNAs are nanostructures that enable the safe and effective delivery of nucleic acid therapeutics into cells and tissues. The technology originated in Mirkin’s laboratory at the Northwestern University International Institute for Nanotechnology, where he is a professor. The $250,000 Kabiller Prize is the largest monetary award in the world for outstanding achievement in the field of nanotechnology and its application to medicine and biology. Exicure’s lead programs utilize proprietary SNA technology to address inflammatory diseases, genetic disorders and oncology. Using SNA technology to mobilize the body's natural defense against cancer, Exicure’s lead immunotherapy compound, AST-008 (initially being investigated in selected solid and hematological tumors) is a toll-like receptor 9 agonist designed to utilize the SNA's beneficial properties to drive a potent anti-cancer immune response. The treatment could accompany other systemic therapies while driving a stronger immune response than other technologies. Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for immuno-oncology, inflammatory diseases and genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. We believe Exicure's proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure's lead program is in a Phase1b/2 trial in patients with advanced solid tumors. Exicure is based outside of Chicago, IL.  ]]> https://biospectrumindia.com/news/57/14204/recursion-pharmaceuticals-secures-121m-in-series-c-funding.html https://biospectrumindia.com/news/57/14204/recursion-pharmaceuticals-secures-121m-in-series-c-funding.html Tue, 16 Jul 2019 12:35:00 +0530 Recursion, a next-gen biopharma company combining automated, experimental biology with artificial intelligence to discover and develop drugs at scale has announced the closing of a $121 million Series C financing. The round was led by Baillie Gifford’s flagship investment trust, Scottish Mortgage Investment Trust PLC, with participation by new institutional investors Intermountain Ventures, Regents of the University of Minnesota, Texas Tech University System, and select angel investors. All prior institutional investors also participated in the round, including Lux Capital, Data Collective, Mubadala Ventures, Two Sigma Ventures, Obvious Ventures, Felicis Ventures, Epic Ventures, Menlo Ventures, AME Cloud Ventures, and CRV. The new financing will support Recursion’s continued build-out of its machine learning-enabled drug discovery platform alongside new capabilities designed to radically accelerate new chemical entity chemistry and predict safety pharmacology. In addition, the Company will continue to advance its growing pipeline of pre-clinical and clinical assets, including clinical-stage programs for cerebral cavernous malformation and neurofibromatosis type 2. “We’re very excited to see companies bringing innovation from different fields together to try to radically change healthcare,” said Marina Record, Investment Manager at Baillie Gifford. “Recursion impressed us with its multidisciplinary effort and ambitious vision to improve our understanding of biology and discover new drugs in a way that is faster and cheaper. We are proud to support Chris and his team as they continue to build out their technology and take their programs through clinical development.” While Recursion plans to prioritize the advancement of treatments for rare diseases within its own pipeline, it will continue to forge strong partnerships with industry-leading pharmaceutical companies in a variety of therapeutic areas, including immuno-oncology, oncology, ageing, and inflammation. “In under two years since closing our Series B round, we have put two drugs discovered on our platform into clinical trials, had our first discoveries with Takeda optioned, grown our automated experimental bandwidth by an order of magnitude, expanded beyond rare diseases into new therapeutic areas like inflammation, infectious disease and immuno-oncology, grown our team from 64 to 150-plus and added all-stars from the biotech and tech worlds, and opened a state-of-the-art, 100,000 square-foot headquarters in downtown Salt Lake City,” said Chris Gibson, PhD., CEO, Recursion. Added Gibson: “We could not continue to scale up our business and achieve our mission of decoding biology to radically improve lives without this incredible investor syndicate. With these new resources, we will continue to drive toward a future in which drugs are developed -- by people -- with a new level of understanding about human biology that was simply not possible before machines.”   ]]> https://biospectrumindia.com/news/57/14202/illumina-expands-genomics-accelerator-to-cambridge-uk.html https://biospectrumindia.com/news/57/14202/illumina-expands-genomics-accelerator-to-cambridge-uk.html Tue, 16 Jul 2019 12:05:00 +0530 Illumina has announced the global expansion of Illumina Accelerator to Cambridge, United Kingdom. Founded in the San Francisco Bay Area in 2014, Illumina Accelerator is a company creation engine focused on partnering with entrepreneurs to build breakthrough genomics startups. Illumina Accelerator is proud to open its first international location at Illumina’s Europe, Middle East and Africa (EMEA) headquarters in Cambridge, UK. The inaugural funding cycle of Illumina Accelerator Cambridge will begin in Spring 2020. “With 21 years of experience advancing the field of genomics, Illumina is delighted to foster the next generation of global genomics innovators,” said Paula Dowdy, Illumina’s Senior Vice President and General Manager, Commercial Operations, EMEA. “With the launch of Illumina Accelerator Cambridge, we are expertly positioned to further catalyze the rapidly expanding genomics ecosystem across EMEA.” During two, six-month funding cycles per year, Illumina Accelerator provides selected startups with access to seed investment, access to Illumina sequencing systems and reagents, as well as business guidance, genomics expertise, and fully operational lab space adjacent to Illumina’s campuses in Cambridge, UK or the San Francisco Bay Area. Illumina Accelerator Cambridge is partnering with several leading venture capital firms across Europe, including SV Health Investors, Sofinnova Partners, Seventure Partners, F-Prime Capital, and Illumina Ventures, to provide selected startups with hands-on company-building expertise and coaching during the six-month funding cycle in Cambridge. Professor Sir John Bell FRS, Lead for the UK Life Sciences Industrial Strategy, Board Member of Genomics England, Regius Professor of Medicine at Oxford University, said: “I am delighted that Illumina has chosen Cambridge as the first location to expand its Accelerator. Illumina Accelerator Cambridge will undoubtedly contribute to the UK’s life sciences effort by galvanizing genomics startups to harness the rapid and affordable next-generation sequencing technology pioneered by Illumina and develop applications that will benefit human health the world over.” “In launching Illumina Accelerator Cambridge, we look forward to partnering with leading entrepreneurs and venture investors to harness the unique strengths and genomics expertise in the UK and beyond,” said Mostafa Ronaghi, Ph.D., Illumina’s Senior Vice President, Chief Technology Officer and Co-founder of Illumina Accelerator. “As one of the most successful biotech accelerators, Illumina Accelerator has made 33 investments since its inception with an unparalleled track record in building venture backable startups, including novel applications in therapeutics, diagnostics, software, and consumer genomics.” Applications for the inaugural funding cycle in Cambridge, UK and for the eleventh funding cycle in the San Francisco Bay Area are due by November 1, 2019. Through a single, global application process, Illumina Accelerator will select up to five companies in each location to participate in two, six-month cycles per year. llumina Accelerator is the world’s first business accelerator focused solely on creating an innovation ecosystem for the genomics industry. It provides select startups with access to seed investment, business guidance, Illumina’s sequencing systems and reagents, and fully operational lab space in the San Francisco Bay Area or Cambridge, the UK during each six-month funding cycle. Since launching in 2014, Illumina Accelerator has invested in 33 genomics startups from across the globe, which has collectively raised over $300 million in venture capital funding.  ]]> https://biospectrumindia.com/news/57/14188/abbott-launches-starlims-html5-quality-manufacturing-lims.html https://biospectrumindia.com/news/57/14188/abbott-launches-starlims-html5-quality-manufacturing-lims.html Mon, 15 Jul 2019 15:40:00 +0530 Abbott announced the launch of a laboratory information management system, STARLIMS Quality Manufacturing Solution QM 12.0, to support integration with various types of platforms and manage data from product concept to consumer. STARLIMS QM 12.0 is designed for the global manufacturing and R&D sectors including pharmaceuticals/biotech, chemicals and petrochemicals, oil and gas, food and beverage, contract services, consumer products and general manufacturing. This new offering is built on the latest version of the STARLIMS Technology platform 11.7. Mark Spencer, vice president and general manager, Informatics, Abbott said, "Due to market demand for more intuitive user experiences, STARLIMS QM 12.0 is designed to offer increased freedom of interoperability. STARLIMS QM 12.0 is more versatile than ever, reducing IT complexity and delays, and removing the challenges associated with supporting older browser technologies." Jacqueline Barberena, global marketing and product management director, Informatics, Abbott said, "Manufacturers can operate more effectively if they have a real-time, holistic view of workflow progress in their laboratories. The product enhancements in the new STARLIMS QM 12.0 not only provide an intuitive visual interface but also help ensure transparency and support regulatory compliance."  STARLIMS QM 12.0 offers the following benefits: HTML5: STARLIMS QM 12.0 has been converted to HTML5, so customers now have a fresh, new look up front.    A Verification Kit: As an add-on, the kit offers templates that will be particularly valuable for customers who have little experience validating a LIMS, or who are still working to establish methodologies for validating electronic systems. The kit includes a set of documentation that can be leveraged when validating the software's core functionality. Integrated Request Management Portal: Customers continue to experience the same ease of collaboration with internal departments and external partners that submit sample testing requests; however, with the addition of a branding kit, customers can either retain the standardized login page layout or personalize the login entry point. A default entry point dashboard makes navigation fast and simple, and shows user-relevant tasks up front, while additional support for unknown material testing and test requests will simplify managing nonstandard requests. Applications: The latest STARLIMS QM 12.0 also features applications for streamlining sample and batch management, with intuitive instrument integration and out-of-the-box interfacing with third-party applications such as Thermo Scientific™ Chromeleon™ Chromatography Data System software, Waters' Empower™ Chromatography Data Software, and SAP, or through Web services API.     ]]> https://biospectrumindia.com/news/57/14184/bio-techne-launches-rnascope-hiplex-assay.html https://biospectrumindia.com/news/57/14184/bio-techne-launches-rnascope-hiplex-assay.html Mon, 15 Jul 2019 13:55:00 +0530 Bio-Techne Corporation has announced the expansion of the Advanced Cell Diagnostics™-branded RNAscope platform with release of the RNAscope HiPlex Assay. The RNAscope platform is an advanced in situhybridization assay that enables visualization of single-molecule gene expression with single-cell resolution directly in intact tissues. The RNAscope HiPlex Assay enables researchers to gain greater insights into cellular mechanisms and functions by combining a simplistic workflow with the capability of simultaneously detecting up to twelve RNA targets. Comprehensive spatial studies require tools that permit higher multiplexing capabilities with minimal time, simple processing, and quality performance, while conserving precious samples. Such multiplexing cannot be achieved with traditional in situ hybridization techniques. The RNAscope HiPlex Assay utilizes Bio-Techne's patented signal amplification and background suppression technology to deliver unrivalled specificity and sensitivity with optimal signal generation. Using this assay, researchers are able to perform experiments that generate more data per sample with better characterization of the samples, such as identifying specific cell types with known cellular markers, without compromising the morphological features of the tissue in question. Jacob Swanson at the Hospital for Special Surgery in New York City, NY, commented, "The RNAscope HiPlex Assay allows a researcher to add histological context to scRNAseq data, which is important for fully understanding the biology of distinct cell populations. Being able to stain a single section of tissue with up to twelve mRNA probes makes the RNAscope HiPlex Assay a powerful tool for distinguishing cell types in situ. I would recommend the RNAscope HiPlex Assay to anyone looking to visualize distinct populations of cells from scRNAseq data in situ." ]]> https://biospectrumindia.com/news/57/14183/abbott-gets-fda-approval-for-alinity-s-system.html https://biospectrumindia.com/news/57/14183/abbott-gets-fda-approval-for-alinity-s-system.html Mon, 15 Jul 2019 13:25:00 +0530 Abbott has announced that U.S. Food and Drug Administration (FDA) approval for its new blood and plasma screening Alinity™ s System.  This new solution will bring the latest screening technology to U.S. blood and plasma centers. Alinity s is designed to screen blood and plasma more efficiently within a smaller space versus commercially available competitive systems. In a testing specialty that can require extensive hands-on time, the additional automation and flexibility of Alinity s will help blood and plasma centers improve productivity and maintain the highest levels of accuracy. "Alinity s is a significant leap forward when it comes to speed, automation and efficiency for blood and plasma screening," said Louis Morrone, vice president, Transfusion Medicine, Abbott. "These elements are important to blood and plasma services of all sizes, supporting Abbott's overall mission to help people live longer, healthier lives by keeping the global blood and plasma supply safe." Alinity s will help transform the blood and plasma screening process in terms of speed, capacity and "walk-away" time (i.e., when lab professionals are free to manage other responsibilities while the instrument processes samples) as a result of a number of new features: Expands capacity to run up to 600 tests per hour. Improves centers' ability to track all activities and actions associated with the testing and processing of each donation in accordance with regulatory requirements. Increases walk-away time to a minimum of three hours while adding the ability to continuously access to refill/restock when convenient to the technician. Equips laboratory professionals with the ability to continuously load and unload samples and supplies without pausing or stopping the system. Features an intuitive software interface, menu design and sample loading layout, shared with other Alinity instruments, making it easy for lab technicians to learn and use. "In order to ensure a safe blood and plasma supply, we need access to the most advanced technologies to screen donations," said Rachel-Louise Beddard, M.D., senior vice president and chief medical officer, QualTex Laboratories. "Alinity s will help us transform the way we conduct screening, so we can do our jobs most efficiently, allowing us to get the life-saving blood and plasma products to people facing their most critical situations." ]]> https://biospectrumindia.com/news/57/14181/marken-acquires-three-european-logistics-companies.html https://biospectrumindia.com/news/57/14181/marken-acquires-three-european-logistics-companies.html Mon, 15 Jul 2019 12:20:00 +0530 Marken have acquired HRTL based in Italy along with two additional companies in Austria and Hungary under the respective names of HETO and Der Kurier.  Together the group operates with offices in Vienna, Milan, Rome, and Gyor (near Budapest) to deliver 7,000 clinical trial shipments per month.  This brings Marken's total network of sites to 51, including 10 GMP qualified clinical storage depots.  The acquisition further strengthens Marken's commitment to providing logistics services to the pharmaceutical and life sciences industries in Europe. HRTL was founded in 2011 as a specialist courier serving the clinical trials industry. The group has since acquired its own licenses to operate in their respective countries and developed strong relationships with local providers, airlines and customs brokers. Each of the group's locations are situated in close proximity to major airports to provide maximum flexibility for expediting time and temperature-sensitive shipments. The acquisition by Marken will expand its core clinical trials logistics opportunities in central and eastern Europe.  Italy, Hungary and Austria are important sources of drug manufacturing, particularly drugs which are manufactured in sterile format.  Sterile drug products are particularly sensitive and require specific temperature conditions during transport to ensure stability.  Eastern and Central Europe are also important locations for recruitment of clinical trial patients and this acquisition further strengthens Marken's biologic sample services in the region.  Marken's hybrid services, which employ the use of UPS' network and airline, will be offered to and from gateway airports in Rome, Milan, Vienna and Budapest. ]]> https://biospectrumindia.com/news/57/14180/janssen-submits-application-to-get-usfda-nod-for-darzalex.html https://biospectrumindia.com/news/57/14180/janssen-submits-application-to-get-usfda-nod-for-darzalex.html Mon, 15 Jul 2019 12:10:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new subcutaneous (SC) formulation of DARZALEX® (daratumumab), an intravenous (IV) treatment approved for certain patients with multiple myeloma. The submission is supported by data from the Phase 3 COLUMBA (MMY3012) study first presented at the American Society of Clinical Oncology (ASCO) Annual Meeting that included a non-inferiority comparison to DARZALEX IV administration for co-primary endpoints of overall response rate and maximum Ctrough concentration. Data from the Phase 2 PLEIADES (MMY2040) study are also included in the BLA. The subcutaneous formulation of DARZALEX is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's ENHANZE® drug delivery technology]. "This submission represents our commitment to develop innovative treatment options for people living with multiple myeloma," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "The DARZALEX subcutaneous formulation showed non-inferiority to the existing IV formulation, both as a monotherapy and in combination with common background therapies, while administered with a considerably shorter infusion time. We look forward to working closely with the FDA in their review of the data supporting this regulatory application." Today's submission follows two recent milestones for the DARZALEX intravenous formulation, including an approval of DARZALEX in combination with lenalidomide and dexamethasone for the treatment of newly diagnosed, transplant ineligible patients with multiple myeloma supported by the Phase 3 MAIA study, and Priority Review designation following submission of a supplemental BLA based on the Phase 3 CASSIOPEIA study, which is seeking approval of DARZALEX in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant eligible. ]]> https://biospectrumindia.com/news/57/14163/celsius-and-jj-sign-rd-collaboration-agreement.html https://biospectrumindia.com/news/57/14163/celsius-and-jj-sign-rd-collaboration-agreement.html Fri, 12 Jul 2019 10:00:00 +0530 Celsius Therapeutics, a company focused on the discovery and development of precision therapeutics for patients with autoimmune diseases and cancer has announced a collaboration with Janssen Biotech, Inc. Under the terms of the agreement, Celsius will apply its proprietary single-cell genomics and machine learning platform to identify predictive biomarkers of response from Janssen’s VEGA study, a Phase 2a clinical trial evaluating the efficacy and safety of combination therapy with guselkumab and golimumab in patients with ulcerative colitis. “We are very pleased to be collaborating with Janssen, a company with a long-standing commitment to improving the lives of patients with inflammatory bowel disease,” said Tariq Kassum, M.D., chief executive officer of Celsius. “As our first industry partnership, it serves as a model for how we can apply our integrated platform to identify the specific patients who will benefit from existing and investigational therapies, while simultaneously gathering data that will fuel Celsius’ novel target and drug discovery engine.” Celsius will receive undisclosed payments along with potential milestones based on the use of biomarkers identified in the collaboration. Celsius retains the ability to integrate the clinical and sample-level data generated from the study into its growing database of patient and single-cell genomic information, and will further interrogate the data for its own target and drug discovery efforts. “Celsius has built an industrialized platform at the scale necessary to consistently process intact patient samples and to rapidly integrate and interrogate the large datasets being generated across this global multicenter study,” said Christoph Lengauer, Ph.D., co-founder and chief scientific officer of Celsius. “The longitudinal patient datasets and sample-level information generated through this large study will enable Celsius and Janssen to extract deep molecular and cellular insights, which we hope will ultimately lead to better treatments for patients.” ]]> https://biospectrumindia.com/news/57/14171/jazz-pharma-acquires-pre-clinical-pan-raf-inhibitor-program-.html https://biospectrumindia.com/news/57/14171/jazz-pharma-acquires-pre-clinical-pan-raf-inhibitor-program-.html Thu, 11 Jul 2019 13:05:00 +0530 Jazz Pharmaceuticals plc has announced that the company has signed a definitive agreement under which Jazz has acquired Redx Pharma's (Redx) pan-RAF inhibitor program for the potential treatment of RAF and RAS mutant tumors.  Redx will perform certain pre-clinical activities for the program under a separate collaboration agreement with Jazz.  Jazz will be responsible for further development, regulatory activities and commercialization. Under the terms of the agreement, Jazz will pay Redx an upfront payment of $3.5 million.  Redx is eligible to receive up to $203 million in development, regulatory and commercial milestone payments from Jazz, and incremental tiered royalties in mid-single digit percentage, based on any future net sales. "We are excited to acquire Redx's pan-RAF inhibitor program.  It has the potential to work in RAF driven tumors where current selective B-RAF inhibitors and their respective combinations are ineffective due to acquired resistance mechanisms.  In addition, there is the potential to address RAS driven tumors," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals.  "We look forward to advancing the pan-RAF inhibitor program that is part of a novel class of next generation precision oncology drugs and is highly complementary to our growing R&D portfolio of early-stage, innovative, hematology/oncology therapies." ]]> https://biospectrumindia.com/news/57/14167/gsks-2-drug-regimen-meets-primary-goal-to-control-hiv-1.html https://biospectrumindia.com/news/57/14167/gsks-2-drug-regimen-meets-primary-goal-to-control-hiv-1.html Thu, 11 Jul 2019 11:35:00 +0530 ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, have announced positive Week 48 results from its phase III TANGO study. The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen (2DR) of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the TAF-containing regimen. The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. The safety results for the 2DR of dolutegravir plus lamivudine were consistent with the product labelling for the medicines. Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019), to be held from 21-24 July in Mexico City. ]]> https://biospectrumindia.com/news/57/14162/sandoz-extends-symjepi-injection-launch-to-us.html https://biospectrumindia.com/news/57/14162/sandoz-extends-symjepi-injection-launch-to-us.html Wed, 10 Jul 2019 16:30:00 +0530 Sandoz Inc. (Sandoz), a Novartis division has announced the US retail launch of SYMJEPI™ (epinephrine) 0.3 mg and 0.15 mg Injections, making both the adult and pediatric doses immediately available in local pharmacies across the nation. SYMJEPI is a small, single-dose, pre-filled syringe and device combination as an alternative to epinephrine auto-injectors for the emergency treatment of allergic reactions (Type 1), including anaphylaxis, a severe reaction that can lead to death if left untreated. The US Food and Drug Administration (FDA) recently highlighted ongoing shortages of epinephrine auto-injectors from several drug manufacturers, which can  put people’s lives in jeopardy if they have a severe allergic reaction and do not have access to this life-saving medicine. “Patients and health care professionals are trying to navigate this critical shortage of self-injectable epinephrine products, which is why Sandoz is immediately making SYMJEPI available in adult and pediatric doses to patients at their local pharmacies,” said Carol Lynch, President of Sandoz Inc. “Our collaboration with retail partners will enable patients and their caregivers to conveniently access SYMJEPI, a cost-effective treatment option with a compact and user-friendly design.” Sandoz launched SYMJEPI 0.3 mg Injection in the institutional (hospital) setting earlier this year, and has a certified sales force educating hospital providers on the device, demonstrating its use and advising on how to write a prescription to include epinephrine injections.  Sandoz large wholesaler customers are now fully stocked to supply hospitals and clinics with both SYMJEPI 0.3 mg and 0.15 mg Injections inventory in the US. Doctors who determine that epinephrine medicine alternatives are appropriate for their patients should write the prescription as “epinephrine injection” rather than “epinephrine auto-injector,” so that pharmacies can ensure patients receive epinephrine medicine alternatives during their first attempt to fill their prescription. In addition to physicians writing the prescription for the greatest access to epinephrine injections, federal and state legislation in 18 states should change to allow for more alternatives such as SYMJEPI by amending the definition of “auto-injectors”. By limiting the definition to only permit the use of auto-injectors, federal and states are inadvertently restricting what schools and other entities could have on hand. These narrowly worded laws will not allow for new products that may be cost efficient and effective to be dispensed. Sandoz, in partnership with other stakeholders, has had early success amending existing legislation in multiple US states. Epinephrine is a critical medicine for many people nationwide, including the 200,000 people in the US who require emergency medical care for allergic reactions to food each year. The availability of SYMJEPI may provide confidence to patients given its small size and ease of use to encourage it being on-person when needed, and confidence in its use. ]]> https://biospectrumindia.com/news/57/14156/lyndra-therapeutics-gilead-sciences-to-develop-ultra-long-acting-hiv-therapies.html https://biospectrumindia.com/news/57/14156/lyndra-therapeutics-gilead-sciences-to-develop-ultra-long-acting-hiv-therapies.html Wed, 10 Jul 2019 09:00:00 +0530 Lyndra Therapeutics, the company making daily pills a thing of the past, has announced a partnership with Gilead Sciences, Inc. to develop and commercialize ultra-long-acting oral HIV therapies. Gilead will have exclusive rights to Lyndra’s therapeutics platform for ultra-long-acting formulations related to HIV. Lyndra’s ultra-long-acting dosage form has the potential to improve medication adherence by allowing patients to take a pill once a week, or even less frequently, rather than daily. “Gilead has led the way in HIV prevention and treatment by focusing on reducing pill burden through the development of single-tablet oral regimens for their therapies, addressing an epidemic that affects nearly 40 million people globally*,” said Amy Schulman, CEO and co-founder of Lyndra Therapeutics. “At Lyndra, our commitment to HIV is foundational and we are delighted to continue to work with strong research and development partners such as the Bill & Melinda Gates Foundation and, now, Gilead.” “Gilead is committed to advancing therapies for all people living with or at risk for HIV, including potential strategies for long-acting regimens that would reduce pill burden. This early partnership with Lyndra is the latest step in our ongoing investment in HIV research and development,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. This partnership announcement comes just months after Gilead joined Lyndra’s oversubscribed $60.9 million Series B financing round. *Global HIV & AIDS statistics – 2018 fact sheet, UNAIDS.   ]]> https://biospectrumindia.com/news/57/14155/puretech-announces-issuance-of-patent-to-support-its-lyt-200-product-candidate.html https://biospectrumindia.com/news/57/14155/puretech-announces-issuance-of-patent-to-support-its-lyt-200-product-candidate.html Tue, 09 Jul 2019 16:55:00 +0530 PureTech Health, an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,344,091 to support the Company’s internal immuno-oncology product candidate, LYT-200. The patent covers compositions of matter directed to fully human anti-galectin-9 antibodies, which PureTech intends to develop for historically difficult-to-treat cancers including pancreatic, colorectal, and cholangiocarcinoma, among other cancer types. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020. “PureTech’s galectin-9 antibody has been designed to address the challenges encountered with current immuno-oncology treatments due to redundancies in the immunosuppressive tumour microenvironment. Our now patented antibody composition leverages a new mechanism of action to disrupt the immunosuppressive environment, potentially enabling the body’s immune system to attack cancers that have historically been hard to treat,” said Joe Bolen, Ph.D., chief scientific officer of PureTech. “This patent provides important coverage for our immuno-oncology proGalectin-9, gram, and we look forward to continuing the development of LYT-200 to address the tremendous patient need that exists.” Galectin-9 induces robust immunosuppression that allows tumours to evade immune system attack. It is a foundational immune modulator that is expressed in the tumour microenvironment, on tumour cells, and in the blood of cancer patients, globally inducing and maintaining immunosuppression in cancer. High galectin-9 expression has been demonstrated in a number of patient tumour samples, including those that do not respond well to current checkpoint inhibitors. By blocking galectin-9, PureTech’s potentially first-in-class, fully human, monoclonal antibody is designed to intercept the immunosuppressive pathways that galectin-9 stimulates, potentially enabling an immune-mediated response against tumours. While existing therapies have not been sufficiently effective in the treatment of aggressive tumours, PureTech’s approach has shown favourable drug properties and safety in pre-clinical models, and it is being explored as both a single-agent and in combination with other modalities for cancer treatment, including other immunotherapies and chemotherapies. About LYT-200  PureTech’s immuno-oncology program, LYT-200, is a fully human, potentially first-in-class, IgG4 monoclonal antibody designed to target galectin-9, which is a fundamental immunosuppressive mechanism in hard-to-treat cancers such as pancreatic, colorectal, and cholangiocarcinoma, among other tumour types. LYT-200 has demonstrated proof-of-concept in both mouse and preclinical human cancer models, indicating that targeting galectin-9 activates T cells in tumours and reduces tumour growth, which could significantly extend survival. These data suggest that LYT-200 has strong potential to be used as both a monotherapy and in combination with existing immuno-oncology therapies. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020. About PureTech  PureTech is an advanced biopharmaceutical company developing highly differentiated medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis. The Company has gained deep insights into the connection between these systems and the resulting role in diseases that have been resistant to established therapeutic approaches. By harnessing this emerging field of human biology, PureTech is developing new categories of medicines with the potential to have a great impact on people with serious disorders. PureTech is advancing a rich pipeline of innovative therapies with an unbiased, nimble, and capital-efficient R&D model across its affiliates and its internal R&D pipeline. PureTech’s pipeline comprises more than two dozen product candidates, including several clinical-stage programs, one product that has been cleared by the US Food and Drug Administration (FDA), and a second product candidate that has been filed with the FDA for review. The PureTech pipeline includes ground-breaking platforms and therapeutic candidates that were developed in collaboration with some of the world’s leading experts. PureTech’s internal pipeline is centered on lymphatic targeting and tissue-selective immunomodulation for the potential treatment of immune and central nervous system disorders, lymphatic conditions, and cancers. The company is advancing multiple platforms to enable oral administration of therapies directly into the lymphatic system, regulate lymphatic flow and function, and target immunosuppressive mechanisms in oncology. ]]> https://biospectrumindia.com/news/57/14154/cell-bt-appoints-joshua-ofman-to-board-of-directors.html https://biospectrumindia.com/news/57/14154/cell-bt-appoints-joshua-ofman-to-board-of-directors.html Tue, 09 Jul 2019 16:40:00 +0530 Cell BT, an immuno-therapy company focused on the discovery and development of innovative cancer therapeutics based on next-generation CAR-T antibody constructs directed to novel biological targets, today announced that Joshua J. Ofman, M.D., MSHS, has been appointed to the CBI Board of Directors. CBI is discovering and developing novel immuno-oncology therapies for the treatment of B-cell lymphomas, leukemias and selected solid tumours. The Company’s biological targets and therapeutic candidates are based on the leading research and clinical practice of co-founders Jacek Pinski, M.D., Ph.D., Alan L. Epstein, M.D., Ph.D., and Peisheng Hu, Ph.D., of the Norris Comprehensive Cancer Center and Keck School of Medicine of the University of Southern California. Dr. Pinski serves as CBI’s Chief Medical Officer and Dr. Epstein as CBI’s Chief Scientific Officer. Interim CEO and co-founder of CBI, Michael Meyers, remarked, “With great enthusiasm, we welcome Dr. Ofman to the board of CBI. Dr. Ofman’s prior leadership position with Amgen, and his prior research and clinical experience will greatly benefit CBI as we advance our programs into the clinic. Additionally, Dr. Ofman’s market access and health policy expertise will help to inform important considerations for CBI as we look to the future of cell therapy. My CBI colleagues and I look forward to benefitting from Dr. Ofman’s insights, experience and judgment as we continue the discovery and development of immuno-oncology therapies and addressing the tumor microenvironment.” Dr. Ofman stated, “I am extremely honoured to be joining the board of such an innovative company with leaders who are so passionate about improving outcomes for cancer patients. With CBI’s novel targets and approaches, the next generation of cell-based therapies has even greater potential to make an impact. I look forward to helping CBI navigate a rapidly evolving oncology landscape to get these novel therapeutic candidates to patients in need.” Dr. Ofman was recently appointed Chief of Corporate Strategy and External Affairs at GRAIL, Inc., a company that is developing diagnostic products for the early detection of cancer, when treatment may be more successful. Prior to joining GRAIL, Dr. Ofman spent 16 years with Amgen, most recently as Senior Vice President, Global Value Access & Health Policy. Before joining Amgen in 2003, Dr. Ofman was a member of the academic faculty in the Department of Medicine and Health Services Research, University of California, Los Angeles (UCLA) School of Medicine, Cedars-Sinai Medical Center. He also served as Senior Vice President of Zynx Health Inc., a healthcare IT company, and a subsidiary of the Cerner Corp. Dr. Ofman obtained his undergraduate degree from the University of California, Berkeley and his medical degree from the University of California, Irvine, School of Medicine. He conducted his internship and residency in internal medicine and fellowship in digestive diseases at the UCLA Department of Medicine. In addition, he completed a RAND/VA/UCLA fellowship in ambulatory care and health services research, specializing in technology assessment, and obtained his MSHS from the UCLA School of Public Health. Dr. Ofman is widely published in health economics and technology assessment, public health program evaluation, and health policy analysis. CBI was established in February 2016 to discover and develop CAR T-cells, antibodies and associated immunotherapy cellular approaches for treating hematologic and solid tumors. Based on the research and clinical practice of the Company’s three scientific founders at the Norris Comprehensive Cancer Center and Keck School of Medicine at the University of Southern California - Jacek Pinski, M.D., Ph.D., Alan L. Epstein, M.D., Ph.D., and Peisheng Hu, Ph.D., CBI has engineered a series of cell- and molecular-based technologies, including antigen and targeted receptors, monoclonal antibodies, and fusion proteins used in conjunction with immune system cells in order to effect a targeted immune response to various types of cancer. Among other pipeline programs, CBI has discovered and is developing an advanced approach to CAR-T/antibody constructs utilizing the Company’s novel next generation co-stimulatory and co-signaling domains. CBI plans to commence clinical development of the Company’s lead program in certain B-cell lymphomas and leukemias in the second half of 2020. CBI has also advanced the development of a novel immuno-prognostic bioassay that measures a critical immune suppressor cell population found in blood samples of cancer patients. This test has potential to be used in combination with therapeutic agents in order to enable the monitoring of tumor regression, with the potential to provide a novel method to determine early tumor recurrence ]]> https://biospectrumindia.com/news/57/14153/bi-announces-dabigatrans-safety-and-efficacy-for-management-of-vte-in-children.html https://biospectrumindia.com/news/57/14153/bi-announces-dabigatrans-safety-and-efficacy-for-management-of-vte-in-children.html Tue, 09 Jul 2019 16:35:00 +0530 Boehringer Ingelheim has announced results from two paediatric studies of dabigatran etexilate, which were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress in Melbourne, Australia. The data showed dabigatran to be as effective and have a comparable safety profile to the current standard of care (SOC) for the treatment of acute venous thromboembolism (VTE) in children. A favourable safety profile for dabigatran was also established in a second study, the first of its kind to assess direct oral anticoagulant (DOAC) for the prevention of recurrent VTE in children with persistent VTE risk factors. Current SOC for treatment and prevention of recurrent VTE in children have several limitations, including the need for frequent monitoring and non-oral means of administration. The aim of these new dabigatran studies was to provide additional insight and knowledge on anticoagulation in paediatric patients with VTE or at risk of recurrent VTE. “The diagnosis and incidence of VTE has risen dramatically over the years, and childhood VTE is associated with considerable morbidity. Although treatments are currently available to help manage VTE, there is still a need for effective, safe and more convenient options that have been investigated in children. We therefore wanted to assess if dabigatran’s established safety and efficacy, in treating adults with VTE, also translated through to paediatric patients,” said Prof. Dr Martina Brückmann, Global Head of Clinical Development Cardiovascular, Cardiometabolic Medicine, Boehringer Ingelheim. “It is therefore encouraging that these studies suggest a comparable safety profile and efficacy for dabigatran for the potential treatment and prevention of recurrent VTE in children.” Pradaxa is not approved in any country for paediatric patients with VTE. The studies form part of the ongoing commitment from Boehringer Ingelheim to expanding scientific knowledge of thrombosis care. The safety and efficacy profile of dabigatran in adults has been proven and well-documented in the extensive RE-VOLUTION clinical trial programme. About the DIVERSITY study, Ablisetti M et al Open-label, randomised, multicentre, Phase IIb/III trial evaluated the efficacy and safety of dabigatran vs SOC (low molecular weight heparin or vitamin K antagonist) in children aged from birth to <18 years old with acute VTE requiring anticoagulation therapy for 3 months. The combined efficacy endpoint was the proportion of children with recurrent VTE, VTE-related death, and thrombus resolution. The secondary endpoints included safety as determined by bleeding events, and pharmacokinetic/pharmacodynamic relationships. The results from the DIVERSITY trial demonstrated that dabigatran was non-inferior to SOC for paediatric patients at high risk of VTE, with comparable bleeding rates. About the secondary VTE prevention study, Brandao L et al. Open-label, single-arm, prospective cohort, Phase III trial is the first study of its kind to describe outcomes in children treated with a direct oral anticoagulant for secondary VTE prevention. In the study, approximately 200 children received dabigatran for up to 12 months. The primary endpoints for this study included VTE recurrence, bleeding events, and mortality at 6 and 12 months. The study showed a low overall frequency of recurrent VTEs and any major bleeding events. Based on these results, the authors concluded that this trial showed “favourable safety results” with dabigatran in children with VTE and persistent thrombosis risk factors. ]]> https://biospectrumindia.com/news/57/14138/who-prequalifies-mylan-hiv-self-test.html https://biospectrumindia.com/news/57/14138/who-prequalifies-mylan-hiv-self-test.html Tue, 09 Jul 2019 11:00:00 +0530 Global pharmaceutical company Mylan N.V. and medical device manufacturer Atomo Diagnostics have announced that the Mylan HIV Self Test, a handheld in vitro HIV rapid diagnostic test for self-testing, has received Prequalification approval by the World Health Organization (WHO PQ).  The WHO PQ process includes a rigorous evaluation of the test's technical performance and manufacturing sites. Prequalification signifies that the product meets global standards of quality, safety and performance and is a signal to global funders and Ministries of Health that the product can be procured. The Mylan HIV Self Test detects the presence or absence of HIV antibodies through a fingerstick. It uses one-fifth the volume of blood necessary for other tests and provides a result in just 15 minutes.  The convenience and discretion afforded by self-testing enables individuals to test in the comfort and privacy of their own home, making the test an effective way of reaching hard-to-reach populations. In September 2018, Mylan announced a partnership with Atomo Diagnostics, the manufacturer of the test, covering more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS), and Latin America. ]]> https://biospectrumindia.com/news/57/14128/biocorp-strikes-4-m-deal-with-sanofi-for-diabetes-management.html https://biospectrumindia.com/news/57/14128/biocorp-strikes-4-m-deal-with-sanofi-for-diabetes-management.html Mon, 08 Jul 2019 13:00:00 +0530 French Company Biocorp has entered into exclusive negotiations with Sanofi to use their Mallya connected device with Sanofi's integrated diabetes care platform. Under the terms of these exclusive negotiations, BIOCORP will get an initial payment of €4 million from SANOFI to support related development activities. Mallya is a smart sensor that turns conventional insulin pens into connected devices.  Mallya records the key treatment information (selected dose, date and time of injection) and sends it to a dedicated mobile application. The app also allows the patient-user to view a summary report of doses injected over a period of time (up to 90 days). This device allows an automatic recording of the doses injected with the highest accuracy, removing the need for manual logbooks. Mallya is the only device available in its category to be labeled CE medical device, class IIb. Eric Dessertenne, Chief Operating Officer of BIOCORP, said: “This exciting first step towards a partnership with Sanofi, one of the three largest diabetes care companies, confirms our position as the world leader in connected devices. For us, this is a result of the promises we have made to our shareholders, employees and partners since our initial public offering in 2015. We are proud to bring a breakthrough device to the market to improve the daily lives of patients with diabetes. We believe our innovative Mallya has great potential to become the standard in its class and should contribute significantly, and in a short time, to our very strong growth.” ]]> https://biospectrumindia.com/news/57/14127/sangamo-pfizer-announce-updated-phase-1-2-results-for-sb-525-investigational-hemophilia-a-gene-therapy-.html https://biospectrumindia.com/news/57/14127/sangamo-pfizer-announce-updated-phase-1-2-results-for-sb-525-investigational-hemophilia-a-gene-therapy-.html Mon, 08 Jul 2019 12:35:00 +0530 Sangamo Therapeutics, a genomic medicine company, and Pfizer has announced updated results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. The data showed that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII (FVIII) activity levels. The first two patients treated at the 3e13 vg/kg dose rapidly achieved normal levels of FVIII activity as measured using a chromogenic assay, with no reported bleeding events, and the response continues to be durable for as long as 24 weeks, the extent of follow-up. The two patients more recently treated at the 3e13 vg/kg dose level are demonstrating FVIII activity kinetics that appear consistent with the first two patients treated in this dose cohort at similar early time points. Data from 10 patients treated with SB-525 were presented during an oral presentation on July 6 at the XXVII Congress of the International Society on Thrombosis and Haemostasis (ISTH), in Melbourne, Australia. “The initial results with SB-525 gene therapy for patients with severe hemophilia A continue to look very promising,” said Barbara Konkle, M.D., Bloodworks Northwest, Professor of Medicine at University of Washington and a Principal Investigator of the Alta study. “It is encouraging that patients in the 3e13 vg/kg cohort have attained normal Factor VIII levels within 5-7 weeks of treatment with SB-525 gene therapy and have sustained Factor VIII activity with no bleeding episodes. It will be important to continue to follow these patients to understand the potential long-term durability of this gene therapy.” Alta study data presented at ISTH included 10 patients treated across four ascending dose cohorts: 9e11 vg/kg (2 patients), 2e12 vg/kg (2 patients), 1e13 vg/kg (2 patients) and 3e13 vg/kg (4 patients). Factor VIII activity data presented at ISTH included results through June 18, 2019. All other data presented at ISTH were as of May 30, 2019. Across the dose cohorts, patients demonstrated a dose-dependent increase in FVIII levels and a dose-dependent reduction in the use of FVIII replacement therapy. In the two patients treated with the 1e13 vg/kg dose, FVIII activity levels have been durable through weeks 52 and 32. For the four patients in the 3e13 vg/kg cohort, FVIII activity data were available through 24, 19, 6, and 4 weeks of follow-up, respectively. The first two patients treated in the 3e13 vg/kg cohort (Patients 7 and 8) remained in the normal range, as measured using a chromogenic assay, through 24 and 19 weeks of follow-up, respectively. The next two patients in the 3e13 vg/kg cohort (Patients 9 and 10), with 6 and 4 weeks of follow-up, respectively, demonstrated rapid FVIII activity kinetics that appear consistent with Patients 7 and 8 at similar early time points. Also noted in the presentation at ISTH, Patient 9 attained normal FVIII activity levels at week 7, subsequent to the data transfer for the conference. No patient in the 3e13 vg/kg dose cohort has experienced bleeding events as of the data cut-off date, nor have patients in this dose cohort required factor replacement following initial use of prophylactic factor. SB-525 was generally well tolerated. Patients in the Alta study were not treated with prophylactic steroids. One treatment-related serious adverse event (SAE) was reported. This patient experienced hypotension and fever six hours after completion of SB-525 infusion; this fully resolved with treatment and the patient was discharged as planned within 24 hours. No similar hypotension event was observed in the three subsequent patients dosed. Adverse events observed in 10% (n=1) or more patients included: increased alanine aminotransferase (30%) and aspartate aminotransferase (10%), pyrexia (30%), fatigue (10%), hypotension (10%), myalgia (10%), and tachycardia (10%). No patients treated with SB-525 have experienced an alanine aminotransferase (ALT) elevation associated with a loss of Factor VIII expression. In the 3e13 vg/kg cohort, two subjects experienced a transient grade 1 ALT elevation (>1.5 x baseline) managed with a tapering course of oral steroids. “The initial results of the Alta study presented at ISTH demonstrate that SB-525 has the potential to be a predictable and reliable treatment that may bring clinical benefit to patients with hemophilia A,” said Adrian Woolfson, M.D., Ph.D., Executive Vice President of Research and Development, Sangamo. “The results show that SB-525 is well tolerated, that Factor VIII levels in the first two patients in the 3e13 vg/kg cohort reached normal, sustained levels as measured using a chromogenic assay, and that variability of Factor VIII activity is low, both within each patient and within each dose cohort. We look forward to continuing to follow these patients to further understand the durability of response to SB-525 gene therapy and to working with Pfizer to potentially advance a registrational study.” Based on the accumulating results from the Alta study, the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation for SB-525 gene therapy to treat severe hemophilia A. RMAT designation is granted to regenerative medicine therapies intended to treat, modify, reverse, or cure a serious condition, for which preliminary clinical evidence indicates that the medicine has the potential to address an unmet medical need. The RMAT designation includes all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with FDA. “We are encouraged by the initial clinical data suggesting safety, tolerability, and efficacy of SB-525 and are beginning preparations, including manufacturing, to potentially advance into a registrational study. We are also encouraged by our interactions with regulators and by the FDA’s recent RMAT designation,” said Seng Cheng, Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Diseases Research Unit. “If FVIII levels are sustained, and patients continue to have no bleeding episodes and remain off factor replacement therapy, we believe that this gene therapy may potentially represent a transformative treatment paradigm for severe hemophilia A.” The fifth patient in the 3e13 vg/kg cohort (Patient 11) is expected to be treated soon. Sangamo and Pfizer are working on plans to advance SB-525 to a registrational study. Pfizer will assume responsibility for SB-525 late-stage development and manufacturing. Transfer of the SB-525 manufacturing process from Sangamo to Pfizer has been initiated. In addition to the collaboration for the development and commercialization of gene therapies for hemophilia A, Sangamo and Pfizer are also working together on the development of gene therapies for amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) using Sangamo’s proprietary zinc finger protein transcription-factor technology (ZFP-TF).   ]]> https://biospectrumindia.com/news/57/14126/fsd-pharma-closes-deal-and-acquires-prismic-pharmaceuticals.html https://biospectrumindia.com/news/57/14126/fsd-pharma-closes-deal-and-acquires-prismic-pharmaceuticals.html Mon, 08 Jul 2019 12:10:00 +0530 FSD Pharma and Prismic Pharmaceuticals,  a US-based specialty R&D pharmaceutical company has announced that, on June 28, 2019, they finalized the acquisition by FSD Pharma of all of the issued and outstanding securities of Prismic Pursuant to the terms of a previously-announced securities exchange Agreement, FSD Pharma has acquired all outstanding common and preferred shares of Prismic for an aggregate purchase price of approximately US$17.5 million (CAD$23.4 million based on an exchange rate of US$1 to CAD$1.3349), satisfied by the issuance of approximately 102.7 million Class B subordinate voting shares in the capital of FSD Pharma (each, an “FSD Share”) at a deemed price of CAD$0.2275 (US$0.1704) per FSD Share. In addition, FSD Pharma has agreed to assume approximately US$3.05 million of outstanding Prismic long- and short-term liabilities. All of the outstanding Prismic stock options and warrants have been converted into options and warrants to purchase FSD shares, with the number and exercise price of such securities having been adjusted in accordance with the exchange ratio under the Agreement. The FSD Shares issued to the former Prismic shareholders were deposited into escrow at the closing of the Transaction, and are subject to an 18-month staggered release. FSD Pharma will continue to be led by Raza Bokhari, MD, Executive Co-Chairman & CEO. Zachary Dutton, co-founder of Prismic, will continue to serve as the CEO of Prismic, reporting to Edward Brennan, Jr. MD, FACS, President of the FSD Biosciences Division. Peter Moriarty, co-founder and previous Chairman of the Board of Prismic, has been named Chairman of the newly-formed FSD BioPharmaceutical Industry Advisory Board. Dr. Raza Bokhari, Executive Co-Chairman and CEO stated, “On behalf of the FSD Pharma shareholders and Board of Directors, it is with immense pleasure that I welcome Prismic shareholders and stakeholders to the FSD Pharma family. Over the past several weeks, Dr. Brennan and our M&A team have worked very closely with the Prismic leadership to finalize this transaction under budget and ahead of schedule. I must commend Dr. Brennan on his laser sharp focus and attention to detail and I must also express my special gratitude to Zach Dutton and Peter Moriarty for their efforts in resolving some outstanding issues to close the transaction.” Dr. Bokhari continued, “The Prismic acquisition represents strategic depth in the vision and mission of FSD Pharma and signals a paradigm shift in the overall outlook of the company. We are relying heavily on the expertise of Dr. Brennan, who is a seasoned pharmaceutical industry veteran with substantial experience from working at Glaxo Smith Kline and Johnson & Johnson to navigate us through the various stages of the FDA approval process for drug development, with the goal of eventually making synthetic cannabinoid prescription medications available for commercial use to help alleviate the pain and suffering of patients. We are confident, Peter Moriarty, another well-known pharmaceutical industry veteran, who was also one of the founders of Shire Pharmaceuticals, will make a meaningful contribution to the FSD Pharma story as the Chairman of the BioPharmaceutical industry advisory board.” FSD Pharma is focused on the research and development of novel cannabinoid-based treatments for several central nervous system disorders, including chronic pain, fibromyalgia and irritable bowel syndrome and on the development of the highest quality indoor grown, pharmaceutical grade cannabis. The Company is licensed to cultivate cannabis in approximately 25,000 square feet. Prismic is a US-based specialty pharmaceutical company dedicated to addressing the opioid crisis by developing novel non-addictive prescription drugs for the treatment of pain, inflammation, and neurological disorders, based on formulations utilizing the company’s micro-PEA development platform (palmitoylethanolamide with particle sizes of 0.6 – 10 microns). Such formulations take advantage of micro-PEA’s “synergistic” or “entourage” effect on certain drugs impacting the endocannabinoid system. This means that lower doses of those drugs may be administered together with micro-PEA to achieve the desired therapeutic effect. This includes the potential combination or concomitant use of micro-PEA formulations with drugs such as THC, CBD, certain anticonvulsants, and opioids where studies have indicated opioid-sparing and tolerance delaying properties of micro-PEA may impact the development of dependence in patients. Prismic’s first prescription drug candidate, PP-101, a 600 mg tablet of micro-PEA, is anticipated to commence a Phase 2/3 accelerated clinical development program in 2020 as a concomitant medication to be administered with pregabalin (Pfizer’s Lyrica®) for the treatment of fibromyalgia. Prismic was founded by three healthcare industry veterans, Zachary Dutton, Danilo Casadei Massari, and Peter Moriarty, who was also one of the founders of Shire Pharmaceuticals. ]]> https://biospectrumindia.com/news/57/14121/facility-in-stein-ch-will-complement-lonza-pharma-biotechs-current-parenteral-drug-product-offering-in-basel-ch.html https://biospectrumindia.com/news/57/14121/facility-in-stein-ch-will-complement-lonza-pharma-biotechs-current-parenteral-drug-product-offering-in-basel-ch.html Fri, 05 Jul 2019 15:55:00 +0530 Lonza has announced its entry into a binding contractual commitment for the purchase of a sterile drug product fill & finish facility from Novartis. The closing is expected to take place within the coming months. The new facility, in Stein (CH) will enable Lonza Pharma & Biotech to build on existing parenteral drug product development and testing capabilities and offer an end-to-end service to its customers for clinical supply and launch. It will be the first sterile drug product fill and finish facility in Lonza’s network.  The sterile, multi-product facility currently serves as the Novartis Center of Excellence for sterile clinical (phases 1 to 3) drug product manufacture. The facility has an excellent quality and safety track record and is cGMP approved.   Following closing, Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers.  Operational since 2009 the facility includes classified cleanroom areas for cGMP manufacture as well as office, lab space, utilities and storage. The facility will continue to perform sterile manufacturing including liquid and lyophilized dosage forms for up to 200L bulk volumes for clinical supply and commercial launch. Lonza will continue to employ the highly experienced team at the facility.  Since entering the field of drug product development services at the end of 2016, Lonza Pharma & Biotech has met considerable demand from the market and has already announced expansions at its sites in Basel and Visp (CH). From 2020 the group will expand development and testing labs into a larger building in Basel and expects its IbexTM Solutions fill and finish facility in Visp to be operational on-track from mid-2021.  The new facility in Stein will be fully incorporated into Lonza’s offering and will give pharma and biotech customers immediate access to the full range of development, testing and manufacturing services for parenterally administered medicines.  ]]> https://biospectrumindia.com/news/57/14117/gamamabs-pharma-announces-result-of-murlentamab-phase-2-study.html https://biospectrumindia.com/news/57/14117/gamamabs-pharma-announces-result-of-murlentamab-phase-2-study.html Fri, 05 Jul 2019 14:45:00 +0530 GamaMabs Pharma, a clinical stage biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, announces the oral presentation of clinical data from its phase 2 study of murlentamab in metastatic colorectal cancer (mCRC), at the ESMO World Congress on Gastrointestinal Cancer in Barcelona (Spain).   In combination with trifluridine/tipiracil (FTD/TPI - Lonsurf®), progression-free survival (PFS) was longer than expected (40% and 31% at 4 and 6 months respectively). This was especially pronounced in patients with more than 20% AMHRII-positive tumor cells, with respectively 83% and 75% patients free of progression at 4 and 6 months. 1.7-fold and 3.6-fold tumor growth rate decrease was observed with murlentamab single agent and murlentamab combined with trifluridine/tipiracil, respectively.   Immune activation under murlentamab was consistently observed in the tumor microenvironment (macrophage and T-cell activation) and in peripheral blood (monocytes and neutrophils activation). No serious adverse events related to murlentamab were reported.   Fourteen patients treated with murlentamab as a single agent (SA) and 15 patients treated in combination with FTD/TPI have been evaluated for efficacy in two parallel non-randomized cohorts.   “These first clinical and pharmacodynamic data are really encouraging for these patients who have so few options,” said Professor Eric Van Cutsem, University Hospitals Leuven (Belgium), principal investigator of the study. “These results support further development of murlentamab in combination with standard chemotherapies and/or immunological agents in colorectal cancers.”   “AMHRII expression was found in more than 80% of the tumor biopsied at treatment initiation in the metastatic setting, confirming our previous findings in primary tumors,” said Dr. Isabelle Tabah-Fisch, Chief Medical Officer at GamaMabs Pharma. “Besides the encouraging clinical data, the pharmacodynamics changes under murlentamab confirm the rewire of the tumor microenvironment by murlentamab, from macrophage to cytotoxic T lymphocyte activation.”    Results are being presented at the ESMO World Congress on Gastrointestinal Cancer on July 3-6 in Barcelona (Spain) as an oral presentation during the Emerging New or Combination Drugs in GI Cancer session on Friday, July 5, 8:00 - 9:20 a.m. (local time), and as a poster presentation.   ‘Phase 2 study results of murlentamab, a monoclonal antibody targeting the Anti-Mullerian-Hormone-Receptor II (AMHRII), acting through Tumor-Associated Macrophage engagement in advanced/metastatic colorectal cancers’ by E Van Cutsem and co-authors.   Murlentamab is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor, is re-expressed in a variety of solid tumors. Murlentamab is currently being evaluated in two clinical trials, phase 1b in gynecological cancers and phase 2 in advanced or metastatic colorectal cancers. Murlentamab exerts its anti-tumor activity through tumor-associated macrophages reprogramming, resulting in enhanced tumor phagocytosis and subsequent cytotoxic T cell reactivation.   ]]> https://biospectrumindia.com/news/57/14111/appili-signs-3m-grant-contract-with-the-us-defense-.html https://biospectrumindia.com/news/57/14111/appili-signs-3m-grant-contract-with-the-us-defense-.html Thu, 04 Jul 2019 15:00:00 +0530 Appili Therapeutics Inc. (“Appili”), a biopharmaceutical company focused on anti-infective drug development has announced that  the United States Department of Defense, (DOD) Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program (PRMRP) has completed the contract awarding the Company a $3.0 million USD grant. Appili will use the funds to continue advancing its ATI-1503 antibiotic program, which targets drug-resistant, Gram-negative bacteria also known as ‘superbugs.’ The ATI-1503 program has the ability to target 4 out of 6 “ESKAPE” pathogens, which are the leading cause of hospital acquired infections worldwide [i]. PRMRP grants support military health-related research that has the potential to make a strong impact on patient care. According to the World Health Organization, drug-resistant bacteria, particularly the superbugs that are resistant to most or sometimes all available anti-infectives, are among the highest threats to human health worldwide. The U.S. Centers for Disease Control and Prevention (CDC) report that they are responsible for more than 2 million infections and 23,000 deaths each year in the U.S. alone. In addition to the widespread civilian vulnerabilities that they present, these superbugs pose serious challenges in both internationally deployed troops and domestic military personnel in veterans’ hospitals. The significance of these threats, and their prevalence worldwide, have made solutions to multi-drug resistant bacteria a priority research area for the Department of Defense (DOD). Appili’s ATI-1503 program is a new class of antibiotics based on the negamycin scaffold, which is a naturally occurring compound with intrinsic Gram-negative antibacterial activity.  The class has broad spectrum activity, which allows it to potentially address the deadliest Gram-negative bacteria, including the superbugs Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa.  These are high priority pathogens for the CDC and WHO because of the lack of effective antibiotic treatment options for the most resistant strains. ]]> https://biospectrumindia.com/news/57/14110/bioinvent-gets-ind-nod-for-phase-i-iia-trial-of-anti-fcriib-antibody.html https://biospectrumindia.com/news/57/14110/bioinvent-gets-ind-nod-for-phase-i-iia-trial-of-anti-fcriib-antibody.html Thu, 04 Jul 2019 14:55:00 +0530 BioInvent International AB (BINV)  has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with an Investigational New Drug (IND) application for a Phase I/IIa clinical trial of an immune-modulatory anti-FcγRllB antibody in combination with an anti-PD1 antibody in solid tumors. The anti-FcγRllB antibody is part of BioInvent’s FcγRIIB-targeting program, which has emerged from its F.I.R.S.T™ platform technology, which simultaneously identifies both targets and high-quality antibodies that bind to them, generating potentially promising new drug candidates. The Phase I/IIa trial is planned to be carried out in the U.S. and the EU. “This antibody may improve the therapeutic efficacy of anti-PD1 targeting antibodies, and this study will explore the potential to improve responses observed in the treatment of solid cancers. Progressing this first in class monoclonal antibody into clinical development further reinforces the productivity of BioInvent’s platform, which continues to produce novel cancer therapies which not only broaden our own pipeline, but also add further licensing and partnering opportunities,” says BioInvent’s CEO Martin Welschof. The Phase I/IIa study is one of four new clinical programs in solid cancers that the Company intends to initiate. These also include BI-1607 (an anti-FcγRllB antibody) in combination with a checkpoint inhibitor; BI-1808 (an anti-TNFR2 antibody); and the collaboration with Transgene to develop oncolytic viruses encoding a validated anti-CTLA-4 antibody. ]]> https://biospectrumindia.com/news/57/14100/fosun-launches-fourth-edition-of-its-acceleration-program-protechting.html https://biospectrumindia.com/news/57/14100/fosun-launches-fourth-edition-of-its-acceleration-program-protechting.html Thu, 04 Jul 2019 10:30:00 +0530   Fosun and its portfolio companies Fidelidade, Luz Saude and  Hauck & Aufhauser launched the fourth edition of the startups acceleration program - Protechting - which aims to support the development of international projects which contribute to improve the protection of people in strategic areas, such as Healthtech, Insurtech and Fintech, but with an increased concern on sustainable development issues. The Protechting program, developed with the support of Beta-i, aims to foster a culture of innovation acceptance and development, enabling access to important resources for the evolution and materialization of business ideas. As a result of the first three editions, 33 startup pilot projects continue to maintain collaboration with Fosun's portfolio companies and, so far, five startups have signed commercial agreements, contributing to the creation and implementation of innovative solutions. Following the success of previous editions, this fourth edition, dedicated to the promotion of international entrepreneurship, strengthens its global scope. Luz Saude, one of the largest Portuguese health care groups, will reinforce its participation in the program, as well as the German private bank Hauck & Aufhauser. The Peruvian insurer La Positiva Seguros y Reaseguros will join for the first time. In this edition of the acceleration program, Fosun and its portfolio companies also aim to attract Healthtech, Insurtech and Fintech that bring a sustainable approach to their business model. In order to continue to attract global startups, Protechting 4.0 will also promote international scouting activities during the scouting phase, together with partners and in entrepreneurial events in South America, Africa, Europe, Chinese Mainland and Chinese Macao. According to Guo Guangchang, Chairman of Fosun, "Innovation makes the world develop and human beings progress. For companies, the importance of innovation is even more evident. Through Protechting, startups are bringing innovation in areas Fosun and its portfolio companies can all relate to. As long as we really invest more in innovation, we will have more opportunities in the future". The applications of the fourth edition of Protechting will be open from July to September. The selection phase will take place between September and October and the Pitch Day to access the Bootcamp will take place in November. Protechting 4.0's top three final projects will be awarded a roadshow in China, with access to some of the world's largest investors. The winner, with the best business project, will  be awarded with a monetary prize of 10 thousand euros. Positioning itself more and more as an international acceleration program reference, Protechting has staged three editions and attracted a total of 494 startups from 42 countries. ]]> https://biospectrumindia.com/news/57/14098/leo-pharma-completes-the-acquisition-of-bayers-dermatology-business.html https://biospectrumindia.com/news/57/14098/leo-pharma-completes-the-acquisition-of-bayers-dermatology-business.html Wed, 03 Jul 2019 16:15:00 +0530 LEO Pharma and Bayer have announced the achievement of the relevant closing conditions to allow the transfer of Bayer's global prescription dermatology business to LEO Pharma. The companies first announced the proposed transaction on July 31, 2018 and completed the first step of the acquisition with the closing in the United States on September 4, 2018. Today's second and final closing covers all other countries. Gitte Aabo, President and CEO of LEO Pharma said: "Today is a historic day for LEO Pharma. With the strong prescription dermatology brands and the new colleagues from Bayer, LEO Pharma advances significantly towards our goal of helping 125 million patients by 2025. We broaden our treatment range within the areas of acne, fungal skin infections and rosacea, as well as our range of topical steroids. By completing the final part of the acquisition, we considerably enhance our size in key markets like Brazil, Austria, and South Africa – underlining our ambition to become a world leader in medical dermatology." "We're pleased to have found the right owner in LEO Phama to take our Rx Dermatology business to the next level," said Heiko Schipper, member of Bayer's Board of Management and President of Consumer Health. "With this divestiture we further our goal to focus on our core OTC categories and develop our Consumer Health business to its full potential." As announced as part of the agreement, LEO Pharma has now acquired the global product rights for Bayer's global prescription dermatology business with the exception of Afghanistan and Pakistan. This includes a production facility in Segrate, Italy and a total of 347 employees who will join LEO Pharma. Subject to applicable laws, LEO Pharma and Bayer have worked closely together to secure an effective transition and an uninterrupted supply of prescription dermatology treatments. ]]> https://biospectrumindia.com/news/57/14096/hansen-adopts-nicelabel-technology-to-support-mission-critical-production.html https://biospectrumindia.com/news/57/14096/hansen-adopts-nicelabel-technology-to-support-mission-critical-production.html Wed, 03 Jul 2019 13:15:00 +0530 Chr. Hansen develops and produces cultures, enzymes, probiotics and natural colors for the food, confectionary, beverages, dietary supplements and animal feed industries. Founded in 1874, it has more than 3,000 employees in more than 30 countries. More than one billion people consume its products across the world, resulting in 3,000 label print requests per day across 30 different locations. The NiceLabel Label Management System, with its universal label templates and label variant technology, allows Chr. Hansen to reduce and consolidate their label templates, remove inconsistencies, and improve workflow and quality assurance when designing and printing its labels. Jens Berth, Senior IT Project Manager at Chr. Hansen says: “We operate in the life sciences industry which means our processes, including labeling, must be validated according to the criteria set forth by the Food andDrug Administration (FDA). We need to ensure that our label variants, which are the exact finished labels for our products, are fully approved by our QA staff and cannot be changed once the variant is created. NiceLabel’s variant technology enables this so I can be confident that each label is fully compliant.”The NiceLabel solution integrates with Chr. Hansen’s enterprise resource planning system, SAP, using NiceLabel’s SAP ABAP package. The built-in label template approval process, with a delayed publishing workflow, allows labels to be built in the NiceLabel system and approved in the NiceLabel document management system (DMS). Label information is sent to SAP so that the correct templates, variants and versions are used in each batch. In addition, if an unapproved label is used, the system issues a warning, ensuring both compliance and traceability for all label versions. Berth adds: “Having a web printing application that lets us print the label job that was previously created by SAPis key for the way we work — we have hundreds of workers across many countries creating orders in SAP all the time. In addition, the NiceLabel solution has allowed us to reduce the number of templates we use, making the process much easier to manage and spot any errors than previously.” Miso Duplancic, Product Management Director at NiceLabel says: “Labeling is a business-critical function for Chr. Hansen and using old technology systems can lead to high costs and cumbersome processes. Our label management system enables them to achieve the highest levels of integration quickly, and at a much lower cost than with legacy approaches to integration. The ABAP package provides their IT team with rapid integration and faster time to value. They don’t need to spend several months doing a really tight integration.” ]]> https://biospectrumindia.com/news/57/14095/tsinghua-university-officially-launches-amgen-scholars-program-.html https://biospectrumindia.com/news/57/14095/tsinghua-university-officially-launches-amgen-scholars-program-.html Wed, 03 Jul 2019 12:55:00 +0530 Last September, Tsinghua University was selected as the first and only Chinese host institution for ASP, one of the 24 world-leading universities including Harvard University, Stanford University, the University of Cambridge and others. ASP is an undergraduate summer research program, initiated and supported by the Amgen Foundation through a 16-year, $74 million commitment. This 8 to 10-week practice-based program aims to recruit outstanding undergraduates from across the globe, who have strong interests in biomedical research, life sciences or related fields, to conduct cutting-edge research at world-class laboratories and institutions. Tsinghua Amgen Scholars Program is hosted by the School of Pharmaceutical Sciences (SPS). Global recruitment of Tsinghua Amgen Scholars began last November, and the admission process was highly competitive. By February 1 this year, nearly 300 applications from over 50 countries were received and only 15 candidates were selected through intensive evaluation by the faculties for Class 2019. They come from 11 countries (the United States, Germany, Portugal, Korea, India, Malaysia, Indonesia, Vietnam, Japan and others.) and are currently studying at top universities such as Harvard University, Yale University, Princeton University, University of Oxford, University of Edinburgh, Nagoya University and others. Starting from July 1, the Tsinghua Amgen Scholars will work under close supervision of a SPS faculty member on specific research projects over an 8-week period. As research at SPS is highly interdisciplinary across a comprehensive set of therapeutic modalities of small molecule, biologics, gene therapy, cell therapy and medical device, these Scholars' projects will span a wide spectrum of topics in fundamental biology, chemistry, pharmaceutical technologies and disease understanding and targeting. In addition, they will participate in diverse academic activities including visiting the Global Health Drug Discovery Institute (GHDDI) in Beijing, a transformative drug discovery and translational platform aiming to tackle the world's most pressing disease challenges for developing countries, and attending an ASP symposium at the National University of Singapore, where they will meet their peers and hear from leading scientists. They will also have the opportunities to experience the rich culture of the University as well as the city of Beijing. ]]> https://biospectrumindia.com/news/57/14093/horizon-technology-finance-provides-8m-venture-loan-to-outbound-engine.html https://biospectrumindia.com/news/57/14093/horizon-technology-finance-provides-8m-venture-loan-to-outbound-engine.html Wed, 03 Jul 2019 11:30:00 +0530 Horizon Technology Finance Corporation, a leading specialty finance company that provides capital in the form of secured loans to venture capital-backed companies in the technology, life science, healthcare information and services, and cleantech industries has announced that it has provided an $8 million venture loan to OutboundEngine. OutboundEngine is an all-in-one marketing software that includes a responsive website, relevant content created and sent automatically across email and social media, and hands-free social advertising on Facebook and Instagram. OutboundEngine serves as a command center for managing contacts, tracking marketing results, optimizing online reputation, and following up with leads -- all from a smartphone. OutboundEngine offers subscription options ranging from $199 to $449 per month. OutboundEngine's largest investors include Silverton Partners, S3 Ventures, Noro-Moseley Partners, Harmony Partners, and Floodgate Fund. OutboundEngine will use the proceeds to fund its growth strategy and for general corporate purposes. "OutboundEngine's proven and successful marketing software has allowed them to build a strong base of over 10,000 customers across the small business and independent professional landscape," said Gerald A. Michaud, President of Horizon. "Importantly, OutboundEngine has a key differentiator with 'content done for me' which provides customers with easy-to-use and sector-specific marketing content at an affordable price point. We are pleased to be able to support OutboundEngine's overall plans to expand." "We are excited to partner with Horizon as we embark on our next phase of development," said Marc Pickren, Chief Executive Officer of OutboundEngine."With the additional funding from Horizon, we expect to hire additional sales representatives, establish new customer acquisition channels through channel partnerships, and officially launch the ability to purchase, onboard and use the software 100% online. This will allow new users to enjoy the benefits of the platform while considering which of our full-service packages to subscribe to. OutboundEngine believes that small business is the backbone of the American economy and that these brave individuals deserve an all-in-one, low cost marketing solution that is pivotal in guiding them to success on their terms and not getting left behind. Horizon's investment in OutboundEngine will further our ability to serve a larger addressable market and to substantially grow our ability to provide value at scale."     ]]> https://biospectrumindia.com/news/57/14091/karolinska-development-appoints-fredrik-jrrsten-as-deputy-ceo.html https://biospectrumindia.com/news/57/14091/karolinska-development-appoints-fredrik-jrrsten-as-deputy-ceo.html Wed, 03 Jul 2019 11:15:00 +0530 Karolinska Development AB has announced that Fredrik Järrsten has been appointed as Deputy Chief Executive Officer and Chief Financial Officer. Fredrik Järrsten joined Karolinska Development as Chief Financial Officer in 2017. Fredrik Järrsten (b.1967), M.Sc. in Business and Economics, has more than 25 years of experience within investments and business development, including 13 years in the Life Science sector. “The appointment of Fredrik Järrsten as Deputy CEO is a consequence of his deep engagement and significant contributions to the leadership of Karolinska Development. Alongside his continuous responsibilities as CFO, Fredrik will now be able to focus even more on strategic development and related areas,” says Viktor Drvota, CEO, Karolinska Development AB. Karolinska Development AB is a Nordic life science investment company. The company focuses on identifying breakthrough medical innovations that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders. Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success. Karolinska Development has established a portfolio of nine companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases. The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network. ]]> https://biospectrumindia.com/news/57/14090/cancer-research-uk-forms-partnership-with-sv-health-investors-in-life-sciences-investment-fund-to-accelerate-development-of-cancer-medicines.html https://biospectrumindia.com/news/57/14090/cancer-research-uk-forms-partnership-with-sv-health-investors-in-life-sciences-investment-fund-to-accelerate-development-of-cancer-medicines.html Wed, 03 Jul 2019 11:00:00 +0530 Cancer Research UK, the world's largest independent funder of cancer research has announced a strategic partnership with SV Health Investors (SV), a leading life sciences venture capital and growth equity firm, focused on accelerating the translation of Cancer Research UK’s research and the development of new cancer medicines for patients. In conjunction with the partnership, Cancer Research UK is investing at least US$25 million in SV’s seventh biotech-focused venture capital fund, SV7 Impact Medicine Fund (the Fund), which is expected to raise US$250 million. Oncology is an important component of the Fund, which will target investing 60% into companies focused on oncology or oncology-related opportunities. Cancer Research UK invests more than £400 million every year in cancer research, including through its UK network of 18 core-funded research centres, to accelerate the transition of lab-based discovery research into the clinic for the benefit of people affected by cancer. A key focus for Cancer Research UK is turning the charity’s promising science into successful cancer therapeutics, vaccines, diagnostics and enabling technologies. More than 30 partnered potential medicines are in pre-clinical and clinical development, and eight treatments are already available on the market and benefiting patients. SV has been investing in biotech companies since the early 1990s and brings a proven track record of identifying early-stage cancer research opportunities and supporting their development into novel medicines. In 1998, SV worked closely with Cancer Research UK to establish Kudos Pharmaceuticals – inventor of olaparib, the first-in-class approved DNA damage response (DDR) inhibitor for cancer patients with BRCA mutations. In 2016, SV founded Artios, focused on developing next generation DDR inhibitors, also based on Cancer Research UK assets and sector expertise. In 2017, SV’s sixth diversified healthcare fund raised US$400 million, of which 45% was focussed on early stage Biotech investments, of which 66% were allocated to cancer-related research opportunities. SV7 will be solely focussed on Biotech investments. Accelerating Cancer Research UK’s innovation through this partnership will complement the charity’s existing paths to commercialisation, which include research alliances with other scientific institutions, building spin-outs and licensing agreements with pharmaceutical companies. Cancer Research UK will collaborate closely with SV to identify promising, novel research from within the charity’s network that could be rapidly developed and scaled by securing external investment. Michelle Mitchell, Cancer Research UK’s chief executive, said: “The strength of our science portfolio is unrivalled but only through working in partnership can we achieve the greatest impact. This partnership is a huge opportunity to accelerate our research and support the successful development of the much-needed treatments for people with cancer.” Iain Foulkes, Cancer Research UK’s executive director, research & innovation and CEO of Cancer Research Technology, said: “We need to encourage more entrepreneurialism if we want to get more medicines to patients to beat cancer. This was recognised in the UK Life Sciences Strategy and this new fund, in partnership with SV, will be a huge boost to advancing cancer research here in the UK. The UK has some of the very best research in the world and partnering with a world leading venture group such as SV will accelerate progress and generate new biotech to be established here.” Kate Bingham, SV Health Investors’ Managing Partner, said: “Cancer Research UK is, undoubtedly, a world-leader in this field with the brightest scientists exploring the latest technologies and innovations. Working in close partnership gives us an opportunity to identify promising research within Cancer Research UK’s labs and give that science the investment, resources and expertise it needs to progress.”   ]]> https://biospectrumindia.com/news/57/14085/biotek-unveils-enhancements-to-market-leading-405-ts-washer.html https://biospectrumindia.com/news/57/14085/biotek-unveils-enhancements-to-market-leading-405-ts-washer.html Tue, 02 Jul 2019 16:15:00 +0530 BioTek Instruments continues to improve laboratory workflows while simplifying the user experience with the launch of their next generation 405 TS Microplate Washer. With new capabilities, 405 TS provides even more time-saving convenience and value for applications such as cell-based assays, ELISAs, bead washing and more.   Updated software allows the user to define a specific volume to remain in the wells after aspiration and a fully adjustable regulator enables fine-tuning of the vacuum pressure, protecting fragile cell layers and spheroids from disruption. Once created via the user-friendly touchscreen interface, protocols may be password-protected to prevent unauthorized or accidental changes, and quickly recalled for use. When integrated with BioTek’s BioStack™ Microplate Stacker, 405 TS displays the plate number in process and remaining overall processing time for all plates in the stack.   The new updates add to existing, advanced 405 TS features that enable any laboratory to operate at peak efficiency, including Verify™ technology to identify manifold tube blockages and report suspected clogs, and patented Ultrasonic Advantage™ for thorough, automated and hands-free manifold cleaning. ]]> https://biospectrumindia.com/news/57/14084/oncovita-signs-exclusive-licensing-agreement-with-institut-pasteur.html https://biospectrumindia.com/news/57/14084/oncovita-signs-exclusive-licensing-agreement-with-institut-pasteur.html Tue, 02 Jul 2019 15:55:00 +0530 Oncovita, a biotech company dedicated to the development of life-saving new treatments, in particular anti-cancer therapies, announces today that it has entered into a licensing agreement with Institut Pasteur, granting it an exclusive worldwide license to develop, manufacture and commercialize therapies based on the immuno-oncolytic measles virus platform. Financial terms of the agreement were not disclosed.   The live-attenuated measles virus has been used for decades to immunize billions of children worldwide. It is one of the safest and most efficacious vaccines.   The licensed technology is based on changes in the measles viral genome designed to dramatically increase its anti-tumor properties. This technology has been developed by the viral genomics and vaccination unit of Institut Pasteur, Paris, France. The viral genomics and vaccination unit has previously successfully developed and patented other genetically modified measles vaccine viruses to be used as recombinant vaccines which are currently under clinical development (chikungunya, zika, dengue fever and others).   For the anti-cancer candidates, Oncovita, a spin-off of Institut Pasteur, has been selected to be the exclusive holder of the worldwide rights on the modified measles virus technology.     ]]> https://biospectrumindia.com/news/57/14079/viela-bio-appoints-mitchell-chan-as-cfo.html https://biospectrumindia.com/news/57/14079/viela-bio-appoints-mitchell-chan-as-cfo.html Tue, 02 Jul 2019 12:20:00 +0530 Viela Bio has announced the appointment of Mitchell Chan as Chief Financial Officer, effective July 1. In this role, he will be responsible for leading corporate financing, financial operations, treasury, investor relations, corporate communications and corporate strategy. Previously, Mr. Chan served as Viela’s Vice President, Head of Finance & Corporate Strategy. “We are pleased to announce Mitch’s appointment to the CFO position,” said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. “Mitch brings a deep understanding of capital markets and the life sciences industry. He has a proven track record of successful financial leadership and was integral in supporting Viela in raising capital, including our recent Series B financing. We look forward to his continued contributions as we approach our first regulatory milestone with inebilizumab and advance the entirety of our pipeline in autoimmune and inflammatory disease.” Mr. Chan has more than 15 years of finance experience. Prior to joining Viela in 2018, he served as Director of Investor Relations for AstraZeneca, North America. Previously, Mr. Chan held various roles of increasing responsibility at Genentech-Roche, including in BioOncology Commercial Finance, R&D Finance, and Mergers & Acquisitions. Mr. Chan is the recipient of Executive Certifications from Stanford University, University of California (Haas), and University of Pennsylvania (Wharton) and earned his BSc, MSc and MBA (Rotman School of Management) from the University Toronto. Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.   ]]> https://biospectrumindia.com/news/57/14078/actobio-therapeutics-progresses-to-phase-ib-iia-for-ag019.html https://biospectrumindia.com/news/57/14078/actobio-therapeutics-progresses-to-phase-ib-iia-for-ag019.html Tue, 02 Jul 2019 12:00:00 +0530 ActoBio Therapeutics,  a wholly owned subsidiary of Intrexon Corporation and innovative clinical-stage biotechnology company focused on a new class of microbe-based therapeutic agents, has announced that it will progress to the next stage of the Phase Ib/IIa clinical trial for investigational drug AG019 for the treatment of early-onset type 1 diabetes (T1D). This follows a scheduled review by the independent Data and Safety Monitoring Board, which supported moving forward with the study. Therefore, the Company may now initiate enrollment of the next two patient cohorts of the study: AG019 dosing in patients 12-17 years of age and combination dosing of AG019 plus teplizumab (PRV-031) in adults. ActoBiotics AG019 is an investigational drug designed to induce oral immune tolerance to reverse T1D, a disease with no approved disease-modifying treatment that is currently managed through lifestyle modification and diet combined with exogenous insulin. AG019 is formulated as an oral capsule consisting of engineered Lactococcus lactis specifically modified to deliver human proinsulin and the tolerance-enhancing cytokine human interleukin-10 to the mucosal lining of the gastro-intestinal tissues. In the next stage of the study, AG019 will be utilized in combination with PRV-031, a Phase III anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D, pursuant to a collaboration with Provention Bio. Inc., (NASDAQ: PRVB), a clinical-stage biopharmaceutical company. The Phase IIa study will evaluate AG019 administered for 8 weeks in combination with PRV-031 for the first 12 days as compared to placebo. Pre-clinical studies of AG019, in association with a short-term treatment with a systemic anti-CD3 monoclonal antibody, induced reversion to normal blood sugar levels in 60% of diabetic mice and reversed the disease in 89% of mice treated at early stage of the disease. The results of the current trial are expected in 2020 and will provide initial data regarding the safety and efficacy of AG019 in humans. "PRV-031 immunotherapy has shown remarkable promise as a single agent for the interception and prevention of type 1 diabetes," commented Ashleigh Palmer, Provention Bio's Co-Founder and Chief Executive Officer. "Combination strategies offer potential opportunities to improve outcomes for early onset type 1 diabetes. We share ActoBio's commitment to investigating new disease-modifying therapeutic options for type 1 diabetes patients and their families, and we look forward to learning more about the combination of PRV-031 plus AG019 as this study advances." Pieter Rottiers, PhD, Chief Executive Officer of ActoBio Therapeutics stated, "We are excited to start the AG019 trial in the 12- to 17-year-old patient cohort, since T1D onset occurs most frequently in adolescents. We are also looking forward to collaborating with Provention Bio in this next stage of testing in patients. We have high hopes that the combination of AG019 and PRV-031 will prove safe and well-tolerated, to allow us to then move on to study efficacy as we aim to make a difference to T1D patients' lives. We believe that AG019, alone or in combination with teplizumab, offers potential as a new therapeutic option to address this high unmet need." ActoBio Therapeutics is pioneering a new class of microbe-based ActoBiotics Lactococcus lactis biopharmaceuticals that enable expression and local delivery of disease-modifying therapeutics. The ActoBiotics platform produces biologics following oral or topical administration with possible treatment applications across many diseases including oral, gastrointestinal and autoimmune/allergic disorders. ActoBio Therapeutics™ has a strong R&D pipeline with the latest stage candidate in Phase IIb and an extensive portfolio of candidates ready for clinical development across a number of potential indications.  ]]> https://biospectrumindia.com/news/57/14061/thermo-fisher-completes-sale-of-anatomical-pathology-biz-to-phc-.html https://biospectrumindia.com/news/57/14061/thermo-fisher-completes-sale-of-anatomical-pathology-biz-to-phc-.html Mon, 01 Jul 2019 12:55:00 +0530 Thermo Fisher Scientific, the world leader in serving science has recently completed the previously announced sale of its Anatomical Pathology business to PHC Holdings Corporation, a leading global healthcare company providing innovative solutions, for approximately $1.14 billion in cash. The Anatomical Pathology business, with approximately 1200 employees in the U.S., Europe and Asia, generated approximately $350 million in annual revenue and was part of Thermo Fisher's Specialty Diagnostics Segment. ]]> https://biospectrumindia.com/news/57/14060/carestream-group-acquires-christie-medical-holdings.html https://biospectrumindia.com/news/57/14060/carestream-group-acquires-christie-medical-holdings.html Mon, 01 Jul 2019 11:40:00 +0530 The CAREstream Group has announced its acquisition of Christie® Medical Holdings, Inc. of Memphis, TN. Christie Medical Holdings is the leader in vein visualization and operates in over 50 countries worldwide. The CAREstream Group is the premier distributor for clinical, respiratory, anesthesia, EMS, aesthetic and regenerative solutions for a variety of applications. Christie Medical Holdings' two dominant products are the VeinViewer® Vision 2, the optimal vein finder device for hospitals and institutions; and the VeinViewer® Flex, a portable vascular visualization device. These high-quality products stand alone as the leaders in vein visualization in the world. Dr. Al Sperry, Chairman of the CAREstream Group, commented, "We are honored that Christie has chosen CAREstream as the new owner of Christie Medical Holdings. We, as a distributor, have sold Christie VeinViewer® products for over 10 years and know they are the best in the world. We look forward to enhancing and improving future generations of products to continue that leadership. We also have multiple complementary products that we will add to the portfolio." Paul Damiani, one of CAREstream's senior group members, will become the President of Christie Medical Holdings and be responsible for all aspects of the business. "Paul's international business experience and track record of strong leadership make him the ideal person to lead this group," continued Sperry. ]]> https://biospectrumindia.com/news/57/14059/biological-dynamics-receives-grant-award-funding-from-bill-melinda-gates-foundation.html https://biospectrumindia.com/news/57/14059/biological-dynamics-receives-grant-award-funding-from-bill-melinda-gates-foundation.html Mon, 01 Jul 2019 11:20:00 +0530 Biological Dynamics, an innovative diagnostic company committed to improving global health outcomes, today announced a new grant award from the Bill & Melinda Gates Foundation. This collaboration focuses on enabling complex decision-making by combining results from point-of-care tests with smartphone data – creating essential opportunities in countries with limited access to sophisticated laboratory testing. This work will explore the feasibility of integrating wireless technologies intended to simplify field-based workflows and to reduce dependence on wired power sources into OmniVeritaM – the smartphone-enabled portable diagnostic platform being developed by Biological Dynamics. The ultimate objective of the portable is to enable affordable, user-friendly, and sensitive diagnostic testing for high-burden conditions that can be successfully deployed to resource-poor settings on a global scale. “We are thrilled to expand our engagement with the Bill & Melinda Gates Foundation, beyond our current work in tuberculosis testing. With the sensitivity and scalability of our platform, we can empower healthcare workers by providing actionable, affordable, and timely clinical-grade diagnostic information by putting diagnostics at their fingertips,” said Raj Krishnan, Ph.D., CEO of Biological Dynamics. “We believe in the potential of this collaboration to bring much-needed real-time health decision making to underserved populations in low- and middle-income countries.” The technology is powered by Biological Dynamics’ novel isolation platform, Verita™, which enables the isolation of circulating biomarkers such as cell-free DNA and exosomes from whole blood, serum, and plasma without the need to pre-process samples. The Company is currently applying the cutting-edge isolation capabilities of Verita™ to develop the next generation of lab and point-of-care tests for the early detection and treatment response monitoring of cancer. Biological Dynamics is an  innovative diagnostic company committed to improving global health outcomes by empowering healthcare communities with accessible diagnostics. Biological Dynamics’ proprietary technology platform, Verita, isolates nanoparticles and macromolecules directly from whole blood, serum, or plasma without the need for pre-processing samples. The Company is developing a portfolio of novel oncology and infectious disease products designed to enable early detection and individualized treatment response monitoring. In addition to lab-focused products, Biological Dynamics is also developing a smartphone-enabled portable version of the platform with the goal of bringing blood-based DNA testing into the home. ]]> https://biospectrumindia.com/news/57/14051/perkinelmer-fdna-to-augment-genetic-testing-with-ai.html https://biospectrumindia.com/news/57/14051/perkinelmer-fdna-to-augment-genetic-testing-with-ai.html Mon, 01 Jul 2019 10:00:00 +0530 US based FDNA, a leader in artificial intelligence and precision medicine, has announced the launch of Face2Gene LABS as part of a broader collaboration with PerkinElmer, Inc., a global leader committed to innovating for a healthier world. Together, they will offer genomic services paired with next-generation phenotyping (NGP) technologies for more efficient and accurate diagnoses. By combining FDNA’s artificial intelligence-based technologies and services with PerkinElmer’s longstanding diagnostics expertise and state-of-the-art clinical genomics program, Face2Gene LABS will give clinicians access to: FDNA’s unprecedented phenotypic and genotypic data associated with more than 10,000 diseases from over 150,000 patients around the world; PerkinElmer Genomics’ global laboratory network and extensive database of known genetic variations from different ancestries around the world; Improved test selection, gene targeting, and variant prioritization through the integration of NGP technologies into molecular analysis, while reducing time spent and lowering testing costs; ISO 27001 certified platform that facilitates secure communication of patient information between clinicians and labs.   ]]> https://biospectrumindia.com/news/57/14041/touchpoint-medical-launches-workflo-point-of-care-solution.html https://biospectrumindia.com/news/57/14041/touchpoint-medical-launches-workflo-point-of-care-solution.html Fri, 28 Jun 2019 18:05:00 +0530 TouchPoint Medical, Inc., on 26 June 2019, announced the expansion of its point-of-care solutions with the workFLOTM series. The new workFLO product line is designed to help deliver better patient experiences through its streamlined and easy-to-manoeuvre design. workFLO features a series of workstations and device stands that are designed to make delivery of care more efficient by providing a solution that is easy for them to use even during a busy shift. The product line offers durable and intuitive workstations that provide easy manoeuvre ability at roughly half the weight of traditionally powered carts. The series features a stable base design with tracking casters, an array of accessories and multiple technology mounting options from all-in-one devices (AIOs) to small tablets. Expanded product line delivers elegant simplicity for today’s fast-paced healthcare environment. The workFLO series offer Single monitor documentation workstation, Laptop documentation workstation, adjustable height documentation workstation, fixed height documentation workstation and Device Mount Roll Stand models. “A clinician’s comfort is a key ingredient in delivering a high level of patient care,” said Bradley Carlson, product manager of point-of-care solutions. “With the expansion of our point-of-care mobile workstation offering, TouchPoint Medical is providing our customers with a greater breadth of solutions that meet their specific clinical and IT mobility requirements.” ]]> https://biospectrumindia.com/news/57/14044/benvenue-medical-receives-fda-clearance-for-luna-xd-minimally-invasive-expandable-interbody-device.html https://biospectrumindia.com/news/57/14044/benvenue-medical-receives-fda-clearance-for-luna-xd-minimally-invasive-expandable-interbody-device.html Fri, 28 Jun 2019 16:10:00 +0530 Benvenue Medical, an innovative developer of minimally invasive surgery (MIS) expandable implant solutions for lumbar fusions has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s enhanced Luna XD MIS expandable interbody device. Luna XD combines anterior lumbar interbody fusion (ALIF) principles with a minimally invasive controlled posterior approach to provide anterior column stability, strength, and fusion in patients with symptomatic degenerative disc disease (DDD). It utilizes a small incision while providing the largest implant footprint, affording surgeons a large graft chamber to facilitate fusion success, maximum height restoration, and optimized sagittal balance, with minimal impaction, neural retraction, or subsidence. The device is part of Benvenue’s suite of MIS lumbar fusion products that includes the Orbit™ Articulating Discectomy System. Orbit is a minimally invasive discectomy system that uses a small, posterior incision to achieve efficient disruption, removal of disc tissue and endplate preparation. It utilizes a novel articulating rotary shaver that enables rapid, high-volume removal of diseased tissue. “With the introduction of Luna XD, we believe that we have an exciting opportunity to advance better patient outcomes through MIS lumbar fusion techniques,” said Robert K. Weigle, CEO of Benvenue Medical. “We are thrilled about the clinician feedback we have received in our early launch of Luna XD, which allows physicians to provide cost-effective, minimally-invasive procedures to patients, with the goal of improving overall quality of life and reducing pain. In combination with our new Orbit discectomy platform, Luna XD demonstrates our core competency with material science and commitment to developing new products that will change the future of MIS lumbar fusion in both the hospital and increasingly, in the ASC setting.” MIS spine surgery is growing at a rate of 7.6% annually and outpatient procedures are expected to grow 35% over the next 10 years.1 “Luna XD is a significant advancement in MIS fusion surgery and offers a more robust and reproducible expandable cage that allows me to put in an ALIF footprint cage, through a TLIF approach with minimal to no nerve retraction,” said Sandeep Kunwar, M.D., F.A.C.S., Co-Medical Director, Bell Neuroscience, Professor, UCSF. “It also allows for endplate to endplate grafting post-expansion.” “The Orbit System, combined with the Luna XD makes the procedure more efficient and truly addresses the unmet needs across all discectomy procedures,” said Richard G. Fessler, M.D., Ph.D., Rush University. “In 25 years of performing MIS surgery, the Orbit System is the best set of discectomy tools I’ve ever used.” Luna XD will be available initially as part of a controlled launch at select centers. 1 Sg2: Sg2 2017 Impact of Change Forecast: Finding Growth. Posted May 5, 2017; Accessed April 2, 2018. ]]> https://biospectrumindia.com/news/57/14042/ewib-partners-with-bio.html https://biospectrumindia.com/news/57/14042/ewib-partners-with-bio.html Fri, 28 Jun 2019 15:45:00 +0530 Executive Women in Bio (EWIB), a committee comprised of senior leaders in the life sciences and biopharma operating within the national non-profit organization, Women In Bio (WIB), is pleased to announce a new partnership with the Biotechnology Innovation Organization (BIO). Through this partnership, senior women executives who complete EWIB’s Boardroom Ready program can elect to be listed on BIO Boardlist, a searchable directory of eligible executives in which members can recommend peers and companies can find board candidates that best fit their business needs. With less than 15 percent of life science company board positions filled by women, increasing equity in consideration for these leadership positions will take a change in thinking across the industry. Motivated by both the moral obligation to give all eligible candidates equal opportunity to advance up the corporate ladder, as well as the growing body of research indicating that diverse boards tend to generate returns above the industry average, EWIB and BIO have developed programs and taken steps to counteract women’s underrepresentation on executive boards. “Executive Women In Bio established the Boardroom Ready program to help experienced female leadership overcome the hurdles to obtaining a corporate board seat,” said Carolyn Brougham, executive liaison at WIB. ”Adding the program alumnae to the BIO Boardlist furthers the mission of EWIB and Boardroom Ready by expanding the resources, network, and opportunities available for these outstanding life science executives.” Each year, EWIB’s Boardroom Ready program selects 20 top biotech and pharmaceutical executive women to participate in an intensive board competency-building curriculum to refine each candidate’s understanding of the responsibilities related to serving on both public and private boards. A key benefit of this program is leveraging the extensive network of WIB, experienced board mentors, and supporters throughout the life sciences. To date, program participants have been appointed to 32 board positions. “It makes more than just common sense, but also business sense, that governing boards of biopharmaceutical companies reflect the diversity seen within the ranks of their scientists, entrepreneurs, investors, and patients,” said Helen Torley, M.B. Ch.B., M.R.C.P, President, CEO and member of the Board of Directors of Halozyme Therapeutics and chair of BIO’s Workforce Development, Diversity & Inclusion (WDDI) Committee. “We have launched the BIO Boardlist, to accelerate gender, racial, ethnic and LGBTQ representation on biotech company boards. We are excited to partner with EWIB to populate this database and showcase the wealth of talent that lies within senior leadership.” BIO Boardlist is a part of The Right Mix Matters initiative, which recently launched to advance a more globally competitive industry through resources and tools for BIO members and the larger biotech community. This is just one of many ways BIO is working to promote diversity and inclusion in life sciences hiring practices and expand representation on biotech company boards, in c-suites and in functional leadership positions. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. ]]> https://biospectrumindia.com/news/57/14037/velabs-therapeutics-raises-3-m-to-advance-antibody-screening-programme.html https://biospectrumindia.com/news/57/14037/velabs-therapeutics-raises-3-m-to-advance-antibody-screening-programme.html Fri, 28 Jun 2019 11:45:00 +0530 Velabs Therapeutics GmbH, a leader in rapid screening of functional therapeutic antibodies has announced the closing of a €3 million Series B financing round to advance its functional antibody screening programme and to strengthen its own pipeline of preclinical functional antibodies against diseases with poor treatment options. Further details of the financing round were not disclosed. Velabs Therapeutics, a young spin-off company of the European Molecular Biology Laboratory (EMBL), is a pioneer of microfluidic technology for the screening of antibodies with modulatory function on complex signalling proteins such as GPCRs, ion channels or other regulatory signalling proteins. Its proprietary high-throughput screening platform makes it possible to test millions of correctly paired, fully natural human and mouse antibodies for their therapeutic effects, not just for binding. Results are achieved in only a fraction of the time required by other technologies. The company offers customized screening services for users worldwide. In addition to existing pharma co-development partnerships, Velabs is currently building its own pipeline of therapeutic antibody candidates for further joint development with interested partners. ]]> https://biospectrumindia.com/news/57/14027/the-hippo-pathway-keeps-cancer-at-bay.html https://biospectrumindia.com/news/57/14027/the-hippo-pathway-keeps-cancer-at-bay.html Thu, 27 Jun 2019 15:10:00 +0530 A cancer research project conducted recently at the Weizmann Institute of Science evokes an unusual image: hippos. The research is not about the weighty, mud-basking mammals, but about the Hippo pathway, a chain of biochemical reactions that, when disrupted, can cause fruit flies to grow so large, they somewhat resemble hippopotamuses. In humans, however, the malfunction of two key genes in this pathway, LATS1 and LATS2, can cause cancer. The LATS genes regulate the activity of the tumor suppressor gene p53, known as a master protector of the human genome. Drs. Noa Furth and Yael Aylon became interested in the LATS genes when both worked in the p53 research lab of Prof. Moshe Oren of the Molecular Cell Biology Department. Drs Furth was then a research student in the lab and Drs Aylon is a staff scientist in Prof Oren’s team. The two wrote a review of research delving into the role of LATS in cancer and became so captivated with these genes that Prof Oren encouraged them to serve as joint principal investigators of an in-depth study on this topic. Both LATS genes are known to be expressed at lower-than-normal levels in many breast cancer tumors. Drs Furth and Aylon, together with colleagues, designed a study aimed at clarifying exactly how low expression levels of LATS1 or LATS2 facilitate the development of breast cancer and, on a more general level, how disruptions in the Hippo pathway lead to malignancy. Lacking LATS The researchers started out with a bioinformatics analysis: analyzing databases of gene expression in breast cancer using computer algorithms. Next, they genetically engineered two groups of tumor-disposed mice – one lacking the LATS1 gene, the other lacking LATS2 – and waited for these mice to develop mammary tumors. The scientists then performed a gene expression analysis of tumors in the two groups, comparing them to tumors harboring intact copies of both LATS1 and LATS2. In addition, in collaboration with researchers from the University of Athens, they examined the distribution of LATS proteins in tumors from breast cancer patients. As reported in the journal Life Science Alliance, these studies confirmed that both LATS genes are tumor suppressors. These genes provide cells with an additional layer of protection on top of p53 to prevent the cells from turning cancerous – something like an emergency hand brake in a car in addition to the foot-operated one. This finding helps explain why a malignancy can develop despite the normal activity of p53: Certain defects in the LATS could disrupt regulation of the main tumor-suppressor gene. Most important, the study also revealed that, despite looking very similar, LATS1 and LATS2 play different roles in protecting the organism against breast cancer; malfunctions in one or the other lead to different cancer types. “Breast cancer is a general term, it covers different types of malignancy that can be regarded as entirely different diseases,” says Furth. When the activity of LATS1 is deficient or absent, the result is a type of cancer resembling a subtype of human breast cancer called basal-like. Such tumors tend to be more aggressive and don’t respond to hormonal treatment. In contrast, absence of LATS2 results in tumors resembling a subtype of human breast cancer called luminal. Luminal tumors are dependent on estrogen and respond well to such estrogen-blocking drugs as tamoxifen. Furthermore, the researchers identified other genes, within the framework of the Hippo pathway and beyond, that contribute to malignancy characterized by reduced activity of LATS. In particular, they discovered that low levels of LATS2 expression lead to a metabolic rewiring of the cell, causing it to become highly dependent on the glucose that supplies the cancer with energy. When they genetically engineered breast cancer cells to increase LATS2 expression and exposed them to rosiglitazone – an antidiabetic drug that alters glucose metabolism – these cells often died.   “We hope that by understanding alterations that occur during cancer development, such as decreased expression of LATS genes, we might discover an Achilles heel of breast tumors,” Aylon says. Understanding which patients may benefit If these findings are supported by further research, they may improve the treatment of breast cancer by facilitating a personalized approach. Currently, the decision to administer hormone therapy relies mainly on checking whether tumor cells have estrogen receptors. A genetic analysis determining whether a tumor has reduced LATS1 or LATS2 activity might provide a more precise measure, helping to select patients who are likely to benefit from hormone therapy and sparing unnecessary treatment for those who are not. Moreover, the discovery that tumors with reduced LATS2 activity are critically dependent on glucose may help develop new treatment options against breast cancer and other malignancies characterized by increased glucose metabolism. The Weizmann Institute of Science in Rehovot, Israel, is multidisciplinary research institutions.       ]]> https://biospectrumindia.com/news/57/14022/storm-therapeutics-appoints-dr-john-haurum-on-board.html https://biospectrumindia.com/news/57/14022/storm-therapeutics-appoints-dr-john-haurum-on-board.html Thu, 27 Jun 2019 13:20:00 +0530 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics has announced the appointment of Dr John Haurum as an independent Non-Executive Director with immediate effect. Dr Haurum has over 20 years' experience in the international biotech industry. Previously John was Chief Executive Officer of F-star, a clinical-stage biopharmaceutical company pioneering the development of novel bispecific antibodies, with multiple strategic collaborations with AbbVie, Merck KGaA, Denali and Boehringer Ingelheim. Prior to F-star, Dr Haurum was VP Research at ImClone Systems, and was previously CSO and Co-Founder of Symphogen. He is currently Executive Chairman of the Board at Synklino, Chairman of the Board of Agomab and is on the board of NeoPhore and Synact Pharma ApS. Dr Haurum has a Medical Degree and MSc in Immunology from AarhusUniversity, and a DPhil in Immunology from the University of Oxford. ]]> https://biospectrumindia.com/news/57/14021/gilead-partners-with-louisiana-health-dept-to-eliminate-hepatitis-c.html https://biospectrumindia.com/news/57/14021/gilead-partners-with-louisiana-health-dept-to-eliminate-hepatitis-c.html Thu, 27 Jun 2019 12:55:00 +0530 Governor John Bel Edwards joined Secretary Rebekah Gee of the Louisiana Department of Health, Secretary James LeBlancof the Louisiana Department of Corrections, and Asegua Therapeutics LLC, a wholly-owned subsidiary of Gilead Sciences, Inc., to announce a deal that will allow the implementation of an innovative payment model for hepatitis C treatment, part of Louisiana’s plan to eliminate the disease.  “This new model has the potential to save many lives and improve the health of our citizens. It is an important day for our state, for our partner Asegua Therapeutics, for providers, but most importantly for the patients and their families who will benefit from treatment,” said Governor Edwards. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this five year partnership. Ultimately, our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”  “An elimination plan and innovative payment model will ensure that we can cure this deadly disease and prevent long-term illness and disability in those who have it,” said Dr. Rebekah Gee, secretary of the Louisiana Department of Health. “The Department of Health’s goal is to treat at least 31,000 people by the end of 2024 and eventually eliminate this disease.” After extensive research and work with policy experts across the nation, the Department of Health released a solicitation of offers in January of 2019 in search of a pharmaceutical company willing to partner with Louisiana on a subscription model. Asegua Therapeutics was announced as the selected partner in April, and through subsequent discussions the parties have agreed to a modified model. The innovative payment model for Louisiana addresses the needs of patients and joins the goals of both Louisiana and Asegua to extend a cure to those in need. “This partnership will have a direct and immediate impact on the most vulnerable populations with hepatitis C – people who are on Medicaidor who receive care through the state corrections system. These populations are disproportionately affected by hepatitis C and often face the greatest difficulty in accessing care,” said Gregg Alton, Chief Patient Officer at Gilead Sciences. “We are committed to supporting efforts to eliminate hepatitis C in communities around the world and are excited to partner with the visionary leaders in Louisiana to make this public health opportunity a reality in this state.” The innovative payment model allows the state to purchase an unlimited amount of Asegua’s direct-acting antiviral medication, the authorized generic of Epclusa® (sofosbuvir/velpatasvir) to treat patients within Louisiana’s Medicaid and Department of Corrections populations and caps the State’s medication costs. The Department of Health and Asegua completed and signed a formal contract for the purchase of Asegua’s hepatitis C medication, the authorized generic of Epclusa, over five years, and for people enrolled in the Medicaid program and incarcerated people in Louisiana. The Department of Health continues to implement an elimination plan that engages partners across the state to educate the public on the availability of a cure and reach out to high-risk populations for screenings; connect people living with hepatitis C to care; expand provider capacity; and establish partnership across the state to eliminate hepatitis C in Louisiana. ]]> https://biospectrumindia.com/news/57/14020/mammaprint-becomes-the-only-molecular-diagnostic-recommended-for-early-stage-node-positive-breast-cancer-patients.html https://biospectrumindia.com/news/57/14020/mammaprint-becomes-the-only-molecular-diagnostic-recommended-for-early-stage-node-positive-breast-cancer-patients.html Thu, 27 Jun 2019 11:40:00 +0530 Agendia, a world leader in precision oncology has announced that its MammaPrint Breast Cancer Risk-of-Recurrence Test is the only molecular diagnostic indicated for use with patients who have breast cancer that has spread to their lymph nodes according to the updated Cancer Care Ontario Guidelines. The guidelines, which also recommend the test for select patients with node-negative breast cancer, are endorsed by the American Society of Clinical Oncology (ASCO). The microarray technology-based MammaPrint, which has extensive clinical validation, uses the proprietary, 70-gene expression profile to classify patients with breast cancer as having a “low” or “high” risk of recurrence over a period of 10 years. Oncologists and breast surgeons use the information provided by MammaPrint to help guide overall treatment strategy for patients diagnosed with early stage breast cancer. The guidelines by Cancer Care Ontario, a governmental agency of the province that is responsible for improving cancer services for residents across the territory, recommend MammaPrint for patients with ER/PR-positive, HER2-negative breast cancer who are also considered high clinical risk for recurrence. Patients can either be negative for lymph node involvement or positive with one to three lymph nodes positive for metastases. MammaPrint can help patients and their doctors determine whether adjuvant systemic chemotherapy should be part of their treatment regimen. “We know that cancer often does not remain localized to a specific part of the body. It can easily spread, especially through the lymph nodes, but that does not always mean that the patient is going to benefit from adjuvant systemic chemotherapy,” said William Audeh, MD, Medical Oncologist and Agendia Chief Medical Officer. “Unfortunately, due to a lack of adherence to clinical guidelines, clinicians have used genomic assays that are not validated for patients with lymph node-positive breast cancer to help make decisions about the most beneficial treatment approach. We are pleased that the new guidelines now provide access to both centralized microarray and local next-generation sequencing platforms for Canadian patients and healthcare providers, and that the agency recognizes that MammaPrint is the only assay with enough evidence to be used in such a high-risk group of patients.” The guidelines were also published by ASCO and build upon 2016 recommendations for the use of MammaPrint. Agendia is a privately-held, leading precision oncology company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. The company’s offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology. The MammaPrint BluePrint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world. In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years. The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines. ]]> https://biospectrumindia.com/news/57/14018/fda-approves-first-treatment-for-chronic-rhinosinusitis-with-nasal-polyp.html https://biospectrumindia.com/news/57/14018/fda-approves-first-treatment-for-chronic-rhinosinusitis-with-nasal-polyp.html Thu, 27 Jun 2019 10:55:00 +0530 The U.S. Food and Drug Administration has approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps. Dupixent is given by injection. The efficacy and safety of Dupixent were established in two studies with 724 patients, 18 years and older with chronic rhinosinusitis with nasal polyps who were symptomatic despite taking intranasal corticosteroids. Patients who received Dupixent had statistically significant reductions in their nasal polyp size and nasal congestion compared to the placebo group. Patients taking Dupixent also reported an increased ability to smell and required less nasal polyp surgery and oral steroids. Dupixent was originally approved in 2017 for patients 12 and older with eczema that is not controlled adequately by topical therapies or when those therapies are not advisable. In 2018, Dupixent was approved as an add-on maintenance treatment for patients 12 years and older with moderate-to-severe eosinophilic asthma or with oral corticosteroid-dependent asthma. The FDA granted this application Priority Review. The approval of Dupixent was granted to Regeneron Pharmaceuticals. ]]> https://biospectrumindia.com/news/57/14016/abbvie-to-acquire-allergan-in-a-deal-worth-63b.html https://biospectrumindia.com/news/57/14016/abbvie-to-acquire-allergan-in-a-deal-worth-63b.html Wed, 26 Jun 2019 18:20:00 +0530 AbbVie and Allergan has announced that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie’s common stock of $78.45 on June 24, 2019. “This is a transformational transaction for both companies and achieves unique and complementary strategic objectives,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. “The combination of AbbVie and Allergan increases our ability to continue to deliver on our mission to patients and shareholders. With our enhanced growth platform to fuel industry-leading growth, this strategy allows us to diversify AbbVie’s business while sustaining our focus on innovative science and the advancement of our industry-leading pipeline well into the future.” “This acquisition creates compelling value for Allergan’s stakeholders, including our customers, patients and shareholders. With 2019 annual combined revenue of approximately $48 billion, scale in more than 175 countries, an industry-leading R&D pipeline and robust cash flows, our combined company will have the opportunity to make even bigger contributions to global health than either can alone,” said Brent Saunders, chairman and chief executive officer, Allergan. “Our fast-growing therapeutic areas, including our world-class medical aesthetics, eye care, CNS and gastrointestinal businesses, will enhance AbbVie’s strong growth platform and create substantial value for shareholders of both companies.” Major highlights: Provides immediate scale and profitability to AbbVie’s growth platform, excluding Humira, significantly expanding and diversifying its revenue base with new therapeutic areas, including Allergan’s leading medical aesthetic business Enhances long-term R&D funding capacity, allowing for continued investment and sustained focus on innovative science and advancement of an industry-leading pipeline Increases global commercial scale to further maximize the value of Allergan’s attractive portfolio of fastgrowing products  Combined company will produce robust cash flow to support continued dividend growth, further investment in the pipeline and reduction of debt levels Transaction delivers significant and immediate accretion and provides an attractive return on invested capital Creates substantial value for shareholders of both companies and is expected to close in early 2020 Allergan Shareholders will receive 0.8660 AbbVie Shares and $120.30 in cash for each Allergan Share, for a total consideration of $188.24 per Allergan Share  Transaction equity value of approximately $63 billion ]]> https://biospectrumindia.com/news/57/14014/elios-therapeutics-appoints-phillip-johnson-as-cfo.html https://biospectrumindia.com/news/57/14014/elios-therapeutics-appoints-phillip-johnson-as-cfo.html Wed, 26 Jun 2019 17:50:00 +0530 Elios Therapeutics, a biopharmaceutical company developing innovative autologous, particle-delivered, dendritic cell cancer vaccines, today announced the appointment of Phillip Johnson as chief financial officer, effective immediately. Mr. Johnson brings more than 25 years of financial and operational leadership experience in both publicly traded and private companies. "We are delighted to welcome Phil to Elios," said Buddy Long, chief executive officer of Elios Therapeutics. "Phil is a seasoned healthcare and financial executive with a distinguished track record of building commercial opportunities, raising capital and negotiating business development transactions. His range of industry expertise and leadership skills will serve us well as we advance our leading personalized therapeutic cancer vaccine, TLPLDC (tumor lysate, particle-loaded, dendritic cell vaccine), through clinical trials and into commercialization for the prevention of disease recurrence in patients with high-risk melanoma." "I am thrilled to join Elios Therapeutics at this exciting time in the Company's growth and development," said Phillip Johnson. "Elios has a truly innovative immuno-oncology platform with potential applicability across a broad range of tumor types. I look forward to working with the management team to advance the program and further Elios' mission of developing next-generation immunotherapies that may make a meaningful difference in the lives of patients, caregivers and physicians." Mr. Johnson joins Elios after having served as an executive and consultant for a number of publicly traded, privately held, private equity and pre-IPO companies, developing strategy and leading efforts to support fundraising, acquisitions, deal structures, growing finance functions, and improving working capital. Over the course of his career, Mr. Johnson has provided companies with more than $850M in debt and equity financing to provide sound financial footing and substantial growth – including the development of corporate environments that have delivered shareholder returns ranging from 50 to 1,700 percent. Prior to consulting, Mr. Johnson served as chief financial officer for Xeris Pharmaceuticals where he raised $65M in equity capital in Series B and C financings. Prior to Xeris, Mr. Johnson was vice president and corporate controller at ArthroCare Corporation, a publicly traded private equity backed medical device company. During his tenure at ArthoCare, Mr. Johnson helped lead the financial reengineering activities that helped increase the Company's market capital from $100M to $1.7B before it was acquired in May 2014. Earlier in his career, he served in several key finance and leadership roles at Maverick Tube Corporation, SAVI, LLC and Primary Webworks and completed two commissions with Arthur Andersen and KPMG. Mr. Johnson is a certified public accountant and holds a Bachelor of Arts in Accounting from Furman University.     ]]> https://biospectrumindia.com/news/57/14007/cobra-biologics-symbiosis-complete-4-8m-viral-vector-supply-chain-collaboration.html https://biospectrumindia.com/news/57/14007/cobra-biologics-symbiosis-complete-4-8m-viral-vector-supply-chain-collaboration.html Wed, 26 Jun 2019 10:50:00 +0530 Cobra Biologics, an international contract development and manufacturing organisation (CDMO) focused on viral vector drug substance production, and Symbiosis Pharmaceutical Services (Symbiosis), a contract manufacturing organisation (CMO) specialising in the sterile manufacture of injectable viral vector drug products, today announced the successful completion of their collaboration to develop synergistic and world-leading capabilities. Intended to accelerate the clinical and commercial production of viral vectors, which represent part of the burgeoning Advanced Therapeutics Medicinal Product (ATMP) drug development space and the frontier of personalised medicine, the 18-month joint project saw a combined investment of £4.8m including significant support from a grant received under the UK Governments’ Innovate UK Health and Life Sciences Programme. The collaboration significantly increases both companies’ existing commercial capacity and simplifies the supply chain process for manufacture of viral vectors for use in gene therapy and immunotherapy. By aligning the technical expertise and manufacturing capabilities of Cobra and Symbiosis, the complexity, time and risk of viral vector manufacturing projects will be greatly reduced meaning that customer companies developing viral vector ATMPs can derive their own competitive value from accelerating their progression along the drug development critical path. As a result of the subsequent simplification and enhanced efficiency of the viral vector supply chain, Cobra and Symbiosis can support new and existing customers’ clinical and commercial ambitions to deliver a growing number of innovative cell and gene therapy medicines to market and to the patients most in need of their therapeutic benefits. Peter Coleman, Chief Executive at Cobra Biologics, said: “The Innovate UK grant has enabled Cobra and Symbiosis to form a close partnership to provide a seamless viral vector service to the global community for both clinical and commercial supply. In conjunction with Symbiosis, we have now helped to establish the UK as world leader in this exciting field.” Colin MacKay, Chief Executive of Symbiosis, added: “The strategic focus of Innovate UK in proactively supporting the development of a supply chain which aligns multiple service providers – such as Symbiosis and Cobra - to specifically enhance their joint means to facilitate the development of viral vectors and other ATMPs here in the UK is not only astute but will generate tangible value which will benefit the UK, the CDMOs receiving grants alongside their respective clients, and ultimately the patients most in need of those innovative medicines. “The relationship that Symbiosis and Cobra have forged during this grant collaboration project represents an excellent foundation for both companies to strengthen their aligned ability to develop world class personalised medicines more quickly for shared clients from around the world.” Cobra Biologics is a leading international contract development and manufacturing organisation (CDMO) providing biologics and pharmaceuticals for pre-clinical, clinical and commercial supply. Cobra has two GMP approved facilities in Sweden and the UK, each with expertise tailored to serving our customers around the world. We offer a broad range of integrated and stand-alone contract development and manufacturing services for clinical trials and the commercial market. As a trusted provider and a key partner in the drug development and commercialisation process, we take pride in our manufacturing excellence and a comprehensive range of services to the pharmaceutical and biotech industries. Symbiosis Pharmaceutical Services (Symbiosis) is a CMO established in 2011 in response to an increasing global demand for niche, sterile manufacturing specialists that could satisfy product supply needs for clinical trials. The company created its purpose-built facility in Stirling, Scotland, specifically designed with biologic and small molecule production capabilities in mind to support biotech and speciality pharmaceutical companies worldwide that require small-scale injectable products. Manufacturing capability takes place within an MHRA-licensed facility, which enables the team at Symbiosis to fill bulk volumes up to 100 litres, including products that require aseptic liquid filling and lyophilisation. Regulatory compliance, technical capability and operational flexibility are core to Symbiosis’ offerings and direct access to the best people who deliver projects on time is what its clients demand and receive every day. ]]> https://biospectrumindia.com/news/57/14000/usfda-accepts-gsks-application-for-zejula-niraparib-in-late-stage-ovarian-cancer-.html https://biospectrumindia.com/news/57/14000/usfda-accepts-gsks-application-for-zejula-niraparib-in-late-stage-ovarian-cancer-.html Tue, 25 Jun 2019 12:50:00 +0530 GlaxoSmithKline has announced that TESARO, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA) to the USFDA for ZEJULA (niraparib). The application was granted priority review and has an action date of 24 October 2019. The sNDA supports a potential new indication for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either BRCA mutation or Homologous recombination deficiency (HRD) and have progressed more than six months after the last platinum-based chemotherapy. Mary Lynne Hedley, President and Chief Operating Officer of TESARO, said, “The results of the QUADRA study demonstrate that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with ZEJULA.” Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “We know ZEJULA plays an important role in helping women with ovarian cancer whose disease has progressed despite initial therapy. Our hope is that over time, our ongoing clinical trials will demonstrate that this medicine can benefit even more patients.” The niraparib sNDA is supported by data from the QUADRA trial. Data from the QUADRA trial were recently published in Lancet Oncology. QUADRA is a large multicenter, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients with relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were treated with three or more previous chemotherapy regimens. Patients received oral niraparib 300 mg once daily continuously until disease progression. The primary objective was the proportion of patients achieving an investigator-assessed confirmed overall response in patients with homologous recombination deficiency (HRD)-positive tumours (including patients with BRCA and without BRCA mutations) sensitive to their last platinum-based therapy. Additional objectives of the study was to evaluate the efficacy of niraparib in the broad late-line ovarian cancer population overall, and in subgroups defined by clinical and molecular biomarkers, such as platinum-sensitivity and BRCAmut and HRD status.” Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer.   ]]> https://biospectrumindia.com/news/57/13999/who-unveils-multi-partner-trust-fund-to-combat-amr.html https://biospectrumindia.com/news/57/13999/who-unveils-multi-partner-trust-fund-to-combat-amr.html Tue, 25 Jun 2019 12:40:00 +0530 In a major boost to combat one of the gravest risks to global health a funding vehicle allowing partners to devote resources to accelerate global action against Antimicrobial Resistance (AMR) was unveiled recently by WHO at a Ministerial Conference. The Tripartite – a joint effort by the Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE) and the World Health Organization (WHO), launched the AMR Multi-Partner Trust Fund, which is being supported by an initial contribution of US$5 million from the Government of the Netherlands. The AMR Trust Fund has a five-year scope, through 2024, and aims to scale up efforts to support countries to counter the immediate threat of AMR, arguably the most complex threat to global health. Antimicrobial resistance refers to the natural ability of bacteria and other microbes to develop resistance to the medicines we use to treat them, and the process is accelerated by inappropriate or excessive use of pharmaceutical products designed to kill unwanted pathogens in humans, animals and crops. In particular, the overuse and misuse of antibiotics in human and animal health is fueling resistance.   The rise of AMR, poses a threat described as a “silent tsunami”.   Drug-resistant microorganisms now account for an estimated 700,000 deaths a year, a figure that could increase to 10 million deaths each year if no action is taken.   Bruno Bruins, Netherlands Medical Care and Sports Minister said, “Combating antibiotics resistance is fundamentally a behaviour change issue. I’m not talking about washing hands more often, but about ensuring antibiotics are prescribed less readily and that work methods are changed to reduce the chance of resistant bacteria spreading. This topic is so important that it deserves to stay at the top of the international political agenda. Countries have made outstanding plans and it’s time now to carry them out. The Multi-Partner Trust Fund that we’re launching today will help us do this because the problem is too big for countries to tackle alone.” Carola Schouten, the Netherlands Minister of Agriculture, Nature and Food Quality said, “Unfortunately, borders don’t stop bacteria. But by pooling our efforts and knowledge, we can help each other combat AMR. There’s still scope for improving the way antibiotics are used in livestock production, too. This conference is an excellent opportunity to engage in dialogue and learn from each other.” OIE Director General, Dr Monique Eloit said, “We all have a role to play to protect the efficacy of antimicrobial agents and the AMR Trust Fund gives us the opportunity to support the efforts of the different sectors at national, regional and global levels. AMR must be addressed in a One Health approach and supported by long-term commitments from all stakeholders. The OIE is committed to supporting the animal health sector in fulfilling its commitments to ensure that both animals and humans will continue to benefit from available and efficient antimicrobials to treat their diseases for the future. FAO Deputy-Director General, Climate and Natural Resources Maria Helena Semedo said, “FAO is fully dedicated to help eliminate hunger, food insecurity and malnutrition and dedicated to produce safe food for a growing world population in a sustainable way. Antimicrobials are necessary tools to ensure food security, but they need to be used in a responsible way. FAO considers the Multi Partner Trust Fund as a milestone in our Tripartite efforts to reduce AMR.” Dr Zsuzsanna Jakab, Deputy Director-General, WHO said, “This new Trust Fund signals an important new commitment to combat antimicrobial resistance. AMR is a serious challenge to reaching universal health coverage and a threat to achievement of the Sustainable Development Goals.” The immediate funding appeal is for US$70 million, to be used to support countries and the implementation of the Tripartite’s AMR Workplan 2019-2020, particularly in providing technical support to countries designing National Action Plans on AMR and to scale up local action. Prominent among the AMR Trust Fund’s ultimate desired outcomes is a world where infectious diseases can continue to be treated with effective and safe antimicrobials and one in which resistance is monitored and controlled at a slower pace. The pathway to that success entails activities ranging from awareness raising and the drafting of national action plans to surveillance of AMR trends and better ensuring responsible antimicrobial sales and use patterns. Inaction, due to policy or implementation inadequacies, threatens to make common infections more difficult to treat and lifesaving medical procedures and treatments riskier to perform.   Inaction could also raise food insecurity and rural poverty, when animal illnesses can no longer be effectively treated using veterinary medicines. The AMR Trust Fund provides a joint mechanism for clear attribution and transparency of all sources of finance, while its activities will be based on the application of best practices, scaling up activities that have worked and innovative approaches to ensure that today’s cures are available for future generations. ]]> https://biospectrumindia.com/news/57/13998/gilead-carna-biosciences-announce-rd-collaboration.html https://biospectrumindia.com/news/57/13998/gilead-carna-biosciences-announce-rd-collaboration.html Tue, 25 Jun 2019 12:25:00 +0530 US headquartered Gilead Sciences and Japan based Carna Biosciences has announced that the companies have entered into a research and development collaboration to develop and commercialize small molecule compounds in immuno-oncology and to access Carna’s proprietary lipid kinase drug discovery platform. Under the terms of the license agreement, Gilead will license from Carna worldwide rights to develop and commercialize inhibitors against an undisclosed immuno-oncology target. In connection with this agreement, Carna will receive an upfront payment of $20 million and is eligible to receive up to an additional $450 million in potential milestone payments upon achievement of certain development and commercial milestones. Carna will also receive royalties on future net sales. "We are delighted to partner with Gilead on our immuno-oncology pipeline targeting the lipid signaling pathway, as we believe modulators of lipid signaling have the potential to become the next generation of cancer immunotherapies,” said Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences. Under the collaboration, Gilead will also have exclusive access to Carna’s proprietary lipid kinase drug discovery platform. “We are excited to work with Gilead, a biopharmaceutical company known for its science-driven innovation and productivity,” said Kohichiro Yoshino, Ph.D., President and Chief Executive Officer at Carna Biosciences. “We are proud that our drug discovery support team can also help the development of potentially innovative cancer immunotherapies at Gilead by utilizing Carna’s proprietary kinase drug discovery technology platform.” “Gilead is committed to building a pipeline in immuno-oncology with a focus on opportunities with the potential to be first-in-class or to be meaningfully differentiated from other therapeutic options,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development at Gilead Sciences. “Our Carna collaboration also reflects this strategy and we look forward to working with the Carna team to advance novel immunotherapies into clinical testing for the potential benefit of patients.” ]]> https://biospectrumindia.com/news/57/13996/north-america-europe-to-account-for-over-65-revenue-share-through-2028-says-a-market-study-of-automated-esr-analyzer.html https://biospectrumindia.com/news/57/13996/north-america-europe-to-account-for-over-65-revenue-share-through-2028-says-a-market-study-of-automated-esr-analyzer.html Tue, 25 Jun 2019 12:05:00 +0530 A new research report projects that the global revenue of automated ESR analyzer market will account for revenues roughly equating US$ 495 Mn by the end of 2028. The rising prevalence of infectious diseases, advancements in technology, increasing healthcare spending, and growing elderly population susceptible to infections and diseases are some of the major factors responsible for driving the demand for automated ESR analyzers. The report has envisaged nearly 5.3% CAGR for the revenue growth of the automated ESR analyzer market during 2018-2028. However, certain factors, such as the lack of skilled professionals and the absence of streamlined laws in developing regions continue to hamper the growth of the automated ESR analyzer market. Fully automated ESR analyzers segment will hold a prominent share in the global automated ESR analyzer market revenue. Portable automated ESR analyzers are likely to remain highly preferred over benchtop variants in the automated ESR analyzer market. Hospitals and diagnostic laboratories are estimated to hold maximum revenue share in the automated ESR analyzer market, in terms of adoption North America automated ESR analyzer market and the Europe automated ESR analyzer market are expected to collectively hold a share of over 65% of the global automated ESR analyzer market during the forecast period. This can be primarily attributed to the adoption of highly advanced technology and the consolidation of healthcare facilities in these regions. Several regulatory bodies and governments of various countries, especially developed economies, are adopting numerous cost-containment measures to reduce their healthcare burden. Technological advancements are paving the way for the development of automated ESR analyzers from manual ESR analyzers, which is driving the global automated ESR analyzer market. Growing availability of automated ESR analyzers with advanced and innovative technology has been boosting the laboratory workflow, in addition to improving the turnaround time, which is another strong factor pushing adoption of automated ESR analyzers at a global level. Associated with the symptoms of an active form of cancers, it is highly likely that the demand for automated ESR analyzers will experience a constant high with the rapid increasing in prevalence of cancers. Moreover, automated ESR analyzers will also continue to receive strong demand owing to conditions such as inflammation, collagen vascular disease, infection, blood disease, diabetes, and heart disease. However, due to negative results, people are becoming inclined toward alternative options, such as C-reactive protein, which provide a better indicator of inflammation as compared to ESR. The slow response of ESR to the acute phase reaction leads to early false negatives in an inflammatory process. In the US, around more than 100,000 deaths per year can be attributed to adverse drug reactions. The adverse and negative results of ESR owing to the effect of the consumption of certain drugs during the treatment, such as vitamin A, oral contraceptives, aspirin, and cortisone, makes automated ESR analyzers less desirable, and this is expected to hinder the growth of the global automated ESR analyzer market. Some of the key players of the automated ESR analyzer market are Streck, Inc., Alifax Holding S.p.A., RR Mechatronics, Greiner Group (Greiner Bio One International GmbH), ALCOR Scientific Inc., Diesse Diagnostica Senese Spa, ELITechGroup, Beijing Succeeder Technology Inc., and SFRI Medical Diagnostics. These insights are based on a report on Automated ESR Analyzer Market by Persistence Market Research   ]]> https://biospectrumindia.com/news/57/13990/glenmark-novartis-to-promote-respiratory-products-in-brazil.html https://biospectrumindia.com/news/57/13990/glenmark-novartis-to-promote-respiratory-products-in-brazil.html Mon, 24 Jun 2019 12:55:00 +0530 Glenmark has announced that its Brazilian subsidiary, Glenmark Farmacêutica Ltda has entered into an exclusive partnership agreement with Novartis Biosciences S.A, a subsidiary of Novartis AG, for three respiratory products indicated towards treatment of the symptoms of chronic obstructive pulmonary disease (COPD) in Brazil. This agreement will be effective from July 01, 2019 onwards. The products involved in the agreement are Seebri® (Glycopyrronium bromide), Onbrize® (Indacaterol) and Ultibro® (combination of Indacaterol and Glycopyrronium), which are indicated for relief of symptoms in adults with COPD. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals said, “We are pleased to partner with Novartis in Brazil. This arrangement with a leading global pharmaceutical company will strengthen our respiratory franchise in Brazil. This partnership is in line with our vision to expand our respiratory product offerings for patients and prescribers in Brazil and further consolidate our position in this segment.” Under the terms of the agreement, Novartis remains the holder of the registration of these medicines and will be responsible to manufacture them with all technical excellence in line with its global commitment to quality, effectiveness and safety. Glenmark will be responsible for promoting, commercializing and distributing of these products in Brazil. ]]> https://biospectrumindia.com/news/57/13987/ec-approves-pfizers-talzenna-.html https://biospectrumindia.com/news/57/13987/ec-approves-pfizers-talzenna-.html Mon, 24 Jun 2019 11:45:00 +0530 Pfizer has announced that the European Commission approved TALZENNA  (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. This approval follows the medicine’s approval by the U.S. Food and Drug Administration (FDA) in October 2018. “Today’s approval of TALZENNA for certain patients with advanced-stage breast cancer and an inherited BRCA mutation is the latest example of our successful precision medicine approach to drug development,” said Andreas Penk, M.D., Regional President, Oncology International Developed Markets at Pfizer. “This important milestone builds on Pfizer’s decades-long legacy of developing therapies that improve outcomes for patients with breast cancer. We are thrilled that we can now offer these patients in Europe, who are often diagnosed at a younger age and have limited treatment options, an effective, once-daily, alternative treatment to chemotherapy.” The European Commission’s approval of TALZENNA, which was acquired as part of Pfizer’s acquisition of Medivation, is based on results from the EMBRACA trial - the largest Phase 3 study of a PARP inhibitor in gBRCA-mutated, HER2- LA or MBC. The global trial evaluated once-daily TALZENNA compared to physician’s choice standard chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine) in patients with an inherited BRCA1/2 mutation in triple-negative or HR+/HER2- LA or MBC who may have received up to three prior cytotoxic chemotherapy regimens for their advanced disease. The primary endpoint was progression-free survival (PFS), as assessed by blinded independent central review (BICR).1,2 “In the EMBRACA trial, TALZENNA reduced the risk of disease progression by 46 percent and more than doubled the overall response rate compared to chemotherapy,” said Johannes Ettl, M.D., Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich in Germany and an investigator in the EMBRACA trial. “This improvement in outcomes for patients treated with TALZENNA reinforces the increasingly key role of genetic testing in treatment decision-making for patients with locally advanced or metastatic breast cancer.” In the EMBRACA trial, TALZENNA significantly outperformed chemotherapy, extending median PFS to 8.6 months compared to 5.6 months for those treated with standard chemotherapy [95% CI: 7.2-9.3 vs. 4.2-6.7, respectively]. The superior PFS benefit with TALZENNA was observed across prespecified patient populations, including patients with triple-negative breast cancer, HR+/HER2- disease, with or without a history of CNS metastasis, and those who received prior cytotoxic chemotherapy regimens. Secondary endpoints from the EMBRACA trial included objective response rate (ORR), overall survival (OS) and safety. TALZENNA demonstrated an ORR of 62.6% (95% CI: 55.8-69.0), more than double that in the standard chemotherapy arm (27.2%) (95% CI: 19.3-36.3). OS is an event-driven endpoint and the data are not yet mature.1 Based on pooled data from patients who received 1 mg TALZENNA in clinical studies for solid tumors, the most common adverse reactions (≥ 25%) of patients receiving TALZENNA were fatigue (57.1%), anemia (49.6%), nausea (44.3%), neutropenia (30.2%), thrombocytopenia (29.6%) and headache (26.5%). Grade 3 or higher adverse reactions (≥ 10%) in patients treated with TALZENNA were anemia (35.2%), neutropenia (17.4%) and thrombocytopenia (16.8%).   ]]> https://biospectrumindia.com/news/57/13985/canon-medical-showcases-new-ultrasound-product-line-at-ase-2019.html https://biospectrumindia.com/news/57/13985/canon-medical-showcases-new-ultrasound-product-line-at-ase-2019.html Mon, 24 Jun 2019 11:30:00 +0530 Canon Medical Systems USA, Inc. is showcasing its innovative new line of ultrasound systems, the Aplio a-series, at this year’s American Society of Echocardiography (ASE) annual meeting. The new platform delivers high performance in cardiac imaging, among a full host of clinical uses, at an affordable price point. Among its broad range of capabilities, the Aplio a-series, which includes the a550 and a450, was designed with the imaging, ergonomics and workflow capabilities of Canon Medical’s premium ultrasound systems in mind, including its unique a-Beam technology to deliver high-definition images and advanced penetration to enable cardiologists to see more for quick and reliable diagnoses. Additional details on the platform include: High-end image quality that seamlessly integrates into workflow for a wide range of everyday imaging needs, including high-resolution 2D imaging with depth and detail for challenging scanning situations. Support for sonographers’ health with intuitive controls for easy operation and stress-free ergonomics for various patient exams with help from Canon Medical’s Healthy Sonographer Program – a CME accredited training and web support offering. Wide range of qualitative and quantitative tools thanks to iSense technology which enables easy operation and more objective, reproducible results. Advanced applications like AutoEF and Strain Imaging (Wall Motion Tracking), available on the Aplio a550, provide clinicians with the ability to meet a broad range of clinical needs. “With our customers and patients in mind, we designed the Aplio a-series by integrating industry-leading imaging technologies, advanced applications and intuitive controls all at an affordable price point,” said Dan Skyba, director, Ultrasound Business Unit, Canon Medical Systems USA, Inc. “The platform offers a complete solution that delivers diagnostic confidence over a wide range of cardiovascular imaging needs, empowering cardiologists to easily perform both routine and complicated imaging exams to advance patient care.” The Aplio a-series is part of Canon Medical’s suite of Collaborative Imaging tools which puts integrated imaging intelligence at the center of a patient’s journey. The initiative fuses multiple diagnostic imaging modalities with leading clinical applications to deliver holistic, optimized patient information to clinicians at the point of care. Canon Medical Systems is showcasing the new Aplio a-series ultrasound systems at this year’s American Society of Echocardiography (ASE) 2019 annual meeting in Orlando, Fla., June 21 – 25, 2019. ]]> https://biospectrumindia.com/news/57/13983/fda-approves-vertexs-symdeko.html https://biospectrumindia.com/news/57/13983/fda-approves-vertexs-symdeko.html Mon, 24 Jun 2019 11:25:00 +0530 Vertex Pharmaceuticals Incorporated has announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to SYMDEKO. It was previously approved by the FDA for use in patients with cystic fibrosis 12 years and older with two copies of the F508del mutation or one copy of a responsive mutation in the U.S. An additional dosage strength of SYMDEKO tablets is now available (tezacaftor 50 mg/ivacaftor 75 mg and ivacaftor 75 mg) in connection with this approval. “Today’s expanded approval of SYMDEKO in children ages 6 through 11 is an important step in our efforts to continue to bring treatment options to the youngest patients possible and importantly brings us closer to our goal of developing medicines for all people living with CF,” said Reshma Kewalramani, M.D., Executive Vice President and Chief Medical Officer at Vertex. Vertex completed a 24-week Phase 3 open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of tezacaftor/ivacaftor and ivacaftor in children ages 6 through 11 years in the U.S. and Canada. The regimen was generally well tolerated, and safety data were similar to what was observed in previous studies of patients aged 12 years and older. The full data from this study will be published later this year. “We’ve seen the clinical impact of SYMDEKO in people with CF aged 12 years and above, and this approval marks a crucial milestone for patients ages 6 through 11 years who may benefit from CFTR modulation, enabling us to treat the basic defect in CF at an earlier stage of disease,” said Seth Walker, M.D., University Hospitals of Cleveland, Cleveland Medical Center, Rainbow Babies and Children’s Hospital. “SYMDEKO is an important treatment option for eligible people with CF who either never started or have discontinued another CFTR modulator.” SYMDEKO/SYMKEVI (tezacaftor/ivacaftor and ivacaftor) is already approved in the U.S., Canada, Switzerland, Australia and the EU for the treatment of CF in patients ages 12 years and older with certain mutations. Vertex plans to submit an application for the use in patients ages 6 through 11 years in the European Medicines Agency in the second half of 2019. Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people in North America, Europe and Australia. ]]> https://biospectrumindia.com/news/57/13980/ricoh-announces-strategic-business-partnership-with-elixirgen-scientific.html https://biospectrumindia.com/news/57/13980/ricoh-announces-strategic-business-partnership-with-elixirgen-scientific.html Fri, 21 Jun 2019 16:40:00 +0530 Ricoh Company, Ltd., has announced it has entered into a strategic business partnership with Elixirgen Scientific to develop innovative biomedical products and services that support drug discovery based on cell differentiation technology. Ricoh and Elixirgen Scientific plan to grow this biomedical business into a 20-billion-yen ($1.86 billion) business by 2025. Together the two companies will support drug discovery through the manufacture and delivery of cells differentiated from induced pluripotent stem (iPS) cells, cell chips seeded with precisely differentiated cells, and evaluation services for drug responses. As part of the agreement, Ricoh will acquire a 34.5 percent stake in Elixirgen Scientific and launch a biomedical business in North America this year. Elixirgen Scientific owns Quick-Tissue™ technology that can induce iPS cells and embryonic stem cells*5 to various types of cells directly, and this technology achieves highly efficient and homogeneous cell differentiation within just 10 days. It is expected that disease specific iPS cells, which means iPS cells derived from patients with that disease, can be used as a disease model for drug screening. As differentiated cells manufactured in this process have functions close to mature cells*6, those cells show phenotypes specific to that disease very well. Ricoh's bioprinting technology enables precise control of the number and placement of cells using its inkjet head technology, which has been perfected over the last 40 years. Nobuhiro Gemma, Fellow, General Manager of HealthCare Business Group, Ricoh Company, Ltd., stated, “We are thrilled to partner with Elixirgen Scientific on this new biomedical development initiative. By combining the technologies from our two companies, it will be possible to produce disease-specific cell chips derived from multiple iPS cell lines, for example. These cell chips can evaluate the diversity of human responses of chemicals at one time in terms of efficacy and toxicity before moving to the clinical trial stage. In the process of drug discovery, this method using the cell chips will greatly improve the entire drug development process because human diversity is considered in the earliest stage.” Ricoh entered the healthcare market with software and services 12 years ago in order to help address issues arising from an aging society, combined with a corresponding reduction in healthcare expenditure, among other operational efficiencies. Ricoh is focused on addressing social challenges, such as those relating to the disparity in the level of healthcare available in different parts of the world. In the area of healthcare, Ricoh focuses on three disciplines: healthcare solutions, medical imaging, and biomedical. “Ricoh has an established healthcare business with solutions such as its RICOH Regional Health Net; and in the medical imaging area, with its magnetoencephalography solution. We have also been developing technologies such as 3D Bioprinter and reference DNA plates, and with today's announcement, this agreement establishes Ricoh firmly as a player in the biomedical field,” added Nobuhiro Gemma. ]]> https://biospectrumindia.com/news/57/13978/regeneron-sanofi-announce-positive-results-for-il-33-antibody-for-asthma.html https://biospectrumindia.com/news/57/13978/regeneron-sanofi-announce-positive-results-for-il-33-antibody-for-asthma.html Fri, 21 Jun 2019 15:35:00 +0530 Regeneron Pharmaceuticals and Sanofi have announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. The trial also met a key secondary endpoint, demonstrating REGN3500 monotherapy significantly improved lung function compared to placebo.  In the trial, the greatest improvement was observed in patients with blood eosinophil levels ≥300 cells/microliter. Patients treated with Dupixent® (dupilumab) monotherapy did numerically better than REGN3500 across all endpoints, although the trial was not powered to show differences between active treatment arms. The combination of REGN3500 and Dupixent also did not demonstrate increased benefit compared to Dupixent monotherapy in this trial. More detailed results will be presented at an upcoming medical meeting. "This trial suggests that REGN3500 may provide an alternative targeted approach for patients suffering from asthma," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "We look forward to working with Sanofi to advance REGN3500 through our asthma clinical trial program, as well as continuing our ongoing trials in atopic dermatitis and chronic obstructive pulmonary disease."   Adverse events (AEs) occurred in 61.6% of patients who received REGN3500, 66.2% of patients receiving both REGN3500 and Dupixent, 56.8% of patients who received Dupixent and 64.9% of patients who received placebo. The incidence of serious AEs and AEs leading to treatment discontinuations was low. Despite standard-of-care treatment with inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) therapy, people with moderate-to-severe asthma often have inadequately controlled, persistent symptoms that may make them suitable for treatment with a biologic therapy. These people live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations. "Asthma is a heterogeneous disease and not everyone experiences it in the same way. Therefore, there is value in evaluating new therapies with distinct and novel mechanisms such as anti-IL-33," said Steve Pascoe, M.D., Head of Immuno-Inflammation Development at Sanofi. "We have ongoing studies for REGN3500 in atopic dermatitis and chronic obstructive pulmonary disease. We will evaluate the results of these studies as well as the findings in asthma to determine the best path forward for this therapy." REGN3500 is a fully-human monoclonal antibody that inhibits interleukin-33 (IL-33), a protein that is believed to play a key role in type 1 and type 2 inflammation. Preclinical research showed REGN3500 blocked several markers of both types of inflammation. In moderate-to-severe asthma, there can be multiple sources of underlying inflammation that new therapies may help address.   ]]> https://biospectrumindia.com/news/57/13974/axovant-yposkesi-collaborate-for-gene-therapy-development.html https://biospectrumindia.com/news/57/13974/axovant-yposkesi-collaborate-for-gene-therapy-development.html Fri, 21 Jun 2019 14:40:00 +0530 Axovant Gene Therapies Ltd., a clinical-stage company developing innovative gene therapies, today announces it has signed a strategic partnership with Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) for preferred access and reserved capacity for cGMP grade viral vector production. Under this strategic collaboration, Yposkesi will provide expertise in process development, technology transfer, manufacturing scale-up, quality control and quality assurance. The ongoing prioritized access for manufacturing resources will support Axovant’s gene therapy programs as they proceed through development and commercialization, with an initial focus on the AAV-based gene therapies.    Yposkesi is the largest European CDMO for gene therapy with capabilities to expand manufacturing for AAV and lentiviral vector production in its current 50,000 ft2 (approx. 5,000 m2) state-of-the-art facility, which houses multiple independent manufacturing suites. By 2021, Yposkesi plans to increase this footprint to 100,000 ft2 (approx. 10,000m2) to expand capacity with additional large-scale bioreactors (1,000 L) to further support growing demand for production. As a spin out from Genethon, a pioneer in the discovery and development of gene therapies, Yposkesi has 25 years of experience in GMP development and manufacturing and a team of over 150 scientific, industrial and technical specialists.  Yposkesi’s current manufacturing processes comply with both European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) manufacturing requirements.   ]]> https://biospectrumindia.com/news/57/13971/pds-biotechnology-corp-gets-u-s-and-european-patents-for-versamune.html https://biospectrumindia.com/news/57/13971/pds-biotechnology-corp-gets-u-s-and-european-patents-for-versamune.html Fri, 21 Jun 2019 12:45:00 +0530 PDS Biotechnology Corporation, a clinical-stage immuno-oncology company pioneering the development of novel multifunctional immunotherapeutic products, today announced that the United States Patent and Trademark Office and the European Patent Office have granted U.S. Patent No. 10,286,064 and European Patent Publication No. 2861245 respectively. The patent includes claims that cover compositions of the immunologically active enantiomer of the cationic lipid R-1,2-dioleoyl-3-trimethyl-ammonium-propane (DOTAP) or its racemic mixture with Granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce the population of myeloid derived suppressor cells within the tumor microenvironment. Dr. Frank Bedu-Addo, PDS Biotechnology’s President and Chief Executive Officer, said: "The award of this patent is a significant milestone for PDS as it provides further protections for our Versamune platform technology and pipeline of Versamune–powered therapeutic candidates, including our lead candidate, PDS0101. The patent adds to our robust portfolio of exclusively-owned international patents that cover the compositions and use of cationic lipids to activate key immunological pathways that facilitate T-cell priming and activation of antigen specific CD8+ T-cells while also reducing the population of immune suppressive regulatory T-cells. A major limitation of T-cell activating immunotherapies in the treatment of cancer is the need to overcome the tumor’s immune-suppressive environment. However, we believe that through our work with the National Cancer Institute we have received additional validation for the use of cationic lipids to activate key immunological signaling pathways that are essential to prime the right phenotype of tumor targeting T-cells in-vivo, while simultaneously making the tumor cells much more susceptible to killing by the primed T-cells.” A portion of the work leading to this invention was carried out with support from the United States Government provided under the National Institutes of Health CRADA No. 2644. Therefore, the United States Government has certain rights in and to the present invention.   ]]> https://biospectrumindia.com/news/57/13969/astrazeneca-nccn-collaborate-for-ovarian-cancer-treatment.html https://biospectrumindia.com/news/57/13969/astrazeneca-nccn-collaborate-for-ovarian-cancer-treatment.html Fri, 21 Jun 2019 11:35:00 +0530 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) is collaborating with AstraZeneca, a global, science-led biopharmaceutical company, to further quality in cancer care for people with advanced ovarian cancer. This follows a recently announced and still active request for proposals, also in collaboration with AstraZeneca, on innovative approaches for improving care in unresectable stage III and IV non-small cell lung cancer.  "Advanced and recurrent ovarian cancer remains a treatment challenge," explained Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "It's currently the deadliest gynecologic cancer, and requires a coordinated, multi-disciplinary approach. With this project, we're looking for research that focuses on how to optimize multiple facets of management effectiveness by harnessing innovative technologies or addressing knowledge gaps." Some areas of particular interest for proposals include: Adhering to standard of care management Delivering care through innovative methods (e.g. telemedicine and/or coordination of care between academic centers and community practices) Improving adoption of appropriate genetic testing Discovering new strategies for sharing and implementing novel findings expeditiously Creating shared decision-making models Improving the use of supportive services Utilizing technology to enhance quality of life in patients ]]> https://biospectrumindia.com/news/57/13968/optum-completes-acquisition-of-davita-medical-group-from-davita.html https://biospectrumindia.com/news/57/13968/optum-completes-acquisition-of-davita-medical-group-from-davita.html Fri, 21 Jun 2019 11:25:00 +0530 Optum, a leading health services company, completed its acquisition of DaVita Medical Group, one of the nation’s leading independent medical groups, from DaVita Inc. As part of the transaction, HealthCare Partners Nevada, DaVita Medical Group’s primary care practice in southern Nevada, will become part of Intermountain Healthcare. DaVita Medical Group joins OptumCare, which serves more than 80 health plans, and will provide quality care to a combined 16 million patients. “We are excited to take this important step in building a next-generation comprehensive, coordinated health care organization. Together we will improve patient health and experiences while lowering costs across the continuum of care – including primary, specialty, urgent and surgical care,” said Andrew Witty, CEO of Optum. “In joining Optum, DaVita Medical Group begins an exciting new chapter, helping physicians further advance patient care,” said Kent Thiry, Executive Chairman of DaVita Inc. “DaVita will continue its focus on improving quality of life for patients and expanding access to integrated care in the kidney care space,” said Javier Rodriguez, CEO of DaVita Inc. DaVita Inc. will continue to own and operate its U.S. and international kidney care businesses.   ]]> https://biospectrumindia.com/news/57/13966/who-highlights-scarcity-of-treatment-for-epilepsy-in-low-income-countries.html https://biospectrumindia.com/news/57/13966/who-highlights-scarcity-of-treatment-for-epilepsy-in-low-income-countries.html Fri, 21 Jun 2019 10:20:00 +0530 Three quarters of people living with epilepsy in low-income countries do not get the treatment they need, increasing their risk of dying prematurely and condemning many to a life of stigma. The findings are published in “Epilepsy, a public health imperative” released recently by WHO and leading nongovernmental organizations for epilepsy, the International League Against Epilepsy and the International Bureau for Epilepsy. Dr Tarun Dua, from WHO’s Department of Mental Health and Substance Abuse said, “The treatment gap for epilepsy is unacceptably high, when we know that 70% of people with the condition can be seizure-free when they have access to medicines that can cost as little as US$5 per year and can be delivered through primary health systems.” Premature death is three times higher in people with epilepsy The risk of premature death in people with epilepsy is up to three times higher than for the general population. In low- and middle-income countries, early death among people with epilepsy is significantly higher than in high-income countries. Reasons for this premature mortality in low- and middle-income countries are likely associated with lack of access to health facilities when seizures are long-lasting or occur close together without recovery in between, and preventable causes such as drowning, head injuries and burns. Roughly half of adults with epilepsy have at least one other health condition. The most common are depression and anxiety: 23% of adults with epilepsy will experience clinical depression during their lifetime and 20% will have anxiety. Mental health conditions such as these can make seizures worse and reduce quality of life. Development and learning difficulties are experienced by 30-40% of children with epilepsy. Stigma is widespread Dr Martin Brodie, President of the International Bureau for Epilepsy said, “Stigma about the condition is also widespread. “The stigma associated with epilepsy is one of the main factors preventing people from seeking treatment. Many children with epilepsy do not go to school and adults are denied work, the right to drive and even to get married. These human rights violations experienced by people with epilepsy need to come to an end.” Public information campaigns in schools, workplaces, and the broader community to help reduce stigma and the introduction of legislation to prevent discrimination and violations of human rights are also important elements of the public health response. Treatment for epilepsy can be integrated into primary health services But the report also shows that when the political will exists, the diagnosis of and treatment for epilepsy can be successfully integrated into primary health services. Pilot programmes introduced in Ghana, Mozambique, Myanmar and Viet Nam as part of WHO’s “Reducing the epilepsy treatment gap” programme have led to a considerable increase in access, such that 6.5 million more people have access to treatment for epilepsy should they need it. Dr Samuel Wiebe, President of the International League Against Epilepsy said, “We know how to reduce the epilepsy treatment gap. Now action to introduce the measures needed to make a difference needs to be accelerated. Ensuring uninterrupted supply of access to antiseizure medicines is one of the highest priorities, as is training of non-specialist health providers working in primary health-care centres.” 25% epilepsy cases can be prevented Causes of epilepsy include injury around the time of birth, traumatic brain injury, infections of the brain (such as meningitis or encephalitis) and stroke. It is estimated that 25% of cases can be prevented. Effective interventions for prevention of epilepsy can be delivered as part of broader public health responses in maternal and newborn health care, communicable disease control, injury prevention and cardiovascular health. Screening for pregnancy complications and the presence of trained birth attendants can help prevent injury around the time of birth; immunization against pneumonia and meningitis; malaria control programmes in endemic areas; initiatives to reduce road traffic injuries, violence and falls; and health and community interventions to prevent high blood pressure, diabetes, obesity and tobacco use can all help reduce epilepsy rates. Epilepsy is one of the most common neurological diseases, affecting nearly 50 million people of all ages around the world. It is a brain disease characterized by abnormal electrical activity causing seizures or unusual behaviour, sensations and sometimes loss of awareness. Epilepsy affects people of all ages, with peaks among children and the over-60s. It has neurological, cognitive, psychological and social consequences.   ]]> https://biospectrumindia.com/news/57/13963/edesa-biotech-receives-approval-to-proceed-with-its-clinical-investigation.html https://biospectrumindia.com/news/57/13963/edesa-biotech-receives-approval-to-proceed-with-its-clinical-investigation.html Thu, 20 Jun 2019 22:50:00 +0530 Edesa Biotech, a clinical-stage biopharmaceutical company has reported that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis. The FDA "safe to proceed" letter formally approves the company's Phase 2b clinical protocol and authorizes the company to begin its clinical investigation. Edesa expects the first patient to be enrolled in the coming quarter following the manufacturing of its drug candidate. EB01 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, like ibuprofen, the topical treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in contact dermatitis patients. "There are limited options for ACD patients and we have been pleased with the level of interest from physicians in the U.S.," said Dr. Par Nijhawan, Chief Executive Officer of Edesa. "The company is committed to rapidly advancing our clinical plans and remains on track to initiate our clinical study for EB01." In addition to its lead product candidate, Dr. Nijhawan noted that the company plans to selectively target additional indications within the areas of dermatology and gastroenterology. The company also plans to expand its portfolio with assets that can drive long-term growth opportunities. "This is an active and exciting time for Edesa and we look forward to providing clinical and business updates over the coming quarter," said Dr. Nijhawan. Clinical Protocol for Phase 2b Trial of EB01 The protocol evaluates EB01 in a randomized, double-blind, vehicle-controlled, sample size adaptive design. ACD patients in this study will be treated for 28 days with various strengths of EB01 cream. Primary outcome measures will evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream. The company plans to complete an interim analysis following the enrollment of the first cohort to determine the total sample size in the second part of the study; up to 166 total patients may be enrolled. ]]> https://biospectrumindia.com/news/57/13962/verastem-oncology-announces-leadership-changes.html https://biospectrumindia.com/news/57/13962/verastem-oncology-announces-leadership-changes.html Thu, 20 Jun 2019 22:45:00 +0530 Verastem,  a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced that Robert Forrester has decided to step down as President and Chief Executive Officer. Mr. Forrester has agreed to continue serving Verastem Oncology in an advisory capacity. Dan Paterson, the Company’s Chief Operating Officer, has been appointed to serve as President and Chief Operating Officer and will assume the leadership of the executive team while the Board of Directors conducts a search to identify a successor. Mr. Paterson will be supported by other members of the senior leadership team, including Chief Financial Officer, Rob Gagnon, whose role is being expanded to include Chief Business Officer. Mr. Paterson joined Verastem Oncology in 2011 and has served as its Chief Operating Officer since 2014. He brings more than 25 years of experience at healthcare and biotechnology companies, including leadership roles as Chief Business Officer (CBO), Chief Operating Officer (COO) and Chief Executive Officer (CEO), with specific expertise in oncology drug and diagnostic product development, business development and launch planning. “On behalf of the entire Board, I want to thank Robert for his countless contributions and leadership for the past six years and his unwavering commitment to Verastem Oncology’s patients, employees and shareholders,” said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. “We remain confident in the growth potential of COPIKTRA™ and we intend to hire a CEO with commercial expertise who will build on the foundation that Robert has established and execute on our ambitious goals for the future.” “With COPIKTRA, the experienced team and the resources we have in place, we are in a strong position to continue executing on our mission to improve outcomes for patients,” said Mr. Paterson. “I look forward to working closely with the Company’s Board, executive leadership, and the broader management team to accelerate the COPIKTRA launch and the future expansion of this important medicine into other hematologic malignancy indications.” “It has been a true honor to serve as the CEO of Verastem Oncology over the past six years,” said Mr. Forrester. “I am extremely proud of the Verastem Team, the progress we have made, and our many accomplishments aimed at improving the lives of patients diagnosed with cancer, one patient at a time. I have great confidence in Verastem Oncology’s potential and I will work with the entire team to ensure a seamless transition for all of our stakeholders.” The Company is reiterating its previously issued financial guidance for the full year 2019. The Company continues to expect net product revenue from the sales of COPIKTRA to be in the range of $10-12 million, based on product revenue to date, current run rates and near-term expectations. Verastem Oncology is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer. ]]> https://biospectrumindia.com/news/57/13961/genocea-announces-pricing-of-36750000-public-offering-of-common-stock.html https://biospectrumindia.com/news/57/13961/genocea-announces-pricing-of-36750000-public-offering-of-common-stock.html Thu, 20 Jun 2019 22:40:00 +0530 Genocea Biosciences, a biopharmaceutical company developing personalized cancer immunotherapies has announced the pricing of its previously announced underwritten public offering of 10,500,000 shares of its common stock at a public offering price of $3.50 per share, before underwriting discounts and commissions. In addition, Genocea has granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of common stock at the public offering price per share, less the underwriting discounts and commissions. The gross proceeds from the offering are expected to be $36,750,000 before deducting underwriting discounts and commissions and offering expenses payable by Genocea. All of the shares are being sold by Genocea. The offering is expected to close on or about June 24, 2019, subject to satisfaction of customary closing conditions. SVB Leerink and Stifel are acting as joint book-running managers for the offering. Baird and Needham & Company are acting as co-managers for the offering. A registration statement on Form S-1 relating to the offering was filed with and declared effective by the Securities and Exchange Commission (the “SEC”). The offering is being made only by means of a prospectus included in the registration statement declared effective by the SEC. Genocea is a biopharmaceutical company developing personalized cancer immunotherapies. Its unique ATLAS technology platform allows identifying immunotherapy targets based on each person’s tumor antigen-specific T cell responses. It is advancing complementary programs built from ATLAS insights:  GEN-009, a neoantigen vaccine candidate for which they are conducting a Phase 1/2a clinical trial across a variety of solid tumor types, and GEN-011, a neoantigen-specific adoptive T cell therapy, for which we intend to file an Investigational New Drug Application in the first half of 2020. ]]> https://biospectrumindia.com/news/57/13955/researchers-develop-mind-controlled-robotic-arm.html https://biospectrumindia.com/news/57/13955/researchers-develop-mind-controlled-robotic-arm.html Thu, 20 Jun 2019 12:55:00 +0530 A team of researchers from Carnegie Mellon University, in collaboration with the University of Minnesota, has made a breakthrough in the field of noninvasive robotic device control. Using a noninvasive brain-computer interface (BCI), researchers have developed the first-ever successful mind-controlled robotic arm exhibiting the ability to continuously track and follow a computer cursor. Being able to noninvasively control robotic devices using only thoughts will have broad applications, in particular benefiting the lives of paralyzed patients and those with movement disorders. BCIs have been shown to achieve good performance for controlling robotic devices using only the signals sensed from brain implants. When robotic devices can be controlled with high precision, they can be used to complete a variety of daily tasks. Until now, however, BCIs successful in controlling robotic arms have used invasive brain implants. These implants require a substantial amount of medical and surgical expertise to correctly install and operate, not to mention cost and potential risks to subjects, and as such, their use has been limited to just a few clinical cases. A grand challenge in BCI research is to develop less invasive or even totally noninvasive technology that would allow paralyzed patients to control their environment or robotic limbs using their own "thoughts." Such noninvasive BCI technology, if successful, would bring such much needed technology to numerous patients and even potentially to the general population. However, BCIs that use noninvasive external sensing, rather than brain implants, receive "dirtier" signals, leading to current lower resolution and less precise control. Thus, when using only the brain to control a robotic arm, a noninvasive BCI doesn't stand up to using implanted devices. Despite this, BCI researchers have forged ahead, their eye on the prize of a less- or non-invasive technology that could help patients everywhere on a daily basis. Bin He, Trustee Professor and Department Head of Biomedical Engineering at Carnegie Mellon University, is achieving that goal, one key discovery at a time. "There have been major advances in mind controlled robotic devices using brain implants. It's excellent science," says He. "But noninvasive is the ultimate goal. Advances in neural decoding and the practical utility of noninvasive robotic arm control will have major implications on the eventual development of noninvasive neurorobotics." Using novel sensing and machine learning techniques, He and his lab have been able to access signals deep within the brain, achieving a high resolution of control over a robotic arm. With noninvasive neuroimaging and a novel continuous pursuit paradigm, He is overcoming the noisy EEG signals leading to significantly improve EEG-based neural decoding, and facilitating real-time continuous 2D robotic device control. Using a noninvasive BCI to control a robotic arm that's tracking a cursor on a computer screen, for the first time ever, He has shown in human subjects that a robotic arm can now follow the cursor continuously. Whereas robotic arms controlled by humans noninvasively had previously followed a moving cursor in jerky, discrete motions—as though the robotic arm was trying to "catch up" to the brain's commands—now, the arm follows the cursor in a smooth, continuous path. In a paper published in Science Robotics, the team established a new framework that addresses and improves upon the "brain" and "computer" components of BCI by increasing user engagement and training, as well as spatial resolution of noninvasive neural data through EEG source imaging. The paper, "Noninvasive neuroimaging enhances continuous neural tracking for robotic device control," shows that the team's unique approach to solving this problem not enhanced BCI learning by nearly 60% for traditional center-out tasks, it also enhanced continuous tracking of a computer cursor by over 500%. The technology also has applications that could help a variety of people, by offering safe, noninvasive "mind control" of devices that can allow people to interact with and control their environments. The technology has, to date, been tested in 68 able-bodied human subjects (up to 10 sessions for each subject), including virtual device control and controlling of a robotic arm for continuous pursuit. The technology is directly applicable to patients, and the team plans to conduct clinical trials in the near future. "Despite technical challenges using noninvasive signals, we are fully committed to bringing this safe and economic technology to people who can benefit from it," says He. "This work represents an important step in noninvasive brain-computer interfaces, a technology which someday may become a pervasive assistive technology aiding everyone, like smartphones." This work was supported in part by the National Center for Complementary and Integrative Health, National Institute of Neurological Disorders and Stroke, National Institute of Biomedical Imaging and Bioengineering, and National Institute of Mental Health. ]]> https://biospectrumindia.com/news/57/13946/cytuvax-presents-positive-results-of-hbai20-vaccine-trial.html https://biospectrumindia.com/news/57/13946/cytuvax-presents-positive-results-of-hbai20-vaccine-trial.html Wed, 19 Jun 2019 15:55:00 +0530 CyTuVax B.V.has released the results of the HBAI20 Phase 2 “BE-Responder” trial. This trial focused on so-called non-responders to hepatitis B vaccination, persons who have been vaccinated with at least one complete vaccination course (3 injections of a licensed hepatitis B vaccine) without achieving a protective immune response. In this study population of hepatitis B vaccine non-responders, the HBAI20 vaccine is able to reduce the percentage of non-responders to 8% compared to 21% in the HBVaxPro-10 group (p = .068 Fisher). Statistical evaluation using a generalized linear mixed model demonstrates that subjects who have received the HBAI20 vaccine are 3.5 times more likely to attain seroprotection at the end of the study compared with subjects who received the licensed HBVaxPro-10 vaccine (p < .05).  With the HBAI20 vaccine, seroprotection was achieved earlier than with the HBVAxPro-10 vaccine. 83% of the non-responders attained seroprotection after only 2 vaccinations. In contrast, with the licensed HBVaxPro-10 vaccine, even after 3 injections only 79% of the non-responders achieved seroprotection. The safety profile of HBAI20, as compared to HBVaxPro-10, showed a temporary higher number of transient mild and moderate local side effects: impaired arm movement, redness, and pain at injection site indicating that HBAI20 induces a stronger immune response. No differences regarding systemic side effects were observed. The “BE-Responder” study was a double-blind randomized controlled phase 2 clinical trial, and enrolled 133 adults subjects in 2 arms with a ratio of 3:1 (HBAI20 : HBVaxPro-10). Subjects were recruited at 3 sites: MUMC (Maastricht), ZOL/UH (Genk), and VAXINFECTIO (Antwerp). Both vaccines were administered 3 times in a 0, 1, and 2 months schedule. CyTuVax adjuvant for the HBAI20 vaccine consisted 20 µg of depot-formulated Interleukin-2 aggregates. ]]> https://biospectrumindia.com/news/57/13945/be-the-match-biotherapies-partners-with-trakcel-.html https://biospectrumindia.com/news/57/13945/be-the-match-biotherapies-partners-with-trakcel-.html Wed, 19 Jun 2019 15:25:00 +0530 Be The Match BioTherapies®, an organization offering solutions for companies developing and commercializing cell and gene therapies, and TrakCel, a software developer for cell and gene therapy supply chain tracking and orchestration systems have announced a collaboration that will provide integrated solutions for companies developing cell and gene therapies. This strategic partnership will enable cell and gene therapy developers to benefit from an integrated suite of industry-leading services and technology platforms. This combination of services and platforms has been designed to improve operations at every step of the cell and gene therapy supply chain. These steps range from clinical delivery to commercial-scale operations and coordination of these activities through a single software platform. Be The Match BioTherapies and TrakCel will identify the unique challenges faced by cell and gene therapy developers and integrate services and platforms that provide direct solutions. Be The Match BioTherapies will contribute solutions for cell sourcing, cell therapy supply chain, clinical study design and execution, cellular therapy outcomes registry, and IT systems. TrakCel will provide its chain of custody/chain of identity (COC/COI), scheduling and logistics management software platform. The integration will increase efficiencies and eliminate redundancies while supporting all aspects of the supply chain in accordance with regulatory and protocol requirements. Both companies are already working together to deliver the integrated offering in support of a client’s CAR-T development program. ]]> https://biospectrumindia.com/news/57/13938/imcyse-raises-35m-in-series-b-funding-and-additional-grants.html https://biospectrumindia.com/news/57/13938/imcyse-raises-35m-in-series-b-funding-and-additional-grants.html Wed, 19 Jun 2019 12:15:00 +0530 Imcyse, a developer of active specific immunotherapies for the treatment and prevention of severe chronic diseases, today announces that it has raised €35M ($39.5M) in a Series B financing round and through other channels.   The financing round of €28M ($31.6M) in equity was led by LSP together with Belgian investors including Epimède, the Société Régionale d'Investissement de Wallonie (SRIW), and the Société Fédérale de Participations et d'Investissement (SFPI). Existing shareholders (Biogenosis, Noshaq, KU Leuven) also participated in the round.   Further to this, Imcyse also received a grant worth €4.6M ($5.2M) from the Walloon region (DGO6) and a bank loan of €2M ($2.3M) from Belfius.   These proceeds will be used to advance phase 2 clinical development of Imcyse’s Imotopes™ technology in type 1 diabetes, to initiate clinical trials in multiple sclerosis and other auto-immune diseases and to expand the technology to further indications.   Imcyse’s unique technology platform uses modified peptides (Imotopes™), which have the potential to cure and to prevent severe chronic autoimmune diseases, such as type 1 diabetes, multiple sclerosis and other auto-immune diseases, for which there are currently no cure.   At the end of 2017, Imcyse launched a double-blind, placebo-controlled, dose-escalation clinical study in patients with recent onset insulin-dependent type 1 diabetes in seven European countries (Belgium, Denmark, France, Germany, Lithuania, Sweden and the UK). The trial investigates the safety, immune responses and efficacy of Imcyse’s Imotopes™ technology, with results expected end of summer 2019.   “Imcyse’s unique technology platform has shown great potential and we are thrilled to see it advance in type 1 diabetes as well as it being extended to novel indications,” said Jörg Neerman, Partner at LSP.   “We are happy to have raised this substantial amount of private and public financing for our future research and clinical developments,” said Pierre Vandepapelière, CEO and CMO of Imcyse. “The success of this round is a further validation of the technology platform, following already established collaborations with major pharma companies. We are convinced that Imcyse’s technology can bring great hope for patients with severe diseases such as type 1 diabetes, multiple sclerosis and many orphan indications. It is also a clear recognition for Imcyse’s team, who have worked hard to improve the platform and the company and to generate excellent results.”    PE Group and NautaDutilh Belgium acted as advisors to Imcyse for this transaction. Dentons Europe LLP acted as advisor to the investors for this transaction. ]]> https://biospectrumindia.com/news/57/13936/who-launches-new-tool-to-handle-amr.html https://biospectrumindia.com/news/57/13936/who-launches-new-tool-to-handle-amr.html Wed, 19 Jun 2019 11:20:00 +0530 WHO has launched a global campaign urging governments to adopt a tool to reduce the spread of antimicrobial resistance (AMR), adverse events and costs.  The AWaRe tool was developed by the WHO Essential Medicines List to contain rising resistance and make antibiotic use safer and more effective. It classifies antibiotics into three groups – Access, Watch and Reserve – and specifies which antibiotics to use for the most common and serious infections, which ones should be available at all times in the healthcare system, and those that must be used sparingly or preserved and used only as a last resort. The new campaign aims to increase the proportion of global consumption of antibiotics in the Access group to at least 60%, and to reduce use of the antibiotics most at risk of resistance from the Watch and Reserve groups. Using Access antibiotics lowers the risk of resistance because they are ‘narrow-spectrum’ antibiotics (that target a specific microorganism rather than several). They are also less costly because they are available in generic formulations. In the absence of new significant investments into the development of new antibiotics, improving the use of antibiotics is one of the key actions needed to curb further emergence and spread of antimicrobial resistance. By classifying antibiotics into three distinct groups, and advising on when to use them, AWaRe makes it easier for policy-makers, prescribers and health workers to select the right antibiotic at the right time, and to protect endangered antibiotics. ]]> https://biospectrumindia.com/news/57/13929/varian-expands-with-interventional-oncology-acquisitions.html https://biospectrumindia.com/news/57/13929/varian-expands-with-interventional-oncology-acquisitions.html Tue, 18 Jun 2019 14:45:00 +0530 Varian has acquired Endocare® Systems, based in Austin, Texas; and Alicon, based in Hangzhou, China.  Endocare is a leading provider of technology for cryoablation and microwave ablation.  In China, Alicon is a leader in embolic therapy agents for treating liver cancer.  Endocare’s lead product is the Cryocare CS®  System, a fully integrated planning, placement, and treatment system designed to simplify cryotherapy.  Alicon’s lead product is Caligel, comprised of calibrated resorbable gelform particles commonly used as an embolic agent for treating liver cancer. “This expansion into interventional oncology represents a significant step in our long-term strategy to become a global leader in multidisciplinary, integrated cancer care solutions, enabling us to touch more patient lives and have a broader impact across the cancer care continuum,” said Kolleen T. Kennedy, president of Varian Proton Solutions and chief growth officer.  “We are confident that the portfolio of products and both companies’ dynamic R&D pipelines will expand our clinical partners’ treatment options in the years to come. Varian is uniquely positioned to create an interventional oncology platform that combines software and services for treatment planning with advanced interventional treatment delivery,” said Dow Wilson, president and chief executive officer of Varian. “We are excited about the opportunity to join Varian,” said David Chen, chief executive officer of Endocare and Alicon. “Endocare, Alicon, and Varian share a common goal of delivering innovative cancer care solutions, and this transaction will advance a united ability to develop the solutions necessary to achieve that goal. On a personal note, I am deeply proud of the products the Endocare and Alicon teams have developed, and I look forward to expanding our global patient impact together with Varian.” ]]> https://biospectrumindia.com/news/57/13927/pfizer-announces-results-from-xeljanz-xr-oral-shift-study.html https://biospectrumindia.com/news/57/13927/pfizer-announces-results-from-xeljanz-xr-oral-shift-study.html Tue, 18 Jun 2019 11:45:00 +0530 Pfizer Inc. has announced positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis (RA). Patients who achieved low disease activity (LDA) with XELJANZ® (tofacitinib) extended release (XR) 11 mg once daily (QD) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of XELJANZ XR 11 mg QD as monotherapy after MTX withdrawal compared with XELJANZ XR with continued MTX. The study demonstrated non-inferiority of MTX withdrawal with XELJANZ XR 11 mg QD compared to XELJANZ XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score (DAS28-4[ESR]) from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48. The study results will be presented during a late-breaking oral session at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (15 June). “The results of ORAL Shift provide important information on the use of XELJANZ XR as monotherapy after methotrexate withdrawal, which is significant as some people living with rheumatoid arthritis are unable or unwilling to use methotrexate,” said Stanley Cohen, MD, Metroplex Clinical Research Center, Dallas, TX. “From a clinical perspective, these results give physicians data to help inform the decision to take appropriate patients off methotrexate.” XELJANZ® (tofacitinib) is approved in the U.S. for adult patients in three indications: moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and moderately to severely active ulcerative colitis (UC). Globally, XELJANZ is approved in more than 130 countries for the treatment of moderately to severely active RA and has been prescribed to an estimated 205,000 patients. As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions. ]]> https://biospectrumindia.com/news/57/13925/pfizer-to-acquire-array-biopharma-in-a-11-4b-deal.html https://biospectrumindia.com/news/57/13925/pfizer-to-acquire-array-biopharma-in-a-11-4b-deal.html Tue, 18 Jun 2019 11:30:00 +0530 Pfizer Inc. and Array BioPharma Inc. have announced that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion. The Boards of Directors of both companies have approved the merger. Array’s portfolio includes the approved combined use of BRAFTOVI®(encorafenib) and MEKTOVI® (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in over 30 clinical trials across several solid tumor indications, including the Phase 3 BEACON trial in BRAF-mutant metastatic colorectal cancer (mCRC). In addition to the combination therapy for BRAF-mutant metastatic melanoma, Array brings a broad pipeline of targeted cancer medicines in development, as well as a portfolio of out-licensed potentially best-in-class and/or first-in-class medicines, which are expected to generate significant royalties over time. Upon the close of the transaction, Array’s employees will join Pfizer and continue to be located in Cambridge, Massachusetts and Morrisville, North Carolina, as well as Boulder, Colorado, which becomes part of Pfizer’s Oncology Research & Development network in addition to La Jolla, California and Pearl River, New York. ]]> https://biospectrumindia.com/news/57/13922/gsk-joins-forces-with-the-university-of-california-to-advance-genomic-research-.html https://biospectrumindia.com/news/57/13922/gsk-joins-forces-with-the-university-of-california-to-advance-genomic-research-.html Mon, 17 Jun 2019 17:35:00 +0530 GlaxoSmithKline plc has announced a five-year collaboration with the University of California to establish a state-of-the-art laboratory for CRISPR technologies, the Laboratory for Genomics Research (LGR). The new laboratory will explore how gene mutations cause disease and develop new technologies using CRISPR to rapidly accelerate the discovery of new medicines. The LGR is the brainchild of Professor Jennifer Doudna, University of California Berkeley (UCB), a co-inventor of CRISPR technology and Howard Hughes Medical Institute (HHMI) Investigator; Professor Jonathan Weissman, University of California San Francisco (UCSF), a pioneer of CRISPR screening technology and HHMI Investigator; and Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK. With the recent explosion of information from human genetics, scientists need powerful tools to understand why small changes in a person’s genetic make-up can increase the risk of diseases, an area of science called functional genomics. The most powerful tool in functional genomics, CRISPR, allows this to be done at a scale once thought impossible. Through this research, scientists can discover and develop novel therapies that have a higher likelihood of becoming medicines. Dr Barron said: “Technology is key to our innovation strategy at GSK, and CRISPR is one of the most important technologies of our time. With the expertise of Jennifer and Jonathan helping to steer the LGR, I am confident the lab will significantly advance our scientific understanding of the relationship between genes and disease to help find better medicines faster.” The LGR represents a novel hybrid model that brings together industrial and academic researchers under a single roof working on projects both together and independently. The outputs of those research projects will be focused on technologies, new drug targets and biological mechanisms that will foster both academic and industrial advances. The new laboratory will also be a resource for investigators at both University of California (UC) campuses, who can access and use its technology to answer their own biomedical or other biological questions, and to develop new tools that explore how genes work. Prof Doudna said: “Over the last seven years, CRISPR has transformed academic research, but until the LGR, we haven’t had a focused effort to catalyze the kind of research we know will lead to new innovation using this CRISPR tool. LGR is about building that space where creative science is partnered with the development of robust technology that will help develop tomorrow’s drugs. I think we’re going to be able to do science that none of us can even imagine today.” The LGR will receive up to $67 million in funding over a five-year period which will include facilities for 24 full-time university employees funded by GSK, plus up to 14 full-time GSK employees. With a focus on immunology, oncology and neuroscience, the laboratory will be based near the UCSF Mission Bay campus in San Francisco. GSK’s artificial intelligence and machine learning group will also be involved in building the necessary computational pipelines to analyze all the data. The LGR aims to automate existing CRISPR approaches so that this work can be done at scale. Ultimately the goal is to deepen our understanding of genetics and discover new targets, and to create next generation technologies that will become future standard practice for the pharmaceutical industry. Prof Weissman said: “One of our key goals is to advance the field overall and make these tools as broadly available as possible. The LGR screening center will enable labs at UCSF and Berkeley, and having access to it will give our scientists opportunities to advance their research in ways that would be very hard for them to do in their own labs.” In keeping with UC’s public mission, the tools that are developed in the lab will be described in published papers, subject to intellectual property provisions, and will be available for use by other academic and non-profit labs. The collaboration will be governed by a Joint Steering Committee with equitable University and GSK representation, with additional joint sub-committees covering patents, scientific and project management. Prof Doudna and Prof Weissman will be members of the Joint Steering Committee, together with GSK’s new head of functional genomics, Dr Chris Miller, who just joined GSK from AbbVie. This builds on the work of the Innovative Genomics Institute (IGI), a separate UC Berkeley/UCSF nonprofit research center co-directed by Prof Doudna and Prof Weissman, whose mission is to use CRISPR to improve public health. The collaboration will build on GSK’s existing collaborations with companies such as 23andMe, which delivers genetic information at scale. By applying artificial intelligence and machine learning to identify correlations between genetic variants and disease, researchers can select for clinical trials those patients who are most likely to benefit, thereby speeding up the drug development process. ]]> https://biospectrumindia.com/news/57/13913/us-scientist-develops-virtual-biopsy-device.html https://biospectrumindia.com/news/57/13913/us-scientist-develops-virtual-biopsy-device.html Mon, 17 Jun 2019 11:30:00 +0530 Using sound vibrations and pulses of near-infrared light, a Rutgers University scientist has developed a new “virtual biopsy” device that can quickly determine a skin lesion’s depth and potential malignancy without using a scalpel. Currently, physicians who perform surgical biopsies often don’t know the extent of a lesion – and whether it will be necessary to refer the patient to a specialist for extensive tissue removal or plastic surgery – until surgery has already begun. The first-of-its-kind experimental procedure, called vibrational optical coherence tomography (VOCT), creates a 3-D map of the legion’s width and depth under the skin with a tiny laser diode. It also uses soundwaves to test the lesion’s density and stiffness since cancer cells are stiffer than healthy cells. An inch-long speaker applies audible soundwaves against the skin to measure the skin’s vibrations and determine whether the lesion is malignant. The research team tested the device over six months on four skin excisions and on eight volunteers without skin lesions. Further studies are needed to fine-tune the device’s ability to identify a lesion’s borders and areas of greatest density and stiffness, which would allow physicians to remove tumors with minimally invasive surgery. ]]> https://biospectrumindia.com/news/57/13904/novartis-continues-to-innovate-in-cml.html https://biospectrumindia.com/news/57/13904/novartis-continues-to-innovate-in-cml.html Fri, 14 Jun 2019 15:55:00 +0530 Long-term follow-up data from the ongoing, pivotal open-label ENESTfreedom and ENESTop trials showed sustained treatment-free remission (TFR) after stopping frontline and second-line Tasigna (nilotinib) therapy in eligible adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP). Separate data demonstrate promising results for asciminib (ABL001), an investigational allosteric BCR-ABL inhibitor, in combination with three different tyrosine kinase inhibitors (TKIs) in heavily pre-treated Ph+ CML-CP patients. The results will be presented at the 24th Congress of the European Hematology Association (EHA) in Amsterdam1-4. "We are pleased to report many of our Tasigna clinical-trial patients continue to maintain treatment-free remission for nearly four years with a low adverse event burden," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. "Long-term trials like ENESTfreedom and ENESTop, as well as promising Phase I data from asciminib, are helping us to reimagine medicine and the way CML is treated." Results from the ENESTfreedom study showed that about 44% of patients remained in TFR (84/190) for 192 weeks after stopping frontline Tasigna treatment. The treatment-free survival rate at 192 weeks was nearly 49%. About 99% (90/91) and 92% (84/91) of patients who resumed nilotinib due to loss of major molecular response (MMR) during the TFR phase regained MMR and molecular response4.5, respectively. Among 91 patients who resumed nilotinib, the most common adverse events (AEs) were nasopharyngitis (18.7%) as well as pruritus, fatigue and increased lipase (14.3% each). The majority of AEs were grade 1/21. Consistent results were observed in the ENESTop trial: About 46% of patients remained in TFR (58/126) for 192 weeks after stopping second-line Tasigna treatment. The treatment-free survival rate at 192 weeks was over 50%. Among 59 patients who resumed nilotinib, the most common AEs were hypertension (20.3%) and arthralgia (13.6%). The majority of AEs were grade 1/22. Novartis will also present data from a Phase I trial of asciminib in combination with ATP-competitive TKI in heavily-pretreated patients with Ph+ CML-CP. Importantly, each combination was evaluated in a dose finding study assessing different asciminib dose levels, so results are not comparable across the three treatment arms. The preliminary results showed: Among patients who at baseline did not achieve BCR-ABL1 International Scale [IS] <1%, by 48 weeks3,4: 60% (9/15) achieved molecular response <1% in the asciminib-plus-imatinib arm, and 43% (6/14) and 56% (5/9) patients achieved molecular response <1% in the asciminib-plus-nilotinib and asciminib-plus-dasatinib arms, respectively. In evaluable patients without MMR at baseline, by 48 weeks3,4: 42% (8/19) achieved MMR with asciminib plus imatinib with median treatment exposure of 54.6 weeks, and 31% (4/13) patients with asciminib plus nilotinib and 36% (5/14) patients with asciminib plus dasatinib, respectively, achieved MMR. No patients with MMR at baseline lost MMR due to either of the three combination therapies. All combinations showed tolerable safety profile in heavily pretreated CML patients3,4: Among patients who received asciminib plus imatinib, the most common any-grade AEs were nausea (32%), increased lipase (20%), as well as abdominal pain, peripheral edema and vomiting (16% each). Among patients who received asciminib plus nilotinib, most common any-grade AEs were myalgia (35%), increased lipase (29%), and increased amylase, fatigue and pruritus (24% each). Among patients who received asciminib plus dasatinib, most common any-grade AEs were increased lipase (35%) and diarrhea, headache and nausea (18% each). "While the introduction of TKIs has changed the CML treatment paradigm, there remains a subset of patients who are intolerant or resistant to TKI therapy," said Jorge Cortes, MD, Deputy Chair and Professor of Medicine in the Department of Leukemia at MD Anderson Cancer Center, Houston Texas. "These initial results from combination therapy with currently available TKIs and a BCR-ABL1 inhibitor like asciminib are encouraging - and give us the potential to increase molecular response and prevent development of mutations." ]]> https://biospectrumindia.com/news/57/13902/blackstone-therapeutics-closes-76-m-series-b-financing.html https://biospectrumindia.com/news/57/13902/blackstone-therapeutics-closes-76-m-series-b-financing.html Fri, 14 Jun 2019 15:50:00 +0530 BlackThorn Therapeutics, a clinical-stage, neurobehavioral health company pioneering next-generation artificial intelligence (AI) technologies to advance targeted therapeutics, today announced the close of its $76 million Series B financing. New investors, including Polaris Partners, Premier Partners, Scripps Research, and Vertex Ventures HC joined the round, along with existing investors Alexandria Venture Investments, Altitude Life Science Ventures, ARCH Venture Partners, Biomatics Capital, GV (formerly Google Ventures), Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and Mercury Fund. In connection with the financing, Brian Chee, a managing partner at Polaris Partners, Lori Hu, a managing director at Vertex Ventures HC, and Julie Sunderland, a managing director at Biomatics Capital joined BlackThorn’s board as directors. “Making personalized medicine for mental health a reality requires the ability to gather, integrate and analyze a wide variety of data at scale,” said Paul Berns, Executive Chair of BlackThorn and a Venture Partner at ARCH Venture Partners. “BlackThorn has positioned itself at the forefront of these efforts by building the largest library of deeply phenotyped clinical neurobiological data and a cloud-based platform powered by artificial intelligence and machine learning (AI/ML) to inform rational, targeted drug discovery and development.” “BlackThorn was founded to bring new therapies to patients by applying advances in computational sciences to address patient heterogeneity, one of the biggest historical challenges in the field of neuropsychiatric drug development,” said Bill Martin, Ph.D., BlackThorn’s president and chief operating officer. “Three years later, insights from our data-driven approaches are yielding patient enrichment strategies that could increase the probability of clinical trial success and improve patient outcomes. We are grateful for our investors’ support to continue advancing our platform and therapeutic pipeline as we build out a world-class team at the intersection of technology and clinical neuroscience.” BlackThorn also announced two appointments to its executive management team: Jane Tiller, MBChB, FRCPsych, as chief medical officer, and Laura Hansen, Ph.D., as vice president, corporate affairs. Dr. Tiller, who brings extensive clinical psychiatry and drug development experience, will lead BlackThorn’s clinical and regulatory efforts. Dr. Hansen, who brings extensive strategic communications experience, is responsible for public and investor relations, scientific communications, and patient advocacy. “I am thrilled to join BlackThorn particularly at this time when the nexus between artificial intelligence and the latest advances in neuroscience promises to modernize the way we understand and treat behavioral disorders,” said Dr. Tiller. BlackThorn Therapeutics, a clinical-stage neurobehavioral health company pioneering the next generation of artificial intelligence technologies to advance its pipeline of targeted therapeutics for treating brain disorders. The company has engineered PathFinder™, a cloud-based computational psychiatry and data platform, to enable the collection, integration and analysis of multimodal data at great speed and scale. BlackThorn applies its data-driven approaches to create an understanding of the core underlying pathophysiology of neurobehavioral disorders and uses these insights to generate objective neuromarkers, which support drug target identification, patient stratification and objective clinical trial endpoints. By identifying more homogenous patient subgroups who share underlying neurobiology, BlackThorn aims to direct its drug candidates to neurobiologically-defined patient populations most likely to respond. ]]> https://biospectrumindia.com/news/57/13892/ibm-kpmg-merck-walmart-to-evaluate-use-of-blockchain-in-pharma.html https://biospectrumindia.com/news/57/13892/ibm-kpmg-merck-walmart-to-evaluate-use-of-blockchain-in-pharma.html Fri, 14 Jun 2019 12:10:00 +0530 IBM, KPMG, Merck and Walmart have announced that the companies have been selected by the United States Food and Drug Administration (FDA) to be included in a program in support of the U.S. Drug Supply Chain Security Act (DSCSA) that addresses requirements to identify, track and trace prescription medicines and vaccines distributed within the United States. The program is intended to assist drug supply chain stakeholders, including FDA, in developing the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. Craig Kennedy, Senior Vice President, Supply Chain, at Merck, which is known as MSD outside the U.S. and Canada said, “Our supply chain strategy, planning and logistics are built around the customers and patients we serve. Reliable and verifiable supply helps improve confidence among all the stakeholders—especially patients—while also strengthening the foundation of our business.” Each company brings unique expertise to the project, which will create a shared permissioned blockchain network that allows real-time monitoring of products. The proposed network is intended to help reduce the time needed to track and trace inventory; allow timely retrieval of reliable distribution information; increase accuracy of data shared among network members; and help determine the integrity of products in the distribution chain, including whether products are kept at the correct temperature. Karim Bennis, Walmart’s Vice President of Strategic Planning and Implementation, Health and Wellness said, “With successful Blockchain pilots in pork, mangoes and leafy greens that provide enhanced traceability, we are looking forward to the same success and transparency in the biopharmaceutical supply chain. We believe we have to go further than offering great products that help our customers live better at everyday low prices. Our customers also need to know they can trust us to help ensure products are safe. This pilot and U.S. Drug Supply Chain Security Act requirements will help us do just that.” Blockchain is designed to establish a permanent record and may be integrated with existing supply chain and traceability systems. Mark Treshock, IBM Global Solutions Leader for Blockchain in Healthcare & Life Sciences said, “Blockchain could provide an important new approach to further improving trust in the biopharmaceutical supply chain. We believe this is an ideal use for the technology because it can not only provide an audit trail that tracks drugs within the supply chain; it can track who has shared data and with whom, without revealing the data itself. Blockchain has the potential to transform how pharmaceutical data is controlled, managed, shared and acted upon throughout the lifetime history of a drug.” IBM, KPMG, and Walmart, the largest retailer in the U.S., have extensive experience in implementing blockchain solutions to help enhance the safety and traceability of products. Increasingly, customers are requesting more detailed information about products. Arun Ghosh, KPMG Blockchain Leader said, “Blockchain’s innate ability within a private, permissioned network to provide an ‘immutable record’ makes it a logical tool to deploy to help address DSCSA compliance requirements. The ability to leverage existing cloud infrastructure is making enterprise blockchain increasingly affordable and adaptable, helping drug manufacturers, distributors and dispensers meet their patient safety and supply chain integrity goals.” The pilot project is scheduled to be completed in fourth quarter of 2019, and results are expected to be published in an FDA DSCSA program report. At that time, the project’s participants will evaluate next steps.   ]]> https://biospectrumindia.com/news/57/13881/novo-nordisk-announces-results-of-pioneer-6-trial-on-people-with-high-cardiovascular-risk.html https://biospectrumindia.com/news/57/13881/novo-nordisk-announces-results-of-pioneer-6-trial-on-people-with-high-cardiovascular-risk.html Thu, 13 Jun 2019 11:10:00 +0530 Novo Nordisk has announced that the PIONEER 6 trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with oral semaglutide compared with placebo, both in addition to standard of care. The primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke and non-inferiority for cardiovascular safety of oral semaglutide versus placebo was confirmed with a hazard ratio (HR) of 0.79 (p<0.001) in favour of oral semaglutide compared with placebo. The results are based on an accumulation of 137 first major adverse cardiovascular events and a median follow-up time of 16 months. The main results from PIONEER 6 were presented at the American Diabetes Association (ADA) 79th Scientific Sessions and simultaneously published in The New England Journal of Medicine (NEJM). Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analogue in a pill.  The MACE results were driven by the individual components of cardiovascular death [15 (0.9%) events with oral semaglutide vs 30 (1.9%) events with placebo, HR 0.49, p=0.03] and non-fatal strokes [12 (0.8%) events with oral semaglutide vs 16 (1.0%) events with placebo, HR 0.74, non-significant]. The number of non-fatal myocardial infarctions with oral semaglutide was not significantly different than placebo [37 (2.3%) events with oral semaglutide vs 31 (1.9%) events with placebo, HR 1.18, non-significant]. Among the secondary endpoints, the number of all-cause deaths was significantly lower in people treated with oral semaglutide compared with placebo [23 (1.4%) events vs 45 (2.8%) events, HR 0.51, p=0.008]. "Cardiovascular disease is the most common cause of disability and death in people with type 2 diabetes," said Dr Mansoor Husain, PIONEER 6 investigator and lead author for the NEJM publication of PIONEER 6 and director of the Ted Rogers Centre for Heart Research and Toronto General Hospital Research Institute, Canada. "The PIONEER 6 trial demonstrates that oral semaglutide does not increase the risk of major adverse cardiovascular events while providing further evidence for the overall cardiovascular profile of semaglutide." The safety profile of oral semaglutide was consistent with that of the GLP-1 receptor agonist class and similar to those seen with subcutaneous semaglutide. "The results of PIONEER 6 further strengthen the overall clinical evidence for oral semaglutide, building upon the strong clinical data reported throughout the PIONEER clinical trial programme," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are excited about the potential of oral semaglutide to become the first and only oral GLP-1 treatment for people with type 2 diabetes."   About PIONEER 6 and the PIONEER clinical trial programme PIONEER 6 was an event-driven, pre-approval cardiovascular outcomes trial for oral semaglutide. It was a randomised, double-blinded, placebo-controlled trial evaluating the cardiovascular safety of oral semaglutide vs placebo when added to standard of care in 3,183 people with type 2 diabetes at high risk of cardiovascular events. The PIONEER phase 3a clinical development program for oral semaglutide was a global development programme that enrolled 9,543 people with type 2 diabetes across 10 clinical trials. ]]> https://biospectrumindia.com/news/57/13880/roche-diagnostics-announces-new-corporate-executive-committee.html https://biospectrumindia.com/news/57/13880/roche-diagnostics-announces-new-corporate-executive-committee.html Thu, 13 Jun 2019 11:00:00 +0530 Roche has announced that Peter Voser (61), a member of the Board of Directors of Roche Holding Ltd since 2011, has decided to step down as a member of the Board of Directors of Roche at the end of June 2019 due to his additional role as interim CEO of ABB. Roche Chairman Christoph Franz: "Peter Voser has made important contributions to Roche's success as a member of the Board and the Compensation Committee. On behalf of the Board of Directors of Roche, I would like to thank him most sincerely for his contribution.” At the same time, Roche announced the following changes to the Corporate Executive Committee: Michael Heuer (65), CEO Roche Diagnostics and member of the Corporate Executive Committee, will retire as planned at the end of July. The Board of Directors has appointed Thomas Schinecker (44), currently Head of Centralised and Point of Care Solutions, as CEO Roche Diagnostics and a member of the Corporate Executive Committee with effect from 1 August 2019. Stephan Feldhaus (57), Head of Group Communications and member of Roche’s enlarged Corporate Executive Committee, has decided to continue his career outside the company as of the end of September 2019. He will be succeeded on 1 October 2019 by Barbara Schädler (57), currently Head of Communications and Public Affairs at E.ON SE. Barbara Schädler will report to CEO Severin Schwan as a member of the enlarged Corporate Executive Committee. Severin Schwan: "Michael Heuer joined Roche following the acquisition of Boehringer Mannheim in 1998 and, after a long and distinguished career, has played a key role in making our company the world's leading provider of diagnostic solutions. We are extremely grateful to him for his personal contribution". Schwan added: "I am delighted that we have been able to appoint Thomas Schinecker, an internal successor with a strong track record, as the new CEO for our Diagnostics Division. Thomas Schinecker has broad and international experience in our business". Severin Schwan continued: "Stephan Feldhaus has shaped our communications over the past ten years and made a significant contribution to the positive reputation of our company. I thank him very much for his valuable contribution and wish him all the best. I am pleased that we have Barbara Schädler joining Roche as his successor. She has worked successfully for many years as a communications executive in global private companies and in the public sector". Michael Heuer joined Boehringer Mannheim in 1983 and was appointed to his current position in 2018. Following the acquisition of Boehringer Mannheim by Roche in 1998, he held various management positions in sales, marketing and product development in Germany, Austria and the United States before being appointed Head of Roche's Near Patient Testing business unit. Prior to his current role, he was Head of Diagnostics Europe, Middle East, Africa and Latin America region. Michael Heuer holds a PhD in Chemistry from the University of Kiel. Thomas Schinecker began his career in 2003 as a trainee for Roche Diagnostics under the Roche Perspectives programme. He has held various management positions in marketing & sales and product development in Singapore, Austria, Sweden and the United States. Before assuming his current position as Head of the Global Business Area Centralised and Point of Care Solutions based in Rotkreuz, Switzerland, he was General Manager for Roche Diagnostics Germany. Thomas Schinecker holds a PhD in Molecular Biology from New York University, USA. Stephan Feldhaus joined Roche in 2010 as Head of Group Communications and is a member of the enlarged Corporate Executive Committee, where he has since been responsible for the Group's internal and external communications. He previously held various management positions in communications at Siemens and worked as a social ethicist and theologian. He received his doctorate in theology from the University of Munich. Barbara Schädler's previous career as communications manager included positions at E.ON SE, Lufthansa, SAP and the German Federal Ministry of Finance. She holds a Master's degree in Economics from the Johannes Gutenberg University of Mainz. ]]> https://biospectrumindia.com/news/57/13874/proximo-medical-expands-portfolio-with-pmt-partners.html https://biospectrumindia.com/news/57/13874/proximo-medical-expands-portfolio-with-pmt-partners.html Wed, 12 Jun 2019 16:00:00 +0530 Proximo Medical announced it has been selected by PMT Partners, a medical device innovator focused on the advancement of angiographic injectors, for commercialization of the PowrSyringe and AirTight Control Syringe technologies. Proximo Medical is a fractional commercial organization for start-up medical device technologies that delivers market validation, an experienced workforce and scalability to deliver accelerated revenues. With over 20 million global angiographic procedures performed each year, Proximo Medical will position the PowrSyringe and AirTight Control Syringe as tools every interventionalist should have during an angiography procedure. The PowrSyringe has an ergonomic handle that reduces hand fatigue and improves injection speed in angiography. The device is designed to reduce contrast usage and radiation exposure while improving image quality. PowrSyringe provides less setup time and up to 120% faster injection. "Interventionalists need a faster, high pressure injection solution. By partnering with Proximo, we can aggressively launch these technologies with a proven team whose sales expertise will accelerate clinical adoption," states Chris Livingstone, Vice President of Sales and Marketing for PMT Partners. "Proximo opens the door to establishing how our technologies improve patient outcomes while reducing costs and improving service." The AirTight Control Syringe provides finger loops that rotate independent of the manifold, reduce the "wobble" effect and eliminate the likelihood of air leaks, which slows the process and impact of the procedure. Both syringe devices aim to be the standard of care in angiography procedures. ]]> https://biospectrumindia.com/news/57/13873/amcor-completes-acquisition-of-bemis.html https://biospectrumindia.com/news/57/13873/amcor-completes-acquisition-of-bemis.html Wed, 12 Jun 2019 15:55:00 +0530 Amcor is a global leader in developing and producing responsible packaging for food, beverage, pharmaceutical, medical, home- and personal-care, and other products. Amcor has announced the successful completion of its acquisition of Bemis Company Inc., effective 11 June 2019. The combined company will now operate as Amcor plc (Amcor), trading on the New York Stock Exchange under the ticker symbol "AMCR" and the Australian Securities Exchange under the ticker symbol "AMC." Amcor is included in both the S&P 500 and S&P/ASX 200 indices. Amcor Chief Executive Officer Ron Delia described the acquisition as "a significant milestone as two strong companies with histories each dating back over 150 years look forward to one great future." "The acquisition of Bemis brings additional scale, capabilities and footprint that will strengthen Amcor's industry leading value proposition and generate significant value for shareholders," said Mr. Delia. Amcor makes responsible packaging for food, beverage, pharmaceutical, medical, home- and personal-care, and other consumer products. During the 2018 financial year, the company generated combined revenues of more than USD 13.4 billion from operations at approximately 245 locations in more than 40 countries. ]]> https://biospectrumindia.com/news/57/13872/oral-semaglutide-establishes-cardiovascular-safety-in-type-2-diabetic-people.html https://biospectrumindia.com/news/57/13872/oral-semaglutide-establishes-cardiovascular-safety-in-type-2-diabetic-people.html Wed, 12 Jun 2019 12:30:00 +0530 Novo Nordisk announced that the PIONEER 6 trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with oral semaglutide compared with placebo, both in addition to standard of care. The primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke and non-inferiority for cardiovascular safety of oral semaglutide versus placebo was confirmed with a hazard ratio (HR) of 0.79 (p<0.001) in favour of oral semaglutide compared with placebo. The results are based on an accumulation of 137 first major adverse cardiovascular events and a median follow-up time of 16 months. The main results from PIONEER 6 were presented today at the American Diabetes Association (ADA) 79th Scientific Sessions and simultaneously published in The New England Journal of Medicine (NEJM). Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analogue in a pill.  "Cardiovascular disease is the most common cause of disability and death in people with type 2 diabetes," said Dr Mansoor Husain, PIONEER 6 investigator and lead author for the NEJM publication of PIONEER 6 and director of the Ted Rogers Centre for Heart Research and Toronto General Hospital Research Institute, Canada. "The PIONEER 6 trial demonstrates that oral semaglutide does not increase the risk of major adverse cardiovascular events while providing further evidence for the overall cardiovascular profile of semaglutide." The safety profile of oral semaglutide was consistent with that of the GLP-1 receptor agonist class and similar to those seen with subcutaneous semaglutide. "The results of PIONEER 6 further strengthen the overall clinical evidence for oral semaglutide, building upon the strong clinical data reported throughout the PIONEER clinical trial programme," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are excited about the potential of oral semaglutide to become the first and only oral GLP-1 treatment for people with type 2 diabetes."  ]]> https://biospectrumindia.com/news/57/13868/merck-to-acquire-tilos-therapeutics.html https://biospectrumindia.com/news/57/13868/merck-to-acquire-tilos-therapeutics.html Tue, 11 Jun 2019 15:45:00 +0530 Merck known as MSD outside the United States and Canada has announced that it has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases. Dr. Dean Li, senior vice president, discovery and translational medicine, Merck Research Laboratories said, “At Merck we continue to enhance our robust pipeline through active execution of our business development strategy. Tilos has developed a compelling portfolio of candidates that employ a novel approach to modulating the potent signaling molecule TGFβ by binding to latency-associated peptide, with potential applications across a range of disease indications.” Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Tilos for total potential consideration of up to $773 million, including an upfront payment as well as contingent milestone payments. Dr. Barbara Fox, CEO, Tilos said, “We are proud that the Tilos team has advanced the discoveries of our scientific founders by developing a portfolio of anti-LAP antibodies designed to realize the full potential of TGFβ-modulating therapeutics. This agreement with Merck, an industry leader in biopharmaceutical research and development, provides meaningful validation for our therapeutic approach and best positions our pipeline for broad clinical and commercial success.” Tilos was founded by Boehringer Ingelheim Venture Fund and Partners Innovation Fund, based on discoveries by the laboratory of Dr. Howard Weiner at Brigham and Women’s Hospital and Harvard Medical School. Additional investment was provided by ShangPharma Innovation Fund. TGFβ is a potent cytokine believed to play an important role in the development of cancer and fibrotic diseases. TGFβ is secreted as a complex with the protein, latency-associated peptide (LAP). LAP forms a cage around TGFβ, holding the cytokine in an inactive state until it is deployed. Evidence has shown that anti-LAP antibodies block the release of TGFβ from the TGFβ-LAP complex with the potential to provide a novel therapeutic mechanism to reduce TGFβ activity.   ]]> https://biospectrumindia.com/news/57/13861/fda-grants-roches-polivy-accelerated-approval-to-treat-lymphoma.html https://biospectrumindia.com/news/57/13861/fda-grants-roches-polivy-accelerated-approval-to-treat-lymphoma.html Tue, 11 Jun 2019 11:50:00 +0530 Roche recently announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Accelerated approval was granted for this indication based on complete response rates observed in a randomised, controlled clinical trial. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. “Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.” The accelerated approval of Polivy was based on the results from the phase Ib/II GO29365 study. This is the first and only randomised pivotal clinical trial to show higher response rates over BR, a commonly used regimen, in people with R/R DLBCL who are ineligible for a haematopoietic stem cell transplant. The US FDA granted Priority Review for the company’s Biologics License Application for Polivy in February 2019. Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. In addition, Polivy was granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with R/R DLBCL in 2017. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies. ]]> https://biospectrumindia.com/news/57/13851/thermo-fisher-scientific-acquires-highchem.html https://biospectrumindia.com/news/57/13851/thermo-fisher-scientific-acquires-highchem.html Mon, 10 Jun 2019 14:40:00 +0530 Thermo Fisher Scientific, the world leader in serving science has recently announced that it has completed the acquisition of HighChem, Ltd., a leading developer of mass spectrometry software based in Bratislava, Slovakia. HighChem software solutions are used to analyze complex data and identify small molecules in pharmaceutical and metabolomics laboratories. "Our customers rely on us to provide advanced software solutions that interpret data quickly and accurately to make compound identification simple and understandable," said Mitch Kennedy, president, chromatography and mass spectrometry, Thermo Fisher Scientific. "The addition of HighChem's software solutions to our existing mass spectrometry software portfolio will enable us to deliver greater value for our mass spectrometry customers." HighChem will be integrated into the chromatography and mass spectrometry business within the Analytical Instruments Segment. Terms of the acquisition were not disclosed. ]]> https://biospectrumindia.com/news/57/13850/thermo-scientific-launches-rheometer-series-for-quality-control-labs.html https://biospectrumindia.com/news/57/13850/thermo-scientific-launches-rheometer-series-for-quality-control-labs.html Mon, 10 Jun 2019 14:35:00 +0530 The Thermo Scientific HAAKE MARS iQ Rheometer was specifically designed to meet the needs of QC labs with built-in features that assist users to deliver more reliable results. Key features such as touchscreen control that allows users to quickly execute standard operating procedures (SOPs) and intuitive "Connect Assist" functionalities mean QC lab technicians can deliver more consistent and reliable results, even in busy labs with multiple operators running tests. "The capabilities of the new HAAKE MARS iQ Rheometer series were expanded to equip customers with an extremely capable and reliable QC instrument that can be customized for a lab's needs today and in the future," said Hanna Granö-Fabritius, senior business director of material characterization at Thermo Fisher Scientific. Those capabilities include: An intuitive, multilingual 7-inch touchscreen which allows users to run SOPs directly from the instrument with step-by-step guidance. The unique touchscreen on the instrument also shows instructions with images from the customer's own lab to clearly illustrate how to do the analysis correctly, step-by-step, for each user that is specific to that lab's process. "Assist" functionalities that provide lab technicians comprehensive guidance to reduce user errors. For example, the Connect Assist for temperature modules and measuring geometries allows technicians to quickly change accessories with quick coupling, automatic recognition and accurate alignment. Advanced testing methods and normal force capabilities measure axial forces in two directions. This supports texture analysis for sample bending, breaking and squeezing tests or tribology measurements for testing friction, lubrication and wear. A newly designed frame and lift mechanism provide high vibrational damping, minimal temperature expansion and higher chemical resistance to help ensure consistent results. ]]> https://biospectrumindia.com/news/57/13844/merck-foundation-meets-the-first-lady-of-guinea-to-plan-the-launch-of-programs.html https://biospectrumindia.com/news/57/13844/merck-foundation-meets-the-first-lady-of-guinea-to-plan-the-launch-of-programs.html Mon, 10 Jun 2019 11:35:00 +0530 Merck Foundation, the philanthropic arm of Merck KGaA Germany met The First Lady of Guinea to plan the launch of their programs and initiatives in the country. The meeting was held between The First Lady of Guinea, H.E. Madam DJENE CONDE and Dr. Rasha Kelej, CEO of Merck Foundation. The First Lady of Guinea, H.E. Madam DJENE CONDE and Ambassador of Merck More Than a Mother emphasized, “Guinea is all set to welcome the programs of Merck Foundation. These programs are going to be very beneficial for our people and their social and economic well-being. Merck Foundation will help us build healthcare capacity and break the stigma of infertility in the country.” Merck Foundation had appointed The First Lady of Guinea as the Ambassador of Merck More Than a Mother in 2017. Dr. Rasha Kelej, CEO of Merck Foundation and President, Merck More Than a Mother explained, “I am happy to work closely with Her Excellency First Lady of Guinea. We acknowledge her great efforts as “Merck More Than a Mother” Ambassador to empower infertile women in the country. With the launch of our programs, we will underscore our long -term partnership to build healthcare capacity and train doctors in the fields of Cancer Care, Fertility, and Diabetes care.” Merck Foundation will be working closely with the Office of First Lady to support the establishment of first-ever public IVF center in the country by providing technical advice and training to medical and paramedical staff. Merck Foundation also plans to introduce other unique initiatives in the country to get the desired culture shift with regard to the stigma related to infertility. “Few initiatives include announcing the Merck more than a Mother Media Recognition Award and Media Health Training in partnership with The First Lady of Guinea together with Ministry Health and Ministry of Communication & Information. Creating songs and movies in partnership with local artists to address the stigma related to infertility and educate people across the country. Also, involving fashion industry to deliver the message of breaking the stigma of infertile women to the community in day to day life which will be achieved by organizing ‘Merck More Than a Mother’ Fashion Awards,” explained Dr. Rasha Kelej. “Another innovative initiative is to launch an inspiring cartoon storybook for children to empower our boys at elementary level, to develop true respect for women and teach them family values of love and respect and few facts about Infertility, prevention and how it affects both men and women equally,” Dr. Rasha Kelej added. Merck Foundation has provided clinical training on fertility specialty in the past two years and will continue this program in partnership with the ministry of health to improve access to quality and equitable fertility care in the country. Merck Foundation will also continue enrolling doctors from Guinea in their two-year oncology fellowship program and master degree as a contribution to improve cancer care in the country. Merck foundation will also continue to enrol doctors for their Diabetes Blue Points Project. About Merck Oncology Fellowship Program The Merck Oncology Fellowship Program, a key initiative of Merck Cancer Access Program, focuses on building additional capacity through medical education and training. The lack of financial means is not the only challenge in Africa and developing countries, but a scarcity of trained health care personnel capable to tackle the prevention, early diagnosis and management of cancer at all levels of the health care systems is even a bigger challenge. Merck Oncology Fellowship Program focuses on building professional cancer care capacity with the aim to increase the limited number of oncologists in Africa and Developing countries. The program provides a One-year fellowship program at Tata Memorial Centre - India, One and half-years Oncology Fellowship programs at University of Malaya - Malaysia, Two years Oncology Fellowship Program at University of Nairobi - Kenya and Two years Master degree in Medical, Surgical, Pediatric and Radiation Oncology at Cairo University - Egypt, in partnership with African Ministries of Health, Local Governments and Academia. Launched in 2016, over 43 candidates from more than 21 African countries have rolled in the Merck Oncology Fellowship Program. The program will continue to build cancer care capability in African countries such as Botswana, Cameroon, CAR, Chad, Ethiopia, Gambia, Ghana, Guinea, Liberia, Mauritius, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Tanzania, Uganda and Zambia. ]]> https://biospectrumindia.com/news/57/13838/novartis-announces-new-leader-for-pharma-business-unit.html https://biospectrumindia.com/news/57/13838/novartis-announces-new-leader-for-pharma-business-unit.html Mon, 10 Jun 2019 09:00:00 +0530 Novartis has announced that Marie-France Tschudin, currently President, Advanced Accelerator Applications (AAA), a Novartis company, has been appointed President, Novartis Pharmaceuticals. She will report to Vas Narasimhan, CEO Novartis, and will join the Executive Committee with immediate effect. Marie-France Tschudin succeeds Paul Hudson who will be leaving Novartis to take the CEO position of a multinational pharmaceuticals company. Vas Narasimhan, CEO Novartis, said: "I am pleased that Marie-France Tschudin is ready to take over from Paul Hudson to further grow the business and lead the expected upcoming launches of our transformative medicines. Marie-France has a strong record of accomplishments in driving commercial excellence and a culture of inclusiveness and integrity founded on her exemplary commitment to patients and customers. She has always been highly respected by people working with her and will bring new and diverse perspectives to our executive leadership team. I would like to thank Paul for his exceptional leadership in positioning our pharmaceuticals business for strong future growth. He also established a new culture of commercial excellence, integrity and nurtured a strong, diverse talent pool." Regarding her appointment, Marie-France Tschudin said: "I'm honored and excited to be given the opportunity to lead and further develop one of the greatest businesses in our industry. I would like to thank Paul for his leadership and his focus on people and I wish him continued success going forward. I'm excited to deliver my part in reimagining medicine for as many people as possible together with our associates at Novartis." Marie-France Tschudin has more than 25 years of broad, multi-national experience in the pharmaceuticals and biotech industry. She joined Novartis in January 2017.  As a member of the Novartis Pharmaceuticals Executive Committee and Head of Novartis Pharmaceuticals, Region Europe she successfully grew the largest regional business within Novartis across countries, therapeutic areas and products to over USD 8 Billion in sales by the end of 2018. She also built a diverse leadership team, managed the entire pharmaceuticals portfolio and oversaw the preparations for our potential blockbuster launches in Europe.  Before joining Novartis, Marie-France spent 10 years at Celgene in a variety of leadership and general management positions and led their Hematology-Oncology business for Europe, Middle East and Africa from 2014 to 2016. Marie-France Tschudin is a Swiss citizen. She speaks six languages, graduated from Georgetown University, Washington D.C. and holds a Master in Business Administration from the Institute for Management Development (IMD), Lausanne. ]]> https://biospectrumindia.com/news/57/13836/vertex-expands-into-new-disease-areas-and-enhances-gene-editing-capabilities-.html https://biospectrumindia.com/news/57/13836/vertex-expands-into-new-disease-areas-and-enhances-gene-editing-capabilities-.html Fri, 07 Jun 2019 15:10:00 +0530 Vertex Pharmaceuticals Incorporated has announced that the company is enhancing its gene editing capabilities to develop novel therapies for Duchenne Muscular Dystrophy (DMD) and Myotonic Dystrophy Type 1 (DM1) by expanding its collaboration with CRISPR Therapeutics and acquiring Exonics Therapeutics. Vertex and CRISPR Therapeutics (CRSP) have expanded their collaboration and entered into an exclusive licensing agreement to discover and develop gene editing therapies for the treatment of DMD and DM1. Vertex and Exonics Therapeutics have entered into a definitive agreement under which Vertex will acquire privately held Exonics, a company focused on creating transformative gene editing therapies to repair mutations that cause DMD and other severe neuromuscular diseases. “Through the expanded collaboration with CRISPR and the acquisition of Exonics, we are bringing together the intellectual property, technologies, and scientific expertise needed to establish a leading gene editing platform for DMD and DM1. These transactions are highly aligned with our strategy of investing in scientific innovation to create transformative medicines for people with serious diseases,” said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex. “We are continuing to build a toolbox of small molecule and nucleic acid technologies and capabilities that will allow us to drive scientific innovation to produce transformative medicines for a broad portfolio of diseases.” “This agreement with Vertex reflects the strong collaboration we have built together in other programs and underscores Vertex’s commitment to gene editing,” said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “We continue to make significant advancements in enabling in vivo approaches for gene editing and are excited about the possibility of developing potentially curative therapies for DMD and DM1 together with Vertex.” “DMD and DM1 are devastating muscle diseases with no curative therapies available,” said Eric Olson, Ph.D., Founder and Chief Science Advisor of Exonics, and Professor and Chair of the Department of Molecular Biology at UT Southwestern Medical Center. “Vertex has a proven track record of developing important therapies for serious diseases and we are excited to combine our efforts to potentially develop a safe and efficacious one-time treatment for severe neuromuscular diseases.” ]]> https://biospectrumindia.com/news/57/13835/neomed-labs-strengthens-its-immunology-franchise-by-acquiring-pairimmune.html https://biospectrumindia.com/news/57/13835/neomed-labs-strengthens-its-immunology-franchise-by-acquiring-pairimmune.html Fri, 07 Jun 2019 14:30:00 +0530 The recently merged NEOMED-LABS / Pacific Biomarkers (NLPBI), a leading immunology centric service provider specialized in assay development and clinical laboratory testing for vaccines and soluble large molecules has announced the acquisition of PAIRimmune, Laval, Quebec, a non-GLP preclinical immunology service provider. With a legacy of more than 20 years in the assay development, immunogenicity and efficacy predictive in vitro and in vivo models, PAIRimmune's CEO Danielle Poirier and her team have a solid reputation for outstanding science within the community. Since 2015, they work as a CRO with small Biotech, academic groups and the most prestigious vaccine and large molecule Pharma companies. "As a science-driven organization, nothing makes us happier than seeing talented scientists joining forces with us. This acquisition strengthens our ligand binding and neutralization assays R&D capabilities, and this is a determinant growth engine for each of our biomarkers, bioanalytical and vaccine divisions. PAIRimmune also increases our flow cytometry capacity currently in high demand and places us in a situation to answer positively to requests with either an in vivo, ex-vivo or immunohistology component. A perfect match!" said Dr Benoit Bouche, NLPBI President and Chief Executive Officer. This acquisition reinforces NLPBI's ability to serve the needs of the health industry from the preclinical stage where this is so critical to develop robust data needed to take informed go/no-go decisions. PAIRimmune will pursue its operations under the leadership of Danielle Poirier, Director of Preclinical Services and Matthieu Daugan, Associate Director of Preclinical Services. PAIRimmune will be rebranded this fall at the same time than NEOMED-LABS and Pacific Biomarkers under the same new corporate identity currently in development. ]]> https://biospectrumindia.com/news/57/13831/dupont-microbiome-announces-a-strategic-partnership-with-biome-oxford.html https://biospectrumindia.com/news/57/13831/dupont-microbiome-announces-a-strategic-partnership-with-biome-oxford.html Fri, 07 Jun 2019 11:05:00 +0530 The DuPont Microbiome Venture announces a strategic investment and partnership with BioMe Oxford Ltd. BioMe Oxford is an early stage startup located in Oxford, United Kingdom, which is developing BioCapture®, a smart, orally delivered capsule that can sample gut microbiota in both humans and animals. DuPont will partner with BioMe Oxford and the University of Sheffield’s Advanced Manufacturing Research Centre (AMRC) to further the development of BioCapture®. This technology would allow unique insights into the impact that live microbes and other microbiome modulators have on the gut microbiota in various sections of the gastrointestinal tract. “We are delighted to partner with BioMe Oxford to develop the next generation of tools to accelerate innovation in the field of the microbiome. When ready, BioCapture® will allow us to deepen our understanding of the impact our probiotics and other ingredients have on the microbiome in parts of the GI tract that are very difficult to access today other than through endoscopy procedures. Additionally, we will be able to support our customers and academic partners in accelerating insights gathered into the microbiome and how it can be modulated to improve health,” said DuPont Microbiome Venture Leader Sebastien Guery. With its highly skilled team and its partnership with the world-class AMRC in Sheffield, BioMe Oxford is developing a simple, robust and innovative way to sample the gut microbiota in both humans and animals that will provide new insights on how diets, ingredients and probiotics influence the gut microbiota. “The microbial community inhabiting our gut is known to vary significantly in terms of abundance, composition and function between different segments. Targeted and minimally invasive sampling using BioCapture® has the potential to open up new areas of microbiome research by enabling routine access to previously unchartered territories. DuPont is a global leader in the nutrition and microbiome field, and we are excited to be working with their team of expert scientists to accelerate the development of BioCapture®,” said BioMe Oxford Co-Founder and CEO Soren Krogsgaard Thomsen, Ph.D. DuPont established the Microbiome Venture to accelerate microbiome science-based solution development through a combination of selected strategic partnerships with microbiome science leaders and internal investments. The Microbiome Venture is an entrepreneurial team established in 2017 with a strong connection to the larger DuPont organization, tapping into capabilities including R&D, manufacturing, regulatory, legal and marketing. The Microbiome Venture investment will complement DuPont’s existing product portfolio, especially in the areas of probiotics and prebiotics, including human milk oligosaccharides (HMOs), and enable precision nutrition to prevent and potentially treat chronic illnesses and various other health conditions. ]]> https://biospectrumindia.com/news/57/13828/philips-uvm-health-network-sign-pact-to-improve-patient-care.html https://biospectrumindia.com/news/57/13828/philips-uvm-health-network-sign-pact-to-improve-patient-care.html Thu, 06 Jun 2019 15:55:00 +0530 Royal Philips, a global leader in health technology, and the University of Vermont (UVM) Health Network, a leading provider of quality care have announced a long-term, strategic partnership of 10 years. The partnership, which extends an existing relationship between the two organizations, will help support staff in providing high-quality care and advance efforts to improve the health of the population in Vermont and Northern New York. Connecting the UVM Health Network with advanced digital Philips innovations like imaging systems, ultrasound, patient monitoring, and clinical informatics, the partnership will offer a comprehensive range of clinical and business solutions and consulting services. These technologies and services will help the UVM Health Network better integrate workflows for a more seamless patient experience.   The UVM Health Network provides high-quality care for patients on both sides of Lake Champlain, from the Green Mountains of Vermont to the Adirondacks of Northern New York. The six hospitals in Vermont and New York are working together as a network to ensure that patients get the right care, in the right place, at the right time – whether that care is best delivered in a physician’s office in rural Elizabethtown, or in an operating room in Burlington. The partnership with Philips will support these efforts, including the UVM Medical Center’s Robert E. and Holly D. Miller Building, where staff will rely on the latest in Philips technology to anticipate and respond to patient needs.  The Philips and the UVM Health Network relationship have evolved into a true partnership with a common mission of improving people’s lives by transforming how care is delivered.  The partnership will help create a consistent patient experience across the UVM Health Network, as well as contribute to predictability in costs. Further, the UVM Health Network will work with Philips to streamline workflows, optimize medical technology deployment, and collaborate to achieve operational excellence. This will include access to Philips technologies and services such as PerformanceBridge, which can further drive operational efficiency across modalities.  The UVM Health Network is the latest forward-thinking healthcare network to sign a long-term, strategic partnership (LSP), further cementing Philips leadership in this unique business model. Since implementing LSPs in North America, Philips has signed multiple agreements with leading health systems looking to achieve the quadruple aim.    ]]> https://biospectrumindia.com/news/57/13826/fujifilm-introduces-novel-fully-integrated-continuous-production-system.html https://biospectrumindia.com/news/57/13826/fujifilm-introduces-novel-fully-integrated-continuous-production-system.html Thu, 06 Jun 2019 14:55:00 +0530 FUJIFILM Corporation has announced an initial $10M USD investment to establish a full scale, fully integrated continuous processing facility for non-GMP manufacture of biopharmaceuticals at its FUJIFILM Diosynth Biotechnologies, Billingham, UK location. This perfusion based facility represents the culmination of 3 years of in-house innovation by Fujifilm group companies and includes the introduction of patented, disruptive downstream bioprocessing technology to the biopharmaceutical industry. Fujifilm's advanced upstream perfusion process utilizes a proprietary process control system with automatic feedback control for cell density and nutrient addition to maintain steady state conditions. Perfusion is a cell culture manufacturing process that involves the constant feeding of fresh media and processing of harvested media over several weeks. Fujifilm has developed an in-house, defined medium suitable for very high density perfusion culture and has adapted its Apollo X cell line for perfusion processing. This system offers a compelling, cost effective alternative to traditional fed batch cell culture processes given high efficiency and superior and consistent product quality (given reduced degradation and aggregation). Adoption of perfusion processing by the biopharmaceutical industry has been hindered somewhat by an inability to continuously purify the culture downstream due to equipment limitations and the large buffer volumes involved. Fujifilm has dedicated significant scientific and engineering resource to re-think the existing paradigm. Fujifilm has developed and patented a novel multi-functional system for downstream purification and is able to deliver all required unit operations including chromatography, ultra and dia-filtration (UFDF), single pass tangential flow (SP-TFF), viral inactivation and filtration and point of use in-line preparation of buffers within a common single-use flow paths. This technology can be deployed in both batch and continuous processing environments. The new facility will include a 500L single use perfusion bioreactor and 7 patented downstream processing units that is expected to yield >15kg of antibody from a single 4 week batch at 500L scale. The new system is available for process development services in Fall 2019. ]]> https://biospectrumindia.com/news/57/13822/peptidream-enters-into-strategic-partnership-with-pharmain.html https://biospectrumindia.com/news/57/13822/peptidream-enters-into-strategic-partnership-with-pharmain.html Thu, 06 Jun 2019 12:15:00 +0530 PeptiDream, a public Kanagawa-based biopharmaceutical company has recently announced a strategic partnership with PharmaIN Corporation ("PharmaIN") for the purpose of investigating the use of PharmaIN's proprietary drug carrier and delivery Protected Graft Co-Polymer ("PGC™") technology in combination with PeptiDream's peptide discovery and development programs. PharmaIN's breakthrough PGC™ technology is a PEG-based excipient that reversibly binds the therapeutic peptide and unlike PEGylation or other peptide PK extending technologies, does not require the peptide to be modified in anyway, thereby fully preserving the potency, function, and mobility of the therapeutic peptide payload.  Additionally, the PGC™ technology offers a number of other potentially significant advantages in that it can improve the solubility of the peptide payload, protects the peptide payload from degradation, thereby increasing stability, and acts to slowly releases the peptide payload resulting in a significantly longer circulation half-life.  The PGC™ technology has also shown to passively target the peptide payload to tumor sites/ sites of inflammation/infection and can significantly decrease the risk of injection site reactions common to conventional injectables. Under the partnership, PeptiDream will have the ability to broadly use PharmaIN's PGC™ technology across its discovery programs to formulate applicable therapeutic peptides with PGC™ and evaluate in vivo the drug carrier/delivery benefits.  Clinical development and commercialization of any peptide employing PharmaIN's PGC™ technology would require a specific development and commercialization license. ]]> https://biospectrumindia.com/news/57/13821/jeff-settleman-joins-pfizer-to-lead-oncology-research-and-development.html https://biospectrumindia.com/news/57/13821/jeff-settleman-joins-pfizer-to-lead-oncology-research-and-development.html Thu, 06 Jun 2019 12:00:00 +0530 Pfizer has announced that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading all early oncology research, from discovery to proof of concept clinical studies. Dr. Settleman, a leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, will report directly to Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer, and will be based in La Jolla, California. “Dr. Settleman brings to Pfizer a breadth of experience in fundamental cancer biology, cancer genetics, and innovative thinking related to the role of tumor heterogeneity in the development of drug tolerance and resistance. I look forward to seeing his expertise help Pfizer further accelerate potential breakthroughs for people living with cancer,” said Dr. Dolsten. “Dr. Settleman’s distinguished career in both academic research and drug discovery will be critical to Pfizer’s continuous pursuit of new therapeutic paradigms in cancer research.” Dr. Settleman will join Pfizer effective July 1 from Calico Life Sciences, where he was Distinguished Principal Investigator and Head of Oncology Research. Prior to Calico, Dr. Settleman led Discovery Oncology at Genentech. His distinguished career as an academic scientist started when he was a postdoctoral fellow at the Whitehead Institute for Biomedical Research at Massachusetts Institute of Technology in Dr. Robert Weinberg’s laboratory, before joining the Harvard School of Medicine faculty in 1992. During his 18 years as a member of the Harvard faculty, Dr. Settleman was named the Laurel Schwartz Professor of Oncology, served as Director of the Center for Molecular Therapeutics and Scientific Director of the Massachusetts General Hospital Cancer Center, and led the Cancer Cell Biology program of the Dana Farber Harvard Cancer Center. He has authored more than 240 peer-reviewed publications. Dr. Settleman received his B.A. in Neuroscience from the University of Pennsylvania and a Ph.D. in Genetics from Yale University. “I am privileged to be joining a world-class team of scientists who have made many important contributions to the landscape of cancer treatments for patients over several decades,” said Dr. Settleman. “There has never been a more exciting time in cancer research and I look forward to helping advance and grow a highly promising pipeline that includes a variety of targeted therapies and immunotherapies, with opportunities for rational combination treatments.” Robert T. Abraham, Ph.D., who has led the Oncology Research & Development group at Pfizer since 2011, has decided to retire at the end of 2019. During Dr. Abraham’s tenure, ten new Pfizer oncology medicines were approved, benefitting hundreds of thousands of patients around the world. Pfizer’s Oncology Research and Development group is focused on advancing next-generation cancer medicines through a diversified and comprehensive approach to target the tumor and the tumor microenvironment. With three distinct groups, Tumor Cell Biology, Cancer Immunology Discovery and Targeted Therapeutics, the organization is comprised of more than 400 dedicated scientists. Dr. Settleman will also become site head of Pfizer’s La Jolla Research & Development hub where nearly 800 employees work each day in support of Pfizer’s oncology mission. As of April 30, 2019, Pfizer’s Oncology pipeline includes 44 programs from Phase 1 through Registration. ]]> https://biospectrumindia.com/news/57/13819/beckman-coulter-life-sciences-acquires-cytobank.html https://biospectrumindia.com/news/57/13819/beckman-coulter-life-sciences-acquires-cytobank.html Thu, 06 Jun 2019 10:55:00 +0530 Beckman Coulter Life Sciences has announced its acquisition of Cytobank, a privately held, single cell data analysis, software as a service (SaaS) company based in Santa Clara, California. Cytobank provides an industry-leading, cloud and machine learning-based software platform for multi-parametric single-cell data analysis, sharing and archiving. The platform accelerates research productivity by enabling efficient high-dimensional multi-omics data analysis, visualization and collaboration across multiple sites. The technology pairs naturally with Beckman Coulter Life Sciences' CytoFLEX LX 21-color flow cytometer to meet the growing high-complexity workflow and data analysis needs of basic and clinical research scientists. Cytobank will transition into Beckman Coulter Life Sciences under the Danaher Life Sciences platform, which generated approximately $6.5 billion in revenue during 2018.  ]]> https://biospectrumindia.com/news/57/13817/cannabis-science-appoints-dr-sulma-mohammed-to-propel-cancer-clinical-trial.html https://biospectrumindia.com/news/57/13817/cannabis-science-appoints-dr-sulma-mohammed-to-propel-cancer-clinical-trial.html Wed, 05 Jun 2019 17:30:00 +0530 Cannabis Science, a U.S. company specializing in the development of cannabinoid-based medicines, is pleased to announce the appointment of Dr. Sulma Mohammed, Professor of Cancer Biology at Purdue University, to the Company’s Scientific Advisory Board. Dr. Mohammed has extensive knowledge of molecular biology, cell biology, biochemistry, and microbiology, basic and applied medical sciences through her graduate programs at Cornell University and Purdue University, as well as experience in cancer research from the basic levels, to pre-clinical research in animal models, through to human clinical trials. Based on the Company’s selection of successful pre-clinical targeted research using cannabinoid-based medicines, Dr. Mohammed will work closely with CBIS and its research collaborators currently planning a number of clinical trials this year including its partnership with the Harvard International Phytomedicines Institute (IPI). The selection is targeted, but not limited to; Lung Cancer, Breast Cancer, Basel Cell Carcinoma, Kaposi Sarcoma, Cancer Pain, Chronic Prostatitis, Obsessive Compulsive Disorder (OCD), Oro-bucco-lingual Dyskinesias, Oxidative Stress, Psychosis, and Post Traumatic Stress Disorder (PTSD) outlines the successful CBIS drug development pipeline. CBIS is also currently in negotiations to license the Company’s U.S. patent number 9,763,991 for the Compositions of Cannabinol (CBN) for Treatment of Various Neurobehavioral Disorders, including, but not limited to; Sleep Disorders, CTE, Anxiety, and PTSD. Dr. Mohammed is a Professor of Cancer Biology at the Department of Comparative Pathobiology, Purdue Center for Cancer Research, and Indiana University School of Medicine. As previous Director of the Purdue Cancer Center Drug Discovery Shared Resource, Dr. Mohammed developed protocols and consulted on the design and implementation of in vitro and in vivo experiments. In addition, she devoted much effort to the characterization of a unique animal model, which develops spontaneous pre-malignant lesions very similar to humans’ lesions in all morphological, molecular, and clinical diversity. Dr. Mohammed secured research funding as a principal investigator as well as a co-investigator through extramural grants from federal agencies and foundations, including the National Cancer Institute/National Institutes of Health, the United States Department of Defense, the Showalter Trust Fund, and industry funding sources.  “Dr. Sulma adds ‘Great Strength’ to our clinical trials team! As we begin our cancer clinical trials, we are honored to bring on board another cancer specialist such as Dr. Mohammed on board our Scientific Advisory Board. The Harvard GHC Summit year after year has provided us with a solid platform to grow, we greatly appreciate Dr. Wil Ngwa for the opportunity to grow with him and his team at Harvard; it makes a huge difference when people just get it. As industry partner we plan to utilize the new Harvard International Phytomedicines Institute to the full extent of our offerings. As Dr. Mohammed has Harvard GHC Summit relations already, Dr. Mohammed will certainly help us expedite the release of our targeted products through the Harvard IPI industry partnership and subsequent clinical trials as fast as possible. End goal is to provide the doctors across America with the tools to write an educated cannabinoid prescription, with actual clinical verified dosing, and a sense of toxicity ease, all required for this new drug to be released with peace of mind. The main work is done, the pre-clinical work always continues forward with positive results and negative comparables, as the guess work is done, now is time for action.  “Focused on clinical trials, we are bringing in many different types of new partners and not just for the money they can make, it's on many different levels. We are partnering with different types of organizations, non-profits, individuals, private and public companies of like mind and spirit we will bring through the Harvard IPI system. We will continue to raise capital to affect the transition; we believe we have a number of block-buster targets for clinical trials, so we will share the wealth. At this point, we don’t think we can do all, not all by ourselves, we can partner on product releases and clinical trials, education, economic development - the list goes on. We will proceed one step at a time and get these products out to the public, ASAP, that is our number one priority," concludes Cannabis Science Inc. President & CEO, Co-Founder, Mr. Raymond C. Dabney.  ]]> https://biospectrumindia.com/news/57/13816/pharmaceutical-industry-invests-in-the-development-of-early-clinical-research-in-quebec.html https://biospectrumindia.com/news/57/13816/pharmaceutical-industry-invests-in-the-development-of-early-clinical-research-in-quebec.html Wed, 05 Jun 2019 17:25:00 +0530 During the 2019 BIO (Biotechnology Innovation Organization) International Convention (BIO 2019), CATALIS Québec has announced that its eight pharmaceutical partners have renewed their financial commitments. Since its launch, GlaxoSmithKline, Pfizer, AbbVie, Takeda, Novartis, Merck, Servier and Roche have invested nearly CAD 1.6 million in the CATALIS initiative to support Quebec’s role as a global leader in the field of early clinical research. Since 2017, this innovative public-private partnership has rallied some fifteen organizations working jointly to develop and establish clinical research global best practices for the benefit of patients and the public in Quebec. “To ensure our life sciences industry enjoys a solid reputation and a competitive edge, it is critical to attract more private investment. By mobilizing all actors of this sector of the economy, the CATALIS initiative strengthens Québec’s position as a leader in early-stage clinical research. The government is proud to support this project, which clearly shows the industry’s innovative character,” stated Pierre Fitzgibbon, Minister of Economy and Innovation. “From the outset, our association has supported the CATALIS initiative, and several members of Innovative Medicines Canada are now involved in this network, which is a major asset for Quebec. We endorse several actions of the 2017-2027 Québec Life Sciences Strategy, including this partnership model, based on converging interests, to accelerate the discovery of innovative treatment solutions for patients,” declared Pamela Fralick, president of Innovative Medicines Canada. In addition to developing resources for the entire clinical research ecosystem in Quebec, the CATALIS initiative supports five institutions in the Quebec health care system: the Centre hospitalier de l’Université de Montréal (CHUM), the McGill University Health Centre (MUHC), the Centre hospitalier universitaire Sainte-Justine, the CHU de Québec – Université Laval and the Centre de Recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS). These partner institutions have received funding to support them as they implement their expertise in early clinical research, notably allowing them to hire highly qualified research staff. “CATALIS has created a unique partnership network that brings together the key players in the field of clinical research in Quebec. By working together, we’ll stimulate the launch of new clinical trials and generate positive impacts for Quebec’s economy and for the health of its people,” stated Danika Laberge, general manager of CATALIS Québec. Early-stage clinical trials (phases 1 and 2) are the first studies conducted on humans to provide scientific proof of the safety and efficacy of a medication or some other therapeutic approach. These trials, which involve a small group of patients, often represent an opportunity to find a potential treatment for patients with serious diseases when standard therapies have failed. ]]> https://biospectrumindia.com/news/57/13814/genecare-jupiter-chain-to-provide-secure-online-genetic-profiling-platform.html https://biospectrumindia.com/news/57/13814/genecare-jupiter-chain-to-provide-secure-online-genetic-profiling-platform.html Wed, 05 Jun 2019 14:55:00 +0530 Genetic testing is the core of preventive healthcare. Clients must first understand their genetic makeup to lower the risks of developing an illness or disease. A leading ASEAN company, Genecare, is one genetics testing company that allows clients to better understand their risks. The company makes use of whole genome sequencing to detect a client's genetic variance and susceptibility to diseases or abnormalities. Once ready, the results will be uploaded onto Genecare's app called NexTx. It contains medical professionals and lifestyle service providers who offer precise and targeted advice based on the client's genetic profiling for preventive healthcare consultation. For example, medical experts will offer customised medical recommendations, while lifestyle service providers, such as fitness clubs, can create tailor-made exercise plans based on the client's genetic makeup. The providers will then be able to input their observations and recommendations into the client's profile. The NexTx technology reduces time to track down information across different systems. However, as convenient as this may sound, there are widespread concerns about privacy since any form of medical data is highly sensitive. To address these worries, Genecare is working with Jupiter Chain to enable blockchain technology for NexTx's ecosystem. Jupiter Chain is a smart, consentable data platform that allows users to maintain data privacy by encrypting their data and requiring consent before other parties can access the necessary information to perform big data analytics. ]]> https://biospectrumindia.com/news/57/13813/bio-technes-liquid-biopsies-to-improve-personalized-care-in-lung-cancer-diagnostics.html https://biospectrumindia.com/news/57/13813/bio-technes-liquid-biopsies-to-improve-personalized-care-in-lung-cancer-diagnostics.html Wed, 05 Jun 2019 14:00:00 +0530 Bio-Techne has recently announced the publication of a recent validation study demonstrating that the proprietary exosome-based liquid biopsy tests from Bio-Techne's Exosome Diagnostics brand may be used to assess the mutational status of the Epidermal Growth Factor Receptor (EGFR) gene in patients with non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. Approximately 10-40% of patients with NSCLC have mutations within the EGFR gene. Several treatment options for NSCLC use drugs targeting cells with EGFR mutations; however, over half of these patients develop resistance during treatment due to the emergence of a resistance mutation in the gene. It is critical that tumor mutations be monitored during therapy of NSCLC patients, given the aggressive nature of this lung cancer, and to ensure that patients receive the most effective treatment option. The study published in Oncotarget describes Bio-Techne's proprietary technique to co-isolate exosomal RNA/DNA and cell-free tumor DNA in a single step, followed by a qPCR-based assay to detect 29 different types of mutations in EGFR, including EGFR T790M. Highlights of the data include: The extended EGFR panel achieved a sensitivity of 92% (L858R) and 95% (T790M) both at 100% specificity, and 86% sensitivity for exon 19 indels at 94% specificity in patients with M1b extra-thoracic disease. Including the challenging patients with intrathoracic (M0/M1a) disease resulted in a sensitivity of 90% (L858R), 83% (T790M) and 73% for exon 19 indels. "This a game-changer for liquid biopsies," stated Steven Silverman, VP and General Manager of Bio-Techne's Exosome Diagnostics brand. "The results from this validation study shows not only that our proprietary technique increases the performance of liquid biopsy mutation assays, but it can also be used to measure changes on the RNA transcriptome. In addition, we can enrich for exosomes derived from specific tissues using surface markers, making it possible to profile the RNA transcriptome from those tissue-specific cells in the biofluids." ]]> https://biospectrumindia.com/news/57/13812/bruker-launches-timstof-flex-with-esi-and-maldi-for-spatialomx.html https://biospectrumindia.com/news/57/13812/bruker-launches-timstof-flex-with-esi-and-maldi-for-spatialomx.html Wed, 05 Jun 2019 13:00:00 +0530 A. SpatialOMx Life Sciences and Translational Mass Spectrometry Imaging Bruker introduces the novel timsTOF fleX mass spectrometer, which includes a software-switchable MALDI source adapted to the ESI timsTOF Pro platform. This new, combined ESI/MALDI capability enables spatially-resolved omics, SpatialOMx , on a single instrument. The timsTOF fleX comes with Bruker’s proprietary 10kHz SmartBeamTM 3D laser with true pixel fidelity for rapid, label-free MALDI imaging at high-spatial resolution, while fully preserving the unparalled 4D proteomics and phenomics sensitivity of the timsTOF Pro in ESI mode. With this unique SpatialOMx approach, researchers gain insights into spatial molecular distributions in tissues from MALDI imaging, to guide 4D omics molecular expression studies, e.g. on proteins, low-level cancer antigen peptides, lipids, glycans, metabolites, or xenobiotics, which cannot be observed by traditional staining or labelling techniques. MALDI-guided SpatialOMx allows for specific targeting of cell sub-populations for subsequent ESI-TIMS/PASEF-based dda or dia 4D proteomics or 4D lipidomics/metabolomics. Both can now be performed on a single robust instrument, the timsTOF fleX, with the ultra-high sensitivity needed to advance single-cell biology research, as a perfect complement to single-cell transcriptomics by RNA-seq. Professor Richard Drake, Director of the Proteomics Center at the Medical University of South Carolina, stated: “The data from our samples using the new timsTOF fleX system was unprecedented in terms of spatial resolution and depth of glycan coverage. As glycans are emerging as potential clinical markers in tissue and serum to monitor overall immune status, and healthy or unhealthy aging, the unique capabilities of the timsTOF flex will greatly accelerate these efforts. The timsTOF flex allows our cumulative approaches that we have developed for tissue and biofluid analysis of cancers and immunotherapies to converge on one platform. I can see unlimited applications of such an instrument in many research areas for rapid glycan tissue imaging and biofluid 4D omics analysis.” Dr. Rohan Thakur, Executive Vice President at Bruker Daltonics, added: “Most tissue proteomics studies blend cells from diverse sub-populations, with an undesirable averaging effect that obscures a lot of important biology and pathobiology. MALDI-guided spatialOMx on the timsTOF fleX enables the profiling of spatially-defined tissue regions, thereby allowing subsequent 4D proteomics to selectively target cell-type sub-populations. The robust, ultra-high sensitivity timsTOF fleX bridges the divide between molecular tissue imaging and body fluids analysis by offering nanoLC-TIMS-MS/MS on the same instrument. This unique combination will make the timsTOF fleX an invaluable research tool for spatially-resolved 4D proteomics and phenomics, as well as for advancing single-cell biology, pharmaco-proteomics, and translational 4D cross-omics workflows on large cell numbers or patient cohorts.” Bruker is also launching IntelliSlides specifically designed to automate timsTOF fleX workflows. The IntelliSlides come pre-inscribed with software-readable ‘teach marks’ on the conductive surface to indicate where to place the tissue sample, a bar code and tracking number. IntelliSlides automation removes sources of inefficiency from sample loading, as they are inherently correctly labelled, oriented properly, and MALDI image registration occurs at the touch of a button. With specialized software, IntelliSlides now make MALDI Imaging even easier for everyone.  Moreover, Bruker introduces SCiLS Lab 2020 MALDI imaging software, now integrated with MetaboScape5.0 for providing automated annotations of lipids and metabolites in tissue molecular images in spatialOMx. This unique combination automatically matches ions measured on tissue to molecular information in metabolomics and lipidomics workflows, highlighting biologically relevant pathway information using MALDI imaging. Dr. Daniel Krug, Assistant Professor at the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), commented: “We use mass spectrometry in the fields of pharmaceutical research and spatial metabolomics. This includes in particular the analysis of myxobacterial secondary metabolomes for novel natural products. Our lab has been using Bruker’s instrumentation and software for years, in particular SCiLS Lab and MetaboScape. The new molecular imaging workflow that integrates both of these software solutions greatly simplifies and speeds up the entire MALDI imaging pipeline. It translates ion images into molecular images with confidence in the annotated molecules.” The new integrated imaging and metabolomics workflow also supports data from Bruker’s scimaX MRMS platform, as well as from the new timsTOF fleX. MetaboScape’s unique T-ReX 2D algorithm performs feature extraction, de-isotoping, and ion deconvolution on MALDI imaging datasets. Within MetaboScape, molecular features are annotated based on accurate mass and isotopic fidelity using SmartFormula and molecular information, e.g. from public databases such as HMDB and LipidMaps. MetaboScape now also offers the unique ability to increase ID scoring confidence by integrating accurate TIMS collision cross-sections (CCS) from timsTOF analyses. Identifications flow back to SCiLS Lab for fully annotated molecular images. SCiLS Lab is the market-leading software for MS imaging, while MetaboScape is the software solution of choice for identification of metabolite markers and pathway mapping. B. 4D Proteomics and 4D Phenomics InnovationsdiaPASEF and MBR-ddaPASEF Advances in 4D Proteomics Bruker’s revolutionary timsTOF Pro for next-generation nLC-TIMS-MS/MS 4D proteomics has been further enhanced by combining PASEF with data-indepedent (DIA) acquisition, in diaPASEF for ultra-high sensitivity bottom-up proteomics. While the unmatched duty-cycle of data-dependent acquistion (DDA) PASEF dramatically improved sensitivity and depth of coverage using short nanoLC runtimes, the stochastic nature of DDA results in missing values, an issue significantly improved by diaPASEF workflows, or by match-between-runs (MBR) for ddaPASEF. The novel diaPASEF¹ workflow, shown at ASMS 2019 as work-in-progress available to methods development customers, uses overlapping windows in the ion mobility domain to trigger MS/MS, efficiently using the quadrupole to transmit the precursor ions at high sensitivity. By using the inherent duty-cycle advantage of PASEF, the new diaPASEF workflow typically results in a 30% improvement, now with over 7,000 proteins identified in a 120 minute single-shot experiments with 200 ng of HeLa digest injected. Data analysis, including 4D feature alignment in mass, retention time, ion mobility and intensity, is performed using the new Mobi-DIK software, which is based on the OpenMS software developed in the group of Professor Hannes Roest at the University of Toronto. Dr. Gary Kruppa, Bruker’s Vice President of Proteomics, explained: “Adding the diaPASEF workflow is a major step forward in addressing the missing values problem in bottom-up proteomics, and in improving label free quantification (LFQ). The timsTOF Pro is fast gaining a reputation of delivering increased depth of coverage using short gradients, and for providing industry-leading robustness due to its orthogonal source and dual-TIMS funnel design. Furthermore, peptide CCS values obtained on the timsTOF Pro are proving fundamental to increasing protein ID numbers in diaPASEF workflows, and also in using CCS for match-between-runs (MBR) in ddaPASEF, in order to further improve data completeness and LFQ performance at low protein abundance. We would like to thank our scientific partners Drs. Matthias Mann, Ruedi Aebersold, Ben Collins and Hannes Roest for the most fruitful diaPASEF collaboration, and Dr. Juergen Cox for the excellent further progress with MBR-ddaPASEF.” Dr. Juergen Cox, Group Leader of Computational Systems Biochemistry at the Max-Planck Institute of Biochemistry in Martinsried, stated: “We have developed a highly parallelizable 4D feature detection algorithm for timsTOF Pro datasets that extracts peaks which are assembled to isotope patterns, followed by mass re-calibration using non-linear fitting of m/z, and also alignment in retention time, ion mobility and signal intensity. The missing value problem in label-free protein quantification over many samples can now be greatly reduced by MS1-level CCS-aware match-between-runs (MBR)², resulting in significantly improved assay precision and accuracy using a benchmark.” New Consumables and Software for 4D ProteomicsBruker and PreOmics GmbH announced a co-development and co-markting agreement, which will focus on PreOmics iST sample preparation technology on the timsTOF Pro. The inStageTip (iST) technology removes detergents, polymers, salts, lipids and other contaminants, and has exceptional peptide recovery. New iST protocols enable robust and reproducible sample preparation with a significant time advantage (over 40 hrs saved) compared to common protocols, and iST is suitable for integration in semi-automated, high-throughput sample prep. Drs. Nils Kulak and Garwin Pichler, Managing Directors at PreOmics, commented: “We are very excited to work with Bruker on end-to-end workflows that make protein analysis simply better, and to share these improvements with our highly valued academic and biopharma customers around the world. We are convinced that the power of the timsTOF Pro for 4D proteomics is a perfect match for our iST sample processing technology.” For proteomics software, Bruker and Genedata announced a partnership for the Genedata Expressionist software platform, which now supports the timsTOF Pro 4D omics format. Native support of the latest timsTOF Pro data file format opens new opportunities for streamlining and automating the most complex proteomics, metabolomics and biotherapeutics characterization studies. The power of intelligent precursor selection for deep proteome coverage with fast gradients of the timsTOF Pro in combination with the scalability and speed of Genedata Expressionist enables the implementation of a next-generation host cell protein (HCP) analysis platform. Dr. Peter Hufnagel, Life Sciences Software Manager at Bruker, expanded: “Our API-driven open data file format philosophy is helping to accelerate the adoption of timsTOF data into many important third party software solutions. Incorporation into Genedata Expressionist is an important further step requested by mutual biopharma customers for HCP analysis, and this was rapidly accomplished by Genedata due to our open file format architecture.” Dr. Markus Brosch, Business Unit Head for Genedata Expressionist, said: “Genedata Expressionist® builds on its proven proteomics capabilities to identify and quantify host cell proteins (HCPs) right down to the detection limit. It uniquely supports a wide range of HCP search and analysis strategies leveraging a high-performance enterprise architecture, offering unprecedented speed and scalability required to process large volumes of complex proteomics data. Our joint customers can now not only automate and accelerate HCP analysis, but utilize one software platform for all their needs across proteomics, metabolomics and biotherapeutics characterization.” Novel Ultra-high Sensitivity 4D Lipidomics Workflow Building on the success of MetaboScape and CCSPredict, Bruker announces advances to ultra-high sensitivity 4D lipidomics workflows on the timsTOF Pro and timsTOF fleX platforms, demonstrating high-throughput and high-sensitivity measurements using LC-TIMS-MS/MS. Optimization of novel PASEF 4D lipidomics methods now enables the number of identified lipids in single-shot analysis to be almost doubled, whilst obtaining attomole sensitivity. This innovative workflow uses nanoLC-TIMS-PASEF to quantify approximately 500 lipids with very high quantitative accuracy and reproducibility from just a few thousand cells, in addition to building a library of more than 1,000 accurate CCS values from human plasma, mouse liver and human cancer cells. Dr. Florian Meier, postdoctoral fellow at Max-Planck Institute of Biochemistry and senior author of the study³, added: “Our study establishes 4D lipidomics and paves the way for more sensitive lipidomics using PASEF. The precision and accuracy obtained using TIMS can be leveraged to facilitate lipid assignment, in addition to the comprehensive MS/MS information generated by PASEF. Additionally, high-precision CCS values provide a basis for machine learning techniques to predict CCS values more accurately and for a broader range of lipid classes.” Parallel accumulation serial fragmentation combined with data independent acquisition (diaPASEF): Bottom up proteomics with near optimal ion usage, by Florian Meier, Andreas-David Brunner, Max Frank, Annie Ha, Eugenia Voytik, Stephanie Kaspar-Schoenefeld, Markus Lubeck, Oliver Raether, Ruedi Aebersold, Ben C Collins, Hannes L Rost, and Matthias Mann. www.biorxiv.org/content/10.1101/656207v1  MaxQuant software for ion mobility enhanced shotgun proteomics, by Nikita Prianichnikov, Heiner Koch, Scarlet Koch, Markus Lubeck, Raphael Heilig, Sven Brehmer, Roman Fischer, Jürgen Cox. www.biorxiv.org/content/10.1101/651760v1 Trapped ion mobility spectrometry (TIMS) and parallel accumulation - serial fragmentation (PASEF) enable in-depth lipidomics from minimal sample amounts, by Catherine G Vasilopoulou, Karolina Sulek, Andreas-David Brunner, Ningombam Sanjib Meitei, Ulrike Schweiger-Hufnagel, Sven W. Meyer, Aiko Barsch, Matthias Mann, and Florian Meier. www.biorxiv.org/content/10.1101/654491v1 ]]> https://biospectrumindia.com/news/57/13809/new-efficacy-tests-independently-prove-lanxess-virkon-s-and-virkon-lsp-highly-effective-against-asf.html https://biospectrumindia.com/news/57/13809/new-efficacy-tests-independently-prove-lanxess-virkon-s-and-virkon-lsp-highly-effective-against-asf.html Tue, 04 Jun 2019 17:25:00 +0530 With African Swine Fever (ASF) continuing its rapid spread across Europe, China and Southeast Asia, and with no vaccine or other medical treatment currently available, specialty chemicals company LANXESS recently submitted their premium livestock veterinary disinfectants, Virkon S and Virkon LSP, for independent evaluation against the virus. The efficacy testing for both was undertaken by the Centre for Animal Health Research (CISA) in Madrid, Spain, in accordance with the EN 14675 test method, which was modified to enable testing against the ASF virus. CISA is the European Union reference laboratory for ASF  since 2002. Virkon LSP achieved complete inactivation of the ASF virus at a 1:400 dilution rate with a 10 minute contact time, with Virkon S killing the pathogen in just 5 minutes at 1:200 dilution. The test method employed included the presence of high organic soiling, hard water and was conducted at low temperature (10˚C), in order to assess both Virkon S and Virkon LSP’s performance and suitability for use in real world ‘on-farm’ conditions.  “These new test results provide independently proven data on the ability of Virkon S and Virkon LSP to effectively and completely kill the African Swine Fever virus rapidly, in real farm conditions,” Stephan Cho, Head of Market Segment Disinfection in the Material Protection Products business unit (MPP) at LANXESS, explains. “Implementing strict biosecurity barrier controls is the only real and proven way of stopping the spread of ASF from one swine production facility to another,” Cho continues. “Therefore, producers need to achieve the highest possible levels of biosecurity, utilizing independently proven effective disinfectants, to help prevent and control the spread of this catastrophic disease”. As part of their commitment to providing biosecurity advice and support, LANXESS has developed the Virkon 360° approach to biosecurity, focusing on the key elements of biosecurity best practice for surfaces, equipment, air, and drinking water delivery systems. In addition, the company is offering global swine producers timely advice on the clinical symptoms of ASF and guidance on implementing enhanced biosecurity best practice protocols across the range of possible infection vectors, including, transport and service vehicles, animal housing, moveable equipment, personnel and visitors, footwear, wild boar, other animals and birds.  Virkon – the science to kill pathogens “Virkon disinfectants are scientifically formulated to address the major disease concerns facing modern livestock production. These formulations, based on extensive scientific research, offer swine producers disinfectant solutions with performance characteristics that have defined biosecurity standards for over 30 years, making them the disinfectants of choice to help prevent and control the spread of epidemic diseases such as ASF,” adds Cho. ]]> https://biospectrumindia.com/news/57/13801/thermo-fisher-extends-industry-leading-mass-spectrometry-portfolio.html https://biospectrumindia.com/news/57/13801/thermo-fisher-extends-industry-leading-mass-spectrometry-portfolio.html Tue, 04 Jun 2019 11:25:00 +0530 Thermo Fisher Scientific Inc. the world leader in serving science, is accelerating the pace of innovation in the lab with the introduction of a new generation of intelligence-driven mass spectrometry instruments, workflows and software. The company will showcase these new additions to its industry-leading offering during the 67th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, being held June 2–6, in Atlanta, Georgia. "We recognized the ability to transform the mass spectrometry market when our groundbreaking Orbitrap mass analyzer technology was presented 20 years ago at ASMS," said Dan Shine, senior vice president and president of analytical instruments for Thermo Fisher Scientific. "As the demand for high-performance, accurate analytical instruments and innovative software continues to evolve, we are excited to introduce new technology that will allow scientists to acquire data more quickly and with greater accuracy than ever before. We are pushing the pace of discovery in protein research with the launch of new mass spectrometers that enable unprecedented proteome analysis, down to the level of single-cell analysis." High-performance mass spectrometers advance protein-based analysis Leading the new-generation mass spectrometry (MS) platforms is the Thermo Scientific Orbitrap Exploris 480 mass spectrometer. This innovative new system is designed to combine proven technology, advanced capabilities and intelligence-driven data acquisition techniques to enable researchers to deploy MS for more rigorous, high-throughput protein identification, quantitation and structural characterization. With a smaller footprint than previous generations, the new system maintains high-resolution, mass accuracy and spectral quality, and includes new features to extend uptime and improve serviceability. In addition, the new Thermo Scientific Orbitrap Eclipse Tribrid mass spectrometer provides scientists in academic, government and biopharmaceutical labs with access to a high-performance Orbitrap Tribrid mass spectrometer featuring flexibility and built-in intelligence to drive critical insights and enable technology breakthroughs. The system incorporates important advancements that improve sensitivity over previous generations and expand the ability to characterize and quantify complex biomolecules and biological systems.  Both new systems can be combined with the Thermo Scientific FAIMS Pro interface, a differential ion-mobility device, offering labs access to a comprehensive solution that improves selectivity and provides increased productivity across a range of proteomics workflows. Single, high-resolution workflow for monitoring protein therapeutics  The Thermo Scientific HR Multi-Attribute Method (MAM) is designed to meet the demand for a single, high-resolution mass spectrometry-based workflow to directly assess the quality of increasingly complex biotherapeutics. The workflow replaces the complicated sequence of lower-resolution methods that have previously prolonged characterization timelines. Supported by Thermo Scientific Chromeleon Chromatography Data System (CDS) software, the HR MAM method simplifies and standardizes biotherapeutic characterization throughout the product development pipeline, expediting the transition of new drugs from initial research to development and manufacturing.  Software enhancements deliver improved performance, usability and connectivity New enhancements to Thermo Fisher’s leading analytical software solutions now bring Thermo Scientific Compound Discoverer Software, Mass Frontier Software and mzCloud/mzVault libraries together to help customers identify unknown compounds and compare them to known compounds across multiple databases – whether connected to the cloud or offline. Scientists can also benefit from Thermo Scientific TraceFinder Software 5.0, which offers quicker and easier access to important information from Thermo Scientific TSQ Quadrupole and Q Exactive Hybrid Quadrupole-Orbitrap mass spectrometry platforms.  Additionally, the Thermo Scientific Almanac web-based application can be readily integrated by labs, enabling users to remotely access instruments to monitor run status and data acquisition in real time through a browser or mobile device, whether or not they are in the lab.  Events, meetings and workshops at ASMS 2019 Thermo Fisher is hosting several users' meetings and software and breakfast workshops during ASMS 2019. ]]> https://biospectrumindia.com/news/57/13792/obp-launches-cordless-surgical-retractor-with-multi-led-light-source.html https://biospectrumindia.com/news/57/13792/obp-launches-cordless-surgical-retractor-with-multi-led-light-source.html Mon, 03 Jun 2019 15:35:00 +0530 obp, the leading global developer of single-use, self-contained, illuminating medical devices has recently announced the launch of ONETRAC LX, a new and improved line of single-use, cordless surgical retractors with an integrated multi-LED light source and dual smoke evacuation channels. “The commercialization of ONETRAC LX represents a significant milestone for obp,” said Jason Swift, CEO of obp. “We have developed this product based on feedback from surgeons and healthcare practitioners around the world who are seeking state-of-the-art surgical pocket lighting coverage all in a compact single-use cordless retractor. ONETRAC LX is the first of its kind offering both surgeons and operating room nurses maximum smoke clearance capabilities with our integrated dual smoke evacuation system built into each unit.” The Occupational Safety and Health Administration (OSHA) estimates that 500,000 healthcare workers are exposed to surgical smoke each year. Not only can surgical smoke obstruct a surgeon’s view of the surgical site, but it has been shown to contain dangerous contaminants that impact both the patients and healthcare practitioners – including toxic gases, viruses, bacteria, as well as many other potentially hazardous materials. In fact, several states are beginning to address these concerns, including recent regulations in Colorado and Rhode Island requiring facilities to adopt and implement a policy that prevents human exposure to surgical smoke through the implementation of a surgical smoke evacuation system. ONETRAC LX effectively retracts, illuminates and evacuates surgical smoke, all with one fully integrated device. Within seconds, ONETRAC LX effectively provides illumination and smoke evacuation in the depths of a surgical pocket. ONETRAC LX comes complete with a fully integrated multi-LED light source enabling surgeons to choose their optimal lighting configuration and brightness level along the blade. Fiber-optic surgical retractors typically require the use of a fiber-optic cord and external light source, which generate a significant amount of potentially harmful heat and can be a fire hazard if not managed properly. By removing fiber-optic cords, ONETRAC LX addresses the fire hazard risk while providing cooler illumination. This ready-to-use device eliminates the time and expense associated with cleaning and preparing devices for reuse, while reducing the risk of cross-contamination in the surgical setting by making reusable devices obsolete. Each ONETRAC LX unit comes out of the package ready for use – with no additional parts, components, fiber-optic cords or additional assembly required. ONETRAC LX is ideal for breast and reconstructive procedures as well as other surgical procedures requiring access, illumination and retraction of soft tissue. ]]> https://biospectrumindia.com/news/57/13791/headaterm-receives-approval-by-tga-australia-.html https://biospectrumindia.com/news/57/13791/headaterm-receives-approval-by-tga-australia-.html Mon, 03 Jun 2019 15:20:00 +0530 WAT Medical, a company that develops safe, effective, and user-friendly wearable medical products, recently announced that HeadaTerm, its migraine treatment product, has received official clearance from TGA Australia. With a team of devoted staff leading in the field of medical research and development, an efficient and convenient medical service is being provided for individual customers worldwide. The mission is to supply innovative self-care medical devices. Homemed is WAT Medical's partner in Australia that has made great contributions to its TGA certification, and it is part of the BMedical Group Pty Ltd. It is a web-based store for the BMedical group offering a complete selection of products to aid in the treatment of sleep apnea, snoring, and insomnia across Australia and New Zealand. After WAT Medical's leading product that treat migraines, HeadaTerm, received its clearance from FDA (US), HC (Canada), CE (EU), it has now also received official clearance from TGA Australia at the end of April 2019. TGA ensures that all of its certified medical products are of the highest quality and provide the best care for patients to improve their lives. WAT Medical has reached its long-awaited milestone and is pleased to introduce its innovative technology to Australia. The product is widely used in a variety of treatments including migraine and insomnia. HeadaTerm uses neuromodulation by sending precise electrical pulses to the target area in the brain responsible for endorphin release. HeadaTerm relieves migraine within a few minutes after initial headache, and can also be an effective preventive measure by reducing the frequency and intensity of migraine attacks. ]]> https://biospectrumindia.com/news/57/13789/boehringer-ingelheim-gubra-collaborate-for-the-development-of-anti-obesity-peptide-poly-agonists.html https://biospectrumindia.com/news/57/13789/boehringer-ingelheim-gubra-collaborate-for-the-development-of-anti-obesity-peptide-poly-agonists.html Mon, 03 Jun 2019 15:00:00 +0530 Boehringer Ingelheim and Gubra announce a second collaboration and license agreement for the development of novel poly-agonist peptides to treat obesity. It will bring together Gubra’s established expertise in the design, synthesis, pharmaceutical characterization and in vivo testing of therapeutic peptides with Boehringer Ingelheim’s expertise in the research and development of innovative medicines in cardiometabolic diseases. This second joint research and development program between Boehringer Ingelheim and Gubra builds on a successful ongoing collaboration in the obesity field, which was launched in 2017, and which has already achieved important milestones. It contributes to the growing Boehringer Ingelheim research and development stage portfolio in the obesity field. “We look forward to expanding our productive collaboration with the Gubra team,” said Clive R. Wood, Ph.D., Corporate Senior Vice President Discovery Research at Boehringer Ingelheim. “I anticipate that these programs will help us bring much needed new treatment options for obesity patients.” Boehringer Ingelheim has built a broad portfolio of marketed products for thromboembolic diseases, type 2 diabetes, acute stroke and myocardial infarction, hypertension and cardiovascular death risk reduction. With its extensive experience in the field and commitment to innovation, the company aims to transform the lives of people with cardiometabolic diseases. Henrik Blou, CEO of Gubra said, “We are very pleased to enter into a second collaboration and license agreement with Boehringer Ingelheim focusing on the treatment of obesity. It is important for Gubra to find strong partners for our proprietary research programs, and our first collaboration with Boehringer Ingelheim has shown that the strengths of both companies are nicely complementary. Joining forces on this novel research program has the potential to take obesity treatment to the next level to the benefit of patients around the world.”   ]]> https://biospectrumindia.com/news/57/13777/boehringer-ingelheim-and-gubra-collaborate-to-treat-obesity-.html https://biospectrumindia.com/news/57/13777/boehringer-ingelheim-and-gubra-collaborate-to-treat-obesity-.html Mon, 03 Jun 2019 12:00:00 +0530 Boehringer Ingelheim and Gubra announce a second collaboration and license agreement for the development of novel poly-agonist peptides to treat obesity. It will bring together Gubra’s established expertise in the design, synthesis, pharmaceutical characterization and in vivo testing of therapeutic peptides with Boehringer Ingelheim’s expertise in the research and development of innovative medicines in cardiometabolic diseases. This second joint research and development program between Boehringer Ingelheim and Gubra builds on a successful ongoing collaboration in the obesity field, which was launched in 2017, and which has already achieved important milestones. It contributes to the growing Boehringer Ingelheim research and development stage portfolio in the obesity field. Boehringer Ingelheim has built a broad portfolio of marketed products for thromboembolic diseases, type 2 diabetes, acute stroke and myocardial infarction, hypertension and cardiovascular death risk reduction. With its extensive experience in the field and commitment to innovation, the company aims to transform the lives of people with cardiometabolic diseases. Henrik Blou, CEO of Gubra said, “We are very pleased to enter into a second collaboration and license agreement with Boehringer Ingelheim focusing on the treatment of obesity. It is important for Gubra to find strong partners for our proprietary research programs, and our first collaboration with Boehringer Ingelheim has shown that the strengths of both companies are nicely complementary. Joining forces on this novel research program has the potential to take obesity treatment to the next level to the benefit of patients around the world.”   ]]> https://biospectrumindia.com/news/57/13776/argon-medical-devices-acquires-mana-tech-ltd-.html https://biospectrumindia.com/news/57/13776/argon-medical-devices-acquires-mana-tech-ltd-.html Fri, 31 May 2019 13:00:00 +0530 Argon Medical Devices, Inc., a global manufacturer of specialty medical devices used in interventional procedures, announced that it has completed the acquisition of Mana-Tech, Ltd., its exclusive distributor for the United Kingdom and Ireland. "The acquisition of Mana-Tech, Ltd. represents a compelling growth opportunity to expand our commercial reach in the UK, Ireland and throughout Europe," George Leondis, President and Chief Executive Officer of Argon Medical Devices, commented. "We are excited to have this very talented group join Argon and to work even more closely with them to continue their successful growth trajectory." The entire Mana-Tech team, including its management, sales, customer service and distribution groups, will join Argon as part of the acquisition. ]]> https://biospectrumindia.com/news/57/13775/tespo-launches-nature-made-multivitamin-pods-for-women-and-men.html https://biospectrumindia.com/news/57/13775/tespo-launches-nature-made-multivitamin-pods-for-women-and-men.html Fri, 31 May 2019 11:35:00 +0530 Tespo, a home health technology company, today announced that Nature Made-branded Tespo Pods are available for purchase. This milestone furthers Tespo's leadership position as a platform for delivering in-home healthcare and technology that is desired by the best brands across consumer health & wellness, as well as healthcare. The Nature Made Multi for Her and Nature Made Multi for Him Pods are the first products that expand the footprint of the Tespo platform, and are offered alongside Tespo's Personalized and pre-formulated Men's, Women's and Children's vitamin and supplement Pods. Tespo Pods deliver premium active ingredients with fewer added fillers. Each Nature Made Multi Pod is formulated to help people fill potential nutrient gaps and support their health. Tespo customers simply place a Pod into the sleekly designed Tespo Connect – a Wi-Fi connected, countertop vitamin dispenser – and an individual serving gets mixed with water to become a small liquid vitamin serving at the push of a button. The Tespo dispenser syncs with an app allowing consumers to earn rewards and drive better adherence in their daily vitamin and supplement routine that will, likely, result in improved health outcomes. "Our platform merges smart technology capable of delivering a N-of-1 model, with a direct to consumer delivery system of the best, freshest ingredients that people can drink in a cup," said Ted Mills, CEO and Co-founder of Tespo. "We believe we will continue to attract the best brand partnerships, and this is evidenced by Nature Made—the #1 trusted vitamin and supplement brand—coming on board as our inaugural partner." "Pharmavite is committed to driving innovation in the vitamin industry and launching Nature Made Pods on the Tespo platform is an important part of delivering on that promise," said Tobe Cohen, EVP and Chief Science, Technology and Innovation Officer at Pharmavite, the makers of Nature Made vitamins. "Tespo is a pioneer in re-imagining how consumers can leverage supplements to lead healthier lives, and we're proud to collaborate with them to offer the highest quality nutrition solutions to people seeking new delivery forms." ]]> https://biospectrumindia.com/news/57/13773/sema4-launches-new-genomic-testing-and-digital-tools-for-use-in-oncology.html https://biospectrumindia.com/news/57/13773/sema4-launches-new-genomic-testing-and-digital-tools-for-use-in-oncology.html Fri, 31 May 2019 11:30:00 +0530 Sema4, a patient-centered health intelligence company, has announced the launch of several new genomic testing services and digital tools to help oncologists deliver on the promise of precision medicine. Together, these products provide a comprehensive approach that can be used throughout a patient’s journey, from assessing risk to analyzing cancer and monitoring in remission. Demonstrations of the products will be available at Sema4’s booth (#7140) at the American Society for Clinical Oncology 2019 Annual Meeting taking place in Chicago from May 31 to June 4. Sema4’s new genomic profiling solution that will soon be available for oncology includes whole exome sequencing (for tumor and normal samples) and whole transcriptome sequencing (for tumor samples only). Based on 250x tumor coverage and 100x normal coverage across all genes, with 100 million RNA reads, these services provide clinically actionable information about a broad range of genomic variants, gene fusion and alternative splicing, and tumor mutational burden and microsatellite instability. The services are designed for use with FFPE, bone marrow, blood, or saliva samples. The new digital tools are built on Sema4’s innovative Centrellis™ health intelligence platform and are currently used for research purposes. They include: Patient Journey — providing an interactive timeline visualization of the patient’s health journey, complete with diagnoses, treatments, molecular profiles, and more Cohort Builder — offering the ability to define groups of patients according to specific parameters such as stage, histology, and treatments to understand treatment patterns, identify appropriate clinical trials, and enable data-driven decisions about patient care VONC — automated variant curation platform pulling from a wide array of databases to support curation of genetic information at scale with the most relevant clinical evidence to inform therapy decisions Clinicians at the Mount Sinai Health System, together with Sema4, have been jointly developing and piloting these digital tools for application in oncology. “Sema4 is helping the objectives of the Tisch Cancer Institute because it’s aggregating clinical data sets on our patients. Marrying that with the genomic information and deploying it in usable tools is allowing us to have better insights about what’s happening in our patient population,” said Ramon Parsons, MD, PhD, Director of the Tisch Cancer Institute and Chair of the Department of Oncological Sciences at Icahn School of Medicine at Mount Sinai. William Oh, MD, Chief of the Division of Hematology and Medical Oncology at Mount Sinai and Deputy Director of the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai commented: “Working with a large healthcare system and as a practicing oncologist myself, the most important thing is getting this molecular data and the informatics in a timetable that allows me to continue to take care of my patients. Working with a company like Sema4 allows us to make the best decisions for our patients to get the best possible outcomes.” According to Andrew Kaufman, MD, Vice Chairman of the Department of General Thoracic Surgery at Mount Sinai, “In healthcare, like any other industry, we’re really looking for efficiency in connecting the dots of so much data. Sema4 has come up with a novel way to look at patient data that is extremely powerful. I use these tools almost like a Google search, looking up information about my patients’ clinical and scientific data to give each person the best care.” Elisa Port, MD, Chief of Breast Surgery and Director of the Dubin Breast Center at Mount Sinai, commented: “Sema4 is going to have a very widespread impact on the patients we treat here because the company’s tests open up the opportunity for genetic testing across a much broader base of patients and streamline and expedite the process. Sema4 helps us by quickly getting us the genetic testing information we need so we can make important clinical decisions about surgery options for each individual.” “Sema4’s mission to help physicians implement precision medicine is built on our deep foundation in data science and developing genomic tests,” said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. “Our team’s expertise in data mining, analysis, machine learning, and predictive modeling gives us a unique advantage in generating and making sense of information in ways that will give oncologists an edge in battling cancer, particularly when combined with advanced genomic profiling.” Sema4 is a patient-centered health intelligence company founded on the idea that more information, deeper analysis, and increased engagement will improve the diagnosis, treatment, and prevention of disease. Sema4 is dedicated to transforming healthcare by building dynamic models of human health and defining optimal, individualized health trajectories, starting in the areas of reproductive health and oncology.  ]]> https://biospectrumindia.com/news/57/13772/lantheus-collaborates-with-nanomab.html https://biospectrumindia.com/news/57/13772/lantheus-collaborates-with-nanomab.html Fri, 31 May 2019 11:25:00 +0530 Lantheus Holdings, parent company of Lantheus Medical Imaging, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents, today announced that it has entered into a strategic collaboration and license agreement with NanoMab, a privately-held biopharmaceutical company focusing on the development of next generation radiopharmaceuticals to be used in the development of immuno-oncology therapies. This collaboration will provide the first broadly-available imaging biomarker research tool to pharmaceutical companies and top academic centers conducting research and development on immuno-oncology treatments, including combination therapies. Since the first programmed cell death protein 1 (PD-1) inhibitors launched in 2014, the global checkpoint inhibitor market has grown to greater than $14 billion in 2018 and is anticipated to continue growing at a double-digit rate1. Currently more than 1,500 clinical trials on checkpoint inhibitors are ongoing according to the Cancer Research Institute, an increase of six fold in the last three years2. Although PD-(L)1 checkpoint inhibitors have achieved impressive results in certain patient populations, improving response rates and extending survival across multiple tumor types, challenges remain in optimizing the use of these therapies. Across tumor types, only about 20% of patients respond to treatment with checkpoint inhibitors, even with the use of PD-L1 immuno-histochemistry assays to select patients3. There is a need for biomarkers that improve utilization of immunotherapies by identifying those patients most likely to benefit from therapy, which may also serve to avoid unnecessary cost to patients and health systems. Under the collaboration agreement, Lantheus will license NanoMab’s NM-01, a proprietary radiopharmaceutical biomarker camelid single-domain antibody that has demonstrated a high affinity for PD-L1 protein. NM-01 could provide a specific, non-invasive approach to diagnosis, including use in whole-body imaging, or virtual biopsy. NM-01 potentially allows detection of PD-L1 expression in immuno-oncology studies, either before or during immuno-oncology treatment. Lantheus will provide NM-01 as a clinical research tool, together with support and analytics, to pharmaceutical companies and the largest academic centers conducting clinical research in immuno-oncology. “Our collaboration with NanoMab provides Lantheus the opportunity to extend our diagnostic and radiopharmaceutical expertise into the fast growing market of immuno-oncology,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “We already serve the oncology field with several radiopharmaceutical agents and are excited to work with NanoMab to bring the first broadly available PD-L1 imaging research tool to the global pharmaceutical community.” “NanoMab is proud to partner with Lantheus for the development and the commercialization of NM-01, as we think our unique technology can help progress innovation in immuno-oncology,” said Ting Hong Hoi, CEO of NanoMab. “Lantheus has the infrastructure, established expertise and the reach to best optimize the value of NM-01 for patients and our shareholders.” NM-01 is in Phase 1 clinical development with 21 patients currently enrolled in a study that will eventually recruit a total of 50 patients. The agent has a short half-life and provides diagnostically significant results in approximately two hours. Early Phase 1 study data was published in the February 22, 2019 issue of the Journal of Nuclear Medicine (Xing et al.). NanoMab plans to file an Investigational Medicinal Product Dossier (IMPD) in the United Kingdom in the second half of 2019. Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. NanoMab Technology Limited is a privately-held biopharmaceutical company focusing on the development of next generation radiopharmaceuticals for cancer precision medicine to address the unmet diagnostic and medical needs of cancer patients around the world. NanoMab’s goal is to develop a pipeline of theranostic couple camelid antibodies with its proprietary camelid antibodies platform to address the unmet diagnostic and medical need for cancer patients around the world.    1. GlobalData. Drug Sales and Consensus Forecast Advance Export - Drug Details: Immune Checkpoint Modulator.2. Cancer Research Institute. http://www.cancerresearch.org/scientists/clinical-accelerator/landscape-of-immuno-oncology-drug-development/pd-1-pd-l1-landscape. Accessed May 29, 2019.3. Xu-Monette Zy, Zhang M, Li J and Young KH (2017) PD-1/P-L1 Blockage: Have We Found the Key to Unleash the Antitumor Immune Response? Front. Immunol. 8:1597.doi: 10.3389/fimmu.2017.01597 ]]> https://biospectrumindia.com/news/57/13770/roche-and-ge-healthcare-launch-navify-tumor-board.html https://biospectrumindia.com/news/57/13770/roche-and-ge-healthcare-launch-navify-tumor-board.html Fri, 31 May 2019 10:55:00 +0530 Roche has announced the release of NAVIFY Tumor Board 2.0, the first collaboration product from a partnership with GE Healthcare. Incorporating medical image viewing and storage capabilities with other patient data, the product enables tumour boards - multi-disciplinary teams who determine treatment plans for cancer patients - to have a more comprehensive view of each patient in one place.Bringing together patient medical records from various systems for review by tumour boards can be time-consuming and cumbersome. The integration of GE Healthcare’s medical image viewer into NAVIFY Tumor Board 2.0 enables radiologists to upload their patient records to the same dashboard where patient files from other disciplines in the cancer care team are stored. Having complete patient diagnostic information in one location helps specialists use the limited time they have during tumour boards to review all relevant files quickly and align on the best possible treatment plan for each cancer patient. The partnership combines Roche expertise in advanced lab testing and the GE Healthcare leadership in medical imaging and monitoring to provide an ecosystem of workflow solutions and apps on an industry-first shared integrated diagnostics platform. The companies are aiming to design products to enable seamless integration and analysis of comprehensive lab and medical imaging data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have confidence that they are making the best possible treatment decision for each patient.The new version of NAVIFY Tumor Board is initially available in the United States and Canada with additional markets to follow in the near future. ]]> https://biospectrumindia.com/news/57/13767/merck-foundation-partners-with-the-first-lady-of-liberia-for-building-healthcare-capacity.html https://biospectrumindia.com/news/57/13767/merck-foundation-partners-with-the-first-lady-of-liberia-for-building-healthcare-capacity.html Fri, 31 May 2019 10:15:00 +0530 Merck Foundation, the philanthropic arm of Merck KGaA Germany together with The First Lady of Liberia, H.E. CLAR WEAH and Ministry of Health will launch new programs to build equitable healthcare capacity and break the infertility stigma in the country. H.E. CLAR WEAH, The First Lady of Liberia and Ambassador of Merck More Than a Mother emphasized, “We welcome Merck Foundation to launch our joint programs which are going to be very beneficial for our people. Their initiatives are very innovative in nature and will help changing the healthcare scenario of our country.” Dr. Rasha Kelej, CEO of Merck Foundation and President, Merck More Than a Mother explained, “We are very happy to underscore our long term commitment to build healthcare capacity in Liberia. We are also very proud to work closely with H.E. First Lady of Liberia as the ambassador of Merck more than a Mother campaign to raise awareness about infertility prevention, male infertility and define interventions to break infertility stigma. Moreover, we will be happy to provide training to Liberian doctors in the fields of Fertility, Diabetes and Cancer Care.” Merck Foundation together with the office of the First Lady of Liberia will work closely to introduce innovative ideas that will engage different sectors to create a culture shift with the aim to break the stigma of infertility and make a great impact in a short time. The initiatives include the Media Health Training organized recently for journalists and media students of Liberia. Also, applications were invited for their ‘Merck More than a Mother’ Media Recognition Award. Moreover, Merck Foundation will partner with local artists to create songs to address this topic and sensitize people across the country. In addition, the first-ever “Merck More Than a Mother’ Fashion Awards will also be announced in Liberia to involve local fashion industry to deliver the message of breaking the stigma of infertile women to the community in day to day life. Another important program to start in 2019 is the Merck Foundation Diabetes Blue Points project which will help improve access to equitable and quality diabetes care across Liberia by providing one-year on-line diabetes diploma doctors from different districts in Liberia. Every diploma graduate should be able to establish a diabetes clinic in his Health Centre or Hospital with the aim to help prevent and manage the disease in their respective communities. Merck Foundation has provided doctors enrollment from Liberia and shall continue enrolling for the next 5 years in their one year and two-year oncology fellowship program and Master degree program respectively as a contribution to improve cancer care in the country. Merck Foundation in partnership with Minister of Gender and Social Welfare, has provided embryology andclinical training on fertility specialty in the past two years and will further continue this program in partnership with Ministry of Health to improve access to quality and equitable fertility care in the country. ]]> https://biospectrumindia.com/news/57/13765/inova-diagnostics-quanta-flash-rf-igm-and-iga-get-fda-clearance.html https://biospectrumindia.com/news/57/13765/inova-diagnostics-quanta-flash-rf-igm-and-iga-get-fda-clearance.html Thu, 30 May 2019 15:40:00 +0530 Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of QUANTA Flash® Rheumatoid Factor (RF) IgM and QUANTA Flash RF IgA assays by the US Food and Drug Administration (FDA). These chemiluminescent assays complement Inova Diagnostics previously cleared QUANTA Flash CCP3 assay that detects anti-citrullinated peptide antibodies (ACPA) and expands the number of FDA-cleared assays available on BIO-FLASH®, a random access chemiluminescent system. Rheumatoid arthritis (RA) affects approximately one percent of the global population and leads to progressive and permanent joint damage. The American College of Rheumatology and the European League Against Rheumatism classification criteria include both RF and ACPA. RF IgM has been reported to be the main RF isotype in confirmed RA patients with a prevalence of 70-80%. RF IgA, while less prevalent than the IgM isotype, has been reported to be associated with more severe erosive disease and an increased likelihood for Sjӧgren's Syndrome or other extra-articular manifestations. There is also value in testing for multiple RF isotypes as the specificity and predictive value for RA increases when more than one isotype is positive.  ]]> https://biospectrumindia.com/news/57/13763/leica-biosystems-to-sell-its-digital-pathology-system-for-primary-diagnosis.html https://biospectrumindia.com/news/57/13763/leica-biosystems-to-sell-its-digital-pathology-system-for-primary-diagnosis.html Thu, 30 May 2019 15:25:00 +0530 Leica Biosystems, the global leader in pathology workflow solutions, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S. A multi-center study supporting this clearance was conducted with pathologists at 5 clinical study sites in the U.S.: University of California Davis, Pacific Rim Pathology, Dignity Health, TriCore Reference Laboratories, and Intermountain Healthcare. One of the largest clinical concordance studies ever completed on digital whole slide images, the participating pathologists read approximately 16,000 cases. The study compared reads of pathology slides under a microscope with on-screen digital reads.   The Aperio AT2 DX System is a high-throughput automated scanning and viewing platform. The platform will be launched commercially with clinical image management software for an integrated digital pathology workflow solution. ]]> https://biospectrumindia.com/news/57/13745/picosun-strengthens-its-presence-in-the-healthcare-industries.html https://biospectrumindia.com/news/57/13745/picosun-strengthens-its-presence-in-the-healthcare-industries.html Wed, 29 May 2019 16:30:00 +0530 Finland based Picosun Group, the global provider of AGILE ALD (Atomic Layer Deposition) thin film coating solutions, continues its breakthrough into healthcare industries by supplying ALD technology to produce bioactive coatings on surgical implants at a major, leading manufacturer. In the recent couple of years, healthcare industries have truly awakened to the endless possibilities ALD offers to them. As the population ages, the need for various 'spare parts' of the body, such as artificial hips, knee joints, dental implants, and stimulators for heart or brain functions grows. Along with the increasing miniaturization of implantable microelectronics and wireless sensors, remote health monitoring and therapeutics is also becoming commonplace. "Picosun has worked with medical companies for a long time, for example with Russian-based implant manufacturer Conmet LLC, and with Swedish Nanexa AB, who uses ALD for drug particle surface functionalization for targeted and controlled drug delivery. We also collaborate with several universities where medical ALD technology is developed. These projects have given us unique insight into this business, which is quite different from the semiconductor industries, the most typical 'playground' for ALD," says Mr. Juhana Kostamo, Managing Director of Picosun Group. The common fact to all implantable medical devices is that they need protection from the rather hostile environment inside human body. Body fluids are corrosive so the implant must be isolated from them, and vice versa - the body needs to be protected from possible rejection reaction or metal ion leakage caused by the implant. This is where ALD, with its capability to form intrinsically biocompatible, reliably hermetic and ultra-thin sealing around the implanted device, shows its strength. ALD encapsulation increases the implant lifetime and safety, potentially reducing the number of replacement surgeries or 'maintenance' operations of the implanted device. "Our PicoMEDICAL™ solutions are tailored especially to the needs of medical industries that are often still new to ALD. We provide not only the equipment, but the whole chain starting from application consultancy to equipment and process optimization, production ramp-up and comprehensive after-sales support to ensure our customers' production keeps running smoothly and with minimum downtime. We are happy that we have been chosen as the ALD solutions provider to a yet new prominent customer in this field. Our technology shows again its agility and the potential to improve the quality of life for so many implant patients now and in the future," continues Mr. Kostamo. Picosun provides the most advanced ALD thin film coating technology to enable the industrial leap into the future, with turn-key production solutions and unmatched expertise in the field. Today, PICOSUN™ ALD equipment are in daily manufacturing use in numerous major industries around the world. Picosun is based in Finland, with subsidiaries in Germany, North America, Singapore, Taiwan, China and Japan, offices in India and France, and a world-wide sales and support network.  ]]> https://biospectrumindia.com/news/57/13744/sygnature-discovery-renasci-strengthen-in-vivo-pharmacology-service-offering.html https://biospectrumindia.com/news/57/13744/sygnature-discovery-renasci-strengthen-in-vivo-pharmacology-service-offering.html Wed, 29 May 2019 15:35:00 +0530 Sygnature Discovery, a leading drug discovery and pre-clinical services company, have appointed Dr Nick Moore as Senior Director, Business Development, in a newly-created role to promote the in vivo pharmacology and consultancy services offered by RenaSci, a wholly-owned subsidiary company. Dr Moore is an internationally recognised drug discovery and development specialist who has spent nearly 40 years working in the field of in vivo pharmacology. Previous roles include research appointments at Eli Lilly, Lundbeck Research USA, and Albany Molecular Research Inc. (AMRI), and business development positions at Brains On-Line and Charles River Laboratories. He earned his PhD in neuropharmacology from the University of Birmingham and career highlights include a key involvement in the development of Lilly’s anti-psychotic drug Zyprexa (olanzapine).One of Dr Moore’s key tasks will be to ensure that the synergistic in vitro and in vivo services and drug discovery expertise offered by Sygnature Discovery and RenaSci are maximised for the benefit of clients. "I plan to focus on growing the in vivo pharmacology business and ensure that both current and new customers are aware of the expanded service-offering that the wider Sygnature Group is now able to provide", Dr Moore said."Nick is a very experienced drug discovery scientist who brings a huge amount of in vivo pharmacology know-how and proficiency into the business," said Dr Paul Clewlow, Sygnature Discovery’s Senior Vice President, Business Development and a member of the Board at Sygnature and RenaSci. "I am pleased that Nick has joined my team as he will work closely with colleagues at RenaSci and Sygnature to convey the enhanced capabilities and expertise we offer to clients and identify new in vivo pharmacology capabilities that will complement and augment our current integrated offering."RenaSci, founded in 2001, became part of the Sygnature Group in July 2018 following several successful project collaborations with joint clients. Sygnature and RenaSci were amongst the first companies to be established at BioCity Nottingham, the R&D site where Boots Pharmaceuticals discovered ibuprofen. The strategic acquisition of RenaSci by Sygnature stemmed from a long-standing mutual respect between the organisations and the firm belief by Sygnature that combining the two companies would be beneficial not only to their customers, but ultimately to patients with considerable unmet medical need in abuse and dependence, CNS disorders, obesity, diabetes, NASH and kidney disease."We realised that RenaSci and Sygnature Discovery were highly-complementary businesses because we have a strong shared focus on high-quality science and delivering new and efficacious drugs to patients," said Dr Sharon Cheetham, Assistant Professor and Executive Director at RenaSci. "I am delighted to welcome Nick to the Group and we look forward to working with him to expand our business and better serve our clients in the drug discovery and pre-clinical sector." Sygnature Discovery is a leading independent integrated drug discovery and pre-clinical services company. Private equity-backed since 2017, we operate fully enabled research facilities in Nottingham and Alderley Park, UK, housing over 200 research scientists (over 80% with PhDs). Our experienced drug hunters possess all the professional skills and know-how required to undertake the most demanding of research programmes and drive them from target validation through hit identification, hit-to-lead and lead optimisation to pre-clinical development candidate. Since 2011, we have delivered 14 drug candidates to our clients which have subsequently entered the clinic (Phases I, II and III). In 2017, Sygnature Discovery received the prestigious Queen’s Award for Enterprise for International Trade.  RenaSci provides an integrated blend of consultancy and experimental services to clients from all sectors of the pharmaceutical and biotech industry to help maximise research productivity and streamline drug development. Since the company was established in 2001, they have specialised in CNS, metabolic disorders, NASH, kidney disease and abuse/dependence testing; core areas of expertise where they have facilitated more than 30 NCE’s into clinical development and 10 drugs to the market. In July 2018 RenaSci was acquired to become part of the Sygnature Group of Companies. ]]> https://biospectrumindia.com/news/57/13731/ge-healthcare-launches-automation-software-for-cell-therapy.html https://biospectrumindia.com/news/57/13731/ge-healthcare-launches-automation-software-for-cell-therapy.html Tue, 28 May 2019 11:50:00 +0530 GE Healthcare builds on its digital capabilities with the Chronicle web application, the next generation development of my.Cryochain™ software now supporting the complete cell therapy workflow. Chronicle automation software is a GMP compliant fit-for-purpose digital solution designed to optimize complex cell therapy process development and manufacturing. With real-time supply chain tracking, hardware performance monitoring, SMS or email alarms, and comprehensive electronic batch records, Chronicle automation increases efficiency while meeting regulatory compliance.  Chronicle automation software capabilities include: a unified digital space that monitors all facility manufacturing operations and supply chain logistics with real-time data acquisition and notifications electronic batch records that trace every manufacturing step with automation to increase productivity, reinforce GMP compliance, and improve the security of patients’ samples through increased traceability eSOPs designed for specific processes to manage deviations, promote adherence to protocol, and provide guidance to ensure sensitive patient cells are handled appropriately ]]> https://biospectrumindia.com/news/57/13728/vifor-pharma-university-of-basel-jointly-establish-the-worlds-first-research-professorship.html https://biospectrumindia.com/news/57/13728/vifor-pharma-university-of-basel-jointly-establish-the-worlds-first-research-professorship.html Tue, 28 May 2019 10:50:00 +0530 Nanomedicines are playing an increasingly important role in the development of innovative new medications. These drugs are able to overcome specific cellular barriers in the human body with a view to targeting their effect even more precisely. Nanopharmacy, therefore, promises to help advance medical science and bring significant benefit to patients. At present, however, researchers are only just beginning to acquire the in-depth scientific insights needed for a fundamental understanding of the development of nanomedicines, their applications and especially the regulatory requirements for their approval across Europe and worldwide. Likewise, there is a lack of experts with the necessary specialist knowledge – and these experts are urgently needed in industry, at regulatory authorities and in medical practice, including in Switzerland. As with other areas of cutting-edge research, this will take the form of a global race: those able to present findings as quickly as possible will be able to assert themselves as a centre of excellence in nanopharmaceutics. Spread over 10 years, the commitment of CHF 10 million by the Vifor Pharma Group is intended to establish the field of nanopharmacy research at the University of Basel and to support the training of corresponding experts. The newly-created professorships in Nanopharmaceutical and Regulatory Science will be based at the Department of Pharmaceutical Sciences. There are also plans to establish and develop an internationally renowned Excellence Platform for the development, authorisation and application of nanopharmaceuticals, as well as the training of experts in the field. Vifor Pharma views its contribution as start-up funding for this Excellence Platform, which is supported and jointly endorsed by stakeholders from academia, industry and public authorities. The aim is for the platform to both focus on research and teaching, and also to seek out international partnerships, organise conferences and incorporate additional sponsors with a view to becoming a leading international centre for nanopharmacy. “In order to make rapid progress in nanopharmaceutics, we’re reliant on clear and scientifically sound parameters for authorisation and patient safety,” says Etienne Jornod, Executive Chairman of the Board of Directors at Vifor Pharma. “The field of nanopharmacy is growing quickly, and it’s important to secure a leading position in this innovative area of medicine with the help of qualified experts. That’s why we want to help ensure that Switzerland establishes a strong research foundation in this emerging area of pharmaceutical development.” For the University of Basel, this collaboration marks an important step in the further development of its life sciences focal area. “We’re proud to be able to develop this promising field of research in collaboration with a major industrial partner,” says Professor Andrea Schenker-Wicki, President of the University of Basel. “The crucial thing here is that we’re not only developing the scientific foundations, but also training the experts who will take this knowledge with them into industry and public authorities.” It is, she says, a key step for Basel and Switzerland in terms of their ability to compete on the international stage. Vifor Pharma Group is a global pharmaceuticals company headquartered in Switzerland. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. The Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care.  The University of Basel has an international reputation of outstanding achievements in research and teaching. Founded in 1460, the University of Basel is the oldest university in Switzerland and has a history of success going back over 550 years. As a comprehensive university offering a wide range of high-quality educational opportunities, the University of Basel attracts students from Switzerland and the entire world, offering them outstanding studying conditions as they work towards their bachelor’s, master’s or PhD degrees.  ]]> https://biospectrumindia.com/news/57/13722/fda-approves-the-novottf-100l-system-for-malignant-pleural-mesothelioma.html https://biospectrumindia.com/news/57/13722/fda-approves-the-novottf-100l-system-for-malignant-pleural-mesothelioma.html Mon, 27 May 2019 12:50:00 +0530 Novocure has announced that the U.S. Food and Drug Administration (FDA) has approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM). NovoTTF-100L is a non-invasive, antimitotic cancer treatment that delivers Tumor Treating Fields to the region of the tumor. Tumor Treating Fields therapy uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. NovoTTF-100L is the first treatment for MPM approved by the FDA in more than 15 years. Preclinical data showed that human mesothelioma cells are highly sensitive to Tumor Treating Fields.  MPM is a rare cancer that has been strongly linked to asbestos exposure. Approximately 3,000 people are diagnosed with MPM in the United States annually. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM. NovoTTF-100L for MPM is classified as a Humanitarian Use Device (HUD) and was approved under Humanitarian Device Exemption (HDE). The HDE pathway was created to encourage companies to innovate in rare diseases with underserved patient populations. The FDA approved Optune®, another Tumor Treating Fields delivery system, under the Premarket Authorization (PMA) pathway in 2011 for the treatment of glioblastoma (GBM). Since 2011, more than 12,000 patients with GBM have been treated with Tumor Treating Fields. Bill Doyle, Novocure’s Executive Chairman said, “Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer. FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and health care providers who partnered with us to make this possible.” Mary Hesdorffer, NP, Executive Director of the Mesothelioma Applied Research Foundation said, “MPM is a devastating disease, with only 10 to 20 percent of patients being candidates for surgery to remove the tumor. Typically, mesothelioma patients who cannot have surgery receive palliative care to mitigate their symptoms. NovoTTF-100L provides unresectable MPM patients with a treatment option that may improve survival. We are encouraged by the FDA approval and hope it is just the beginning of innovation in the treatment of this aggressive disease.” The FDA approval is based on the results of the STELLAR trial. STELLAR was a prospective, single-arm trial designed to study the safety and efficacy of NovoTTF-100L plus chemotherapy first-line in patients with unresectable MPM. The trial included 80 patients with unresectable and previously untreated MPM who were candidates for treatment with pemetrexed and cisplatin or carboplatin. In addition, the STELLAR trial demonstrated that NovoTTF-100L could be combined with chemotherapy. There was no increase in serious systemic adverse events when NovoTTF-100L was added to chemotherapy. ]]> https://biospectrumindia.com/news/57/13714/amprions-pmca-technology-receives-breakthrough-device-designation-from-u-s-fda.html https://biospectrumindia.com/news/57/13714/amprions-pmca-technology-receives-breakthrough-device-designation-from-u-s-fda.html Fri, 24 May 2019 15:55:00 +0530 Amprion has announced that its proprietary technology, Protein Misfolding Cyclic Amplification (PMCA) using CSF and plasma alpha-Synuclein (αS) to aid in the diagnosis of Parkinson's disease, received a Breakthrough Device designation from U.S. FDA. "Prions are proteins gone rogue. This is a small victory in our war against Prions," says Amprion CEO Russ Lebovitz, M.D./PhD. "We are honored and look forward to working closely with FDA to fast-track the development and review of our aS PMCA tests toward final regulatory approval. Early diagnosis of Parkinson's represents a giant leap for science to crack the code on this disease. Our goal is to stop Parkinson's on its destructive path." FDA's Breakthrough Devices Program is designed to speed up development, assessment and review of medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Parkinson's disease currently affects approximately 10 million people worldwide. Despite tremendous capital expenditures in research and drug development, there are still no effective treatments. Why? "There is no specific, sensitive and objective laboratory test for the diagnosis of Parkinson's disease presently. Patients are now diagnosed based on clinical symptoms, which means the disease is relatively advanced," explains Claudio Soto, PhD, Amprion's co-founder and chief scientific officer who also serves as professor of neurology at McGovern Medical School at UTHealth. "Our PMCA test tracks alpha-Synuclein, a protein that misfolds into toxic shapes in the brain and this likely begins decades before disease symptoms. Amprion's ability to monitor Misfolded Proteins at early stages is both significant and meaningful. This enables us to work with major pharmaceutical companies to develop Prion-targeted drugs to stop or slow the disease." Dr. Lebovitz acknowledges the support of three key partners in the development of Amprion's breakthrough technology: The Michael J. Fox Foundation for Parkinson's Research, National Institutes of Health SBIR/STTR programs and McGovern Medical School at the University of Texas Health Science Center at Houston. "Efforts across Parkinson's research seek to better define, measure and treat alpha-Synuclein pathology. This assay is a valuable tool in that work and we're proud that The Michael J. Fox Foundation could partner toward its development with funding, samples and consult," said Samantha Hutten, PhD, senior associate director of research partnerships at The Michael J. Fox Foundation for Parkinson's Research. The company anticipates market roll-out of FDA-approved early detection testing for Parkinson's within 18 months.  Amprion pioneers Prion Early Detection Testing for Alzheimer's and Parkinson's. Its breakthrough technology tracks specific Prion biomarkers including Abeta, Tau and Synuclein, prior to any clinical symptoms using CSF and blood. Early detection accelerates drug development pathways to stop the disease. The company anticipates launching early detection diagnostics in the next 18 months. ]]> https://biospectrumindia.com/news/57/13713/fda-permits-marketing-of-first-diagnostic-test-for-detection-of-prosthetic-joint-infections.html https://biospectrumindia.com/news/57/13713/fda-permits-marketing-of-first-diagnostic-test-for-detection-of-prosthetic-joint-infections.html Fri, 24 May 2019 15:45:00 +0530 The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant. "Prior to today's authorization, there were no FDA-authorized diagnostic tests specifically designed to help health care professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause," said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "With this test, health care professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery. Whereas before surgeons may have opted for surgery when the presence of an infection was unclear, with this test, they have more information and could potentially reduce patient risk by avoiding unnecessary revision operations for replacement joints." Joint replacement is a surgical treatment option for people with severe joint damage, including the knees or hips. During a joint replacement surgery, the surgeon removes damaged cartilage and bone from the surface of the joint and replaces it with a prosthetic joint implant. Potential complications of joint replacement include scarring, inflammation, blood clots and infections. If an infection occurs, it can lead to pain, redness, swelling and decreased joint function and potentially require antibiotics and revision surgery to treat the infection and install a new prosthetic implant. Physicians typically evaluate for potential infections using X-ray images or laboratory analysis of joint fluid, which can take days for results. The Synovasure Lateral Flow Test Kit detects proteins called human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes. Alpha defensins are antimicrobial proteins released by activated neutrophils (white blood cells) in response to infection. The Synovasure Lateral Flow Test Kit is intended as an aid to determine whether there is an infection present in synovial fluid. It is not intended to identify a specific type of infection. The test results are also intended to be used in conjunction with other clinical and diagnostic findings to aid in a patient's diagnosis of prosthetic joint infection. The FDA reviewed data from a clinical study that analyzed 305 prospective synovial fluid samples collected from individuals with a total knee or hip joint replacement who were being evaluated for revision surgery. The study showed that 89.5% of subjects with an infection diagnosis based on standard of care criteria were also identified as positive for alpha defensin by the Synovasure Lateral Flow Test Kit. The FDA reviewed data for the Synovasure Lateral Flow Test Kit through the de novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which determine the requirements for demonstrating the safety and effectiveness of tests to detect and measure non-microbial analytes (substances) that aid in the detection and identification of localized human infections. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for these tests. The FDA granted marketing authorization of the Synovasure Lateral Flow Test Kit to CD Diagnostics Inc.   ]]> https://biospectrumindia.com/news/57/13708/targovax-to-focus-on-oncos-oncolytic-virus-program.html https://biospectrumindia.com/news/57/13708/targovax-to-focus-on-oncos-oncolytic-virus-program.html Thu, 23 May 2019 15:30:00 +0530 Targovax ASA, a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, announces that going forward the company will strengthen the commitment to oncolytic viruses and focus resources to advance the ONCOS program with full force.  With the reporting of encouraging median overall survival and three-year survival rate, the TG01 trial in resected pancreatic cancer has been successfully completed. The natural next step in this indication is to continue with a larger randomized clinical trial within the current standard of care setting. The Company has decided to not pursue this opportunity on a stand-alone basis and will instead allocate all resources on the ONCOS oncolytic virus program. Oncolytic viruses are increasingly recognized as an important future class of immune activators, and Targovax is well positioned as one of the leaders in this rapidly evolving field. Maintaining that position will require speed and agility. Therefore, the decision has been made to focus the company's resources on advancing the ONCOS program with full force and to deliver the important ONCOS-102 data read-outs in the mesothelioma, melanoma and peritoneal trials over the next 6-18 months, as well as advancing the pre-clinical development of the next generation of double-transgene ONCOS viruses. Although Targovax will not utilize future resources on the TG program in its current form, we continue to believe in RAS as an important immunotherapeutic target. Management will seek and implement strategic alternatives for TG and assess opportunities for how our expertise and IP can be utilized to develop novel mutant RAS targeting strategies that can complement the oncolytic virus approach.       ]]> https://biospectrumindia.com/news/57/13707/merck-grants-1-99-mn-to-acs-to-improve-cancer-care-.html https://biospectrumindia.com/news/57/13707/merck-grants-1-99-mn-to-acs-to-improve-cancer-care-.html Thu, 23 May 2019 14:05:00 +0530 The Merck Foundation (the Foundation) and the American Cancer Society (ACS) announced that the Foundation awarded a $1.99 million, five-year grant to ACS to improve support and access to care for people living with cancer in low-and-middle-income countries, particularly in sub-Saharan Africa. This funding will help ACS further develop its capacity development approach to expanding patient navigation to countries with a growing burden of cancer. More than 70% of the 9 million cancer-related deaths worldwide are in resource-limited settings, where patients face many barriers in seeking a timely diagnosis and receiving high-quality cancer care. Patient navigators—whether nurses providing cancer education or lay health workers linking patients to transportation services in the community—play a vital role in supporting patients from the point of diagnosis at a health facility through their treatment journey. With support from the Foundation, ACS will fortify its patient navigation program in Kenyatta National Hospital (KNH), a national referral hospital in Kenya, and adapt it for a high need facility in Uganda – The Uganda Cancer Institute (UCI), which serves about 200 patients daily. This grant is a first step toward broad expansion of patient navigation programs to help more patients in resource-limited settings receive timely, high-quality cancer care. As part of this effort, ACS will develop a comprehensive guide and toolkit to develop and implement patient navigation programs, designed specifically for health facilities in low- and middle-income countries. Lessons learned from collaborating with hospitals in Kenya and Uganda will be incorporated into this guide, which ACS will pilot in health institutions in Asia and Latin America. ACS hopes to demonstrate that resource-limited health care institutions can use patient navigation as an effective tool to improve cancer care. Looking ahead, ACS will help KNH and UCI integrate patient navigation services into the way they deliver cancer care, with the goal of transforming the patient experience so patients continue to receive the timely, high-quality cancer care they need.  “Uganda has a population of 43 million, but there are only 20 oncologists in the entire country. That’s one of the reasons why patient navigators are so important in helping patients manage the day-to-day challenges that prevent them from receiving care and empowering them to seek treatment and stay in care,” says Dr. Jackson Orem, Executive Director of the Uganda Cancer Institute. ACS will work with the Rollins School of Public Health at Emory University in Atlanta to evaluate the implementation of the patient navigation programs in Kenya and Uganda as well as the pilot of the program design guide and implementation toolkit. The evaluation team will disseminate its findings to the global cancer community and other interested stakeholders to advance the field’s knowledge of how to effectively support cancer patients in resource-limited settings. ]]> https://biospectrumindia.com/news/57/13705/merck-to-acquire-peloton-therapeutics.html https://biospectrumindia.com/news/57/13705/merck-to-acquire-peloton-therapeutics.html Thu, 23 May 2019 13:45:00 +0530 Merck, known as MSD outside the United States and Canada, and Peloton Therapeutics, Inc. announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire privately held Peloton, a clinical-stage biopharmaceutical company focused on the development of novel small molecule therapeutic candidates targeting hypoxia-inducible factor-2α (HIF-2α) for the treatment of patients with cancer and other non-oncology diseases. Peloton’s lead candidate is PT2977, a novel oral HIF-2α inhibitor in late-stage development for renal cell carcinoma (RCC). “This acquisition exemplifies Merck’s strategy to pursue novel therapeutic candidates based on exceptionally promising and innovative research,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Peloton scientists have applied their unique expertise in HIF-2α biology to develop PT2977, which has already shown intriguing activity in the treatment of renal cell carcinoma. We look forward to advancing this late-stage asset as part of our broad oncology R&D program.” Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Peloton in exchange for an upfront payment of $1.05 billion in cash. In addition, Peloton shareholders will be eligible to receive a further $1.15 billion contingent upon successful achievement of future regulatory and sales milestones for certain candidates. The closing will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The companies anticipate the acquisition will close in the third quarter of 2019. Merck was represented by Covington & Burling LLP as legal advisor and Credit Suisse as financial advisor. Peloton was represented by Wilson Sonsini Goodrich & Rosati as legal advisor and Centerview Partners as financial advisor. ]]> https://biospectrumindia.com/news/57/13703/eli-lilly-introduces-lower-priced-insulin-in-the-us.html https://biospectrumindia.com/news/57/13703/eli-lilly-introduces-lower-priced-insulin-in-the-us.html Thu, 23 May 2019 10:35:00 +0530 Eli Lilly and Company's Insulin Lispro Injection is now available for order in pharmacies for people who use Lilly's rapid-acting insulin and need a lower-cost option. Lilly's Insulin Lispro Injection has a 50 percent lower list price than its identical medicine, Humalog® U-100 (insulin lispro injection) and is available in both a vial and KwikPen®. Because they are the same insulin, pharmacists will be able to substitute Insulin Lispro Injection for Humalog. In March, Lilly announced plans to introduce Insulin Lispro Injection, which fills another gap in the healthcare system. The people who are most likely to benefit from Insulin Lispro Injection are Medicare Part D beneficiaries, people with high-deductible health plans and the uninsured who use Humalog. Currently, about 95 percent of people in the U.S. pay $95 or less a month for their Humalog prescription and 43 percent pay $0 at the retail pharmacy. With the launch of Insulin Lispro Injection, even more people will pay lower amounts at the pharmacy. Because most insurance plans provide affordable copays for chronic medicines that are much lower than list price, people should ask their pharmacist whether Insulin Lispro Injection or Humalog is the lower-cost option for them. Insulin Lispro Injection has a list price of $137.35 per vial and $265.20 for a package of five KwikPens. ]]> https://biospectrumindia.com/news/57/13693/owlstone-medical-and-actelion-to-develop-a-breath-based-test.html https://biospectrumindia.com/news/57/13693/owlstone-medical-and-actelion-to-develop-a-breath-based-test.html Thu, 23 May 2019 09:00:00 +0530 Owlstone Medical, the global leader in Breath Biopsy® for applications in early disease detection and precision medicine has announced a strategic collaboration with Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson and a global leader in pulmonary arterial hypertension (PAH), to discover and validate a breath-based test to help facilitate the early diagnosis of pulmonary hypertension and its subtypes. This development program will be solely funded by Actelion. Pulmonary hypertension (PH) is a progressive cardiopulmonary disease where the blood pressure increases in the vessels that transport blood from the heart to the lungs, placing strain on the right side of the heart and often leading to heart failure. Unfortunately, early diagnosis of PH is very difficult, and even at an advanced stage presents similar to other heart and lung conditions, so a delay of years between the onset of symptoms and diagnosis and treatment is common.  There is therefore an urgent need for effective tools to facilitate screening and early diagnosis of patients presenting with early signs of PH and its sub-groups. The collaboration will initially involve collecting breath exhaled Volatile Organic Compounds (VOCs) from over 1,000 patients using Owlstone Medical’s proprietary sampling device, ReCIVA® from sites in the UK, US and other countries in the EU. These VOCs will be analyzed by Owlstone Medical to identify those that are associated with PH, in order to develop biomarker signature(s) that can help facilitate earlier detection of the disease. ]]> https://biospectrumindia.com/news/57/13700/novo-nordisk-to-present-data-from-its-diabetes-portfolio-at-ada.html https://biospectrumindia.com/news/57/13700/novo-nordisk-to-present-data-from-its-diabetes-portfolio-at-ada.html Wed, 22 May 2019 20:45:00 +0530  Novo Nordisk has announced that new data from its diabetes portfolio will be presented at the upcoming 79th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, California from June 7-11, 2019. Novo Nordisk will feature 26 presentations throughout the meeting. Results from seven phase 3a PIONEER clinical trials for oral semaglutide in patients with type 2 diabetes will be presented including the cardiovascular outcomes trial (PIONEER 6) at a highly anticipated symposium highlighted by the ADA on June 11. Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analog in a pill. "Our exciting data at ADA 2019 reflect a deep commitment at Novo Nordisk to develop innovative treatment options that have the potential to transform the way clinicians and patients manage diabetes," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "With a focused approach and passion for pioneering scientific advancements, we continue to seek new options and approaches that address the needs of millions of patients living with this serious disease." Semaglutide is a GLP-1 analog.1 Oral semaglutide is an investigational once-daily GLP-1 analog in a pill that is in development for the treatment of type 2 diabetes. The PIONEER phase 3a global clinical trial program for oral semaglutide comprises 10 clinical trials that enrolled 9,543 adults with type 2 diabetes. ]]> https://biospectrumindia.com/news/57/13694/evotec-jump-starts-biologics-with-acquisition-of-just-biotherapeutics.html https://biospectrumindia.com/news/57/13694/evotec-jump-starts-biologics-with-acquisition-of-just-biotherapeutics.html Wed, 22 May 2019 14:05:00 +0530 Evotec announced the signing of a definitive agreement under which Evotec will acquire Just Biotherapeutics, Inc., for up to $ 90 m including potential performance-based earn-out components expected within the next three years. Just.Bio is a unique technology company that integrates highly synergistic scientific expertise and ML driven technologies for design, development, and manufacturing of biologics. Founded only in 2014/15, It has approx. 90 employees, mainly scientists, all working at a state-of-the-art discovery, development and manufacturing facility in Seattle, WA, USA. The acquisition is expected to close in the second quarter 2019. The acquisition of Just.Bio will add considerable business opportunities for further acceleration of Evotec’s long-term strategy to be the industry partner of choice for external end-to-end innovation. The acquisition grows Evotec’s business into a comprehensive offering including biologics in therapeutic areas such as oncology, CNS, pain, inflammation, metabolics, and infectious diseases. Dr Werner Lanthaler, Chief Executive Officer of Evotec, said: “We are excited about the acquisition and warmly welcome Just.Bio’s expert team as a new part of the Evotec family and also welcome Dr Jim Thomas in his new management role EVP, Global Head, Biotherapeutics, President US Operations. Broadening our platform into biologics has always been key to our strategy. With this acquisition we finally found the perfect match to complement our leadership in small molecules.” Dr James Thomas, Chief Executive Officer of Just.Bio, commented, “Combining Just.Bio with Evotec creates a technological powerhouse that will fuel our long-term mission to make important biologics accessible to patients worldwide. We are thrilled to be part of the Evotec family.” The acquisition of 100% of the issued and outstanding equity interests of the company will be paid in cash to a syndicate of institutional investors of ARCH Venture Partners, Merck & Co., Lilly Asia Ventures and the Bill & Melinda Gates Foundation.    ]]> https://biospectrumindia.com/news/57/13692/mercia-invests-2-0-million-in-transdermal-drug-delivery-specialist-medherant.html https://biospectrumindia.com/news/57/13692/mercia-invests-2-0-million-in-transdermal-drug-delivery-specialist-medherant.html Wed, 22 May 2019 12:45:00 +0530 Medherant Limited (“Medherant”), the UK based clinical-stage developer of innovative transdermal delivery products for pain and CNS diseases using its unique TEPI Patch® technology, has announced a new £2 million investment. The additional funding from Mercia Technologies PLC, the national investment group focused on the identification, creation, funding and scaling of innovative technology businesses with high growth potential, is part of a circa £2.4 million syndicated investment round. The global transdermal drug delivery market in which Medherant operates is expected to reach $7.1 billion by 2023 from an estimated $5.7 billion in 2018, at a CAGR of 4.5% during the forecast period[1]. Medherant spun out of the University of Warwick in 2014 and received its first investment from Mercia’s managed funds in 2015. Since then the company has secured an exclusive worldwide licence from Bostik SA for the medical use of a novel adhesive which is protected by an extensive patent estate. Mercia now holds a 33.6% direct equity stake in the business. This latest investment will enable Medherant to finalise the selection of three TEPI Patch® products to take into clinical development. Nigel Davis, CEO of Medherant, said: “TEPI Patch technology holds great promise as a better way of delivering many different types of drugs. We are pleased to have supportive investors led by Mercia who are enabling us to progress the development of patch products that will bring significant benefits to patients across the globe.” ]]> https://biospectrumindia.com/news/57/13691/i-holland-launches-online-training-for-pharmaceutical-nutraceutical-professionals.html https://biospectrumindia.com/news/57/13691/i-holland-launches-online-training-for-pharmaceutical-nutraceutical-professionals.html Tue, 21 May 2019 21:55:00 +0530 The introduction of technology enabled learning is helping companies improve the skills of their staff and is seeing huge growth in recent years. This increase is being seen through all industries including those in pharmaceutical and nutraceutical manufacturing. To meet this growing demand I Holland has launched an online learning platform. The e-learning program offers professionals comprehensive and flexible courses in a wide variety of disciplines. I Holland, leaders in the manufacture of tablet tooling has put together a series of courses which combines over 70 years of experience. Alex Bunting, I Holland marketing manager explains: “We have a long history and extensive experience in sharing our knowledge with our partners in solid dosage manufacturing through our face to face technical seminars held all over the world. We believe in supporting those in manufacturing who are looking to improve their technical skills and understanding of tablet compression tooling. However, we recognise that in the busy modern manufacturing environment, people can’t always be available to attend training and seminars. With that in mind we have created I Holland’s Online Training courses. They are designed for everyone from director level to engineers and operators looking to improve their knowledge in areas of tablet compression tooling.” “We have put together a carefully selected list of courses making online learning accessible with specially designed modules that can fit easily around the working day. These are tailored to work to the skillset of the person undertaking the course and are comprised of a variety of animations, illustrations, videos, diagrams and interactive quizzes, making them interesting and engaging.” Courses are designed with a hierarchical system giving training managers and supervisors a full audit, tracking and reporting of employee development and certification. Following the completion of each course, certification can be issued in line with a company’s operating procedures and guidelines including scheduling re-qualification after a period of elapsed time.  With a compartmentalised structure, courses can be used across different departments, job roles, sites and even countries for comparison purposes. This makes each course highly flexible allowing employees to further their knowledge in their own time. Modules include a variety of subjects from an ‘Introduction to tablet tooling’ and ‘Tooling maintenance’, to ‘Troubleshooting production problems’ and ‘Improving productivity’. All courses can be accessed via desktop computers or mobile devices making it easily available, allowing employees to be educated and updated on the best industry practices and tablet tooling developments. ]]> https://biospectrumindia.com/news/57/13690/stryker-gets-fda-premarket-approval-for-the-neuroform-atlas-stent-system.html https://biospectrumindia.com/news/57/13690/stryker-gets-fda-premarket-approval-for-the-neuroform-atlas-stent-system.html Tue, 21 May 2019 18:10:00 +0530 Stryker has announced the Premarket Approval (PMA) of the Neuroform Atlas Stent System by the U.S. Food and Drug Administration (FDA).  Neuroform Atlas is only the second aneurysm adjunctive stent to be granted PMA approval for the treatment of wide-neck, intracranial aneurysms in conjunction with embolic detachable coils.  Neuroform Atlas Stent System was previously approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval.  PMA approval was granted based on robust clinical trial evidence proving the efficacy of the device. "Neuroform Atlas represents a significant advancement in the treatment of wide-neck aneurysms which is now backed by the largest IDE stent-coil trial completed to date," said Dr. Osama O. Zaidat, Director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio, and Co-Principal Investigator of the U.S. Neuroform Atlas investigational trial.  "More impressive were the results with an 84.7% primary efficacy rate, a 4.4% primary safety rate and a 3.8% retreatment rate." "Enhanced stent conformability, a low-profile delivery system and high deployment accuracy even in distal anatomy puts Neuroform Atlas in a category of its own," said Dr. Brian Jankowitz, Director of the NeuroEndovascular Fellowship program at the University of Pittsburgh Medical Center and Co-Principal Investigator of the study.  "This product is changing my clinical practice by allowing more patients with difficult aneurysms an option at endovascular treatment while improving the quality and safety of treatment." Mark Paul, president of Stryker's Neurovascular division, added, "Proving the safety and efficacy of our products through landmark clinical trials is a top priority and key differentiator for Stryker.  Meaningful clinical data enables our market leading products to better serve patients suffering from debilitating cerebrovascular disease.  PMA approval of Neuroform Atlas Stent System is a significant milestone in providing world class technology to our physicians." ]]> https://biospectrumindia.com/news/57/13689/delsitech-gets-fund-for-contraceptives-and-hiv-antiviral-injectables.html https://biospectrumindia.com/news/57/13689/delsitech-gets-fund-for-contraceptives-and-hiv-antiviral-injectables.html Tue, 21 May 2019 17:40:00 +0530 DelSiTech Ltd, a drug delivery and drug development company based in Finland announced significant grant funding to support the development of long-acting controlled release formulations for family planning as well as for human immunodeficiency virus (HIV) antivirals, from the Bill & Melinda Gates Foundation. DelSiTech is the global leader in advanced silica-based, sustained and controlled release delivery technologies for administration of injectable, implant and topical eye drop dosage forms. Its technology offers long-acting injectable medical solutions to enable longer treatment periods and fewer injections. DelSiTechTM Silica Matrix technology allows the drug substances, ranging from small molecules to biologics to be encapsulated in matrix microparticles, providing stability for the drug substance and a true controlled long-acting release based on the matrix dissolution. This allows the injection to release a stabilized product for months or over a year. ]]> https://biospectrumindia.com/news/57/13684/qiagen-introduces-next-gen-platform-for-syndromic-insights.html https://biospectrumindia.com/news/57/13684/qiagen-introduces-next-gen-platform-for-syndromic-insights.html Tue, 21 May 2019 11:10:00 +0530 QIAGEN N.V. has announced the U.S. launch of its QIAstat-Dx syndromic testing system after receiving 510(k) clearance by the U.S. Food and Drug Administration (FDA), along with the multiplex QIAstat-Dx® Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens. QIAstat-Dx (formerly Stat-Dx DiagCORE®) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective and flexible syndromic testing with novel Sample to Insight solutions powered by QIAGEN chemistries. The system, based on the proprietary DiagCORE® technology, received CE-IVD marking in January 2018 and already has a significant installed base. QIAstat-Dx is being launched in the U.S. with a comprehensive respiratory panel that detects more than 20 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx in the U.S., with plans to launch a gastrointestinal panel later in 2019. With the ability to multiplex as high as 48 targets, a deep pipeline is planned that will span infectious diseases, oncology, companion diagnostics and other disease areas. ]]> https://biospectrumindia.com/news/57/13681/gtreebnt-gets-patent-for-new-ophthalmic-formulation-.html https://biospectrumindia.com/news/57/13681/gtreebnt-gets-patent-for-new-ophthalmic-formulation-.html Mon, 20 May 2019 17:10:00 +0530 RegeneRx Biopharmaceuticals (RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, reported that its U.S. joint venture partner and Pan Asian licensee, GtreeBNT, has been granted a new U.S. patent for a method of preventing or treating dry eye syndrome by administering Tβ4 with non-active ingredients to provide improved pharmacodynamics.  Tβ4 is the active component of RGN-259, currently in separate phase 3 clinical trials for dry eye syndrome and neurotrophic keratitis.  The expiry of this new patent is 2035. "We are pleased that Gtree has been granted another patent related to Tβ4 in the ophthalmic field emanating from its comprehensive development of RGN-259, our sterile, preservative-free eye drop solution.  New intellectual property, such as patents and know-how developed under our licenses to Gtree and our U.S. joint venture, ReGenTree LLC, expands and extends the IP portfolio underlying these licenses," stated J.J. Finkelstein, president and chief executive officer.     Dry eye syndrome is a common condition affecting millions of people throughout the world.  It is a multi-factorial disorder where loss of homeostasis of the tear film results in pain, itching, blurry vision, and dryness, among other symptoms. RGN-259 eye drops contain an active small protein, thymosin beta 4, which is naturally occurring in tears and other body fluids.  RGN-259 eye drops have demonstrated wide-ranging and multifunctional activities.  Such activities underlie the efficacy of RGN-259 eye drops seen to date in alleviating both the signs and symptoms of dry eye.  RGN-259 eye drops are safe and well-tolerated by patients, and in both ARISE-1 and ARISE-2 clinical trials, patients reported minimal ocular discomfort similar to that of the placebo.  RGN-259 is currently the subject of a 700-patient phase 3 clinical trial in the U.S, ARISE-3. ]]> https://biospectrumindia.com/news/57/13677/abbott-partners-with-nih-on-brain-initiative.html https://biospectrumindia.com/news/57/13677/abbott-partners-with-nih-on-brain-initiative.html Mon, 20 May 2019 12:05:00 +0530 Abbott has announced that it has partnered with the National Institutes of Health (NIH) on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) initiative to accelerate advancements in neuroscience research. As part of the agreement, Abbott will provide the company's neuromodulation technologies—including directional deep brain stimulation (DBS), spinal cord stimulation (SCS), and dorsal root ganglion (DRG) therapy—for research related to these NIH initiatives to explore their application for chronic pain and progressive movement disorders, like Parkinson's disease. Nick B. Langhals, Program Director for Neural Engineering within the Division of Translational Research at the National Institute of Neurological Disorders and Stroke said, “The NIH is investigating the application of these devices for the treatment of a wide range of neurological and neuropsychiatric conditions and chronic pain. The neuromodulation technologies provided by Abbott will help us determine the inner workings of the nervous system to help fill gaps in our current knowledge of the brain and provide opportunities for exploring how the brain interacts with the human body in patients with neurological conditions." Neurological disorders and diseases present a significant burden to the United States healthcare system, with over 100 million people experiencing at least one of the known neurological disorders.1 With age being a contributing factor to many neurological diseases such as Parkinson's disease, this number is expected to increase by 2050. Launched in 2013, the BRAIN Initiative looks to understand the functions of the human brain by researching and developing new uses for innovative technologies. Keith Boettiger, vice president, Neuromodulation, Abbott said, "Researchers at Abbott are continuously striving to better understand how neuromodulation technology can benefit people living with chronic pain or movement disorders. In addition to our own research efforts, including clinical and real-world studies, working together with world-class scientists at the NIH will help us further validate our neuromodulation therapies and explore new avenues where they may benefit patients affected by devastating neurological conditions." For people living with chronic pain and movement disorders, Abbott's neuromodulation portfolio of therapies help them move and feel better, allowing chronic pain patients to reduce or stabilize the long-term use of opioids and get back to living their lives, while helping patients with movement disorders combat the symptoms of their condition. ]]> https://biospectrumindia.com/news/57/13676/cyclica-announces-integration-of-the-poem-machine-learning-predictive-engine-.html https://biospectrumindia.com/news/57/13676/cyclica-announces-integration-of-the-poem-machine-learning-predictive-engine-.html Mon, 20 May 2019 11:50:00 +0530 Cyclica a leading biotechnology company that leverages artificial intelligence and computational biophysics to enable the discovery of new medicines, has announced the addition of a machine learning predictive engine called POEM to its Ligand Express platform. POEM has been applied to the prediction of ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) properties, which provides critical insight into a molecule’s expected behavior in the body. Unlike conventional quantitative structure activity relationship (QSAR) models that have existed in pharma for decades, POEM is parameter-free, based on multiple fingerprints, and does not require time-consuming model training. Ligand Express, is a cloud-based platform that uncovers the polypharmacological profiles of small molecules, and allows scientists to gain insights into structural pharmacogenomics by incorporating systems biology databases including single nucleotide variant data. With the integration of POEM, Ligand Express now offers insights into the pharmacokinetic properties of small molecules, providing a better understanding of the predicted behaviour of potential drug molecules. This integration will further augment workflows within pharma, providing scientists with a deeper understanding of a small molecule’s polypharmacology and its key pharmacokinetic properties. “Enabling more effective drug discovery through an integrated computational platform is a central tenant at Cyclica,” said Naheed Kurji, President & CEO of Cyclica. “With the integration of POEM in Ligand Express, our users can readily access predictive ADMET properties of their small molecules in an elegantly designed user interface, enabling them to make effective decisions and bring better medicines to the market faster. We will continue to enhance Ligand Express with new features as we believe an end-to-end enabling platform will be essential to transform drug discovery.” “We recognize that drug discovery is a process, and part of that process requires the evaluation of many possibilities. It is impossible to pursue every possibility, so choosing the best starting point is essential, but it’s not always easy,” said Vijay Shahani, Head of Design of Cyclica. “We designed the user interface of POEM in Ligand Express to facilitate comparisons between multiple small molecules, making it easier to identify better starting points. We are actively developing new features to allow greater molecular exploration and enable the selection of top candidates.” Cyclica is committed to building out a platform that will facilitate effective drug discovery, and do more with artificial intelligence to design medicines for patients. The integration of POEM into Ligand Express further demonstrates Cyclica’s commitment to accelerating pharma R&D, and making drug discovery faster, cheaper, and safer. On May 22nd at the Collision Conference in Toronto, Cyclica will announce its novel, first-in-class, multi-objective, drug design technology, which also incorporates POEM.  ]]> https://biospectrumindia.com/news/57/13674/jefferson-and-wills-eye-launch-first-of-its-kind-center-for-neurological-diseases.html https://biospectrumindia.com/news/57/13674/jefferson-and-wills-eye-launch-first-of-its-kind-center-for-neurological-diseases.html Mon, 20 May 2019 11:40:00 +0530 Poets have called eyes the windows to the soul. Now, Jefferson and Wills Eye researchers will be able to use eyes as windows into debilitating diseases of the brain. Thomas Jefferson University, in partnership with Wills Eye Hospital and thanks to the generosity of several prescient philanthropists, has launched the world's first center focused on the visual signatures of neurological diseases. The William H. Annesley, Jr., MD '48 EyeBrain Center will explore the connections between the retina, optic nerve, and disorders of the brain, potentially revealing novel treatments for confounding diseases such as stroke, Alzheimer's, Parkinson's, multiple sclerosis, and dementia. "Because of the anatomic and physiological connections between the eye and brain, ophthalmology and neurology are inextricably linked," said Robert C. Sergott, MD, an international expert in neuro-ophthalmology and the Center's founding Executive Director. "This is the perfect synergy. The Annesley EyeBrain Center will leverage the strengths of the region's most extensive neuroscience network with the nation's leading hospital for vision care." Named in honor of ophthalmology pioneer and Jefferson alumnus William H. Annesley, Jr., MD, the Annesley EyeBrain Center will be housed within Jefferson's renowned Vickie and Jack Farber Institute for Neuroscience. Initial funding for the Center was provided by philanthropic gifts from friends and family of the late Dr. Annesley, including lead benefactor Margaret Annesley Hayne. "If you want to change the world, you have to think differently, and that's what the team at the Annesley EyeBrain Center will do," said Stephen K. Klasko, MD, MBA, President, Thomas Jefferson University and CEO, Jefferson Health. "At a time when far too many individuals are falling victim to debilitating, incurable disorders of the brain, the Annesley EyeBrain Center will be more than a destination for premier neuro-ophthalmologic research and care—it will serve as a powerful beacon of hope. We are incredibly grateful to Margaret Annesley Hayne and the early philanthropic investors for their visionary support." "As the first center exploring the connections between the retina and disorders of the brain, the Annesley EyeBrain Center will revolutionize ophthalmic and neurological care and establish a new frontier in neuro-ophthalmology," said Julia A. Haller, MD, the William Tasman, MD Endowed Chair and Ophthalmologist-in-Chief of Wills Eye Hospital and Professor and Chair of the Department of Ophthalmology at Sidney Kimmel Medical College of Thomas Jefferson University. "And as a tribute to the remarkable life and career of Dr. Annesley, it will cement his legacy of excellence, preserving his values and reputation for generations to come. " One of the Annesley EyeBrain Center's revolutionary areas of research involves mitochondrial function in the retina. Mitochondria are the main producers of energy for all types of cells, and their malfunction is implicated as the final common pathway in many neurologic and ophthalmic diseases. Mitochondria produce flavoprotein, a compound that emits a green light when excited by a blue light. When more green light is visible, the mitochondria are working harder to maintain retinal and neurologic function. Using Multi-Color Optical Coherence Tomography (OCT), a breakthrough technology, researchers can now see mitochondrial function disruption before there is cell-death or even disease symptoms, opening an entirely new frontier in the diagnosis and treatment of devastating neurological disorders such as multiple sclerosis, ALS, Alzheimer's and Parkinson's disease. "There are tremendous advantages to creating a Center like this that is the first of its kind," said Robert H. Rosenwasser, MD, the Jewell L. Osterholm, MD, Professor and Chair of the Department of Neurological Surgery at Thomas Jefferson University and the President, Vickie and Jack Farber Institute for Neuroscience. "We'll be in a unique position to capitalize on and potentially develop new technologies and techniques. It's an opportunity to innovate and utilize our entrepreneurial expertise." ]]> https://biospectrumindia.com/news/57/13658/dna-script-raises-38-5-m-in-series-b-financing.html https://biospectrumindia.com/news/57/13658/dna-script-raises-38-5-m-in-series-b-financing.html Thu, 16 May 2019 15:30:00 +0530 DNA Script has announced an oversubscribed Series B fundraising of $38.5M led by LSP, one of Europe’s largest and most experienced healthcare investment firms. Bpifrance, through its Large Venture fund, joined the round, alongside existing investors Illumina Ventures, M. Ventures, Sofinnova Partners, Kurma Partners and Idinvest Partners. The proceeds will enable DNA Script to accelerate the development of the company’s first products based on its industry-leading enzymatic technology for de novo synthesis of nucleic acids. The company is prioritizing the recruitment of top talent in the U.S. for its product development and commercialization teams in preparation for product launch, as well as on expanding its Paris-based research team. DNA Script's innovative technology provides affordable, rapid, high-quality production of important genomic experimental precursors, such as oligonucleotides. The technology overcomes many of the inefficiencies of today’s synthetic DNA production. It features a novel biochemical process for nucleic acids synthesis based on the use of highly efficient enzymes, thus enabling enhanced performance while minimizing the use of harsh chemicals. The product portfolio based on DNA Script’s proprietary enzymatic synthesis platform will enable molecular biology researchers to accelerate their experiments — with the goal of moving from design to results within a day for a broad range of applications. “In less than two years since our last financing round, the DNA Script team has developed enzymatic synthesis technology at an incredibly fast pace and extended the company’s lead in this exciting and quickly expanding sector. As we announced earlier this year at the AGBT General Meeting, DNA Script was the first company to enzymatically synthesize a 200mer oligo de novo with an average coupling efficiency that rivals the best organic chemical processes in use today. Our technology is now reliable enough for its first commercial applications, which we believe will deliver the promise of same-day results to researchers everywhere, with DNA synthesis that can be completed in just a few hours,” said Thomas Ybert, CEO and co-founder of DNA Script. “We are thrilled to lead this round with participation of such a respected group of founders and investors. We see DNA Script as the clear leader in this nascent field,” said Joachim (JR) Rothe, Managing Partner at LSP and new member of DNA Script’s board. “The progress made by DNA Script in only two years is amazing, and we believe the company will shift the current DNA synthesis paradigm, not only in the research market but also in the broader pharma business — for personalized therapies and diagnostics in particular.” Founded in 2014 in Paris, DNA Script is the world’s leading company in manufacturing de novo synthetic nucleic acids using an enzymatic technology. The company aims at accelerating innovation in life sciences and technology through rapid, affordable, and high-quality DNA synthesis. DNA Script’s approach leverages nature's billions of years of evolution in synthesizing DNA to enable genome scale synthesis. The Company’s technology has the potential to greatly accelerate the development of new therapeutics, sustainable chemicals production, improved crops as well as data storage. ]]> https://biospectrumindia.com/news/57/13657/fda-clears-the-worlds-first-ai-solution-for-pulmonary-embolism.html https://biospectrumindia.com/news/57/13657/fda-clears-the-worlds-first-ai-solution-for-pulmonary-embolism.html Thu, 16 May 2019 15:00:00 +0530 Aidoc, the leading provider of AI solutions for radiologists, was granted Food and Drug Administration (FDA) clearance for an additional product in its expanding suite of AI-based workflow orchestration solutions. The clearance is for Aidoc's Pulmonary Embolism (PE) solution that works with radiologists to flag and triage PE cases in chest CTs. The approval comes just weeks after Aidoc closed a $27 million funding round, bringing its total funding to $40million. "In addition to the significant value provided to the department by Aidoc's ICH solution, we recently added the PE module to the workflow", says Dr. Pressman, Chair of Imaging at Cedars-Sinai Medical Center. "I was impressed by the fact that the coverage continuously grows, allowing us to add this product in the workflow of more radiologists, becoming part of our daily work. I was also pleased by the ability of the software to prioritize PE studies accurately." "It is clear that AI will play a tremendous role in the future of radiology," said Daniel J. Durand, M.D., Chair of Radiology at LifeBridge Health. "Considering the complexity of vascular diagnosis, we are eager to see how Aidoc's solutions can benefit our pulmonary embolism patients and bring tomorrow's technology to LifeBridge Health, today." LifeBridge Health operates four hospitals in and around Baltimore, Maryland. The new clearance, combined with Aidoc's other proven solutions, gives Aidoc the most clearances for deep learning solutions in radiology and positions it firmly at the forefront of making AI standard of care. Aidoc's solutions analyze medical images directly after the patient is scanned and notify the radiologists of cases with suspected findings to assist with prioritization of time-sensitive, and potentially life-threatening cases. Aidoc cuts the time from scan to diagnosis for some patients from hours to under five minutes, speeding up treatment and improving prognosis. ]]> https://biospectrumindia.com/news/57/13653/j-j-outlines-strategy-to-deliver-above-market-growth-.html https://biospectrumindia.com/news/57/13653/j-j-outlines-strategy-to-deliver-above-market-growth-.html Thu, 16 May 2019 14:05:00 +0530 Johnson & Johnson will host a meeting with industry analysts to review the strategy of its Janssen Pharmaceutical Companies to deliver above-market, compound annual growth through 2023. The company will also discuss its progress across its six therapeutic areas, pipeline developments and capital allocation framework. Chairman and Chief Executive Officer Alex Gorsky and members of the Johnson & Johnson leadership team, along with leaders of each of the company’s six therapeutic areas, including Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, Oncology and Pulmonary Hypertension, will provide a detailed overview of the company’s strategy to continue to drive a robust pipeline of innovative medicines to generate near- and long-term, volume-driven growth. Johnson & Johnson will outline its key drivers to deliver above-market growth at Janssen. This strategy includes: Maximizing the clinical potential of the company’s industry-leading portfolio with new indications, patient populations and lines of therapy. A well-established industry leader in R&D productivity, Janssen has earned major-market regulatory approvals for 18 new products since 2011 spanning the company’s diverse portfolio across six therapeutic areas. Janssen anticipates filing for regulatory approval of more than 40 line extensions through 2023 to reach additional patients with unmet medical needs. Delivering on the pipeline with new, differentiated medicines, with at least 10 NME filings and/or launches anticipated through 2023. In 2019 to date, Janssen has gained U.S. regulatory approvals for two first-in-class molecular entities, SPRAVATO (esketamine) nasal spray for treatment-resistant depression in adults and BALVERSA (erdaftinib) for the treatment of adults with bladder cancer that has spread or cannot be removed surgically. Additional medicines will be discussed that have the potential to file or launch by 2023, including four that are new to the pipeline, as well as advanced therapeutic modalities such as gene therapy and RNA therapeutics. Forging new approaches to discovery, development and delivery of the company’s transformational medicines. Janssen has an evolving and differentiated R&D strategy that embraces both disease areas and biological pathways, as well as new technologies such as cell and gene therapy and broad-based application of data science. Together with strong partnerships, this strategy will help Janssen discover, develop and deliver the next wave of transformational medicines. Investing in innovation will continue to be a key pillar of Johnson & Johnson’s disciplined capital allocation strategy. The company is also committed to delivering a competitive and increasing dividend, having paid $9.5 billion in dividends to shareholders in 2018, and will continue to deploy capital to value-creating acquisitions with more than $5 billion dollars invested in acquisitions across the company in recent months. Additionally, Johnson & Johnson is focused on returning capital to shareholders through share repurchases and has completed more than one-third of its $5 billion authorization announced last year as of March 2019. Together with its significant free cash flow and strong balance sheet, the company intends to execute all levers of its capital allocation strategy to fund future growth opportunities while providing attractive returns to shareholders.   ]]> https://biospectrumindia.com/news/57/13649/sekisui-diagnostics-invests-1-9-m-in-microbial-biopharma-cdmo-business.html https://biospectrumindia.com/news/57/13649/sekisui-diagnostics-invests-1-9-m-in-microbial-biopharma-cdmo-business.html Wed, 15 May 2019 17:15:00 +0530 Sekisui Diagnostics Enzyme business has announced the completion of a new BioProcess Innovation Centre at the site in Maidstone, Kent by the end of 2019, following a $1.9 million investment. This investment is part of a long-term investment strategy to grow its share of the Microbial Biopharma CDMO market, with future investment expected to focus on expanding cGMP manufacturing capabilities. Previously part of Genzyme Diagnostics, Sekisui Diagnostics' Enzyme business launched its Microbial Biopharma CDMO service offering, BioProduction by Sekisui, in 2017, building on over 40 years' experience in this field. The new BioProcess Innovation Centre will more than double its development laboratory space to facilitate Process Transfer and Development. Specialized in expression and purification from microbial fermentation, the group has wide experience, including but not limited to recombinant systems such as E. coli and Pichia pastoris, with associated purification and analytical technologies. Its main expertise lies in the production of enzymes, however, its capabilities are also suitable for plasmids, antibody fragments, and other protein production. With production capabilities from 20L to 5,000L, Sekisui handles projects from pre-clinical through to commercialization. "Over many years we have built both technical and operational competency and expertise in enzyme production and microbial fermentation," said Robert Schruender, President & CEO of Sekisui Diagnostics and Sekisui Medical Board Member. "As the Biopharma CDMO market grows, we aim to further leverage this capability to grow our share in this market. This investment represents our commitment to serve our customers with innovative process development solutions." Sekisui Diagnostics is a global company committed to improving patient's lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network. Product lines include clinical chemistry and coagulation systems, reagents, rapid test kits, point-of-care systems. The Enzyme business forms part of this group and, in addition to BioProduction by Sekisui, offers a broad portfolio of Diagnostic enzymes and critical raw materials. ]]> https://biospectrumindia.com/news/57/13643/grail-receives-breakthrough-device-designation-from-fda.html https://biospectrumindia.com/news/57/13643/grail-receives-breakthrough-device-designation-from-fda.html Wed, 15 May 2019 14:55:00 +0530 GRAIL, Inc., a US based healthcare company whose mission is to detect cancer early, when it can be cured, has announced that its multi-cancer test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The investigational blood test is in development for the early detection of multiple cancer types in individuals aged 50 or older. The FDA grants Breakthrough designation to devices that have the potential to provide for more effective diagnosis of life-threatening diseases such as cancer. The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices granted the designation by speeding up their development, assessment, and review. GRAIL previously reported data from the first pre-planned sub-study of its Circulating Cell-free Genome Atlas (CCGA) study, which showed that its three prototype next-generation sequencing (NGS) blood tests were able to detect multiple deadly cancer types from a single blood draw, with a low rate of false positive results (high specificity).1 The company has since selected methylation as its preferred approach and has developed a methylation sequencing blood test that preferentially targets the most informative regions of the genome to both detect the presence of multiple types of cancer and identify the tissue of origin (the part of the body where the cancer originated). The blood test is currently being evaluated in the second pre-planned sub-study of CCGA. ]]> https://biospectrumindia.com/news/57/13638/merck-pfizers-combination-drug-gets-fda-nod-to-treat-rcc.html https://biospectrumindia.com/news/57/13638/merck-pfizers-combination-drug-gets-fda-nod-to-treat-rcc.html Wed, 15 May 2019 13:00:00 +0530 Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with axitinib(Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC. The approval of BAVENCIO in combination with axitinib was based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006). "As we look to continue to improve outcomes for people with advanced RCC, new treatment approaches have the potential to benefit patients," said Robert J. Motzer, M.D., Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center, New York, US, and principal investigator for JAVELIN Renal 101. "With today's FDA approval of avelumab in combination with axitinib, we can now offer patients with advanced RCC a first-line treatment option that combines a PD-L1 immunotherapy with a well-known VEGFR TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib." "A kidney cancer diagnosis is life-changing for both patients and their loved ones, and having a treatment strategy for their disease quickly becomes a priority," said Dena Battle, President, KCCure. "The approval of new treatments such as BAVENCIO in combination with axitinib gives patients with advanced RCC much-needed options." There is a significant unmet need for first-line treatments that delay progression and have an acceptable safety profile. Approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.4,5 About half of patients living with advanced RCC do not go on to receive additional treatment after first-line therapy,6,7 for reasons that may include poor performance status or adverse events from their initial treatment.6,8,9 The European Medicines Agency (EMA) validated the Type II variation application for BAVENCIO in combination with axitinib in advanced RCC in March 2019, and a supplemental application for BAVENCIO in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019. The combination of BAVENCIO and axitinib is only approved for the first-line treatment of advanced RCC in the United States. ]]> https://biospectrumindia.com/news/57/13636/pneuma-respiratory-partners-with-leads-biolabs.html https://biospectrumindia.com/news/57/13636/pneuma-respiratory-partners-with-leads-biolabs.html Wed, 15 May 2019 10:55:00 +0530 Pneuma Respiratory, Inc., developer of a proprietary breath-activated digital inhaler (BDI), and Leads Biolabs Inc. announce an agreement granting Pneuma an exclusive license to develop Leads Biolabs' panel of immuno-oncology monoclonal antibodies and fusion protein molecules for the pulmonary delivery of Leads' antibodies and molecules.  Using Pneuma's digital inhaler platform, the agreement provides access to the untapped potential of pulmonary delivery of Leads' immuno-oncology therapies in the treatment of oncologic or immune-mediated lung diseases.  In a recent publication, Pneuma announced the completion of a study demonstrating the feasibility of antibody delivery to the lungs via its digital inhaler platform.  This study, conducted in an animal model, indicates that the Pneuma digital inhaler platform may provide a method for the pulmonary delivery of monoclonal antibody therapies, enabling the targeted treatment of oncologic or immune-mediated lung diseases. "This collaboration is an exciting development for the field of immuno-oncology," said Ronald Bukowski, MD, physician emeritus, Cleveland Clinic Foundation.  "Approaches utilizing the regional administration of novel checkpoint inhibitors may provide new treatment opportunities for patients with a variety of malignancies." "We are pleased to enter into a license agreement for Leads Biolabs monoclonal antibody portfolio," said Pneuma Chief Executive Officer and co-founder Eric Hunter. "We look forward to working with their team to conduct studies that may lead to positive change in the future treatment of non-small cell lung cancer." ]]> https://biospectrumindia.com/news/57/13635/boehringer-ingelheims-road-to-digitisation.html https://biospectrumindia.com/news/57/13635/boehringer-ingelheims-road-to-digitisation.html Tue, 14 May 2019 17:35:00 +0530 From drug discovery to analysing speech patterns for detecting brain disorders and many other possibilities Boehringer Ingelheim is exploring and trying a wide range of new ideas by jumping on a digital bandwagon. Artificial intelligence-supported software, virtual molecular models and open innovations are currently finding their way into Boehringer Ingelheim’s research laboratories at Ingelheim (Germany) with a goal to develop better medicines. “For us Digitalisation is the generic term for new technologies for employing data – that is capturing, processing and analysing – and the automated steering of processes,” said Hubertus von Baumbach, Chairman of the Board of Managing Directors of Boehringer Ingelheim.  One can hear many acronyms like ADAM, NTC, BRASS, PSP, BI X in the vicinity of the company’s sprawling campus here. ADAM stands for Advanced Design Assistant for Molecules while PSP for Pathological Speech Processing, NTC stands for “New Therapeutic Concepts”, And BI X is the digital lab set by the company to focus on the development of innovative digital healthcare products and solutions. Set up in July 2017 with an investment of Euro 20 million to test new technologies quickly and efficiently and to develop innovative digital products, BI X is at the forefront of the company’s efforts to ride the digital wave. “The company recently topped up its corporate venture fund with an extra €50 million earmarked specifically for digital health investments,” said Michael Schmelmer, Member of the Board of Managing Directors responsible for Finance. He also funded BI X and is in charge of it. He described in detail the process and the possible timelines for ideas getting converted into rollouts and explained how 60 ideas finally get converted into roll outs.  ADAM is an application effectively used in drug development for sorting molecules. It constantly keeps updating its algorithms by adding new information as well as using the data from countless current and previous company projects from the company’s 50 years of archives. Using this information, within a few seconds each assistant in ADAM informs scientists about what is known about a molecule variant at Boehringer Ingelheim, without users having to search for it every time, making the life easier for the drug developers. “Thanks to digital assistants, we will be able to work much more efficiently in the near future,” remarked Dr Matthias Zentgraf from the research department. PSP, the company’s programme which can monitor speech patterns to diagnose mental illness, is ready to start clinical trials. Using machine learning, the programme analyses speech patterns to detect brain disorders. Graphical analysis of the speech indicates the possibility of the mental disorder since the speech graphs of a healthy person differs from one with mental disorders. The minor differences in the graph could be detected by the computer. The company wants to develop PSP as a diagnostic tool. A digital assistant called BRASS will soon be available for medical scientists of the company for phramacovigilance. The experts can enter their own experiences and assessments we well as background information in the application. Using various analytical methods BRASS can independently develop new findings. It can place data in the context of biomedical expertise.   Researchers need to identify the most relevant disease mechanisms they want to address for a drug discovery. The NTC studio application combines and analyses data from the widest range of internal and external sources. “The volume of information that is relevant for our research comes from all over the world and increases every day,” said Dr Jan Kriegl, Project Leader. He added, “Thanks to NTC Studio, researchers have access to many different sources and are always up- to-date with the current state of research.” “Digital technologies help us to identify relevant disease mechanisms, to discover promising molecules and to explore the unexpected far beyond current horizons – through open innovation. The time, quality and knowledge we gain thereby will above all benefit our patients worldwide,” explained Dr Michel Pairet, Member of the Board of Managing Directors with responsibility for the Innovation Unit. According to Schmelmer, the future technologies and the trends in the digital health will be 3D bio engineering & tissue engineering and drugs tested on virtual models. In this changing world, “the key challenge for us is to enable BI to seize these opportunities rapidly and efficiently,” he said and added the complex, expensive and time consuming process of discovering and developing new medicines will be revolutionised with the digital transformation in line with the company’s motto – better, faster, further.   Milind Kokje     (The writer was invited by Boehringer Ingelheim to its headquarters in Germany) ]]> https://biospectrumindia.com/news/57/13632/researchers-develop-gold-nanorods-to-kill-cancer-cell.html https://biospectrumindia.com/news/57/13632/researchers-develop-gold-nanorods-to-kill-cancer-cell.html Tue, 14 May 2019 15:45:00 +0530 Scientists at the University of Birmingham are working with a Canadian tech company to investigate whether gold nanorods can be used to target cancer cells in the human body. They have joined experts at Sona Nanotech Inc. to develop the next generation of nanorods for tissue imaging. The team will work with its Canadian partners - beginning by creating luminescent nanorods by transforming gold nanorods provided by Sona with transition metals using technology created at Birmingham. Team leader Zoe Pikramenou, Professor of Inorganic Chemistry and Photophysics at the University of Birmingham, said: “The scientific community is only just beginning to explore the exciting potential of gold nanoparticles in medical applications such as diagnostics, drug delivery and cancer treatment. “With its unique CTAB-free gold nanorods, Sona Nanotech has produced an innovative next-generation product that is ideally suited for these applications, which is why we have such high hopes for this collaborative project.” Professor Pikramenou runs an interdisciplinary research programme on Photophysics in Nanoscience and Biomolecular Chemistry using supramolecular design and synthesis, coordination chemistry, luminescence spectroscopy and imaging. Her team will evaluate differences in uptake with conventional nanoparticles and evaluate the attachment of antibodies for specific targeting of cancer tissues using techniques established in the group. Compared to other gold nanoparticles, gold nanorods have several advantages, including high surface area, unique physical, chemical and optical properties, biocompatibility and the ability to be conjugated with other molecules. This enables them to be used in more efficient drug targeting and delivery and enhanced bio-imaging, which is driving market demand. ]]> https://biospectrumindia.com/news/57/13631/ascension-healthcare-announces-positive-update-on-its-ip-portfolio.html https://biospectrumindia.com/news/57/13631/ascension-healthcare-announces-positive-update-on-its-ip-portfolio.html Tue, 14 May 2019 15:10:00 +0530 Ascension Healthcare, a clinical stage biopharmaceutical company developing and commercialising nano lipid technologies for unmet medical needs has announced that it has received a notice of no opposition from the European Patent Office (EPO) for a key patent underlying one of its important technology platforms. Patent EP20100742250 covers the key technology and composition of matter behind Ascension’s market disrupting Sequessome Technology that is used in the unique biolubricating Flexiseq gel.  Flexiseq is clinically proven to provide a long-term, entirely drug-free solution to chronic joint pain such as osteoarthritis. Richard Garraway, Chief Operating Officer, noted: “We were delighted when this patent was granted in Europe in July 2018.  The expiry of the nine-month limit of no opposition is now a further milestone of confidence in Ascension’s technology and its application.” Biresh Roy, Chief Executive Officer, commented: “Ascension continues to build value based upon the strength of its nanolipid platforms, both in its clinical stage haemophilia programmes and in marketed products such as Flexiseq, which is based on the technology in this patent.  This notice is further proof of the extraordinary science supporting all of our products and programmes.” Ascension Healthcare is a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapies for the treatment of haemophilia and osteoarthritis. The Company has three products in clinical or pre-clinical development for the treatment of Haemophilia A and also a range of internationally marketed products for osteoarthritis sufferers.   ]]> https://biospectrumindia.com/news/57/13627/philips-announces-collaboration-with-medtronic-.html https://biospectrumindia.com/news/57/13627/philips-announces-collaboration-with-medtronic-.html Tue, 14 May 2019 11:35:00 +0530 Royal Philips has announced a collaboration with Medtronic to further advance treatment of paroxysmal atrial fibrillation (PAF), a common heart rhythm disorder. Through the agreement, Medtronic will facilitate sales of products on behalf of Philips to provide an innovative, integrated image guidance solution for cryoablation procedures. Philips will bring to market the novel KODEX-EPD cardiac imaging and navigation system with cryoablation specific features to enable electrophysiologists to perform cryoablation procedures with reduced need for X-ray imaging. Atrial fibrillation (AF) affects more than 33 million people worldwide. Cryoballoon ablation is used in a minimally invasive procedure to isolate the pulmonary veins, which are a source of erratic electrical signals that cause AF. The technology uses cold energy rather than heat (radio frequency (RF) ablation) to create scar tissue and interrupt these irregular electrical pathways in the heart. Marlou Janssen, Business Leader Philips EPD Solutions said, “This integrated solution can guide physicians during the treatment of AF patients with ablation, as they can view detailed, CT-like 3D anatomy, reducing the need for X-ray imaging. Partnering with Medtronic extends the reach of our KODEX-EPD cardiac imaging and navigation system. Today, this technology is simplifying navigation, and in the future it has potential for a wide range of applications, including addressing the key unmet need of real-time therapy assessment – one of the more significant limitations of the current standard of care.” Rebecca Seidel, vice president and general manager of the Atrial Fibrillation Solutions division, which is part of the Cardiac and Vascular Group at Medtronic said, “When available, physicians will have the ability to use an innovative cardiac imaging and mapping system during cryoablation procedures, while also realizing the significant benefits of our best-in-class cryoablation therapy. AF is a growing epidemic and we are committed to providing solutions to electrophysiologists that help address the needs of their patients." Philips’ KODEX-EPD system uses dielectric imaging to create CT-like 3D, high-definition images of a patient’s cardiac structures in real time. A completely new approach to imaging the heart, dielectric imaging offers many benefits in comparison to current approaches, for both cryo and RF ablation procedures. The technology provides real-time 3D imaging, reducing the need for X-ray imaging. It also has mapping capabilities without the need to reset a reference point if the patient moves. As a result, the KODEX-EPD system provides excellent visualization and simplifies navigation, enhancing procedure efficiency and patient care. In pulmonary vein isolation (PVI) cryoablation procedures, the system confirms the positioning of the Medtronic Achieve™ Mapping Catheter, supporting quick visualization of the pulmonary veins. Philips is also developing balloon visualization capabilities for the KODEX-EPD system. KODEX-EPD is CE marked and has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for mapping and navigation during arrhythmia ablation procedures. KODEX-EPD systems are in clinical use at limited sites worldwide. ]]> https://biospectrumindia.com/news/57/13623/prospects-of-compounding-pharmacies-in-the-us-to-see-an-upsurge-study.html https://biospectrumindia.com/news/57/13623/prospects-of-compounding-pharmacies-in-the-us-to-see-an-upsurge-study.html Mon, 13 May 2019 23:10:00 +0530 According to a recent research, the global compounding pharmacies market is estimated to have accounted around US$ 8 Bn in terms of value during 2018. The report on the U.S. compounding pharmacies market also projects that the market will grow at a CAGR of approximately 5% during the period 2018-2028. The U.S. compounding pharmacies market revenue is expected to increase at a robust growth rate over the next few years despite the reporting of several adverse events and drug mismanagement-related deaths. The U.S. compounding pharmacies market is expected to gain popularity in several regions of the U.S. due to upcoming products and therapeutic areas that are yet to be tapped by branded manufacturers. Focus on factors, such as the availability of drugs in innovative medium/forms and the administration of varying dosages for various indications, is expected to drive the adoption of newer dosage forms of compounded medications.  Market Remains Influenced by Availability of Compounded Pain Management Drugs The growing popularity of pain management therapies is fuelling the growth of U.S. compounding pharmacies market. Compounded pain management drugs are not FDA-approved, however, they come under the State Pharmacies Board supervision in the U.S. For example, medical guidelines such as the Chronic Pain Guidelines stated by the Medical Treatment Utilization Schedule (MTUS) do not support the use of compounds such as Gabapentin and Baclofen for pain management. However, compounding pharmacies use these compounds as well as several others in varying strengths to attract customers and increase their revenue. Moreover, an increase in the shortage of prescription medicine is expected to upsurge the demand for compounding pharmacies. According to the U.S. FDA, only 154 drugs were in short supply or not available in 2007, as compared to 456 in 2012. Currently, the number of drugs in short supply is around 300. Medicinal drought is prominent in the U.S. as compared to other countries, which is also fuelling the revenue growth of the U.S. compounding pharmacies market.   On the other hand, increasing regulatory pressures are expected to hamper the growth of the U.S. compounding pharmacies market. Compounding pharmacies are engaged in trans-boundary drug compounding, and the manufacturing of bulk drugs & ingredients need to be registered with the FDA, undergo mandatory inspections, and abide by GMP guidelines. For instance, the FDA has stated that around 70% of registered firms have been inspected, of which 28 firms have been issued FDA Form 483s (non-adherence to cGMP regulations and unsafe compounding practices), and five warning letters, which implies a very high rate of action. Compounding pharmacies registering with the FDA could serve to increase credibility. However, inspections and compliance with good manufacturing practices is compulsory. Regulatory pressures on compounding pharmacies are expected to force the smaller ones to close their business primarily due to unsafe compounding practices, which are likely to directly impact patient safety. Hormone Replacement Therapeutic Area to Hold over 38% Revenue Share in Market By product type, oral medication is the expected to dominate the U.S. compounding pharmacies market in term of revenue, which is then followed by topical medication. The injectable segment by product type of the U.S. compounding pharmacies market is projected to grow at a significant rate as compared to other segments. The hormone replacement therapy segment is the leading segment in terms of revenue among all the therapeutic area segments of the U.S. compounding pharmacies market, and is estimated to gain a 38.4% revenue share in 2019. Among the pharmacy type segments, the 503A pharmacy segment is expected to gain a major revenue share as compared to the 503B pharmacy segment over the forecast period. By application, the adults segment is estimated to dominate the U.S. compounding pharmacies market, followed by the paediatrics segment. The veterinary segment is expected to grow at a faster pace as compared to the other application segments of the U.S. compounding pharmacies market.   The U.S. compounding pharmacies market report tracks some of the key companies operating in the market, which include Avella Specialty Pharmacy, Central Admixture Pharmacy Services, Inc., Fagron N.V., Wedgewood Pharma, PharMEDium Services LLC, Doughertys Pharmacy, Institutional Pharmacy Solutions, Lorraine’s Pharmacy, Village Compounding Pharmacy, Triangle Compounding Pharmacy, Olympia Pharmacy, Hoye's Pharmacy, Vertisis Custom Pharmacy, Smith Caldwell Drug Store, AIS HealthCare, Soleo Health, Millers Pharmacy, Centene Corporation, Infinity Care Solutions, Triumph Pharmacy, and Sixth Avenue Medical Pharmacy. ]]> https://biospectrumindia.com/news/57/13615/treefrog-therapeutics-raises-over-7m-in-series-a-funding.html https://biospectrumindia.com/news/57/13615/treefrog-therapeutics-raises-over-7m-in-series-a-funding.html Mon, 13 May 2019 14:55:00 +0530 TreeFrog Therapeutics, an expert stem cell company, announces that it has raised €7.1M ($7.8M) in a Series A funding round. The proceeds will be used to transition the company’s C-Stem™ technology to cGMP standards by 2021 and to develop proprietary and collaborative cell therapy research programs in a wide array of indications (Huntington’s disease, Parkinson’s disease, heart failure, diabetes, NASH) with the objective of a first-in-man clinical trial in 2024.   The Series A funding round was led by French-German venture capital team XAnge (Siparex Group), joined by private equity fund Galia Gestion as a new investor and historical investors from the earlier seed funding round, Irdi Soridec, Aquiti Gestion and SATT Aquitaine.   In addition to attracting €6.5M ($7.2M) in equity, TreeFrog Therapeutics was granted a further €600k ($670k) non-dilutive funding in March by the Nouvelle-Aquitaine Region, Bpifrance and the French Ministry of Higher Education, Research and Innovation.   TreeFrog Therapeutics was incorporated in November 2018. Over the past four years, the project has already received a total of €3M ($3.3M) from the University of Bordeaux, the French National Centre for Scientific Research (CNRS), the French National Research Agency (ANR) and the Technology Transfer Office for the Nouvelle-Aquitaine region, France (AST Innovations).   The key bottleneck in cell therapy research today is the culture of pluripotent stem cells, which are fragile and difficult to grow. Therefore, current cell therapy programs are limited by manufacturing capacity, cell processing costs and cell quality. To address this challenge, TreeFrog Therapeutics developed C-Stem™, its proprietary technology for stem cell culture; a 3D cell culture system enabling the mass production of stem cells with short lead times, while preserving genomic integrity. C-Stem aims to significantly lower costs and accelerate bioproduction.   The company recently announced that it has delivered the first batch of 143 million human IPS cells to Imagine Institute. These cells were amplified in only seven days without compromising on quality. This amplification factor is about ten times higher than current industry standards and genomic integrity was proved 100% preserved by Imagine Institute. ]]> https://biospectrumindia.com/news/57/13610/headspace-announces-one-billion-minute-challenge-in-support-of-mental-health-awareness-month.html https://biospectrumindia.com/news/57/13610/headspace-announces-one-billion-minute-challenge-in-support-of-mental-health-awareness-month.html Mon, 13 May 2019 13:05:00 +0530 Headspace, a global leader in mindfulness and meditation has announced a worldwide community challenge to benefit Mind, a mental health charity that provides advice and support to anyone experiencing a mental health problem, in support of Mental Health Awareness Month and World Meditation Day on May 15. Headspace is one of the leading players in the meditation category committed to advancing the field of mindfulness meditation through clinically-validated research. With one of the largest research pipelines of any digital health and wellness company, Headspace has been shown to reduce negative emotions by 28 per cent, increase resilience by 11 per cent, reduce stress, and improve satisfaction with life. “Since its inception, Headspace’s mission has been to improve the health and happiness of the world,” said Rich Pierson, CEO and Co-Founder of Headspace. “By partnering with Mind to celebrate Mental Health Awareness Month, we are hoping to further advance the conversation around mental health and improve access to as many tools for as many people around the world as possible.” Headspace members will automatically participate anytime they engage with content within the Headspace app, logging minutes of either guided meditation or non-meditation content such as Audio Guided Runs or Sleep by Headspace. At the end of May, Headspace will donate one thousand dollars to Mind for every million minutes spent with Headspace, up to one million dollars. Paul Farmer, Chief Executive of Mind, said: “We are delighted to partner with Headspace. The partnership will help us to reach a point where anyone with a mental health problem feels able to ask for, and access, the help they need. Money raised will fund our vital work including our Mind Infoline, information and advice services, and our campaigning to ensure everyone who has a mental health problem gets support and respect.” In addition to the Billion Minute Meditation Challenge, Headspace has also launched “Living Mindfully,” a new featured collection of meditation content designed to infuse more mindfulness into everyday life with guided meditations on topics such as: Life, to help members better connect to themselves and the world around them Work, to find better ways to cope with workplace stressors Finding Balance, to remind members to breathe, reset and renew The featured collection demonstrates Headspace’s commitment to providing members with curated content to strengthen their meditation practice. For non-paying subscribers, Headspace offers daily sessions around a different theme, allowing everyone to improve their meditation practice. ]]> https://biospectrumindia.com/news/57/13611/sunovion-psychogenics-announce-grant-of-breakthrough-therapy-designation-for-sep-363856.html https://biospectrumindia.com/news/57/13611/sunovion-psychogenics-announce-grant-of-breakthrough-therapy-designation-for-sep-363856.html Mon, 13 May 2019 13:05:00 +0530 Sunovion Pharmaceuticals and  PsychoGenics have announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for SEP-363856, a novel agent for the treatment of people with schizophrenia. Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints.1 “Schizophrenia is a major public health challenge associated with persistent abnormalities in thinking, perception and behavior, as well as impairments in quality of life and functional skills, that affects approximately 2.4 million people in the U.S.,”2 said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. “Breakthrough Therapy Designation underscores the potential of SEP-363856 as a novel treatment for patients with schizophrenia, for whom few major advances in treatment have occurred since the advent of antipsychotic pharmacotherapy in the 1950s. Investigational studies to further evaluate the clinical benefit of SEP-363856 are in progress, and we look forward to working closely with the FDA on this important potential new therapy." SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors, which are thought to mediate the effects of currently available antipsychotic medicines. Although the exact mechanism of action is unknown, SEP-363856 is believed to activate TAAR1 (trace amine-associated receptor 1) in addition to 5-HT1A (serotonin 1A) receptors. The FDA granted Breakthrough Therapy Designation for SEP-363856 based on pivotal, Phase 2 data from Study SEP361-201, which were presented by Sunovion at the 57th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2018, as well as data from Study SEP361-202, a six-month, open-label, safety and tolerability extension study. With this Breakthrough Therapy Designation SEP-363856 is eligible for intensive guidance from the FDA on the drug development program and priority review.1 About SEP 361-201 SEP 361-201, a randomized, placebo-controlled, double-blind, registration study, met its primary endpoint, demonstrating that hospitalized patients with acute exacerbation (worsening) of schizophrenia treated with SEP-363856 showed statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo after four weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001). Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale - Severity (CGI-S) (p<0.001). In addition, improvement was found in all major PANSS (positive, negative and general psychopathology) subscales (p<0.02). SEP-363856 was found to be generally well tolerated with notable similarities to placebo treatment in discontinuation rates; proportion of patients experiencing extrapyramidal symptoms or akathisia (restlessness); and change in metabolic parameters such as weight, lipids, glucose and prolactin. About SEP-363856 SEP-363856 is a psychotropic agent with a novel, non-D2 mechanism of action, distinct from currently marketed antipsychotics. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. SEP-363856 was optimized for antipsychotic activity by Sunovion medicinal chemists based on quantitative structure-activity relationship analysis, in collaboration with PsychoGenics. SEP-363856 is jointly owned by Sunovion and PsychoGenics. Sunovion has exclusive rights to develop and commercialize SEP-363856 globally. SEP-363856 is being studied in a global development program for schizophrenia as well as for Parkinson’s disease psychosis, with additional indications under consideration. Clinical trial results to date demonstrate a predictable pharmacokinetic (PK) profile suitable for once daily use. About Schizophrenia Schizophrenia is a chronic, serious and often severely disabling brain disorder that affects more than 23 million people worldwide2and approximately one in 100 adults (about 2.4 million people) in the United States.3 It is characterized by positive symptoms, such as hallucinations, delusions and disorganized thinking as well as negative symptoms, such as lack of emotion, social withdrawal, lack of spontaneity and cognitive impairment that includes problems with memory, attention and the ability to plan, organize and make decisions.3 References 1 U.S. Food and Drug Administration. Breakthrough Therapy. [Internet]. Available from: https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm. Accessed February 2019.2 Regier DA, Narrow WE, Rae DS, Mandercheid RW, Locke B2, Goodwin, FK. The de Facto US Mental and Addictive Disorders Service System. Arch Gen Psychiatry. 1993;50:85-94. Calculated by extrapolating from the 2008 United States Census Bureau population estimates.3 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed September 2018. ]]> https://biospectrumindia.com/news/57/13600/novartis-to-acquire-xiidra.html https://biospectrumindia.com/news/57/13600/novartis-to-acquire-xiidra.html Fri, 10 May 2019 13:30:00 +0530 Novartis has entered into an agreement with Takeda Pharmaceutical Company Limited to acquire the assets associated with Xiidra® (lifitegrast ophthalmic solution) 5% worldwide. Xiidra is the first and only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease. The transaction would bolster the Novartis front-of-the-eye portfolio and ophthalmic leadership. Closing of the transaction is expected in second half of 2019, subject to customary closing conditions including regulatory approvals. On closing, Novartis plans a smooth transition of operations and integration of Xiidra into its pharmaceuticals portfolio. Dry eye is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. This damage manifests in the form of signs that can be objectively measured by eye care professionals through various clinical tests (such as corneal staining), and symptoms (such as pain and discomfort). Xiidra, with its anti-inflammatory mechanism of action, is the first dry eye treatment approved to treat both the signs of eye damage and the physical symptoms experienced by patients. Additional benefits of Xiidra, exhibited in phase III studies, include a timely onset of action and well-tolerated safety profile. In addition to powering Novartis' ability to serve more patients suffering from eye disease, the additional commercial experience established with Xiidra is expected to better position the company for front-of-the-eye pipeline products currently in development. Deal terms include a USD 3.4 billion upfront payment with potential milestone payments of up to USD 1.9 billion. As part of the agreement, Novartis will be taking on approximately 400 employees associated with the product. ]]> https://biospectrumindia.com/news/57/13593/atelerix-raises-follow-on-funding-round-of-700000.html https://biospectrumindia.com/news/57/13593/atelerix-raises-follow-on-funding-round-of-700000.html Fri, 10 May 2019 11:40:00 +0530 Atelerix, creator of an innovative cell encapsulation technology, recently announces it has closed a second round of funding of £700,000 to accelerate development of its cell transport products to market. Atelerix’s products are used for the storage and transport of human cells and tissues at room temperature, removing the need for cryopreservation and the potential for cell degradation or damage. Atelerix sells its products and services to customers in the cell therapy sector, as well as those developing cells, organoids and assays for use in drug discovery and development. Atelerix was a spin-out from Newcastle University (UK) in 2017 and raised £425,000 in 2018 in a seed investment round led by specialist investor, UK Innovation & Science Seed Fund (UKI2S). This funding allowed the company to validate its technology, develop easy-to-use product formats for use with different cells and tissues and launch products onto the market. The follow-on investment announced will be used to grow the team, increase revenues and expand the business, capitalising on the exciting opportunities in the cell therapy sector where delivery of viable cells to the patient remains a significant logistical challenge. The new investment round was led by existing investors UK Innovation & Science Seed Fund (UKI2S), Oxford Technology Management and Newable Private Investing with new investors also joining the round. Dr Andrew Muir of UKI2S, who joined the board of Atelerix after the previous round, says “As a founding investor, UKI2S is delighted to see Atelerix well-positioned to complete the development of its proprietary platform and launch its products into two large markets. Based on great science, the company’s products have relevance to the large, growing markets of pre-clinical research and cell-based therapy.” Prior to spinning the Company out of Newcastle University, founder Professor Che Connon’s academic research was supported by Biotechnology and Biological Sciences Research Council (BBSRC), a UKI2S partner. Professor Connon commented “Encapsulating cells in the alginate hydrogel is a simple system capable of preserving the viability and functionality of cells at temperatures between 4°C and 21°C for extended periods of time. Used as a method of cell storage and transport, it overcomes the acknowledged problems associated with cryo-shipping. For shipping, cells are encapsulated by the in situ formation of the gel in plates or vials, and can be rapidly released from the gel by the addition of a simple buffer.” ]]> https://biospectrumindia.com/news/57/13588/pfizer-to-acquire-therachon-for-810m.html https://biospectrumindia.com/news/57/13588/pfizer-to-acquire-therachon-for-810m.html Fri, 10 May 2019 09:00:00 +0530 Pfizer has announced that it has entered into a definitive agreement to acquire all the shares of Therachon Holding AG, a privately-held clinical-stage biotechnology company focused on rare diseases, with assets in development for the treatment of achondroplasia and short bowel syndrome (SBS). Under the terms of the agreement, Pfizer will acquire Therachon for $340 million upfront with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46 for the treatment of achondroplasia, a genetic condition and the most common form of short-limbed dwarfism. Achondroplasia can result in serious cardiovascular, neurological and metabolic complications for approximately 250,000 people worldwide. There are currently no approved treatments for achondroplasia. TA-46 is an investigational, soluble recombinant human fibroblast growth factor receptor 3 (FGFR3) decoy, a mechanism of action that is believed to normalize the overactive FGFR3 signaling pathways that underlie bone development abnormalities associated with achondroplasia. Therachon is developing TA-46 as a weekly subcutaneous injection for children and adolescents living with the condition. TA-46 has completed Phase 1 and has received Orphan Drug Designation from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Prior to the closing of the transaction with Pfizer, Therachon will spin-off its apraglutide development program into a separate, independent company. Apraglutide is a once-weekly, potential best-in-class GLP-2 analog in Phase 2 development for short bowel syndrome. Pfizer Ventures, the venture capital arm of Pfizer Inc., currently holds a minority stake and will continue to hold an equity stake in the new company. Mikael Dolsten, Pfizer Chief Scientific Officer and President, Worldwide Research, Development, and Medical said, “At Pfizer, our strategy is focused on advancing the most promising science in the world, regardless of whether it is found inside or outside of our labs. By acquiring Therachon, we hope to leverage Pfizer’s leading scientific and development capabilities to more rapidly advance this potentially promising therapy for people with achondroplasia.” Therachon Chief Executive Officer Luca Santarelli added, “We are thrilled that the work we have done to discover and advance a novel and potentially life-transforming medicine for achondroplasia is now being continued by Pfizer. With its rare disease expertise and worldwide reach, Pfizer is well positioned to accelerate the development of TA-46 and fulfill Therachon’s vision of addressing the complications suffered by children with achondroplasia by targeting the molecular root causes of this condition.” The acquisition complements Pfizer’s existing research portfolio in rare diseases. Seng Cheng, Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Disease Research Unit said, “Through the acquisition of Therachon, we believe that we have a significant opportunity to transform the lives of young people with achondroplasia who courageously endure lifelong complications from short-limb dwarfism. Pfizer’s existing research programs for pediatric growth disorders provide a complementary setting for this potential breakthrough therapy.” Therachon Chairman Tom Woiwode, Managing Director at Versant Ventures said, “Therachon is a great example of the value that can be built from cutting edge European science. By coupling that research with a strong group of investors and an exceptional management team, Therachon developed a highly innovative therapy for a seriously debilitating condition. We look forward to Pfizer continuing to develop TA-46 in the hope that it will significantly improve the lives of children suffering from achondroplasia.” No other terms of the transaction were disclosed. Goldman Sachs is acting as exclusive financial advisor and Cooley LLP and Homburger AG are acting as legal advisors to Therachon. Arnold & Porter and Lenz & Staehelin are serving as legal advisors to Pfizer. ]]> https://biospectrumindia.com/news/57/13577/researchers-discover-revolutionary-stem-cell-treatment.html https://biospectrumindia.com/news/57/13577/researchers-discover-revolutionary-stem-cell-treatment.html Wed, 08 May 2019 15:50:00 +0530 A discovery by researchers at Queen’s University Belfast and King’s College London (KCL) could revolutionise treatment for vascular and diabetes related cardiovascular diseases. The researchers have developed technology that can produce large quantities of stem cells in a short time, using only a small blood sample. They have also found that the stem cells produced can generate and replace damaged cells within blood vessels. This treatment could prevent a range of vascular-related complications including heart attacks, kidney disease, blindness and amputations in people with diabetes. Principal Investigator, Dr Andriana Margariti from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University Belfast, explains: “Being able to produce large quantities of stem cells from a few millilitres of blood in a short timeframe is truly ground-breaking. This could revolutionise how we treat a vast number of blood vessel diseases.” “Previously, this cell transformation process would have involved a skin biopsy, or large volumes of blood, which simply isn’t viable for many patients as it is a risky process which can take a long recovery time.” “This study focused on stem cells for vascular diseases but the same process can be used to produce stem cells for a number of organs, including the brain and kidneys, which has huge implications for the future of healthcare.” The Queen’s and KCL researchers have also discovered that activating a particular gene known as Endothelial Specific Molecule 1 (ESM1) in the stem cells could enhance the production and function of newly generating endothelial cells, which play a key role in a number of vascular diseases.  Endothelial cells line the blood vessels, acting as a protective barrier. As the top layer of cells in the blood vessels, it is these cells that become seriously damaged in cardiovascular disease, and this is often accelerated in patients with diabetes. People with cardiovascular disease and diabetes are more likely to suffer from heart attacks, blindness and poor circulation because their endothelial cells are damaged. Dr Margariti explains: “A major source of mortality among those with cardiovascular diseases, and especially patients with diabetes, is due to irreversible damage to their endothelial cells which can lead to blockage of blood flow to the heart, eyes, kidney and limbs.” The preclinical study, published in Stem Cell Journals, showed that stem cells expressing the ESM1 gene have a remarkable regenerative potential and significantly increased the blood-flow when they were tested in damaged blood vessels. In a concept known as cell therapy, damage can be repaired through the transplantation of healthy endothelial cells. Professor Alan Stitt, Dean of Innovation and Education at Queen’s University Belfast and co-author explained: “Through the technology developed, we can readily produce stem cells to transplant to damaged blood vessels. We have discovered that activating the particular gene ESM1 will improve the production and function of endothelial cells, reversing the damaged cells. This is life-changing as the results have shown that repairing these cells can stop the progressive illnesses, which will prevent blindness and amputations.”    “Cell transplantation has huge potential though it is not suitable for all vascular diseases such as coronary disease. Now we know how to generate and improve the function of these cells, we will focus on screening drugs to see which treatments will further improve the function of these cells and ultimately improve the lives of millions of people afflicted with these illnesses.” ]]> https://biospectrumindia.com/news/57/13573/sigilon-therapeutics-appoints-john-cox-to-board-of-directors.html https://biospectrumindia.com/news/57/13573/sigilon-therapeutics-appoints-john-cox-to-board-of-directors.html Wed, 08 May 2019 13:00:00 +0530 Sigilon Therapeutics, a biopharmaceutical company creating functional cures for chronic diseases using Shielded Living Therapeutics has announced the appointment of distinguished biopharma executive John Cox, MBA, to its Board of Directors. Mr. Cox has over 25 years of experience in biopharmaceuticals, most notably in his former role as Chief Executive Officer of Bioverativ. In that role, Mr. Cox built, grew and led the company to an $11.6 billion acquisition by Sanofi, which was considered one of the most successful spinouts in biopharma history. “I am honored to join Sigilon and to contribute to furthering the progress of its novel pipeline of Shielded Living Therapeutics,” said Mr. Cox. “I care deeply about bettering the treatment of chronic diseases and I believe Sigilon’s technology may offer a novel solution for these patients, freeing them from the burden of daily management of their disease.” Mr. Cox is currently Executive Chairman of Torque Therapeutics. Preceding his work at Bioverativ, Mr. Cox served in several key roles at Biogen, where he oversaw the company’s production facilities, supply chain operations, technical development, quality and engineering across the globe. Mr. Cox holds an MBA from the University of Michigan, an M.S. in cell biology from California State University and a B.S. in biology from Arizona State University. “I’m thrilled to once again work alongside John in pioneering a new first-in-class category of medicine to transform the lives of patients with chronic diseases,” said Rogerio Vivaldi, M.D., MBA, President and Chief Executive Officer of Sigilon. “John’s deep experience in clinical manufacturing and operations will be of immense benefit to Sigilon as we look to enter the clinic next year and as we continue to leverage the Shielded Living Therapeutics™ product platform for the benefit of patients.” “We’re pleased to welcome John to the Sigilon Board of Directors, where he’ll be an invaluable source of insights around company-building, partnership formation and future pipeline growth,” said Doug Cole, M.D., Chairman of the Board. “I look forward to working alongside him to advance Sigilon’s important mission.” ]]> https://biospectrumindia.com/news/57/13572/mercks-belsomra-c-iv-meets-primary-efficacy-endpoint-in-ph3-trial.html https://biospectrumindia.com/news/57/13572/mercks-belsomra-c-iv-meets-primary-efficacy-endpoint-in-ph3-trial.html Wed, 08 May 2019 12:15:00 +0530 Merck known as MSD outside the United States and Canada, has announced the presentation of results of a Phase 3 trial evaluating the efficacy and safety of BELSOMRA (suvorexant) C-IV for the treatment of insomnia in people with mild-to-moderate Alzheimer’s disease dementia. This is the first dedicated Phase 3 polysomnography study of an insomnia medication in people with mild-to-moderate Alzheimer’s disease dementia, and in the trial, BELSOMRA met its primary and secondary efficacy endpoints. For the primary endpoint, 4-weeks of treatment with BELSOMRA improved mean total sleep time (TST) by 28.2 minutes versus placebo (n=135 vs. n=139, respectively; [95% CI:11.1,45.2], p<0.005). This corresponded to a mean increase from baseline of 73.4 minutes with BELSOMRA [95% CI: 61.3, 85.5] and a mean increase from baseline of 45.2 minutes with placebo [95% CI: 33.3, 57.2]. Adverse events were reported in 22.5% of patients receiving BELSOMRA compared to 16.1% of those receiving placebo. The results are being presented at the 2019 American Academy of Neurology Annual Meeting, held May 4-10 in Philadelphia, PA. “Insomnia and other sleep disturbances are more common in people with Alzheimer’s disease dementia, but evidence for the efficacy and safety of sleep medications in this population remains limited,” said Dr. W. Joseph Herring, associate vice president, Global Clinical Research, Neuroscience, Merck Research Laboratories. “We are encouraged by the efficacy and safety results of BELSOMRA in those living with Alzheimer’s disease dementia. Merck plans to file these data with the U.S. Food and Drug Administration for potential inclusion into the BELSOMRA prescribing information.” BELSOMRA (suvorexant) C-IV 5 mg, 10 mg, 15 mg and 20 mg tablets are currently approved in the United States for treatment of insomnia characterized by difficulties with sleep onset and sleep maintenance. Study Design he Phase 3 randomized, double-blind, clinical trial evaluated the efficacy and safety of BELSOMRA (suvorexant) 10 mg, which could be increased to a 20 mg dose based on clinical response (77% of patients treated with BELSOMRA increased their dose from 10 mg to 20 mg after the second week of study) or matching placebo in participants with mild-to-moderate Alzheimer’s disease dementia (a score of 12-26 on the Mini Mental State Examination) and insomnia (mean total sleep time less than 6 hours). Sleep was measured by overnight polysomnography in a sleep laboratory. The trial consisted of a 3-week screening period with a 2-week single blind placebo run in followed by a 4-week double blind randomized treatment period. Overnight polysomnography in a sleep laboratory was performed during a visit 14 days prior to randomization, at a baseline visit 7 days prior to randomization and following the 4-week double-blind treatment period. The primary endpoint of the study was change-from-baseline in polysomnography-measured mean TST in minutes (higher score indicating improved sleep) at Week 4. The secondary efficacy endpoint was mean wake after persistent sleep onset (WASO) measured in minutes and defined as the total wake time over the PSG recording period after the first period of continuous sleep lasting at least 10 minutes (lower score corresponds to better sleep). Additional exploratory measures included physician-assessed Clinician Global Impression of Severity (CGI-S) of insomnia and a caregiver-reported participant subjective Sleep Quality Rating (sSQR). Study Results Of those participants completing the trial (BELSOMRA n=136; placebo n=141), mean (SD) baseline TST was 278 (77) minutes for those receiving BELSOMRA and 274 (84) minutes for placebo. Measurement at Week 4 showed an increase in TST in the BELSOMRA group compared with placebo (model-based least squares mean change-from-baseline in TST: BELSOMRA 73.4 minutes, placebo 45.2 minutes; difference = 28.2 minutes [95% CI:11,45]; p<0.01). The secondary efficacy endpoint measurement at Week 4 showed an improvement in WASO in the BELSOMRA group compared with placebo (model-based least squares mean change-from-baseline in WASO: BELSOMRA -41.8 minutes, placebo -32.5 minutes; difference = 15.7 minutes [95% CI:-28.1,-3.3]; p=0.01). Safety was assessed by adverse event reports, laboratory analyses, electrocardiograms and physical examinations performed as stated in the protocol. Adverse events were recorded in 22.5% (n=32/142) of patients in the BELSOMRA group and 16.1% (n=23/143) in the placebo group. One patient in each group discontinued treatment due to an adverse event. The most common recorded adverse event was somnolence (drowsiness), which was reported in 4.2% (n=6) of patients in the BELSOMRA-treated group and 1.4% (n=2) of placebo-treated patients. Somnolence was recorded as mild-to-moderate severity. Other adverse events included: headache (n=5 on BELSOMRA vs. n=6 on placebo), dry mouth (n=3 vs. n=1) and falls (n=3 vs. n=0). Insomnia and Alzheimer’s Disease Findings indicate that insomnia affects up to 45% of people living with Alzheimer’s disease. Many factors contribute to insomnia, which evidence suggests includes when wake-promoting signaling overrides sleep-promoting signaling in the brain. There are many neurotransmitters in the brain that regulate wakefulness, including the orexin signaling system. Elevated orexin levels in cerebral spinal fluid are found in those living with Alzheimer’s disease. Changes occurring in the brain tissue of people with Alzheimer’s disease are associated with the loss of mental abilities and are also believed to cause disruptions in the sleep/wake cycle resulting in sleep problems. Many people with Alzheimer’s disease wake up more often and stay awake longer than those without the disease, which may lead to significant shifts in sleep/wake patterns. BELSOMRA (suvorexant) is a first-in-class oral, highly selective antagonist for orexin receptors. Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake. The mechanism by which BELSOMRA exerts its therapeutic effect is presumed to be through antagonism of orexin receptors. ]]> https://biospectrumindia.com/news/57/13564/aduro-partners-with-bon-secours-mercy-health-.html https://biospectrumindia.com/news/57/13564/aduro-partners-with-bon-secours-mercy-health-.html Tue, 07 May 2019 17:10:00 +0530 Bon Secours Mercy Health (BSMH) and ADURO announced that BSMH has become a minority investor in ADURO, a leading health and well-being provider for corporations and health systems. This collaboration gives BSMH, the nation's fifth-largest Catholic health system with more than 57,000 employees in 1000 sites of care and $8 billion in net operating income, a leadership position in the digital transformation of today's value-based healthcare industry. BSMH's investment adds to the $22 million in growth funding ADURO received from Boston-based private equity firm Abry Partners in January 2019. ADURO's digital human performance and coaching platform unlocks potential across transformational areas of life including health, finance, personal growth, contribution and flourishing.   BSMH and ADURO have worked closely together for six years to innovate, implement and validate the connection of well-being and clinical care for BSMH employees, patients and community employers. ADURO and BSMH initially enabled an award-winning employee well-being program designed to improve the work and lives of care givers. BSHM then integrated ADURO's holistic well-being solution into the broader care continuum, allowing physicians and other caregivers to use real-time well-being data in patient engagements, and prescribe behavior-changing programs between episodic visits. "Our associates have experienced tremendous success using ADURO's human performance innovations," said Allan Calonge, Chief HR Strategy & Well-being Officer at BSMH. "We look forward to continuing to advance our own ecosystem of well-being and precision care, while supporting ADURO as they continue to play a strategic role in revolutionizing modern healthcare." More recently, BSMH has integrated ADURO's platform into its work with other community employers, offering a coordinated well-being and clinical care solution as part of its comprehensive community population health initiative.   ]]> https://biospectrumindia.com/news/57/13563/redhill-biopharma-reports-q1-2019-results.html https://biospectrumindia.com/news/57/13563/redhill-biopharma-reports-q1-2019-results.html Tue, 07 May 2019 16:55:00 +0530 RedHill Biopharma, a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases reported its financial results and operational highlights for the quarter ended March 31, 2019. “We had a productive quarter with Talicia leading up to the NDA submission to the FDA, announced earlier today. With potential NDA approval as early as the fourth quarter of this year, we have expanded our highly experienced commercial management team and are advancing the preparations for the potential U.S. launch of Talicia with our established sales-force,” said Micha Ben Chorin, RedHill’s chief financial officer. “As of March 31, 2019, we have maintained a cash position of $45.5 million with a debt-free balance sheet and continued decrease of our quarterly cash burn to its lowest level in two years.”   Operational Highlights: Talicia (RHB-105) - Eradication of H. pylori Infection  RedHill submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Talicia for the treatment of H. pyloriinfection following positive results from two Phase 3 studies and a positive pre-NDA meeting with the FDA earlier this year. Talicia was granted Qualified Infectious Disease Product (QIDP) designation by the FDA, including eligibility for six-month priority review and an additional three years of market exclusivity on top of the standard five years, for a total of eight years of U.S. market exclusivity. Assuming FDA approval, RedHill plans to launch Talicia in the U.S. in the fourth quarter of 2019 with the Company’s dedicated sales force. RedHill announced in January 2019 that it had received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for an additional new patent covering Talicia. The patent was subsequently granted and is valid until at least 2034. This is the fifth patent covering Talicia in the U.S. RedHill also announced in March 2019 that the European Patent Office (EPO) and the Japan Patent Office (JPO) accepted pending patent applications covering Talicia for H. pylori infection. The Japanese patent was subsequently granted and is valid until 2034. RHB-104 - Crohn’s Disease RedHill plans to meet with the FDA in the second half of 2019 to discuss the development path toward potential approval of RHB-104, including the design of a confirmatory Phase 3 study. This meeting follows the positive results from the first Phase 3 study with orally-administered RHB-104 for the treatment of Crohn’s disease (MAP US study). The MAP US study successfully met both its primary endpoint and its key secondary endpoints and presented the broad benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn’s disease, including anti-TNFs. RedHill continues to assess additional data from the positive study as it becomes available. RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Infections RedHill plans to initiate a pivotal Phase 3 study with RHB-204 for the treatment of pulmonary NTM infections in the second half of 2019, subject to completion of the ongoing supportive non-clinical program and additional input from the FDA. The study is intended to assess the efficacy and safety of RHB-204 and potentially support its approval as a stand-alone, first-line treatment for pulmonary NTM infections caused by Mycobacterium avium complex (MAC). BEKINDA (RHB-102) - Gastroenteritis and Gastritis and Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) RedHill is currently working toward a confirmatory Phase 3 study to support a potential NDA for BEKINDA for acute gastroenteritis and gastritis. This study follows the successful completion of a first Phase 3 study with BEKINDA for acute gastroenteritis and gastritis and guidance provided by the FDA. RedHill held a positive end-of-Phase 2 Type B meeting with the FDA to discuss the clinical and regulatory pathway toward potential U.S. approval of BEKINDA for the treatment of IBS-D. RedHill is currently finalizing the design of two pivotal Phase 3 studies with BEKINDA for IBS-D. YELIVA (opaganib, ABC294640) - Cholangiocarcinoma  The ongoing Phase 2a study evaluating the activity of orally-administered YELIVA in advanced cholangiocarcinoma (bile duct cancer) continues to enroll patients in the second stage of the two-stage study design. Enrollment of the full cohort of 39 evaluable patients is expected to be completed by the end of 2019. Commercial Highlights: RedHill is continuing its preparations for the potential U.S. launch of Talicia in the fourth quarter of 2019 with its dedicated sales force. RedHill currently commercializes and promotes several GI-specialty products in select U.S. territories, including Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), EnteraGam (serum-derived bovine immunoglobulin/protein isolate SBI) and Mytesi (crofelemer 125 mg delayed-release tablets). Financial highlights for the quarter ended March 31, 20195 Net Revenues of $1.7 million in the first quarter of 2019, an increase of 28% compared to the fourth quarter of 2018. The growth was attributable to an increase in revenues from promoted products.  Gross Profit of $1.3 million in the first quarter of 2019, compared to $0.8 million in the fourth quarter of 2018, with gross margin increased from 57% to 76%. The growth was attributable to an increase in revenues from promoted products.  Research and Development Expenses of $5.4 million in the first quarter of 2019, compared to $5.8 million in the fourth quarter of 2018, resulting from the successful finalization of the confirmatory Phase 3 study with Talicia.    Selling, Marketing and Business Development Expenses of $3.1 million in the first quarter of 2019, compared to $3.2 million in the fourth quarter of 2018.   General and Administrative Expenses of $2.0 million in the first quarter of 2019, compared to $1.9 million in the fourth quarter of 2018.   Operating Loss of $9.2 million in the first quarter of 2019, compared to $10 million in the fourth quarter of 2018. The decrease in Operating Loss was primarily due to the increase in Gross Profit and the decrease in Research and Development Expenses, as described above.  Net Cash Used in Operating Activities of $7.5 million in the first quarter of 2019, compared to $8.2 million in the fourth quarter of 2018.   Cash Balance as of March 31, 2019, was $45.5 million, compared to $53.2 million as of December 31, 2018. RedHill Biopharma is a specialty biopharmaceutical company, primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes several gastrointestinal products in the U.S.: Donnatal - a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; EnteraGam - a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools and Mytesi - an anti-diarrheal drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. RedHill’s key clinical late-stage development programs include: (i) Talicia (RHB-105) for the treatment of Helicobacter pylori infection with a U.S. NDA submitted; (ii) RHB-104, with positive top-line results from a first Phase 3 study for Crohn's disease; (iii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iv) BEKINDA (RHB-102), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) YELIVA (ABC294640), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; (vi) RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vii) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. ]]> https://biospectrumindia.com/news/57/13561/pfizer-gets-usfda-approval-for-vyndaqel-and-vyndamax.html https://biospectrumindia.com/news/57/13561/pfizer-gets-usfda-approval-for-vyndaqel-and-vyndamax.html Tue, 07 May 2019 16:20:00 +0530 Pfizer Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved both VYNDAQEL® (tafamidis meglumine) and VYNDAMAX™ (tafamidis) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat ATTR-CM. Transthyretin amyloid cardiomyopathy is a rare, life-threatening disease characterized by the buildup of abnormal deposits of misfolded protein called amyloid in the heart and is defined by restrictive cardiomyopathy and progressive heart failure. Previously, there were no medicines approved to treat ATTR-CM; the only available options included symptom management, and, in rare cases, heart (or heart and liver) transplant. It is estimated that the prevalence of ATTR-CM is approximately 100,000 people in the U.S and only one to two percent of those patients are diagnosed today. "The approvals of VYNDAQEL and VYNDAMAX are a testament to the significant research and development investment in our innovative cardiovascular outcomes trial, ATTR-ACT. We are proud to bring these medicines to ATTR-CM patients who are in dire need of treatment," said Brenda Cooperstone, MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development. "VYNDAQEL and VYNDAMAX reduce cardiovascular mortality and the frequency of cardiovascular-related hospital stays in patients with wild-type or hereditary forms of this rare disease, giving them a chance for more time with their loved ones." "ATTR-CM is not only fatal, but also significantly underdiagnosed, with some patients cycling through multiple doctors and a myriad of tests over a period of years while the disease progresses," said Isabelle Lousada, Founder and CEO, Amyloidosis Research Consortium. "ATTR-CM is a rare disease for which more education and awareness is needed. The approval of these medicines represents an important advance for patients; however, it is equally important that we work as a community to recognize the critical importance of early diagnosis." The FDA approval was based on data from the pivotal Phase 3 Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), the first global, double-blind, randomized, placebo-controlled clinical study to investigate a pharmacological therapy for the treatment of this disease. ]]> https://biospectrumindia.com/news/57/13549/sime-completes-study-validating-clinical-ai-platform-in-rds.html https://biospectrumindia.com/news/57/13549/sime-completes-study-validating-clinical-ai-platform-in-rds.html Mon, 06 May 2019 16:10:00 +0530 SIME, a Clinical AI company generating unique biological data to deliver life-saving solutions, announced the publication of its pivotal 'Fast Assessment of Lung Maturity at Birth' study. The study validates the first application on the company's patented AI Platform: a rapid point-of-care neonatal Lung Maturity Test (LMT). Building on previous clinical data published in 2016, the 'Fast Assessment of Lung Maturity at Birth' study demonstrates that by measuring lung maturity biomarkers, AI can predict Respiratory Distress Syndrome (RDS) with high accuracy (91% sensitivity) moments after birth. RDS is the leading cause of mortality and morbidity in premature babies, and although it can be alleviated with immediate treatment, there is currently no clinical tool that is able to predict the disease fast enough to be clinically effective. LMT generates the information needed to screen millions of babies for RDS each year, addressing one of the most urgent unmet needs in neonatology. SIME's novel Data Engine generates unique data from biological samples at the point of care. These data are then analysed by the platform's proprietary AI algorithms to predict disease, discover new biomarkers and develop life-saving tools for doctors and nurses. LMT is the first example of how this technology, and the data it generates, can be used to deliver preventative care, improve outcomes and reduce healthcare costs.       Completion of the study has enabled SIME to accelerate platform development, and begin next phase clinical studies of LMT in China, Europe and, following a recent clinical partnership agreement, the US. Keeping with the company's commitment to full clinical data transparency, all study results will be published and disseminated. ]]> https://biospectrumindia.com/news/57/13546/fbi-approves-verogens-next-gen-forensic-dna-technology-for-national-dna-index-system.html https://biospectrumindia.com/news/57/13546/fbi-approves-verogens-next-gen-forensic-dna-technology-for-national-dna-index-system.html Mon, 06 May 2019 14:30:00 +0530 Verogen Inc., the world’s first DNA sequencing company dedicated to forensic science has announced that the United States Federal Bureau of Investigation has approved the company’s next-gen forensic DNA technology for use by forensic laboratories generating DNA profiles for upload to the National DNA Index System (NDIS). The FBI manages NDIS to enable comparison of eligible DNA profiles contributed by participating federal, state, and municipal forensic laboratories. Verogen’s MiSeq FGx Forensic Genomics System is the first NDIS approved solution for genomic DNA analysis that harnesses “Next Generation Sequencing” (NGS) technology to dramatically increase profiling efficiency and data recovery from biological evidence. “This is an important advancement,” said Dr. Jenifer Smith, Director of the Washington, D.C., Department of Forensic Sciences. Dr. Smith’s laboratory was part of the consortium of forensic U.S. laboratories that submitted internal validation results to the FBI as part of the NDIS approval process. “NGS enables us to efficiently generate more comprehensive and useful data. This means we will be able to aid more investigations and close more cases,” Dr. Smith said. The MiSeq FGx Forensic Genomics System is a sample-to-answer workflow including the ForenSeq DNA Signature Prep kit, MiSeq FGx sequencing instrument platform, and ForenSeq Universal Analysis Software. The system allows forensic scientists to analyze up to 231 genomic DNA markers simultaneously—supplying significantly more actionable data than commonly analyzed using older methods. The Verogen system can develop more detailed profiles from degraded, mixed, and limited biological evidence samples, addressing a wider range of forensic questions in a single test. With NDIS approval granted, U.S. forensic laboratories can now access a much larger pool of federal funding administered by the National Institute of Justice to adopt and implement this powerful crime fighting tool. “Obtaining NDIS approval is an enormous step forward for the forensic genomics community, and for mainstream adoption of this technology,” said Brett Williams, Verogen CEO. “Verogen is proud to advance the transition of NGS technology from a visionary method to a fully validated, NDIS-approved tool for forensic science.” The MiSeq FGx Forensic Genomics System is available worldwide. It has been approved for use in the national DNA databases of France and the Netherlands—and now the United States. ]]> https://biospectrumindia.com/news/57/13545/fda-approves-genentechs-kadcyla.html https://biospectrumindia.com/news/57/13545/fda-approves-genentechs-kadcyla.html Mon, 06 May 2019 14:15:00 +0530 Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment. “This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.” The goal of treating EBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach. While we come closer to this goal with each advance, many people still have a disease recurrence in the long term. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery and aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning. The FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, leading to approval 12 weeks after completing the submission. Kadcyla is the first Genentech medicine approved under the RTOR pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. For this indication, Kadcyla was also granted a Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. This approval is based on results of the Phase III KATHERINE study showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin as an adjuvant treatment in people with HER2-positive EBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%. People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease. The most common Grade 3 or higher side effects (>2%) with Kadcyla in the KATHERINE study were decreased platelet count and high blood pressure. The most common side effects (>25%) with Kadcyla were fatigue; nausea; increased blood levels of liver enzymes; musculoskeletal pain; bleeding; decreased platelet count; headache; numbness, tingling or pain in the hands or feet; and joint pain.   ]]> https://biospectrumindia.com/news/57/13539/samsung-biologics-signs-contract-with-gi-innovation.html https://biospectrumindia.com/news/57/13539/samsung-biologics-signs-contract-with-gi-innovation.html Fri, 03 May 2019 17:25:00 +0530 Samsung BioLogics and GI Innovation have signed a Contract Development Organization (CDO) contract for immunochemotherapy at Samsung BioLogics headquarters. GI Innovation signed this second contract with Samsung BioLogics based on their satisfaction with the high quality and production services received during their first project with Samsung BioLogics in June of last year. This agreement is the first among a five, multi-project deal, and Samsung BioLogics will provide CDO services from the development of cell lines to the production of Phase I drug substances to GI Innovation, which is also the world's first bio-venture company to explore the development of new drugs through the combination of microbiome (human microorganism) and protein drugs. This deal is expected to further leverage Samsung BioLogics leading CDO technology and capacity with GI Innovation's competitive candidates to accelerate new drug development. The CDO market has grown at a CAGR of over 15%, and as the development of new biopharmaceuticals has increased, small and medium-sized biotech companies have outsourced development and production to CDMOs. In addition, the CDO business is becoming more significant in the industry, as it is naturally linked to the CMO (Contract Manufacturing Organization) business in the future. In 2018, Samsung BioLogics launched its CDO business and within a year secured new drug development projects comprising of eight domestic and overseas companies including GI Innovation, quickly establishing a track record of success as a globally advanced player in terms of speed, price competitiveness, quality, and efficiency. "As Samsung BioLogics provides consistent services for CRO (contract research), CDO (contract development) and CMO (contract manufacturing), biopharmaceutical companies will dramatically reduce costs and time," said Dr. Tae Han Kim, "We will do our best to help domestic bio-venture companies, including GI Innovation, advance into the global market and commercialize their products through our CDO technology." "Thanks to Samsung BioLogics' CDMO business, we can overcome the problem of producing high-quality clinical test samples, the biggest barrier of bio venture companies," said Dr. Nam, "We are very positive that global pharmaceutical companies interested in the R&D pipeline of GI Innovation will be able to access global new drug licensing (BLA) and biotech drug business through Samsung BioLogics' CDMO service. Through this collaboration, we wish to demonstrate the win-win model of venture firms and large corporations that the people and the government want."   ]]> https://biospectrumindia.com/news/57/13538/samsung-biologics-signs-cdo-contract-with-gi-innovation.html https://biospectrumindia.com/news/57/13538/samsung-biologics-signs-cdo-contract-with-gi-innovation.html Fri, 03 May 2019 17:00:00 +0530 Samsung BioLogics and GI Innovation signed a Contract Development Organization (CDO) contract for immunochemo therapy. GI Innovation signed this second contract with Samsung BioLogics based on their satisfaction with the high quality and production services received during their first project with Samsung BioLogics in June of last year. This agreement is the first among a five, multi-project deal, and Samsung BioLogics will provide CDO services from the development of cell lines to the production of Phase I drug substances to GI Innovation, which is also the world's first bio-venture company to explore the development of new drugs through the combination of microbiome (human microorganism) and protein drugs. This deal is expected to further leverage Samsung BioLogics leading CDO technology and capacity with GI Innovation's competitive candidates to accelerate new drug development. The CDO market has grown at a CAGR of over 15%, and as the development of new biopharmaceuticals has increased, small and medium-sized biotech companies have outsourced development and production to CDMOs. In addition, the CDO business is becoming more significant in the industry, as it is naturally linked to the CMO (Contract Manufacturing Organization) business in the future. In 2018, Samsung BioLogics launched its CDO business and within a year secured new drug development projects comprising of eight domestic and overseas companies including GI Innovation, quickly establishing a track record of success as a globally advanced player in terms of speed, price competitiveness, quality, and efficiency.   ]]> https://biospectrumindia.com/news/57/13536/hikma-sponsors-mit-grand-hack-to-support-global-healthcare-innovation.html https://biospectrumindia.com/news/57/13536/hikma-sponsors-mit-grand-hack-to-support-global-healthcare-innovation.html Fri, 03 May 2019 16:35:00 +0530 Hikma Pharmaceuticals PLC the multinational generic pharmaceutical company, announced that it will serve as a Gold Sponsor of the Massachusetts Institute of Technology's Grand Hack taking place this weekend (May 3-5, 2019) in Cambridge, Massachusetts.  The Grand Hack is MIT Hacking Medicine's annual flagship event dedicated to energise, infect and teach healthcare entrepreneurship and digital strategies to scale medicine as a way to solve health problems worldwide.  More than 500 participants, mentors and sponsors from 25 US states and 29 countries are expected to gather on campus in the MIT Media Lab for this year's Grand Hack, the largest healthcare hackathon in the US. As a strategic sponsor, Hikma and its venture capital arm Hikma Ventures will support the Grand Hack's 'Personalised Medicine' theme, which focuses on solving challenges in improving preventative medicine, treatment affordability and personalised medicine dosages.  Hikma will also have representatives on-site to speak with those attendees interested in exploring opportunities to join Hikma in its mission of putting better health within reach of millions of people through its high-quality medicines and healthcare solutions. "We established Hikma Ventures because we believe that technology and digital tools in healthcare are now a necessity for all healthcare stakeholders, and pharma's role will be key in the adoption and spread of emerging technologies," said Lana Ghanem, Managing Director Hikma Ventures. Hikma Ventures is the corporate venture capital fund of Hikma that is focused on investing in global digital health startups. "We invest in companies that can supplement Hikma's business model and differentiate Hikma's offering to address a range of healthcare challenges." "Hackathon" is a combination of the words "hack" and "marathon." Hackathons are commonly associated with programming and computer science but, in health hackathons, not all participants are coders. They come from diverse backgrounds, address pain points in healthcare delivery, and assess business viability as an integral component of their hacks. MIT's hackathons bring together the whole healthcare ecosystem – patients, nurses, doctors, engineers, developers, designers, business people, insurance and policy experts. Together they attack healthcare challenges using a diverse and interdisciplinary approach. MIT Hacking Medicine was founded in 2011 and offers immense promise to the healthcare community.  It comprises MIT students and community members who are aimed at energising the healthcare community and accelerating medical innovation. They accomplish this by carrying out health hackathons, design thinking workshops, and networking gatherings to teach healthcare entrepreneurship. The group has organised more than 150 events across 15 countries and 5 continents. More than 40 companies have been created through these MIT-related hackathons, raising over $150 million in venture funding. ]]> https://biospectrumindia.com/news/57/13532/amgen-syapse-enter-precision-medicine-collaboration-in-oncology.html https://biospectrumindia.com/news/57/13532/amgen-syapse-enter-precision-medicine-collaboration-in-oncology.html Fri, 03 May 2019 11:30:00 +0530 Amgen, a world leader in biotechnology, and Syapse, a company powering precision medicine insights through its global provider network, today announced a precision medicine collaboration in oncology. Under the terms of the agreement, Amgen and Syapse will develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology. This effort will identify existing patients within the Syapse Learning Health Network that could be eligible for Amgen-sponsored clinical trials and seek to bring these trials to community health system sites. The companies will create opportunities for physicians and researchers within the Syapse Network to gain access to analytics, real-world evidence-based insights, and collaborative research opportunities. Amgen will have access to real-world evidence for potential use in regulatory filings in support of certain agreed upon development candidates in oncology. Amgen will also work with Syapse to develop real-world evidence standards to support the acceleration of therapies to market.    ]]> https://biospectrumindia.com/news/57/13526/canopy-growth-acquires-c3-cannabinoid-compound-company.html https://biospectrumindia.com/news/57/13526/canopy-growth-acquires-c3-cannabinoid-compound-company.html Thu, 02 May 2019 17:10:00 +0530 Canopy Growth Corporation has acquired German-based, Bionorica SE-founded C3 Cannabinoid Compound Company ("C3") in a transformative deal that will see established single cannabinoid medicines brought together with the world's leading full-spectrum medical cannabis offering. The all cash-acquisition for €225.9 million (CDN $342.9 million) furthers Canopy Growth's expansion into European markets with prescription medicines and gives the Company immediate access to a wealth of knowledge and intellectual property that C3 has developed in its nearly 20 years of research and development into synthetic and natural cannabis medical products. C3's primary medicinal offering is dronabinol, a pure chemical compound with standardized concentrations of tetrahydrocannabinol (THC), one of the active ingredients found in cannabis plants that is responsible for various pharmacological effects. Dronabinol is available in Austria, Denmark, and Germany for nausea and vomiting refractory to conventional treatment in oncology and palliative care, and for cancer pain. In Germany, dronabinol can be prescribed for any type of chronic pain and for any condition in palliative care. C3 has a total of five medicines in the market and its commercial operations generated €27.1 million (CDN $41.5 million) in 2018. The acquisition will allow Canopy Growth to further empower European physicians with the knowledge and therapies drawn from the full range of synthetic to naturally-derived cannabinoid-based medicines. Adding dronabinol to Canopy Growth's product offering in Europe and potentially other key markets will allow the Company's medical division, Spectrum Cannabis, to present an expanded, medically validated suite of cannabinoid therapies to the benefit of healthcare professionals and patients. Furthermore, C3's infrastructure including production, distribution, and sales & marketing significantly adds to the Spectrum Cannabis footprint in Europe, including an expanding product line and additional reach into pharmacy and medical specialists' networks. C3's clinical research programs currently underway are expected to complement Canopy Growth's own clinical activities and provide data that could potentially be applied to emerging product lines, enhancing the Company's prospects for bringing new approved products to market sooner. C3's founding company, Bionorica SE, one of the world's leading manufacturers of scientifically researched herbal medicines and Canopy Growth have also entered into a separate cooperation agreement and will be collaborating in areas spanning clinical research, IP development and distribution opportunities. With its substantial cash reserve, Canopy Growth will continue to make strategic investments and acquisitions that will drive growth, create competitive advantage, enhance Canopy's IP portfolio, and accelerate development and approval of cannabis-based therapeutics to continue to better serve its patients globally.   ]]> https://biospectrumindia.com/news/57/13524/fda-grants-breakthrough-device-designation-to-concept-medical-.html https://biospectrumindia.com/news/57/13524/fda-grants-breakthrough-device-designation-to-concept-medical-.html Thu, 02 May 2019 15:50:00 +0530 Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to subsequent tissue proliferation at the stented site. ISR is observed in about 10 percent of patients who undergo a drug eluting stent (DES) implantation and in more than 30 percent of patients who undergo bare-metal stent (BMS) implantation. Such patients, who come back with re-clogging of the coronary arteries following an earlier procedure of a bare metal or a drug-eluting stent implant, are candidates for treatment with the MagicTouch. The goal of the FDA "Breakthrough Devices Program" is to provide patients and health-care providers in the U.S. with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, consistent with the agency's mission to protect and promote public health. The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Under the program, FDA will provide CMI with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions. "The FDA's designation of MagicTouch for the Breakthrough Device Program will allow CMI to meet its ambition to provide this promising technology and innovative treatment for ISR patients in the USA. Our confidence in MagicTouch emanates from the positive feedback that we are receiving from the users of our product from current and ongoing commercial sales of MagicTouch in many European countries," said cardiologist Dr. Kiran Patel, chairman of CMI. "CMI is encouraged that the selection of MagicTouch, with its unique drug delivery technology, for the FDA's Breakthrough Device Program may allow timely access of this promising new technology to the U.S. patients with coronary ISR, with a potential to provide safe and effective treatment." ]]> https://biospectrumindia.com/news/57/13514/fda-approves-first-vaccine-for-dengue-prevention.html https://biospectrumindia.com/news/57/13514/fda-approves-first-vaccine-for-dengue-prevention.html Thu, 02 May 2019 11:05:00 +0530 The U.S. Food and Drug Administration has announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands. The safety and effectiveness of the vaccine was determined in three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacificregion. The vaccine was determined to be approximately 76 percent effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease. Dengvaxia has already been approved in 19 countries and the European Union. The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases. The approval was granted to Sanofi Pasteur. Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. This is because in people who have not been infected with dengue virus, Dengvaxia appears to act like a first dengue infection – without actually infecting the person with wild-type dengue virus – such that a subsequent infection can result in severe dengue disease. ]]> https://biospectrumindia.com/news/57/13509/fda-approves-mavyret-for-treating-all-hep-c-genotypes-in-children.html https://biospectrumindia.com/news/57/13509/fda-approves-mavyret-for-treating-all-hep-c-genotypes-in-children.html Wed, 01 May 2019 14:10:00 +0530 The U.S. Food and Drug Administration has approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017. With this approval, dosing information is provided for Mavyret for the treatment of adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of six identified HCV genotypes either without cirrhosis or with compensated cirrhosis. The safety and efficacy of Mavyret in pediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 100 percent of patients who received Mavyret for eight or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured. In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or genotype 5 or 6 HCV infection, the safety and efficacy of Mavyret are supported by previous studies observed in glecaprevir and pibrentasvir in adults. The adverse reactions observed were consistent with those observed in clinical studies of Mavyret in adults. Treatment duration with Mavyret differs depending on treatment history, viral genotype and cirrhosis status. The most common adverse reactions in patients taking Mavyret were headache and fatigue. Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin. ]]> https://biospectrumindia.com/news/57/13501/un-calls-for-urgent-action-to-avert-amr-crisis.html https://biospectrumindia.com/news/57/13501/un-calls-for-urgent-action-to-avert-amr-crisis.html Tue, 30 Apr 2019 12:25:00 +0530 UN, international agencies and experts has released a groundbreaking report demanding immediate, coordinated and ambitious action to avert a potentially disastrous drug-resistance crisis. If no action is taken - warns the UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance who released the report – drug-resistant diseases could cause 10 million deaths each year by 2050 and damage to the economy as catastrophic as the 2008-2009 global financial crisis. By 2030, antimicrobial resistance could force up to 24 million people into extreme poverty.  Currently, at least 700,000 people die each year due to drug-resistant diseases, including 230,000 people who die from multidrug-resistant tuberculosis. More and more common diseases, including respiratory tract infections, sexually transmitted infections and urinary tract infections, are untreatable; lifesaving medical procedures are becoming much riskier, and our food systems are increasingly precarious.  The world is already feeling the economic and health consequences as crucial medicines become ineffective. Without investment from countries in all income brackets, future generations will face the disastrous impacts of uncontrolled antimicrobial resistance. Recognizing that human, animal, food and environmental health are closely interconnected, the report calls for a coordinated, multisectoral “One Health” approach.  It recommends countries: prioritize national action plans to scale-up financing and capacity-building efforts;  put in place stronger regulatory systems and support awareness programs for responsible and prudent use of antimicrobials by professionals in human, animal and plant health; invest in ambitious research and development for new technologies to combat antimicrobial resistance; urgently phase out the use of critically important antimicrobials as growth promoters in agriculture. Amina Mohammed, UN Deputy Secretary-General and Co-Chair of the IACG said, “Antimicrobial resistance is one of the greatest threats we face as a global community. This report reflects the depth and scope of the response needed to curb its rise and protect a century of progress in health. It rightly emphasizes that there is no time to wait and I urge all stakeholders to act on its recommendations and work urgently to protect our people and planet and secure a sustainable future for all.” The recommendations require immediate engagement across sectors, from governments and the private sector, to civil society and academia. Convened at the request of world leaders after the first ever UN High-Level Meeting on Antimicrobial Resistance in 2016, the expert group brought together partners across the UN, International organizations and individuals with expertise across human, animal and plant health, as well as the food, animal feed, trade, development and environment sectors, to formulate a blueprint for the fight against antimicrobial resistance.  José Graziano da Silva, Director-General of the Food and Agriculture Organization of the United Nations (FAO) said, “The report’s recommendations recognize that antimicrobials are critical to safeguard food production, safety and trade, as well as human and animal health, and it clearly promotes responsible use across sectors. Countries can foster sustainable food systems and farming practices that reduce the risk of antimicrobial resistance by working together to promote viable alternatives to antimicrobial use, as laid out in the report’s recommendations.” This report reflects a renewed commitment to collaborative action at the global level by the World Food and Agriculture Organization of the UN (FAO), the World Organisation for Animal Health (OIE) and the World Health Organization (WHO).   Dr. Monique Eloit, Director General of the World Organisation for Animal Health (OIE) said, “Antimicrobial resistance must be addressed urgently, through a One Health approach involving bold, long-term commitments from governments and other stakeholders, supported by the international organisations. This report demonstrates the level of commitment and coordination that will be required as we face this global challenge to public health, animal health and welfare, and food security. We must all play our part in ensuring future access to and efficacy of these essential medicines.” Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization and Co-Chair of the IACG said, “We are at a critical point in the fight to protect some of our most essential medicines. This report makes concrete recommendations that could save thousands of lives every year.” The report highlights the need for coordinated and intensive efforts to overcome antimicrobial resistance: a major barrier to the achievement of many of the UN Sustainable Development Goals, including universal health coverage, secure and safe food, sustainable farming systems and clean water and sanitation.   ]]> https://biospectrumindia.com/news/57/13500/eyenuks-ai-eye-screening-system-for-diabetic-retinopathy-demonstrates-exceptional-performance.html https://biospectrumindia.com/news/57/13500/eyenuks-ai-eye-screening-system-for-diabetic-retinopathy-demonstrates-exceptional-performance.html Tue, 30 Apr 2019 12:15:00 +0530 Eyenuk, a global artificial intelligence (AI) medical technology and services company and the leader in real-world applications for AI Eye Screening has announced results from its landmark prospective, multi-center, pivotal clinical trial to validate the EyeArt AI Eye Screening System for autonomous detection of diabetic retinopathy (DR), a blinding disease estimated to affect 191 million people globally by the year 2030. The results were presented at the ARVO Imaging in the Eye Conference by Jennifer Lim, MD, Marion H. Schenk Esq. Chair and Professor of Ophthalmology and Director of Retina Service at the University of Illinois at Chicago. The EyeArt AI Eye Screening System makes in-clinic, real-time DR screening possible for any physician, enabling quick and accurate identification of patients with referable DR during diabetic patient’s regular physician visit. Once the patient’s fundus images have been captured and submitted to the EyeArt System, the DR screening results are available to view and export to a PDF report in less than 60 seconds. The EyeArt system can free eye care specialists to focus on sight-saving treatment rather than screening for DR. Key aspects of this prospective, multi-center, pivotal clinical trial (NCT03112005) include:  942 subjects enrolled at 15 centers that included primary care, endocrinology, ophthalmology, and retina specialty clinics. EyeArt AI system’s assessment of 2-field undilated images was compared to comprehensive clinical reference standard comprising adjudicated grading of 4 wide-field dilated stereo images on the ETDRS severity scale2. The grading was performed by the Wisconsin Fundus Photograph Reading Center. Multiple fundus camera models were included and evaluated with the EyeArt AI eye screening system. Board-certified ophthalmologists (in a subset of sites) independently performed dilated ophthalmoscopy, the most-prevalent method for DR screening today. Study results show that all pre-determined primary endpoints were met with p<0.0001.  “This study is significant as it shows this AI system is quite accurate in determining the presence of referable diabetic retinopathy by a very rigorous method which compared the AI results to that of photos read by expert graders of diabetic retinopathy,” said Dr. Jennifer Lim, an Investigator in the EyeArt pivotal trial. “In this prospective multi-center study, we showed feasibility and applicability of this system for screening for referable diabetic retinopathy. This holds great promise in accomplishing screening of the millions of diabetic patients for referable diabetic retinopathy in order to identify those at risk of visual loss and refer them for prompt treatment by ophthalmologists!” Dr. Lim continued, “The high sensitivity and specificity achieved by the EyeArt system shows that it can enable point-of-care DR screening and that it is a safe way to identify patients with DR who require ophthalmology referrals.” “Completion of this EyeArt prospective pivotal trial is an exciting step for Eyenuk, and this study once again validates the EyeArt System’s exceptional diagnostic sensitivity and specificity without needing dilation,” said Kaushal Solanki, PhD, Founder and CEO of Eyenuk. “Today I am proud to say that artificial intelligence is living up to its promise and can deliver substantial and meaningful impact to patients’ lives globally. Regular and quality eye screening can soon be accessible and affordable to hundreds of millions of people living with diabetes, leading to vision preservation for many of them.” About the EyeArt AI Eye Screening System The EyeArt AI Eye Screening System is the most extensively validated AI technology for autonomous detection of DR, tested in the real-world on more than half million patient visits globally with over two million images collected in real-world clinical environments. The EyeArt System was developed with funding from the US National Institutes of Health (NIH) and is validated by the UK National Health Service (NHS). The EyeArt System has CE marking in the EU and a Health Canada license. In the US, the EyeArt System is limited by federal law to investigational use. About Diabetic Retinopathy (DR) DR is a complication of diabetes caused by damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina). It is a silently progressing disease that at first may cause no symptoms or only mild vision problems. Eventually, it can cause blindness. The condition can develop in anyone who has type 1 or type 2 diabetes. It is estimated that one-third of all patients with diabetes will develop DR, making it the leading cause of vision loss in working-age adults. While DR screening is recommended for all diabetic patients, less than half get screened annually, even in the developed world. Since diabetic patients outnumber ophthalmologists by 1,600 to 1 in the U.S., there are just not enough eye care specialists to meet the DR screening needs of the growing diabetic population. Even for those receiving their annual screening, ophthalmology appointment wait times for DR screening can be weeks or even months. Eyenuk is a global artificial intelligence (AI) medical technology and services company and the leader in real-world AI Eye Screening for autonomous disease detection and AI Predictive Biomarkers for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk and Alzheimer’s disease. ]]> https://biospectrumindia.com/news/57/13497/gencove-gets-phase-i-sbir-grant-to-validate-polygenic-risk-score-estimation-.html https://biospectrumindia.com/news/57/13497/gencove-gets-phase-i-sbir-grant-to-validate-polygenic-risk-score-estimation-.html Tue, 30 Apr 2019 11:20:00 +0530 Gencove, the leading low-pass sequencing platform announced that the receipt of a Phase I grant from the National Human Genome Research Institute under the auspices of the Small Business Innovation Research (SBIR) program of the National Institutes of Health. The grant will be used to validate methods for accurate calculation of polygenic risk scores from low-pass sequencing data that allow for population-scale screening applications, with a first application to coronary artery disease. As clinical evidence for the benefit of screening patients for polygenic risk of diseases continues to accumulate, there will be increasing need for a scalable and flexible assay to measure these scores. Gencove's low-pass genome sequencing combined with its imputation algorithms can address the technological challenge to provide a highly accurate estimate of a polygenic risk score across ethnic groups using an assay that can scale financially and operationally to entire health care systems. Low-pass sequencing is an approach to combine the throughput and cost-effectiveness of genotyping arrays with the accuracy and population portability of whole genome sequencing. Regarding this award, Gencove's CEO Joe Pickrell said, "The flexibility, operational efficiency, cost-effectiveness, and population-agnostic nature of low-pass sequencing make it a great choice for calculating polygenic risk scores at scale." ]]> https://biospectrumindia.com/news/57/13495/scientists-set-to-eradicate-hiv-with-natural-killer-cells.html https://biospectrumindia.com/news/57/13495/scientists-set-to-eradicate-hiv-with-natural-killer-cells.html Tue, 30 Apr 2019 11:10:00 +0530 A collaborative research team at the University of Minnesota has used Tri-specific killer engagers (TriKE) to target HIV-infected cells in preclinical testing. The team, led by Jeffrey Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota, and Timothy Schacker, MD, Vice Dean of Research at the University of Minnesota Medical School and Director of the Program in HIV Medicine, has used their combined expertise to now find an innovative approach to potentially cure HIV. After years of the Miller team working with natural killer (NK) cells to target cancer, and the Schacker group researching HIV reservoirs, the two physicians joined together to combine their efforts. The potential to use a cancer-based therapy on a disease like HIV was an opportunity the teams couldn't pass up. "This exciting work is the result of years of collaboration between our groups, one of the great assets of team science at UMN," said Dr. Miller. "After years of work trying to target the immune system to fight cancer, and the Miller team learning more about HIV, we decided to work together with the Schacker group to target HIV reservoirs." The TriKE, designed and developed at the University of Minnesota, was designed to bind NK cells, on one end, to target cancer cells on the other end, along with costimulation by an IL-15 cytokine linker contained between the two binding domains in the same protein. The IL-15, in this case, will be combined with CD4 T cells to potentially eliminate the HIV reservoir. "The goal in this research is to eliminate the T cells, where HIV hides out in the body," said Dr. Schacker. "If successful, this has the potential to contribute to a cure for HIV." Next steps for the research group will be to optimize the TriKE constructs, followed by testing in vitro, and then in vivo. If all goes as planned in that phase, the team will prepare for clinical trials. ]]> https://biospectrumindia.com/news/57/13486/fda-approves-new-device-to-help-in-lung-transplant.html https://biospectrumindia.com/news/57/13486/fda-approves-new-device-to-help-in-lung-transplant.html Mon, 29 Apr 2019 09:00:00 +0530 The U.S. Food and Drug Administration has approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant.  The device allows the transplant team to perform a more careful assessment of lung function to get a better sense of how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant. The Xvivo Perfusion System was originally granted marketing authorization in 2014 under a humanitarian device exemption (HDE), a regulatory pathway that limits the device's use to a maximum of 8,000 patients per year. The approval through the FDA's more stringent premarket approval (PMA) pathway does not limit yearly patient use of the device, thereby allowing an increased number of lungs to be available for transplant and potentially increasing the number of patients who can benefit from this technology. "Sadly, too many patients on transplant lists die waiting for suitable lungs. Providing patients with access to safe medical devices that have the potential to be lifesaving remains a top FDA priority, and we support the development of innovative technologies that can increase the donor organ pool for transplant patients in need of suitable lungs," said Benjamin Fisher, Ph.D., director of the Division of Reproductive, Gastro-renal, Urological Devices at the FDA's Center for Devices and Radiological Health. The Xvivo Perfusion System works by allowing marginal quality lungs that initially failed to meet standard transplant criteria to be ventilated, oxygenated and perfused at a standard normal body temperature for up to five hours. This provides an opportunity for surgeons to reassess transplant suitability, allowing them to transplant a certain percentage of lungs that were initially deemed to be unsuitable. The device consists of a perfusion cart with mechanical and electrical components that ventilate, oxygenate and perfuse the lungs with a lung preservation solution. ]]> https://biospectrumindia.com/news/57/13481/record-59-new-us-drugs-launched-in-2018-iqvia.html https://biospectrumindia.com/news/57/13481/record-59-new-us-drugs-launched-in-2018-iqvia.html Fri, 26 Apr 2019 16:30:00 +0530 Ongoing changes in the clinical development process led to a record number of drug approvals in 2018, with 59 novel treatments reaching patients in the United States alone. During the next five years, trial productivity will be heavily influenced by key trends, including wider use of biomarkers, pre-screened patient pools, regulatory shifts and application of artificial intelligence and predictive analytics. To examine historical and future clinical trial productivity trends across therapy areas a new report from the IQVIA Institute for Human Data science titled, The Changing Landscape of Research and Development: Innovation, Drivers of Change, and Evolution of Clinical Trial Productivity puts forth a proprietary Clinical Development Productivity Index that reflects changes in trial complexity, success and duration. Using this index, the report takes a 10-year historical view of these metrics and recasts the data with a future perspective that identifies critical productivity changes expected through 2023. IQVIA experts shed light on those productivity shifts using the proprietary IQVIA Clinical Development Trends Impact Assessment, identifying the quantitative impact of the eight key trends driving change in clinical development at a therapyarea level. Those drivers are: Digital health technologies to enable the capture of drug efficacy and safety data remotely, which can improve patient safety, enable virtual trial formats and ease site work burden. Patient-reported outcomes that will shed new light on patient experience and drug efficacy and safety outside the clinical setting and lead to accelerated trial times as endpoints shift.  Real-world data to optimize trial design, speed investigator and site selection, and enable new trial designs by acting as virtual control arms and supporting pragmatic, adaptive and RWE registry trials. Predictive analytics and artificial intelligence to identify new clinical hypotheses, reduce trial design risks and speed enrollment by identifying protocol-ready patients. Shifts in types of drugs tested, for instance, to targeted therapies and next-generation biotherapeutics that improve efficacy and success rates and have accelerated development timelines but require longer-term patient follow-up. Biomarker testing availability to help narrow patient populations to those more likely to see effect, resulting in improvements in efficacy, safety and success. Regulatory landscape changes that will encourage the adoption of precision medicine approaches, novel trial designs and endpoints while providing means for accelerated drug approvals and regulatory success. Pools of pre-screened patients and direct-to-patient recruitment, which will facilitate enhanced trial enrollment, shortened trial duration and faster market availability. “As advances in science, technology and data gradually find application within clinical development, the length of time that trials take to complete, the resources required due to trial complexity and likelihood of trial success are all shifting, with impacts varying by therapy area,” said Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science. “Our study assesses the current activity within research and development, the productivity levels of the clinical development process and how key trial trends will transform clinical development over the next five years.” ]]> https://biospectrumindia.com/news/57/13474/u-s-fda-approves-abbvies-skyrizi-for-moderate-to-severe-plaque-psoriasis.html https://biospectrumindia.com/news/57/13474/u-s-fda-approves-abbvies-skyrizi-for-moderate-to-severe-plaque-psoriasis.html Fri, 26 Apr 2019 14:40:00 +0530 AbbVie, a research-based global biopharmaceutical company has announced that the U.S. Food and Drug Administration approved SKYRIZI (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In clinical trials, SKYRIZI produced high rates of durable skin clearance – most people (82 and 81 percent) treated with SKYRIZI achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100). "The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said Kenneth B. Gordon, M.D., a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I'm pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response." The recommended dose for SKYRIZI is 150mg administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and 4. SKYRIZI can be administered in-office or by self-injection after training. "The approval of SKYRIZI is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time," said Michael Severino, M.D., vice chairman and president, AbbVie. "SKYRIZI builds on AbbVie's legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions." Affecting 7.5 million Americans, psoriasis is the most prevalent autoimmune disease in the U.S. It is characterized by over-activation of the immune system and widespread inflammation that causes painful, itchy plaques anywhere on the skin. People with psoriasis also experience a significant emotional, psychological and social burden that can negatively impact their quality of life. "People living with plaque psoriasis can be profoundly impacted by their disease both physically and emotionally," said Stacie Bell, Ph.D., vice president of research and medical affairs, National Psoriasis Foundation. "The approval of a new therapy represents an important step forward in the treatment of psoriasis, offering dermatologists another option to help patients achieve their treatment goals." The approval of SKYRIZI is supported by results from AbbVie's global Phase 3 psoriasis program, which assessed the safety and efficacy of SKYRIZI in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance, and IMMvent. The co-primary endpoints of these studies were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placebo. KYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally. AbbVie recently received approval of SKYRIZI from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis, as well as from Health Canada for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. AbbVie also received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for SKYRIZI for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, with a regulatory decision in Europe expected in the first half of this year. ]]> https://biospectrumindia.com/news/57/13472/bioinvent-receives-0-75-m-under-mitsubishi-tanabe-pharma-partnership.html https://biospectrumindia.com/news/57/13472/bioinvent-receives-0-75-m-under-mitsubishi-tanabe-pharma-partnership.html Fri, 26 Apr 2019 14:35:00 +0530 BioInvent International has announced that it has received a €0.75 million milestone payment under its collaboration with Mitsubishi Tanabe Pharma Corporation in connection with enrollment of the first patient in Phase II clinical trial of an antibody identified from BioInvent's proprietary n-CoDeR antibody library. The license agreement with Mitsubishi Tanabe Pharma covers the development of antibodies from the n-CoDeR antibody library. "It is very satisfying to see that our high quality recombinant human antibody library n-CoDeR is not only delivering candidates for BioInvent's proprietary programs but is also proving beneficial for our partners in developing their own pipeline," said BioInvent CEO Martin Welschof. Under the terms of the agreement, payments are due to BioInvent when certain clinical milestones are achieved and royalty payments are due when a product is sold on the market. Enrollment of a first patient in Phase II clinical trial is a milestone that triggers a payment to BioInvent. BioInvent International is focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies to treat cancer. The Company's lead program BI-1206 is currently in Phase l/ll for non-Hodgkin lymphoma and chronic lymphatic leukemia. BioInvent's pre-clinical portfolio is focused on targeting key immune suppressive cells and pathways of the tumor microenvironment, including regulatory T cells, tumor-associated myeloid cells, and mechanisms of antibody drug-resistance. The Company has a strategic research collaboration with Pfizer Inc., and partnerships with Transgene, Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma. BioInvent generates near term revenues from its fully integrated manufacturing unit producing antibodies for third parties for research through to late-stage clinical trials.    ]]> https://biospectrumindia.com/news/57/13473/skin-microbiome-summit-showcases-scientific-developments-for-treating-skin-conditions.html https://biospectrumindia.com/news/57/13473/skin-microbiome-summit-showcases-scientific-developments-for-treating-skin-conditions.html Fri, 26 Apr 2019 14:30:00 +0530 The Nestlé Skin Health SHIELD Skin Microbiome Summit in New York showcased the rapid research developments which have been advancing in recent years. Professor Cath O’Neil of Manchester University, a pioneer in the skin biome, who is also CEO of SkinBioTherapeutics, welcomed the scientific focus on treating the many conditions that make life miserable for patients with skin conditions. Professor O’Neil commented “Unfortunately there are many skin products which make claims which are not scientifically proven. It is excellent when major companies sponsor these scientific forums so that we can really develop products which work.” The skin microbiome, or the skin microbiota, is the population of bacteria that live on the skin. Over 1,000 species of bacteria have been identified, as well as viruses, fungi, and even mites. Research into the skin microbiome is about 20 years behind research on the gut microbiome, but there is evidence that certain bacteria can help stop pathogenic bacteria growing and causing infections on the skin. While there have been significant advances in the scientific understanding of the microbiota living on and in our skin, the most exciting research now being conducted focuses on how altering the composition of the skin microbiome could lead to improvements in skin health and even treatments for serious diseases. SkinBioTherapeutics is at the forefront of this exciting research with its work using ‘lysates’, or extracts, of particular probiotic bacteria to deliver targeted health benefits. The lysates which have been shown to increase the skins barrier integrity; protect the skin from infection by outcompeting harmful pathogens; and increase the rate of skin healing in response to injury. The target treatment areas for SkinBioTherapeutics are cosmetics, reducing the incidence of eczema flares, and infection prevention. Recently released human study data shows that SkinBioTherapeutics’ therapy is safe and well tolerated, and that it showed a statistically significant increase in skin hydration. ]]> https://biospectrumindia.com/news/57/13466/tableu-mapbox-exasol-and-alteryx-commit-4-3-m-to-accelerate-malaria-elimination-efforts.html https://biospectrumindia.com/news/57/13466/tableu-mapbox-exasol-and-alteryx-commit-4-3-m-to-accelerate-malaria-elimination-efforts.html Thu, 25 Apr 2019 16:15:00 +0530 Tableau, Mapbox, Exasol, and Alteryx has announced a collective $4.3 million technology contribution over the next three years to help governments eliminate malaria for an estimated 60 million at-risk people in sub-Saharan Africa. This new grant to PATH, a global organization dedicated to accelerating health equity, expands on the early success of its Visualize No Malaria initiative and was announced at the World Malaria Day 2019 event hosted by the RBM Partnership to End Malaria in partnership with the City of Paris and the French government at the Hotel de Ville in Paris. With the grant, PATH will support national governments and regional organizations in up to six sub-Saharan countries in the use of real-time data and analytics to bolster decision-making around elimination efforts. These data-informed insights allow officials to determine where and how to deploy resources to respond most effectively in fighting disease. The investment will also provide training to hundreds of frontline health workers and officials on how to use the power of timely and accurate data to tackle malaria and other diseases. "Successful malaria elimination programs require accurate data that moves faster than the disease itself—to help shorten the distance and time it takes to find and treat cases, and even to predict risk and direct resources before cases occur," said Steve Davis, President and CEO of PATH. "We're excited to continue working with our technology partners to expand the support and tools governments need to get the upper hand in controlling and eventually eliminating a disease that still kills more than 400,000 people every year." Originally launched in 2015 as a collaboration between PATH, Tableau Foundation, and the Zambian Ministry of Health, the Visualize No Malaria digital technologies make real-time, actionable data about malaria available to everyone from national and district-level health officials to thousands of frontline health workers. Through the combination of improved use of data with other malaria control efforts, the Zambian government has reduced reported malaria cases by 85 percent and malaria-related deaths by 92 percent across a population of 1.8 million people in the country's Southern Province. Reducing the amount of time to see and understand health data from months to hours, health officials can now make faster decisions about the best ways to deploy a mix of interventions, including drug delivery, indoor residual spraying, bed net distribution, and other proven techniques to most effectively respond to existing cases and prevent new ones. In low-burden areas, this approach has proven to be a cost-effective way for governments to control malaria, and in high-burden areas, it could be an important differentiator in creating and sustaining steep drops in disease incidence. The Visualize No Malaria tools and approach are currently being replicated in Senegal, which has seen a similar 60 percent drop in reported malaria cases across a northern Senegal population of 1.8 million in just two years, and the initiative is set to expand in Senegal and neighboring countries under this new commitment by partners. "Senegal's National Malaria Control Program sees new tools to make data faster and easier to use and act upon as critical to helping us win the fight against malaria," said Dr. Doudou Séne, Director of Senegal's National Malaria Control Program. "With this new commitment, we can increase the number of districts where we use the Visualize No Malaria stack and make informed, real-time decisions across the nation, as well as support our cross-border collaboration with The Gambia." In 2017, an estimated 219 million cases of malaria occurred globally, which resulted in an estimated 435,000 deaths, the vast majority in sub-Saharan Africa where the Visualize No Malaria effort is concentrated. Sixty-one percent of these deaths occurred in children under the age of five. With this renewed commitment, PATH will work to mobilize an additional $2.5 million in funding through its country and agency partners—and together, the Visualize No Malaria initiative will: Scale nationally across Zambia to serve the country's total population of 17 million people by equipping four remaining provinces.Build on work and relationships in Senegal and The Gambia to expand the tools and training across West Africa.Expand to three additional countries in the Elimination 8 initiative in southern Africa, allowing those countries to collaborate on an interoperable regional disease surveillance system.For Tableau Foundation, this is the second major grant and first in the global health space following the $100 million pledge announced by Tableau CEO Adam Selipsky at the 2018 Tableau Conference. It also honors the commitment made in March 2018 at the Commonwealth Heads of Government meeting to expand the Visualize No Malaria initiative in sub-Saharan Africa. "Data and analytics are only as valuable as the ability of a decision-maker to use them. Since the outset of the Visualize No Malaria initiative, we've seen countries and communities develop incredibly effective resources for fighting malaria and other complex health issues," said Neal Myrick, Global Head of Tableau Foundation. "We're proud to work alongside so many of our technology partners to help a generation of leaders make a meaningful difference in the lives of millions of men, women, and children." As part of its Alteryx for Good program, Alteryx is contributing the data science and analytics engine as well as on-site training in Africa. This will allow spatial analytics, custom macros, data validation and cleansing, and repeatable workflows to accurately target and eliminate malaria across borders. The Alteryx Platform workflows designed for Visualize No Malaria run in 0.6 seconds, analyzing tens of millions of records and producing multiple outputs to address different analytical questions. "The Alteryx for Good program was designed to empower nonprofit organizations in delivering game-changing social outcomes with data science and analytics," said Tori Adamo, Senior Manager, Alteryx for Good at Alteryx. "The Visualize No Malaria initiative is a prime example of our commitment to influencing social change with the Alteryx Platform and the impact technology can have in solving some of the world's biggest challenges. We are proud to support PATH and partner with fellow technology leaders to help eliminate malaria across the globe." Exasol's in-memory analytics database compresses massive amounts of data and serves them up fast in low-resource, lower-bandwidth settings. "We strongly support Visualize No Malaria's approach of using data as the foundation for decision-making as part of their initiative to wipe out malaria," said Eva Murray, Head of Business Intelligence at Exasol. "We are proud to be part of this partnership and look forward to our continuous involvement in improving the lives of people in sub-Saharan Africa with our tools, expertise, and our passion for doing the right things." Mapbox powers the mapping tools and geospatial data that can be combined with other datasets to create interactive maps within the Visualize No Malaria dashboards. Mapbox is providing remote and on-site technical support and training, as well as testing new offline mapping tools. "Our company's roots began with global development projects in Afghanistan, Congo, Haiti, and the United States, so the mission of Visualize No Malaria is very close to our hearts," said Mapbox CEO Eric Gundersen. "We built these tools to help people understand context in data so they can solve problems. It's incredible to see people use these platforms to literally save lives." ]]> https://biospectrumindia.com/news/57/13464/start-codon-to-deliver-premier-life-science-and-healthcare-business-acceleration-program.html https://biospectrumindia.com/news/57/13464/start-codon-to-deliver-premier-life-science-and-healthcare-business-acceleration-program.html Thu, 25 Apr 2019 15:40:00 +0530 Start Codon, a new strategic initiative aimed at driving the translation of world-class research into commercially successful companies, has been founded and launched with funding from keystone investors including Cambridge Innovation Capital, Babraham Bioscience Technologies, Genentech, a member of the Roche Group, Dr. Jonathan Milner and Dr. Ian Tomlinson. Start Codon will identify and recruit high potential life science and healthcare companies from across the UK and beyond, provide seed-funding, and leverage the world-class resources of the Cambridge Cluster to reduce risk and prepare them for a successful Series A fundraiser. The accelerator will be the first within the Cambridge Cluster to provide life science start-ups with significant investment (up to £250K), a full-time dedicated team of experienced and active mentors, and office and lab space (located at the Milner Therapeutics Institute). Start Codon now plans to invest in and support up to 50 start-up companies over the next 5 years. Start Codon’s executive team will be led by Dr Jason Mellad, previously CEO of Cambridge Epigenetix, which he transformed into a liquid biopsy diagnostic development firm via obtaining broad and exclusive patent rights to the use of epigenetic biomarker 5hmC in cancer diagnostics and leading a successful Series C to fundraise of c.$30m. Jason brings over a decade of experience in product development and commercialization, building and managing cross-disciplinary teams, intellectual property protection and exploitation, and closing deals with strategic biotech and pharma partners. Dr. Ian Tomlinson has been appointed Chairman of the Start Codon Board. Dr. Tomlinson is also Chairman of Apollo Therapeutics and the Stevenage Bioscience Catalyst. He has over 25 years of experience in the life sciences sector from academic research to biotech start-up to big pharma. He founded Domantis Limited with Sir Gregory Winter, which was acquired by GSK in 2006 for $454 million. He then served as Senior VP, Head of Worldwide Business Development and Head of Biopharm R&D at GSK. Dr. Mellad and Dr. Tomlinson will be joined by Michael Anstey of Cambridge Innovation Capital, Jo Parfrey, and Jonathan Milner as Directors of Start Codon. Dr. Jason Mellad, CEO Start Codon, said: “Our ambition is to provide life science and healthcare companies with a unique combination of funding, facilities, mentoring and support to fast track their development and success. We are selecting the most exciting pre-Series A companies from around the world, and bringing them to Cambridge, helping to solidify the region’s position as a leading global cluster.” Dr. James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche, said: “We’re very pleased to support Start Codon in harnessing the best research from the region and fostering healthcare innovation at its earliest stages. We believe some of the most cutting-edge science in the world is happening in Cambridge, and this investment builds on our commitment to driving scientific advances within the UK and globally.” Dr. Michael Anstey, Ph.D., Investment Director at Cambridge Innovation Capital, added: “Cambridge is the best place in Europe to build a life science business. Start Codon will bring together all the key elements here, to enable emerging companies to rapidly embark on their growth journey. We are proud to have been part of the Start Codon initiative from inception and we are excited to support the world-class businesses that will emerge from its programme in the future. The Cambridge ecosystem has already created over a dozen billion-pound businesses and we see Start Codon as an important facilitator in creating more such successes.” Dr. Jonathan Milner, Ph.D., Co-founder and Deputy Chairman of Abcam plc, commented: “In this golden age of biology, Cambridge stands out as the worlds centre for healthcare innovation and translation. Start Codon’s innovative supercharged model will establish nurture and spin out the next generation of world-class healthcare companies that will positively impact all our lives. I am super thrilled to be working with such an esteemed and experienced set of stakeholders to guarantee the success of Start Codon. We look forward to enabling the next generation of Cambridge healthcare unicorns.” Jo Parfrey, a Non-Executive Director at Babraham Bioscience Technologies Ltd who will represent the company on the Start Codon Board, commented: “We are delighted to be involved in the Start Codon initiative as it looks to identify, support and develop future scale-up life-sciences companies. Our aim as a Campus is to not only positively impact the local Cambridge cluster, but also bio-science across the UK. As an ideal location to accommodate these ventures as they mature through the Start Codon journey, we hope to play a significant part in facilitating the next generation of innovative and entrepreneurial companies. We see the Start Codon initiative as complementary to our ongoing Accelerate@Babraham programme and are looking forward to working together to ensure these young ventures have access to the facilities and opportunities which will help them to develop successfully.” The first cohort of 5 companies is now being recruited. Start Codon is looking for companies with disruptive innovations that will revolutionize modern healthcare and platform technologies underpinned by strong intellectual property, with a particular emphasis on novel therapeutics, diagnostics, medtech, and digital health. ]]> https://biospectrumindia.com/news/57/13462/satsuma-raises-62-m-in-series-b-funding.html https://biospectrumindia.com/news/57/13462/satsuma-raises-62-m-in-series-b-funding.html Thu, 25 Apr 2019 14:55:00 +0530 Satsuma Pharmaceuticals (Satsuma), a clinical-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced a $62 million Series B preferred stock financing led by Wellington Management Company, with participation by existing investors RA Capital Management, TPG Biotech, and Shin Nippon Biomedical Laboratories, and new investors, Osage University Partners, CAM Capital, Surveyor, Eventide Asset Management, Cormorant, Lumira Ventures, and SBI Investment.  Financing proceeds will support Phase 3 development of STS101. In consultation with the FDA, Satsuma has established key elements of its Phase 3 development program, including the design of the Phase 3 efficacy study, to support a New Drug Application (NDA) for STS101 for the acute treatment of migraine. Satsuma plans to initiate its randomized, double-blind, placebo-controlled Phase 3 clinical trial of STS101 in the third quarter of 2019.  ]]> https://biospectrumindia.com/news/57/13459/vanda-pharma-appoints-phaedra-chrousos-to-board-of-directors.html https://biospectrumindia.com/news/57/13459/vanda-pharma-appoints-phaedra-chrousos-to-board-of-directors.html Thu, 25 Apr 2019 14:15:00 +0530 Vanda Pharmaceuticals Inc. has recently announced that Phaedra Chrousos has joined Vanda's Board of Directors, effective April 23, 2019. Following Ms. Chrousos' appointment, Vanda's Board of Directors is now comprised of six directors. Ms. Chrousos currently serves as the Chief Strategy Officer of The Libra Group, where she leads a wide range of strategic initiatives spanning technology transformation to operational development. Headquartered in New York and London, The Libra Group is a diverse, international business group that is active in 35 countries and focused on six business areas: aviation, energy, hospitality, real estate, shipping, and diversified investments. Immediately prior to being appointed Chief Strategy Officer, Ms. Chrousos served as the group's Chief Innovation Officer. "Phaedra is a terrific addition to the Vanda Board. She brings new skill sets, particularly in the areas of entrepreneurship and consumer health care marketing, to the Board.  Also, she helps us further broaden the diversity of experiences and perspectives among our Board members, which is critical for the Company's growth," said H. Thomas Watkins, Chairman of Vanda's Board of Directors. Previously, Ms. Chrousos served as a political appointee for the Obama Administration in various roles, including as an Associate Administrator for the General Services Administration. In this capacity, Ms. Chrousos led the Office of Citizen Services and 18F, a digital services team that implemented online service delivery projects and open data initiatives at more than a dozen agencies, including NIH, HHS and the VA. Prior to her departure from the Administration, Ms. Chrousos helped found the Technology Transformation Service, which serves as a foundation for the government's ongoing digital transformation; she served as its Founding Commissioner. Prior to entering public service, Ms. Chrousos co-founded and led two companies, including HealthLeap, a health tech company that reimagined the way doctors and patients communicate. HealthLeap was acquired by Vitals.com 10 months after its launch. She also has several years of consulting experience with The Boston Consulting Group and The World Bank. Ms. Chrousos sits on several non-profit boards, including that of a maternal mental health foundation, and was twice named one of the Federal Government's '50 Women in Technology' by FedScoop and one of Greece's '40 under 40' by Fortune Magazine. Ms. Chrousos holds a B.A. from Georgetown University, an MSc from The London School of Economics and Political Science, and an M.B.A. from Columbia Business School. ]]> https://biospectrumindia.com/news/57/13455/jackson-immunoresearch-launches-secondary-antibodies-for-vhh-discovery-.html https://biospectrumindia.com/news/57/13455/jackson-immunoresearch-launches-secondary-antibodies-for-vhh-discovery-.html Wed, 24 Apr 2019 17:30:00 +0530 Jackson ImmunoResearch, manufacturer of secondary antibodies for the life science market, announces a new range of products for scientists developing single-domain VHH antibodies. The new Anti-Alpaca secondary antibody product line targets the IgG repertoire of camelid immunoglobulins, including whole molecule, subclass and VHH domain specificities. They are raised against alpaca and cross-react with llama. Anti-Alpaca IgG subclasses 2+3 specific antibodies enable scientists to monitor immune response and pinpoint the optimal B cell harvest timeframe. Anti-Alpaca VHH domain antibodies were also developed to detect single-domain antibodies across all immunotechniques and will be an indispensable tool in diagnostics and drug development.  David A. Fancy PhD, chief operating officer, commented “Jackson ImmunoResearch is very excited to bring anti-camelid secondary antibodies to the marketplace. The single-domain antibody market is rapidly expanding. These antibodies are 1/10th the size of canonical immunoglobulins making them ideal for drug delivery and super-resolution imaging, among many other potential uses. Secondary antibodies for VHH discovery are designed to support research needs, reduce project time and improve success rates.” ]]> https://biospectrumindia.com/news/57/13454/knopp-biosciences-receives-fda-orphan-drug-designation-for-treatment-of-hypereosinophilic-syndrome.html https://biospectrumindia.com/news/57/13454/knopp-biosciences-receives-fda-orphan-drug-designation-for-treatment-of-hypereosinophilic-syndrome.html Wed, 24 Apr 2019 15:45:00 +0530 Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with high unmet needs has announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to dexpramipexole, its oral drug candidate for the treatment of hypereosinophilic syndrome (HES). HES is a rare and often incapacitating disorder with limited treatment options. The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees. “We are very pleased to receive orphan drug designation for dexpramipexole for HES,” said Michael Bozik, M.D., CEO of Knopp Biosciences. “There is an urgent need for effective treatments for patients suffering from this under-recognized, debilitating disease, especially for oral medications that selectively deplete eosinophils, and this designation represents an important regulatory milestone as we advance our dexpramipexole program toward late-stage clinical development.” Knopp is developing dexpramipexole as a targeted, oral therapeutic for eosinophilic inflammatory disorders. Eosinophils are white-blood cells that play a central role in severe diseases such as asthma and HES, and dexpramipexole has been shown to selectively, profoundly, and persistently reduce blood and tissue eosinophil levels in multiple clinical trials. Results of a Phase 2 study of dexpramipexole in HES have been presented to the American Society of Hematology and published in the journal Blood. Knopp Biosciences, based in Pittsburgh, PA, USA, is a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with a high unmet need. Knopp’s clinical-stage small molecule, dexpramipexole, is entering Phase 2 clinical trials in eosinophilic asthma and Phase 3 development in hypereosinophilic syndrome. Knopp’s preclinical Kv7 platform is directed to small molecule treatments for neonatal epileptic encephalopathy, other rare epilepsies, tinnitus, and neuropathic pain. ]]> https://biospectrumindia.com/news/57/13452/irras-provides-update-on-ce-mark-re-certification-of-irraflow.html https://biospectrumindia.com/news/57/13452/irras-provides-update-on-ce-mark-re-certification-of-irraflow.html Wed, 24 Apr 2019 14:55:00 +0530 IRRAS AB (IRRAS), a commercial-stage medical technology company focused on developing and commercializing innovative solutions for neurocritical care, announced that it received a response from G-MED, its designated European Notified Body, that requests clarifications and additional information regarding the company's CE Mark re-certification of IRRAflow Catheter. G-MED has asked for additional technical clarifications and updates of certain previous older reports performed by the previous Swedish development partner. The requests are part of the routine review cycle and will be addressed by IRRAS in a timely manner. "We finally received the feedback from G-MED after a lengthy period," said Kleanthis G. Xanthopoulos, Ph.D, President and CEO of IRRAS. "We believe that all of their comments are addressable. Having established a productive dialogue with the notified body, we now have a clear path forward, and we anticipate responding shortly to the list of questions. We will continue to work closely with the G-MED team to reintroduce this innovative medical device to the EU market, offering patients, neurosurgeons, and hospitals an effective, intelligent solution to treat intracranial bleeding. In the meantime, the launch of IRRAflow in the United States is on track since our 510(k) clearance last year, and our plans to open other global markets remain unchanged." ]]> https://biospectrumindia.com/news/57/13450/vyome-therapeutics-begins-dosing-in-phase2-trial-of-vb-1953-.html https://biospectrumindia.com/news/57/13450/vyome-therapeutics-begins-dosing-in-phase2-trial-of-vb-1953-.html Wed, 24 Apr 2019 14:10:00 +0530 Vyome Therapeutics Inc., a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes has announced that it has dosed the first patient in its Phase 2 trial of the Company’s lead clinical candidate, VB-1953, for the treatment of moderate to severe inflammatory acne vulgaris. VB-1953 is the first bactericidal antibiotic topical gel formulation for treatment of acne vulgaris capable of not only reducing infection due to P. acnes with anti-inflammation action, but also retarding antibacterial resistance. Venkat Nelabhotla, chief executive officer of Vyome Therapeutics said, “There are about 10 million patients in the US with moderate to severe inflammatory acne who are resistant to the currently-approved bacteriostatic antibiotics. There is an urgent need for a new and effective therapy that yields higher clinical response than what is currently available. With its novel bactericidal and anti-inflammatory mechanisms of action, VB-1953 could potentially meet this unmet need and we look forward to sharing the important results of this trial in early 2020.” The double-blind, randomized, vehicle controlled, dose ranging Phase 2 study is evaluating the safety and efficacy of VB-1953 topical gel when applied once versus twice daily for 12 weeks in subjects with moderate to severe inflammatory facial acne vulgaris. The Company plans to enroll up to 480 patients. The primary efficacy endpoint of the study is the absolute change from baseline in inflammatory lesion counts in each treatment arm at Week 12 and the secondary endpointis the proportion of subjects at week 12 achieving an Investigator’s Global Assessment of Inflammatory Acne (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline. Dr. Angelo Secci, chief medical officer of Vyome Therapeutics said, “Today, patients who are not responding to current medicines have no option outside of oral systemic acne treatments which are well-known for their potential adverse events. VB-1953 has the potential to not only serve as an effective topical therapy for these patients, but also to delay the onset of resistant bacterial strains, serve as a potent anti-inflammatory agent, and prevent patients from needing systemic acne treatments.” Vyome’s lead molecule, VB-1953, is a first-in-class topical bactericidal antibiotic clinical drug candidate with a novel mechanism of action that includes inflammation-reducing capabilities as well as the demonstrated ability to treat antibiotic resistant P. acnes strains. VB-1953 is currently being studied in a Phase 2 clinical trial in the United States. In preclinical studies, VB-1953 showed activity against clindamycin-resistant P. acnes bacteria, a low emergence of resistance and the ability to reduce inflammation. VB-1953 is delivered with a microtechnology gel system that ensures the drug is retained at the site of infection and minimizes systemic exposure. Acne caused by antibacterial-resistant P.acnes currently poses an emerging and unmet need for patients worldwide, with a potential $2B market opportunity in the US alone.   ]]> https://biospectrumindia.com/news/57/13448/who-announces-new-measles-surveillance-data-for-2019.html https://biospectrumindia.com/news/57/13448/who-announces-new-measles-surveillance-data-for-2019.html Wed, 24 Apr 2019 13:00:00 +0530 Measles cases have continued to climb into 2019. Preliminary global data shows that reported cases rose by 300 percent in the first three months of 2019, compared to the same period in 2018. This follows consecutive increases over the past two years. While this data is provisional and not yet complete, it indicates a clear trend. Many countries are in the midst of sizeable measles outbreaks, with all regions of the world experiencing sustained rises in cases. Current outbreaks include the Democratic Republic of the Congo, Ethiopia, Georgia, Kazakhstan, Kyrgyzstan, Madagascar, Myanmar, Philippines, Sudan, Thailand and Ukraine, causing many deaths – mostly among young children. Over recent months, spikes in case numbers have also occurred in countries with high overall vaccination coverage, including the United States of America as well as Israel, Thailand, and Tunisia, as the disease has spread fast among clusters of unvaccinated people. Measles is one of the world’s most contagious diseases, with the potential to be extremely severe. In 2017, the most recent year for which estimates are available, it caused close to 110 000 deaths. Even in high-income countries, complications result in hospitalization in up to a quarter of cases, and can lead to lifelong disability, from brain damage and blindness to hearing loss. The disease is almost entirely preventable through two doses of a safe and effective vaccine. For several years, however, global coverage with the first dose of measles vaccine has stalled at 85 percent. This is still short of the 95 percent needed to prevent outbreaks, and leaves many people, in many communities, at risk. Second dose coverage, while increasing, stands at 67 percent. With governments and partners such as the Measles & Rubella Initiative, Gavi, the Vaccine Alliance, UNICEF and others, response operations are underway to bring country outbreaks under control, strengthen health services, and increase vaccine coverage. After conducting emergency vaccination campaigns targeting 7 million children from 6 months through 9 years of age, Madagascaris now seeing overall declines in measles cases and deaths. In the Philippines, over 3 890 000 doses of the measles and rubella vaccine have been given to children aged under 5 years. In the Democratic Republic of the Congo, the country is preparing to launch a combined response with polio vaccine. In collaboration with local health authorities, WHO and UNICEF conducted a nationwide measles and rubella vaccination campaign in Yemenreaching more than 11.6 million (90%) children aged 6 months–16 years across the country. Responding to measles requires a range of approaches to ensure all children get their vaccines on time, with particular attention to access, quality and affordability of primary care services. It will also take effective public-facing communication and engagement on the critical importance of vaccination, and the dangers of the diseases they prevent. WHO also recommends tailored approaches that ensure immunization services meet the needs of everyone – making sure that clinics are accessible to all areas, at the right times and to all population groups - especially those who face systemic discrimination and disadvantage. Coverage of the 2nd vaccine dose also needs to increase globally, to maximize a population’s protection against the disease. Today, 25 countries still need to make the 2nd dose part of their essential immunization programme.     ]]> https://biospectrumindia.com/news/57/13436/path-and-mmv-launch-5-year-global-initiative-to-support-elimination-of-relapsing-malaria-.html https://biospectrumindia.com/news/57/13436/path-and-mmv-launch-5-year-global-initiative-to-support-elimination-of-relapsing-malaria-.html Tue, 23 Apr 2019 12:15:00 +0530 PATH and Medicines for Malaria Venture (MMV) announce a 5-year, jointly-led initiative, VivAccess, to support countries in the elimination of Plasmodium vivax (P. vivax) malaria. The initiative is part of the larger global effort to support malaria-endemic countries in the adoption and use of new and existing tools, to facilitate well-tolerated and effective radical cure to prevent relapse. VivAccess's work is funded by the Bill & Melinda Gates Foundation. P. vivax is the most frequently occurring species of malaria parasite outside of sub-Saharan Africa, putting approximately 2.5 billion people at risk and causing around 7.5 million infections a year. Each infection can lead to multiple relapses due to the parasite's ability to lie dormant in the liver. To completely clear the body of parasites and achieve radical cure, two drugs are required: one for the blood stage infection causing malaria symptoms, and another for the liver-stage. The class of liver-stage drugs currently used to treat P. vivax malaria can cause hemolysisin individuals who have the common genetic disorder G6PD deficiency that affects approximately 400 million people globally. It is therefore important to test for G6PD deficiency in order to guide the appropriate use of liver-stage drugs. The goal of VivAccess is to support introduction and increased access to the suite of radical cure products to address these challenges. George Jagoe, Executive Vice President, Access & Product Management at MMV said, "Because one infection caused by the P. vivax parasite has the uncanny ability to cause a patient to relapse in the absence of a new infective mosquito bite, it amplifies the burden of malaria, placing a huge burden on the individuals, communities and countries it infects. New tools to stop this cycle of disease have been developed, and more are in development. VivAccess is set to accelerate their access to those in need and in doing so protect patients from relapses and support countries to move towards malaria elimination." Dr. Larry Slutsker, Director of the PATH Center for Malaria Control and Elimination said, "Relapsing malaria due to Plasmodium vivax is the most geographically widespread malaria, with well over 2 billion people living in areas of risk for infection. Vivax malaria causes massive suffering in terms of illness, anemia, and death. The new tools that we can now bring to bear through the VivAccess partnership present a unique opportunity to make progress against this major public health challenge and underscore the importance of continued investment in malaria research and development." Through VivAccess, the partnership will continue to work closely with the World Health Organization, National Malaria Control Programs, and country-based healthcare partners to support the introduction and use of these effective tools, which include malaria diagnostics, G6PD diagnostics, blood-stage drugs, and liver-stage radical-cure drugs. Guided by the leadership of national health agencies, VivAccess will provide support in terms of market analytics, technical expertise, and product delivery coordination as countries seek to introduce effective radical cure into national malaria protocols and accelerate progress towards their malaria elimination goals. In the process, the initiative will strengthen national and local capacities in alignment with the WHO malaria strategic agenda.   ]]> https://biospectrumindia.com/news/57/13432/lynparza-gets-ec-approval-to-treat-advanced-breast-cancer.html https://biospectrumindia.com/news/57/13432/lynparza-gets-ec-approval-to-treat-advanced-breast-cancer.html Tue, 23 Apr 2019 11:05:00 +0530 AstraZeneca and MSD Inc., have recently announced the European Commission(EC) has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer. Under the licensed indication, patients should have previously been treated with an anthracycline and a taxane in the (neo) adjuvant or metastatic setting unless they were unsuitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Dave Fredrickson, Executive Vice President, Oncology, said: “With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer. It also reinforces the importance of testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients.” Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “In the OlympiAD trial, which supported this approval, Lynparza demonstrated a meaningful improvement in progression-free survival compared to chemotherapy in patients with germline BRCA-mutated metastatic breast cancer. We look forward to making this new option available across the EU, where we hope it will improve outcomes for many patients.” This is the third indication for Lynparza in the EU, and AstraZeneca and MSD are working together to deliver Lynparza as quickly as possible to more patients across multiple settings.  ]]> https://biospectrumindia.com/news/57/13431/lilly-avidity-bio-announce-licensing-and-research-collaboration.html https://biospectrumindia.com/news/57/13431/lilly-avidity-bio-announce-licensing-and-research-collaboration.html Tue, 23 Apr 2019 11:00:00 +0530 Eli Lilly and Company and Avidity Biosciences, Inc. have announced a global licensing and research collaboration focused on the discovery, development and commercialization of potential new medicines in immunology and other select indications. The companies will utilize Avidity's technology platform to progress new therapeutic approaches toward clinical development and commercialization. Avidity's platform seeks to combine the tissue selectivity of monoclonal antibodies and the precision of oligonucleotide-based therapeutics to potentially overcome barriers to the delivery of oligonucleotides and target genetic drivers of disease. Under the terms of the agreement, Avidity will receive an upfront payment of $20 million, as well as an investment of $15 million. Avidity is also eligible to receive up to approximately $405 million per target for development, regulatory and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales. ]]> https://biospectrumindia.com/news/57/13425/fda-approves-mercks-keytruda-in-combination-with-inlyta.html https://biospectrumindia.com/news/57/13425/fda-approves-mercks-keytruda-in-combination-with-inlyta.html Mon, 22 Apr 2019 16:30:00 +0530 Merck has announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA in combination with axitinib (KEYTRUDA-axitinib combination) compared to sunitinib. Consistent results were observed across pre-specified subgroups, IMDC risk categories and PD-L1 tumor expression status. For the main efficacy outcome measures of OS and PFS, the KEYTRUDA-axitinib combination reduced the risk of death by 47% compared to sunitinib (HR=0.53 [95% CI, 0.38-0.74]; p<0.0001); for PFS, the KEYTRUDA-axitinib combination showed a reduction in the risk of progression of disease or death of 31% compared to sunitinib (HR=0.69 [95% CI, 0.57-0.84]; p=0.0001). The ORR, an additional efficacy outcome measure, was 59% for patients who received the KEYTRUDA-axitinib combination (95% CI, 54-64) and 36% for those who received sunitinib (95% CI, 31-40) (p<0.0001). This is the first indication for KEYTRUDA in advanced RCC, the most common type of kidney cancer, and the first anti-PD-1 therapy FDA-approved as part of a combination regimen that significantly improved OS, PFS, and ORR versus sunitinib in patients with advanced RCC. “This represents a new treatment option for patients with advanced renal cell carcinoma, who will now have access to KEYTRUDA as part of a first-line combination regimen,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Today’s approval reflects Merck’s commitment to patients with cancer and further supports the use of KEYTRUDA to help improve survival outcomes for patients with advanced renal cell carcinoma.” Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below. “Given the aggressive nature of the disease, many patients with advanced renal cell carcinoma need additional treatment options that can help improve survival outcomes,” said Dr. Brian Rini, medical oncologist at Cleveland Clinic Cancer Center and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. “Pembrolizumab in combination with axitinib offers an important new therapeutic option for physicians to consider when approaching initial treatment for patients newly diagnosed with advanced renal cell carcinoma.” Dr. Rini reports consulting and research funding from Merck. The approval was based on data from the pre-specified interim analysis of Phase 3 KEYNOTE-426 trial, a randomized, multi-center, open-label trial conducted in 861 patients who had not received systemic therapy for advanced RCC. Patients were enrolled regardless of PD-L1 tumor expression status. Randomization was stratified by International Metastatic RCC Database Consortium (IMDC) risk categories (favorable versus intermediate versus poor) and geographic region (North America versus Western Europe versus “Rest of the World”). Patients with an active autoimmune disease requiring systemic immunosuppression within the last two years were ineligible.     ]]> https://biospectrumindia.com/news/57/13421/arrakis-therapeutics-announces-75-m-series-b-financing.html https://biospectrumindia.com/news/57/13421/arrakis-therapeutics-announces-75-m-series-b-financing.html Mon, 22 Apr 2019 15:05:00 +0530 Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small-molecule medicines that directly target RNA, has completed a $75 million Series B financing co-led by venBio Partners and Nextech Invest, with participation by new investors Omega Funds, HBM Healthcare Investments, GV (formerly Google Ventures), WuXi AppTec Venture Fund, and Alexandria Venture Investments, as well as all existing investors, Canaan Partners, Advent Life Sciences, Pfizer Ventures, Celgene Corporation, Osage University Partners and the estate of Henri Termeer. In addition, the company announced that Michael Gilman, Ph.D., will expand his role to full-time Chief Executive Officer in addition to continuing to serve as Chairman of the Board of Directors. “With this financing and an outstanding syndicate of investors, Arrakis will leap to the next stage of realizing our vision of creating a new class of medicines with RNA-targeted small molecules, or rSMs,” said Dr. Gilman. “We have built an end-to-end platform for the discovery of rSMs by creating or adapting tools that allow us to predict and validate the structure of RNA targets, locate druggable pockets, identify drug-like hits, and conduct medicinal chemistry programs to improve potency, selectivity, and safety. We are now operating this platform at scale to create a pipeline of utterly novel rSM medicines. I am excited to commit my full effort, along with the Arrakis team and our investors, to drive our discoveries into powerful new medicines for patients.” The proceeds from the Series B financing will enable Arrakis to build a pipeline of novel RNA-targeted small molecules, with the goal of reaching clinical testing with one or more candidates. The company will focus its internal drug development in oncology and genetically validated targets in other disease areas. In addition, the funding will enable Arrakis to continue to refine and expand its first-in-industry rSM discovery platform, including a high-throughput, comprehensive suite of computational tools, biophysical and cellular assays, and chemical libraries that are uniquely designed to create new small-molecule drugs for RNA targets. “Arrakis Therapeutics is the clear leader in the emerging rSM field. We are pleased to support their differentiated strategy to transform the drug discovery toolkit to focus on RNA and open hundreds of important new targets to therapeutic intervention. Arrakis’ deeply experienced team is uniquely qualified to execute this strategy,” said Richard Gaster, M.D., Ph.D., Principal at venBio Partners. “The demand for more effective and better-tolerated cancer drugs is high, creating the biggest and fastest growing market in healthcare. RNA is now a validated therapeutic target, and drugging RNA with conventional small-molecule medicines can provide cancer patients with options not achievable by any other means,” said Jakob Loven, Ph.D., Partner at Nextech Invest. In conjunction with the Series B financing, Dr. Gaster and Dr. Loven will join the Arrakis Board of Directors. In its next stage of growth, Arrakis will employ its proprietary rSM drug discovery platform to discover novel RNA-targeted small molecules and advance lead candidates toward clinical testing. Since the company’s inception, Arrakis has systematically reconfigured drug discovery tools for RNA targets and achieved the following: A systematic approach to identify and validate druggable RNA targets, enabling the company to target multiple aspects of RNA biology; these approaches include: in silico tools to identify druggable RNA targets at scale; high-throughput molecular biology tools to validate these targets. Multiple screening methods for identifying tractable targets and chemical matter, including: screening of hundreds of targets to date; identification of druggable RNA binding pockets; deriving the principles of molecular recognition of RNA. Advancement of rSM drug programs against novel RNA targets and with strong intellectual property, including: launch of four programs against RNA targets that encode proteins that are otherwise undruggable; chemical biology tools to elucidate the mechanism of action and selectivity of drug candidates; an intellectual property estate comprising new methods, compounds and targets. ]]> https://biospectrumindia.com/news/57/13419/merck-foundation-african-minister-of-health-defines-interventions-to-break-infertility-stigma-at-iffs-world-congress.html https://biospectrumindia.com/news/57/13419/merck-foundation-african-minister-of-health-defines-interventions-to-break-infertility-stigma-at-iffs-world-congress.html Mon, 22 Apr 2019 14:40:00 +0530 Merck Foundation, the philanthropic arm of Merck KGaA Germany, in partnership with the International Federation of Fertility Societies- IFFS conducted “Merck More Than a Mother” Ministerial Panel during the 23rd IFFS World Congress held in Shanghai, China with the theme of “No to Infertility Stigma”. The Ministerial panel aims to discuss capacity building and improving access to equitable fertility care solutions in Africa and developing countries.Merck more than a Mother Ministerial Panel was chaired by Dr. Rasha Kelej, CEO of Merck Foundation and President of Merck More Than a Mother. The panelists included; H.E. Dr. Isatou Touray, Vice President of The Gambia; Hon. Sarah Opendi, Minister of State of Health of Uganda; Hon. Dr. NDIKUMANA Thadée, Minister of Public Health and Fight Against AIDS of Burundi, Hon. Dr. Balandamio Florent, Vice Minister of Health, Republic of Congo, Prof. Joe Leigh Simpson, Immediate Past President of IFFS and Prof. Oladapo Ashiru, President of Africa Fertility Society. During the Panel Discussion, Dr. Rasha Kelej, CEO of Merck Foundation and President, Merck More Than a Mother emphasized, “Merck Foundation is dedicated to empowering women who suffer discrimination and violence due to their inability to bring children by defining interventions to break infertility stigma and to building equitable and quality fertility care solutions in Africa and developing countries.”H.E. Dr. Isatou Touray, Vice President and Minister of Health, Republic of The Gambia stated, “I have heard and witness the stories of infertile women in my country; the attitude of the people towards these women is not progressive or informed. They are usually mistreated by society. Together with Merck Foundation, we want to remove the stigma associated with it by creating a cultural shift and building cost-effective fertility care in Gambia and rest of Africa”“I have been associated with Merck Foundation from a very long time now. The work they haven doing has been creating a very significant impact in the lives of infertile women and also men around them by improving access to information and change in the culture and mindset” explained Hon. Sarah Opendi, Minister of State of Health, Republic of UgandaHon. Dr. NDIKUMANA Thadée, Minister of Public Health and Fight Against AIDS, Republic of Burundi said, “Most African countries do not have trained fertility experts and embryologists, Merck Foundation has been contributing significantly by providing training to our doctors. This initiative will make history and shape the landscape of fertility care in Burundi and the rest of Africa.”Hon. Dr. Balandamio Florent, Vice Minister of Health, Republic of Congo explained, “Infertility rate is much higher in African Countries as compared to rest of the world. However, African nations do not have the resources and expertise to provide guidance and treatment to infertile couples. This is why “Merck More Than a Mother’ initiative is crucial for our country and other African counties.”Appreciating the efforts of Merck Foundation, Prof. Joe Leigh Simpson, Immediate Past President of IFFS stated, “I am excited to see the work that Merck Foundation has been doing for many years to create awareness and build fertility care capacity in Africa and developing countries. It will indeed create a great impact.”Prof. Oladapo Ashiru, President of Africa Fertility Society emphasized, “It is very critical to create awareness around infertility prevention and management as around 85% of infertility cases in Africa are caused by untreated infectious diseases, hence are preventable in many cases.” ]]> https://biospectrumindia.com/news/57/13415/bi-keen-on-crossing-animal-health-innovation-with-human-pharma.html https://biospectrumindia.com/news/57/13415/bi-keen-on-crossing-animal-health-innovation-with-human-pharma.html Mon, 22 Apr 2019 12:20:00 +0530 Global pharma giant Boehringer Ingelheim (BI), which is present in both human and animal health, is particularly interested in the potential for innovation in animal health where it crosses over with human pharma. “We believe that we will benefit from veterinary expertise in the development of potential tumour vaccines,” Hubertus von Baumbach, Chairman of the Board of Managing Directors of Boehringer told press reporters at the company headquarters here. He elaborated that the company was therefore stepping up the level of exchange between human and animal health. “We are convince that we will in future lean increasingly from one another in R&D,” he said adding that this form of synergy could not be quantified today but as one of the few remaining companies with such a profile, Boehringer sees a distinct strategic advantage.       There were already a number of examples of therapeutics and vaccines which were useful for humans and animal in equal measures. In pain therapy there was a good example of METACAM, which was a focus area for the Boehringer, said Baumbach. With its 90 projects, Boehringer’s innovation pipeline in human pharma is well filled. For the total 90 projects in all phases of research process, the goal is for 75 per cent of them to be either the first molecules in their active ingredients class of first in a new therapeutic area. “Today that is already the case for 67 per cent of our current projects. At over 65 per cent, the proportion of substances or indications with the potential for medical breakthrough is even significantly higher than our internal target level of 50 per cent,” he said. The company has focussed on specific therapeutic areas. “We want to make a significant contribution towards a superior treatment of cancer,” said Baumbach. He added that in addition the company is conducting research, among others, into fibrotic, metabolic and immunological diseases and its research pipeline was well-filled.   In oncology, the focal points are cancers of the lung, stomach and intestine, while in fibrotic diseases the focus is on systematic scleroderma with interstitial lung disease. In metabolic diseases non-alcoholic steatohepatitis, known as NASH, is the main focus of research. In immunology, research is paying attention to chronic inflammatory diseases of the skin and intestine. Other projects address diseases of the central nervous system, such as Alzheimer’s and schizophrenia, obesity and retinopathy. For a specific question about NASH, Baumbach said he could not tell the specific of the project. But at the abstract level it has become one of the core areas of work. “We are convinced that there is synergy between these areas of activity, that, for example, we can use the experiences from immunology in oncology and fibrotic diseases,” said Baumbach and added decades of experience in R&D has taught us that we learn from cooperation with third parties and can inly improve thereby. Hence, the Boehringer Ingelheim deliberately seeks outside the company and supplement its in house expertise with more than 150 active cooperations at every level of research value chain. It has also set a target for itself that a third of its product pipeline should be based on in-licensed mechanisms or molecules. Boehringer’s Research Beyond Borders Programme addresses fields of nnhigh medical need that lie outside of its core therapeutic areas. Hence, it has launched an “Immuno Infection Hub” with partnership of Tsinghua University of Beijing to develop new methods of treatment in the light of globally increasing infection with multi-resistant germs, with initial focus on tuberculosis. Boehringer has done some acquisitions keeping in mind its research focus. Just recently it acquired biotech company ICD Therapeutic. With this the company could integrate a new technology into its research activities which can address the intracellular molecular targets that it was currently unable to reach with traditional antibodies or with small chemical molecules. When asked about the major trend the company was looking at, Baumbach responded immune oncology was going to change very positively. But, indivisualised tumour vaccines is a major challenge and the company is moving in this direction, he added. The company was looking at immune-oncology since it wanted to transform the so-called cold tumours into hot tumours. The scientific hypothesis assumed that they were thereby more easily recognised by the body’s own immune system and were better to treat with immune checkpoint inhibitor medications already available today. Responding to a question, Baumbach said 40 per cent of the company’s products are made of biopharma processes and an equal percentage of total research pipeline is devoted to biopharma product processes. It will be increasing further, he added. Baumbach elaborated on Boehringer’s open innovative portal opnMe for the scientists around the world to order online the molecule that originated from the company’s research. Boehringer thinks of ‘open source’ as other scientists may have their own ideas on how to employ its molecules and wanted to test them in experiments which possibly the company has not thought of. Since 2017 when the portal was launched, 1700 shipments have been sent.            At 2.8 billion euros, R&D investments in human pharma corresponded to a 22.1 per cent share of human pharmaceuticals’ net sales.  An additional initiative of Boehringer is the BI venture fund which is endowed with 250 million euros of risk capital and currently has a portfolio of 26 companies. In a medium term, Boehringer sees good opportunities in immunology for various indications which it would track with additional molecules. In the long term it is focusing on the potential of its active ingredient candidates in oncology and cardio vascular and metabolic diseases as well as central nervous system, concluded Baumbach.  ]]> https://biospectrumindia.com/news/57/13414/boehringer-ingelheim-registers-impressive-financial-growth.html https://biospectrumindia.com/news/57/13414/boehringer-ingelheim-registers-impressive-financial-growth.html Mon, 22 Apr 2019 11:15:00 +0530 Research driven Pharmaceutical giant Boehringer Ingelheim registered net sales of 17.5 billion Euros in 2018 and with net sales of 12.6 billion euros of the human pharma division its share share in total net sales was 72 per cent. The company is investing 230 million euros to expand and improve its biopharmaceutical development capacities. “Compare to the earlier year, on one hand the currency effects have had significant negative impact on the net sales and on the other hand decline in net sales from discontinued operations plays a significant role,” Michael Schmelmer, Member of the Board of Managing Directors responsible for Finance, told a press conference at the company headquarter here. Still, the income before taxes increased by 320 million euros, 11.2 per cent to 3.5 billion euros and profit after tax increased to 2.1 billion euros. The company was able to increase the return on net sales from 19.3 to 19.8 per cent, said Scamelmer. Adjusted for currency effects, as well as one-off effects due to the asset swap with Sanofi in 2017, net sales grew in 2018 by 4 per cent, he added. The company continued to be in a solid position in liquidity and healthy equity ratio, which is fundamental to any company’s financial health. “At 3 billion euros, the cash flow from operating activities, once again significantly exceeded our investment in tangible and intangible assets of 1.1 billion euros,” he added. The equity ratio has increased from 38 per cent to 40 percent with equity of 12.3 billion euros and total assets of 30.9 billion euros. The company has invested in setting up new production facilities or expanding the existing ones in four countries. Besides the investments in physical infrastructure, Boehringer also invested 2.8 billion euros in human pharma R&D, 22.1 per cent of the net sales from the human pharmaceuticals. Keeping aside the income from global licensing business, the company registered growth of 5.1 per cent in human pharmaceuticals. At almost 1 billion euros (+9 per cent), investments in tangible assets were highest than ever before. Operating income amounted to 3.5 billion euros (-0.4 per cent).  Foreseeable declines in net sales, due to expiring patents for innovative medicines, were more than compensated for, the human pharma business thereby achieving currency-adjusted growth of 5.1 per cent. Revenues from the global licensing business were lower than the previous year and have reduced the overall rate of growth in this business area to 3.3 per cent. Respiratory medicine SPIRIVA achieved the highest net sales contributions with 2.4 billion euros followed by type 2 diabetes medicine family JARDIANCE, including SYNJARDY and GLYXAMBI with 1.8 billion euros, the anticoagulant PRADAXA with 1.5 billion euros and the type 2 diabetes medicine TRAJENTA with 1.4 billion euros as well as OFEV for the treatment of idiopathic pulmonary fibrosis with 1.1 billion euros.       (As Reported by Milind Kokje present at the Boehringer Ingelheim headquarters in Germany at the invitation of the company) ]]> https://biospectrumindia.com/news/57/13411/fda-permits-to-sell-first-medical-device-for-adhd-treatment.html https://biospectrumindia.com/news/57/13411/fda-permits-to-sell-first-medical-device-for-adhd-treatment.html Mon, 22 Apr 2019 10:00:00 +0530 The U.S. Food and Drug Administration recently permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA. "This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind," said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health. "Today's action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs." ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person's functioning and cause the person to fall behind normal development for his or her age. The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior. The stimulation should feel like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. Patients should consult with their health care professional after four weeks of use to assess treatment effects. The Monarch eTNS System's efficacy in treating ADHD was shown in a clinical trial that compared eTNS as the sole treatment, or monotherapy, to a placebo device. The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. The FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma.  ]]> https://biospectrumindia.com/news/57/13385/perkinelmer-joins-accentures-life-sciences-ecosystem-for-research-and-innovation-in-drug-discovery.html https://biospectrumindia.com/news/57/13385/perkinelmer-joins-accentures-life-sciences-ecosystem-for-research-and-innovation-in-drug-discovery.html Sun, 21 Apr 2019 09:00:00 +0530 PerkinElmer, a global leader committed to innovating for a healthier world has announced that it has joined Accenture’s open partner ecosystem, designed to help solution providers, software vendors and life sciences companies team more effectively to accelerate drug discovery and improve patient outcomes. The ecosystem is an integral part of Accenture’s cloud-based informatics research platform focused on improving productivity, efficiency and innovation in the drug discovery process. Accenture is currently working with a select number of independent software vendors and organizations, including PerkinElmer, to integrate their technology and content into Accenture’s research platform. Joining the ecosystem is in sync with PerkinElmer’s strategy to deliver advanced informatics solutions that empower researchers to more quickly and easily spotlight key findings amidst the ever-growing volume, types and complexity of scientific big data. PerkinElmer is making its informatics solutions compatible with Accenture’s integrated ecosystem starting with the following: key functionality of electronic laboratory notebooks, which allow for effective organization and sharing of experimental data; TIBCO Spotfire software for data visualization in research and clinical analytics; and ChemDraw software, a leading application for chemistry-based analytics and workflows. PerkinElmer Signals solutions, which provide advanced analytics for R&D such as lead discovery and translational medicine, are also planned to be available via the Accenture ecosystem in the future. “Today’s pharmaceutical companies are dealing with tremendous silos of data that are hard to access, expensive to maintain and can create missed opportunities to connect insights that propel new patient therapies,” said David Wang, general manager of Informatics at PerkinElmer. “Forward-looking life science organizations are reimagining, streamlining and accelerating the power of their research organizations by digitizing and integrating their big data. This is the promise of informatics in the lab, and we are pleased to be the largest instrument and informatics solution provider to join the Accenture ecosystem to date.” “As PerkinElmer is a leading provider of lab instrument and informatics solutions, we’re pleased to welcome the company to Accenture’s open partner ecosystem and to be working closely with them to integrate their capabilities into our cloud-based research platform,” said Joe Donahue, a managing director in Accenture’s Life Sciences practice. “Our clients will benefit from access to PerkinElmer’s solutions and we look forward to collaborating with them to help our mutual clients gain insights from data to drive scientific discovery—ultimately improving patient outcomes.” ]]> https://biospectrumindia.com/news/57/13407/shimmer-launches-version-2-0-of-its-neurolynq-neuromarketing-platform.html https://biospectrumindia.com/news/57/13407/shimmer-launches-version-2-0-of-its-neurolynq-neuromarketing-platform.html Fri, 19 Apr 2019 12:50:00 +0530 Shimmer, a global leader in wearable technology for research applications has announced the launch of version 2.0 of its NeuroLynQ biometrics neuromarketing platform. NeuroLynQ uses scientifically-validated galvanic skin responses (GSR) to monitor an audience’s nonconscious emotional response to stimuli, such as a live performance or new advertising material. NeuroLynQ v2.0 features an entirely new analytics module.  GSR, also known as skin conductance, refers to changes in sweat gland activity, which reflect the intensity of participants’ emotional state – or ‘emotional arousal’.  NeuroLynQ permits an audience’s emotional response to be measured in real time in a real-world setting. It can provide results from up to 45 people simultaneously in a format that is easy to use and interpret.  “NeuroLynQ’s new analytics capabilities dramatically change the economics of analyzing biometric data, reducing the time required for neuromarketing data analysis from days and weeks to minutes and hours,” said Geoff Gill, president of Shimmer Americas. “For example, using a beta version, we calculated 1,380 summary metrics from 115 Super Bowl ads collected live in just six minutes allowing Ipsos to release their analysis before start of business the next morning. In another example, we completed a detailed multi-segment analysis of NeuroLynQ data collected during 36 sessions conducted on four days in three countries in four hours.”  Mr. Jones said, “We used Shimmer’s GSR+ sensor when we did this study, but I wish NeuroLynQ v2.0 had been available. We could have collected all our data in one session, instead of 22. We are really excited to see NeuroLynQ’s new analytic capabilities, which will dramatically streamline our data analysis.”  NeuroLynQ’s new analytics module provides several useful features: easy session aggregation and segmentation, peak counting, z-scoring, and enhanced export features. These advances enable neuromarketing researchers to integrate seamlessly data from multiple sessions conducted at different times and locations to create detailed studies. They can also define their own demographics and segments, allowing them to analyze the data in innumerable ways. The addition of z-scoring metrics permits the aggregation of GSR signals, providing a quantitative measure of arousal. Enhanced export features enable tailored exporting of segments, event marks, and summary metrics. “Researchers can also access the NeuroLynQ algorithms. NeuroLynQ provides complete transparency to ensure reliable results,” added Mr. Gill.  ]]> https://biospectrumindia.com/news/57/13402/certara-selects-four-global-leaders-for-its-simcyp-division.html https://biospectrumindia.com/news/57/13402/certara-selects-four-global-leaders-for-its-simcyp-division.html Thu, 18 Apr 2019 16:00:00 +0530 Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services has announced four senior executive appointments in its Simcyp division. Simcyp is the leading provider of innovative mechanistic modeling technologies used to inform drug development, including physiologically-based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP) and quantitative systems toxicology and safety (QSTS) approaches. For example, the Simcyp Simulator has been used to inform 50 novel drug applications, including more than 200 label claims made without the need for clinical trials.  Rob Aspbury, PhD, joins Simcyp as Chief Operating Officer; Frederic Yves Bois, PharmD, PhD, is the division’s new Senior Scientific Advisor and Head of Mechanistic Modeling;Will Redfern, PhD, is Vice President, Quantitative Systems Toxicology and Safety; and Noriko Okudaira, PhD, is Senior Consultant/Scientific Advisor supporting Certara’s clients locally in Japan.  Dr. Aspbury brings more than 17 years’ commercial and scientific leadership experience with Covance to Certara. Dr. Aspbury was appointed Global Finance Director for Covance’s Clinical Pharmacology Services Division in 2003 and was rapidly promoted within the division to Managing Director, then Vice President, Europe, and later Vice President and General Manager, Global. His most recent appointment was Vice President of Covance Strategic Solutions, Biosimilars.  Dr. Bois was Research Director of the French National Institute for Industrial Environment and Risks (INERIS) before joining Certara. For six years, he also served in parallel as Professor and Chair of Mathematical Modeling for Systems Toxicology at UTC and INERIS. Dr. Bois is a recognized expert in Bayesian calibration of complex differential equation-based models. He has also served as a public health policy and regulatory risk assessment consultant to the US FDA, EPA and OSHA, the European Commission, and the French Ministry of the Environment. Dr. Bois is author or co-author of more than 150 peer-reviewed articles and recipient of the American Statistical Association’s Outstanding Statistical Application Award, and the French Epidaure Prize for Environmental Health Research.  Dr. Redfern is an international key opinion leader with more than 30 years’ experience in in vivo central nervous system and cardiovascular safety pharmacology. He joins Certara from AstraZeneca R&D in Cambridge (UK) where he was Principal Scientist for Safety and Mechanistic Pharmacology. Dr. Redfern is author or co-author of 36 peer-reviewed articles, six book chapters, 91 conference proceedings abstracts, and two drug patents. He is a past president of the Safety Pharmacology Society and has received both the organization’s Technological Innovation Award and its Distinguished Service Award.  Dr. Okudaira comes to Certara from Daiichi Sankyo Co., Ltd. where she served as Director of the Clinical Pharmacology Department. Prior to that, she was Senior Researcher and later Senior Director of Daiichi Sankyo’s Drug Metabolism and Pharmacokinetic Research Laboratories.   ]]> https://biospectrumindia.com/news/57/13380/dr-justin-sanchez-joins-battelle-as-life-sciences-research-technical-fellow.html https://biospectrumindia.com/news/57/13380/dr-justin-sanchez-joins-battelle-as-life-sciences-research-technical-fellow.html Tue, 16 Apr 2019 16:25:00 +0530 Dr. Justin Sanchez, a noted expert in neurotechnology and Director of the Biological Technologies Office (BTO) at DARPA, will join Battelle as a Technical Fellow, a prestigious position where he will guide Battelle’s life sciences research business. Battelle is the world’s largest independent research and development organization and has a rich history of scientific innovation for nearly 90 years. Dr. Sanchez becomes the second Technical Fellow within Battelle, joining Dr. Amy Heintz who is a recognized leader in Advanced Materials. Battelle’s Tech Fellows are scientists and engineers whose body of work, reputation in their field, and vision for the future are nationally recognized. Tech Fellows operate at the general management level, serve on the leadership team, lead the organization’s overall technical investment strategies, and drive collaboration across Battelle as well as with government, industry and academia. “We’re very pleased that Dr. Sanchez will be joining Battelle to lead scientific advancement across our broad portfolio of life science offerings in medical devices, pharmaceutical research, biosecurity, and public health,” said Matt Vaughan, President of Battelle’s Contract Research business. “Justin’s long list of achievements, and the respect he commands in both government and industry, cannot be overstated. His vision, drive and willingness to take risks will be instrumental in accelerating innovation and building partnerships that accelerate our contribution to the next generation of transformative technologies that advance national security, human health and well-being.” In his most current position at DARPA, Sanchez led the office responsible for developing breakthrough biological technologies and capabilities for national security including those in neurotechnology, gene editing/synthetic biology and infectious disease. He led strategy development and during his tenure as the Director of BTO was responsible for growing the office to develop 31 new DARPA programs and investing more than $1.65 billion at national labs, industry, and academic institutions. “I am thrilled to be joining Battelle, an organization that has a one-of-a-kind mix of deep scientific expertise, market leadership, and philanthropy to help those in need,” Sanchez said. “Battelle’s potential for growth is a unique product of its fundamental understanding of some of the most disruptive scientific fields, and the practical skills to bring breakthroughs to market rapidly. From idea to prototype to product, Battelle brings all of the engineering, productization and commercialization capabilities together under one roof. Combined with an open partnership model, these assets provide an amazing platform for growth.” Added Sanchez, “Biological technologies are opening the door to transformative solutions that will impact human health, national security, and industries of the future. I’m honored to have the opportunity to provide technical leadership, strategic direction and deep expertise in this fascinating area of science, which has the potential to improve the lives of so many.” Sanchez has published more than 100 peer-reviewed papers, authored two books on the design of neurotechnology and holds seven patents. Prior to joining DARPA, he was an associate professor of Biomedical Engineering and Neuroscience at the University of Miami. He directed the Neuroprosthetics Research Group where he oversaw the development of neural-interface medical treatments. He holds a Doctor of Philosophy and Master of Engineering degrees in Biomedical Engineering, and a Bachelor of Science degree in Engineering Science, all from the University of Florida. Sanchez officially will begin work at Battelle in late June, following the conclusion of his duties at DARPA.   ]]> https://biospectrumindia.com/news/57/13378/novartis-seeks-fda-nod-of-brolucizumab-for-wet-amd-patients-.html https://biospectrumindia.com/news/57/13378/novartis-seeks-fda-nod-of-brolucizumab-for-wet-amd-patients-.html Tue, 16 Apr 2019 14:15:00 +0530 Novartis announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Seeking to make brolucizumab available as quickly as possible, Novartis used a priority review voucher to expedite FDA review. If approved by the FDA, Novartis anticipates launching brolucizumab by the end of 2019. Estimates suggest that by 2020, 1.5 to 1.75 million people in the U.S. will be living with wet AMD, a leading cause of blindness worldwide and a rapidly growing public health concern. As the disease progresses, patients may experience loss of central vision, resulting in an inability to complete daily tasks. Without treatment, vision can rapidly deteriorate and may lead to blindness. The regulatory application is primarily based on Phase III data from the HAWK and HARRIER trials — prospective, randomized, double-masked multi-center studies. "Wet AMD robs people of their precious sight and takes a major toll on the lives of millions of people who face not only vision loss, but also the burden of frequent injections into their eyes," said Dawn Prall George, executive director, The Support Sight Foundation. "We are always excited about potential new treatment options and hopeful they may help people manage this devastating disease." ]]> https://biospectrumindia.com/news/57/13373/mount-sinai-launches-clinical-trial-of-imaging-device-for-cancer-surgeries.html https://biospectrumindia.com/news/57/13373/mount-sinai-launches-clinical-trial-of-imaging-device-for-cancer-surgeries.html Tue, 16 Apr 2019 11:50:00 +0530 The device, called Otis Wide Field OCT (by Perimeter Medical Imaging), is an ultra-high-resolution imaging system that can image tumor specimens in real time during surgery, allowing surgeons to remove all of the cancerous tissue during one procedure, rather than waiting for traditional pathology results to come in afterward, which can often lead to additional procedures. Patients in the trial agree to have their tumors placed in the system for imaging, which is then compared to the standard pathology evaluation. “State-of-the-art imaging platforms, such as the Otis system and others, will likely play a significant role in the future of head and neck cancer surgery. While traditional pathologic examination of tissues is the standard around the world, we need new technology to allow us to detect cancer and ensure adequate resection at the time of surgery,” explains lead investigator Brett Miles, DDS, MD, Associate Professor of Otolaryngology at the Icahn School of Medicine at Mount Sinai, and Co-Chief of the Division of Head and Neck Oncology for the Mount Sinai Health System. “Data from this study, and other projects in the optical imaging program, will help us understand how beneficial these technologies may be and drive future innovation during head and neck cancer surgery.” Investigators from the Head and Neck Cancer Research Program at the Icahn School of Medicine at Mount Sinai are also conducting a high-risk HPV screening study, along with colleagues from Johns Hopkins University and three other institutions. The study, known as MOUTH, is a clinical trial to better understand how risk factors affect oral HPV infection rates. In this study, researchers are collecting samples of blood, saliva, and urine to test them for HPV antibodies. So far, approximately 630 samples have been collected, and patients who screened positive for high-risk HPV viral types are entering the close observational arm of the study, in which they will receive clinical visits and imaging, such as ultrasound and MRI, to monitor them for head and neck cancer.  They will be monitored annually for the next five years. The study is currently open and enrolling patients. “We are pleased to be participating in this groundbreaking study, and glad that patients are willing to participate in this work. Currently there exists no accepted screening method for HPV-related head and neck cancer, despite the fact that there are currently more cases diagnosed in the United States than cases of cervical cancer [which is also caused by HPV]. It’s truly an epidemic. In many cases the cancer is asymptomatic for significant periods of time, making the discovery of new detection methods vital. This study provides important information on who is at risk, and who needs additional follow-up for high-risk HPV infection in the head and neck,” explains Dr. Miles. ]]> https://biospectrumindia.com/news/57/13358/gardp-in-search-for-new-antibiotics.html https://biospectrumindia.com/news/57/13358/gardp-in-search-for-new-antibiotics.html Tue, 16 Apr 2019 09:00:00 +0530 The Global Antibiotic Research and Development Partnership (GARDP) is partnering with Calibr, the Helmholtz Centre for Infection Research (HZI), in particular its location Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), and the University of Queensland’s (UQ) Community for Open Antimicrobial Drug Discovery (CO-ADD) in its efforts to develop and ensure new antibiotics are globally available to all patients who need them. The agreement allows GARDP to access and test Calibr’s ReFRAME compound library and HIPS natural products library. Both libraries will be screened by CO-ADD to discover novel compounds or combinations of drugs that will kill the priority pathogens identified by the World Health Organization in critical need for research and development of new antibiotics. This is GARDP’s first discovery collaboration that links partners in Germany and the USA with Australia. Through this screening, GARDP seeks to identify novel compounds suitable for optimization and clinical development as drugs for patients. ]]> https://biospectrumindia.com/news/57/13371/omron-healthcare-to-launch-blood-pressure-monitor-with-ekg-capability.html https://biospectrumindia.com/news/57/13371/omron-healthcare-to-launch-blood-pressure-monitor-with-ekg-capability.html Mon, 15 Apr 2019 15:55:00 +0530 Omron Healthcare, Inc., the global leader in personal heart health and wellness technology, has secured FDA clearance on its new Complete™, the first blood pressure monitor with EKG capability in a single device, and will open pre-orders on April 15th at 12:00 pm EST in the U.S. on OmronHealthcare.com. Omron developed Complete in partnership with AliveCor, the market leader in FDA-cleared personal EKG technology. Complete uses the advanced new algorithm designed by AliveCor for improved detection of the possibility of Afib along with trusted medical-grade blood pressure measurement from Omron.   Complete is an upper arm blood pressure monitor that allows users to simultaneously monitor EKG and blood pressure readings at home. EKG readings can be measured by touching electrodes conveniently located on the top face and both sides of the monitor for easy access and comfort. EKG is an essential measurement for those with atrial fibrillation, also known as arrythmia or Afib, a condition causing irregular heartbeat that can lead to heart health-related complications, including increased risk of stroke and heart failure.  Complete is the recent recipient of the iF Design Award 2019, presented by iF International Forum Design GmbH, one of the world’s most prestigious design awards. This award was presented to Complete for its uniqueness, innovation, aesthetic appearance and performance. ]]> https://biospectrumindia.com/news/57/13360/rayvios-new-xr-308-nm-uvb-led-can-lower-treatment-costs-and-improve-treatment-processes.html https://biospectrumindia.com/news/57/13360/rayvios-new-xr-308-nm-uvb-led-can-lower-treatment-costs-and-improve-treatment-processes.html Mon, 15 Apr 2019 10:10:00 +0530 RayVio Corp., an advanced health and hygiene company, is shipping its new, 308 nm XR UVB LEDs and supporting the development of phototherapy treatments for skin diseases. RayVio's new XR UV LEDs enable targeted therapies, smaller and lower cost treatment devices, and superb reliability. Available directly from Digi-Key as an emitter or pre-mounted on a star board for easy development and product integration, RayVio's new LEDs deliver 13 mW at 100 mA and are rated for up to 10,000 hours of continuous use. "UV Treatment of Psoriasis and Vitiligo have been limited because of the size and cost of the equipment as well as the risk to healthy surrounding tissue," said Yitao Liao, Chief Innovation Officer and co-founder at RayVio. "Excimer laser systems address the targeting of treatment to avoid damaging healthy skin, but the systems are bulky and very expensive. Our 308 nm UV LEDs are being put into compact, handheld devices that are portable." RayVio has achieved record-setting performance of 300 mW output at 308 nm from a single UV LED package and is already sampling this option to customers. Its advances in LED technology for phototherapy and Vitamin D production are also advancing and the company is preparing a more powerful, 293 nm emitter in 2019. RayVio's work in the UVB range for phototherapy applications complements its pioneering UVC LED technology that offers leading performance for disinfection and sterilization applications like water purification. RayVio Corp. is an advanced health and hygiene company that delivers clean water and environments. RayVio helps protect billions from germs and creates new markets and revenue streams by enabling a new class of products. Its powerful and efficient UV LED technology can be integrated into a variety of applications, powering versatile on-demand solutions that give consumers control over health without chemicals or costly consumables. ]]> https://biospectrumindia.com/news/57/13352/fda-approves-expanded-monotherapy-label-for-mercks-keytruda.html https://biospectrumindia.com/news/57/13352/fda-approves-expanded-monotherapy-label-for-mercks-keytruda.html Fri, 12 Apr 2019 15:20:00 +0530 Merck known as MSD outside the United States and Canada has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. The approval is based on results from the Phase 3 KEYNOTE-042 trial, in which overall survival (OS) was sequentially tested as part of a pre-specified analysis plan. In the trial, KEYTRUDA monotherapy demonstrated a statistically significant improvement in OS compared with chemotherapy alone in patients whose tumors expressed PD-L1 with a TPS ≥50%, with a TPS ≥20%, and then in the entire study population (TPS ≥1%). “This expanded first-line indication now makes KEYTRUDA monotherapy an option for more patients with non-small cell lung cancer, including those for whom combination therapy may not be appropriate,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below. “The KEYNOTE-042 trial demonstrated a survival benefit with KEYTRUDA monotherapy across histologies in certain patients with stage III or metastatic non-small cell lung cancer whose tumors expressed PD-L1 in at least 1% of tumor cells,” said Dr. Gilberto Lopes, associate director for global oncology at the Sylvester Comprehensive Cancer Center at the University of Miami. “As a practicing oncologist, having additional options available for patients is important in the rapidly evolving treatment landscape for lung cancer, which remains the leading cause of cancer death in the United States.” KEYTRUDA was the first anti-PD-1 therapy in metastatic NSCLC approved in the first-line setting as combination therapy or monotherapy. ]]> https://biospectrumindia.com/news/57/13349/gilead-sciences-novo-nordisk-to-collaborate-for-nash-trial.html https://biospectrumindia.com/news/57/13349/gilead-sciences-novo-nordisk-to-collaborate-for-nash-trial.html Fri, 12 Apr 2019 15:05:00 +0530 Gilead Sciences and Novo Nordisk have announced that the companies intend to collaborate on a clinical trial combining compounds from their respective pipelines in nonalcoholic steatohepatitis (NASH). The intended clinical trial will be a proof of concept study combining Novo Nordisk’s semaglutide (GLP-1 analogue) and Gilead’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with NASH. The companies are also exploring the potential to collaborate on preclinical research to advance understanding of the disease. NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring or fibrosis, that impairs liver function. If left untreated, individuals living with NASH may face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality. “NASH is a complex disease that often affects people with diabetes and metabolic syndrome. Currently, patients living with NASH have limited treatment options. We are excited to work with Novo Nordisk on this important collaboration, which would bring together Novo Nordisk’s broad expertise related to diabetes and metabolism and Gilead’s expertise in both liver disease and combination therapies,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development at Gilead Sciences. “We look forward to working with the Novo Nordisk team to explore opportunities to advance our complementary research capabilities and approaches in NASH to help address this significant unmet need for patients.” “We are very pleased about the potential to enter into this clinical collaboration with Gilead, which would combine Novo Nordisk’s semaglutide program in NASH with Gilead’s clinical programs to provide novel approaches for the treatment of NASH. By combining the leading molecular science and clinical expertise of our two companies within the rapidly expanding liver and metabolic diseases, we aim to develop innovative, new and effective combination therapies to help people with NASH,” said Mads Krogsgaard Thomsen, Chief Science Officer and Executive Vice President of Novo Nordisk. Cilofexor and firsocostat, alone or in combination, are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents. Semaglutide has not been approved by the FDA or any other regulatory authority for the treatment of patients living with NASH. ]]> https://biospectrumindia.com/news/57/13348/sandoz-resubmits-biosimilar-pegfilgrastim-application-to-us-fda.html https://biospectrumindia.com/news/57/13348/sandoz-resubmits-biosimilar-pegfilgrastim-application-to-us-fda.html Fri, 12 Apr 2019 14:40:00 +0530 Sandoz, a Novartis division and a global leader in biosimilars, recently announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016. Pegfilgrastim is a long-acting version of filgrastim and may be prescribed to appropriate cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells. Sandoz biosimilar pegfilgrastim is designed to match the reference medicine. Sandoz is pursuing approval of biosimilar pegfilgrastim to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  The resubmission includes new data from a pivotal pharmacokinetics (PK) and pharmacodynamics (PD) study. This was a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim. Sandoz is focused on strengthening its portfolio in oncology care and remains well-positioned as a leader in the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Sandoz has three approved biosimilars in the US and markets eight biosimilars in the European Economic Area (EEA), including biosimilar pegfilgrastim. ]]> https://biospectrumindia.com/news/57/13346/pps-bioanalytix-to-create-global-analytic-service-partner-for-biopharmaceuticals.html https://biospectrumindia.com/news/57/13346/pps-bioanalytix-to-create-global-analytic-service-partner-for-biopharmaceuticals.html Fri, 12 Apr 2019 10:55:00 +0530 Protagen Protein Services GmbH (PPS), a full-service contract research organization (CRO) in protein analytics and BioAnalytix Inc., a Cambridge (MA)-based specialized provider of advanced analytics in biopharmaceutical development announced a merger that will transform the combined company into a leading global analytic services provider for the biopharmaceutical industry. The announcement creates a best-in-class partner for biopharmaceutical companies worldwide to benefit from the most advanced, integrated and complete analytic services capabilities in biopharmaceutical development, from clone selection through drug approval to commercialization. In working together with its pharmaceutical partners, the PPS and BioAnalytix teams generate best-in-class analytic data packages and provide scientific, technical and regulatory support to advance, de-risk and accelerate all stages of biopharmaceutical development at the highest of quality from clone through clinic. By combining analytic platforms, programs and highly experienced analytic teams based both in US and in Europe, PPS and BioAnalytix will work directly and more broadly with leading biopharmaceutical companies in designing, generating and delivering integrated analytical data packages, and strategic support along the full development continuum, from developability and lead optimization, clone selection and process development, extended characterization and comparability, stability testing for control strategy design and CMC filings through commercialization and full GMP testing of commercial products. ]]> https://biospectrumindia.com/news/57/13337/glytec-gets-patent-allowance-for-therapy-advisor.html https://biospectrumindia.com/news/57/13337/glytec-gets-patent-allowance-for-therapy-advisor.html Thu, 11 Apr 2019 11:55:00 +0530 The United States Patent and Trademark Office has granted  Glytec another patent allowance for systems and methods related to a product registered under the brand name, Therapy Advisor. Currently, under development, the new product will extend the company’s core competencies beyond insulin optimization to include oral, inhaled and non-insulin injectable diabetes medications. The patent allowance depicts the following key systems and methods:  A dosing controller comprising data processing hardware in communication with memory hardware periodically obtains, at the end of a reoccurring, configurable time interval, training data for a plurality of patients, including patient-state information such as age, gender, medical history, body mass index, risk factors and financial attributes; also, for those who use anti-diabetes medications: dose-combinations and a glycated hemoglobin measurement associated with each dose-combination, and for those who use insulin: blood glucose history, meal bolus doses administered during scheduled time intervals, and outcome attributes associated with each meal bolus dose. The data processing hardware then identifies for the plurality of patients included the training data, as applicable: optimum dose-combinations of anti-diabetes medications and/or optimum meal bolus doses of insulin for each scheduled time interval. Upon receiving patient-state information for a new treated patient, the data processing hardware determines, as applicable, a next recommended dose-combination of anti-diabetes medications based on one or more of the optimum dose-combinations identified within the training data and/or a next recommended meal bolus dose of insulin for a scheduled time interval based on a combination of the meal bolus doses of insulin previously administered by the new treated patient and one or more of the optimum meal bolus doses of insulin identified within the training data. The data processing hardware then transmits the next recommended dose-combination of anti-diabetes medications and/or the next recommended meal bolus dose of insulin to a portable device configured to display the information to the new treated patient, and as applicable, automatically dial in the number of units of insulin and administer them to the new treated patient. Glytec has grown its intellectual property portfolio to more than two dozen issued and allowed patents. “Developing cutting-edge innovations is a hallmark of Glytec’s DNA, and Therapy Advisor is the latest example of that,” says Robby Booth, Senior Vice President Research & Development. “This newest allowance is one of many more to come, both domestic and international. We’ll be issuing additional announcements in the near future.” A dosing controller comprising data processing hardware in communication with memory hardware periodically obtains, at the end of a reoccurring, configurable time interval, training data for a plurality of patients, including patient-state information such as age, gender, medical history, body mass index, risk factors and financial attributes; also, for those who use anti-diabetes medications: dose-combinations and a glycated hemoglobin measurement associated with each dose-combination, and for those who use insulin: blood glucose history, meal bolus doses administered during scheduled time intervals, and outcome attributes associated with each meal bolus dose. The data processing hardware then identifies for the plurality of patients included the training data, as applicable: optimum dose-combinations of anti-diabetes medications and/or optimum meal bolus doses of insulin for each scheduled time interval. Upon receiving patient-state information for a new treated patient, the data processing hardware determines, as applicable, a next recommended dose-combination of anti-diabetes medications based on one or more of the optimum dose-combinations identified within the training data and/or a next recommended meal bolus dose of insulin for a scheduled time interval based on a combination of the meal bolus doses of insulin previously administered by the new treated patient and one or more of the optimum meal bolus doses of insulin identified within the training data. The data processing hardware then transmits the next recommended dose-combination of anti-diabetes medications and/or the next recommended meal bolus dose of insulin to a portable device configured to display the information to the new treated patient, and as applicable, automatically dial in the number of units of insulin and administer them to the new treated patient. Glytec has grown its intellectual property portfolio to more than two dozen issued and allowed patents. “Developing cutting-edge innovations is a hallmark of Glytec’s DNA, and Therapy Advisor is the latest example of that,” says Robby Booth, Senior Vice President Research & Development. “This newest allowance is one of many more to come, both domestic and international. We’ll be issuing additional announcements in the near future.” Founded in 2006, Glytec is the pioneer of digital therapeutics, improving the lives of people with diabetes by making insulin a more effective and accessible option for millions unable to achieve their treatment goals. The company’s patented eGlycemic Management System s the only FDA-cleared software-as-a-medical-device (SaMD) platform to enable the mass personalization of insulin across the continuum of care: inpatient, outpatient and virtual settings alike. Glytec offers several comprehensive programs combining evidence-based decision support technologies with expert professional services proven to aid providers in achieving best practices and standardization while reducing hyperglycemia, hypoglycemia, A1C, readmissions, length of stay and cost     ]]> https://biospectrumindia.com/news/57/13336/gilead-launches-grant-programmes-for-research-in-liver-diseases-.html https://biospectrumindia.com/news/57/13336/gilead-launches-grant-programmes-for-research-in-liver-diseases-.html Thu, 11 Apr 2019 11:25:00 +0530 Gilead Sciences announced the launch of five new global grants programmes to continue to support investigator-sponsored research in chronic hepatitis C virus (HCV) and hepatitis B virus (HBV), HCV and HIV co-infection, nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The programmes will accept applications from around the world for projects that seek to address pressing unmet patient needs in liver disease, including improving screening and linkage to care, simplifying HCV testing and treatment, developing innovative referral pathways to help patients with NASH access care, addressing gaps in HBV care for special populations and understanding PSC epidemiology. The new grant programmes are: HCV STAT (Simplification and Test and Treat Strategies toward HCV Elimination) This programme will fund approximately fifteen projects with a total commitment of US $10M focused on simplifying HCV care delivery and implementing test and treat strategies to overcome barriers to patient care. Applications will be accepted from April 11 to June 30, 2019. STAT is the latest addition to the LEGA-C platform, “Local Elimination programmes Leading to Global Action in HCV” and includes the ongoing programmes CITE, SCALE, CHIME, and NoCo. To date, Gilead has committed $50M to support 79 elimination projects around the world through LEGA-C. HIV/HCV NoCo (NoCo-Infection) In the third installment of NoCo, this programme will fund approximately six to eight projects with a total commitment of US $3M focused on investigating strategies to link patients living with HCV and HIV co-infection to HCV treatment. Applications will be accepted from May 1 to June 14, 2019. NASH Models of Care This programme will fund approximately eight to ten projects with a total commitment of US $4M focused on investigating care pathways between multidisciplinary providers for screening, identifying, and helping to refer high-risk patients living with NASH to appropriate medical care. Applications will be accepted from June 3 to July 15, 2019. HBV CARE (Linkage to CARe & Epidemiology in Special Populations) This programme will fund approximately six projects with a total commitment of US $1M focused onimproving linkage to care among underserved population andanalyzingor identifying data gaps inHBV epidemiology in specific demographics or geographies. Applications will be accepted from August 1 to September 15, 2019. PSC PACE (PrimAry Sclerosing Cholangitis Epidemiology) This programme will fund up to five projects with a total commitment of US$1M focused on identifying gaps in PSC epidemiology data and improving understanding of the cascade of care. Applications will be accepted from September 16 to October 11, 2019. ]]> https://biospectrumindia.com/news/57/13335/inaugural-who-partners-forum-launches-new-push.html https://biospectrumindia.com/news/57/13335/inaugural-who-partners-forum-launches-new-push.html Thu, 11 Apr 2019 11:15:00 +0530 To meet the world’s most pressing health challenges, WHO, governments and global health leaders recently called for improved partnerships and resourcing to support WHO’s mission to deliver care, services and protection for billions of people by 2023. The inaugural two-day WHO Partners Forum opened in Stockholm and was co-hosted with the Government of Sweden. The meeting resulted in a shared understanding of how to strengthen partnerships and improve effective financing of WHO, with an emphasis on predictability and flexibility. Global leaders in health and development, representing the public sector, health partnerships and non-State actors, came together to launch a new era of collaboration and innovation around WHO’s resource needs. Under the Organization’s Thirteenth General Programme of Work (GPW13), WHO needs US$14.1 billion between now and 2023. “WHO is committed to leaving no one behind as we strive for the highest attainable standard of health,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “WHO is building stronger and more strategic partnerships with governments, international organizations, philanthropies and the private sector to deliver on the health-related targets in the Sustainable Development Goals (SDGs).” Other participants in the Inaugural WHO Partners Forum include leadership of the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Bill & Melinda Gates Foundation, International Federation of Red Cross and Red Crescent Societies and Gavi, the Vaccine Alliance. ]]> https://biospectrumindia.com/news/57/13330/first-human-study-of-skinbiotix-shows-efficacy.html https://biospectrumindia.com/news/57/13330/first-human-study-of-skinbiotix-shows-efficacy.html Wed, 10 Apr 2019 14:30:00 +0530 Results from its first human study show that SkinBiotix®, SkinBioTherapeutics’ technology derived from probiotic bacteria, is safe and well tolerated and has efficacy in certain age groups. The skin, the body’s largest organ, is colonised by a diverse range of microorganisms which has to be managed for long-term good health. SkinBioTherapeutics’ patented technology is developing a range of products based on lysates - extracts of probiotic bacteria - which will help keep the skin healthier and treat certain conditions. The study was primarily undertaken to show the effects of SkinBiotix® on the barrier of healthy skin. An important secondary endpoint was to show that the technology is safe and well tolerated in a large group of people (129) using it twice a day for an extended period of time (29 days).   The results of this independent study demonstrate that the change in skin hydration and water loss are in line with expectations from laboratory studies which have shown that SkinBiotix® increases the levels of proteins within the skin that are crucial for a healthy barrier. The increase in skin hydration in the younger group at day 15 may reflect the ability of younger skin to respond to the SkinBiotix® faster than older skin.  Measures of the barrier were then performed in all groups at 15 days and 29 days. The primary measures were Corneometry – a measure of how hydrated the skin is, and Transepidermal water loss  (“TEWL”) -a measure of water loss from the skin. A change to the barrier might be expected to be reflected in an increase in skin hydration or a reduction in TEWL. Some additional measurements of skin elasticity were also taken.  These positive results follow the announcement, made in February, which detailed the £1.5 million investment SkinBioTherapeutics raised from its original investor Seneca. This investment will enable the company to further explore opportunities for its existing technology and support new areas of development. ]]> https://biospectrumindia.com/news/57/13329/twb-aims-to-become-european-leader-in-industrial-biotechnology-.html https://biospectrumindia.com/news/57/13329/twb-aims-to-become-european-leader-in-industrial-biotechnology-.html Wed, 10 Apr 2019 14:05:00 +0530 TWB has presented an excellent activity report for 2018 with a turnover of €8 million. Having consolidated its ambition to become the European leader in industrial biotechnologies, TWB also has plans to actively pursue its international development activities. Since its creation in 2012, the cumulative results of TWB are €5 million of which €0.74 million were attained in 2018. Thanks to its unique economic model, the structure differs to those of France and Europe with its exclusive technological offer and by the excellent quality of services provided. Today, TWB numbers 90 employees who contribute to its success. Facilitating the interface between public research and industry, the structure supportsthe most efficient public/private collaborative R&D projects in France. In 2018, TWB managed 60 projects, 40 of which were new. 65% of the business was for industrial contracts to the value of €8.3 million, a 40% increase on the previous year. Of the remaining projects, 17% were as a result of research projects and the balance of 18% were a diverse mix including some European undertakings. Among the iconic projects for the year, the collaboration of TWB with the industrialist Adisseo stands out: Adisseo aims to develop the organic production of a molecule to be included in the provision of animal feed. The objective is to progress from the laboratory scale to an industrial pilot. Another beacon collaboration was with the start-up MicroPep Technologies - accommodated on the TWB premises - whose focus is the development of natural molecules capable of controlling plant growth and the development of biocontrol solutions as alternatives to chemical fertilizers and herbicides. Three new partners joined the consortium in 2018: an indication of the success of the TWB model: Braskem, the leading Brazilian manufacturerin biosourced plastic, IFPEN and MilliDrop. In 2019 the TWB consortium counted amongst its total of 50 members 34 industrial companies, (L’Oreal, Michelin, Roquette, Total, ARD, Carbios, Deinove, Global Bio Energies, Processium…) 4 investment partnerships, (Auriga Partners, BPI France, Sofinnova Partners, IRDI SORIDEC), 3 development organisations(Bioaster, Toulouse Tech Transfert and INRA Transfert) and 9 public body partners, (INRA, INSA, CNRS, Toulouse Métropole, La Région Occitanie…). This year TWB has also carried out numerous international activities. In addition to the arrival of new international partners, TWB organised the 'TWB START-UP DAY' which brought together 130 biotech stakeholders (start-upers, industrialists, investors, etc.) from all over Europe and co-organised the EFIB congress (European Forum for Industrial Biotechnology & the Bioeconomy), the leading European congress on industrial biotechnology, in Toulouse for 500 participants from over 30 countries. The goal of TWB is to become the leader in industrial biotechnology in Europe in the coming years. TWB wishes to consolidate its position in the world of industrial biotechnology, by enhancing its distinct appeal with the strengthening of its in-house technological capacity and in the creation of alliances with its partners, so that it can offer innovative and sustainable pathways. Over the coming years, TWB wishes to maintain the sound financial health it has demonstrated during the last 5 years. The objective for 2019 is to achieve signed contracts worth £10 million. ]]> https://biospectrumindia.com/news/57/13324/concerto-healthai-enters-precision-oncology-collaboration-with-pfizer.html https://biospectrumindia.com/news/57/13324/concerto-healthai-enters-precision-oncology-collaboration-with-pfizer.html Wed, 10 Apr 2019 10:55:00 +0530 Concerto HealthAI has announced that they have entered into a collaboration with Pfizer to advance work in Precision Oncology using Concerto HealthAI’s eurekaHealth platform, artificial intelligence (AI) models and Real World Clinical Electronic Medical Record (EMR) and healthcare claims. Data from clinical practices participating in the American Society of Clinical Oncology’s CancerLinQ® initiative and others throughout the U.S. will be utilized for the collaboration and is one of the most comprehensive Real World Data (RWD) sets available. The collaboration’s goal is to quicken the pace for actionable patient insights for Pfizer‘s investigational therapies and commercialized therapeutics used in the treatment of solid tumors and hematologic malignancies. Chris Boshoff, Chief Development Officer, Oncology, Pfizer Global Product Development said, “Pfizer believes real-world data have tremendous potential to inform how we develop and use medicines to improve patient outcomes. We are pleased to work with Concerto HealthAI –– to accelerate insights and outcomes studies that may lead to a more comprehensive understanding of patients’ experience with our medicines.” Jeff Elton, CEO of Concerto HealthAI said, “This collaboration aims to find and help patients who may benefit from new therapeutic combinations. We are using our definitive real-world data, AI-enabled abstraction, data science expertise, and strength in outcomes research to identify new and more precise treatment options; refine study designs; and speed up the completion times for various outcomes studies.” Romesh Wadhwani, Executive Chairman of Concerto HealthAI said, “The talented individuals of Pfizer and Concerto HealthAI working together, with our eurekaHealth AI platform and real-world data, allows us to go much faster when it comes to finding and acting on meaningful insights in key cancer subpopulations.” The collaboration will conduct novel synthetic control arm and prospective RWD outcomes study designs for therapeutics that are both pre- and post-approval. This builds on work in study designs based on RWD that CancerLinQ, Concerto HealthAI, and others have undertaken in collaboration with the U.S. Food and Drug Administration. A Concerto HealthAI-Pfizer joint steering committee will oversee the collaboration. The first outcomes research and publications are expected in early 2020. ]]> https://biospectrumindia.com/news/57/13317/enesi-pharma-to-bring-vaccine-for-plague.html https://biospectrumindia.com/news/57/13317/enesi-pharma-to-bring-vaccine-for-plague.html Tue, 09 Apr 2019 14:45:00 +0530 Enesi Pharma ("Enesi"), an innovative pharmaceutical company developing unique injectable solid dose drug-device vaccine products and scientists at the world-renowned Oxford Vaccine Group ("OVG") at the University of Oxford, announce they have entered into a collaborative agreement to create and test a solid dose vaccine against plague. The collaboration will leverage Enesi's ImplaVax® needle-free technology and a proprietary vaccine against the bacteria causing plague (Yersinia pestis) developed by OVG, based on a ChAdOx adenovirus vector. Plague is a serious infectious disease with a high mortality rate unless treated early with antibiotics. There is no approved vaccine available. According to the World Health Organization, most cases of plague since 1990 have occurred in Africa (particularly in Madagascar), however, outbreaks have been reported worldwide including in the United States. Plague is recognised by public health authorities globally as a potential agent of bioterrorism with Y. pestis classed as a Category A priority pathogen by the US National Institute of Allergy and Infectious Disease (NIAID) and considered a priority pathogen by the UK Vaccine Network based on the high risk that plague poses to national security and public health. The collaboration between Enesi and OVG aims to create a stable and easy-to-use solid dose plague vaccine for use in areas around the world where outbreaks occur as well as for building strategic stockpiles as part of government preparedness for rapid deployment in the event of a bioterrorism incident. ]]> https://biospectrumindia.com/news/57/13314/waveform-tech-partners-with-a-menarini-for-global-supply-of-cgm-solutions.html https://biospectrumindia.com/news/57/13314/waveform-tech-partners-with-a-menarini-for-global-supply-of-cgm-solutions.html Tue, 09 Apr 2019 13:55:00 +0530 WaveForm Technologies Inc. a wholly owned subsidiary of AgaMatrix Holdings LLC and developer of novel products for continuous glucose monitoring, and A. Menarini Diagnostics S.r.l., a leading diagnostics company, recently announced a partnership to commercialize the WaveForm Technologies Continuous Glucose Monitor (CGM). The innovative WaveForm CGM was specifically chosen to integrate within A. Menarini Diagnostics' connected diabetes care platform. According to the agreement, A. Menarini Diagnostics will perform sales, marketing, training, and customer support for the WaveForm CGM in a long term partnership in territories throughout EMEA and LATAM. The WaveForm CGM system is based on several pioneering, patented innovations in glucose sensor technology, facilitating a virtually pain-free insertion process, limited interferences, and extended wear time. This agreement establishes the first wave of distribution for the WaveForm CGM system and international commercialization, following WaveForm's anticipated CE clearance in 2019. In addition, A. Menarini Diagnostics S.r.l. and AgaMatrix Holdings LLC, are discussing terms to commercialize a Bluetooth® enabled blood glucose monitor and future enhancements to the WaveForm CGM. ]]> https://biospectrumindia.com/news/57/13306/illumina-lundbeck-foundation-geogenetics-centre-collaborate-to-decode-evolution-of-mental-health-issues.html https://biospectrumindia.com/news/57/13306/illumina-lundbeck-foundation-geogenetics-centre-collaborate-to-decode-evolution-of-mental-health-issues.html Mon, 08 Apr 2019 15:15:00 +0530 Illumina and the Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark partner to explore the relationship between the evolutionary history of select mental and neurological disorders and infectious pathogens. One of the first projects of its kind worldwide, the endeavor aims to acquire new knowledge in terms of the medical and biological understanding of special factors underlying the development of human neuropsychiatric diseases through the ages. Ultimately, the project may provide a new approach to the development of medicines and other therapeutic treatments for mental and neurological conditions. n an effort to shed light on the role of microbes in the pathogenesis of neuropsychiatric illnesses, such as Alzheimer’s disease and schizophrenia, Professor Eske Willerslev and his team will build one of the largest genomic datasets of its kind, by complete DNA mapping of thousands of ancient Eurasian human remains. The data will be obtained from bones and teeth, the oldest remains dating back 10,000 years. The international, multi-disciplinary team of scientists, which includes specialists in ancient genomics, neuro-genetics, population genetics, archaeology, linguistics, and experts in brain health, among others, will focus on creating two unique subsets of genomic data. The first panel is a 5,000 ancient human genomes panel. The second panel will consist of ancient pathogen DNA that is associated with human diseases. Both panels, which will be made publicly available, will together advance our understanding of the evolution of disease variance and its interaction with the human genome and pathogen pressure. The project will generate and analyze one of the largest sets of ancient human and pathogen genome panels ever created. “Over the past 10,000 years, mankind has experienced some of the greatest lifestyle changes in the history of our species,” said Professor Willerslev, Lundbeck Foundation Professor at the University of Copenhagen and Prince Philip Professor at the University of Cambridge. “Our diet changed as we developed from hunter-gatherers into farmers, our settlement patterns changed, and there have been changes in pressure of infection from the pathogenic micro-organisms to which we were exposed due to altered living conditions. We also know that chronic viral, bacterial and fungal infections might be causative factors in neuropsychiatric diseases, so there is every reason to believe that the analyses of DNA from this period will show significant trends, giving us the ability to create new, publicly available reference sets, to enhance both the scientific and healthcare communities’ understanding of disease evolution.” In order to decode the genetic origins and evolution of human diseases, Professor Willerslev and his team will utilize Illumina’s most powerful sequencer, the NovaSeq™6000 System, which was designed to open new horizons for larger, more robust experiments, providing the throughput to properly power large-cohort studies. Projects of this scale benefit from speed, throughput and data quality, and as such this project will leverage the S4 flow cell to sequence up to 20 billion ancient DNA fragments every two days. “The NovaSeq 6000 was the obvious choice for this project with its unrivaled data quality and high-throughput capabilities,” remarks Professor Willerslev. “While we conceived this project to explore the evolutionary origins of genetic disorders years ago, it was simply impossible to realize before Illumina’s NovaSeq System came on the market. We are delighted that Lundbeck Foundation had the foresight to see the importance of our project and that Illumina’s technology will make the research possible.” “Illumina is thrilled to be working with Professor Willerslev and his team on this extraordinary project,” said Paula Dowdy, Senior Vice President and General Manager for Europe, Middle East and Africa atIllumina. “It will be extremely valuable, if by going back 10,000 years, we can acquire new information about when, and under which environmental conditions, a brain disorder may have been introduced into human DNA. This project has the potential to influence future product developments in genetics and precision medicine by providing invaluable insights to those affected by mental health issues.” ]]> https://biospectrumindia.com/news/57/13291/uneven-access-to-health-services-drives-life-expectancy-gaps-who.html https://biospectrumindia.com/news/57/13291/uneven-access-to-health-services-drives-life-expectancy-gaps-who.html Fri, 05 Apr 2019 11:50:00 +0530 Women outlive men everywhere in the world – particularly in wealthy countries. The World Health Statistics 2019 – disaggregated by sex for the first time – explains why. Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, “Breaking down data by age, sex and income group is vital for understanding who is being left behind and why. Behind every number in the World Health Statistics is a person, a family, a community or a nation. Our task is to use these data to make evidence-based policy decisions that move us closer to a healthier, safer, fairer world for everyone.” The gap between men’s and women’s life expectancy is narrowest where women lack access to health services. In low-income countries, where services are scarcer, 1 in 41 women dies from a maternal cause, compared with 1 in 3300 in high-income countries. In more than 90 per cent of low-income countries, there are fewer than 4 nursing and midwifery personnel per 1000 people. Attitudes to healthcare differ. Where men and women face the same disease, men often seek health care less than women. In countries with generalized HIV epidemics, for example, men are less likely than women to take an HIV test, less likely to access antiretroviral therapy and more likely to die of AIDS-related illnesses than women. Similarly, male TB patients appear to be less likely to seek care than female TB patients. The report also highlights the difference in causes of death between men and women – some biological, some influenced by environmental and societal factors, and some impacted by availability of and uptake of health services. Of the 40 leading causes of death, 33 causes contribute more to reduced life expectancy in men than in women. In 2016, the probability of a 30-year-old dying from a noncommunicable disease before 70 years of age was 44% higher in men than women. Global suicide mortality rates were 75% higher in men than in women in 2016. Death rates from road injury are more than twice as high in men than in women from age 15, and mortality rates due to homicide are 4 times higher in men than in women. Published to coincide with World Health Day on 7 April, which this year focuses on primary health care as the foundation of universal health coverage, the new WHO statistics highlight the need to improve access to primary health care worldwide and to increase uptake. “One of WHO’s triple billion goals is for 1 billion more people to have universal health coverage by 2023. This means improving access to services, especially at community level, and making sure those services are accessible, affordable, and effective for everyone – regardless of their gender”, said Dr. Tedros Dr. Samira Asma, WHO Assistant Director General for Data, Analytics and Delivery said, “These statistics underscore the need to prioritize primary health care urgently to effectively manage noncommunicable diseases, and to curb risk factors. For example, something as simple as controlling blood pressure is just not happening on the scale needed and tobacco use remains a leading cause of premature death.” Life expectancy has improved since 2000 Between 2000 and 2016, global life-expectancy at birth increased by 5.5 years, from 66.5 to 72.0 years.  Healthy life expectancy at birth - the number of years one can expect to live in full health- increased from 58.5 years in 2000 to 63.3 years in 2016. Life expectancy remains strongly affected by income. In low-income countries, life expectancy is 18.1 years lower than in high-income countries. One child in every 14 born in a low-income country will die before their fifth birthday. Dr. Richard Cibulskis, the report’s main author said, “Closing data gaps will accelerate and is important to closing the gender gap. Collecting, analyzing, and using good quality, disaggregated data is central to improving people’s health and wellbeing. Health policy and practice must be underpinned by robust and reliable data, generated in countries.” For the first time, this year, WHO’s Global Health Statistics have been disaggregated by sex. This new analysis has provided insights into the health and needs of people around the world. But many countries still struggle to provide gender disaggregated information.   ]]> https://biospectrumindia.com/news/57/13287/congresswoman-dingell-honored-as-innovator-in-biotechnology.html https://biospectrumindia.com/news/57/13287/congresswoman-dingell-honored-as-innovator-in-biotechnology.html Fri, 05 Apr 2019 10:40:00 +0530 Congresswoman Debbie Dingell was recognized by the Biotechnology Innovation Organization (BIO) for her leadership as an Innovator in Biotechnology. Congresswoman Dingell received the award in conjunction with BIO Legislative Day Fly-In. BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries. “The life sciences industry in Michigan provides jobs for over 40,000 people. Congresswoman Dingell has been an invaluable advocate for the biotechnology community – both in Michigan’s 12th District and the nation at large,” said Stephen Rapundalo, PhD and President & CEO of the Michigan Bioscience Industry Association - MichBio. “On behalf of the Michigan life science industry, we thank her for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.” “Congresswoman Dingell has been a stalwart advocate for sound public policies that advance the jobs creating potential of America’s biotechnology industry as we address the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world,” said BIO President and CEO Jim Greenwood. “Her commitment to support the needs of America’s innovative life science companies allows them to focus on what matters – delivering life-saving and life-enhancing products.” More than 200 biotechnology industry representatives from over 40 states, representing hundreds of thousands of American workers, will participate in hundreds of meetings with Members of the House and Senate during the BIO Legislative Day Fly-In. Participants will discuss issues critical to the biotechnology industry, including drug development, discovery and delivery reforms, targeting abuses of the U.S. patent system while protecting innovation, providing adequate reimbursement for vital therapies under Medicare, FDA funding, trade, tax policy, Farm Bill Implementation, protecting the Renewable Fuel Standard and capital formation issues relevant to biotechnology companies.   ]]> https://biospectrumindia.com/news/57/13286/fda-to-review-framework-for-ai-based-medical-devices.html https://biospectrumindia.com/news/57/13286/fda-to-review-framework-for-ai-based-medical-devices.html Fri, 05 Apr 2019 09:00:00 +0530 FDA has announced steps to consider a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence algorithms. Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used to aid in screening for diseases and to provide treatment recommendations. Last year, the FDA authorized an artificial intelligence based device for detecting diabetic retinopathy, an eye disease that can cause vision loss. The agency also authorized a second artificial intelligence based device for alerting providers of a potential stroke in patients. FDA is taking the first step towards developing a novel and tailored approach to help developers bring artificial intelligence devices to market by releasing a discussion paper. Other steps in the future will include issuing draft guidance that will be informed by the input FDA receives. The approach will focus on the continually-evolving nature of these promising technologies. FDA plans to apply the current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these devices. ]]> https://biospectrumindia.com/news/57/13280/syncardia-appoints-don-as-ceo-peter-as-president-and-cco.html https://biospectrumindia.com/news/57/13280/syncardia-appoints-don-as-ceo-peter-as-president-and-cco.html Thu, 04 Apr 2019 12:30:00 +0530 SynCardia Systems, LLC, LLC, manufacturer of the world's only clinically-proven and commercially approved total artificial heart, is pleased to announce that Don Webber has been promoted to Chief Executive Officer, and Peter Spadaro has been appointed as the President and Chief Commercial Officer (CCO). Don Webber joined SynCardia in 2018 as Chief Operating Officer (COO), leading Manufacturing Operations and Engineering, Quality and Supply Chain Logistics for the SynCardia product line. Don's demonstrated leadership as COO led to his promotion in January 2019 to Chief Executive Officer (CEO).  He brings extensive management experience from more than 25 years in public and private sector life science companies.  Prior to joining SynCardia, Don had been the COO at OptiScan since 2010. In addition, he's previously served as VP of Manufacturing Operations at C.R. Bard, VP of Operations at EKOS Corporation, and President and CEO of Mitralign. He holds a bachelor's degree in industrial engineering technology from the State University of New York and an MBA from Nova Southeastern University. Peter Spadaro has joined SynCardia's leadership team as the President and Chief Commercial Officer. Peter will be responsible for oversight of the global Sales and Marketing Organizations and for driving the company's sales growth. He assumed the new role on April 2, 2019 reporting directly to the CEO, Don Webber.  Peter started his career at St. Jude Medical as a Sales Representative in New York City. During his almost 30-year career with St. Jude Medical he progressed through the organization's Sales and Marketing organizations taking on leadership roles that included Vice President of Global Marketing, Vice President of Cardiovascular Sales, and Division Vice President of Cardiac Rhythm Management to name a few. Peter comes to SynCardia from his recent leadership role at Medtronic as Senior Director of Sales, Cardiac Surgery. He holds a bachelor's degree from Fordham University. ]]> https://biospectrumindia.com/news/57/13279/inovios-hpv-therapy-shows-effectiveness-against-rrp.html https://biospectrumindia.com/news/57/13279/inovios-hpv-therapy-shows-effectiveness-against-rrp.html Thu, 04 Apr 2019 12:15:00 +0530 Inovio Pharmaceuticals has announced its novel therapy INO-3106 against the human papilloma virus type 6 (HPV 6) demonstrated clinical efficacy in a study of two patients with recurrent respiratory papillomatosis (RRP). RRP is an HPV-associated disease that can cause noncancerous tumor growths leading to life-threatening airway obstructions, and occasionally progresses to cancer. RRP is primarily caused by two strains of HPV, HPV 6 and 11, which also predominantly cause genital warts. RRP may occur in adults (adult-onset RRP) as well as in children (juvenile-onset RRP) who are thought to have contracted the virus during childbirth. Currently, the disease is incurable and can only be treated by surgery to remove the tumors, which temporarily restores the airway. The tumor always recurs and the surgery must be repeated, usually multiple times a year. Inovio's pilot clinical study enrolled two adult patients with RRP and one adult patient with tracheal cancer, all positive for HPV 6. One patient with tracheal cancer discontinued the study prior to the completion of follow-up. In the two patients with RRP, their condition had required surgery approximately every six months to clear the tumor growths. Following their last dose of Inovio's HPV therapy, both patients have been surgery-free, due to lack of tumor recurrence. One patient has not needed surgery for over two years; the other has been surgery-free for over one year. A complete study report is being prepared as a medical publication. Inovio plans to further develop INO-3106 as a novel non-invasive immunotherapy for the treatment of RRP, a rare, orphan disease, for both adult and pediatric populations. This data was presented at this week's Annual Meeting of American Association for Cancer Research by David B. Weiner, Ph.D., Executive Vice President and Director of the Vaccine & Immunotherapy Center at the Wistar Institute and Inovio's co-founder.   ]]> https://biospectrumindia.com/news/57/13269/jj-sells-asp-biz-to-fortive-corporation-.html https://biospectrumindia.com/news/57/13269/jj-sells-asp-biz-to-fortive-corporation-.html Wed, 03 Apr 2019 14:20:00 +0530 Johnson & Johnson announced that it has completed the divestiture of its Advanced Sterilization Products (ASP) business, a division of Ethicon, Inc., to Fortive Corporation for an aggregate value of approximately $2.8 billion, consisting of $2.7 billion of cash proceeds from Fortive Corporation and $0.1 billion of retained net receivables. ASP is a global leader in innovative infection prevention solutions with 2018 net revenue of approximately $800 million. ASP supports healthcare facilities in the fight to protect patients against hospital-acquired infections, which are a leading cause of morbidity and mortality. ASP solutions include capital, consumables and software for use in Low-Temperature Terminal Sterilization and High-Level Disinfection of reusable surgical instruments. ]]> https://biospectrumindia.com/news/57/13268/jj-completes-acquisition-of-auris-health.html https://biospectrumindia.com/news/57/13268/jj-completes-acquisition-of-auris-health.html Wed, 03 Apr 2019 14:00:00 +0530 Johnson & Johnson announced that its subsidiary Ethicon has completed the acquisition of Auris Health for approximately $3.4 billion in cash. Additional contingent payments of up to $2.35 billion, in the aggregate, may be payable upon reaching certain predetermined milestones. With Auris Health’s robotic platform technology, currently used in diagnostic and therapeutic procedures in the lung, Johnson & Johnson will advance its commitment to combatting lung cancer and expand its digital surgery portfolio across multiple surgical specialties. The Auris technology complements robotic platform technologies currently in development in general surgery with Verb Surgical, through the Johnson & Johnson collaboration with Verily, and in orthopaedics with the acquisition of Orthotaxy. Johnson & Johnson aspires to bring disruptive innovation to the full continuum of procedures, including open, laparoscopic, robotic and endoluminal. The company will discuss the transaction further during its next quarterly earnings call on April 16, 2019.   ]]> https://biospectrumindia.com/news/57/13267/merck-lifts-up-its-biocontinuum-platform-strategy.html https://biospectrumindia.com/news/57/13267/merck-lifts-up-its-biocontinuum-platform-strategy.html Wed, 03 Apr 2019 13:45:00 +0530 Merck discloses it’s BioContinuum™ Buffer Delivery Platform, a new building block in the BioContinuum™ Platform for next-generation bioprocessing, at INTERPHEX in New York City. The BioContinuum™ Buffer Delivery Platform is part of Merck’s BioContinuum™ Platform to deliver “contiGuous” bioprocessing.  The BioContinuum™ Buffer Delivery Platform is an integrated solution for more efficient buffer delivery and is tailored to provide the highest level of accuracy and precision in buffer preparation and management. Its launch is timely, as industry adoption of liquid buffers is expected to expand from seven to 56 percent, according to Merck’s internal market research.  Merck has obtained certain exclusive rights to sell the buffer dilution system developed by LEWA-Nikkiso America Inc (now a part of YMC Co., Ltd.) for customers involved in the development or production of diagnostics and biopharmaceuticals.  This buffer dilution system offers the highest accuracy available for dilution of highly concentrated buffer, and Merck is the only supplier providing such an integrated offering. Merck’s BioContinuum™ Buffer Delivery Platform supplies process buffers at a fraction of the resources and facility space, resulting in a more streamlined buffer suite and a more efficient manufacturing process.  The configurable platform is comprised of four components: a selection of distinct buffer concentrates, reliably delivered in Mobius® Select single-use assemblies and an automated, highly accurate and precise buffer dilution system with tailored system services.  ContiGuous manufacturing goes beyond just connecting the individual unit operations — it will include the orchestration and management of all the processing steps (materials, production, testing and analytics) with an industry-leading streamlined and optimized approach.  Merck also introduced Emprove® Evolve, a new product line under the Emprove® Program. Emprove® Evolve provides a new area of regulatory support in risk assessment for critical raw materials, helping drug manufacturers meet developing regulatory requirements. The program contains a high level of product characterization and documentation, providing more control of the manufacturing process and allowing manufacturers to select the appropriate quality of raw materials for drug development.  ]]> https://biospectrumindia.com/news/57/13265/addf-to-advance-digital-tools-for-alzheimers-detection.html https://biospectrumindia.com/news/57/13265/addf-to-advance-digital-tools-for-alzheimers-detection.html Wed, 03 Apr 2019 12:20:00 +0530 As part of its Diagnostics Accelerator research program, the Alzheimer's Drug Discovery Foundation (ADDF) has announced a new initiative that aims to fast-track the development of digital tools for Alzheimer's disease and related dementias. Digital tools may allow the remote capture of changes in a patient's physical and mental status at various stages of Alzheimer's disease. Information gathered can span from cognitive assessments to motor ability to sleep disruptions. The Diagnostics Accelerator program was created in July 2018 with initial funding commitments totaling nearly $35 million from partners including ADDF Co-Founder Leonard Lauder, Bill Gates, the Dolby family, and the Charles and Helen Schwab Foundation, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. Since its inception, the Diagnostics Accelerator program has welcomed additional funders such as The Association for Frontotemporal Degeneration. The latest to join this coalition of philanthropists include Jeff and MacKenzie Bezos, bringing the current program funding to nearly $50 million. ]]> https://biospectrumindia.com/news/57/13264/c3j-therapeutics-has-received-u-s-patent-covering-synthetic-bacteriophage-composition.html https://biospectrumindia.com/news/57/13264/c3j-therapeutics-has-received-u-s-patent-covering-synthetic-bacteriophage-composition.html Wed, 03 Apr 2019 12:15:00 +0530 C3J Therapeutics,  a private clinical stage biotechnology company focused on the development of novel targeted antimicrobials based on bacteriophage has announced that the United States Patent and Trademark Office (USPTO) has issued patent No. 10,221,398, entitled “Compositions of and Methods for In Vitro Viral Genome Engineering.” The patent, which covers the composition of a synthetically engineered Pseudomonas aeruginosa phage, is an important addition to C3J’s expanding patent estate, and the Company’s first issued patent covering its proprietary technology platform that enhances natural bacteriophage through genetic engineering. The patent includes claims intended to improve host range and increase the antimicrobial activity of wild type (natural) phage, including activity against biofilm. C3J possesses a significant library of naturally occurring phage and other biological materials that are critical for the creation of synthetic phage via the C3J phage engineering platform. C3J is committed to protecting its novel therapeutics in key jurisdictions. Related international patent applications are currently under examination in several countries. These applications support C3J’s work in building a strong intellectual property portfolio around its technology and strengthening its leadership position in the field of synthetic phage-based therapies. Todd Patrick, President and Chief Executive Officer of C3J, said, “This is an important patent for our company. Not only does it strengthen our program in Pseudomonas aeruginosa but it also exemplifies our strategy of protecting each individual phage that is created using our synthetic biology-based phage engineering platform.” On January 4, 2019, C3J and AmpliPhi Biosciences Corporation, a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, announced that the companies have agreed to merge. The consummation of the merger transaction will result in a combined company that has a diverse clinical-stage pipeline, including a Phase 1/2-ready natural phage candidate targeting Staphylococcus aureus, as well as a synthetic phage candidate targeting Pseudomonas aueriginosa respiratory infections poised to enter Phase 1 development later this year. In addition, the combined company will have an extensive natural phage library and the capability to develop synthetic phage against a wide range of microbial agents. ]]> https://biospectrumindia.com/news/57/13257/puma-biotechnology-pierre-fabre-enter-into-exclusive-license-agreement.html https://biospectrumindia.com/news/57/13257/puma-biotechnology-pierre-fabre-enter-into-exclusive-license-agreement.html Tue, 02 Apr 2019 14:50:00 +0530 Puma Biotechnology and Pierre Fabre have entered into an exclusive license agreement under which Pierre Fabre will develop and commercialize NERLYNX® (neratinib) within Europe and part of Africa. In September 2018 the European Commission granted marketing authorization for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab-based therapy.   Pierre Fabre will have exclusive commercialization rights for NERLYNX in European countries excluding Russia and Ukraine, along with countries in North Africa and francophone countries of West Africa. Pierre Fabre will also be responsible of conducting additional clinical studies and leading regulatory activities in connection with the European Medicines Agency (EMA). Under the terms of the agreement, Puma will receive an upfront payment of $60 million, as well as additional regulatory and commercial milestone payments totaling up to $345 million. In addition, Puma will receive significant double-digit royalties on NERLYNX sales throughout the territory covered by the license agreement between Puma and Pierre Fabre. ]]> https://biospectrumindia.com/news/57/13253/merck-to-invest-150m-for-manufacturing-biotech-medicines.html https://biospectrumindia.com/news/57/13253/merck-to-invest-150m-for-manufacturing-biotech-medicines.html Tue, 02 Apr 2019 12:55:00 +0530 Merck has announced an investment of €150 million in its manufacturing site at Aubonne, Switzerland, to expand manufacturing capacity for its biotech medicines. The investment will cover a new building dedicated to Merck biotech medicines destined for more than 150 countries, helping to meet increasing patient needs for flagship medicines such as fertility treatment Gonal-f®, newly launched therapies such as cancer drug Bavencio® and potential future products currently in clinical development such as cancer investigational treatment M7824 (bintrafusp alfa). Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare said, “This investment reflects our commitment to ensuring that our medicines always meet the highest quality standards and are readily available to patients all over the world whenever they need them. It is an expression of our confidence in the future growth of our Healthcare business sector.” Philippe Leuba, Vaud State Councillor said, “With this latest investment, Merck is taking one step further towards a strong positioning of the Canton de Vaud as a Health Valley, which already includes 360 companies, 400 laboratories and 20,000 jobs. Merck’s presence in the Vaud canton is highly valued and this further investment will have a lasting and positive impact on the region.” The new building will be equipped with technologies dedicated to aseptic filling and quality control, with an innovative design and a flexible operations model to deliver increased productivity. The new lines for the aseptic filling of biotech medicines will be equipped with isolator technology, representing best practice in aseptic filling to ensure the safety of injectable medicines. One line will be dedicated to freeze-dried formulations, the other to liquid formulations. These two new lines, as well as the new quality control labs, will replace existing infrastructure with technological upgrades and higher capacity allowing to produce up to 27 million vials per year. The construction of the new building is expected to be completed in 2020, with the new quality control labs operational in 2021 and the new lines for aseptic filling in 2023, following validation by regulatory authorities. Everything will be designed to comply with the highest international standards of quality, environment, health and safety. The Aubonne and Vevey sites are part of a network of 18 manufacturing sites worldwide dedicated to the production of Merck’s biotech and pharmaceutical medicines and serving 70 million patients across the globe each and every day.   ]]> https://biospectrumindia.com/news/57/13244/global-multiple-myeloma-market-set-to-reach-27-8b-by-2027.html https://biospectrumindia.com/news/57/13244/global-multiple-myeloma-market-set-to-reach-27-8b-by-2027.html Mon, 01 Apr 2019 15:40:00 +0530 The Multiple Myeloma (MM) market is expected to grow from $14.5bn in 2017 to $27.8bn by 2027 across the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and China ) at a compound annual growth rate (CAGR) of 6.7%, according to GlobalData, a leading data and analytics company. The company’s latest report, ‘Multiple Myeloma: Global Drug Forecast and Market Analysis to 2027’, states that the main driver of growth in the global MM market for the next ten years will be the approval and launch of pipeline therapies in multiple treatment lines. Volkan Gunduz, PhD, Senior Oncology Analyst at GlobalData, says: “The modest growth of the MM market will be driven by increasing prevalence, primarily by aging populations, as well as the approval and launch of new branded therapies: isatuximab, bb2121, JNJ-4528, GSK2857916, AMG 420, Venclexta, selinexor, Ygalo, BL-8040, galinpepimut-S, and Opdivo. In addition, label expansion of currently marketed therapies: Darzalex, Kyprolis, Pomalyst, Ninlaro, and Empliciti will promote market growth during the forecast period.” BCMA-targeting class of therapies is highly anticipated in MM and they are expected to improve treatment outcome in heavily-treated patients, an area of major unmet need in MM. Generic and biosimilar erosion of some of the mainstays of MM treatment is also expected between 2017 and 2027. Gunduz continues: "A major barrier for market growth in MM will be the increased use of generics, in particular generic lenalidomide. The branded Revlimid alone brought in around $6.1bn in the US in 2018. Patent expiry is also expected for other major current standards of treatment, Velcade, Kyprolis, Pomalyst, Ninlaro, and Darzalex, during the forecast period. Generic and biosimilar erosion is expected to temper market growth significantly.” Among the pipeline, BCMA-targeting therapies are expected to result in significant revenues due to premium pricing and clinical benefit in heavily pretreated patients. This class will be represented by four drug candidates, BCMA CAR-Ts bb2121 and JNJ-4528, the bispecific T-cell engager AMG 420, and the antibody-drug conjugate GSK2857916. The combined revenues of all four therapies is expected to reach $10bn in 2027. GlobalData’s report also found that label expansion of the anti-CD38 Darzalex and launch of the ‘me-too’ isatuximab are other major drivers of the MM market. Gunduz concludes: “Darzalex’s use is expanding in MM, translating into higher revenues. Despite being second-to-market, high KOL opinion of anti-CD38 class of therapies and the extensive clinical development of isatuximab in MM will facilitate its adoption in a sizable patient population following launch.” ]]> https://biospectrumindia.com/news/57/13241/celgene-receives-positive-chmp-opinion-for-lenalidomide-and-pomalidomide-for-multiple-myeloma-patients.html https://biospectrumindia.com/news/57/13241/celgene-receives-positive-chmp-opinion-for-lenalidomide-and-pomalidomide-for-multiple-myeloma-patients.html Mon, 01 Apr 2019 14:55:00 +0530 Celgene Corporation has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD® medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide). The CHMP recommended approval of an expanded indication of REVLIMID as combination therapy with bortezomib and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The committee also recommended approval of IMNOVID in combination with bortezomib and dexamethasone (PVd), for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. “The CHMP positive opinions for our IMiD combinations, RVd and PVd represent very good news for patients with multiple myeloma in Europe,” said Nadim Ahmed, President, Hematology/Oncology for Celgene. “We look forward to potential EMA approvals, which would make these new triplet regimens available to patients, as we aim to improve patient outcomes across multiple stages of their disease.” The CHMP positive opinion for REVLIMID was based on the data from SWOG S0777, a phase 3 trial evaluating the triplet combination of REVLIMID, bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma, without an intent for immediate autologous stem cell transplant (ASCT). Results from SWOG S0777 showed statistically significant progression-free (PFS) and overall survival improvements in patients treated with RVd compared to those treated with REVLIMID and dexamethasone alone (Rd). The choice of treatment in a first-line therapy setting is important as patients progressively become less responsive to therapy and experience shorter periods of remission at later lines of treatment. The CHMP positive opinion for PVd was based on the data from OPTIMISMM, the first prospective phase 3 trial to evaluate an IMNOVID-based triplet regimen in patients who were previously treated with REVLIMID, and who were, in the majority (70 percent), REVLIMID refractory. This patient population represents a growing unmet medical need for which new treatment options are necessary. Results from OPTIMISMM showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm. REVLIMID in combination with bortezomib and dexamethasone and IMNOVID in combination with bortezomib and dexamethasone are not approved for any use in any country. ]]> https://biospectrumindia.com/news/57/13239/boehringer-ingelheim-acquires-icd-therapeutics.html https://biospectrumindia.com/news/57/13239/boehringer-ingelheim-acquires-icd-therapeutics.html Mon, 01 Apr 2019 14:50:00 +0530 Boehringer Ingelheim has announced that it acquired ICD Therapeutics. The acquisition includes rights to ICD’s innovative MacroDel biologics-delivery platform. Boehringer Ingelheim will employ this platform for the development of novel therapeutics in collaboration with nanoPET Pharma GmbH, a former shareholder of ICD Therapeutics. Further details of the acquisition are not being disclosed. “Boehringer Ingelheim’s collaboration with nanoPET Pharma has the potential to eliminate the hurdle that many cancer biologics face: getting access to targets inside tumor cells,” said Norbert Kraut, Ph.D., Global Head of Cancer Research, Boehringer Ingelheim. “We will use ICD’s MacroDel technology to develop first-in-class potential drug candidates for intracellular targets across a variety of tumor types, for the benefit of patients who so far have no or only inadequate treatment options.” Engineered proteins and peptides offer great potential to block protein-protein interactions inside cancer cells, but their large size is generally assumed to prevent intracellular delivery. ICD’s MacroDel technology exploits transporter proteins in the cell membrane to deliver such drug candidates inside tumor cells. This opens up therapeutic targets that would be otherwise inaccessible. “nanoPET Pharma looks forward to collaborating with Boehringer Ingelheim on the pre-clinical refinement of ICD’s MacroDel to achieve effective intracellular delivery of macromolecules such as peptides and proteins,” said Andreas Briel, Ph.D., Managing Director of nanoPET Pharma GmbH. “We are excited to contribute to Boehringer Ingelheim’s discovery and development of innovative medicines for patients in need.” Tree-like highly branched molecules known as dendrimers form a fundamental component of the MacroDel platform. The size, shape and electrical charge of this structure permit it to grasp large therapeutic biological molecules. After binding with the biologic, the resulting compound selectively interacts with transporter proteins known to be highly expressed on tumor cell wall membranes. These transporters help “carry” the compound through the membrane and into the cell. The medicinal cargo is then in position to disrupt the disease process in a precise manner at a molecular level. A prior investment from Boehringer Ingelheim’s Venture Fund (BIVF) supported ICD’s development of the MacroDel technology. The BIVF strategically invests in groundbreaking therapeutics-focused biotechnology companies to enable development of their technologies for therapeutic applications that have potential for strategic partnerships with Boehringer Ingelheim or other pharmaceutical partners.   ]]> https://biospectrumindia.com/news/57/13228/bristol-myers-squibb-and-concerto-healthai-announce-strategic-agreement-.html https://biospectrumindia.com/news/57/13228/bristol-myers-squibb-and-concerto-healthai-announce-strategic-agreement-.html Mon, 01 Apr 2019 10:00:00 +0530 Bristol-Myers Squibb and Concerto HealthAI, a company in oncology-specific Real-World Data (RWD) and advanced Artificial Intelligence (AI)-enabled insight solutions for Real-World Evidence (RWE) generation has announced a multi-year strategic agreement that will cover a diverse range of cancers, integrate multiple data sources, and apply AI and machine learning to accelerate clinical trials, enable robust protocol design and generate insights for precision treatment and improved patient outcomes. Bristol-Myers Squibb will use Concerto HealthAI’s Real-World Data and novel AI insights platform, eurekaHealth™, to accelerate insights through novel health economic outcomes and clinical development synthetic control arm studies. With this agreement, the companies will advance the use of RWE for regulatory purposes, validate clinical application of AI solutions and execute clinical studies to advance patient care. Jeff Elton, Ph.D. and CEO of Concerto HealthAI said, “With the increasing importance of Real-World Data and Real-World Evidence, healthcare providers and regulators need to have confidence in the credibility and accuracy of the data sources and methods of evidence generation. Our agreement with Bristol-Myers Squibb is a recognition that we have reached a pivot-point for RWE – it is not just a tool for generating insights into the current standard of care, but a field in its own right that can lead to optimization of current treatments and new therapeutic innovations.” Jeff Conklin, Senior Vice President and Head of Business Insights and Analytics at Bristol-Myers Squibb said, “At Bristol-Myers Squibb, we have seen the value of Real-World Data in our efforts to discover, develop and deliver medicines for patients. This strategic agreement with Concerto HealthAI – a leader in AI solutions for precision oncology – reinforces our commitment to pursue data science to accelerate disease insights, advance novel study concepts and achieve precision in treatment, with the goal of improving patient outcomes.” “Concerto HealthAI’s singular mission,” said Dr. Elton “is to partner with leading medical societies, healthcare providers and life science companies to bring together data, technology and talent to enable new RWE insights and improve the use and broaden the beneficial impact of cancer therapies for patients. The strategic agreement between Bristol-Myers Squibb and Concerto HealthAI reflects both how far the field has advanced and its high near-term potential.” Concerto HealthAI integrates data from sources including CancerLinQ®, a platform that collects and analyzes real-world data from patients at practices nationwide and delivers knowledge back to physicians and researchers.   ]]> https://biospectrumindia.com/news/57/13230/astrazeneca-to-help-build-life-science-innovation-park-in-china.html https://biospectrumindia.com/news/57/13230/astrazeneca-to-help-build-life-science-innovation-park-in-china.html Fri, 29 Mar 2019 14:05:00 +0530 AstraZeneca is spearheading the creation of a new life sciences park, in Wuxi, China, that aims to nurture innovation by bringing together local and international companies, government, and medical and academic institutions to help create a world-class healthcare innovation ecosystem. The International Life Science Innovation Park will be built by the Wuxi municipal government and Wuxi High-tech District and supported by AstraZeneca as a founding partner. AstraZeneca recently signed a Memorandum of Understanding (MOU) with Wuxi High-tech District at the Boao Forum for Asia (BFA) Annual Conference 2019. The new Wuxi ecosystem will provide companies with shared resources, including laboratories, equipment and services. It will also facilitate collaboration with AstraZeneca's global R&D network to accelerate innovation, supporting the end-to-end development and commercialisation of medicines in China. Leif Johansson, Chairman of the Board, AstraZeneca, said: “With the all-round opening up of China, I believe that a variety of industries will embrace international cooperation opportunities. The establishment of this agreement builds on our strong legacy of innovation in China and is well aligned to our open innovation approach and firm belief in the value of strong local innovation ecosystems.”  Leon Wang, Executive Vice President, International and President of AstraZeneca China, said, AstraZeneca is committed to patient-centric, open innovation and the International Life Science Innovation Park in Wuxi is another example of our continuing efforts to improve China’s healthcare system. We look forward to working with the municipal government and Wuxi High-tech District to co-create a partnership-led ecosystem that can support and accelerate progress of potential new medicines from early research and development through to commercialisation, in China and beyond.” Steve Bates, Chief Executive of the UK BioIndustry Association, said: “China is an important and exciting opportunity for UK life science companies. The chance to participate in the creation of the new Wuxi cluster is one not to be missed. This new opportunity will enable UK companies to co-locate with AstraZeneca in China, within a truly supportive local ecosystem, making it easier for UK life sciences companies to partner, grow and innovate with like-minded dynamic companies and investors in China.” The initiative also received backing from the Company’s current partners BioVentureHub in Sweden and The Skolkovo Foundation in Russia which were present at the signing of the MOU alongside the UK BioIndustry Association which pledged to help UK life sciences companies establish a presence in Wuxi. The MOU follows the establishment of AstraZeneca’s China Commercial Innovation Centre, also in Wuxi, that is developing new ways of working with China’s healthcare system.   ]]> https://biospectrumindia.com/news/57/13226/luye-pharmas-rykindo-gets-us-fda-approval-.html https://biospectrumindia.com/news/57/13226/luye-pharmas-rykindo-gets-us-fda-approval-.html Fri, 29 Mar 2019 12:40:00 +0530 Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration ("FDA") for Rykindo®, completed on March 28. Rykindo® (LY03004) Risperidone Extended-release Microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States. The NDA submission for Rykindo® is regarded as a milestone step for the company, expecting a big pay-off from the potential industrialization of its long-invested long-acting and extended-release technology R&D platform. This is not only a key step in Luye Pharma's globalization initiative, but also a major step for China in bringing innovative formulations to the world, receiving wide attention from all walks of life. After going through R&D, CMC and process optimization testing, the scaling-up of production, registration review and commercial preparations, Luye Pharma is now fully prepared for the global launch of Rykindo® and other innovative formulations. Rykindo® is an extended-release microsphere independently developed by Luye Pharma. It is administered once every two weeks by intramuscular injection to treat schizophrenia and bi-polar disorder. The NDA submission this time includes the results from one pivotal and two supportive clinical studies, involving a total of 172 patients in the U.S. The results of the pivotal study demonstrated no lag period with the first injection and an equivalent pharmacokinetic profile of Rykindo® at steady state when compared to the marketed reference product of risperidone long-acting injection. Similar safety profiles were observed between Rykindo® and the reference product in all three studies. Rykindo® as an injectable drug can improve medication compliance in patients with schizophrenia, which is a common issue with oral antipsychotic drugs, simplifying the treatment regimen due to the need for an injection only once every two weeks. Furthermore, Rykindo® has several advantages over the reference drug, for example, there is no need to administer an oral formulation for three weeks after the first injection of Rykindo® when compared to the reference drug. Steady plasma drug level can also be achieved much faster with Rykindo® when compared to the reference product. According to Luye Pharma, Rykindo® is expected to be launched in the U.S. and China first, during the 2019 - 2020 period. Meanwhile, Rykindo®'s registration process in Europe and other emerging countries is progressing smoothly. In the central nervous system (CNS) therapeutic area where Rykindo® is applied, the global patient population is extremely large and constantly growing. Luye Pharma's strategic approach in this treatment area will set the tone for the company's next stage of business growth. ]]> https://biospectrumindia.com/news/57/13215/proteonic-licenses-protein-production-tech-to-bayer.html https://biospectrumindia.com/news/57/13215/proteonic-licenses-protein-production-tech-to-bayer.html Thu, 28 Mar 2019 14:50:00 +0530 ProteoNic Biotechnology BV has licensed its 2G UNic™ technology for boosting recombinant protein production to the pharmaceutical company Bayer.Under the agreement, Bayer gains non-exclusive, worldwide commercial rights for application of the technology to the development of its proprietary products. Financial details of the agreement were not disclosed. The companies reached agreement following evaluation of the technology by Bayer regarding levels of recombinant protein production as well as product characteristics.  Bayer will present the data at the Conference “Cell Line Development and Engineering Europe 2019”, held in Vienna April 2-4. ProteoNic’s protein expression technology is designed to improve cell line production levels across a range of host cells, selection systems and protein targets. This is achieved via the combined effect of novel genetic elements, which synergistically exert a positive effect on recombinant protein production levels. ProteoNic’s 2G UNic™ can be combined with other expression-enhancing technologies to improve their performance. ]]> https://biospectrumindia.com/news/57/13212/lilly-and-immunext-announce-licensing-and-research-collaboration.html https://biospectrumindia.com/news/57/13212/lilly-and-immunext-announce-licensing-and-research-collaboration.html Thu, 28 Mar 2019 12:25:00 +0530 Eli Lilly and ImmuNext has announced a global licensing and research collaboration focused on the study of a preclinical novel target that could lead to potential new medicines for autoimmune diseases by regulating immune cell metabolism. Ajay Nirula, Vice President of immunology at Lilly said, "Immunology is an important area of research for Lilly, and we seek novel targets that could develop into new medicines for patients suffering with autoimmune diseases. Regulating the metabolism of immune cells is a promising approach to treating these diseases, and we look forward to working with ImmuNext to advance their immunometabolism target." Jay Rothstein, Chief Scientific Officer at ImmuNext, states that "We are pleased to work with Lilly to bring forward a first-in-pathway antibody that specifically targets the metabolism of lymphocytes to reprogram rather than suppress the immune system." Under the terms of the agreement, ImmuNext will receive an upfront payment of $40 million, and is eligible to receive up to approximately $565 million in development and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales. In return, ImmuNext will grant Lilly an exclusive, worldwide license to develop and commercialize the novel immunometabolism target. In addition, Lilly and ImmuNext will establish a 3-year research collaboration to support the target's development. This transaction is subject to customary closing conditions.   ]]> https://biospectrumindia.com/news/57/13194/cytosmart-raises-5-2-million-euros-for-expansion.html https://biospectrumindia.com/news/57/13194/cytosmart-raises-5-2-million-euros-for-expansion.html Wed, 27 Mar 2019 10:30:00 +0530 CytoSMART, that develops and manufactures digital microscopes for monitoring live cell cultures, has received 5.2 million Euros to fund the growth of their business. New investor Eindhoven Venture Capital Fund II joined existing investors Holland Capital and BOM Brabant Ventures. The funding will be used by CytoSMART to further develop its microscopes and to expand its international sales and marketing strategies.  CytoSMART has created three highly innovative microscopes that scientists can use to digitally and remotely count, screen, check, and film their cell cultures. CytoSMART’s latest microscope is the Omni, the world’s fastest live-cell imager. The company has also created a wide range of options for using the collected images to conduct experiments in its own cloud service. The additional funding will be used for product innovation, expanding product functions, and upscaling the company’s international sales and marketing.  ]]> https://biospectrumindia.com/news/57/13193/bayer-focuses-on-long-term-partnership-with-healthcare-startups-.html https://biospectrumindia.com/news/57/13193/bayer-focuses-on-long-term-partnership-with-healthcare-startups-.html Wed, 27 Mar 2019 09:00:00 +0530 As a pioneer when it comes to collaborating with digital health startups, Bayer is now taking the next step. Instead of one-off startup programs, it is now focusing on collaborating in specific digital health focus areas, e.g. digital therapeutics, AI for drug discovery, and patient engagement platforms to name a few. To do this, Bayer is combining the G4A programs and concentrating on longer-term collaborations and investments. “The digital health ecosystem has matured over the years and there are some very well developed start-ups across the value chain. We wanted to simplify the process for entrepreneurs to work with Bayer and scale innovative solutions together, faster. That’s why it’s time to take the way we collaborate to the next level,” says Eugene Borukhovich, Global Head of Digital Health at Bayer.  The three existing programs (Accelerator, Dealmaker and Generator) are being combined to form G4A Partnerships, a joint initiative aimed at start-ups in the health care sector at various stages of development. Specific business challenges will be defined for which the start-ups can put forward their proposed solutions. The most suitable approaches will then be developed further in collaborative teams with Bayer. The cooperation will be underpinned by a letter of intent. Not only will the start-ups be given one-time initial funding (EUR 50,000 to EUR 100,000), they will also receive additional payments when jointly defined milestones are reached. The first business challenges will be announced at the beginning of April. “For us, it’s all about developing new health solutions that can change the experience of health,” says Dr. Zsuzsanna Varga who’s heading G4A Partnerships. “We’re convinced that long-term collaborations with digital health companies sharing the same passion and vision are the best way to achieve this.”  ]]> https://biospectrumindia.com/news/57/13192/hitgen-enters-into-research-collaboration-with-almirall-.html https://biospectrumindia.com/news/57/13192/hitgen-enters-into-research-collaboration-with-almirall-.html Tue, 26 Mar 2019 16:25:00 +0530 HitGen Ltd announced that the company has entered into research collaboration with Almirall to identify novel small molecule leads for targets of interest. In this collaboration, HitGen will apply its advanced technology platform, based on DNA-encoded library design, synthesis and screening, to discover novel leads for Almirall. Under the terms of the agreement, HitGen will receive upfront payments, and be eligible for milestone payments from Almirall. Specific financial details were not disclosed. “We are delighted to enter this collaboration with Almirall, a leading medical dermatology focused global pharmaceutical company. This collaboration further emphasizes the role of HitGen in the rapidly developing field of DNA-encoded chemistry. We will work closely with Almirall scientists to generate novel leads for their innovative research programs to address unmet medical needs. said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen. Dr. Bhushan Hardas, Chief Scientific Officer of Almirall, commented that “this agreement keeps us on the track to achieve our goal of becoming a leading medical dermatology company. We look forward to collaborate with HitGen in identifying new molecules with the potential of becoming new treatment options for patients with atopic dermatitis” ]]> https://biospectrumindia.com/news/57/13188/cytena-raises-3-million-in-series-a-funding.html https://biospectrumindia.com/news/57/13188/cytena-raises-3-million-in-series-a-funding.html Tue, 26 Mar 2019 14:45:00 +0530 A life science start-up Cytena GmbH successfully completes another financing round. In total, two private investors and High-Tech Gründerfonds (HTGF) are investing another 3 million euros in the company. The new capital will be used to continue developing its single-cell printer lab technology, expand sales activities and tap into the potential of new applications more quickly. The analysis of individual biological cells has rapidly gained in importance in recent years. Single cells are used in the development of modern drugs, so-called biopharmaceuticals, as well as in cancer and stem cell research. The Cytena family of single-cell printers consists of laboratory devices for handling and sorting individual viable cells. These instruments are innovative tools for the life sciences and make a long-term contribution to the development and manufacturing of new drugs ]]> https://biospectrumindia.com/news/57/13181/enterome-dana-farber-institute-team-up-for-cancer-immunotherapy.html https://biospectrumindia.com/news/57/13181/enterome-dana-farber-institute-team-up-for-cancer-immunotherapy.html Tue, 26 Mar 2019 09:00:00 +0530 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the key functional and molecular interactions between the gut microbiome and the human body to develop targeted therapeutics, has entered into a research and development collaboration with Dana-Farber Cancer Institute (Boston, MA) to evaluate and develop gut microbiome-derived antigens as potential cancer immunotherapies. Enterome is developing an innovative approach to cancer immunotherapy, based on the concept of “molecular mimicry,” whereby microbiome-derived bacterial antigens show molecular similarity with Tumor-associated Antigens (TAAs) and Tumor-specific Neoantigens (TSNAs). Based on this similarity, bacterial antigens (“onco-mimics”) mimic key tumor antigens that are highly expressed by tumors to trigger tumor-specific cytotoxic T cell immune responses. Enterome has developed a discovery platform to identify such onco-mimics from the human gut microbiome and has advanced EO2401 as its first clinical candidate. EO2401 comprises several microbiome-derived antigens that mimic antigens highly expressed by brain tumors and is targeting first clinical trials in 2019 as a potential new immunotherapy for recurrent glioblastoma multiforme (GBM) for which no curative treatments exist. The collaboration brings together Enterome’s ability to identify potential TAAs and TSNAs as well as to generate bacterial onco-mimics for the selected TAAs and TSNAs with the complementary translational expertise from the research groups at Dana-Farber Cancer Institute led by Dr. David Reardon at the Center for Neuro-Oncology and Dr. Paul Kirschmeier at the Belfer Center for Applied Cancer Science. Drs. Reardon’s and Kirschner’s groups are focused on driving innovative research programs and clinical trials to improve cure rates in patients with brain and spinal cancers, with a particular focus on immunotherapies. Through this collaboration Enterome will have access to knowledge, scientific expertise and preclinical models at Dana-Farber Cancer Institute that are intended to support the in vivo validation and further development of Enterome’s immunotherapy approach for the treatment of cancer. ]]> https://biospectrumindia.com/news/57/13171/research-from-xjtlu-advances-rna-modification-mapping.html https://biospectrumindia.com/news/57/13171/research-from-xjtlu-advances-rna-modification-mapping.html Fri, 22 Mar 2019 17:35:00 +0530 Researchers from Xi'an Jiaotong-Liverpool University have completed a high-resolution prediction of the whole-transcriptome m6A RNA modification, successfully creating the world's most accurate map of the m6A epitranscriptome. Led by Dr Jia Meng from the Department of Biological Sciences, the research was recently published in Nucleic Acids Research. Dr Meng says the results may have promising implications for a range of diseases. "It's hard to predict which diseases will benefit from the research into m6A RNA methylation but studies indicate the enzymes of m6A RNA methylation play a key role in leukemia, lung cancer and breast cancer," he says. "As a fundamental layer of gene regulation, I wouldn't be surprised to see epitranscriptome regulation through reversible m6A RNA methylation playing an important role in many diseases. "Cancer is proving to be a promising direction to explore further." Dr Meng says RNA stands for ribonucleic acid – known as the 'cousin' of DNA – and that m6A RNA modification is a type of biochemical modification of RNA molecules, which can alter their biological properties and regulate gene expression without changing its sequences. "Previously the accuracy of m6A RNA modification site prediction could only reach approximately 80 percent using conventional sequence information," he says. "What we found is that by adding 35 additional genomic features, we can increase the accuracy to 90 per cent, which is a big step forward." Dr Meng says it's a hot topic in biological science today, as there are more than 100 different types of RNA modifications, and their functions are largely unknown. According to Dr Meng, the m6A is the most abundant and is likely to be the most valuable to study. The research team used a machine-learning approach when drafting the map of the m6A epitranscriptome, establishing a prediction model based on the conventional sequence features and new genomic features to predict the precise locations on genes that might be related to RNA modifications. PhD student Kunqi Chen says more accurate predictions and a better understanding of the site of the RNA modifications allow scientists to more easily identify which enzymes are involved in the process. "Our work contributes to the study of genetic functions and traits, and the relationship between genes and some human diseases," he says. ]]> https://biospectrumindia.com/news/57/13169/visionpharm-earns-acclaim-from-frost-sullivan-for-transforming-anatomic-pathology.html https://biospectrumindia.com/news/57/13169/visionpharm-earns-acclaim-from-frost-sullivan-for-transforming-anatomic-pathology.html Fri, 22 Mar 2019 17:25:00 +0530 Based on its recent analysis of the global digital pathology software solutions market, Frost & Sullivan recognises Denmark-headquartered Visiopharm A/S with the 2019 Global Company of the Year Award. The company has accelerated anatomic pathology's digital transformation with its end-to-end digital pathology software solutions, Qualitopix™ and Oncotopix®. The platforms leverage artificial intelligence (AI) and machine learning (ML) to integrate digitized, high-throughput pathology lab workflows for improved diagnostic accuracy, increased productivity, and cost savings. "Visiopharm uncovered and quantified two particularly important error sources in the diagnostic workflow--histological staining and manual image reading and interpretation," said Unmesh Lal, Program Manager at Frost & Sullivan. "In many countries, pathology labs using immunohistochemistry/in situ hybridisation stains rely on external quality assessment (EQA) programs to maintain staining quality. With Qualitopix™, Visiopharm became the first and only solution provider supporting EQA organisations with a software platform that allows them to improve the efficiency and scalability of their activities." Qualitopix, a novel, patented platform technology, helps pathologists administrate quality runs and scalability through computer-assisted stain quality assessment. The digitised slides facilitate interactions with pathology labs, which, in turn, optimises resource utilisation. Moreover, the administration platform supports and facilitates protocol review with participating labs that fail the proficiency testing. The solution is rapidly gaining acceptance as the standardisation and quality of staining with diagnostic tissue-biomarkers is central to achieving precision pathology and sustainable cancer healthcare. Meanwhile, Oncotopix® addresses the critical pain point of significant inter- and intra-reader variability in diagnostic tissue pathology. It achieves this by combining image analysis, machine learning, and artificial intelligence with workflows supporting the analysis of massive data sets, data management, reporting, connectivity to laboratory information management system and picture archiving and communication system, and compatibility with all image/slide formats. "Its fully automated software suite offers reproducible, quantifiable, precise data, helping pathologists read and interpret regions inside and outside of the tumor as well as tumor heterogeneity. Currently, Visiopharm has more than 100 APPs published, providing full flexibility for biopharma and academic research," noted Lal. "The company's strategically located subsidiaries in Sweden, the UK, the US, and re-sellers in Asia serve customers across Europe, North America, and Asia. With plans to expand its global distributor network, and wider integration with partners, Visiopharm is all set to capture a greater market share and entrench itself in the market." Each year, Frost & Sullivan presents a Company of the Year award to the organisation that demonstrates excellence in terms of growth strategy and implementation in its field. The award recognises a high degree of innovation with products and technologies, and the resulting leadership in terms of customer value and market penetration. Frost & Sullivan Best Practices awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry. Visiopharm is a world leader in Augmented Pathology solutions; that comprise precision pathology and high-throughput pathology for tissue-diagnostics and research. ]]> https://biospectrumindia.com/news/57/13164/ecommerce-offers-preferred-platform-for-drug-and-medical-device-biz-survey.html https://biospectrumindia.com/news/57/13164/ecommerce-offers-preferred-platform-for-drug-and-medical-device-biz-survey.html Fri, 22 Mar 2019 15:15:00 +0530 As the tech-savvy millennial population has come to expect a high level of user experience (UX), the healthcare industry has begun to digitize products, services, and commerce models. The industry is setting up personalized UX/user interface (UI)-enabled eCommerce platforms and websites, which are expected to be the preferred digital channels for browsing and ordering medical devices and supplies. This will not only improve access, quality, and affordability of healthcare, but also promote predictive, preventive, and outcome-based care models. The overall benefits of supply chain optimization and improved UX are expected to result in an eCommerce channel that will reach $200 billion at a compound annual growth rate (CAGR) of 15 percent by 2022. "Drug and device OEMs and distributors should prioritize their eCommerce strategy based on the maturity of their buyer/market using a mix of available digital tools for educating, researching product information, and order and payment management," said Kamaljit Behera, Industry Analyst, Transformational Health. Frost & Sullivan's recent analysis, Healthcare eCommerce Market in North America, Forecast to 2022, examines the key trends and developments in healthcare eCommerce with specific focus on the eCommerce market for pharma drugs and medical devices in North America. It also provides market projections, opportunity analysis by supply chain participants, strategic imperatives, and industry best practices or case studies for both segments. "The convergence of healthcare with IT and retail industries has opened the market up to non-traditional players, which is disrupting the existing business channels and future revenue streams. For example, Google, Amazon, Facebook, Apple, and Microsoft (GAFAM) in the West, and Baidu, Ali Health, and Tencent (BAT) in East will continue to make further headways in the healthcare industry," noted Behera. "Amazon will have a particularly high impact on emerging home or individual care concepts like telehealth, telemedicine, and direct-to-consumer (D2C) commerce." Some of the most prominent trends and growth opportunities in the healthcare eCommerce space include: Hospital buyers are more willing to repurchase from a B2B digital marketplace that offers transparency, personalization, and competitive pricing for stable medical devices, implants, and consumables. Selling, general & administrative (SG&A) expenses accounting for 35 percent to 40 percent of the overall healthcare industry cost, which creates a need for an efficient eCommerce distribution model by automating sales representatives' routine and tactical works. Development of business models that support the integration of the product sale and service functions (maintenance, repairs) in the eCommerce channel. Furthermore, the integration of eCommerce channels with customer relationship management (CRM), business intelligence (BI), and social relationship management (SRM) tools will help standardize the purchasing process. eCommerce platforms offering not only robust account management functionalities but also integration with warehouse and fulfillment software to provide real-time inventory updates and delivery status to customers. Apart from drug or device types and purchase volumes, factors such as market positioning, target end users, and reimbursement playing a critical role in eCommerce channel selection and success. Retail pharmacy, consumer devices, and medical supplies segments present a scope for large profit pool disruption by eCommerce. At the same time, digital marketplace and centralized contract management platforms such as OpenMarkets, Amazon Business, DST Pharmacy Solutions, and Global Healthcare Exchange (GHX) are viewed both as an opportunity and threat by groups of purchasing organization (GPOs) and pharmacy benefit management (PBMs). eCommerce will solve the humongous medication adherence challenge and it presents an opportunity to increase transparency in drug pricing- a problem plaguing the United States healthcare system for decades. ]]> https://biospectrumindia.com/news/57/13159/servier-collaborates-with-harvard-researchers-to-fight-metabolic-diseases.html https://biospectrumindia.com/news/57/13159/servier-collaborates-with-harvard-researchers-to-fight-metabolic-diseases.html Fri, 22 Mar 2019 11:30:00 +0530 Servier has entered into a collaborative study with Harvard University researchers to explore a new avenue for the treatment of type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). Servier and Harvard researchers will embark on a three-year preclinical research project where the ultimate objective is to develop therapeutics targeting the microbiota for the treatment of type 2 diabetes and NAFLD. The work will be conducted by a multidisciplinary team of researchers from both parties. The research team at Harvard University will be led by Emily P. Balskus, Professor of Chemistry and Chemical Biology, and the team at Servier will be led by Philippe Delerive, Head of Research for Cardiovascular and Metabolic Diseases. The collaboration combines the expertise of Servier researchers in the field of metabolism and drug development with Prof. Balskus' expertise in chemical discovery relating to the gut microbiome. Together, the parties hope to make important advances in understanding disease biology and to use emerging technologies to develop new treatment options for diseases with high unmet medical need. “Gut microbiota is an untapped resource for the identification of novel targets in the field of metabolic diseases. It opens up new perspectives for the development of increasingly precise and personalized innovative therapies. The close collaboration between our researchers and academic researchers from Harvard represents a major step in this direction, for the ultimate benefit of patients,” stated Servier Group Executive Vice-President Research & Development, Claude Bertrand. Non-alcoholic fatty liver disease (NAFLD) affects over 25% of the world's population. The condition, in which too much fat is stored in the liver, is very often linked to excess weight and/or type 2 diabetes. This, in turn, is due to the build-up of fatty acids and scar tissue, which can lead to steatohepatitis (NASH), cirrhosis and, in some cases, to the development of liver cancer. Currently there are no therapies available to patients for this disease. This collaboration is a project under the strategic alliance established between Servier and Harvard University in 2017. Under the terms of the alliance agreement, Servier will support multi-year research projects initiated by Harvard faculty and focused on the development of innovative treatments in its therapeutic fields of expertise. Servier selected this project through a call for proposals. ]]> https://biospectrumindia.com/news/57/13153/valoremrx-partners-with-kroger-specialty-pharmacy.html https://biospectrumindia.com/news/57/13153/valoremrx-partners-with-kroger-specialty-pharmacy.html Thu, 21 Mar 2019 14:20:00 +0530 ValoremRx Specialty Solutions, the group purchasing organization (GPO) formed by a joint venture between Express Scripts and Walgreens, recently announced its new collaboration with Kroger Specialty Pharmacy. Partnered with Express Scripts' specialty pharmacy Accredo® and Walgreens' specialty pharmacy affiliates including AllianceRx Walgreens Prime, Kroger Specialty Pharmacy becomes the third participant to join the GPO. Founded in 2000, Kroger Specialty Pharmacy, Inc. serves patients with chronic illnesses by offering drug therapies and patient-support services to treat chronic, genetic and other complex medical conditions at locations across the United States and its territories. By joining the GPO, Kroger Specialty Pharmacy uniquely positions ValoremRx to use its combination of scale and clinical excellence to ensure sourcing and contracting solutions for specialty medications, simplifying the global supply chain and improving patient care. John Caulfield, Vice President and General Manager, ValoremRx Specialty Solutions, praised Kroger's addition to the combined enterprise: "Our strategic relationship with Kroger Specialty Pharmacy will improve access to cost effective specialty brand drugs and biosimilars across the drug supply chain for those who need it most, delivering high-quality, specialized care and a better patient experience." ]]> https://biospectrumindia.com/news/57/13152/jazz-pharma-set-to-market-sunosi-to-control-excessive-daytime-sleepiness.html https://biospectrumindia.com/news/57/13152/jazz-pharma-set-to-market-sunosi-to-control-excessive-daytime-sleepiness.html Thu, 21 Mar 2019 12:55:00 +0530 Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved Sunosi™ (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to treat excessive daytime sleepiness in adults living with narcolepsy or OSA. Sunosi is expected to be commercially available in the U.S. following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA), which is typically within 90 days of FDA approval. At Week 12, 150 mg of Sunosi for narcolepsy patients and all doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed in test sessions 1 (approximately one hour post-dose) through 5 (approximately nine hours post-dose) of the maintenance of wakefulness test (MWT). The FDA's approval of Sunosi is based on data from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) Phase 3 clinical program, which included four randomized placebo-controlled studies that demonstrated the superiority of Sunosi relative to placebo. The most common adverse reactions (incidence ≥5% and higher than placebo) reported in both the narcolepsy and OSA study populations were headache, nausea, decreased appetite, and anxiety. Sunosi was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea and was shown to maintain its effect relative to placebo after six months of use. In 12 week clinical studies, approximately 68-74% of people taking Sunosi at the 75 mg dose and 78-90% of people taking Sunosi at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale. Although the exact mechanism of action is unknown, the effects of Sunosi are thought to be mediated through its activity as a DNRI. Sunosi is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating Sunosi for excessive daytime sleepiness in OSA. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities. ]]> https://biospectrumindia.com/news/57/13151/merck-opens-first-m-lab-collaboration-centre-in-europe.html https://biospectrumindia.com/news/57/13151/merck-opens-first-m-lab-collaboration-centre-in-europe.html Thu, 21 Mar 2019 10:00:00 +0530 Merck, a leading science and technology company, has officially opened its new M Lab™ Collaboration Centre in Molsheim, France. The centre is Merck's first in Europe and ninth worldwide, providing biopharmaceutical manufacturers with a shared, exploratory environment where they can closely collaborate with Merck scientists and engineers to solve their toughest challenges and accelerate development and production of new therapies. Merck's newest M Lab™ Collaboration centre, which offers 4,000 square meters of space, represents a significant investment in the region. The €10 million centre provides customers in Europe, the Middle East and Africa with a fully equipped, non-GMP pilot and bench scale lab and meeting centre where they can work alongside Merck experts to solve their most pressing processing development challenges without impacting their production line. The centre in Molsheim is the latest in Merck's network of centres around the world. Other M Lab™ Collaboration centres are located in the United States, Brazil, China, South Korea, Singapore, Japan, India (where there are two labs).   ]]> https://biospectrumindia.com/news/57/13143/njii-pall-sign-an-agreement-to-advance-manufacturing-of-cell-and-gene-therapies.html https://biospectrumindia.com/news/57/13143/njii-pall-sign-an-agreement-to-advance-manufacturing-of-cell-and-gene-therapies.html Wed, 20 Mar 2019 13:00:00 +0530 New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology (NJIT) Corporation, has signed an Industry Participation Agreement with Pall Corporation (Pall) to support the development of its BioPharmaceutical Innovation iLab. The partnership will support two key Centers at NJII that will advance the manufacturing of new cell and gene therapies: the Cell and Gene Therapy Development Center and the Center of Advanced Biologic Manufacturing. "We are excited to work with Pall Corporation, a world leader in high-tech filtration, separation and purification, to advance manufacturing of new cell and gene therapies. These therapies represent a new era in the treatment of cancer and other major diseases and hold great promise in achieving successful patient outcomes," explained Dr. Haro Hartounian, NJII Senior Executive Director, Biotechnology & Pharmaceutical Innovation. The NJII Cell and Gene Therapy Development Center will focus on addressing manufacturing process technologies and workforce development challenges faced by the industry. This Center will serve as a dedicated platform where the industry can access shared resources including equipment, expertise and project work to find innovative solutions to manufacturing needs for biologic medicines, such as cell-based immunotherapies. The NJII Center of Advanced Biologic Manufacturing, meanwhile, will address challenges of mass production through continuous processing and viral vector manufacturing. This Center will bring big pharma, emerging biotechnology companies, technology developers and instrumentation companies together with regulatory agencies to pioneer new techniques and train those who will take the technology into commercial practice at an industrial scale. The world leader in continuous bioprocessing, Pall is at the forefront of research and development in the industrialization of gene therapy manufacture and brings significant new resources to both projects. State-of-the-art bioreactors, continuous chromatography units, and an acoustic wave separator have been provided by Pall to both NJII Centers as part of the Industry Participation Agreement. Pall experts will also be deployed to support the experimental program and provide training on the new equipment. "Scaling up the manufacture of gene therapies and gene-modified cell therapies to industrial levels is one of the biggest challenges in modern medicine manufacture. If we're going to tackle the industry's productivity challenges, we need to think smart and invest in finding innovative manufacturing solutions, for example through continuous bioprocessing. NJII is doing remarkable work in this area and we're very excited to partner with them on this innovative program," explained Peter Levison, Pall's Executive Director Business Development. Pall's partnership with NJII is the latest in a series of investments by the filtration, separation and purification world leader in R&D programs to advance continuous manufacturing and the production of gene therapies. In November 2018, a partnership between Pall, Cobra Biologics and Cell and Gene Therapy Catapult was awarded an Innovate UK grant worth nearly $2 Million to investigate continuous manufacturing for gene therapies – the results of which, when complete, may complement NJII's work in the United States. ]]> https://biospectrumindia.com/news/57/13142/arix-co-leads-63m-series-b-investment-round-for-imara.html https://biospectrumindia.com/news/57/13142/arix-co-leads-63m-series-b-investment-round-for-imara.html Wed, 20 Mar 2019 12:40:00 +0530 Arix Bioscience, a global healthcare and life science company supporting medical innovation has announced it has invested in new portfolio company Imara, a company dedicated to developing novel therapeutics for chronic treatment of Sickle Cell Disease and other hemoglobinopathies. As part of the financing, Arix has committed to invest $15.0 million (£11.3 million) for a 10% stake on a fully diluted basis. Arix Investment Director Mark Chin will join Imara's board of directors and Investment Associate John Cassidy will join as an observer. Cambridge, MA-based Imara is developing IMR-687, an orally-administered, highly potent and selective phosphodiesterase 9 (PDE9) inhibitor developed to treat the underlying causes of the pathology of sickle cell disease, a condition characterised by sickling of red blood cells and the occlusion or blockage of small blood vessels by the rigid, sickle-shaped red blood cells. The company has a highly experienced leadership team led by Chief Executive Officer Rahul Ballal, formerly the Chief Business Officer at Northern Biologics and Entrepreneur-in-Residence at Versant Ventures. Early clinical data in SCD patients support the potential for IMR-687 to improve health outcomes and possibly ameliorate disease pathology. The mechanism of IMR-687 is differentiated from other therapies in development by its dual action on both red and white blood cells. IMR-687 successfully completed a Phase 1 study in healthy volunteers and is currently being tested in a global Phase 2a study in adult SCD patients, including sites in the UK. The financing was co-led by new investors Arix and Orbimed Advisors and also included RA Capital and Rock Springs Capital. Existing investors NEA, Pfizer Ventures, Bay City Capital, Lundbeckfonden Ventures and Alexandria Venture Investments also participated in the fundraise. Proceeds from the financing will be used to progress clinical development in sickle cell disease in adults and children, and broader applications in beta thalassemia and other haematological conditions. Joe Anderson, Chief Executive Officer of Arix, commented: "Sickle cell disease affects a large and growing population across the world and is devastating for both patients and families. Imara is led by an exceptional team developing a novel, compelling approach to treating this difficult disease. We look forward to working with the leadership team and our co-investors to help accelerate the development of this exciting company." Rahul Ballal, Chief Executive Officer of Imara, commented:  "This is a transformative moment for Imara, as this financing allows us to accelerate clinical development for IMR-687 in SCD and expand its utility to other populations and related haematological diseases.  We hope to provide patients a meaningful, but easy-to-use therapy in their fight against SCD and related disorders.   "We are delighted by the strong support from Arix as well as our existing and new investors and I look forward to working closely with Mark and John to build the company and team." ]]> https://biospectrumindia.com/news/57/13141/wcg-introduces-a-transformational-solution-for-clinical-research-sites.html https://biospectrumindia.com/news/57/13141/wcg-introduces-a-transformational-solution-for-clinical-research-sites.html Wed, 20 Mar 2019 12:00:00 +0530 WCG (WIRB-Copernicus Group) is the world's leading provider of solutions that measurably improve the quality and efficiency of clinical research. It has introduces WCG SiteReady™, a first-of-its-kind solution aimed at increasing the efficiency and profitability of clinical research for institutions and independent research sites. WCG’s newest offering helps researchers to optimize their performance, gain a competitive edge, and attract more opportunities for externally-funded clinical trials.  “At WCG, we understand the unique challenges that institutions and independent sites face,” said Donald A. Deieso, PhD, Executive Chairman and CEO of WCG. “The research ecosystem is changing rapidly; protocols are increasingly complex, research teams are stretched thin, and patients are more informed than ever. Biopharmaceutical companies are seeking investigators who can perform clinical studies at the highest level of efficiency and integrity. Conversely, leading investigative sites desire opportunities to participate in the exciting advances being developed by the industry. To succeed in this highly competitive landscape, investigators and site teams must continually position themselves for growth.”  The trusted partner of 2,800 institutions, 195 academic medical centers and 140,000 global investigators, WCG develops solutions that give all members of the research ecosystem greater visibility into and control over their research. Combining proven processes and techniques with robust technologies already successfully deployed in the market, WCG SiteReady™ is a comprehensive, end-to-end solution that makes research more efficient, easier to manage, and more profitable for institutions and independent sites. WCG SiteReady™ reduces the administrative burden of regulatory compliance, streamlines contract and budget negotiation, accelerates study start-up, and increases patient enrollment in clinical trials.  “Opportunities for growth in clinical research are significant,” said Jonathan Zung, PhD, WCG Executive Vice President. “Over the past two years, we helped the five largest institutions in our network to grow at annual rates exceeding 20%. Our clients achieved this growth by implementing efficiency measures while working to increase top-line revenue through new study acquisition. We have named this unique solution WCG SiteReady™.”   ]]> https://biospectrumindia.com/news/57/13137/stanford-medicine-announces-results-of-unprecedented-apple-heart-study.html https://biospectrumindia.com/news/57/13137/stanford-medicine-announces-results-of-unprecedented-apple-heart-study.html Tue, 19 Mar 2019 15:20:00 +0530 Stanford Medicine has reported results of the Apple Heart Study, the largest study ever of its kind, which enrolled over 400,000 participants from all 50 states in a span of only eight months. Apple and Stanford created the study to evaluate Apple Watch’s irregular rhythm notification, which occasionally checks the heart's rhythm in the background and sends a notification if an irregular heart rhythm appears to be suggestive of atrial fibrillation (AFib). As part of the study, if an irregular heart rhythm was identified, participants received a notification on their Apple Watch and iPhone, a telehealth consultation with a doctor and an electrocardiogram (ECG) patch for additional monitoring. Jeff Williams, Apple’s COO said, “We are proud to work with Stanford Medicine as they conduct this important research and look forward to learning more about the impact of Apple Watch alongside the medical community. We hope consumers will continue to gain useful and actionable information about their heart health through Apple Watch.” Sumbul Desai, MD, Apple’s vice president of Health said, “As physicians, we are always trying to find ways to offer patients health information that is meaningful to them for individualized care. Seeing medical research reflect what we’re hearing from consumers is positive and we’re excited to see Apple Watch helping even more consumers in the future while collaborating with the medical community to further research.” Stanford Medicine researchers presented their findings at the American College of Cardiology’s 68th Annual Scientific Session and Expo. Study results showed 0.5 percent of the over 400,000 participants received an irregular heart rhythm notification, illustrating the feature’s ability to give a user important health information without creating unnecessary burden to their doctor’s schedule. Many participants sought medical advice following their irregular rhythm notification, using the information to have more meaningful conversations with their doctors.   ]]> https://biospectrumindia.com/news/57/13134/roches-new-initial-treatment-option-gets-fda-nod-to-treat-es-sclc-.html https://biospectrumindia.com/news/57/13134/roches-new-initial-treatment-option-gets-fda-nod-to-treat-es-sclc-.html Tue, 19 Mar 2019 12:10:00 +0530 Roche announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone  in the intention-to-treat (ITT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone . Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq. “Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that have been shown to improve survival compared to chemotherapy. ]]> https://biospectrumindia.com/news/57/13130/cold-genesys-completes-22-m-series-c-funding.html https://biospectrumindia.com/news/57/13130/cold-genesys-completes-22-m-series-c-funding.html Tue, 19 Mar 2019 10:30:00 +0530 Cold Genesys, Inc., a clinical-stage biopharmaceutical company focused on the development of novel immunotherapies, announced the closing of a $22 million Series C preferred stock financing. New investors participated in the round, including lead investor, ORI Healthcare Fund L.P. ("ORI Fund"), with participation from Perseverance Capital Management.  The financing will accelerate the growth of Cold Genesys' ongoing clinical programs and the continued advancement of its lead oncolytic immunotherapy CG0070, which has completed a Phase 2 study (BOND2) and demonstrated clinical safety and efficacy in over 100 patients to date for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).  ]]> https://biospectrumindia.com/news/57/13124/novartis-joins-the-global-chagas-disease-coalition-.html https://biospectrumindia.com/news/57/13124/novartis-joins-the-global-chagas-disease-coalition-.html Tue, 19 Mar 2019 09:00:00 +0530 At the Annual Meeting of the Global Chagas Disease Coalition in Barcelona, Spain, Novartis announced that it is joining the Coalition as a member contributor. In addition, the company announced its commitment to launch a multinational, prospective, randomized study with heart failure drug, Entresto® (sacubitril / valsartan), in people with chronic Chagas cardiomyopathy, one form of heart failure with reduced ejection fraction. This is the first definitive morbidity and mortality study to assess a potential therapy for cardiac disease in this underserved patient population. The clinical trial will assess the efficacy and safety of Entresto vs. enalapril and is expected to start within 2019, with the aim of recruiting approximately 900 patients with confirmed Chagas disease in Latin America. The primary endpoint is time to occurrence of a composite of cardiovascular events, including cardiovascular death or first hospitalization due to heart failure. This definitive study follows an exploratory post hoc analysis from the PARADIGM-HF trial, which suggested that Entresto may have beneficial effects in people with chronic Chagas cardiomyopathy and heart failure with reduced ejection fraction. At the same time, Novartis is working with stakeholders in endemic countries to co-develop tailored access-to-medicine programs and health system strengthening strategies to help ensure lower-income patients suffering from chronic Chagas cardiomyopathy can benefit from the best available treatment. Chagas disease, also known as American trypanosomiasis, is a potentially life-threatening neglected tropical disease estimated to affect approximately six million people globally and is responsible for approximately 12 000 deaths annually. The disease is endemic in 21 Latin American countries, where it is the second leading cause for developing chronic heart failure. Novartis is also taking steps to advance research efforts around the disease and is committed to providing mentorship opportunities for scientists from Latin America to help strengthen capacity for relevant research regionally. The Novartis Institute for Tropical Diseases (NITD), the Genomics Institute of the Novartis Research Foundation (GNF) and collaborators have developed a promising portfolio of novel drug candidates for the treatment of kinetoplastid diseases. The proteasome inhibitor LXE408 was recently advanced as a promising drug candidate for the treatment of visceral leishmaniasis. This novel mechanism of action is also being explored for other indications, including Chagas disease.   In addition, Novartis is partnering with the World Heart Federation to develop an end-to-end roadmap for addressing Chagas disease. The final roadmap is expected to be launched within 2019. In parallel, we are working together with different stakeholders in Latin American countries, such as Argentina and Colombia, to support existing national plans for an integrated care approach to Chagas disease. ]]> https://biospectrumindia.com/news/57/13128/bionano-genomics-enters-into-debt-and-equity-financing-agreements-totaling-41-5m-in-commitments.html https://biospectrumindia.com/news/57/13128/bionano-genomics-enters-into-debt-and-equity-financing-agreements-totaling-41-5m-in-commitments.html Mon, 18 Mar 2019 15:30:00 +0530 Bionano Genomics, a life sciences instrumentation company that develops and markets Saphyr, a platform for ultra-sensitive and ultra-specific structural variation detection in genome analysis has announced it has entered into financing agreements totaling $41.5 million in debt and equity commitments from affiliates of Innovatus Capital Partners, LLC, East West Bank and Aspire Capital Fund, LLC.   The Company has entered into a Loan and Security Agreement with an affiliate of Innovatus Capital Partners and East West Bank. Innovatus has agreed to make term loans in the aggregate of $25.0 million available to the Company, with funding of $20.0 million expected to occur on or about March 22, 2019. The Company will be eligible to draw on a $5.0 million second tranche upon achievement of certain financial milestones. The Company intends to use approximately $11 million of the term loan proceeds to terminate its existing debt with Midcap Financial Services, LLC. In addition, Innovatus will receive 3.75% warrant coverage on each tranche of the term loan. Pursuant to the agreement, East West Bank has agreed to make a revolving line of credit of up to $5.0 million available to the Company.   The Company has entered into a Common Stock Purchase Agreement with affiliates of Innovatus, pursuant to which such affiliates purchased 406,504 shares of the Company’s common stock for an aggregate purchase price of $1.5 million. The Company also entered into a Registration Rights Agreement with the purchasers of its common stock to facilitate the sale and distribution of all or a portion of such shares pursuant to a registration statement to be filed with the SEC. The Company has entered into a Common Stock Purchase Agreement for up to $10.0 million with Aspire Capital. Aspire has made an initial purchase of 272,479 shares of the Company’s common stock for an aggregate purchase price of $1.0 million. In addition, Aspire Capital has committed to purchase up to $9.0 million of additional shares of the Company’s common stock upon the Company’s request from time to time during a 30-month period and at prices based on the market price at the time of each sale. There are no warrants, derivatives or other securities associated with this agreement. As consideration for Aspire Capital’s obligations under the Agreement, the Company issued 69,444 shares of its common stock to Aspire Capital as a commitment fee. The Company also entered into a Registration Rights Agreement with Aspire Capital that requires the Company to file a registration statement for the resale of the shares sold to Aspire Capital. “Bionano’s technology for detection of structural variants in patients with genetic disease and cancer has the potential to simplify the current diagnostic odyssey and shorten the search for answers,” commented Claes Ekstrom, Managing Director at Innovatus. “We are excited to support Bionano’s quest to yield genetic information for patients that has long been unavailable.” “Given management’s proven track record, attractive comparable valuations based on recent M&A activity, independent validation of the technology platform through publication in high impact journals, and continued progress in improving both cost and throughput of the system, we are very pleased to establish this long-term financial partnership and to support Bionano’s pioneering efforts in the field of digital cytogenetics,” said Steven G. Martin, Managing Member of Aspire Capital. “Through our diligence, we’ve come to recognize the significant limitations conventional technologies have in identifying large structural variants. We believe that Saphyr enables the elucidation of these genomic changes and their potential far-reaching impact on human biology.” “The financing enables us to further develop our global commercialization strategy and enhances our ability to drive the adoption of the Saphyr system,” said Erik Holmlin, Ph.D., CEO of Bionano. “We are delighted to be partnering with Innovatus Capital, East West Bank and Aspire Capital. We are also pleased to have lengthened our current cash runway in such a capital-efficient manner.” ]]> https://biospectrumindia.com/news/57/13115/bpu-international-with-seva-technology-to-create-ai-healthcare-application.html https://biospectrumindia.com/news/57/13115/bpu-international-with-seva-technology-to-create-ai-healthcare-application.html Fri, 15 Mar 2019 14:35:00 +0530 BPU Holdings' entity in the US, BPU International, has partnered with SEVA Technology to collaborate on research and implementation of AEI Framework, an Artificial Emotional Intelligent (AEI) platform.  The project will focus on creating an Artificial Intelligent (AI) mobile application to aid hospital patients with the detection and potential treatment of Delirium and Dementia. Both companies are collaborating to effectively apply AEI Framework technology within hospitals; starting in Arizona. The project includes building an AEI-based chatbot, framework and interactive applications using human conversational scripts, developed by BPU. The application will be designed to track patient's moods as well as interact and engage with patients on emotional levels, which are intrinsically tied to their physical status. AEI Framework will be able to track and learn their routine patterns and set reminders for medication and assess both psychological and physical symptoms outside the doctor's office. Using IoT devices, the technology has the ability to detect unwanted falls and high distress levels that will immediately alert hospitals and the patient's doctor. Medical experts expect the application to be particularly beneficial for long-term care and for seniors who show early signs of delirium and dementia. The prototype will be single-user based, while eventually expanding to a multi-user system. Patient privacy will be HIPAA compliant as all patient records and data will be made private and accessible only to the patient and medical personnel. Records will be cloud-based and encrypted, accessible only by authorization. The application will be built as a commercially viable prototype to be deployed to hospitals as part of the research. Clinical trials are in motion and the project is expected to be ready within two to three years. ]]> https://biospectrumindia.com/news/57/13113/corin-acquires-surgical-robotic-leader-omni-orthopedic.html https://biospectrumindia.com/news/57/13113/corin-acquires-surgical-robotic-leader-omni-orthopedic.html Fri, 15 Mar 2019 13:20:00 +0530 Orthopedic company Corin Group ("Corin"), backed by the Permira funds, has acquired the US-based OMNI Orthopedics ("OMNI"), a pioneer in robotic-assisted total knee replacement. It is further evidence of Permira and their co-investors' determination to accelerate Corin's strong organic growth with a focused M&A strategy. Founded in 1999 by a team of medical device engineers, OMNI is now at the forefront of robotic-assisted knee replacement. Their OMNIBotics® is a unique imageless total knee replacement solution which combines a robotic cutting guide with the world's first robotic tool to measure ligament function. The system allows tailoring of the implant positioning to each individual patient, resulting in less patient pain and faster rehabilitation.   Corin's strategy is to revolutionize orthopedics by gaining, understanding and sharing insight at every stage of the joint replacement experience and delivering  clinically proven implants which are optimized by unique procedural technologies. OMNIBotics®, combined with APEX knee replacement, accelerates Corin's strategy.   Corin is creating a connected digital ecosystem that combines biomechanical, physiological and logistical information to generate insight; this ecosystem will empower patients throughout their treatment journey and support surgeons to improve patient outcomes and maximize value for the healthcare system. This is Connected Orthopaedic Insight. ]]> https://biospectrumindia.com/news/57/13101/gencove-builds-up-3m-to-expand-genome-sequencing-platform-.html https://biospectrumindia.com/news/57/13101/gencove-builds-up-3m-to-expand-genome-sequencing-platform-.html Thu, 14 Mar 2019 16:40:00 +0530 Gencove, the leading low-pass genome sequencing platform, announced a $3 million investment led by Spero Ventures. Alexandria Venture Investments and Burst Capital participated in the round, along with existing investors Third Kind Venture Capital and Version One Ventures. The funding will be used to develop new applications for agricultural markets as well as expand Gencove's commercial operations in human genetics. Shripriya Mahesh, partner at Spero, will join Gencove's board of directors. "Genomics will be foundational to the health and well-being of humanity and the planet," said Shripriya Mahesh. "We are excited partner with Gencove in its mission to bring affordable whole genome sequencing to customers and industries that have never before been able to affordably integrate it at scale." "With their operational expertise and experience in scaling software companies, Spero is the ideal partner as we expand Gencove into new markets," said Joe Pickrell, CEO of Gencove. "We're excited to have a partner on board that brings a deep understanding of opportunities in both human and agricultural genomics." Founded by leading scientists from the New York Genome Center, Gencove develops technologies that enable high-throughput and low-cost genome sequencing. Using its innovative genome imputation technology, Gencove delivers high quality genomic interpretation from small amounts of sequencing data. Gencove's technology partners include BGI and SeqWell. Customers span consumer, clinical, and agricultural markets and include leading academic institutions like the Broad Institute, University of Michigan, and Oxford University. ]]> https://biospectrumindia.com/news/57/13094/labshares-unveils-newly-expanded-lab-space-in-newton.html https://biospectrumindia.com/news/57/13094/labshares-unveils-newly-expanded-lab-space-in-newton.html Thu, 14 Mar 2019 10:45:00 +0530 LabShares Newton, a laboratory incubator for emerging biotechnology and life science companies has unveiled its newly expanded co-working lab and office space. LabShares is a fully equipped shared laboratory for early-stage research companies seeking a collaborative, cost-effective, and entrepreneurial working environment. Mayor of Newton Ruthanne Fuller and John Hallinan, Chief Business Officer at MassBio, attended the reception and ribbon cutting ceremony at LabShares to mark this important occasion. LabShares launched near capacity in October 2018. Due to high demand for affordable, shared office and lab space, the company embarked on a plan to double the size of its footprint to 12,000 square feet, expanding the facility to support up to 30 companies. LabShares’ fully-permitted, professionally maintained facility provides turnkey access to cutting-edge lab instrumentation and equipment so members can immediately start scientific experiments. Basic administrative support, shipping and receiving, access to conference rooms, a fully-stocked kitchen, and other office park amenities, including a fitness center with showers, indoor bike storage, a café and free parking, are all included in a single monthly fee. Members include: AffyImmune Therapeutics, Abcuro Inc., ArrowDots BioMedicals, Extend Biosciences, Harbour Biomed, Siamab Therapeutics, and JA Bio. “LabShares is committed to creating a dynamic community for life science start-ups in Newton,” said Jeff Behrens, Co-founder and Chief Executive Officer of LabShares. “Our goal is to provide a cutting-edge lab and work space at a cost-effective price, and to offer the necessary services, resources, professional development, and networking opportunities to provide a foundation for biotech start-ups to thrive. As vacancy rates for biotech lab and office space continue to fall and rents continue to rise in Cambridge, emerging companies are looking elsewhere for space. With our recent expansion, LabShares is uniquely positioned to meet this growing demand.” To mark the occasion, LabShares has announced a new pitch competition called Launch@LabShares. Together with the support of two sponsors—DT Ward PC, an intellectual property law firm, and Faber Daeufer & Itrato PC, a life-science focused law firm—LabShares is giving away a free, one-year membership valued at $50,000 to an emerging biotech company. The winner will have access to shared office and lab space for one scientist as well as all resources and amenities at LabShares. Added Mr. Behrens, “We are excited to offer a year-long membership to a biotech start-up through our Launch@LabShares contest and help support new and emerging companies in the space. We hope that LabShares will become a central part of the growing life science ecosystem. With this goal in mind, we are also rolling out a monthly lunchtime speaker series to provide members with a forum for information exchange and to learn about industry best practices.” The Lunches@LabShares speaker series provides networking and professional development opportunities to its members and covers best practices and hot topics in life sciences. Speakers include biotech executives, investors and service providers. The lunchtime speaker series will be held at LabShares. Free lunch will be provided. A limited number of spots will be made available to the broader biotech community. LabShares Newton is an office and laboratory incubator for emerging biotechnology and life science start-ups. The shared space provides a collaborative, affordable and entrepreneurial research environment for early-stage companies in a convenient location close to Cambridge and Boston. LabShares has developed a state-of-the-art facility that is fully permitted and professionally maintained and offers a variety of support services and amenities. ]]> https://biospectrumindia.com/news/57/13093/william-hodder-joins-escient-pharmaceuticals-as-chief-business-officer.html https://biospectrumindia.com/news/57/13093/william-hodder-joins-escient-pharmaceuticals-as-chief-business-officer.html Thu, 14 Mar 2019 10:40:00 +0530 Escient Pharmaceuticals, a biotechnology company advancing first-in-class G Protein Coupled Receptor (GPCR)-targeted drugs to address unmet needs for a broad range of therapeutic indications has announced that William Hodder has joined the company as Chief Business Officer. Hodder brings more than 30 years of broad biopharmaceutical industry experience including business development, corporate strategy, product marketing, sales, fundraising and product development. As a member of Escient’s executive team, Mr. Hodder will report to the company’s Chief Executive Officer Alain Baron, M.D. “I am thrilled to welcome Bill to the growing Escient family,” said Dr. Baron. “We are urgently translating our proprietary insights about the biology and functions of the largely unexplored family of Mas-Related G-Protein Receptors, or Mrgprs, to discover novel therapies for serious, unserved medical needs across a broad range of therapeutic indications. As our pipeline continues to advance, Bill will be instrumental in leading all aspects of our planning and growth strategy.” Launched in May 2018, Escient is focused on unleashing the therapeutic potential of specific orphan Mrgprs. Escient is initially pursuing therapies for neuro-immuno-inflammatory and autoreactive diseases. The company is using proceeds from its $40 million Series A financing, syndicated by The Column Group and 5AM Ventures and joined by Osage University Partners, to build out its team, advance its pipeline, and progress its initial preclinical programs to clinical study. “I am very excited to join the Escient team, particularly at this early stage,” said Mr. Hodder. “What’s particularly thrilling about Escient is the ‘white space’-nature of the opportunity – a novel, yet unexplored family of GPCRs that, once harnessed, have the potential to unlock medical solutions for a broad spectrum of patients who today have no effective treatment options. I look forward to working closely with Alain and the team to create a solid business infrastructure to strategically support the promise of Escient’s science.” Escient has made several other key hires since its launch, including Esther Martinborough, Ph.D., as Vice President of Chemistry; Richard Pittner, Ph.D., as Vice President of Biology, and Gregg Timony, MS, as Senior Director of DMPK-Toxicology. “Ensuring we have the right team in place is critical to our near- and long-term success and our ability to deliver a pipeline of novel therapies for patients,” said Dr. Baron. “We are extremely fortunate to have recruited this top-notch talent, who are also just a wonderful group of dedicated, passionate, patient-focused people, over the past few months. We look forward to continuing to add to our team in the months ahead.” Prior to joining Escient, Mr. Hodder was most recently a corporate and business development consultant, advising multiple private and public biotech companies on partnering and fundraising matters. Previously, he was Senior Vice President, Corporate Development at Protagonist Therapeutics (Nasdaq: PTGX), a clinical stage biotech company where he was responsible for all licensing and alliance management as well as certain fundraising and operations activities. At Protagonist, Mr. Hodder led, or played a significant role in, licensing and fundraising transactions that raised over $220 million including the licensing of a pre-clinical asset to Janssen Biotech for upfront and future milestone payments totaling $990 million. Prior to joining Protagonist, Mr. Hodder was a co-founder and CEO of Trenovus, Inc., a biotech company focused on developing novel inhibitors of heterotopic ossification present in several serious and rare conditions including Ankylosing Spondylitis and Fibrodysplasia Ossificans Progressiva. Mr. Hodder also previously served as Vice President of Business Development and Corporate Officer at FibroGen, Inc., where he was responsible for all licensing and M&A activity, raising over $500 million for the company. This included the out-licensing of HIF prolyl hydroxylase inhibitors for anemia indications to Astellas for the European, South Africa and Middle East territories. Prior to joining FibroGen, Mr. Hodder served as Director of Business Development and Marketing at Aradigm, a drug delivery company. He has also held sales, marketing, and product development positions at Penederm (acquired by Mylan Laboratories), Ciba Geigy (now Novartis), Bristol-Myers Squibb Company, and Marion Laboratories (now Sanofi). Mr. Hodder received a B.S. in biology from Oakland University and an M.B.A. from The University of Chicago Booth School of Business.   ]]> https://biospectrumindia.com/news/57/13092/oxford-nanopore-launches-flongle-for-rapid-smaller-dna-rna-sequencing-tests.html https://biospectrumindia.com/news/57/13092/oxford-nanopore-launches-flongle-for-rapid-smaller-dna-rna-sequencing-tests.html Wed, 13 Mar 2019 17:40:00 +0530 Oxford Nanopore has made Flongle starter packs available for purchase after initial testing in an early-access programme.  Flongle introduces a new paradigm of smaller, on-demand DNA or RNA sequencing tests, with the potential to transform a range of applications where rapid insights are required at low cost. Oxford Nanopore's goal is to enable the analysis of any living thing, by anyone, anywhere. Flongle is designed to bring this goal closer and to also allow low-cost sequencing at any time. With its compact format, Flongle opens up possibilities of on-demand testing in a broad range of locations, from scientific laboratories to farms and factories, healthcare settings, outdoor environments or classrooms. Flongle is an adapter for the portable MinION and desktop GridION X5 sequencing devices. It uses the same core nanopore sequencing technology as other Oxford Nanopore devices, producing real-time data, direct sequencing and long reads. The small Flongle flow cells can currently produce as much as 1.8 Gb of sequence data with headroom for more than 3 Gb. This enables many sequencing experiment types, including small-genome sequencing, targeted panels/amplicon sequencing, metagenomics for the identification of viruses, bacteria or characterisation of microbiomes, or species ID. It can also be used for quality control for larger nanopore experiments. At $90 per flow cell, Flongle allows on-demand sequencing at an affordable price point, without needing to wait for the large batches of samples that are often required to achieve low per-test costs on traditional sequencing devices. The workflow is fast and simple, with library preparation in as little as ten minutes and real-time data analysis. Dr Matt Loose, from DeepSeq, School of Life Sciences, University of Nottingham, has been testing the Flongle as part of an early access programme. "We've been using Flongle for testing and developing new protocols such as CRISPR/Cas9 selection for targeting select regions of the human genome, as well as working up new samples before running at scale on PromethION.  We've been very happy with throughput and yield on early access flow cells and are looking forward to incorporating production-ready Flongle into our workflows. It will be really interesting to see how users apply Flongle in the field." Miten Jain, from the University of California, Santa Cruz, has also been trialling Flongle: "Flongle-based sequencing is the best way to check a nanopore library. At UC Santa Cruz, we now routinely sequence native RNA and genomic DNA libraries on a Flongle Flow Cell before scaling them to our PromethION.  We have observed that Flongle-based sequencing is a good predictor of library quality and its performance on the PromethION.  Flongle also permits experimental tests at a more affordable scale and will be an integral part of our nanopore work going forward." Dr Justin O'Grady is a translational researcher from University of East Anglia, UK.  He has been developing nanopore-based research methods for the rapid metagenomic characterisation of pathogens in clinical samples from patients with pneumonia or urinary tract infections.  "I am excited about how Flongle can help identify pathogens and antimicrobial resistance more quickly, and how such technologies could be used in settings much closer to patients in the future."  ]]> https://biospectrumindia.com/news/57/13085/ireland-to-lead-7-million-parkinsons-research-project.html https://biospectrumindia.com/news/57/13085/ireland-to-lead-7-million-parkinsons-research-project.html Wed, 13 Mar 2019 13:20:00 +0530 A new research study aims to deepen the understanding of Parkinson’s so that better treatments can be developed in the future. The project, which will be coordinated by RCSI, has been awarded €7m by the Innovative Medicines Initiative (IMI) with pharmaceutical industry and patient advocacy partners.  The PD-MitoQUANT project aims to increase understanding of how cells in the brain become damaged in Parkinson’s so more effective treatments can be developed for the one million people living with Parkinson’s in Europe today, including 12,000 people in Ireland.  The researchers will focus on parts of the cell, known as mitochondria, that malfunction in people with Parkinson’s. Mitochondria contribute to cell death and neurodegeneration and there is growing evidence of their role in Parkinson’s, but no effective treatments have been developed based on this knowledge.  The EU public-private partnership funding health research and innovation chose the project as it recognises that new, more effective treatments are urgently needed. The most common drug to treat Parkinson’s used in Ireland is more than 50 years old, and no current treatment can stop, slow or reverse the condition.  The key PD-MitoQUANT Investigators based at RCSI are Dr Niamh Connolly and Dr Orla Watters, Department of Physiology and Medical Physics and Centre for Systems Medicine, who will be focusing their research on Parkinson’s in the coming years.  The project involves 14 partners from nine countries, including: academic experts from: RCSI (Royal College of Surgeons in Ireland); Institut du Cerveau et de la Moelle Epinière; German Center for Neurodegenerative Diseases (DZNE); Neuroscience Institute of the National Research Council; University College London; Radboud University Nijmegen Medical Centre; the Centre National de la Recherche Scientifique SMEs: GeneXplain GmbH; Mimetas B.V.; Pintail Limited pharmaceutical companies from the EFPIA members: Teva Pharmaceutical Industries Ltd.; H. Lundbeck A/S and UCB S.A. patient advocacy organisation: Parkinson’s UK  With the project kick-off meeting taking place this month, the project will run for three years, receiving €4.5m in funding from the EU’s Horizon 2020 programme and €2.46m in-kind from European Federation of Pharmaceutical Industries and Associations (EFPIA) members and Parkinson’s UK.   The project has been announced to coincide with National Brain Awareness Week which takes place from 11-17 March ]]> https://biospectrumindia.com/news/57/13083/ajinomoto-bio-pharma-services-announces-its-assets-expansion.html https://biospectrumindia.com/news/57/13083/ajinomoto-bio-pharma-services-announces-its-assets-expansion.html Wed, 13 Mar 2019 11:50:00 +0530 Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading global company which is fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. The company has provided an update on several of its capital projects currently underway in both the United States and Belgium.  These projects total over $100 Million and will further expand Aji Bio-Pharma's offerings and capabilities globally.   In addition to the previously announced highly potent product conjugation and fully isolated fill line which has recently commenced operations in its new state of the art facility in San Diego, Aji Bio-Pharma is also adding a new fully isolated, nested flexible fill line, installing automated packaging and labeling equipment, and upgrading its continuous flow and small molecule API manufacturing capabilities.  ]]> https://biospectrumindia.com/news/57/13079/rocket-pharmaceuticals-sponsors-clinical-trial-at-ucla.html https://biospectrumindia.com/news/57/13079/rocket-pharmaceuticals-sponsors-clinical-trial-at-ucla.html Wed, 13 Mar 2019 10:35:00 +0530 Rocket Pharmaceuticals, a leading U.S.-based multi-platform gene therapy company, has announced a research agreement to support the clinical development of Rocket’s lentiviral vector (LVV)-based gene therapy programs in Leukocyte Adhesion Deficiency-I (LAD-I) and Infantile Malignant Osteopetrosis (IMO) towards registrational trials. Rocket’s LVV-based gene therapy program for LAD-I, RP-L201, is in clinical development with Rocket’s European partners at the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT). The LVV-based gene therapy for IMO, RP-L401, is in preclinical development in Sweden with European partner Lund University.   UCLA and its Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research will serve as the lead U.S. clinical research center for the planned registrational clinical trial for LAD-I and also a lead U.S. clinical site for IMO. Donald B. Kohn, M.D., Professor of Microbiology, Immunology and Molecular Genetics, Pediatrics (Hematology/Oncology), and Molecular and Medical Pharmacology at UCLA, will serve as the principal investigator for the planned trials and will oversee the management of the clinical trial site. Additional terms of the agreement were not disclosed. “Rocket has put the building blocks in place to execute upon our strategy to transform our pipeline with precision and exigency. Dr. Kohn was chosen to lead the LAD-I and IMO programs as he shared our passion for gene and cellular therapy research for rare diseases,” said Gaurav Shah, M.D., Chief Executive Officer and President of Rocket. “We look forward to initiating our first clinical trial for LAD-I in the coming months and advancing our IMO program towards the clinic in 2020.” Rocket’s Investigation New Drug (IND) application for RP-L201 was cleared by the U.S. Food and Drug Administration (FDA) in 2018. The Company expects to initiate a Phase 1/2 clinical trial in support of registration in the second quarter of 2019. The Phase 1 portion of the trial will assess the safety and tolerability of RP-L201. The Phase 2 portion of the trial will evaluate overall survival. ]]> https://biospectrumindia.com/news/57/13078/who-launches-new-global-influenza-strategy.html https://biospectrumindia.com/news/57/13078/who-launches-new-global-influenza-strategy.html Wed, 13 Mar 2019 10:15:00 +0530 WHO has released a Global Influenza Strategy for 2019-2030 aimed at protecting people in all countries from the threat of influenza. The goal of the strategy is to prevent seasonal influenza, control the spread of influenza from animals to humans, and prepare for the next influenza pandemic. Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, “The threat of pandemic influenza is ever-present. The on-going risk of a new influenza virus transmitting from animals to humans and potentially causing a pandemic is real. The question is not if we will have another pandemic, but when.  We must be vigilant and prepared – the cost of a major influenza outbreak will far outweigh the price of prevention.” Influenza remains one of the world’s greatest public health challenges. Every year across the globe, there are an estimated 1 billion cases, of which 3 to 5 million are severe cases, resulting in 290 000 to 650 000 influenza-related respiratory deaths. WHO recommends annual influenza vaccination as the most effective way to prevent influenza. Vaccination is especially important for people at higher risk of serious influenza complications and for health care workers. The new strategy is the most comprehensive and far-reaching that WHO has ever developed for influenza.  It outlines a path to protect populations every year and helps prepare for a pandemic through strengthening routine programmes. It has two overarching goals: Build stronger country capacities for disease surveillance and response, prevention and control, and preparedness. To achieve this, it calls for every country to have a tailored influenza programme that contributes to national and global preparedness and health security. Develop better tools to prevent, detect, control and treat influenza, such as more effective vaccines, antivirals and treatments, with the goal of making these accessible for all countries. “With the partnerships and country-specific work we have been doing over the years, the world is better prepared than ever before for the next big outbreak, but we are still not prepared enough,” said Dr Tedros. “This strategy aims to get us to that point. Fundamentally, it is about preparing health systems to manage shocks, and this only happens when health systems are strong and healthy themselves.” To successfully implement this strategy, effective partnerships are essential.  WHO will expand partnerships to increase research, innovation and availability of new and improved global influenza tools to benefit all countries.  At the same time WHO will work closely with countries to improve their capacities to prevent and control influenza. The new influenza strategy builds on and benefits from successful WHO programmes.  For more than 65 years, the Global Influenza Surveillance and Response System (GISRS), comprised   of WHO Collaborating Centres and national influenza centres, have worked together to monitor seasonal trends and potentially pandemic viruses. This system serves as the backbone of the global alert system for influenza.  Important to the strategy is the on-going success of the Pandemic Influenza Preparedness Framework, a unique access and benefit sharing system that supports the sharing of potentially pandemic viruses, provides access to life saving vaccines and treatments in the event of a pandemic and supports the building of pandemic preparedness capacities in countries through partnership contributions from industry. The strategy meets one of WHO’s mandates to improve core capacities for public health, and increase global preparedness and was developed through a consultative process with input from Member States, academia, civil society, industry, and internal and external experts. Supporting countries to strengthen their influenza capacity will have collateral benefits in detecting infection in general, since countries will be able to better identify other infectious diseases like Ebola or Middle East respiratory syndrome-related coronavirus (MERS-CoV). Through the implementation of the new WHO global influenza strategy, the world will be closer to reducing the impact of influenza every year and be more prepared for an influenza pandemic and other public health emergencies.   ]]> https://biospectrumindia.com/news/57/13073/regeneron-sanofis-dupixent-gets-fda-nod-to-treat-teens-atopic-dermatitis-.html https://biospectrumindia.com/news/57/13073/regeneron-sanofis-dupixent-gets-fda-nod-to-treat-teens-atopic-dermatitis-.html Tue, 12 Mar 2019 16:15:00 +0530 Regeneron Pharmaceuticals and Sanofi  announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids. "For the first time, adolescents with uncontrolled moderate-to-severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms such as chronic itch and widespread rash. Today's approval expands the use of Dupixent in the U.S. to include both adults and adolescents with atopic dermatitis or moderate-to-severe asthma," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "Given that Dupixent targets a key pathway in type 2 inflammation, we are also investigating it in a broad development program in patients with other type 2 inflammatory diseases including eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, where we recently announced positive Phase 3 results and Priority Review of a U.S. regulatory submission, and food and environmental allergies." Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases. The FDA evaluated the Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. Dupixent was also granted Breakthrough Therapy designation by the FDA for inadequately controlled moderate-to-severe atopic dermatitis in adolescents. The Breakthrough Therapy designation was created to expedite the development and review of drugs developed for serious or life-threatening conditions.   Dupixent has been studied in more than 7,000 patients 12 years and older in over 30 clinical trials. The safety profile of Dupixent in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis, and consistent through 52 weeks. ]]> https://biospectrumindia.com/news/57/13072/pharma-tech-startup-to-offer-b2b-platform-for-pharma-traders.html https://biospectrumindia.com/news/57/13072/pharma-tech-startup-to-offer-b2b-platform-for-pharma-traders.html Tue, 12 Mar 2019 14:40:00 +0530 Pharmaoffer, a new start-up, has announced its collaboration with pharmaceutical suppliers. This is to resolve medicine shortages around the world. This tech-pharma start-up presents a global B2B platform where suppliers of pharmaceutical raw materials can offer their products. By using Pharmaoffer, producers of medicines can easily find new qualified suppliers for their raw material needs. It cuts out the middleman and this transparent solution reduces expenses and unnecessary delays in the supply chain by giving more control to all parties involved. The new start-up has recognized how the industry has been suffering from conservative issues. With this user-friendly platform, the industry can adapt to the internet generation and make use of its benefits to the generation where everything is found online. For the production of medicines, companies need raw materials from qualified suppliers. Medicines are a combination of active pharmaceutical ingredients (the actual drug itself) and excipients (inactive ingredients which are used as fillers/binders/coatings of the tablet). The process of finding new qualified suppliers for these raw materials is time-consuming because of all laws and regulations. With Pharmaoffer, buyers are no longer limited to their network of suppliers. The platform has successfully connected buyers and supplier from 172 countries. ]]> https://biospectrumindia.com/news/57/13071/pall-corp-broadley-james-to-provide-single-use-sensor-technologies-in-life-science-market.html https://biospectrumindia.com/news/57/13071/pall-corp-broadley-james-to-provide-single-use-sensor-technologies-in-life-science-market.html Tue, 12 Mar 2019 12:50:00 +0530 Pall Corporation, a global leader in filtration, separation and purification, has partnered with Broadley-James Corporation, a renowned sensor technology provider, to integrate and distribute Broadley-James’ advanced single-use probe and flow cell pH sensors. With applications across upstream and downstream unit operations, the sensor will be integrated into Pall Biotech’s single-use (SU) technologies, as well as other commercially available bioprocessing platforms.  The novel SU pH sensors leverage widely accepted glass electrochemical technology, the only method that meets international standards for pH measurement. The design includes a calibrated buffer storage environment for the sensor to eliminate previous constraints during pre-integration of glass pH sensors into consumables. Users will be able to operate in closed systems, without sacrificing performance.  “Customers currently rely on calibration data gathered before the sensor is sterilized, which can affect the measurement accuracy,” said Robert Garrahy, Vice-President at Broadley-James. “Our patent-pending new storage solutions design features a known pH buffer, enabling robust pre-use calibration. By pairing trusted technology with cutting-edge design, we are able to offer the best balance of risk reduction and performance.”  The Broadley-James single-use probe and flow cell pH sensors are currently in beta testing and when launched will be available exclusively through Pall Biotech. Parallel technical and process development support is also available to optimize use of this new technology. ]]> https://biospectrumindia.com/news/57/13069/sniffphone-device-to-detect-cancer-from-breath.html https://biospectrumindia.com/news/57/13069/sniffphone-device-to-detect-cancer-from-breath.html Tue, 12 Mar 2019 11:00:00 +0530 SniffPhone is a small sensor device developed for cancer screening that can be attached to a smartphone. In practice, the user holds the device in front of his or her mouth and exhales onto the sensor to give breath sample. The device measures the contained Volatile Organic Compounds (VOCs) using highly sensitive nanotechnology-based chemical sensors. The measurements are sent via Bluetooth using a smartphone to a dedicated cloud platform, where they are analysed by the appropriate medical personnel. The new cancer screening method has many advantages over traditional methods: the device is comfortable and painless to use. In addition, it provides a simple, fast and cost-effective alternative for screening gastric cancers. In the project, SniffPhone prototypes have been developed and validated by means of, for example, clinical studies. The next step in the project is finding financiers for this kind of novel cancer screening method. Commercialisation of the device is planned to take place through a spin-off company. VTT’s role as a visionary research, development and innovation partner in the project was the implementation of the platform for transferring data from the smartphone to a cloud-based storage space. VTT has also been building analysis tools and methods for recognising high-risk patients. In addition, VTT developed a mobile application that guides the user in giving a breath sample and provides the user with a preliminary analysis of the sample. Furthermore, a physician’s analysis tool has been developed to display the analysis results of breath samples. VTT was also in charge of the implementation of responsible research and innovation in the project by such methods as engaging final users and stakeholders in the development work through interviews and workshops and integrating responsible design practices into project operations. The SniffPhone project is part of the EU’s Horizon 2020 Funding Programme. The project consortium consists of nine partners: the coordinator Technion - Israel Institute of Technology (Israel), NanoVation (Israel), Cellix Ltd (Ireland), microfluidic ChipShop (Germany), University of Latvia (Latvia), University of Innsbruck (Austria), Siemens (Germany), JLM Innovation GmbH (Germany) and VTT. On 21 November 2018, the SniffPhone project was awarded the 2018 Innovation Award by the European Commission for Most Innovative Project. ]]> https://biospectrumindia.com/news/57/13061/envigo-launches-pathway-an-optimized-safety-assessment-solution-to-enable-first-in-human-clinical-trials.html https://biospectrumindia.com/news/57/13061/envigo-launches-pathway-an-optimized-safety-assessment-solution-to-enable-first-in-human-clinical-trials.html Mon, 11 Mar 2019 16:20:00 +0530 Envigo, a leading provider of non-clinical contract research services and research models has announced the launch of PATHWAY – an integrated solution that optimizes non-clinical safety assessment programs to enable first-in-human clinical trials. PATHWAY is designed to manage the complexity of the entire safety assessment process on behalf of the company’s pharmaceutical and biotechnology customers by integrating safety assessment study types and bioanalytical support with scientific and regulatory consulting, program design and project management. The decision to develop the PATHWAY solution was made in order to help the customers navigate the increased scientific and regulatory complexity facing advanced therapies going through safety assessment.  The intricacy of design and management of these critical non-clinical programs, and the level of interaction with regulatory bodies required, raises the risk of introducing delays and costs to development programs.  PATHWAY has been designed to leverage Envigo’s capacity, capabilities and experience in the field to optimize safety assessment programs and deliver translational biology insights to prepare customers for first-in-human clinical trials.  “Our deep expertise in the complex fields of biologics and advanced therapies adds particular value to our customers with drug development programs in these growing categories. On our customers’ behalf, we frequently work with regulators to determine the most appropriate interpretation of regulatory guidance as it applies to a specific therapeutic,” commented Lee Coney, Envigo’s Chief Scientific Officer. “PATHWAY makes full use of our beginning-to-end understanding of the safety assessment process, and optimizes the journey to first-in-human studies.  Experience of designing and conducting studies in a wide range of therapeutic modalities, and in working with regulatory agencies around the world, means we are able to anticipate the needs of a program at design stage, plan studies accordingly, and manage an optimal timeline of study execution,” Lee Coney added. With harmonized facilities with AAALAC accreditation in Europe and North America, Envigo further seeks to optimize safety assessment programs by ensuring studies are carried out at centers of excellence and where capacity permits the earliest possible start date for commencing work.  ]]> https://biospectrumindia.com/news/57/13053/gsk-gets-chmp-nod-for-zanamivir-to-treat-complicated-influenza.html https://biospectrumindia.com/news/57/13053/gsk-gets-chmp-nod-for-zanamivir-to-treat-complicated-influenza.html Mon, 11 Mar 2019 12:00:00 +0530 GSK recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for intravenous zanamivir for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when the patient’s influenza virus is known or suspected to be resistant to anti-influenza agents other than zanamivir, and/or other anti-viral agents for treatment of influenza, including inhaled zanamivir (Relenza), are not suitable for the individual patient. The marketing authorisation application was submitted under the exceptional circumstances regulatory legislation in the European Union. A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. When approved, the intravenous formulation of zanamivir will be known as Dectova. ]]> https://biospectrumindia.com/news/57/13054/stellar-biotechnologies-and-edesa-biotech-sign-share-exchange-agreement.html https://biospectrumindia.com/news/57/13054/stellar-biotechnologies-and-edesa-biotech-sign-share-exchange-agreement.html Mon, 11 Mar 2019 12:00:00 +0530 Stellar Biotechnologies, a leading manufacturer of a key protein utilized in immunotherapy and immuno-oncology development pipelines, has executed a share exchange agreement with privately-held Edesa Biotech Inc, a Canadian company, and Edesa's shareholders to create a company focused on the development of innovative therapeutics for dermatological and gastrointestinal indications with clear unmet medical needs. Under the terms of the share exchange agreement, Edesa shareholders have agreed to exchange their shares of Edesa for newly-issued common shares of Stellar. At the closing, Edesa will become a wholly-owned subsidiary of Stellar. Following the closing, current Stellar shareholders are expected to own approximately 10%, and the current shareholders of Edesa are expected to own approximately 90%, of the combined company on a fully-diluted basis, subject to a 2% upward or downward adjustment based upon the amount of Stellar's working capital balance immediately prior to the closing. Following the closing, Stellar will change its name to "Edesa Biotech Inc." "We believe this proposed business combination provides new growth opportunities for Stellar shareholders. We have been impressed with Edesa's management team and are looking forward to implementing a new vision for the combined company," said Frank R. Oakes, Stellar President and Chief Executive Officer. "This agreement marks another milestone for Edesa and our mission to efficiently develop novel, safe and effective treatments for conditions where patients have limited treatment options available," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "We believe we are at a significant inflection point in our company's history and look forward to offering shareholders additional value creation opportunities as we reach milestones in our clinical programs." The proposed transaction, which will result in a change in control, is expected to close during the second quarter of 2019, subject to customary closing conditions, including Stellar shareholder approval for the issuance of Stellar common shares to acquire Edesa. Following closing, Stellar intends to develop a plan for the disposition of Stellar's operations, which is expected to include the wind down or spin-off of Stellar's legacy business. Following a diligent review of strategic alternatives, Stellar's Board of Directors has determined that the share exchange agreement is fair and in the best interests of Stellar and Stellar's shareholders. ]]> https://biospectrumindia.com/news/57/13035/fda-agrees-for-priority-review-of-sanofis-dupixent-for-rhinosinusitis.html https://biospectrumindia.com/news/57/13035/fda-agrees-for-priority-review-of-sanofis-dupixent-for-rhinosinusitis.html Fri, 08 Mar 2019 13:20:00 +0530 Regeneron Pharmaceuticals and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patients with severe CRSwNP often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids. The target action date for the FDA decision is June 26, 2019. Currently, there are no FDA-approved biologic medicines to treat CRSwNP, a chronic disease of the upper airway predominantly driven by type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe CRSwNP despite previous treatment with surgery and/or systemic corticosteroids. About 60% of patients in the trials had co-morbid asthma. Data from these trials were presented at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in February 2019. In addition to moderate-to-severe atopic dermatitis and moderate-to-severe asthma, this is the third type 2 allergic inflammatory disease in which Dupixent has demonstrated positive Phase 3 results. Dupixent is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 and interleukin-13 (IL-4 and IL-13). The findings from these trials, as well as from prior trials in atopic dermatitis and asthma, demonstrate that both IL-4 and IL-13 are two key proteins that play a central role in type 2 inflammation, which seems to underlie CRSwNP as well as several other allergic diseases. Other potential uses for Dupixent, including in CRSwNP, are investigational and the safety and efficacy have not been evaluated by the FDA, the EMA or any other regulatory authority.  ]]> https://biospectrumindia.com/news/57/13031/philips-acquires-carestream-health-biz-to-expand-ri-portfolio.html https://biospectrumindia.com/news/57/13031/philips-acquires-carestream-health-biz-to-expand-ri-portfolio.html Fri, 08 Mar 2019 12:25:00 +0530 Royal Philips a global leader in health technology announced that it has signed an agreement to acquire the Healthcare Information Systems business of Carestream Health Inc., a US-based provider of medical imaging and healthcare IT solutions for hospitals, imaging centers and specialty medical clinics. Carestream’s cloud-based enterprise imaging platform will augment Philips’ current radiology informatics (RI) offering for imaging data management, workflow enhancement, and advanced visualization and analysis. Moreover, Carestream’s Healthcare Information Systems business and installed base in Latin America, Europe and Asia are highly complementary to Philips’ market leadership in high-end radiology informatics in North America.  Philips expects to complete the transaction in the second half of 2019, subject to customary closing conditions, including the relevant regulatory approvals. Financial details of the transaction were not disclosed.  Philips’ current enterprise imaging solutions combine deep clinical and informatics expertise with technological innovation to securely connect patients, care teams, and data across entire health systems. Its visualization and analysis applications use adaptive intelligence to support the clinician at the point-of-care by providing clinical insights and improving collaboration among clinical teams.  Upon completion of the transaction, Philips will feature Carestream’s cloud-based enterprise imaging platform—including state-of-the-art Vendor Neutral Archive (VNA), diagnostic and enterprise viewers, multimedia reporting, workflow orchestrator and clinical, operational and business analytics tools—as part of its expanded portfolio. The Healthcare Information Systems business and its approximately 900 employees will become part of Philips’ Healthcare Informatics business within the Diagnosis & Treatment segment.  ]]> https://biospectrumindia.com/news/57/13022/medical-electronics-market-to-exceed-169-b-till-2025.html https://biospectrumindia.com/news/57/13022/medical-electronics-market-to-exceed-169-b-till-2025.html Thu, 07 Mar 2019 11:50:00 +0530 The Medical Electronics Market is set to grow from its current market value of more than $73.3 billion to over $169 billion by 2025; as reported in the latest study by Global Market Insights, Inc. Availability of medical equipment and devices on lease will escalate its demand among healthcare professionals thereby positively influencing the industry growth. Most of the medical electronics available in market are expensive due to integration of advanced technology. Hospitals, diagnostic centers and individual medical practitioners are reluctant to buy them due the huge investment required, and it takes good amount of time to recover the cost. The direct purchase cost of technologically advanced medical devices is high, and the cost of entire healthcare setup can rise steeply. Rising adoption of technologically advanced medical electronic devices in emerging economies such as India and China will significantly boost the industry growth during the analysis period. Although the medical electronic devices are expensive, several government initiatives and favorable FDI policies will trigger the adoption of these devices among the healthcare professionals. However, stringent regulations enforced on the companies involved in manufacturing of medical electronic devices will restrain the industry growth in the forthcoming years. Respiratory care devices segment was valued over USD 6 billion in 2018 and is expected to have considerable revenue size during the forecast timeframe. Growth can be attributed to the increasing prevalence of respiratory diseases such as COPD and asthma. According to Global Asthma Network, asthma kills around 1000 people every day globally that surges the demand for respiratory care devices thereby propelling segmental growth in foreseeable future. Clinics segment will experience 13.2% growth during the forecast timeframe. Considerable segmental growth will be as a result of high adoption rate for medical electronic equipment due to the advent of innovative and cost-effective devices. For instance, ultrasound equipment typically designed for hospitals are now being deployed at clinics. The portable ultrasound machine cost less than full sized equipment. Cost containment pressure from regulatory authorities is driving innovation aimed at introducing cost effective devices with improved performance that will boost the segment growth. China medical electronics market witnessed 13.4% growth during the analysis period and is anticipated to grow exponentially over forecast timeframe. Growing geriatric population is expected to drive the growth. According to China News Service, by the end of 2017, there were around 241 million people in the age group of 60 years and above. Majority of the elderly population base suffers from chronic ailments that raise the demand for medical electronics accelerating the industry growth.      Germany medical electronics market accounted for 27.6% revenue share of Europe market. Technological integrations by the local players operational in medical electronics market have ensured country share. Additionally, the regulations raise entry barriers for the new industry player to establish themselves in Germany that is beneficial for the local players for earning sustainable profits. Key industry players operational in medical electronics industry include Allengers Medical,Boston Scientific, Carestream Health, FUJIFILM Medical Systems, GE Healthcare, Hitachi High Technologies, Corporation Maxim Integrated, Medtronic, Olympus Corp., Philips Healthcare and others. These players implement several strategic initiatives such as collaborations, new product launch, mergers and acquisitions to acquire potential market share. ]]> https://biospectrumindia.com/news/57/13021/researchers-discover-novel-treatment-for-chronic-lung-disease.html https://biospectrumindia.com/news/57/13021/researchers-discover-novel-treatment-for-chronic-lung-disease.html Thu, 07 Mar 2019 11:35:00 +0530 Researchers at Queen’s University Belfast have discovered a novel experimental treatment for chronic lung diseases that could improve the lives for people with Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD). Researchers have found that the symptoms associated with both diseases can be alleviated through inhibiting the activity of an enzyme found in the lungs. This builds on a previous study led by Queen’s University Belfast that found that high levels of a particular enzyme, cathepsin S, in the lungs of children with CF were associated with increased inflammation and lung damage. Lead Investigator, Professor Cliff Taggart from the Wellcome-Wolfson Centre for Experimental Medicine at Queen’s University, said: “We know that this enzyme plays a key role in provoking symptoms of chronic lung diseases such as CF and COPD. We have now discovered that treatment to target this specific enzyme can significantly reduce inflammation, lung damage and mucus obstruction, key hallmark features of CF and COPD.” The CF research, published in the European Respiratory Journal, brought together experts from Queen’s University Belfast, Charité Universitätsmedizin Berlin, INSERM Paris and Virobay Inc. USA. Simultaneously, the researchers at Queen’s jointly led an international study on COPD with the State University of New York in Brooklyn, in collaboration with Imperial College London, which has been published in the American Journal of Respiratory and Critical Care Medicine. Both studies looked at the role of the enzyme cathepsin S in two different lung diseases and produced similar findings – that inhibiting this enzyme could alleviate the symptoms associated with both diseases. Professor Marcus Mall from Charité Universitätsmedizin Berlin, and one of the co-authors, said: “Excessive inflammation in chronic lung diseases such as CF and COPD leads to irreversible damage of the airways, progressive loss of lung function and ultimately death due to respiratory failure. There is a high unmet need for effective anti-inflammatory therapies for patients with these chronic lung diseases and targeting of cathepsin S is a promising strategy that can now be tested in future clinical trials.” Lead author Dr Weldon from Queen’s University added: “Thanks to this research, we now understand the causes and how to reduce the symptoms associated with both CF and COPD. Moving forward, we need to apply this knowledge in further testing so that ultimately, we can improve the quality of life for those affected by these diseases.” The CF research was funded by the Cystic Fibrosis Foundation, the Medical Research Council, the Engineering and Physical Sciences Research Council, and EU FP7 and the Department for the Economy. The COPD research was funded by the Flight Attendant Medical Research Institute and the Alpha One Foundation. ]]> https://biospectrumindia.com/news/57/13015/enteris-biopharma-supports-endometriosis-awareness-month-.html https://biospectrumindia.com/news/57/13015/enteris-biopharma-supports-endometriosis-awareness-month-.html Wed, 06 Mar 2019 17:10:00 +0530 Enteris BioPharma, a biotechnology company developing innovative drug products built around its proprietary delivery technologies, announced its support for Endometriosis Awareness Month, designated as the month of March. Recognizing the work that is being done by nearly a dozen U.S. organizations and associations to raise awareness of endometriosis, Enteris joins with these groups in exploring patient treatment options to help relieve symptoms and find a cure for this debilitating disease. According to recent reports, more than six million women in the United States suffer from endometriosis. With limited approved therapeutic options to treat the discomfort and pain, the most effective approved treatment option for endometriosis entail GnRH agonists, with leuprolide being the most widely used agent in this class of drug. Leuprolide, while effective, has significant limitations in both convenience and tolerability, which are largely attributable to its depot injection delivery method (Lupron Depot). Utilizing its proprietary Peptelligence technology, Enteris is developing an oral tablet formulation of leuprolide called Ovarest that offers the convenience of a pill, while addressing the significant limitations in convenience and tolerability attributable to the depot injection delivery method. Data from the most recent Phase 2a clinical study indicated that Ovarest enabled significant suppression of estradiol (E2), demonstrating a measurable pharmacodynamic effect that is tightly correlated with efficacy in endometriosis. "Endometriosis remains an underserved market due to the challenges women face with currently-approved injectable treatments," said Joel Tune, CEO and Executive Chairman of Enteris BioPharma. "We believe that Ovarest has the potential to meet a critical patient need by enabling leuprolide to be delivered as an oral tablet instead of a depot injection. With the added flexibility of daily oral dosing and rapid reversibility, we believe more patients could benefit from this drug, and we are looking forward to advancing Ovarest into a Phase 2b trial." Endometriosis is an estrogen-dependent, chronic, inflammatory disease characterized by the appearance and growth of endometrial cells or tissues in locations outside the uterus. Sources suggest endometriosis affects millions of women in the United States, with the vast majority of patients remaining undertreated due to the limitations of current options. There is no cure for endometriosis, and the associated pain is currently managed with oral contraceptives, progestins, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists of which Lupron Depot is the standard of care. ]]> https://biospectrumindia.com/news/57/13014/fda-accepts-genentechs-xofluza-for-the-treatment-of-influenza.html https://biospectrumindia.com/news/57/13014/fda-accepts-genentechs-xofluza-for-the-treatment-of-influenza.html Wed, 06 Mar 2019 16:40:00 +0530 Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for XOFLUZA (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. The Centers for Disease Control and Prevention (CDC) defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity or heart disease. The FDA is expected to make a decision on approval by November 4, 2019. “Influenza, or ‘flu,’ can be especially debilitating for people considered to be high risk, as they have an increased likelihood of serious complications, worsening of existing health problems and even hospitalization or death,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “XOFLUZA is the first antiviral medicine to demonstrate a significant and clinically meaningful benefit in people at high risk of complications from the flu, for which there are currently no approved medicines.” The sNDA is based on results from the Phase III CAPSTONE-2 study of a single dose of XOFLUZA compared with placebo or oseltamivir 75 mg, twice daily for five days, in people 12 years of age or older who are at high risk of complications from the flu. The FDA approved XOFLUZA in October 2018 for the treatment of acute, uncomplicated influenza in people 12 years of age or older. It is the first and only single-dose oral medicine approved to treat the flu, and the first new flu medicine with a novel proposed mechanism of action in nearly 20 years. XOFLUZA is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. Unlike other currently available antiviral treatments, XOFLUZA is the first in a new class of antivirals designed to inhibit polymerase acidic endonuclease, an enzyme essential for viral replication. XOFLUZA will be further studied in a Phase III development program including pediatric populations, post-exposure prophylaxis and severely ill hospitalized people with influenza, as well as to assess the potential to reduce transmission in otherwise healthy people. XOFLUZA was discovered by Shionogi & Co., Ltd. and is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to XOFLUZA excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. ]]> https://biospectrumindia.com/news/57/13008/accenture-to-acquire-enterprise-system-partners.html https://biospectrumindia.com/news/57/13008/accenture-to-acquire-enterprise-system-partners.html Wed, 06 Mar 2019 15:50:00 +0530 Accenture has agreed to acquire Enterprise System Partners (ESP), a consulting and manufacturing services provider for the life sciences industry that is headquartered in Cork, Ireland, serving clients around the globe. Upon close, ESP will join Accenture Industry X.0, which helps clients master the digital reinvention of industry, strengthening Accenture’s capabilities to transform manufacturing for pharmaceutical, biotech and medical device clients globally.  ESP has long-standing industry experience in planning and implementing manufacturing solutions, with niche expertise in manufacturing execution systems (MES) and serialization. MES digitally track and document the production process, providing the groundwork for more automated and analytics-driven manufacturing and supply chains. Serialization allows life science companies to digitally track each saleable unit from the packaging line all the way to the patient. Ben Salama, a managing director who leads Accenture Industry X.0 in the United Kingdom & Ireland, said, “Digital technologies are fundamentally transforming the factory floor. With ESP’s manufacturing solutions and our Industry X.0 capabilities, we can help clients take advantage of engineering and product lifecycle management, advanced analytics, and artificial intelligence for a flexible, efficient, and cost-effective production process.” ESP will be the latest of several acquisitions Accenture has made recently to expand Accenture Industry X.0 in Europe and North America, including embedded software company Pillar Technology (US), hardware engineering firm Mindtribe (US), and strategic design consultancy designaffairs. The acquisition will complement others in life sciences that Accenture has made in recent years. This includes the acquisition of LabAnswer in 2017, now the Accenture Scientific Informatics Services (ASIS) business, which helps capture, manage, and analyze complex laboratory and scientific data. Anne Marie O’Halloran, a managing director and lead of Accenture’s Life Sciences Industry X.0 group, said, “New digital technologies and scientific advances are combining and changing how therapies can be developed and delivered to patients. There is significant opportunity for us to help clients drive greater efficiencies in how they manufacture essential medicines for patients around the world with the combination of ESP’s and our life sciences expertise.” Founded in 2003, ESP will bring a team of 200 professionals with deep manufacturing, process and IT knowledge, who will work closely with Accenture’s Life Sciences group. It currently services 17 of the top 20 global pharmaceutical and biotech companies from offices in Ireland, France, the Netherlands, Puerto Rico, Turkey and the United States. Liam O’Brien, managing director of ESP, said, “As part of Accenture Industry X.0, we will be able to offer enhanced services to transform our clients’ operations by streamlining processes from early-stage research through development to manufacturing and distribution. It will expand our capabilities to new regions and provide our team with new career opportunities in a truly global organization.” Alastair Blair, country managing director for Accenture in Ireland, said: “The planned acquisition of ESP underscores our commitment to one of Ireland’s most important and growing industries – life sciences. We continue to invest in Ireland to grow our talent and increase our capabilities to help our clients apply the very latest digital technologies and drive innovation, further strengthening the position of Ireland as a leader in this industry.” In February 2018, Accenture acquired Rothco, an award-winning, full service creative agency in Dublin with more than 170 employees. In February 2017, Accenture opened The Dock, Accenture’s global innovation hub, which now employees over 300 people in Dublin. Completion of the acquisition is subject to customary closing conditions. Terms of the transaction were not disclosed. ]]> https://biospectrumindia.com/news/57/13004/cdc-certara-to-upgrade-the-agencys-death-investigation-and-surveillance-systems.html https://biospectrumindia.com/news/57/13004/cdc-certara-to-upgrade-the-agencys-death-investigation-and-surveillance-systems.html Wed, 06 Mar 2019 11:45:00 +0530 Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, announced that the US Centers for Disease Control & Prevention (CDC) has awarded it a contract to strengthen the Agency’s death investigation and surveillance systems. Certara will use its industry-leading OpenPharma™ technologies, and the CDC’s own open functionality in OpenCDC, to create OpenMDI. This new OpenMDI platform will improve the timeliness and quality of drug mortality data collected, and the interoperability of state electronic death registration systems.  This program was one of 10 focus areas identified by the CDC under its Broad Agency Announcement through which it plans to use applied research to address emerging public health priorities.  CDC is a data-centric organization and its primary tasks include managing information in the most secure, efficient, and insightful way to inform the nation and the world about public health issues. Compounding the complexity of its role, the CDC receives data from 57 US jurisdictions and literally thousands of data systems. These systems were not designed to foster ‘real time,’ automated data delivery and information exchange, which are needed today to support public health surveillance and active response by the agency.  Certara’s Open Application Programming Interface (OpenAPI) specification compliant OpenPharma technology provides a large-scale, modern, real-time services-based architecture platform from which to build sophisticated healthcare solutions. OpenPharma is built to handle ingestion and transformation of a variety of data types, real-time processing of machine-to-machine transactions, and secure, distributed collaboration (using the Hedera Hashgraph distributed ledger technology).  Under the contract, Certara will address several CDC-stated challenges, such as: Developing data standards and standards-based data access mechanisms (e.g., HL7 Fast Healthcare Interoperability Resources [FHIR] Application Programming Interfaces) to help medical examiners and coroner (ME/Cs) offices share critical information regarding deaths with public health significance, Expanding adoption of standards-based, scalable, and software-as-a-service electronic case management systems for ME/Cs, Identifying ways in which existing ME/C case management systems can be enhanced to help promote interoperability—permitting meaningful, automated, multi-directional exchange and use of data—and enable a coordinated response to multistate, high-priority threats, Integrating electronic ME/C case management systems with state-based Electronic Death Registration systems and one other electronic public health system.  These advances will help to maximize the efficiency and applicability of CDC’s response to current and evolving public health threats. ]]> https://biospectrumindia.com/news/57/13003/fda-approves-new-nasal-spray-for-treatment-resistant-depression.html https://biospectrumindia.com/news/57/13003/fda-approves-new-nasal-spray-for-treatment-resistant-depression.html Wed, 06 Mar 2019 10:40:00 +0530 The U.S. Food and Drug Administration has approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS). "There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safey concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient." Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment-resistant depression. The Spravato labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug. Because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose. The REMS requires the prescriber and the patient to both sign a Patient Enrollment Form that clearly states that the patient understands they should make arrangements to safely leave the health care setting to get home and that the patient should not drive or use heavy machinery for the rest of the day on which they receved the drug. Additionally, Spravato must be dispensed with a patient Medication Guide that outlines the drug's uses and risks.  The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor's office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave. ]]> https://biospectrumindia.com/news/57/12999/who-publishes-new-estimates-on-congenital-syphilis.html https://biospectrumindia.com/news/57/12999/who-publishes-new-estimates-on-congenital-syphilis.html Tue, 05 Mar 2019 15:25:00 +0530 Co-authored by WHO and HRP with partners, and published in the scientific journal PLOS ONE, the new estimates show that out of the 661,000 total cases of congenital syphilis, there were 355,000 adverse birth outcomes – which represents a significant proportion of newborn death and disease. The estimates showed that the overall global burden of congenital syphilis decreased over the 2012 to 2016 research period, although non-significantly, from around 750,000 to 660,000 cases. The research also found some improvements in screening, treatment, and surveillance of maternal syphilis. Estimated adverse birth outcomes due to congenital syphilis decreased slightly from 397,000 to 355,000. Syphilis is one of the most common sexually transmitted infections globally, with approximately 6 million new cases each year. If a pregnant woman who is infected does not receive early and effective treatment, she can then transmit the infection to her unborn infant. This is known as ‘congenital syphilis’, which is often fatal. It can also cause low birth weight, prematurity, and other congenital deformities. Congenital syphilis is the second leading cause of preventable stillbirth globally, preceded only by malaria. Congenital syphilis is easily preventable and treatable – as long as testing and treatment are provided to pregnant women early during antenatal care. The risk of adverse outcomes to the fetus is minimal if a pregnant woman, infected with syphilis, receives testing and adequate treatment with benzathine penicillin, early in pregnancy – ideally before the second trimester. Despite the decrease between 2012 and 2016, the numbers of affected women and infants remains unacceptably high. It is crucial that all women are provided with early syphilis screening and treatment as part of high-quality antenatal care for a positive experience of pregnancy. In addition, health systems and programmes need to ensure that all women diagnosed with syphilis, as well as their infants, are effectively treated – and that their sexual partners are reached for testing and treatment. Countries can also work to reduce syphilis prevalence across populations, by ensuring that testing, treatment and partner referral for the infection are put into action, beyond that of antenatal care.   ]]> https://biospectrumindia.com/news/57/12996/procarta-receives-1-5m-investment-for-new-class-of-antibiotics.html https://biospectrumindia.com/news/57/12996/procarta-receives-1-5m-investment-for-new-class-of-antibiotics.html Tue, 05 Mar 2019 13:15:00 +0530 Procarta Biosystems, a privately held UK-based biotech company, has announced €1.5 million of new funding from the Novo Holdings REPAIR Impact Fund to support development of novel therapies to combat antimicrobial resistance (AMR). The new funding will be used to develop a pipeline of an entirely new class of antibiotic precision medicines from Procarta’s proprietary oligonucleotide-based antimicrobial platform. Procarta’s lead asset, PRO-202, is in preclinical development to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). The ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species) are responsible for a significant proportion of cUTIs and cIAIs throughout the world. Moreover, ESKAPE pathogens represent the greatest risk of antibiotic resistance of all clinical infections. Of particular note are the carbapenem-resistant Enterobacteriaceae (CRE), a sub-group of Gram-negative bacteria, e.g. Escherichia coli and Klebsiella species, which are resistant to the carbapenem class of antimicrobials. CRE are often considered as the worst new “superbugs” as these bacteria can kill up to half of the patients who develop bloodstream infections from these pathogens. Worryingly, carbapenem resistance is growing exponentially – resistant Klebsiella rose from 0.6% to 5.4% between 2004 and 2008 in the US, and in Thailand 70% of Pseudomonas infections are carbapenem resistant. ]]> https://biospectrumindia.com/news/57/12994/life-biosciences-appoints-dr-mehmood-khan-as-ceo.html https://biospectrumindia.com/news/57/12994/life-biosciences-appoints-dr-mehmood-khan-as-ceo.html Tue, 05 Mar 2019 11:35:00 +0530 Life Biosciences Inc. has announced Dr. Mehmood Khan, former PepsiCo Vice Chairman and Chief Scientific Officer, is incoming Chief Executive Officer and member of its board of directors. Dr. Khan will lead the Boston-based biotech company, which has raised more than $75 million to pursue the eight pathways of age-related decline (ARD). In his prior role with PepsiCo, a company which generated more than $64 billion in revenue in 2018, Dr. Khan led research and development efforts and oversaw PepsiCo's global sustainability initiatives. He was challenged to create breakthrough innovations across the food and beverages category, including helping to drive growth for its nutritious offerings across the portfolio. "Tristan and David have done a remarkable job establishing Life Biosciences as the leader in the longevity space," said Khan. "Under their guidance, the company has grown tremendously and has already made much progress in tackling the issues of age-related decline. I'm excited to now work beside them in this next phase, continuing to grow and advance Life Biosciences." Prior to joining PepsiCo, Dr. Khan was President of Takeda Global Research & Development Center, overseeing Takeda's worldwide R&D efforts. Before this, he was a faculty member at the Mayo Clinic and Mayo Medical School where he served as Director of the Diabetes, Endocrine and Nutritional Trials Unit in the endocrinology division. Dr. Khan also spent nine years leading programs in diabetes, endocrinology, metabolism and nutrition for the Hennepin County Medical Center in Minneapolis. ]]> https://biospectrumindia.com/news/57/12993/optima-increases-sales-to-record-level-and-creates-it-division.html https://biospectrumindia.com/news/57/12993/optima-increases-sales-to-record-level-and-creates-it-division.html Tue, 05 Mar 2019 11:15:00 +0530 In 2018, the OPTIMA packaging group GmbH from Schwäbisch Hall (Germany) boosted its sales by around 15 percent to more than EUR 400 million, marking a new sales record for the company. Optima generated more than 85 percent of its sales abroad. In 2019, the company is continuing to invest in new buildings at its headquarters in Schwäbisch Hall. An ongoing investment program spanning several years has set aside around EUR 50 million for construction projects. Optima plans to exploit the potential of digitalization even further in the future with an “Industrial IT” division created specifically for this purpose. ]]> https://biospectrumindia.com/news/57/12990/bayer-launches-next-gen-ct-injector-medrad-centargo.html https://biospectrumindia.com/news/57/12990/bayer-launches-next-gen-ct-injector-medrad-centargo.html Mon, 04 Mar 2019 17:55:00 +0530 Bayer recently revealed its new MEDRAD™ Centargo CT injection system at this year’s European Congress of Radiology (ECR) 2019, taking place from February 27 – March 3 in Vienna. The latest addition to Bayer’s range of imaging products, which is expected to receive CE certification this summer, has been developed with the aim of meeting one of the most pressing needs of radiology departments today: doing more with less.  “With a continuously increasing number of patients and sometimes quite complex CT procedures, what we need are product innovations that simplify our workflow and allow us to focus on the quality of the image and most importantly the patient,” said Dr. Casper Mihl, Head of the CT Department and Abdominal and Cardiovascular Radiologist at Maastricht University Medical Center. Key features of MEDRAD Centargo include a daily set-up process that can be completed in less than 2 minutes and a snap-in patient line that is ready for the next patient in less than 20 seconds. Furthermore, the piston-based technology of Centargo has been designed to provide quality fluid delivery, even during the most demanding protocols.  The integrated barcode reader reduces manual data entry and provides easy traceability and access to contrast and injection details. “We have been working in partnership with radiologists to create a new CT injector that meets the demands faced by modern radiology departments,” said Prof. Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. “Centargo offers innovative technology and design that increase efficiency and improve workflow through less manual work and touch time, allowing Radiology teams to spend more time where it matters most – with their patients.” ]]> https://biospectrumindia.com/news/57/12989/halozyme-gets-fda-approval-for-herceptin-hylecta.html https://biospectrumindia.com/news/57/12989/halozyme-gets-fda-approval-for-herceptin-hylecta.html Mon, 04 Mar 2019 16:35:00 +0530 Halozyme Therapeutics, a biotechnology company developing novel oncology and drug-delivery therapies, has announced that Genentech, a member of the Roche Group, has received approval from the U.S. Food and Drug Administration (FDA) for Herceptin Hylecta™, a subcutaneous fixed-dose combination of trastuzumab and hyaluronidase-oysk. Herceptin Hylecta™ is approved for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. Herceptin Hylecta™ is a co-formulation of trastuzumab with Halozyme's proprietary recombinant human hyaluronidase enzyme (ENHANZE® technology). Herceptin Hylecta™ is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous trastuzumab. Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration. ]]> https://biospectrumindia.com/news/57/12983/glenmark-announces-presentation-of-new-subtype-analysis-of-gbr-830.html https://biospectrumindia.com/news/57/12983/glenmark-announces-presentation-of-new-subtype-analysis-of-gbr-830.html Mon, 04 Mar 2019 12:05:00 +0530 Glenmark Pharmaceuticals has announced the presentation of a new post hoc analysis of data from a Phase 2a, proof-of-concept study of GBR 830 at the American Academy of Dermatology (AAD) Annual Meeting in Washington, DC. GBR 830 is an investigational, anti-OX40 monoclonal antibody being studied for the treatment of moderate-to severe atopic dermatitis (AD). The Phase 2a study was conducted to investigate the safety of GBR 830, evaluate its effects on AD biomarkers, and generate the first clinical evidence of its biological activity. The study was not powered for statistical differences between GBR 830 and placebo. The new, post hoc analysis of the Phase 2a study was conducted to evaluate the activity of GBR 830 in patients with intrinsic and extrinsic AD subtypes, and for subjects with elevated IgE levels at baseline. The analyses demonstrated that baseline clinical scores (EASI, SCORAD, IGA) were consistent regardless of a patient’s AD subtype or whether they had elevated IgE. Reductions in SCORAD clinical scores were observed throughout the treatment period. Mahboob Rahman, President and Chief Medical Officer at Glenmark Pharmaceuticals said, “The consistent effect of GBR 830 observed across AD subtypes is important because not all AD therapies are effective or appropriate for all patients, thus increasing the need for precision in diagnosis and treatment. We are pleased to present this evidence at AAD on the potential effectiveness of GBR 830 across subtypes, which is valuable for future clinical development and decision making.” Sixty-two randomized subjects (GBR 830 n=46; placebo n=16) received at least one dose of study drug during the trial. Of the 46 subjects treated with GBR 830, 42 were evaluated by baseline AD subtype (extrinsic n=15, intrinsic n=27, not specified n=4). Baseline clinical scores on the Eczema Area and Severity Index (EASI), Scoring of Atopic Dermatitis (SCORAD) and Investigator’s Global Assessment (IGA) did not show marked differences according to AD subtypes or IgE level. After treatment with GBR 830, decreases in SCORAD were observed during the study regardless of AD subtype or IgE level. These responses were observed shortly after the first dose of GBR 830 and maintained through the study period and beyond. In the study, GBR 830 was safe and well-tolerated. The most common treatment emergent adverse event was headache, with no meaningful differences observed between GBR 830 (13%) and placebo-treated (25%) patients. A Phase 2b clinical trial of GBR 830 in moderate-to-severe AD is underway and currently enrolling patients in the U.S. and Europe. GBR 830 is designed to inhibit OX40, a costimulatory immune checkpoint receptor expressed on activated T cells and memory T cells. Costimulatory signals are essential for T cell activity, and binding between OX40 and OX40L is a biomarker for the severity of autoimmune diseases. The activation of this pathway leads to conversion of activated T cells into memory T cells, which promotes inflammation. In addition, regulatory T cells also contribute to inflammation, and OX40 signaling by these cells downregulates immune suppressing functions. It is believed that GBR 830 may inhibit the dual activities of OX40 and OX40L binding in both activated T cells and regulatory T cells, thus potentially reducing inflammation associated with symptoms of atopic dermatitis. ]]> https://biospectrumindia.com/news/57/12977/ema-accepts-mma-for-hansa-biopharmas-idefirix.html https://biospectrumindia.com/news/57/12977/ema-accepts-mma-for-hansa-biopharmas-idefirix.html Fri, 01 Mar 2019 18:15:00 +0530 Hansa Biopharma AB, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases has declared that the European Medicines Agency (EMA) has accepted the Company's Marketing Authorization Application (MAA) for review of IDEFIRIX™ (INN: imlifidase). Hansa is seeking approval of IDEFIRIX as a treatment to enable kidney transplantation in highly sensitized patients. IDEFIRIX is a novel antibody-degrading enzyme that eliminates immunological barriers. It is administered as a single intravenous infusion immediately prior to transplantation and rapidly inactivates donor specific antibodies (DSAs). This acceptance follows Hansa's submission of the MAA on 5 February 2019 and marks the beginning of the regulatory review process for IDEFIRIX in the European Union (EU). IDEFIRIX has both EU Orphan Drug Designation and PRIority MEdicine (PRIME) designation, an EMA program to enhance support for the development of medicines that target an unmet medical need. An opinion of the Committee for Medicinal Products for Human Use (CHMP) is expected within 210 days (plus any clock-stops for the applicant to provide answers to questions which may arise during the review). After the adoption of a CHMP opinion, a final decision regarding the MAA for IDEFIRIX is made by the European Commission. The MAA for IDEFIRIX is based upon the successful outcomes from five clinical studies demonstrating the efficacy and safety of IDEFIRIX to successfully enable kidney transplantation. In addition, the file includes evidence of the significant medical need for highly sensitized patients who today have extremely limited opportunity for transplantation.   ]]> https://biospectrumindia.com/news/57/12962/ibsa-pharma-launches-liquid-formula-for-hypothyroidism.html https://biospectrumindia.com/news/57/12962/ibsa-pharma-launches-liquid-formula-for-hypothyroidism.html Thu, 28 Feb 2019 17:45:00 +0530 IBSA Pharma is a world leader in the treatment of thyroid disease and has a diversified product portfolio of prescription drugs. With products on five continents and in over 80 countries, IBSA manufactures 14 million vials of hormones, 300 million soft gel capsules and 60 million packages of finished products every year. IBSA Pharma Inc. announced that its Tirosint-SOL (levothyroxine sodium) oral solution is now available in the US market for the treatment of hypothyroidism and pituitary thyrotropin suppression. Tirosint-SOL is the first and only liquid levothyroxine formulation approved by the FDA and is indicated for patients of all ages.  Levothyroxine is a hormone that is normally produced by the thyroid gland. It is used to treat patients who suffer from hypothyroidism or inadequate levels of thyroid stimulating hormone (TSH). Tirosint-SOL is the latest product to be launched in the US by the IBSA Pharma Inc., a fully-owned subsidiary of IBSA Institute Biochemique SA. Tirosint-SOL's unique liquid formulation is made without excipients such as dyes, wheat starch (gluten), lactose, alcohol, sugar and others that may contribute to tolerability and absorption issues. It is packaged in monodose ampules in 12 different dosage strengths, including a 13 mcg/mL dose. Tirosint-SOL may be administered either directly into the mouth or diluted in a glass of water. ]]> https://biospectrumindia.com/news/57/12947/bayer-completes-nda-submission-to-usfda-for-cancer-drug-darolutamide-.html https://biospectrumindia.com/news/57/12947/bayer-completes-nda-submission-to-usfda-for-cancer-drug-darolutamide-.html Wed, 27 Feb 2019 14:45:00 +0530 Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. The company has announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug darolutamide.  The submission, which was initiated in December 2018, is based on data from the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC).These data were recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco.  Bayer has been granted Fast Track designation by the FDA for darolutamide in men with nmCRPC. Bayer is also in discussions with other health authorities regarding a submission of darolutamide. The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. ]]> https://biospectrumindia.com/news/57/12938/the-cowrks-foundry-partners-with-yale-university-.html https://biospectrumindia.com/news/57/12938/the-cowrks-foundry-partners-with-yale-university-.html Tue, 26 Feb 2019 18:10:00 +0530 To address growing health and social disparities in India and around the globe, The CoWrks Foundry has partnered with Yale University with support from the RMZ Foundation, to launch the Sustainable Health Initiative. The Sustainable Health Initiative is a six-month, interdisciplinary accelerator program that will be facilitated through the Yale Institute for Global Health for young and early stage startups building innovative solutions in health.  Up to 10 startups will be chosen per year, over a five-year period. Each startup will each receive $70,000 in seed funding, mentorship from faculty and alumni at Yale, as well as benefit from a network of Indian industry experts. In addition, the program includes structured sessions to help startups evolve a sustainable and scalable business model, refine their go-to market strategy and build a global network. Startups applying to the program will be evaluated on whether their solution is robust, affordable, and addresses pressing healthcare challenges in India and other growing economies. Peter Salovey, president of Yale University and the Chris Argyris, professor of psychology said, “The Yale Institute for Global Health’s partnership with the CoWrks Foundry and RMZ Foundation is based on a shared belief in the power of innovation in addressing pressing global health challenges. Within the Yale community and among young entrepreneurs in India, the Sustainable Health Initiative will catalyze the development of solutions that can improve lives and society.” The CoWrks Foundry, based out of Bangalore, is a business accelerator for early stage businesses in the fields of urban technology, enterprise technology, and social enterprise. The Yale Institute for Global Health works to improve health and health equity for people worldwide. Through the Sustainable Health Initiative, the Yale Institute for Global Health will support students and professionals to innovate within broad thematic areas like infectious and non-communicable diseases, maternal, child and newborn health, water and sanitation, urban health and the environment.  Sten Vermund, Dean, Yale School of Public Health said, “As the first signature program of the Yale Institute for Global Health, we are very excited to launch new and cost-effective solutions that will have a significant impact on the health of communities in India, the U.S., and around the world. SHI will be a unique opportunity to nurture fresh ideas and provide real support to innovative approaches and business opportunities that will address our most pressing health challenges.” Nruthya Madappa, Managing Partner, The CoWrks Foundry said, “Our partnership with theYale Institute for Global Health is aimed at global knowledge transfer resulting in research, that creates sustainable impact in healthcare not only in India, but also in the world’s emerging economies. With a large ecosystem that is growing at an accelerated pace, India is the perfect testbed for generating and promoting new ideas at the intersection of health, technology, environmental science, urbanization, and public policy.”  Anu Menda, Managing Trustee, RMZ Foundation said, “Our objective through the Sustainable Health Initiative is to drive long-lasting solutions in the Indian healthcare sector. We hope to showcase this on a global stage by bringing together world-class education and expertise from industry veterans.”  Startups chosen for Sustainable Health Initiative from India will operate out of the The CoWrks Foundry, situated within the CoWrks HQ at The Millenia, Ulsoor (Bangalore).      ]]> https://biospectrumindia.com/news/57/12937/gain-therapeutics-sa-announces-funding-support-from-a-leading-parkinsons-research-foundation.html https://biospectrumindia.com/news/57/12937/gain-therapeutics-sa-announces-funding-support-from-a-leading-parkinsons-research-foundation.html Tue, 26 Feb 2019 17:55:00 +0530 Gain Therapeutics SA, a biotechnology company discovering and developing novel therapeutics to target lysosomal enzymes involved in inborn errors of metabolism and in CNS diseases has announced that it has received funding support from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA to advance its proprietary non-competitive molecular chaperones for Parkinson’s disease. This grant has been awarded together with Dr. Marta Martínez Vicente from the Vall d’Hebron Research Institute in Barcelona (Spain). MJFF and The Silverstein Foundation’s grant support recognizes Gain Therapeutics’ novel therapeutic approach for Parkinson’s with mutations in the glucocerebrosidase (GBA) gene. The program emerges from Gain’s technology platform, which is able to identify and design brain-penetrant allosteric, non-inhibitory pharmacological chaperones for diseases where lysosomal enzyme functions, folding and intracellular trafficking is affected. “We are honoured to have received this grant from The Michael J. Fox Foundation and The Silverstein Foundation, which recognises the importance of our efforts to develop novel treatment approaches for Parkinson’s disease, which remains an area of significant need for patients, their families and caregivers,” said Dr. Lorenzo Leoni, board representative of Gain Therapeutics SA. Parkinson's disease is a chronic, degenerative neurological disorder with limited treatment options that affects one in 100 people over age 60. More than 6 million people around the world live with Parkinson's disease, a disorder of the central nervous system that results from the loss of cells in various parts of the brain. Mutations in the glucocerebrosidase (GBA) gene are one of the most common risk factors for Parkinson's disease. GBA encodes a lysosomal enzyme, beta-glucocerebrosidase (GCase). Reduced GCase activity is associated with GBA mutations and has been reported in idiopathic PD, suggesting a more general role for GCase pathway dysfunction in Parkinson's. “Gain Therapeutics is proud to be part of the joint effort of these foundations to accelerate and develop novel therapeutic interventions to prevent pathogenic mechanisms triggered by GCase-pathway dysfunction,” said Prof. Xavier Barril, CSO of Gain Therapeutics SA. Said Dr. Liliana Menalled, MJFF senior associate director of Research Programs, “The GBA pathway is a leading target for therapies that aim to slow or stop Parkinson’s progression, and The Michael J. Fox Foundation is committed to supporting innovative treatment approaches in this area. We hope our grant supports successful work that builds evidence for the advancement of these molecular chaperones closer to patient hands.” ]]> https://biospectrumindia.com/news/57/12936/pra-health-sciences-ciscrp-collaborate-to-deliver-trial-results-.html https://biospectrumindia.com/news/57/12936/pra-health-sciences-ciscrp-collaborate-to-deliver-trial-results-.html Tue, 26 Feb 2019 17:15:00 +0530 PRA Health Sciences and the non-profit Center for Information and Study on Clinical Research Participation (CISCRP)have announced that they are collaborating to prepare and deliver Trial Results Summaries to study volunteers. A key focus for PRA is to provide a more positive overall experience for both patients and families throughout the clinical trial process. Keeping patients informed and engaged with meaningful information through this unique collaboration will help achieve that goal. Studies show that although the vast majority of clinical trial participants want to know what research professionals have learned from their participation, very few actually do. A recent study, for example, found that more than 90% of study volunteers want to know the general findings of their clinical trial yet only 11% report receiving the results.  In another study, research volunteers indicated that the return of trial results is one of the top reasons for deciding to participate. The return of plain language trial results summaries will soon become mandatory for studies conducted in the European Union (EU). The EU Clinical Trials Regulation (EU) No 536/2014 is expected to come into effect in 2020 and will require sponsors to provide trial results “for laypersons” through the European Medicines Agency (EMA) portal and database. As a result, a growing number of EU-based and global pharmaceutical and biotechnology companies are looking for support from their contract service providers and from CISCRP. PRA’s medical writers will draft the Trial Results Summaries and implement the company’s quality control processes to ensure the accuracy of both the data and the message. Based on its expertise in health communication, patient engagement and industry best practices developed through nearly a decade of collaboration with research sponsors, CISCRP will ensure the summaries are easy to understand; meet the needs of participants, patients and the public; and are objective and neutral. CISCRP coordinates the review of all summaries through Editorial Panels composed of members of the public as well as patients, patient advocates, and healthcare specialists in the therapeutic area of the study. CISCRP manages production and translation into patient languages of the report and facilitates dissemination to participants through investigative sites. This collaborative effort will ensure the unbiased, non-promotional communication of study results in a systematic and scalable way. Most importantly, this will provide an effective and reliable means of ensuring that trial participants stay informed about what was learned as a result of their participation. PRA Vice President, Medical Writing and Clinical Trial Transparency, Karen Devcich said, "We are delighted to collaborate with CISCRP as part of a cultural transformation towards real patient engagement and to demonstrate genuine commitment to improving the lives of patients.” “We are very pleased to be collaborating with PRA to enhance the experience and engagement of their patients,” added Jill McNair, CISCRP’s Senior Director, Patient Engagement. “This collaboration also helps to further our mission to make the return of plain language trial result summaries a standard practice adopted by the clinical research community.”   ]]> https://biospectrumindia.com/news/57/12932/mallinckrodt-signs-ecp-research-collaboration-treaty-with-transimmune-ag.html https://biospectrumindia.com/news/57/12932/mallinckrodt-signs-ecp-research-collaboration-treaty-with-transimmune-ag.html Tue, 26 Feb 2019 12:00:00 +0530 Mallinckrodt plc, a leading global specialty pharmaceutical company has entered into a research collaboration agreement with Transimmune AG, a company developing novel immunotherapies based on its unique understanding of the physiologic processes underlying the activation of antigen-presenting cells. The companies will collaborate on translational research to further expand understanding of the underlying mechanism of action (MOA) for extracorporeal photopheresis, and its application toward the development of potential next-generation photopheresis technology, with plans to expand on Mallinckrodt's current THERAKOS™ Photopheresis platform through new clinical trials. Beyond enhancing MOA understanding and advancing the technology platform, it is also anticipated that the insights gained through the joint research endeavor with the Transimmune experts can expand potential clinical applicability across diverse immune-mediated disease states. If clinical evidence is shown, these conditions may include Cutaneous T-Cell Lymphoma (CTCL), Graft-versus-Host Disease (GvHD), organ transplant rejection and all autoimmune diseases – all exclusively licensed to Mallinckrodt under the agreement. Transimmune was founded by Richard Edelson, M.D., Lerner Professor of Dermatology, Chair and Professor, Department of Dermatology, Yale University School of Medicine, and a photopheresis pioneer. Dr. Edelson has spent decades studying the photopheresis mechanism of action and founded Transimmune to translate those insights into improving photopheresis therapy. Mallinckrodt and Transimmune will establish a joint governance committee consisting of representatives from both companies to oversee, review and coordinate the activities under the agreement. The companies intend to explore a joint commercial collaboration arrangement related to a next-generation Mallinckrodt photopheresis system. Mallinckrodt is the only provider of an integrated closed loop photopheresis therapy, which is delivered through its latest generation THERAKOS™ CELLEX™ Photopheresis System. ]]> https://biospectrumindia.com/news/57/12927/exicure-announces-dosing-of-first-patient-in-ph1b-2-immuno-oncology-trial.html https://biospectrumindia.com/news/57/12927/exicure-announces-dosing-of-first-patient-in-ph1b-2-immuno-oncology-trial.html Mon, 25 Feb 2019 18:50:00 +0530 Exicure, a clinical stage biotechnology company developing a new class of immunomodulatory and gene regulating drugs and a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, announced today that it has dosed the first patient in its multicenter, open-label, Phase 1b/2 study of AST-008 combined with pembrolizumab. Enrollment in the trial is open to patients with superficial injectable tumors in advanced or metastatic solid tumor conditions including Merkel cell carcinoma, head and neck squamous cell carcinoma, cutaneous squamous cell carcinoma and melanoma. “We believe that combining our immune system agonist drug with checkpoint inhibitors is an important strategy for leveraging the patient’s own immune system to fight cancer. We are excited to bring this approach into cancers like Merkel cell carcinoma, where patients have limited success using currently available treatments,” said Exicure CEO Dr. David Giljohann. “It is also an important milestone for Exicure in the development of our platform technology, which allows us to digitally design drug candidates and potentially bring them into clinic faster.” The primary objective of the Phase 1b dose escalation stage is to assess the safety and tolerability of Exicure’s AST-008 drug alone and in combination with pembrolizumab, and to determine a dose for the Phase 2 stage of the study. Patients in the dose escalation stage may have previously been exposed to antibody checkpoint inhibitors, but not as a requirement for inclusion in the trial. In the Phase 2 portion of the study, Exicure will further evaluate AST-008 in combination with pembrolizumab in patients who have previously received but not responded to anti-PD-1 or anti-PD-L1 antibody therapy. AST-008 is a toll-like receptor nine (TLR9) agonist oligonucleotide in a proprietary SNA format with immune-stimulatory properties. SNAs are dense, radial arrangements of nucleic acids (DNA) that have high cellular uptake and an enhanced presentation of the DNA for TLR9 agonism. AST-008 is designed to enter into and activate immune cells to elicit an immune response to treat solid tumors in combination with other agents such as checkpoint inhibitors. We observed that AST-008 showed potent antitumor activity as a monotherapy and synergized with anti-PD-1 antibodies in multiple preclinical tumor models. In a successful Phase 1 trial in healthy volunteers, AST-008 activated key immune cells and cytokines predictive for an anti-tumor effect in patients.   ]]> https://biospectrumindia.com/news/57/12926/ge-to-sell-biopharma-business-for-21-4b-to-danaher.html https://biospectrumindia.com/news/57/12926/ge-to-sell-biopharma-business-for-21-4b-to-danaher.html Mon, 25 Feb 2019 18:30:00 +0530 GE has announced a definitive agreement to sell its BioPharma business to Danaher Corporation for a total consideration of $21.4 billion, including $21 billion in cash as well as Danaher’s assumption of certain pension liabilities. GE expects to use the proceeds from the transaction to reduce leverage and strengthen its balance sheet. The transaction is expected to close in the fourth quarter of 2019, subject to regulatory approvals and customary closing conditions. GE Chairman and CEO H. Lawrence Culp, Jr. said, “Today’s transaction is a pivotal milestone. It demonstrates that we are executing on our strategy by taking thoughtful and deliberate action to reduce leverage and strengthen our balance sheet. We are retaining full flexibility for growth and strategic optionality with one of the world’s leading healthcare companies, and we are pleased that our BioPharma colleagues will join a strong, established team at Danaher. A more focused portfolio is the right structure for GE, and we have many options for maximizing shareholder value along the way.” GE Healthcare President and CEO Kieran Murphy said, “The BioPharma business has been a strong contributor to our success, and I am confident this agreement represents a great opportunity for our valued colleagues to flourish under the ownership of Danaher. GE Healthcare has unsurpassed scale and scope and we will continue to focus on our investments so that we deliver better outcomes and more capacity to a world striving for Precision Health.” The BioPharma business being divested is part of GE Life Sciences. In 2018, the BioPharma business generated revenues of approximately $3 billion. It is a leading provider of instruments, consumables and software that support the research, discovery, process development and manufacturing workflows of biopharmaceutical drugs. The business comprises process chromatography hardware and consumables, cell culture media, single use technologies, development instrumentation and consumables, and service. Pharmaceutical Diagnostics, currently part of GE Life Sciences, will remain within the GE Healthcare portfolio. This business supplies contrast media and molecular imaging consumables for radiology customers around the world and is highly complementary to GE Healthcare’s medical imaging business. GE’s pharmaceutical imaging agents are used in approximately 90 million patient procedures each year. GE Healthcare has a global installed base of more than 4 million imaging, mobile diagnostic and monitoring units. In 2018 this business, excluding BioPharma, generated approximately $17 billion of revenue with mid-teens operating profit margins. The business is a leader in imaging, monitoring and diagnostics, and also provides services, accessories, consumables, education, training and consulting. The transaction is not subject to a financing condition or a shareholder vote. PJT Partners LP, J.P. Morgan Securities LLC, Citigroup Global Markets Inc. and Goldman Sachs acted as financial advisors and Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as legal advisor to GE on the transaction. ]]> https://biospectrumindia.com/news/57/12920/roche-to-acquire-spark-therapeutics-for-4-3b.html https://biospectrumindia.com/news/57/12920/roche-to-acquire-spark-therapeutics-for-4-3b.html Mon, 25 Feb 2019 13:40:00 +0530 Roche and Spark Therapeutics have entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics at a price of US$ 114.50 per share in an all-cash transaction. This corresponds to a total transaction value of approximately US$ 4.3 billion on a fully diluted basis. This price represents a premium of approximately 122% to Spark Therapeutics’ closing price on 22 February 2019 and a premium of approximately 19% to Spark Therapeutics’ 52 week high share price on 9 July 2018. The merger agreement has been unanimously approved by the boards of Spark Therapeutics and Roche. Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all outstanding shares of Spark Therapeutics common stock, and Spark Therapeutics will file a recommendation statement containing the unanimous recommendation of the Spark Therapeutics board that Spark Therapeutics’ shareholders tender their shares to Roche. Spark Therapeutics, based in Philadelphia, Pennsylvania, is a fully integrated, commercial company committed to discovering, developing and delivering gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases.   ]]> https://biospectrumindia.com/news/57/12919/abbvie-voyager-to-develop-vectorized-antibodies-for-pd.html https://biospectrumindia.com/news/57/12919/abbvie-voyager-to-develop-vectorized-antibodies-for-pd.html Mon, 25 Feb 2019 13:10:00 +0530 AbbVie, a global biopharmaceutical company, and Voyager Therapeutics, a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases have entered into an  exclusive, global strategic collaboration and option agreement to develop and commercialize vectorized antibodies directed at pathological species of alpha-synuclein for the potential treatment of Parkinson's disease (PD) and other diseases (synucleinopathies) characterized by the abnormal accumulation of misfolded alpha-synuclein protein.  The delivery of sufficient quantities of antibodies across the blood-brain barrier is one of the major limitations of current biologic therapies for neurodegenerative diseases that require frequent systemic injections with large amounts of antibodies. Voyager's vectorized antibody platform and approach aims to circumvent this limitation by delivering, with a potential, one-time intravenous administration, the genes that encode for the production of therapeutic antibodies utilizing Voyager's blood-brain barrier penetrant adeno-associated virus (AAV) capsids. This approach could result in the potential for higher levels of therapeutic antibodies in the brain compared with current systemic administration of antibodies. Under the terms of the collaboration and option agreement, Voyager will perform research and preclinical development work to vectorize antibodies directed against alpha-synuclein that are designated by AbbVie, after which AbbVie may select one or more vectorized antibodies to advance into IND-enabling studies and clinical development. Voyager will be responsible for the research, IND-enabling and Phase 1 clinical activities and costs. Following completion of Phase 1 clinical development, AbbVie has an option to license the vectorized alpha-synuclein antibody program for further clinical development and global commercialization for indications including Parkinson's disease and other synucleinopathies. Voyager will receive an upfront cash payment of $65 million and has the potential to earn up to $245 million in preclinical and Phase 1 option payments. Voyager is also eligible to receive up to an additional $728 million in potential development and regulatory milestone payments for each alpha-synuclein vectorized antibody compound.  Voyager is eligible to receive tiered royalties on the global commercial net sales of each alpha-synuclein vectorized antibody and may also earn up to a total of $500 million in commercial milestones.   ]]> https://biospectrumindia.com/news/57/12901/ucb-to-form-a-research-satellite-facility-within-kings-college-london.html https://biospectrumindia.com/news/57/12901/ucb-to-form-a-research-satellite-facility-within-kings-college-london.html Fri, 22 Feb 2019 14:10:00 +0530 UCB, a global biopharmaceutical company focusing on developing innovative treatments for patients with neurological and immunological conditions, has expanded its global satellite research site strategy by signing a new three-year research and development collaboration agreement with King’s College London, UK. The announcement furthers UCB’s strategy of complementing R&D activity undertaken in its two major international research hubs in Belgium and the UK, with smaller satellite facilities that locate industry scientists in innovative environments conducive to building new capabilities. This collaboration with King’s also builds upon the recent successful execution of three satellite research sites in the US resulting from acquisitions of Beryllium (Boston and Seattle) and Element Genomics (Durham, NC) which will boost UCB's capabilities in genomics, protein engineering and structural biology.  Over the course of the collaboration, leading UCB and King’s scientists will work together on-site at the Guy’s Campus - where King’s is developing a Biotech Hub - to optimise collective expertise in effectively translating basic research and clinical insights into impactful treatments for patients with unmet medical needs. It is anticipated that the collaboration will initially focus on the progression of one novel and innovative medicine into human clinical studies by the beginning of 2020.  UCB and King’s will invest in this collaboration over an initial three-year period, with the potential to further extend, based on project outcomes. The collaboration will be managed by a Relationship Board of senior leaders from both organisations that will assess projects to be prioritised and identify new areas of science and technology of interest to both parties to ensure outcomes are maximised. To support the running of this collaboration, UCB will invest financial resource alongside in-kind benefits provided by King’s.  The announcement of this research satellite collaboration follows UCB’s recent news, as part of the Life Sciences Sector Deal last December, that it will invest up to £1 billion over the next five years to keep one of their two major international R&D hubs in the UK, and includes investment of approximately £150-200 million in a new purpose built, state-of-the-art facility. It also aligns with the direction of travel set by the Life Science Industrial Strategy and reaffirmed in the recently published NHS Long Term Plan1 which called for collaboration between industry, academic and NHS partners.    ]]> https://biospectrumindia.com/news/57/12897/who-releases-report-on-global-health-expenditure.html https://biospectrumindia.com/news/57/12897/who-releases-report-on-global-health-expenditure.html Fri, 22 Feb 2019 10:05:00 +0530 Spending on health is growing faster than the rest of the global economy, accounting for 10% of global gross domestic product (GDP). A new report on global health expenditure from the World Health Organization (WHO) reveals a swift upward trajectory of global health spending, which is particularly noticeable in low- and middle-income countries where health spending is growing on average 6% annually compared with 4% in high-income countries. Health spending is made up of government expenditure, out-of-pocket payments (people paying for their own care), and sources such as voluntary health insurance, employer-provided health programmes, and activities by non-governmental organizations. Governments provide an average of 51% of a country’s health spending, while more than 35% of health spending per country comes from out-of-pocket expenses. One consequence of this is 100 million people pushed into extreme poverty each year.  The report highlights a trend of increasing domestic public funding for health in low- and middle-income countries and declining external funding in middle-income countries. Reliance on out-of-pocket expenses is declining around the world, albeit slowly. Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, “Increased domestic spending is essential for achieving universal health coverage and the health-related Sustainable Development Goals. But health spending is not a cost, it’s an investment in poverty reduction, jobs, productivity, inclusive economic growth, and healthier, safer, fairer societies.” In middle-income countries, government health expenditure per capita has doubled since the year 2000. On average, governments spend US$60 per person on health in lower-middle income countries and close to US$270 per person in upper-middle income countries. When government spending on health increases, people are less likely to fall into poverty seeking health services. But government spending only reduces inequities in access when allocations are carefully planned to ensure that the entire population can obtain primary health care. In low- and middle-income countries, new data suggest that more than half of health spending is devoted to primary health care. Yet less than 40% of all spending on primary health care comes from governments. Dr Agnés Soucat, Director for Health Systems, Governance and Financing at the WHO said, “All WHO’s 194 Member States recognized the importance of primary health care in their adoption of the Declaration of Astana last October.  Now they need to act on that declaration and prioritize spending on quality healthcare in the community.” The report also examines the role of external funding. As domestic spending increases, the proportion of funding provided by external aid has dropped to less than 1% of global health expenditure. Almost half of these external funds are devoted to three diseases – HIV/AIDS, Tuberculosis (TB) and malaria. While the report clearly illustrates the transition of middle-income countries to domestic funding of health systems, external aid remains essential to many countries, particularly low-income countries. The new WHO report points to ways that policy makers, health professionals and citizens alike can continue to strengthen health systems. ]]> https://biospectrumindia.com/news/57/12891/takeda-microsoft-eurordis-releases-action-plan-to-end-the-diagnostic-odyssey-.html https://biospectrumindia.com/news/57/12891/takeda-microsoft-eurordis-releases-action-plan-to-end-the-diagnostic-odyssey-.html Thu, 21 Feb 2019 13:15:00 +0530 The Global Commission to End the Diagnostic Odyssey for Children , co-chaired by Takeda, Microsoft and EURORDIS-Rare Diseases Europe, an alliance of more than 800 rare disease patient organizations, announced its actionable recommendations in a report to address the barriers to diagnosis for people living with a rare disease.  In 2018, the Global Commission Co-Chairs, Shire (now Takeda), Microsoft, and EURORDIS, joined forces to bring together a multidisciplinary group of patient advocates, physicians and other experts to help solve the complex challenges impacting the rare disease community. Over the past year, the Global Commission gathered input from patients, families and other expert advisors to gain key insights to guide solutions to shorten the rare disease diagnosis timeline. The roadmap's recommendations can be mapped back to three solution pathways: Empowering patients and families: Create opportunities to develop tools for caregivers to connect seemingly unrelated symptoms, inquire about additional testing and work together with physicians to achieve a correct diagnosis. Equipping frontline providers: Examine ways to equip physicians with the knowledge and tools to quickly and effectively identify patients who may have a rare disease and take appropriate action through solutions such as machine learning technology, expert-level guidance and genetic testing opportunities. Reimagining the genetic consultation: Identify innovative ways to enable medical geneticists to see priority patients more quickly, such as standardizing reporting methods and utilizing telemedicine for increased access to more patients. "There are more than 6,000 identified rare diseases, the vast majority of which begin in childhood, with patients receiving a misdiagnosis more than once in 40 percent of cases," said Wolfram Nothaft, M.D., Chief Medical Officer of Takeda and Global Commission Co-Chair. "As champions for those living with a rare disease, we've outlined real solutions to lessen the time to diagnosis for the more than 300 million people affected worldwide."  The Global Commission is supporting three pilot projects to bring its solution pathways to life, utilizing the expertise of its members and engaging like-minded partners who are pushing the boundaries of innovation. The pilot programs include 1) multifactorial machine learning to recognize symptom patterns, 2) collaboration tools for "intelligent triage" and clinical geneticist virtual panel consultation, and 3) developing a secure patient registry and rare disease passport, which may use emerging technologies like blockchain. In its roadmap, the Global Commission also emphasizes the importance of global policy frameworks for rare diseases to be recognized as an international public health priority. The policy recommendations, designed to support and enable the specific solution pathways, focus on four key areas: Centers of Excellence, Genetic Screening, Data Sharing and Privacy.   ]]> https://biospectrumindia.com/news/57/12890/quest-diagnostics-teams-up-with-houston-healthcare-for-enhancement-of-diagnostic-services.html https://biospectrumindia.com/news/57/12890/quest-diagnostics-teams-up-with-houston-healthcare-for-enhancement-of-diagnostic-services.html Thu, 21 Feb 2019 12:45:00 +0530 Quest Diagnostics, the world's leading provider of diagnostic information services, and Houston Healthcare are teaming up to enhance the quality and value of diagnostic services to patients and their doctors through a new partnership agreement under which Quest will provide full laboratory management services for Houston Medical Center and Perry Hospital.  "We are pleased to partner with Houston Healthcare, a premier healthcare system in central Georgia," said Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics. "In today's pressurized health care environment, health systems like Houston Healthcare are turning to Quest for help executing in their lab strategy. Each relationship begins and ends with how can we help, so they can focus on what they do best, providing quality care to their patients." Under the agreement Quest will provide management expertise, laboratory equipment, supplies and procurement processes for both hospitals, in addition to providing reference testing for both hospitals. "We are pleased to partner with Quest Diagnostics to benefit from their innovative technologies, scale, and commitment to quality," said Charles Briscoe, Chief Operating Officer and Acting CEO of Houston Healthcare. "With the ongoing challenges and opportunities in healthcare, this new relationship allows us to remain focused on improving patient care and outcomes, while teaming up with a leader in the field who has access to the most sophisticated diagnostic equipment available."   ]]> https://biospectrumindia.com/news/57/12889/labcorp-expands-therapeutic-drug-monitoring-portfolio-for-precision-medicine.html https://biospectrumindia.com/news/57/12889/labcorp-expands-therapeutic-drug-monitoring-portfolio-for-precision-medicine.html Thu, 21 Feb 2019 12:25:00 +0530 LabCorp®, a leading global life sciences company that is deeply integrated in guiding patient care, announced a new assay in its therapeutic drug monitoring (TDM) DoseASSURE™ portfolio. The new Certolizumab Concentration and Anti-Certolizumab Antibody DoseASSURE CTZ assay, helps physicians monitor individual drug response for patients who are on Certolizumab, a biologic drug used to treat certain inflammatory diseases, such as rheumatoid arthritis and Crohn’s disease. Biologic drugs are complex, protein-based therapies that can be used to treat certain inflammatory diseases and are among the fastest growing class of drugs available today. However, the expense of these medications and the variability in patient response can present numerous challenges. LabCorp’s DoseASSURE portfolio helps address these challenges by providing quantitative, patient-specific measurement which can guide patient therapy. With the launch of the DoseASSURE CTZ, LabCorp now has the most comprehensive biologics TDM menu in the industry, targeting the largest number of biologic drugs. “Biologic drugs can be life-changing, but individual patient response to biologics can vary greatly,” said David P. King, LabCorp’s chairman and CEO. “LabCorp’s DoseASSURE portfolio helps to deliver on the promise of precision medicine by enabling more effective and more individualized treatment plans that can improve clinical outcomes at reduced costs.” Studies demonstrate the use of TDM can improve efficacy and prolong successful response to biologic treatment. Accordingly, appropriate use of TDM can diminish the need for disease-related surgery and hospitalization by reducing the risk of treatment failure. ]]> https://biospectrumindia.com/news/57/12878/shimmer-launches-verisense-wearable-sensor-platform-for-clinical-trials.html https://biospectrumindia.com/news/57/12878/shimmer-launches-verisense-wearable-sensor-platform-for-clinical-trials.html Thu, 21 Feb 2019 09:00:00 +0530 Shimmer, a global leader in wearable technology for research applications, has announced the launch of Verisense, its next-generation wearable sensor platform designed from the ground up to meet the needs of clinical trial sponsors, sites and participants. This new technology will be unveiled at the SCOPE Summit for Clinical Ops Executives.  “There is a growing demand from pharmaceutical companies, regulators and payers to factor real-world data (RWD) into healthcare decision making. They want to ensure that new therapies, especially those for chronic conditions, deliver objective improvements to participants’ health and quality of life. That requires access to real-world participant data and has spurred the rapid growth in wearable technologies to measure objective quality of life indicators, such as activity levels and sleep patterns,” said Geoff Gill, president of Shimmer Americas.       The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, stated on Dec. 6, 2018 that leveraging RWD to improve regulatory decisions is a key strategic priority for the FDA. He also unveiled the FDA’s new strategic framework to advance use of real-world evidence (RWE) to support development of drugs and biologics. “RWD and RWE can be especially useful for postmarket monitoring of the safety of products during their use in real world settings,” said Dr. Gottlieb. He added that FDA has “new drug applications under review [in the oncology setting] where RWD and RWE are helping to inform our ongoing evaluation as one component of the total complement of information that we’re evaluating.” “But an effective clinical trial solution has to meet very specific requirements, such as providing access to raw participant data and purpose-built management tools, while placing the minimum burden on sponsors, sites and participants. This can’t be done by simply repurposing consumer wearable devices or other current devices. We started by systematically understanding the needs of sponsors, sites, and participants, then designed Verisense from the ground up to meet those needs,” added Mr. Gill. “The initial feedback from customers has been overwhelmingly positive. Starting in March, customers are planning to use Verisense in trials for Alzheimer’s disease, Parkinson’s disease, cancer-related fatigue, and stroke.”  Verisense is a comprehensive and flexible solution for reliably capturing accurate and complete biometric data. Verisense is launching with the Verisense IMU sensor, a general-purpose Inertial Measurement Unit (IMU). Worn on the wrist, it can monitor activity and sleep seamlessly. In addition, it can be used for any IMU application with up to seven sensors worn on different parts of a participant’s body, making it invaluable for studying complex musculoskeletal or neurological conditions, such as dystonia or epilepsy. Furthermore, researchers can draw on a wealth of published data and established metrics from more than a decade of research using Shimmer devices.  The Verisense platform provides complete clinical trial sponsor support. Sponsors gain access to all the raw participant data; they are uploaded to a secure site and can be transferred to an electronic data capture system automatically to ensure data integrity. Built-in algorithms provide validated metrics. A monitoring dashboard shows the status of all the sites at a glance, and provides the ability to drill down to every sensor in the study. From the site perspective, Verisense requires just a five-minute setup to initiate data collection and participant follow up if the system alerts them to a critical issue.  The Verisense platform places the minimum burden on participants. After putting the base station near their bed, or in another location that they visit every day, all they need to do is wear the sensor. It can even be worn in the shower or bath. The Verisense battery lasts for up to six months and the data transfer is completely automatic. The Verisense sensor can be inserted into a wide variety of cradles, ensuring that it meets all style and functional requirements. ]]> https://biospectrumindia.com/news/57/12880/merck-gets-first-u-s-patent-for-improved-crispr-technology.html https://biospectrumindia.com/news/57/12880/merck-gets-first-u-s-patent-for-improved-crispr-technology.html Wed, 20 Feb 2019 12:20:00 +0530 Merck, a leading science and technology company and leader in genome editing, has announced that the United States Patent and Trademark Office has issued a formal notice allowing Merck's patent application directed to its proxy-CRISPR technology "This our first U.S. patent for CRISPR, and as a leading innovator of CRISPR technology, we will continue to collaborate with scientists around the world to ensure that the full potential of this powerful tool is realized, responsibly and ethically," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "This is great news for researchers in the U.S., as they now have more gene-editing options that accelerate drug development." Merck's proxy-CRISPR is a new genome-editing technique that makes CRISPR more efficient, flexible and specific by opening the genome for modification of DNA.The technology can help scientists modify regions of the genome which are difficult to access. This U.S. patent allowance marks Merck's 13th CRISPR patent worldwide. The company's CRISPR patent portfolio includes granted patents in Australia, Canada, Europe, Singapore, China, Israel and South Korea. Those patents are for CRISPR-related technologies covering foundational and alternative genome-editing methods. To deploy the proxy-CRISPR method, two CRISPR systems are designed to target the genome in proximity to each other and work together. One CRISPR system opens a regional "door," pushing away blocking chromatin proteins, while the other walks through it to find the exact location for modification. Since the resulting modification requires two CRISPR binding events, the proxy-CRISPR method can enable twice the specificity of individual CRISPR systems. Merck has received patents for its CRISPR paired nickase technology (cleaving opposite strands of a chromosomal sequence to create a double-stranded break) in Australia, Canada and Europe. Patents for Merck's CRISPR integration technology (chromosomal cutting of the sequence of eukaryotic cells and insertion of a DNA sequence) have been granted in Australia, Canada, Europe, Singapore, China, Israel and South Korea. Merck is licensing its entire patent portfolio for all fields of use. ]]> https://biospectrumindia.com/news/57/12877/thermo-fisher-to-expand-with-35m-supply-chain-facility.html https://biospectrumindia.com/news/57/12877/thermo-fisher-to-expand-with-35m-supply-chain-facility.html Wed, 20 Feb 2019 11:15:00 +0530 Thermo Fisher Scientific announces to start construction of a new $35 million state-of-the-art pharma services supply chain facility in Rheinfelden (Baden) Germany.  The facility expands Thermo Fisher’s footprint in the European Union. The new facility will feature the latest technology and modern infrastructure to significantly increase European capacity for cold and ambient clinical trial materials in support of complex clinical research and so meet the growing needs of customers. The facility will be scalable for mixed-use space and provide a strategic logistical location for shipping either by road or air.  Construction of the 8,000 square meter facility is expected to take 12 to 18 months. Once complete, this new facility will provide up to 200 new jobs locally. The investment includes the option for additional expansion with the potential for doubling the footprint.  The company’s decision to expand is in response to a growing demand for global clinical supply services, worldwide. The new facility will also serve to address GDP guidelines, Clinical Trial Regulations Annex 6 and the new Falsified Medicines Directive 2019. This GMP/GDP facility builds on the company’s existing footprint of 20 purpose-built cGMP facilities globally. ]]> https://biospectrumindia.com/news/57/12869/healthcare-artificial-intelligence-market-to-hit-13b-by-2025.html https://biospectrumindia.com/news/57/12869/healthcare-artificial-intelligence-market-to-hit-13b-by-2025.html Tue, 19 Feb 2019 15:55:00 +0530 Europe healthcare artificial intelligence market witnessed 41.8% growth throughout the analysis period. Adoption of artificial intelligence in research areas and advancement in technology with respect to electronic health records (EHR) and eHealth should drive healthcare artificial intelligence market in Europe. Moreover, European Union undertakes several efforts to stimulate use of healthcare artificial systems to make eHealth stronger. European Union also introduced an innovative technology to develop EHR across Europe named as the European Health Records Organization (EHRO). Thus, efforts undertaken by government authorities will significantly impact the regional industry growth Global Healthcare Artificial Intelligence Market is expected to surpass USD 13 billion By 2025; according to a new research report by Global Market Insights, Inc. Rising adoption of healthcare artificial intelligence solutions and software in research processes and drug development will foster industry growth in near future. Current drug discovery process is witnessing a paradigm shift to meet the growing needs of society and patients. Advancements in clinical research and personal digital assistants have shown incredible potential of artificial intelligence technology over the recent decade. The use of artificial intelligence and its broadening horizons in research areas is likely to drive the AI in healthcare market. In drug research, use of artificial intelligence streamlines selection process of drug development and helps investigators to study only those drugs that are promising and aids in identification of previously undiscovered pathways escalating its adoption amongst the researchers and scientists proving beneficial for the industry growth. Growing applications of healthcare artificial intelligence software and solutions will positively influence the industry growth. Promising application of artificial intelligence in the future includes image recognition to analyze large sets of MRI and CT scans to identify and diagnose malignant tumors with more accuracy than expert radiologists. Moreover, the application of artificial intelligence for assisting and monitoring patients with their needs in the absence of clinical professionals will also augment the industry growth. Wearables segment was valued at USD 99.3 million in 2018 and is expected to have considerable revenue size during the forecast time-frame. Increasing adoption of artificial intelligence, big data and machine learning tools in wearables to provide insights and make effective clinical decisions will foster its adoption amongst adults. Also, development of technologically advanced wearables that utilizes machine learning to identify significant changes in the patient's vital parameters that allows caregivers to deliver quality care will prove beneficial for the segmental growth. Asia Pacific AI in healthcare market was valued at 148.9 million in 2018. Considerable revenue size can be attributed to the rising adoption of healthcare artificial intelligence software and solutions in maintaining large amount of patient database. Emerging countries have huge populations and it becomes difficult to secure the patient data that is vulnerable to several threats. Hence, availability of software and solutions that assures data integrity and security has increased its adoption amongst the healthcare professionals thereby, fostering the regional market growth. ]]> https://biospectrumindia.com/news/57/12864/quest-diagnostics-names-gabrielle-wolfson-as-sr-vp-and-chief-information-and-digital-officer.html https://biospectrumindia.com/news/57/12864/quest-diagnostics-names-gabrielle-wolfson-as-sr-vp-and-chief-information-and-digital-officer.html Tue, 19 Feb 2019 12:50:00 +0530 Quest Diagnostics, the world's leading provider of diagnostic information services has announced that Gabrielle Wolfson, a veteran information technology business leader, has been named Senior Vice President and Chief Information and Digital Officer. She reports directly to Steve Rusckowski, Chairman, President and CEO, and is based at the company's headquarters in Secaucus, N.J. Ms. Wolfson is responsible for leading information technology, data informatics and digital solutions for Quest Diagnostics. These include the company's Quanum suite of healthcare IT solutions and data analytics, myQuest patient mobile app and portal, and digital engagement for the company's 2,200 patient service centers. "Gabrielle is a dynamic business and technology leader with a proven record of harnessing technology and data to create strong businesses and engaged, loyal customers," said Mr. Rusckowski. "She has the vision, experience and business acumen to help Quest improve the way we use technology to create great experiences for consumers, employees, healthcare providers and payers. I'm pleased to welcome Gabrielle to Quest Diagnostics." Ms. Wolfson joins Quest Diagnostics from Xerox Corp. where had she served as Chief Information Officer (CIO) since 2016. At Xerox, she led efforts to drive cost and complexity from the company's technology infrastructure and create a dynamic digital business. Prior to Xerox, Ms. Wolfson was CIO for Wyndham Hotels and Resorts, where she led the global digital transformation for the company's reservation, ecommerce and marketing platforms. Also, she is formerly CIO for both Integra Life Sciences and Par Pharmaceutical, and a practice leader for life sciences and pharmaceutical industries for PricewaterhouseCoopers. Ms. Wolfson earned a bachelor's degree in mathematics from Queens College in New York City, and a master's degree in technology management from Columbia University. She is a member of the Governing Body of the Society of Information Management (SIM). Quest Diagnostics is a leader in healthcare information technologies and services. As many as one in two physicians and hospitals, and 675 electronic health record platforms, connect to one or more Quanum solutions in the United States. The company also provides several data analytics and population services based on its more than 44 billion de-identified laboratory tests. Quest Diagnostics is also a founding member of the Synaptic Health Alliance, which explores the use of blockchain technology to improve data quality and sharing. ]]> https://biospectrumindia.com/news/57/12863/who-itu-standard-to-prevent-hearing-loss-among-1-1-billion-young-people.html https://biospectrumindia.com/news/57/12863/who-itu-standard-to-prevent-hearing-loss-among-1-1-billion-young-people.html Tue, 19 Feb 2019 12:45:00 +0530 Ahead of World Hearing Day (3 March), the World Health Organization (WHO) and the International Telecommunication Union (ITU) have issued a new international standard for the manufacture and use of these devices, which include smartphones and audio players, to make them safer for listening. Nearly 50% of people aged 12-35 years – or 1.1 billion young people – are at risk of hearing loss due to prolonged and excessive exposure to loud sounds, including music they listen to through personal audio devices. Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, "Given that we have the technological know-how to prevent hearing loss, it should not be the case that so many young people continue to damage their hearing while listening to music. They must understand that once they lose their hearing, it won’t come back. This new WHO-ITU standard will do much to better safeguard these young consumers as they go about doing something they enjoy.” Over 5% of the world’s population – or 466 million people – has disabling hearing loss (432 million adults and 34 million children); impacting on their quality of life. The majority live in low- and middle-income countries. It is estimated that by 2050 over 900 million people – or 1 in every 10 people – will have disabling hearing loss. Hearing loss which is not addressed poses an annual global cost of US$ 750 billion. Overall, it is suggested that half of all cases of hearing loss can be prevented through public health measures. Features of safe listening devices The Safe listening devices and systems: a WHO-ITU standard recommends that personal audio devices include: "Sound allowance” function: software that tracks the level and duration of the user’s exposure to sound as a percentage used of a reference exposure. Personalized profile: an individualized listening profile, based on the user’s listening practices, which informs the user of how safely (or not) he or she has been listening and gives cues for action based on this information. Volume limiting options: options to limit the volume, including automatic volume reduction and parental volume control. General information: information and guidance to users on safe listening practices, both through personal audio devices and for other leisure activities. The standard was developed under WHO’s “Make Listening Safe” initiative which seeks to improve listening practices especially among young people, both when they are exposed to music and other sounds at noisy entertainment venues and as they listen to music through their personal audio devices. The WHO-ITU standard for safe listening devices was developed by experts from WHO and ITU over a two-year process drawing on the latest evidence and consultations with a range of stakeholders, including experts from government, industry, consumers and civil society.  ]]> https://biospectrumindia.com/news/57/12862/jj-announces-agreement-to-acquire-auris-health.html https://biospectrumindia.com/news/57/12862/jj-announces-agreement-to-acquire-auris-health.html Tue, 19 Feb 2019 12:30:00 +0530 Johnson & Johnson has announced that Ethicon, Inc., entered into a definitive agreement to acquire Auris Health, Inc. for approximately $3.4 billion in cash.  Auris Health is a privately held developer of robotic technologies, initially focused in lung cancer, with an FDA-cleared platform currently used in bronchoscopic diagnostic and therapeutic procedures. Additional contingent payments of up to $2.35 billion, in the aggregate, may be payable upon reaching certain predetermined milestones. This acquisition will accelerate Johnson & Johnson’s entry into robotics with potential for growth and expansion into other interventional applications. Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson said, “In this new era of health care, we’re aiming to simplify surgery, drive efficiency, reduce complications and improve outcomes for patients, ultimately making surgery safer. We believe the combination of best-in-class robotics, advanced instrumentation and unparalleled end-to-end connectivity will make a meaningful difference in patient outcomes.” With this acquisition, Frederic Moll, CEO and Founder of Auris Health and a visionary in the field of surgical robotics, will be joining Johnson & Johnson upon completion of this transaction. “We’re thrilled to be joining Johnson & Johnson to help push the boundaries of what is possible in medical robotics and improve the lives of patients across the globe. Together, we will be able to dramatically accelerate our collective product innovation to develop new interventional solutions that redefine optimal patient outcomes. This combination is a testament to the incredible work of the Auris Health team and the innovation engine behind the Monarch Platform, which represents a huge step forward in endoluminal technology. We look forward to continuing to shape the future of intervention with the added expertise and resources of the world’s largest healthcare organization”, said Dr. Moll “We are very committed to our partnership with Verily on the development of the Verb Surgical Platform. Collectively, these technologies, together with our market-leading medical implants and solutions, create the foundation of a comprehensive digital ecosystem to help support the surgeon and patient before, during and after surgery,” said Ms. McEvoy. The closing is subject to antitrust clearance and other customary closing conditions. The transaction is expected to close by the end of the second quarter of 2019.     ]]> https://biospectrumindia.com/news/57/12859/skinbiotherapeutics-raises-1-5m-to-widen-its-skin-biome-technology.html https://biospectrumindia.com/news/57/12859/skinbiotherapeutics-raises-1-5m-to-widen-its-skin-biome-technology.html Tue, 19 Feb 2019 12:05:00 +0530 SkinBiotix®, which is already in human studies with its scientifically validated treatments for a variety of skin conditions, has raised £1.5 million(mn)  from its original investor Seneca to further explore opportunities for its existing technology and support new areas of development. Derived from probiotic bacteria, SkinBioTherapeutics technology is being developed for use in cosmetics, infection control products and in the treatment of a variety of skin conditions. The skin, the body’s largest organ, is colonised by a diverse range of microorganisms which has to be managed for long term good health. SkinBioTherapeutics patented technology is developing a range of products based on lysates - extracts of probiotic bacteria - which will help keep the skin healthier and treat certain conditions. Seneca has followed its original investment in SkinBioTherapeutics by taking an additional investment of £1,500,000 via a placing of 9,375,000 new ordinary shares (“Placing Shares”) at a price of 16 pence per share (the “Placing”). This takes Seneca’s holding from 14.6 per cent to 20.9 per cent of the Company’s issued share capital. Dr Cath O’Neill, CEO of SkinBioTherapeutics, commented "Seneca has been a substantial shareholder in SkinBioTherapeutics since the IPO, therefore we see this additional investment as a strong signal of continuing support of our business and strategy. The funding provides additional working capital and headroom to consider some of the other potential applications for the SkinBiotix® technology as well as other skin conditions, such as psoriasis.” The company is due to report on the results of a double-blinded, efficacy study in the next few weeks which will be shared with interested commercial partners. This follows successful safety studies that ensure the treatments do not irritate and that they are effective moisturisers. ]]> https://biospectrumindia.com/news/57/12842/ibm-watson-to-invest-50m-for-ai-application-in-healthcare.html https://biospectrumindia.com/news/57/12842/ibm-watson-to-invest-50m-for-ai-application-in-healthcare.html Mon, 18 Feb 2019 08:00:00 +0530 IBM Watson Health has announced plans to make a 10-year, $50 million investment in research collaborations with two separate academic centres - Brigham and Women's Hospital, which is a teaching hospital of Harvard Medical School, and Vanderbilt University Medical centre - to advance the science of artificial intelligence (AI) and its application to major public health issues. The scientific collaborations with each institution will focus on critical health problems that are ideally suited for AI solutions. Initial areas of study are expected to include the use of AI to improve the utility of electronic health records (EHRs) and claims data to address significant public health issues like patient safety, precision medicine and health equity. The research will also explore physician and patient user experience and interactions with AI technologies. Drawing on the respective areas of expertise from each organization, the collaborations will be a joint effort among IBM Watson Health's newly appointed vice president and chief science officer, Gretchen Purcell Jackson, M.D., Ph.D., David Bates, M.D., M.S., chief of general internal medicine at Brigham and Women's Hospital, and professor of medicine at Harvard Medical School, Kevin Johnson, M.D., M.S., chair of the department of biomedical informatics at Vanderbilt University Medical centre, and Gordon Bernard, M.D., executive vice president for research, at Vanderbilt University Medical centre. ]]> https://biospectrumindia.com/news/57/12838/sana-biotech-launches-engineered-cells-to-create-a-new-class-of-medicines.html https://biospectrumindia.com/news/57/12838/sana-biotech-launches-engineered-cells-to-create-a-new-class-of-medicines.html Fri, 15 Feb 2019 14:45:00 +0530 Sana Biotechnology, a new company focused on creating and delivering engineered cells as medicines for patients has announced its launch. Recent scientific advances make it possible to reprogram cells in the body or replace damaged cells and tissues, creating a new class of medicines to treat a broad array of diseases. Sana is bringing together research, development, and manufacturing capabilities across cell therapy, gene therapy, and gene editing as well as a team of executives, board members, investors, and scientists with deep experience in these areas.  "Cell and gene engineering provide the opportunity to address the underlying cause of disease and provide benefits to patients that have previously been not possible," said Steve Harr, Sana Co-Founder and CEO. "There are challenges in making and delivering these kinds of medicines to patients, but also the opportunity to treat illnesses that today have few, if any, options. Our goal with Sana is to bring together the people, technologies, and resources needed to address these challenges, changing both how we approach treating disease and what we expect as outcomes for patients." The company is building critical core capabilities around – Making cells at scale ex vivo to replace any damaged or missing cells in the body, In vivo delivery to specific cell types of any payload – including DNA, RNA, and proteins to reprogram cells, Immunology expertise to hide allogeneic cells (cells from a donor) or delivery vehicles from the immune system so that the body does not reject or eliminate them, Controllable gene and protein expression systems, Scaled, cost-efficient manufacturing solutions, and Discovery and development of new technologies that will enable the ultimate breadth of application of cell and gene engineering. "I am thrilled to join the leadership team and board as we launch Sana," said Hans Bishop, Co-Founder and Executive Chair of Sana. "We have assembled a scientific team and a portfolio of potential medicines and technologies from proven scientific innovators, including Flagship Pioneering, Harvard University, the University of California San Francisco, and the University of Washington School of Medicine. I look forward to working again with ARCH Venture Partners, focusing on advancing the technologies in the company today as well as bringing in additional technologies and capabilities to make our vision around engineered cells a reality." "Flagship Pioneering originates companies that apply new biological breakthroughs to tackle the most intractable challenges in health, and we believe Sana is one of those companies," said Noubar Afeyan, Sana Co-Founder and Founder and CEO of Flagship Pioneering. "We are thrilled about the opportunity to combine the novel, cell-specific in vivo gene delivery platforms pioneered during several years of R&D within Flagship Labs with the other technologies and potential medicines to form Sana. We look forward to collaborating with our co-founders and partners to develop this best-in-class company." "ARCH partners with experienced, world-class management teams to assemble the technology, talent, and capital to create companies that solve big problems for patients," said Robert Nelsen, Sana Co-Founder and Managing Director and Co-Founder of ARCH Venture Partners. "We believe the time is right to commit the resources needed to create a new pillar of medicine that not only treats disease, but hopefully cures it. Sana is a unique company in a transformative time in science, and we believe this team, combined with its co-founders, has the experience, creativity and know-how to make a big impact on medicine." ]]> https://biospectrumindia.com/news/57/12837/healthec-announces-hiring-of-robert-osburn-as-chief-operating-officer.html https://biospectrumindia.com/news/57/12837/healthec-announces-hiring-of-robert-osburn-as-chief-operating-officer.html Fri, 15 Feb 2019 14:35:00 +0530 HealthEC, LLC, a 2019 Best in KLAS provider of population health management solutions has announced that Robert Osburn has joined the company as Chief Operating Officer to help drive the company’s strategic development and grow its portfolio of government, public sector, commercial, and private clients. “Robert’s government and commercial health plan expertise and record of achievement in both the provider and payer space makes him the ideal professional for this role,” said Arthur Kapoor, President and CEO of HealthEC. “His contracting skills, command of the regulatory landscape and ability to identify revenue opportunities align particularly well with HealthEC’s plans to expand our government business and to show state Medicaid agencies how to leverage our population health management platform to measure and compare evidence-based performance and outcomes of managed care organizations, providers and members.” Prior to joining HealthEC, Osburn held numerous positions at Unisys HIM and Molina Healthcare Corporation’s Molina Medicaid Solutions unit (acquired by DXC Technology in 2018), including Chief Health Policy Officer, Chief Operating Officer, and Vice President of Business & Strategic Development. For more than a decade he drove organizational performance, including strategic planning, product innovation, partnerships, and business development. Osburn has also held senior leadership roles at Healthcare Enhancement Systems Inc., Columbia/HCA Healthcare Corporation, Comprehensive Care Corporation, and other healthcare organizations. He has also served as a Hold Separate Trustee for the Federal Trade Commission. “As the healthcare industry embraces population health management and value-based contracting, and demand for our services grow, we look forward to Robert’s stewardship and the comprehensive experience he brings to the position,” Kapoor said.    Osburn holds master’s degrees in Healthcare Administration and Business Administration from Webster University and is a board member of the Virtual School of Music, the LifeCare Foundation and ReliaCare Holdings.   ]]> https://biospectrumindia.com/news/57/12829/haselmeier-acquires-drug-manufacturing-license.html https://biospectrumindia.com/news/57/12829/haselmeier-acquires-drug-manufacturing-license.html Fri, 15 Feb 2019 09:00:00 +0530 As an innovative and strategic partner for pharmaceutical and biotechnology companies, Haselmeier develops and produces customized, unique self-injection systems that are used worldwide. The quality, reliability and ease of use of these high-tech products play a key role in the therapeutic efficiency and quality of life of patients. Haselmeier has been in possession of an allowance to manufacture pharmaceuticals since December 2018, which is done at the production site in Buchen, Odenwald, in accordance with §13 of the Medicines Act (Arzneimittelgesetz - AMG) or according to Art. 40 of Directive 2001/83/EC. Haselmeier can now offer pharmaceutical and biotechnological companies an assembly, labelling and packaging service. Konrad Betzler, Chief Quality Officer of Haselmeier: "I am pleased that, after extensive preparatory work and in close coordination with the responsible GMP supervisory authority, we have now received the manufacturing permit". Haselmeier will in future assemble the cartridges supplied by customers for the respective therapies with the injection pens as well as label and package the combination products. This service also includes the manufacture of batches for stability testing. Haselmeier thus offers important complete solutions, for example for pharmaceutical companies in the production of small and medium-sized series for clinical studies as well as for biotech start-ups. Haselmeier is a leading developer and manufacturer of innovative self-injection devices that feature company designs and state-of-the-art technology. Haselmeier has more than four decades of experience in the field of medical devices. Through the years, the company has built up a top-class planning and development team that is responsible for the design, planning and industrialization of our innovative self-injection systems - and thus manufactures successful products that are used by pharmaceutical and biotechnology companies worldwide. Haselmeier with headquarters in Switzerland, employs around 200 people worldwide. The company has sales offices in Europe, the United States and India. The Haselmeier-products are manufactured in state-of-the-art production facilities in Buchen, Odenwald (Germany), Dnešice (Czech Republic) and Bengaluru (India). ]]> https://biospectrumindia.com/news/57/12828/navitas-life-sciences-acquires-dataceutics-in-a-45-mm-deal.html https://biospectrumindia.com/news/57/12828/navitas-life-sciences-acquires-dataceutics-in-a-45-mm-deal.html Thu, 14 Feb 2019 13:35:00 +0530 Navitas Life Sciences, a TAKE Solutions Enterprise has announced that it will be acquiring Life Sciences services player, DataCeutics in North America. The acquisition, as part of the 2021 growth strategy, spearheads the growth of Clinical business in accordance with the global Clinical market, which is expected to reach $32.9 B by 2020. The company is poised to gain from the strategic acquisition of DataCeutics, a specialty Clinical Functional Service Provider (FSP), delivering quality statistical programming, clinical reporting and clinical data management. DataCeutics strengthens Navitas Life Sciences in its high-end Data Sciences capabilities which include Clinical Data Management, Biostatistics and Statistical Programming, Medical Writing, Data Standards and Conversions as well as bolstering relationships with major pharma companies in North America. Navitas Life Sciences plans to complement DataCeutics' capabilities with its own AI-driven clinical platform and near real-time data insights and analytics to deliver improved outcomes for clients across safety, quality, compliance, cycle time and cost. The company has core Clinical FSP capabilities and experienced resources in Oncology, Cardiology, Pulmonology, Infectious Disease and CNS. Dr Krishnan Rajagopalan, Chief Growth Officer, Navitas Life Sciences said, "We are delighted to begin 2019 on a high note with this key acquisition. DataCeutics strengthens our capabilities in Data Sciences and FSP / BPO services and widens our therapeutic expertise in Cardiology, Oncology, Pulmonology, CNS, Infectious diseases etc. The addition of these competencies translates to business expansion in North American, European and Asian markets." He further added, "We are looking forward to bolstering the Clinical business further translating to a healthier pipeline in the coming quarters." Benefits of the acquisition: Ability to better target the largely untapped and continuously evolving Data Sciences field supporting R&D efforts of novel therapies across various indications Enhances therapeutic expertise in Cardiology, Oncology, Pulmonology, Mental health, Musculoskeletal diseases, CNS, and Infectious diseases An increase of Life Sciences expertise by 10% Combined footprint will further cover North America, Europe, and Asia ]]> https://biospectrumindia.com/news/57/12826/wehealth-collaborates-with-m-i-t-to-synergize-homecare.html https://biospectrumindia.com/news/57/12826/wehealth-collaborates-with-m-i-t-to-synergize-homecare.html Thu, 14 Feb 2019 11:05:00 +0530 WeHealth by Servier, Servier Group’s Digital Health business unit, and the Massachusetts Institute of Technology (MIT), announced today a collaboration agreement to define new market paradigms of home technologies.  WeHealth and the AgeLab will interact together through the AgeLab C3 Connected Home Logistics Consortium, along with other industry leaders, to conduct collaborative research to envision the development of home services to tackle the growing challenge of connectivity, convenience and care to improve individual health and well-being in elderly people. “This partnership is an unprecedented opportunity to synergize our forces for advancing healthcare” said Dr. David Guez, General Director of WeHealth by Servier.  In a context of increasing chronic diseases and an aging population, the development of home health care is a significant issue. e-Health makes it possible to provide innovative and effective solutions that meet the evolving needs of patients. It facilitates patient‘s distance care and assistance and care pathway in terms of prevention, compliance and homecare services.  e-Health also reflects a change in the behavior of patients who are increasingly involved in their health and treatment plans by being better informed - via specialized websites and mobile health - and better self/ remotely monitored, thanks to the emergence on the market of connected devices (i.e. glucose meter, portable ECG, treatment reminders, sensors) and affordable home diagnostics tests.  Data analytics is the common denominator to all digital technologies. The solutions designed as part of the partnership between WeHealth by Servier and AgeLab MIT will meet with new health needs and requirements in a secured manner to protect and respect patient confidentiality. The innovations will also ensure data interoperability between the different solutions on the market and broader health data (i.e. Electronic Medical Records), ultimately breaking down siloes of data while improving access data by patients and healthcare professionals. ]]> https://biospectrumindia.com/news/57/12822/medidata-cognizant-form-strategic-alliance-for-life-science-clients.html https://biospectrumindia.com/news/57/12822/medidata-cognizant-form-strategic-alliance-for-life-science-clients.html Thu, 14 Feb 2019 10:00:00 +0530 Medidata and Cognizant have entered into a strategic alliance to offer life science clients comprehensive solutions that leverage the market’s leading cloud platform with world-class business and technology services. This provides pharmaceutical, biotech, medical device companies, contract research organizations (CROs), sites and investigators with digital capabilities to facilitate a fast start to clinical trials, simplify operational complexities and drive digital transformation. As part of the multi-year agreement, Cognizant will develop and deliver a comprehensive set of managed services and solutions specific to Medidata’s platform. Cognizant’s expertise in business process, technology and digital services (including biostats, automation and help desks) will combine with solutions across the Medidata platform, such as Randomization and Trial Supply Management. This will create clinical capabilities as-a-service to help address the increasing complexities and global scale of clinical trials. As an example of how Medidata is providing more choices for customers, Medidata Site Payments will seamlessly connect with Cognizant’s Shared Investigator Platform (SIP) -- the industry standard platform designed to improve the experience of investigators, sites and sponsors. Clinical trials are becoming more complex to implement and conduct due to big data, AI and the desire for more targeted therapies. The professional services component of this alliance provides life science companies with technology and expertise to architect, implement and optimize studies. “Most life science companies have stitched together multiple legacy solutions and are in dire need for a clinical refresh. This partnership allows us to offer and manage the most comprehensive platform and suite of services for our clients so that they can focus on the science rather than operational complexities,” said Bhaskar Sambasivan, senior vice president and global head of life sciences at Cognizant. “This alliance exemplifies the power of Medidata’s technology combined with the expertise of the broadest and most advanced partner ecosystem, which we have built in life sciences,” said Tarek Sherif, chairman and chief executive officer, Medidata. “We are deepening our partnership with Cognizant to help customers around the globe fully realize the value of digital transformation.” ]]> https://biospectrumindia.com/news/57/12823/johnson-johnson-to-acquire-auris-health.html https://biospectrumindia.com/news/57/12823/johnson-johnson-to-acquire-auris-health.html Thu, 14 Feb 2019 09:40:00 +0530 Johnson & Johnson entered into a definitive agreement to acquire Auris Health for approximately $3.4 billion in cash. Additional contingent payments of up to $2.35 billion, in the aggregate, may be payable upon reaching certain predetermined milestones. Auris Health is a privately held developer of robotic technologies, initially focused in lung cancer, with an FDA-cleared platform currently used in bronchoscopic diagnostic and therapeutic procedures. This acquisition will accelerate Johnson & Johnson’s entry into robotics with potential for growth and expansion into other interventional applications. With this acquisition, Frederic Moll, M.D., CEO and Founder of Auris Health and a visionary in the field of surgical robotics, will be joining Johnson & Johnson upon completion of this transaction. Johnson & Johnson is continuously working to disrupt medical innovation. With Auris Health’s current focus on lung cancer, the Monarch Platform robotic technology will play an important role within the Lung Cancer Initiative at Johnson & Johnson (LCI), enabling the development of a differentiated digital solution that addresses key steps in the lung cancer care journey, from diagnosis to early stage intervention, that are central to the company’s commitment to develop solutions that prevent, intercept and cure this deadly disease.  Johnson & Johnson continues to make meaningful investments to transform the surgical experience, connecting digital solutions to enhance surgical performance. In addition to advancing the company’s focused initiatives to combat lung cancer, Auris Health’s technology will support Johnson & Johnson’s vision of being a world leader across the continuum of surgical approaches, including open, laparoscopic, robotic and endoluminal. This move is also complementary to the acquisition of Orthotaxy’s robotic technology for orthopaedics and the continued development of the Verb Surgical Platform, through a strategic partnership with Verily. Johnson & Johnson is creating a connected digital ecosystem centered around using data to improve patient outcomes that leverages world-class robotic technology. This ecosystem will empower patients to take charge of their health, guide surgeons through procedures and help them advance their skills and enable healthcare systems to deliver more consistent procedures while also managing costs. The closing is subject to antitrust clearance and other customary closing conditions. The transaction is expected to close by the end of the second quarter of 2019. The company will discuss the transaction further during its next quarterly earnings call on April 16, 2019. ]]> https://biospectrumindia.com/news/57/12821/culture-biosciences-secures-5-5m-to-expand-its-digital-biomanufacturing-platform.html https://biospectrumindia.com/news/57/12821/culture-biosciences-secures-5-5m-to-expand-its-digital-biomanufacturing-platform.html Wed, 13 Feb 2019 15:45:00 +0530 Culture Biosciences, the South San Francisco-based biotech company pioneering biomanufacturing-as-a-service has announced $5.5 million in funding led by Section 32, with participation from Refactor Capital and Verily. Culture will use the funding to expand its digital biomanufacturing platform and develop additional bioreactor facilities. "Biotechnology is poised to transform industries ranging from healthcare to food, but it is limited by arduous and time consuming approaches to fermentation, the key process involved in manufacturing bio-based products at scale," said Culture Biosciences CEO Will Patrick. "Our goal is to make fermentation a digital experience, empowering scientists to run experiments from their computers in the same way a software engineer tests and compiles code. We're proud to have the support of such committed investors as we pursue our vision of supporting companies as they build breakthrough products." Across industrial, pharmaceutical and agricultural biotechnology, companies often struggle to scale their lab-based projects into commercial solutions. This scale-up process is bottlenecked by legacy approaches to fermentation, which require companies to either build in-house fermentation facilities or contract an outside lab to run their experiments. Both approaches are limited in speed, flexibility and convenience, contributing to lengthy lab-to-market timelines that can stretch well beyond five years and cost companies hundreds of millions of dollars in R&D expenses. Culture is developing a digital biomanufacturing platform to enable companies to run, monitor and analyze bioreactor experiments for faster and more convenient biotech product development. Culture's platform, which integrates best-in-class bioreactors, cloud monitoring capabilities and remote operations, is currently being used by leading biotechnology companies to optimize their R&D processes. Customers who join the Culture network have access to custom built and engineered bioreactors equipped with novel robotic systems for more efficient operation, cloud monitoring capabilities to gain real-time insights, fast data transfer and sample shipping, and same-day process design changes. Customers can access the Culture system through any cloud-connected device, and can remotely manage their experiment as if they were running it themselves. "We are excited to lead this investment in Culture Biosciences, which is empowering companies to focus on what they do best – creating groundbreaking technology and turning it into great products," said Dr. Mike Pellini, Managing Partner at Section 32. ]]> https://biospectrumindia.com/news/57/12817/mit-suggests-policy-and-practice-for-accessible-and-sustainable-healthcare-.html https://biospectrumindia.com/news/57/12817/mit-suggests-policy-and-practice-for-accessible-and-sustainable-healthcare-.html Wed, 13 Feb 2019 15:10:00 +0530 The MIT-based Financing and Reimbursement of Cures in the US (FoCUS) consortium released a series of large-scale policy and practice recommendations for financing new and upcoming curative and durable treatments to ensure broad patient access and healthcare system sustainability. The recommendations were released at a FoCUS-hosted conference at the National Press Club. The conference featured keynote remarks from U.S. Senators William Cassidy (R-LA) and Sheldon Whitehouse (D-RI), and 30 other speakers spanning the spectrum of healthcare system stakeholders. Curative and durable treatments encompass a class of therapies with a short, sometimes single dose, treatment regime that offer the opportunity of lasting benefits. Yet, these therapies have a significant health care financing challenge for many consumer and payers. "We have got to establish new paradigms to pay for these drugs," said Senator Cassidy. "The choice is not between paying whatever a company decides to charge for a medication, or denying access to a life-saving drug, but a middle [that] establishes a cost society can afford and a means which facilitates paying that cost, and at the same time rewarding innovation and making sure there's access." Milestone-based contracts, performance-based annuities, and novel Orphan Reinsurer and Benefit Managers (ORBMs) will help healthcare organizations meet new financing challenges by navigating complexity in disease and patient profiles, novel therapies, funding mechanisms, and performance risks. The accompanying policy suggestions for public agencies and programs, such as the FDA and Medicaid, include new performance metrics policies, payment and reimbursement practices, and legal frameworks to sustain innovative therapies. "Cell and gene therapies are giving us the opportunity to cure diseases that we could once only hope to manage," said Senator Whitehouse. "I'm excited about the pilots being launched by MIT to test milestone-based contracts and other creative ways to pay for therapies. These payment models represent a fundamental shift in the way we think about paying for value and they aim to help the market bear medical innovations." "We focus on helping the system catch up with the science in biomedical innovation, and do it in ways that are both patient-centered and system-sustainable," said Dr. Gigi Hirsch, Executive Director of the NEWDIGS Initiative. ]]> https://biospectrumindia.com/news/57/12810/quest-diagnostics-acquires-laboratory-services-biz-of-bbpl.html https://biospectrumindia.com/news/57/12810/quest-diagnostics-acquires-laboratory-services-biz-of-bbpl.html Wed, 13 Feb 2019 09:00:00 +0530 Quest Diagnostics, the world's leading provider of diagnostic information services, has announced that it has completed its previously announced acquisition of the clinical laboratory services business of Boyce & Bynum Pathology Laboratories (BBPL), a leading provider of diagnostic and clinical laboratory services in the Midwest. Through a separate professional services agreement, Boyce and Bynum Pathology Professional Services, Inc. (BBPPS), is now the exclusive pathology provider for Quest Diagnostics clients in Missouri and a preferred pathology provider in the greater Midwestern region. Additional financial terms were not disclosed. The aim for the transaction is to bring a broader menu of innovative clinical laboratory and pathology services to patients and providers throughout the region. In addition, the relationship will provide patients with access to an expanded network of service centers across the Midwest, for greater convenience. ]]> https://biospectrumindia.com/news/57/12809/archerdx-enters-into-strategic-collaboration-with-genosity.html https://biospectrumindia.com/news/57/12809/archerdx-enters-into-strategic-collaboration-with-genosity.html Tue, 12 Feb 2019 17:00:00 +0530 ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, has announced that it has entered into a broad strategic collaboration with Genosity Inc., a biotechnology company that provides expertise, software and technical solutions to unlock the power of precision medicine by advancing genomics and facilitating collaborative research. Under the terms of the collaboration, ArcherDX will co-market Genosity's suite of consulting and laboratory software services designed to facilitate implementation and speed adoption of next-generation sequencing based testing to support precision medicine programs across biopharmaceuticals and health systems.  These services span the full lifecycle of genomic test development including assay and bioinformatics design assistance, validation planning and execution services, variant interpretation support and revenue cycle management optimization. The software solutions covered under this collaboration include Genosity's Genome Explorer, Laboratory Information Management System (LIMS) and Cortex applications.  The Genome Explorer platform integrates with and extends ArcherDX's Archer Analysis Unlimited bioinformatics pipeline with additional Case Analyzer and Report Buildermodules that together provide an end-to-end computational analysis and result reporting solution for next-gen sequencing-based panels.  The LIMS application is designed specifically for NGS workflows to improve laboratory efficiency while enabling quality control monitoring. Pre-configuration of most of the ArcherDX assays in Genosity's LIMS facilitates easier implementation of wet lab workflows in NGS labs.  Genosity's Cortex provides a data warehouse and knowledge base that enables population-level analysis and cohort identification to support R&D and inter and intra-institution collaborations. Financial terms of the collaboration are not being disclosed.   ]]> https://biospectrumindia.com/news/57/12791/eagle-genomics-to-join-microsoft-ai-factory-.html https://biospectrumindia.com/news/57/12791/eagle-genomics-to-join-microsoft-ai-factory-.html Mon, 11 Feb 2019 13:30:00 +0530 Microbiome discovery Platform Company Eagle Genomics has been selected to join the latest cohort of the Microsoft AI Factory, based at the world-renowned Station F startup campus in Paris. The Microsoft AI Factory accelerator programme launched in 2017 in partnership with French computer science and automation institution, INRIA.  It has selected and supported a community of leading AI startups to drive and accelerate innovation in the field. The community, based at the world's largest startup campus, Station F, hosts pioneering companies from a wide range of sectors applying AI to solve some of the grand challenges of our age.  The Eagle Genomics platform utilizes AI to analyze complex genomic and microbiomic data at scale, delivering new insight and allowing enterprise brands to assess the viability, efficacy and safety of products. The company is particularly focused on how the microbiome, the ecosystem of bacteria, fungi and viruses present in virtually all living organisms, is linked with health and affected by the products we use and consume.  Eagle Genomics' selection into the AI Factory follows its participation in the European Microsoft ScaleUp programme and a recently announced partnership with Microsoft Genomics, which marked Microsoft's first venture into the microbiome. The company has also recently secured funding of $3.5M to accelerate the development of its award-winning platform. ]]> https://biospectrumindia.com/news/57/12777/clarivate-analytics-initiates-global-life-science-alliance-program.html https://biospectrumindia.com/news/57/12777/clarivate-analytics-initiates-global-life-science-alliance-program.html Fri, 08 Feb 2019 14:45:00 +0530 Clarivate Analytics, a global leader in providing trusted insights and analytics to accelerate the pace of innovation, recently launched a Life Science Alliances Program to provide drug and medical device developers with a new way to significantly advance their research and development (R&D) and commercialization initiatives. The accredited global program combines Clarivate's solutions with those of world-class technology and service providers to deliver intelligence and actionable insights to biopharmaceutical companies and other researchers around the world. More than ever, drug and medical device researchers are challenged to quickly and efficiently access, synthesize and analyze data from a growing and increasingly complex array of sources across the development lifecycle. Clarivate's Life Science Alliances Program addresses this challenge by enabling greater collaboration and new capabilities, and already features leading service providers in its growing ecosystem, including: Bioinfogate, a forward-thinking biomedical data science organization focused on the development of innovative products and services for all those involved in the finding of better and safer drugs. By aligning with Clarivate's suite of scientific intelligence, including biology, chemistry and pharmacology information, Bioinfogate will empower its OFF-X translational safety intelligence portal to help researchers and decision makers in pharmaceutical and healthcare organizations to de-risk and optimize their R&D programs. Vitrana, a dynamic health sciences technology and consulting firm that is driving major advances in the quality, efficiency and cost of clinical research and patient care. Through its partnership with Clarivate, Vitrana has enhanced its HiLIT Platform, which delivers specialized clinical and healthcare information management services, automation, data transformation, standardization and federation, semantic and ontology enabled search, as well as smart and predictive analytics. Waters Corporation, a leading specialty measurement company focused on improving human health and well-being through the application of liquid chromatography, mass spectrometry, and informatics. Working in concert with Clarivate, the Waters Progenesis QI and Progenesis QI for proteomics statistical software platforms enable the direct transfer of experimental results into biological pathways analytics. These enhanced capabilities are enabled by Cortellis Cloud, an integrated, scalable technology platform that host Cortellis, Clarivate's suite of life science intelligence solutions. Through Cortellis Cloud, datapoints from thousands of sources are harmonized within a single unified platform, making it the industry's richest resource for data-driven insights and advanced analytics for Life Science professionals. The Clarivate Life Science Alliances program will expand to include additional partners in 2019 and beyond. ]]> https://biospectrumindia.com/news/57/12776/certara-to-bring-model-informed-precision-dosing-into-clinics.html https://biospectrumindia.com/news/57/12776/certara-to-bring-model-informed-precision-dosing-into-clinics.html Fri, 08 Feb 2019 14:40:00 +0530 Certara, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services,  announced its latest advances in bringing model-informed precision dosing (MIPD) to the point of care. Certara scientists have been engaged in critical assessments of hurdles to MIPD (starting with a white paper in 2017) and now have published four new MIPD papers in the past months delineating the vision and practical path(s) for making individualized dosing a reality under the efforts for “Precision Medicine.”  MIPD uses computer modeling and simulation to predict the drug dose for a given patient based on their individual characteristics, is most likely to improve efficacy and/or lower toxicity compared with traditional dosing. MIPD is particularly useful when dosing patients who belong to a vulnerable population, such as neonatal or pediatric patients, patients with significant renal or hepatic impairment or the frail elderly who receive multiple drugs and hence are susceptible to drug interactions.Those patients are at increased risk of drug-related harm, so improved dosing will likely enhance their care. This is a significant problem for society as well as individual patients because drug-related harm is estimated to cost about US $42 billion per annum globally.  “Certara recognized several years ago that model-informed drug development (MIDD) could also provide tremendous value if used by healthcare providers (HCPs) to determine the optimal drug dose for individual patients in the clinic,” said Certara Chief Scientific Officer Professor Amin Rostami. “We decided to apply our experience in making MIDD operational by collaborating with colleagues in pharma, academia and global regulatory agencies in the area of MIPD to achieve widespread adoption and practical use in clinic instead of the current restricted applications in academic research settings,” Amin stated further.  This transition is being facilitated by several factors that are improving researchers’ understanding of inter- and intra-individual variability in drug response. They include the availability of fast and affordable genetic testing, the rise of multi-omic technologies to identify biomarkers to monitor handling of the drug by individual patient and the specific effects in each patient, improved medical imaging, rapid pathology testing, characterization of the gut microbiome, superior analysis of biological samples, and powerful computational tools to analyze large quantities of patient data.  “MIPD will be especially valuable for HCPs dosing drugs with a narrow therapeutic index – where a small change in dose can have a large impact on the drug’s therapeutic effect or risk of an adverse reaction – and when treating patients from vulnerable populations, which tend to be more complex cases due to changing physiology or polypharmacy,” said Tom Polasek, MD, PhD, Medical Director of MIPD at Certara and lead author on three of the new MIPD papers. Drugs with a narrow therapeutic index include anti-arrhythmics, anti-coagulants, anti-epileptics, aminoglycoside antibiotics, and immunosuppressants.  Dr. Polasek is also a clinical pharmacology registrar at Royal Adelaide Hospital and an adjunct senior lecturer at the Centre for Medicines Use and Safety at Monash University in Australia. ]]> https://biospectrumindia.com/news/57/12759/cablivi-gets-fda-approval-to-treat-rare-blood-clotting-disorder.html https://biospectrumindia.com/news/57/12759/cablivi-gets-fda-approval-to-treat-rare-blood-clotting-disorder.html Thu, 07 Feb 2019 14:30:00 +0530 The U.S. Food and Drug Administration has approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting. Patients with aTTP develop extensive blood clots in the small blood vessels throughout the body. These clots can cut off oxygen and blood supply to the major organs and cause strokes and heart attacks that may lead to brain damage or death. Patients can develop aTTP because of conditions such as cancer, HIV, pregnancy, lupus or infections, or after having surgery, bone marrow transplantation or chemotherapy. The efficacy of Cablivi was studied in a clinical trial of 145 patients who were randomized to receive either Cablivi or a placebo. Patients in both groups received the current standard of care of plasma exchange and immunosuppressive therapy. The results of the trial demonstrated that platelet counts improved faster among patients treated with Cablivi, compared to placebo. Treatment with Cablivi also resulted in a lower total number of patients with either aTTP-related death and recurrence of aTTP during the treatment period, or at least one treatment-emergent major thrombotic event (where blood clots form inside a blood vessel and may then break free to travel throughout the body). The proportion of patients with a recurrence of aTTP in the overall study period (the drug treatment period plus a 28-day follow-up period after discontinuation of drug treatment) was lower in the Cablivi group (13 percent) compared to the placebo group (38 percent), a finding that was statistically significant. The FDA granted this application Priority Review designation. Cablivi also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. ]]> https://biospectrumindia.com/news/57/12748/ergotron-uv-partners-to-provide-pathogen-free-healthcare-environments.html https://biospectrumindia.com/news/57/12748/ergotron-uv-partners-to-provide-pathogen-free-healthcare-environments.html Wed, 06 Feb 2019 18:35:00 +0530 Ergotron, the movement company that helps people thrive by removing constraints, and UV Partners, developer of the UV Angel® automated disinfection system, today announced plans to integrate the UV Angel technology into many of Ergotron's product lines, starting with CareFit® Pro and StyleView®, which are widely used by healthcare professionals across the globe A growing body of evidence shows that high-touch surfaces such as keyboards, mice and computer workstations are major transmitters of health-related pathogens. Together, Ergotron and UV Partners will provide integrated preventative disinfection solutions to reduce pathogens on these frequently touched, hard-to-clean surfaces around the clock, without disrupting caregiver workflows.   UV Partners' proprietary technology platform, UV Angel, is an intelligent, automated UV-C light disinfection system that continuously monitors surfaces to detect when they have been used and automatically disinfects hundreds of times per day without any assistance from staff. A recent clinical study demonstrated that bacteria levels were reduced by more than 99 percent on surfaces equipped with UV Angel technology. "Integrating UV Angel technology into Ergotron's CareFit Pro medical carts is the latest example of our commitment to meeting our customers' needs and eliminating constraints," said Charles Christ, chief technology officer and senior vice president of product development, Ergotron. "This joint initiative is a game-changer for hospitals, clinics and other healthcare environments concerned with reducing pathogens that can lead to serious, and even deadly, infections. Together with UV Angel technology, we are providing a best-in-class solution that moves healthcare—and healthcare providers—forward by greatly reducing the threat of hospital-borne infections and allowing caregivers to focus more of their energy on patients." UV Angel technology is integrated into Ergotron's new CareFit Pro medical cart, and also may be retrofitted onto existing StyleView medical carts and wall workstations, or requested as an accessory on new orders. Certified service specialists from Ergotron are available to install UV Angel technology throughout customer facilities.   ]]> https://biospectrumindia.com/news/57/12746/tagnos-to-showcase-clinical-logistics-solutions-at-himss19.html https://biospectrumindia.com/news/57/12746/tagnos-to-showcase-clinical-logistics-solutions-at-himss19.html Wed, 06 Feb 2019 16:25:00 +0530 TAGNOS, innovator of clinical logistics solutions for improved healthcare delivery, will showcase its solutions at HIMSS19 Booth 540 where it will demonstrate how the integration of IoT, artificial intelligence (A.I.) / machine learning and mobile communication improve the functional aspects of healthcare delivery. TAGNOS is the only company that's developed an A.I. application that uses machine learning combined with real-time data capturing capabilities to provide a solution that continually updates and adjusts its operational intelligence. The convergence of real-time IoT data with A.I. / machine learning delivers sustained improvement in OR and ED patient flow, along with enhanced asset and supply management. TAGNOS solutions are proven to reduce operational costs, improve outcomes and optimize capacity. Using mobile information access along with a dashboard and reporting suite, TAGNOS breaks down the barriers that often prevent staff from easily accessing data they need to plan care and make real-time course corrections to better run their hospitals and serve patients every day.   "Data is being collected in a variety of hospital systems today, but is often latent, inaccurate and also not integrated together to derive 'smart' operational and situational insight. TAGNOS solves these challenges with the powerful integration of the internet of things (or IoT), the AI application of machine learning and a mobile communication application, to deliver the tools everyone on the care delivery team needs to Orchestrate Excellence," said Neeraj Bhavani, President and CEO of TAGNOS.   Expanding from its early focus on decreasing patient wait times, today TAGNOS delivers orchestrated workflows for care delivery teams that collect data from real-time locating systems such as RFID tags on patient wristbands, and combines it with data from ADT, EHR, CPOE, surgical scheduling, lab, radiology and other systems hospitals use every day. Harnessing the power of A.I.  / machine learning, the TAGNOS system continually gains knowledge to identify patterns, provide predictive metrics and pinpoint areas for increased efficiency, cost reduction and revenue opportunities over time. ]]> https://biospectrumindia.com/news/57/12745/glenmark-pharma-signs-an-agreement-with-grandpharma-.html https://biospectrumindia.com/news/57/12745/glenmark-pharma-signs-an-agreement-with-grandpharma-.html Wed, 06 Feb 2019 14:30:00 +0530 Glenmark Pharmaceuticals has announced that its Swiss subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Grandpharma (China) Co. Ltd. for commercializing its novel nasal spray Ryaltris in China. The agreement with Grandpharma is Glenmark’s third regional licensing deal for Ryaltris. Glenmark has already signed licensing deals for commercializing Ryaltris in Australia, New Zealand and South Korea. Ryaltris [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel, investigational, fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age. Under the terms of the agreement, Glenmark will be responsible to manufacture and supply Ryaltris, while Grandpharma will be responsible for regulatory filing and commercialization of Ryaltris in China. Glenmark will receive an upfront payment, regulatory filing, regulatory approval and commercial milestone payments as well as royalties from Grandpharma for Ryaltris. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals said, “We are happy to partner with Grandpharma in China as its product portfolio complements well with Ryaltris and this partnership gives us an opportunity to tap into one of the largest pharmaceutical markets in the world. This step is aligned with our vision to make Ryaltris the first global brand of Glenmark through launches in multiple markets across the globe.” In May 2018, Glenmark filed a New Drug Application (NDA) for Ryaltris with the US Food and Drug Administration (US FDA), which is currently under review with the regulator. Glenmark plans to commercialize Ryaltris in various markets globally.   ]]> https://biospectrumindia.com/news/57/12741/optima-pharma-at-pharmintech-2019-turnkey-solutions-are-the-focus.html https://biospectrumindia.com/news/57/12741/optima-pharma-at-pharmintech-2019-turnkey-solutions-are-the-focus.html Wed, 06 Feb 2019 13:00:00 +0530 Pharmintech in Bologna (Italy) will be taking place in mid-April. Experts from Optima Pharma will be on hand in the expert zone to showcase a range of solutions, including the company's core competency: turnkey systems that use filling and closing machines and isolator and freeze-drying technologies. High-performance filling systems for pre-filled syringes will also be discussed. The OPTIMA SV 125 filling and sealing machine will be on show at the company's booth. Optima Pharma develops and implements complex production lines with filling and sealing technologies, isolator technology, and freeze drying. This includes planning and implementation, the integrated factory acceptance test (iFAT), site management, and the site acceptance test (SAT) through to comprehensive services for all the machines and components involved in the filling and closing line. The latest engineering technologies such as flow visualizations and simulations also come into play here. In the case of integrated FATs, the complete systems including the isolator and freeze-drying system are assembled and tested at Optima Pharma’s headquarters in Schwäbisch Hall (Germany). The Comprehensive Scientific Process Engineering (CSPE) method is used to ensure that as little time as possible elapses from when the order is placed to when production begins. This revolutionizes the planning and implementation of pharmaceutical filling systems. The systems include filling and closing machines that cover a wide performance range up to very high speeds. Reducing decontamination times even further Optima Pharma’s portfolio is complemented by experts from Metall+Plastic, an Optima Group subsidiary. Some of the latest developments include the extreme shortening of isolator cycle times or the particularly user-friendly and modular STISO sterility test isolator, for example. With DECOpulse®, the company recently presented a new, innovative process, which halves the duration of the overall decontamination cycle and, by using less H2O2, reduces the exposure of materials, active ingredients, and products to H2O2. Using e-beam tunnels to sterilize tub surfaces is another of Metall+Plastic’s strengths.  Compact freeze dryer for small and medium quantities  The Optima Pharma division’s freeze-drying expertise originates in Gladenbach-Mornshausen (Hesse, Germany). Ultra-modern freeze-drying systems are assembled at Optima Pharma’s subsidiary there. One of its latest innovations is the CS freeze dryer. This is tailored to products that are new to the market and are initially produced in small and medium quantities. The space-saving CS freeze dryer is optimized for installation in existing buildings. Experts from Gladenbach-Mornshausen round off the turnkey portfolio with modern SCADA systems for controlling entire production lines. ]]> https://biospectrumindia.com/news/57/12733/dr-benjamin-freedman-earns-stem-cells-young-investigator-award.html https://biospectrumindia.com/news/57/12733/dr-benjamin-freedman-earns-stem-cells-young-investigator-award.html Tue, 05 Feb 2019 16:40:00 +0530 Benjamin “Beno” Freedman, Ph.D., is named STEM CELLS’s Young Investigator of 2018 for his groundbreaking work with organoids in studying kidney structure and disease. This award fosters advancements in the fields of stem cells and regenerative medicine by honoring a young researcher who is principal author of an article published in STEM CELLS that is deemed to have the most impact and to push the boundaries of novel and insightful research. “We were trying to understand whether we can use organoids—complex structures we have generated from stem cells—to learn something new about how the kidney forms,” said Dr. Freedman. “We focused in on a very specific cell type that's found only in the kidneys called a podocyte. It gets its name because it has “feet” (Greek “podo”) coming off of it, at the bottom of the cell.” Dr. Freedman’s award-winning work combines induced pluripotent stem cells and CRISPR gene editing to establish human kidney organoids for disease modeling and regenerative medicine. His work also establishes a powerful new tool for genetic studies of human podocyte development and disease. “We are very happy to present this award to Dr. Freedman for his elegant work demonstrating that the protein podocalyxin is essential for normal kidney development,” said Dr. Jan Nolta, Editor-in-Chief of STEM CELLS. “The combination of cutting edge stem cell gene editing and organoid technologies used in this important report, and the implications for treatment of kidney disease, made Dr. Freedman the clear winner of our Young Investigator Award this year.” Dr. Freedman received his Ph.D. in cell and developmental biology in 2009 from the University of California at Berkeley. He performed postdoctoral studies in the Renal Division of Brigham and Women’s Hospital, at Harvard Medical School. Along with the Young Investigator Award, he has earned several other awards, including the National Research Service Award from the NIH/NIDDK, the Young Investigator Grant from the National Kidney Foundation, and the Research Excellence Award from Brigham and Women’s Hospital. Dr. Freedman is currently an assistant professor of medicine at the University of Washington School of Medicine (UW) in Seattle and a member of the Kidney Research Institute and the Institute for Stem Cell and Regenerative Medicine. ]]> https://biospectrumindia.com/news/57/12731/cirm-approves-6m-to-study-new-treatment-for-huntingtons-disease-.html https://biospectrumindia.com/news/57/12731/cirm-approves-6m-to-study-new-treatment-for-huntingtons-disease-.html Tue, 05 Feb 2019 16:05:00 +0530 Following a California Institute for Regenerative Medicine (CIRM) Independent Citizens Oversight Committee meeting held last week, University of California, Irvine (UCI) researchers  have learned that they will receive $6 million in funding to support the continued development of a promising new treatment for Huntington's disease (HD). Huntington's disease (HD) is a devastating dominantly inherited neurodegenerative disease that strikes individuals in the prime of life, typically beginning between the ages of 35 and 50, although in severe cases it can begin in young adults and even children as young as age two. HD progresses over 15-20 years before eventually killing its victims. No treatment currently exists that can slow or prevent the unrelenting progression of this devastating disease. The new CIRM-funded study will be led by Chancellor's Professor Leslie M. Thompson, PhD, from UCI's Sue and Bill Gross Stem Cell Research Center. The research will continue the development of a human neural stem cell product as a therapeutic treatment for HD. The ultimate goal of the two-year study is to achieve investigational new drug approval from the US FDA to begin first-in-human clinical trials in HD patients. "Based on our pre-clinical studies in mice, human neural stem cells are highly beneficial, reducing the accumulation of a toxic form of the mutant Huntingtin protein and improving HD symptoms and impaired electrical currents in the brain," explained Thompson. HD is caused by a mutation that creates an expansion of a repeating DNA unit (CAG repeat) within the HD gene (HTT); the length of the repeat expansion correlates with the age of onset and severity of the disease. HD leads to widespread neuronal dysfunction and death in multiple brain regions. Symptoms are unrelenting and progressive and include inability to control body movements, declining cognition leading to dementia, and a profound effect on an individual's psychiatric and emotional well-being and personality. Affected individuals eventually lose employment and ability to take care of a family, and usually die within 15-20 years of diagnosis. "Currently, there are no FDA approved treatments available that alter onset or progression of HD. The treatment we are continuing to develop represents a potentially promising approach," said Thompson. ]]> https://biospectrumindia.com/news/57/12729/omnivision-develops-innovative-smart-dental-mirror-.html https://biospectrumindia.com/news/57/12729/omnivision-develops-innovative-smart-dental-mirror-.html Tue, 05 Feb 2019 15:25:00 +0530 OmniVision Technologies, Inc., a leading developer of advanced digital imaging solutions, along with SMARTmirror, a developer of innovative dental products, has announced from MD&M West in Anaheim the world's first Wi-Fi-enabled smart dental mirror, which sends images and video in real time to a connected tablet. This uniquely enables dental professionals and patients to see inside the patient's mouth during exams and procedures. The sapphire mirror is similar in size and weight to a standard dental mirror, which is made possible by OmniVision's tiny OVM6946 CameraCubeChip™ wafer-level camera module. Some patients mistrust dentists and fear that they will suggest unnecessary and painful treatments. As a result, dentists face resistance to treatments that they believe are necessary for a patient's health. The SMARTmirror is designed to alleviate these concerns and improve the communication between dentists and patients. Its sapphire mirror provides 12x magnification and won't scratch or fog up like a standard mirror, and the 36 integrated LEDs with adjustable intensity offer brighter illumination when needed. The OVM6946 camera module is built on OmniVision's OmniBSI+™ pixel architecture and can capture 400 x 400 resolution video at 30 frames per second (fps), providing a 120-degree diagonal field of view and a focusing range from 3mm to infinity. The module measures 1.05 x 1.05 x 2.27mm, which makes it small enough to embed seamlessly within the 4mm thick SMARTmirror. The OVM6946 has also been integrated into a number of single-use medical devices for endoscopy, an application where small size is equally important. The SMARTmirror is currently in pilot testing with 200 dentists, and well over 2,000 inspections and procedures have been performed using the device. It is expected to be available in mass production in Q2 2019. ]]> https://biospectrumindia.com/news/57/12728/proteonic-biotech-licenses-protein-production-technology-to-eli-lilly.html https://biospectrumindia.com/news/57/12728/proteonic-biotech-licenses-protein-production-technology-to-eli-lilly.html Tue, 05 Feb 2019 15:05:00 +0530 ProteoNic Biotechnology BV has announced that it licensed its 2G UNic technology for boosting recombinant protein production to Eli Lilly and Company. Under the agreement, Lilly gains non-exclusive commercial rights for application of the technology to the development of proprietary products. Financial details of the agreement were not disclosed. ProteoNic’s mammalian protein expression technology is designed to improve recombinant cell line production levels across a range of host cells, selection systems and protein targets. It increases transcription and translation rates via the combined effect of novel genetic elements, which together exert a powerful positive effect on recombinant protein production levels as well as on stability of expression. ProteoNic’s 2G UNic can be combined with other technologies to improve their performance. Frank Pieper, CEO of ProteoNic, states that 2G UNic technology can be instrumental in achieving the highest possible production levels and contribute to the economically viable production of both innovator and biosimilar products. ProteoNic will continue to work to reach maximum potential of the production of biologicals for current and future clients. ProteoNic is a privately held company with offices in Leiden, the Netherlands and Boston, USA. The company offers technology and services for the generation of cell lines with greatly improved biologics production characteristics, including production levels and stability. The company commercializes its proprietary 2G UNic technology through licensing and partnership arrangements.   ]]> https://biospectrumindia.com/news/57/12724/jj-vision-announces-launch-of-tecnis-eyhance-.html https://biospectrumindia.com/news/57/12724/jj-vision-announces-launch-of-tecnis-eyhance-.html Tue, 05 Feb 2019 11:15:00 +0530 Johnson & Johnson Vision has announced the launch of its TECNIS Eyhance IOL for the treatment of cataracts in Europe. This next-generation monofocal intraocular lens (IOL) allows patients to experience high-quality vision at both intermediate and far distances. This is an important first for the monofocal IOL category, as today most lenses in the monofocal category only correct vision to help patients with cataracts see things at a distance, and thus do not improve the intermediate vision that is required for many important daily tasks. Tom Frinzi, Worldwide President, Surgical, Johnson & Johnson Vision said, “With the availability of TECNIS Eyhance IOL in Europe, we are proud to deliver another meaningful solution for patients with cataracts. We saw an opportunity to build upon the legacy of the TECNIS® Family of IOLs and the proven design of our 1-piece platform to reimagine what was possible with the standard aspheric monofocal IOL.” As per the company statement,”TECNIS Eyhance IOL allows patients to achieve significantly improved intermediate vision, compared with a standard aspheric monofocal IOL, along with 20/20* distance vision. In addition, data has shown a low incidence of halo, glare or starburst (bright circles of light that surround headlights and other light sources) comparable to what has been reported with the TECNIS® 1-piece IOL. According to patient-reported outcomes, TECNIS Eyhance IOL enables most patients to perform certain activities with greater ease, such as being able to walk on uneven surfaces, and to engage in activities of personal interest, including favorite hobbies.” Dr. Oliver Findl, Chief of Department of Ophthalmology, Hanusch Hospital Vienna and ESCRS Board Member and Secretary said, “Today, patients with cataracts are forced to make a trade-off decision on their vision when selecting a monofocal intraocular lens. They can have corrected vision at a distance, but require glasses for near and intermediate vision activities, which refers to everything at arm’s length such as computer work or looking at a car speedometer. TECNIS Eyhance IOL offers high quality intermediate as well as distance vision, which is an important advancement to allow patients greater ease in certain activities in their day-to-day lives.” TECNIS Eyhance IOL has European CE Mark approval and is now commercially available across Europe, including UK, Italy, France, Spain and Germany. This product is not currently approved or commercially available in other countries. In some countries, TECNIS Eyhance IOL is covered by medical insurance making it an important option for patients when a monofocal IOL is being considered. TECNIS Eyhance IOL is part of the TECNIS® Family of IOLs, which offer a variety of personalized vision options for people with cataracts, all with the goal of ensuring clear, sharp vision to meet individual needs and lifestyles. In particular, presbyopia-correcting IOLs, like TECNIS Symfony® IOL, also exist that may be able to address other visual conditions, help patients wear glasses less often, and enhance focus at a full range of vision – near, intermediate and distance. An estimated 253 million people live with vision impairment: 36 million are blind and 217 million have moderate-to-severe vision impairment. Cataracts, the leading cause of blindness globally account for 35 percent of the blindness and 24 percent of the moderate-to-severe visual impairment. More than 90 percent of people develop cataracts by age 65. Left untreated, cataracts cause vision to deteriorate over time. Cataract surgery is the most common surgery performed around the world.   ]]> https://biospectrumindia.com/news/57/12709/geo-med-stratis-medical-to-take-vce-technology-worldwide.html https://biospectrumindia.com/news/57/12709/geo-med-stratis-medical-to-take-vce-technology-worldwide.html Mon, 04 Feb 2019 12:15:00 +0530 Geo-Med LLC, a Verified Service-Disabled Veteran-Owned Small Business supplier of medical products, is pleased to announce it has entered into an exclusive agreement with Stratis Medical, Inc. one of the nation's leading providers of Video Capsule Endoscopy (VCE) Products. "We chose Stratis MiroCam following extensive due-diligence over other major VCE technologies," said Mike Locke, CEO of Geo-Med.  "We are honored to be partnering with Geo-Med in bringing the industry's most reliable, cost effective and innovative Stratis MiroCam VCE technology to the Veteran Administration Medical Centers and Department of Defense Military Treatment Facilities nationwide," Said, Melahni Ake, Stratis Vice President of Sales and Market Development. The Stratis MiroCam® MC2000B Dual Camera Capsule Endoscope, is the latest VCE technology to receive 510K Market Clearance designed for increased mucosal visualization of the small bowel. ]]> https://biospectrumindia.com/news/57/12707/alkermes-announces-rejection-of-alks-5461-nda.html https://biospectrumindia.com/news/57/12707/alkermes-announces-rejection-of-alks-5461-nda.html Mon, 04 Feb 2019 11:20:00 +0530  Alkermes plc has announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). According to the DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 16.2 million people in the U.S. suffered from MDD in 2016,1 the majority of whom may not adequately respond to initial antidepressant therapy. The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the Agency will inform whether there is a viable path forward for the ALKS 5461 program. The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD. ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist. ]]> https://biospectrumindia.com/news/57/12705/sirion-biotech-expands-presence-in-u-s-.html https://biospectrumindia.com/news/57/12705/sirion-biotech-expands-presence-in-u-s-.html Mon, 04 Feb 2019 11:10:00 +0530 SIRION Biotech which offers the most comprehensive portfolio of custom viral vectors for preclinical and clinical studies has announced the grand opening of a new office. SIRION also hosted a Bavarian-themed grand opening event at the Forsyth Institute to meet and mingle with the Cambridge gene therapy scene. World renowned gene cell therapy developers and viral vector experts talked about the importance of the right viral vectors in making gene therapy a reality. Gene therapy has seen strong clinical advancement, and SIRION is becoming a partner of choice in this growing sector as demonstrated by recent deals with Denali Therapeutics, Orchard Therapeutics, and an additional, undisclosed alliance with a major public company that is advancing the discipline. As transduction and manufacturing efficiencies are critical issues in gene therapy, SIRION’s viral vectors are essential to the success of their partnering companies,” said Dieter Lingelbach, Chief Operating Officer of SIRION Biotech. Dieter continued, “Since two-thirds of SIRION’s revenue already comes from US customers and partners, opening an office in a Life Science hub like Cambridge, Massachusetts further demonstrates our commitment to supporting existing customers and further expanding into the US market.” SIRION Biotech International is a wholly-owned subsidiary of SIRION Biotech GmbH providing custom engineering and manufacturing services of viral vectors for the life sciences industry. Its unique focus on improving transduction efficiencies and safety make SIRION Biotech a valuable technology partner for gene and cell therapy trials. LentiBOOSTTM transduction reagent is actively used to improve, among others, hematopoietic cell transductions in clinical trials. NextGen AAV capsid evolution projects aim to improve tissue targeting and immune escape of capsids to usher in a new generation of therapeutics for international gene therapy companies.   ]]> https://biospectrumindia.com/news/57/12699/mylans-generic-version-of-advair-diskus-for-asthma-copd-patients-gets-fda-approval.html https://biospectrumindia.com/news/57/12699/mylans-generic-version-of-advair-diskus-for-asthma-copd-patients-gets-fda-approval.html Fri, 01 Feb 2019 16:40:00 +0530 Mylan has announced the U.S. Food and Drug Administration approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of ADVAIR DISKUS. Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA earlier this month, which prompted an amendment to the label for certain inhaled corticosteroids, including ADVAIR DISKUS and any generic versions. Wixela Inhub will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients. Mylan CEO Heather Bresch commented, "Mylan remains steadfast in its efforts to expand patient access to medicines, and the FDA approval of Wixela Inhub reinforces our commitment to provide patients greater choice and lower-cost alternatives. This milestone represents the culmination of an extensive research and development program and Mylan's more than $700 million of investment. We're proud of our Wixela Inhub team, who worked tirelessly and in close collaboration with the FDA to bring this important medicine to market and add it to our growing global portfolio of more than 700 respiratory products. As one of the leading providers of prescription medicines in the U.S., we continue to execute on our mission and do our part to reduce costs for patients and identify pathways that help increase sustainability for the U.S. healthcare system overall." Wixela Inhub is indicated for the twice daily treatment of asthma in patients age 4 and older not adequately controlled on long-term asthma control medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm. Mylan President Rajiv Malik added, "We're pleased to offer the first FDA-approved generic of ADVAIR DISKUS, one of the leading treatments for asthma and COPD management today. We've long been confident in the science around this product and are proud of the dedication of our scientific teams to bring Wixela Inhub to market. This complex product required a rigorous research and development program spanning over a decade and close collaboration with FDA to define the regulatory pathway. We also are proud to manufacture Wixela Inhub in our own state-of-the-art plant. This approval reinforces our ongoing commitment to increase access to more affordable treatment options for patients." The research and development program for Wixela Inhub compared all strengths of treatment to ADVAIR DISKUS in order to meet the FDA requirements of therapeutic equivalence for a substitutable generic. In the 28-day, randomized, double-blind, placebo-controlled, parallel group study of 1,128 adult asthma patients conducted to evaluate the local (lung) bioequivalence of Wixela Inhub 100 mcg/50 mcg and ADVAIR DISKUS 100 mcg/50 mcg, the two treatments produced equivalent efficacy. Both treatments were safe and well-tolerated with lower numbers of withdrawals due to asthma compared to the placebo group. The study included both naive and current users of ADVAIR DISKUS. "Patients enrolled in clinical trials found Wixela Inhub easy-to-use and highly effective at controlling their asthma in a clinical bioequivalence study. Asthma and respiratory specialists and primary care providers welcome this generic alternative to benefit many patients with asthma and COPD.  We have waited for years for generic inhalers to emerge in respiratory medicine," said Edward Kerwin, MD of Crisor LLC, a division of the Clinical Research Institute located in Medford, Ore. and a Clinical Investigator on the Wixela Inhub clinical program. ADVAIR DISKUS had U.S. sales of $4.2 billion for the 12 months ending November 30, 2018, according to IQVIA. ]]> https://biospectrumindia.com/news/57/12698/who-trains-30-health-workers-in-ukraine.html https://biospectrumindia.com/news/57/12698/who-trains-30-health-workers-in-ukraine.html Fri, 01 Feb 2019 16:25:00 +0530 To improve the quality of health care services and reduce health risks for over 40 000 people in need in non-government controlled areas of Ukraine’s Luhansk region, WHO trained over 30 health workers on 23—25 January 2019. The training focused on supporting emergency health care specialists in trauma emergency care and lifesaving procedures. After nearly five years of crisis in eastern Ukraine, millions of people on both sides of the contact line still need humanitarian assistance. A lack of trained health care workers and appropriate health care services can result in an increase in avoidable deaths, diseases and disabilities. “WHO has been providing humanitarian assistance to people affected by the conflict in eastern Ukraine since the beginning of this crisis,” said Dr Jarno Habicht, WHO Representative in Ukraine.  “In a protracted emergency, it is crucial that we ensure that no one is left behind. The fundamental humanitarian principle of humanity – together with impartiality, independence and neutrality – is central to WHO’s emergency work.” “Prompt medical intervention after injury affects the patient’s chances for survival and recovery. This is the principle adopted in the advanced trauma training,” added Dr Omar Saleh, a trauma care consultant for the WHO Emergency Programme in Ukraine. “We shared best practices and know-how from our international experience to anaesthesiologists, trauma care specialists and surgeons who are critical pillars in the survival chain. This is needed particularly in conflict-affected areas.” The training was organized with the financial support of the United Nations Central Emergency Response Fund (CERF). Additionally, CERF funds enabled WHO to deliver medicines and medical supplies in eastern Ukraine’s non-government controlled areas. ]]> https://biospectrumindia.com/news/57/12694/sartorius-joins-national-institute-for-innovation-in-manufacturing-biopharma.html https://biospectrumindia.com/news/57/12694/sartorius-joins-national-institute-for-innovation-in-manufacturing-biopharma.html Fri, 01 Feb 2019 12:45:00 +0530 Sartorius, a leading international partner of biopharmaceutical research and the industry, has joined NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals headquartered in Newark, Delaware, USA. The Institute, launched in 2017, is a public-private partnership and has an extensive network of academic and industry partners within the United States. Among the 115 associated members are 71 academic institutions, research laboratories, non-profit organizations and 44 companies – ranging from startups, small, medium and large companies. In addition, NIIMBL also engages several federal agencies. NIIMBL’s multi-pronged mission includes the following: accelerate biopharmaceutical manufacturing innovations, support the development of standards, enable more efficient and rapid manufacturing capabilities and establish an international, leading workforce to fundamentally strengthen the U.S. biopharmaceutical industry. Recently NIIMBL expanded its membership offerings, allowing technology providers wider access to participation. Sartorius has joined the organization through this new affiliate membership program that permits the company to actively support the NIIMBL community activities. Furthermore, the program gives Sartorius the opportunity to influence the organization’s portfolio of existing innovation projects, give feedback to the review of new project proposals and directly sponsor one of the upcoming projects. As a new member, Sartorius will initially learn about the NIIMBL technology project portfolio and seek opportunities to provide expertise on innovative ideas and solutions, including the application of existing technologies from its broad and unique product and technology portfolio. Examples such as single-use sensor technologies along with process analytical tools (PAT), data analytics and innovative solutions for next generation bioprocessing will be among the key technologies Sartorius will contribute to these projects. ]]> https://biospectrumindia.com/news/57/12692/jj-collaborates-with-meiragtx.html https://biospectrumindia.com/news/57/12692/jj-collaborates-with-meiragtx.html Fri, 01 Feb 2019 11:40:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson has announced a worldwide collaboration and license agreement with MeiraGTx Holdings, a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia (ACHM) caused by mutations in either CNGB3 or CNGA3, and X-linked retinitis pigmentosa (XLRP). Further, the companies have formed a research collaboration to explore new targets for other inherited retinal diseases and further develop adeno-associated virus (AAV) manufacturing technology. James List, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development said, “Janssen is excited to expand our portfolio with the addition of innovative assets that have the potential to improve sight or prevent the progression to blindness in inherited retinal diseases which currently have no treatment options. We look forward to partnering with MeiraGTx to develop these assets and explore new potential targets for inherited retinal diseases.” Mathai Mammen, Global Head, Janssen Research & Development said, “This collaboration builds on Janssen’s long-standing heritage of addressing the unmet needs of patients around the world. Through this collaboration we look forward to deepening our expertise in gene therapy and leveraging our breadth of research and development expertise to help bring forward new treatment options for people living with inherited retinal diseases.” Under the terms of the agreement, MeiraGTx will grant Janssen an exclusive worldwide license to certain clinical assets in MeiraGTx’s inherited retinal disease portfolio. The companies have also formed a research collaboration to develop a pipeline of products addressing novel gene targets, giving Janssen the exclusive option to license new treatments for other inherited retinal diseases.   ]]> https://biospectrumindia.com/news/57/12690/fda-expands-lillys-alimta-label.html https://biospectrumindia.com/news/57/12690/fda-expands-lillys-alimta-label.html Fri, 01 Feb 2019 10:00:00 +0530 Eli Lilly and Companyhas announced that USFDA has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with KEYTRUDA® (pembrolizumab), developed and marketed by Merck, and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. This indication is approved based on data from Merck's Phase 3 KEYNOTE-189 trial. ALIMTA in combination with pembrolizumab and carboplatin was first approved in June 2018 under the FDA's accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and PFS data from the Phase 2 study KEYNOTE-021 (Cohort G1). As per the company statement, “In accordance with the accelerated approval process, continued approval was contingent upon verification and description of clinical benefit, which has now been demonstrated in the KEYNOTE-189 trial and has resulted in the FDA converting the accelerated approval to full (regular) approval.” Anne White, president, Lilly Oncology said, "KEYNOTE-189 demonstrated an exceptional effect of the ALIMTA-pembrolizumab-platinum chemotherapy combination in the first-line setting, offering significantly improved survival in patients with metastatic nonsquamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. This new indication reinforces Lilly's continued commitment to providing practice-changing treatment options that can make a meaningful difference for people living with lung cancer."  ALIMTA is indicated in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.  ]]> https://biospectrumindia.com/news/57/12686/nih-grant-to-shoot-innovation-in-kansas-.html https://biospectrumindia.com/news/57/12686/nih-grant-to-shoot-innovation-in-kansas-.html Thu, 31 Jan 2019 17:20:00 +0530 BBC Entrepreneurial Training & Consulting (BBCetc) and its program partner, the University of Kansas, have been awarded a three-year FastTrack STTR (Small Business Technology Transfer) grant from the National Institutes of Health (NIH). The award is intended to help move scientific discoveries and technologies out of the lab and into commercial products to improve human health. Titled "Regional Technology Transfer Accelerator Hubs for Institutional Development Award (IDeA) States," the grant is managed by the National Institute of General Medical Sciences (NIGMS), an NIH Institute. The IDeA program builds research capacities in states that historically have had low levels of NIH funding. It supports basic, clinical, and translational research; faculty and student development; and scientific infrastructure improvements. The NIH grant will support the creation of a shared accelerator called SHARPhub (Sustainable Heartland Accelerator Regional Partnership) in the Central IDeA region comprised of Kansas, Oklahoma, Nebraska, North Dakota and South Dakota. The SHARPhub will collaborate with university leadership in the five states starting with a pilot program in Kansas during year one of grant. SHARPhub will provide infrastructure and expertise, produce educational tools (e.g., curricula, texts, webinars) and offer business development microgrants to promote commercialization of academic research and to build an entrepreneurial culture at the IDeA institutions. Becky Aistrup, managing partner, BBC Entrepreneurial Training & Consulting (BBCetc) and Douglas Wright, PhD, vice chair, Anatomy and Cell Biology, University of Kansas Medical Center, serve as principal investigators on the project. ]]> https://biospectrumindia.com/news/57/12682/eyepoint-pharmaceuticals-appoints-david-guyer-to-board-of-directors.html https://biospectrumindia.com/news/57/12682/eyepoint-pharmaceuticals-appoints-david-guyer-to-board-of-directors.html Thu, 31 Jan 2019 14:10:00 +0530 EyePoint Pharmaceuticals, a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, has announced the appointment of David Guyer, M.D., to the Company’s Board of Directors.  He will also serve on the Company’s Science Committee. Dr. Guyer has led several public and private biotechnology companies focused on ocular diseases, and has held leadership positions in academia and at healthcare venture capital firms. Dr. Guyer currently serves as Executive Chairman of Ophthotech Corporation, a publicly-traded biopharmaceutical company specializing in gene therapy treatments for ocular diseases, which he co-founded. “Dr. Guyer has had a highly successful and multifaceted career in the ophthalmology space. As the former CEO, chairman and board member of numerous ocular disease companies, he has garnered valuable expertise in accelerating the growth of ophthalmology companies by overseeing pipeline creation, fundraising, business development, mergers and acquisitions, commercial launches and regulatory affairs,” said Göran Ando, M.D., Chairman of the Board of Directors of EyePoint Pharmaceuticals. “As we focus on our goals for 2019, including the upcoming commercial launches of two ophthalmic products in the first quarter of 2019, we will greatly benefit from Dr. Guyer’s extensive success and capability as a strategic advisor and executive in the ophthalmology space. On behalf of the entire Board and management team, it is a privilege to welcome Dr. Guyer to the team.” “EyePoint is a company well-suited to take on its mission of addressing the serious unmet needs in ocular diseases that may lead to blindness,” commented Dr. Guyer. “I look forward to supporting EyePoint’s two near-term product launches and assisting the Company on its exciting mission to prevent and treat serious eye diseases.” Before founding Opthotech, Dr. Guyer served as a partner and venture partner at SV Life Sciences Advisers, a venture capital firm focused on healthcare. Dr. Guyer co-founded Eyetech Pharmaceuticals Inc. and served as its Chief Executive Officer and as a member of its Board of Directors from 2000 until it was acquired by OSI Pharmaceuticals, Inc. in November 2005. Prior to co-founding Eyetech Pharmaceuticals, Dr. Guyer was a Professor and served as Chairman of the Department of Ophthalmology at New York University School of Medicine. He currently serves on the Board of Directors of Oxurion NV, a publicly traded biotechnology company. Dr. Guyer received a B.S. from Yale College and an M.D. from Johns Hopkins Medical School. Dr. Guyer completed his ophthalmology residency at Wilmer Ophthalmological Institute, Johns Hopkins Hospital and a retinal fellowship at the Massachusetts Eye and Ear Infirmary at Harvard Medical School.   ]]> https://biospectrumindia.com/news/57/12681/spero-therapeutics-announces-initiation-of-spr720-phase-1-clinical-trial.html https://biospectrumindia.com/news/57/12681/spero-therapeutics-announces-initiation-of-spr720-phase-1-clinical-trial.html Thu, 31 Jan 2019 14:05:00 +0530 Spero Therapeutics,  a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections has announced that it has initiated a Phase 1 clinical trial of SPR720, an orally administered antimicrobial agent being developed for the treatment of non-tuberculous mycobacterial (NTM) infections.  “SPR720 is a promising drug candidate that has the potential to become the first approved oral treatment for NTM infections. NTM infections cause chronic, debilitating disease and represent an area of high unmet need as there are no specifically approved orally administered treatment options,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “We look forward to receiving top-line results from the Phase 1 trial assessing the safety, tolerability and pharmacokinetics of SPR720 in the second half of 2019.” The Phase 1 clinical trial evaluating SPR720 is a double-blind, placebo-controlled, ascending dose, multi-cohort study in healthy subjects consisting of single ascending dose and multiple ascending dose cohorts. The advancement of SPR720 into the Phase 1 clinical assessment was based on SPR720’s favorable profile exhibited in a suite of pre-clinical in vitro and in vivo safety, toxicology and ADME (absorption, distribution, metabolism and excretion) studies, as well as SPR720’s demonstration of potent in vitro and in vivo activity versus multiple, clinically important species of NTM, including Mycobacterium avium complex and Mycobacterium abscessus.  The collective pre-clinical data to date suggest that SPR720 has an acceptable safety profile, encouraging target pathogen efficacy, drug distribution to key sites of infection, such as the lung, and a wide therapeutic margin.  Spero expects to receive top-line data from the Phase 1 clinical trial in the second half of 2019.   ]]> https://biospectrumindia.com/news/57/12675/accuron-technologies-spins-out-medtech-business.html https://biospectrumindia.com/news/57/12675/accuron-technologies-spins-out-medtech-business.html Thu, 31 Jan 2019 11:10:00 +0530 Accuron Technologies Limited announced that it will spin out its MedTech business. The Accuron MedTech Group (Accuron MedTech), Southeast Asia’s largest medical device business, will be established as a leading vertically integrated urology business.  As a result of the spin-out, Accuron MedTech will be directly owned by Temasek. The move will allow Accuron MedTech’s management team to better focus on global MedTech growth and investment opportunities. It is anticipated that the process will be completed by March 2019.  Philip Yeo, Chairman of Accuron Technologies Limited, said: “Accuron MedTech has been managed as an independent division of Accuron Technologies for some time now. The spin out will enable Accuron MedTech to be more agile in managing its operations, putting it on a stronger platform for sustained growth and technology commercialisation. The move will also allow Accuron Technologies Limited to focus its resources to pursue opportunities in the growing Aerospace and Industrial businesses.”  Over the past 3 years, Accuron MedTech has grown its revenue by more than 30% through the launch of new products such as the Delta III, the first SmartLitho for stone treatment, and more than 10 M&A transactions.   ]]> https://biospectrumindia.com/news/57/12670/global-medicine-spending-to-exceeds-1-5-tn-by-2023.html https://biospectrumindia.com/news/57/12670/global-medicine-spending-to-exceeds-1-5-tn-by-2023.html Thu, 31 Jan 2019 10:00:00 +0530 Total spending on medicines is expected to top $1.5 trillion by 2023, up 50 percent from 2014, even as annual growth moderates at 3-6 percent on an annual compound basis compared to 6.3 percent over the past five years, according to new research released from the IQVIA™ Institute for Human Data Science. The study found global drug spending reached $1.2 trillion in 2018, with the key drivers of growth during the next five years to be the United States and pharmerging markets with 4-7 percent and 5-8 percent compound annual growth respectively. In addition to these market trends, The Global Use of Medicine in 2019 and Outlook to 2023: Forecasts and Areas to Watch, analyzes several critical healthcare areas and produces predictions to monitor in coming years. “This report includes the latest predictions for the global pharmaceutical market, including areas of growth by geography, therapy group, and channel,” said Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science. “Our original research explores the impact of new drug launches, explosive growth in biosimilars, as well as rapidly expanding use of specialty medicines. It also features 10 areas to watch, such as the use of digital health tools, artificial intelligence and machine learning, next-generation biotherapeutics, and real-world evidence within clinical development.” A few key highlights featured in the report include: Prescription opioid use in the United States peaked in 2011 on a per capita morphine milligram equivalent basis and has now declined for seven consecutive years. The number of new products launched is expected to increase from an annual average of 46 in the past five years to an average of 54 through 2023. Use of artificial intelligence (AI) and machine learning (ML) by life sciences companies will accelerate and become the norm. Mobile apps are increasingly submitted to the FDA for clearance or approval. Pharmaceutical companies will continue hiring specialists in patient affairs and patient advocacy. ]]> https://biospectrumindia.com/news/57/12668/pherecydes-pharma-treats-patients-effectively-with-bacteriophage.html https://biospectrumindia.com/news/57/12668/pherecydes-pharma-treats-patients-effectively-with-bacteriophage.html Wed, 30 Jan 2019 16:30:00 +0530 Pherecydes Pharma, a biotechnology company specialized in the research and development of anti-infective therapies based on the use of bacteriophages, announces that its bacteriophage therapies have been successfully used to treat a patient with relapsing Staphylococcus aureus prosthetic-joint infection (PJI). The results of the treatment were published in Open Forum Infectious Diseases at the end of last year. The patient had relapsing severe prosthetic joint infection of the hip. As a salvage treatment, in combination with antibiotics, phages selected by Pherecydes from its library and manufactured in an R&D laboratory according to a strict quality control process were applied onto the infection site during surgery. Phages were well tolerated and the treatment led to a favorable outcome. Phage therapy is an innovative therapeutic approach against bacterial infections, particularly those acquired in hospitals (HAI) - and/or resistant to antibiotics. According to the O’Neill report, if antibiotic resistance continues to increase it will result in the deaths of 10 million people each year and a 2 to 3.5% reduction in global GDP from 2050 onwards. The WHO estimates that the annual costs generated represent €7bn ($8.3bn) in Europe and $6.5bn (€5.5bn) in the United States. The rapid development of antibiotic resistance has become a major public health issue. In 2017, the WHO published a list of priority targets, which includes those pathogens selected by Pherecydes. “We are delighted to report the successful use of our bacteriophages for the treatment of a patient,” said Jérôme Gabard, COO of Pherecydes Pharma. “We will continue with our work on phage therapy to provide a new option to address the antibiotic resistance issue.”       ]]> https://biospectrumindia.com/news/57/12665/histogen-appoints-richard-pascoe-as-chairman-and-ceo.html https://biospectrumindia.com/news/57/12665/histogen-appoints-richard-pascoe-as-chairman-and-ceo.html Wed, 30 Jan 2019 11:15:00 +0530 Histogen, a regenerative medicine company focused on stimulating the body's stem cells to regenerate tissues and restore youthful function, has announced that the Company's Board of Directors has appointed Richard Pascoe as Chairman of the Board of Directors and Chief Executive Officer. He will lead the Company through its next stages of clinical, corporate development and financial growth. "Histogen has a compelling story, both in its platform technology and in its product opportunities, and we are on the cusp of developments that point to an exciting year ahead," said Pascoe. "I'm very pleased to join Histogen at this pivotal time, and I look forward to spreading its story to a broader audience as we look to drive value through focused clinical development and business development activities in 2019." Mr. Pascoe brings a strong track record with over 25 years of experience building and leading organizations in transition. He has previously been responsible for raising over $250 million in equity capital, closing business development transactions valued at over $2 billion, and launching prescription therapeutics in the U.S. generating net sales of over $1 billion across multiple therapeutic categories. Most recently, he served as CEO of Apricus Biosciences, Inc., a biopharmaceutical company focused in urology and rheumatology, where he led European regulatory approval efforts and the sale of the ex-US rights for its lead asset Vitaros in 2017 and more recently completing a successful merger with Seelos Therapeutics. "As we look to the key milestones anticipated in 2019, including upcoming data from the clinical trial of HSC660 in female hair loss, the timing is ripe for leadership that will drive Histogen's technology to the next level and maximize its value to our partners and shareholders," said Dr. Stephen Chang, former Chairman. "The Board identified a great fit for this task in Richard Pascoe, and we are excited to welcome him as CEO and Chairman. I look forward to working with him as I continue to serve as a member of the Histogen board." Prior to Apricus, Mr. Pascoe was President and CEO of Somaxon Pharmaceuticals, Inc., where he was responsible for the FDA approval of Somaxon's lead drug Silenor and the merger of Somaxon and Pernix Therapeutics in 2013. Previously, he served as CCO and later COO of ARIAD, where he led the close of key international partnerships and was instrumental in two successful financings. Additional positions held by Mr. Pascoe include a series of senior management roles at King Pharmaceuticals, Inc. (acquired by Pfizer Inc.), and commercial positions at Medco Research, Inc. (acquired by King), COR Therapeutics, Inc. (acquired by Millennium Pharmaceuticals Inc., the Takeda Oncology Company), B. Braun Interventional and The BOC Group. Mr. Pascoe is a member of the board of directors of two public life sciences companies; KemPharm, Inc., and Seelos Therapeutics. He also serves as a member of the board of directors of Biocom, California's leading life science advocacy organization, and the Johnny Mac Soldiers Fund, a charity for military veterans. Mr. Pascoe served as a Commissioned Officer with the U.S. Army 24th Infantry Division where he earned a Bronze Star Medal during Operation Desert Storm. He is a graduate of the United States Military Academy at West Point where he received a B.S. degree in Leadership. ]]> https://biospectrumindia.com/news/57/12663/perrigo-to-get-250m-from-rpi-finance-trust.html https://biospectrumindia.com/news/57/12663/perrigo-to-get-250m-from-rpi-finance-trust.html Wed, 30 Jan 2019 11:05:00 +0530 Perrigo Company plc, a leading global provider of "Quality, Affordable Self-care Products™", has announced that the company expects to receive a milestone payment of $250 million from RPI Finance Trust, an affiliate of Royalty Pharma ("RPI"). This expected payment is the result of RPI's contingent payments for Tysabri® exceeding $333 million in calendar 2018. Perrigo's President and CEO Murray S. Kessler stated, "Receipt of this milestone payment will enhance our financial flexibility to drive growth organically and through bolt-on acquisitions.  We look forward to sharing more details about the company's transformation plans including our capital allocation strategy during our upcoming Analyst Event, planned for this spring." Under Perrigo's agreement with RPI, Perrigo has the right to receive an additional $400 million milestone payment if RPI's contingent payments for Tysabri® sales in 2020 exceed $351 million. ]]> https://biospectrumindia.com/news/57/12661/marinomed-announces-strong-investor-demand-.html https://biospectrumindia.com/news/57/12661/marinomed-announces-strong-investor-demand-.html Wed, 30 Jan 2019 10:45:00 +0530 Marinomed Biotech AG has already received subscription orders for more than 299,000 new bearer shares (base deal incl. 15% over-allotment /Greenshoe) as part of the current IPO and listing on the Vienna Stock Exchange (the "Offering"). The transaction meets the requirements of a qualified public offer in accordance with the terms and conditions of the convertible bonds issued in 2017 that are traded on the Third Market of the Vienna Stock Exchange. The Offer Price is expected to be EUR 75 per share. No adjustment of the Conversion Price I (as defined in the terms and conditions of the convertible bonds) is therefore expected to be necessary. The expected settlement date and first trading day is 1 February 2019. From this date the Marinomed shares are intended to be traded under the symbol "MARI" on the official market (prime market segment) of the Vienna Stock Exchange. ]]> https://biospectrumindia.com/news/57/12664/mrm-proteomics-biodesix-partner-to-develop-precision-lung-cancer-diagnostics.html https://biospectrumindia.com/news/57/12664/mrm-proteomics-biodesix-partner-to-develop-precision-lung-cancer-diagnostics.html Wed, 30 Jan 2019 10:45:00 +0530 MRM Proteomics Inc. and Biodesix have inked a partnership to create novel assays to answer critical clinical questions within the lung cancer continuum of care. Under terms of the deal, MRM Proteomics will grant Biodesix rights to utilize its proprietary iMALDI technologies to further advance its blood-based lung cancer diagnostics. Both companies share a commitment to advancing precision medicine’s accuracy and accessibility to cancer patients. “Examining a patient’s genomic data has advanced targeted therapies. However, proteins are the targets of most drugs and hold the key to unlocking the promise of precision medicine,” said Christoph Borchers, CSO for MRM Proteomics. “Biodesix is a natural partner for our proteomic technology, because they are committed to a multi-omics approach to reveal a more complete molecular profile of lung cancer in the body. We believe that this partnership will produce much-needed advances in the proteomic space and lead to more precise lung cancer diagnostic tools that can help guide treatment decisions.” Lung cancer is a leading cause of cancer deaths worldwide. The ability to diagnose cancer at an early stage can improve overall survival rates; the ability to rule out cancer for those at risk can reduce patient anxiety and unnecessary procedures. Precision diagnostic tools are needed to give patients and clinicians accurate, timely information. The MRM Proteomics / Biodesix partnership underscores the role of proteomics in delivering these tools. “Elevating the importance of proteomics in revealing the full complexity of cancer is critical to getting patients the right treatment at the right time. MRM Proteomics is a leader in providing technologies that can help us unleash this potential,” said Scott Hutton, COO for Biodesix. ]]> https://biospectrumindia.com/news/57/12651/kroger-health-pts-diagnostics-to-spot-and-treat-diabetes-heart-disease.html https://biospectrumindia.com/news/57/12651/kroger-health-pts-diagnostics-to-spot-and-treat-diabetes-heart-disease.html Tue, 29 Jan 2019 13:25:00 +0530 PTS Diagnostics and Kroger Health, The Kroger Co.'s nationwide arm of health and wellness facilities, services and programs, announced today the full rollout of CardioChek Plus analyzers for point-of-care blood testing to help identify individuals at-risk of heart attack, stroke and diabetes. CardioChek Plus analyzers provide accurate, on-site results in as little as 90 seconds using the same technology as clinical laboratories.  Its speed and portability combined with the reach and influence of Kroger Health pharmacies and clinics will increase the number of potential patients who are able to receive preventative health screenings and begin clinical protocols. The CardioChek Plus system accurately tests lipid profile and glucose simultaneously with one fingerstick, eliminating the need for additional testing or machinery, and enabling a more seamless process for the customer. It is one of the fastest, most cost-efficient, and user-friendly analyzers in the world. The system measures total cholesterol, HDL cholesterol, triglycerides and glucose, and provides real-time readings and ratios that are immediately documented by trained associates onsite. Because of its handheld, portable design, the CardioCheck Plus analyzers are easy to transport, store and operate. Implementing the switch to The CardioChek Plus in all Kroger Health locations is another meaningful move towards eliminating preventable disease through early identification, targeting disease progression. Additionally, the speed and portability of The CardioChek Plus combined with the reach and influence of Kroger Health pharmacies and clinics increases the number of patients able to receive preventive screenings and begin clinical protocols. Kroger Health includes more than 22,000 healthcare associates across over 2,100 pharmacies and clinics. Their trained professionals provide services, treatment and coaching in multiple areas, from nutrition counseling and weight loss programs, to diabetes prevention and immunization services. The CardioChek Plus rollout coincides with Kroger Health's broader health and wellness initiatives, including the "Wellness Your Way" campaign, designed to provide personalized solutions for healthcare to the more than 60 million Americans who visit the Kroger family of companies – including Kroger, Ralph's, Fry's, and Fred Meyer - each year.    The CardioChek Plus is FDA – cleared, CLIA – waived and meets National Cholesterol Education Program (NCEP) guidelines for accuracy and precision. The final rollout of analyzers will be complete by February 2019. ]]> https://biospectrumindia.com/news/57/12649/frost-sullivan-divulges-top-growth-opportunities-in-healthcare-.html https://biospectrumindia.com/news/57/12649/frost-sullivan-divulges-top-growth-opportunities-in-healthcare-.html Tue, 29 Jan 2019 12:15:00 +0530 By the end of 2019, up to 15 percent of the global healthcare spending is expected to be directed toward value-based care concepts. This will cause a surge in the number of risk-sharing contracts between providers and drug/device original equipment manufacturers (OEMs), driving business value for providers. While developed countries will adopt the more sophisticated outcome-based models, emerging markets will employ the best practices most suited to their local needs. Digital health technologies enabling out-of-hospital care and monitoring are forecast to grow by 30 percent to cross the $25 billion mark. As the lines between retail, IT and healthcare industries continue to blur, digital marketplace providers such as Amazon and Ali Health will make further headway in the home health space. "In this highly digitized environment, artificial intelligence (AI) will permeate the life sciences ecosystem and its use in healthcare IT (HIT) is likely to cross $1.7 billion by the end of 2019. AI-powered IT tools that manage payers' and providers' business risks in clinical, operational, financial, and regulatory settings will especially find high uptake," said Kamaljit Behera, Industry Analyst, Transformational Health. "Blockchain in healthcare is slowly starting to migrate from pilot proof of concept (PoC) to early commercial implementations. Companies such as Change Healthcare and Hashed Health will be frontrunners demonstrating initial ROIs across enterprise-level, B2B-focused initiatives such as health professional credentialing, medical billing management, and contract adjudication." Frost & Sullivan's recent analysis, Global Healthcare Market Outlook, 2019, presents perspectives and forecasts for the pharmaceuticals and biotech, in-vitro diagnostics, medical technologies, medical imaging, and HIT sectors. The analysis also captures regional trends and identifies areas of opportunities. "Access to affordable and quality care will be a key talking point during the upcoming 2019 elections in emerging markets such as Asia, Africa, and Central and Eastern Europe," noted Behera. "In fact, private drug and device companies will allot up to 10 percent of the R&D budget to localizing innovation to address the unique healthcare needs of developing regions." While the global healthcare market is likely to grow by 5.1 percent in 2019 and exceed $1.96 trillion in manufacturer revenues, the growth opportunities in the key regional markets will vary considerably. The main trends in 2019 are presented below: United States: The priority is defining value across the healthcare continuum. Due to the high variance in healthcare costs, there will be pilot programs to reduce this variance to two standard deviations across all post-acute care modalities. United Kingdom (UK): The healthcare and life sciences sector will be a key topic of discussion during Brexit Europe (excluding the UK): Shifting economic, population, and behavior dynamics will lead to a rise in healthcare expenditure in many EU countries. Japan: This country is facing a formidable shortage of care workers as the aging population raises healthcare costs. During 2019, Japan's policy reforms will aim to reduce hospital length of stay with improvements in the quality of long-term care, especially through digitalization. Latin America: Most of the large to medium economies in Latin America promote universal health coverage. Concerns related to effective healthcare access will drive the adoption of new technologies. China: It is forecast to capture more than 20 percent of the total APAC healthcare revenue owing to aggressive policy making to support medical device and pharma markets. South Korea: It is expected to aggressively invest in developing a more robust clinical trial environment for medical devices and pharmaceuticals in 2019 to become a global clinical trial hub. Southeast Asia: The healthcare benefit cost provided by employee health programs is anticipated to increase by 10 percent to 15 percent across the ASEAN countries. ]]> https://biospectrumindia.com/news/57/12645/brain-biomarkers-could-help-identify-risk-of-severe-ptsd-nih.html https://biospectrumindia.com/news/57/12645/brain-biomarkers-could-help-identify-risk-of-severe-ptsd-nih.html Tue, 29 Jan 2019 10:50:00 +0530 NIH-funded study has linked brain activity related to associative learning with PTSD symptom severity. A study has shed light on the neurocomputational contributions to the development of post-traumatic stress disorder (PTSD) in combat veterans. The findings, published in Nature Neuroscience, revealed distinct patterns for how the brain and body respond to learning danger and safety depending on the severity of PTSD symptoms. These findings could help explain why symptoms of PTSD can be severe for some people but not others. The study was funded in part by the National Institute of Mental Health, part of the National Institutes of Health. Susan Borja, Ph.D., chief of the NIMH Dimensional Traumatic Stress Research Program said, “Researchers have thought that the experience of PTSD, in many ways, is an overlearned response to survive a threatening experience. This study clarifies that those who have the most severe symptoms may appear behaviorally similar to those with less severe symptoms, but are responding to cues in subtly different, but profound, ways.” PTSD is a disorder that can sometimes develop after exposure to a traumatic event. People with PTSD may experience intrusive and frightening thoughts and memories of the event, experience sleep problems, feel detached or numb, or may be easily startled. While almost half of all U.S. adults will experience a traumatic event in their life, most do not develop PTSD. One theory explaining why some symptoms of PTSD develop suggests that during a traumatic event, a person may learn to view the people, locations, and objects that are present as being dangerous if they become associated with the threatening situation. While some of these things may be dangerous, some are safe. PTSD symptoms result when these safe stimuli continue to trigger fearful and defensive responses long after the trauma has occurred.    Despite the prominence of this theory, the way in which this learning occurs is not well understood. In this study, Ilan Harpaz-Rotem, associate professor of psychiatry at Yale University, New Haven, Connecticut; Daniela Schiller, associate professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai, New York City, and colleagues examined how the mental adjustments performed during learning and the way in which the brain tracks these adjustments relate to PTSD symptom severity. Combat veterans with varying levels of PTSD symptom severity completed a reversal learning task in which two mildly angry human faces were paired with a mildly aversive stimulus. During the first phase of this task, participants learned to associate one face with the mildly aversive stimulus. During the second phase of this task this association was reversed, and participants learned to associate the second face with the mildly aversive stimulus. Although all participants, regardless of PTSD symptomology, were able to perform the reversal learning, when the researchers took a closer look at the data, they found highly symptomatic veterans responded with greater corrections in their physiological arousal (i.e., skin conductance responses) and several brain regions to cues that did not predict what they had expected. “What these results tell us is that PTSD symptom severity is reflected in how combat veterans respond to negative surprises in the environment—when predicted outcomes are not as expected—and the way in which the brain is attuned to these stimuli is different. This gives us a more fine-grained understanding of how learning processes may go awry in the aftermath of combat trauma and provides more specific targets for treatment”, said Dr. Schiller. “One’s inability to adequately adjust expectations for potentially aversive outcomes has potential clinical relevance as this deficit may lead to avoidance and depressive behavior,” said Dr. Harpaz-Rotem. The amygdala, a brain area involved in associative learning, value encoding, and emotional responses, was particularly important. Both smaller amygdala volume and less precise tracking of the negative value of the face stimuli in the amygdala independently predicted PTSD symptom severity. Differences in value tracking and associability were also found in other brain regions involved in computation related to threat learning, such as the striatum, the hippocampus, and the dorsal anterior cingulate cortex.   ]]> https://biospectrumindia.com/news/57/12644/medicure-invests-10m-sensible-medical-to-market-reds.html https://biospectrumindia.com/news/57/12644/medicure-invests-10m-sensible-medical-to-market-reds.html Tue, 29 Jan 2019 10:40:00 +0530 Medicure Inc., a cardiovascular pharmaceutical company, is pleased to announce it has entered into an agreement with Sensible Medical Innovations Inc. (Sensible) to become the exclusive marketing partner for the ReDS™ point of care system (ReDS) in the United States. ReDS is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. The lung fluid measurements are used in guiding treatment and monitoring a heart failure patient's condition and may lead to a significant decrease in readmissions and hospital costs.  Clinical studies have shown an 87% reduction in heart failure readmission rates for patients using the ReDS system at home for three months post-discharge versus those who were treated with usual care alone. ReDS is already marketed to U.S. hospitals by Sensible and Medicure expects to begin marketing ReDS immediately using its existing commercial organization.  Under the terms of the agreement, Medicure will receive a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.   In addition, Medicure has invested US$10.0 million in Sensible for a 7.71% equity stake on a fully diluted basis. In connection with the investment, Medicure's President and CEO, Dr. Albert D. Friesen, has been appointed to the Board of Directors of Sensible.     ]]> https://biospectrumindia.com/news/57/12643/jj-announces-usfda-approval-of-imbruvica.html https://biospectrumindia.com/news/57/12643/jj-announces-usfda-approval-of-imbruvica.html Tue, 29 Jan 2019 10:25:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with obinutuzumab in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults. This is the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, and marks the tenth FDA approval for IMBRUVICA since its U.S. launch in November 2013. The approval expands the label for IMBRUVICA in frontline CLL/SLL beyond its use as a monotherapy to include combination use with obinutuzumab. This approval is based on results from the Phase 3 iLLUMINATE study. Craig Tendler, Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development said, “This label update builds upon the established efficacy and safety of IMBRUVICA in the frontline treatment of patients with CLL/SLL, as a monotherapy or in combination with other treatments. This milestone represents our continued commitment to develop IMBRUVICA-based, non-chemotherapy regimens to address the clinical needs of patients living with CLL/SLL.” IMBRUVICA, a Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.   ]]> https://biospectrumindia.com/news/57/12635/purdue-pharma-alivio-therapeutics-partner-for-non-opioid-treatment-for-ic-bps.html https://biospectrumindia.com/news/57/12635/purdue-pharma-alivio-therapeutics-partner-for-non-opioid-treatment-for-ic-bps.html Mon, 28 Jan 2019 16:25:00 +0530 Purdue Pharma, L.P. and Alivio Therapeutics has announced that they have entered into a partnership to advance one of Alivio’s product candidates through clinical development with an option exercisable by Purdue to collaborate on a limited number of additional compounds utilizing Alivio’s inflammation-targeting technology. ALV-107 is a non-opioid treatment being developed for interstitial cystitis/bladder pain syndrome (IC/BPS). Alivio will receive up to $14.75 million in upfront and near-term license exercise payments and is eligible to receive royalties on product sales and over $260 million in research and development milestones. Purdue also has an option to invest in Alivio’s next equity financing. “This collaboration with Alivio is an important milestone in our continued pursuit of non-opioid treatments for pain and represents yet another step to further diversify our portfolio,” said Craig Landau M.D., President and CEO of Purdue Pharma LP. “We are impressed with Alivio’s innovative platform technology as we focus on addressing patient needs – especially in areas where there are few efficacious treatment options.” Alivio’s inflammation-targeting technology is designed to enable therapeutics such as small molecules, biologics and nucleic acids to act exclusively at sites of inflammation based on the degree of inflammation in the tissue, while sparing healthy tissue. This approach is being evaluated by Alivio internally across a variety of inflammatory diseases, including IC/BPS, pouchitis, and inflammatory bowel disease (IBD). “We are delighted to enter into this partnership to advance ALV-107 for the potential treatment of interstitial cystitis/bladder pain syndrome. Alivio’s non-opioid approach could provide a novel treatment option for a disease where there is a tremendous unmet need,” said Eric Elenko, PhD, PureTech’s Chief Innovation Officer and a Co-founder of Alivio Therapeutics. “The Alivio platform technology is designed to address a range of inflammatory conditions, and we are rapidly progressing its potential application across pouchitis and inflammatory bowel disease as part of our internal R&D.” The ALV-107 program recently received a $3.3 million U.S. Department of Defense (DoD) Technology/Therapeutic Development Award. The funds are directed to support Alivio’s preclinical research and development activities, including GMP manufacturing, to enable the filing of an investigational new drug (IND) application. Alivio’s platform technology has demonstrated proof-of-concept in ten different preclinical models of inflammation including a validated preclinical model for the treatment of IC/BPS. ALV-107relieved pain at all study time points post therapy (vs. vehicle-only control: at 2 hr, p=0.002; 4 hr, p=0.002; 24 hr, p=0.0003). In contrast, the conventional lidocaine-treated group showed statistically significant pain relief only 2 hours post-treatment (p=0.030). Safety and efficacy of ALV-107 will be evaluated during a clinical development program. There is no guarantee that this investigational agent will successfully complete clinical development or gain health authority approval. ]]> https://biospectrumindia.com/news/57/12625/olon-s-p-a-expands-globally-by-acquiring-capua-bioservices.html https://biospectrumindia.com/news/57/12625/olon-s-p-a-expands-globally-by-acquiring-capua-bioservices.html Mon, 28 Jan 2019 12:40:00 +0530 Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, has announced the acquisition of Capua BioServices S.p.A., a global provider of CDMO services in the field of microbial fermentation, as part of a continuing expansion of its global footprint. "Following the acquisition of Ricerca Biosciences' Chemical Division in mid-2017 and the manufacturing site in Mahad (India), announced in Q3 2018 with closing in Q1 2019, we have now completed a further step in our strategic plan. With this acquisition Olon has successfully finalized his 3 years' development plan,"said, Paolo Tubertini, CEO of Olon. Capua BioServices is a global provider of high-quality services in the field of custom microbial process development and manufacturing. Capua BioServices offers dedicated solutions for proteins, specialty small molecules and microorganisms for applications in pharma, food, feed and other bio-industrial markets. The site is beta-lactam free with a total fermentation capacity of about 1.400 m3, with approximately 230 employees. Over the past 60 years, the company has built a track record based on extensive experience in working with a variety of bacterial, yeast and fungal systems. No impact on jobs is planned and Olon intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base. ]]> https://biospectrumindia.com/news/57/12624/fda-okays-zimmer-biomets-rosa-knee-system-.html https://biospectrumindia.com/news/57/12624/fda-okays-zimmer-biomets-rosa-knee-system-.html Mon, 28 Jan 2019 12:30:00 +0530 Zimmer Biomet Holdings, Inc. a global leader in musculoskeletal healthcare, has announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries. ROSA Knee features 3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy designed to improve bone cut accuracy and range of motion gap analysis to potentially improve flexion and restoration of natural joint movement. "Complementing the skill and expertise of the surgeon with ROSA Knee's robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency," said Christopher J. Cannova, M.D., Washington Joint Institute at OrthoBethesda. "ROSA Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion." ROSA Knee leverages Zimmer Biomet's ROSA Robotics platform, which includes ROSA Brain for neurosurgical procedures.   ]]> https://biospectrumindia.com/news/57/12614/decode-publishes-the-first-genetic-map-of-the-human-genome.html https://biospectrumindia.com/news/57/12614/decode-publishes-the-first-genetic-map-of-the-human-genome.html Fri, 25 Jan 2019 16:55:00 +0530 Scientists at deCODE genetics in Iceland, a subsidiary of Amgen has published the first genetic map of the human genome developed using whole-genome sequence data. The map provides the most detailed view to date of the location, rate and connection between two key drivers of human evolution: recombination - the reshuffling of the genome that occurs in the formation of eggs and sperm; and de novo mutation - the appearance in every one of our genomes of dozens of usually small variations that we did not inherit from either of our parents. Together these processes guarantee that every person is a unique version of our species, but de novo mutations are also a principal cause of rare diseases of childhood. This paper presents the latest genetic map of the genome developed by deCODE using its unique population genetics resources in Iceland and made available to the scientific community. The first, published in 2002 with 6000 microsatellite markers, was instrumental in correctly assembling the first reference genome. In 2010, coinciding with the launch of the first commercial whole-genome sequencing machines, deCODE used 300,000 markers to create a more detailed map to guide the analysis of this new type of data. Today's study draws on sequence data from some 150,000 Icelanders from multiple generations, comprising nearly half the population and yielding the precise location of 4.5 million crossover recombinations and more than 200,000 de novo mutations. "Over the past twenty years we have been committed to studying and publishing on de novo mutation and recombination and their relevance to human evolution and disease. We have done this both because it is of fundamental interest to understand more about who we are as a species, and because here in Iceland we have unique resources to address these questions and their relevance to health and medicine," said Kari Stefansson, CEO of deCODE and an author on the paper. "The classic premise of evolution is that it is powered first by random genetic change. But we see here in great detail how this process is in fact systematically regulated - by the genome itself and by the fact that recombination and de novo mutation are linked. We have identified 35 sequence variants affecting recombination rate and location, and show that de novo mutations are more than fifty times more likely at recombination sites than elsewhere in the genome. Furthermore, women contribute far more to recombination and men to de novo mutation, and it is the latter that comprise a major source of rare diseases of childhood. What we see here is that the genome is an engine for generating diversity within certain bounds. This is clearly beneficial to the success of our species but at great cost to some individuals with rare diseases, which are therefore a collective responsibility we must strive to address," Dr Stefansson concluded. Based in Reykjavik, Iceland, deCODE is a global leader in analyzing and understanding the human genome. Using its unique expertise and population resources, deCODE has discovered genetic risk factors for dozens of common diseases. The purpose of understanding the genetics of disease is to use that information to create new means of diagnosing, treating and preventing disease. deCODE is a wholly-owned subsidiary of Amgen. The study appears in the online edition of Science. ]]> https://biospectrumindia.com/news/57/12612/medisapiens-partners-with-modul-bio-for-biobanking.html https://biospectrumindia.com/news/57/12612/medisapiens-partners-with-modul-bio-for-biobanking.html Fri, 25 Jan 2019 16:15:00 +0530 MediSapiens, a leading developer and provider of genomic, biomedical and health data solutions, has partnered with Modul-Bio, a leading provider of solutions for biological sample management, Biobank Information Management Systems (BIMS) and collaborative tools for sharing biological sample collections. With the partnership the two companies aim to complement each other's solutions for biobanking, providing biobanks an all-round capability in managing, sharing and commercializing their samples and data. Modul-Bio provides specifically designed software solutions for Biological Resource Centres, cohort projects, biotechnology and cosmetics firms as well as diagnostic companies. The company has earned the recognition of commercial clients, academic clients and hospitals with experience in supporting biobanking operations. MediSapiens provides novel solutions for biomedical and health data, enabling clients to get true value out of their data. Among its clients are both public and commercial biobanks, using MediSapiens' solutions to curate, manage, query and share data with researchers, pharmaceuticals and healthcare providers. "We're very enthusiastic to work with Modul-Bio", states Hans Garritzen, Sales Director of MediSapiens. "By joining the expertise from MediSapiens and Modul-Bio we are able to support the biobanking field with an end-to-end solution for sample and data management and make new insights easily available." "We are dedicated to continuing to provide solutions to expand and improve the industry", comments Mike Woodward, Business Development Manager at Modul-Bio. "It is exciting to co-operate with MediSapiens to further these goals." MediSapiens Ltd. is a Bio-IT and bioinformatics company specialized in pharmaceutical research and translational genomics, providing life science and biomedical companies and research organizations with tools that help them manage and interpret large genomic, biomedical and clinical data sets. Established in 2009 and based in Helsinki, Finland and Cambridge, Massachusetts, MediSapiens creates intuitive software platforms to manage, integrate, and visualize complex multi-dimensional datasets, such as genomic sequencing data. The company's goal is to drive medicine forward by developing tools that provide scientists with a way to quickly analyze and visualize vast amounts of data and turn it into knowledge that fuels innovation. ]]> https://biospectrumindia.com/news/57/12604/basilea-announces-collaboration-with-roche.html https://biospectrumindia.com/news/57/12604/basilea-announces-collaboration-with-roche.html Fri, 25 Jan 2019 12:15:00 +0530 Commercial stage biopharma company, Basilea Pharmaceutica has announced that it entered into a collaboration with Roche to explore a combination of Basilea's derazantinib and Roche's PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq®) in patients with urothelial cancer. Basilea expects to start a biomarker-driven multi-cohort phase 1/2 study mid-2019. Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said, "We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with urothelial cancer." He also added, "The combination of derazantinib and atezolizumab is based on a sound scientific rationale. In addition to its effects on FGFR kinases, derazantinib also inhibits the colony-stimulating factor-1-receptor kinase (CSF1R). CSF1R inhibition has the potential to enhance the response to atezolizumab's immune-checkpoint inhibition. The combination of inhibiting FGFR while, at the same time, enhancing T cell-mediated antitumor effects through CSF1R inhibition is potentially a promising new treatment approach in patients with urothelial cancer." The planned study will assess the safety, tolerability and efficacy of the derazantinib-atezolizumab combination in patients with advanced urothelial cancer and confirmed FGFR genomic aberrations. Basilea will be the sponsor of the study and Roche will provide clinical supply of atezolizumab for the study. Urothelial cancer is the sixth most common cancer in the U.S. These cancers start in the urothelial cells that line the inside of the bladder. 80,000 new cases of bladder cancer have been estimated in the U.S. for 2017. Up to 20 percent of patients will have muscle-invasive disease and present with or will later develop metastases. For patients with metastatic disease, outcomes can be poor due to the often rapid progression of the tumor and the lack of efficacious treatments, especially in relapsed or refractory disease.   ]]> https://biospectrumindia.com/news/57/12599/blood-test-shows-early-detection-of-lung-transplant-rejection-nih.html https://biospectrumindia.com/news/57/12599/blood-test-shows-early-detection-of-lung-transplant-rejection-nih.html Fri, 25 Jan 2019 12:00:00 +0530 Researchers at National Institutes of Health have developed a simple blood test that can detect when a newly transplanted lung is being rejected by a patient, even when no outward signs of the rejection are evident. The test could make it possible for doctors to intervene faster to prevent or slow down so-called chronic rejection—which is severe, irreversible, and often deadly—in those first critical months after lung transplantation. Researchers believe this same test might also be useful for monitoring rejection in other types of organ transplants. The work was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. The study’s findings were published Jan. 22 in EBioMedicine, a publication of The Lancet. Hannah Valantine, M.D., co-leader of the study and lead investigator of the Laboratory of Organ Transplant Genomics in the Cardiovascular Branch at NHLBI said, “This test solves a long-standing problem in lung transplants: detection of hidden signs of rejection. We’re very excited about its potential to save lives, especially in the wake of a critical shortage of donor organs.” The test relies on DNA sequencing, Valantine explained, and as such, represents a great example of personalized medicine, as it will allow doctors to tailor transplant treatments to those individuals who are at highest risk for rejection. Lung transplant recipients have the shortest survival rates among patients who get solid organ transplantation of any kind—only about half live past five years. Lung transplant recipients face a high incidence of chronic rejection, which occurs when the body’s immune system attacks the transplanted organ. Existing tools for detecting signs of rejection, such as biopsy, either require the removal of small amounts of lung tissue or are not sensitive enough to discern the severity of the rejection. The new test appears to overcome those challenges. Called the donor-derived cell-free DNA test, the experimental test begins with obtaining a few blood droplets taken from the arm of the transplant recipient. A special set of machines then sorts the DNA fragments in the blood sample, and in combination with computer analysis, determines whether the fragments are from the recipient or the donor and how many of each type are present. Because injured or dying cells from the donor release lots of donor DNA fragments into the bloodstream compared to normal donor cells, higher amounts of donor DNA indicate a higher risk for transplant rejection in the recipient. In the study, 106 lung transplant recipients were enrolled and monitored. Blood samples collected in the first three months after transplantation underwent the testing procedure. The results showed that those with higher levels of the donor-derived DNA fragments in the first three months of transplantation were six times more likely to subsequently develop transplant organ failure or die during the study follow-up period than those with lower donor-derived DNA levels. Importantly, researchers found that more than half of the high-risk subjects showed no outward signs of clinical complications during this period. “We showed for the first time that donor-derived DNA is a predictive marker for chronic lung rejection and death, and could provide critical time-points to intervene, perhaps preventing these outcomes. Once rejection is detected early via this test, doctors would then have the option to increase the dosages of anti-rejection drugs, add new agents that reduce tissue inflammation, or take other measures to prevent or slow the progression”, Valantine added. This research is supported by The Genomic Research Alliance for Transplantation Study, which is funded by the Division of Intramural Research of NHLBI. The research is also supported by The Genome Transplant Dynamics Study, which is funded by the National Institute of Allergy and Infectious Diseases.     ]]> https://biospectrumindia.com/news/57/12596/bristol-myers-reports-fourth-quarter-financial-results.html https://biospectrumindia.com/news/57/12596/bristol-myers-reports-fourth-quarter-financial-results.html Fri, 25 Jan 2019 11:50:00 +0530 Bristol-Myers Squibb Company has reported results for the fourth quarter and full year of 2018 which were highlighted by strong demand for Opdivo (nivolumab) and Eliquis (apixaban) and a robust operating performance across the portfolio. Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb said, “I am proud of our results in 2018, which were based on superior commercial performance for our prioritized brands and important scientific advances that continue to diversify our R&D pipeline. We are beginning 2019 with good momentum in our current business, with Opdivo and Eliquis continuing as strong and growing franchises.” “Our planned acquisition of Celgene will position us to create a leading biopharma company, with best-in-class franchises, significant near-term launch opportunities and a deep and broad pipeline, creating an even stronger foundation for long-term sustainable growth”, he added. FOURTH QUARTER FINANCIAL RESULTS Bristol-Myers Squibb posted fourth quarter 2018 revenues of $6.0 billion, an increase of 10% compared to the same period a year ago. Revenues increased 12% when adjusted for foreign exchange impact. S. revenues increased 16% to $3.3 billion in the quarter compared to the same period a year ago. International revenues increased 3%. When adjusted for foreign exchange impact, international revenues increased 7%. Gross margin as a percentage of revenue increased from 69.2% to 71.7% in the quarter primarily due to higher inventory write-offs and startup charges in the fourth quarter last year. Marketing, selling and administrative expenses increased 2% to $1.3 billion in the quarter. Research and development expenses decreased 29% to $1.4 billion in the quarter primarily due to license and asset acquisition charges of $377 million in the fourth quarter last year. The effective tax rate was 23.1% in the quarter, compared to 433.7% in the fourth quarter last year. The tax rate in the fourth quarter last year was impacted by a one-time $2.9 billion charge resulting from U.S. tax reform. The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.73 per share, in the fourth quarter, compared to a net loss of $2.3 billion, or $1.42 per share, for the same period in 2017. The results in the fourth quarter last year included the transitional impact of U.S. tax reform. The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.5 billion, or $0.94 per share, in the fourth quarter, compared to net earnings of $1.1 billion, or $0.68 per share, for the same period in 2017. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section. Cash, cash equivalents and marketable securities were $10.7 billion, with a net cash position of $3.3 billion, as of December 31, 2018.   ]]> https://biospectrumindia.com/news/57/12589/creso-pharma-set-for-cbd-biz-with-new-supply-agreement.html https://biospectrumindia.com/news/57/12589/creso-pharma-set-for-cbd-biz-with-new-supply-agreement.html Thu, 24 Jan 2019 16:30:00 +0530 CFN Media Group the leading agency and financial media network dedicated to the North American cannabis industry, announces publication of an article discussing Creso Pharma Ltd. and its unique position with near-term production, existing supply agreements, and an established European cannabidiol (CBD) line of products. With its international presence and clean balance sheet, investors may want to keep a close eye on the stock over the coming months. Canada's cannabis industry is projected to reach C$22.6 billion over the coming years, according to Deloitte analysts, driven by the legalization of adult-use cannabis in October of last year. While many licensed producers have been scaling up their production, the market continues to experience a shortfall in supply that has created an opportunity for investors in companies with near-term production coming online. Canada's Supply Shortage Canada legalized adult-use cannabis late last year, but many consumers haven't been able to partake. With persistent supply shortages, the government has been forced to shut down or delay the opening of many retail locations. Quebec's government-owned stores have been closed three days per week; Alberta has stopped issuing new retail licenses; and, Ontario will initially open just 25 stores in the country's most populated region. Many cannabis executives believe that these supply shortages will persist. Auxly Cannabis Group Inc. CEO Chuck Rifici predicted that it could be at least three years before the market hits equilibrium. These sentiments were echoed by Organigram Holdings Inc. CEO Greg Engel and Valens GroWorks Corp. EVP Everett Knight, who both believe the supply shortage will last a couple of years or more. These supply shortages are largely due to over optimistic projections from many licensed producers. In addition to failing to deliver, these rosy forecasts have caused a decline in the price of many LP stocks. Investors are concerned that LPs that have over promised on production could fail to meet their production, revenue, and profitability goals, while potentially compromising their relationships with the retail side of the industry. TerrAscend Agreement Creso Pharma is uniquely positioned to capitalize on these developments with its near-term production capacity. While many licensed producers have overcommitted, the company has strategically focused on building a diverse global enterprise with a commercial presence in both Canada and around the world. The company is one of just a handful of cannabis companies with existing commercial operations in Europe. In January, the company signed a three-year supply agreement with TerrAscend Corp. to provide premium cannabis product to help meet the significant consumer demand following legalization in October. Creso Pharma committed to selling 100 kilograms of cannabis flower per month to TerrAscend. The company recently completed a 24,000 sq. ft., purpose-built, state-of-the-art cultivation facility in Nova Scotia that's capable of producing more than 4,000 kilograms of cannabis per year. In addition to the new supply agreement, the company is in talks with the Nova Scotia Liquor Corp. to receive preferred placement at the government-run store due to its standing as one of just a handful of local producers. ]]> https://biospectrumindia.com/news/57/12588/b-mogen-cytosen-to-develop-next-generation-natural-killer-cells-.html https://biospectrumindia.com/news/57/12588/b-mogen-cytosen-to-develop-next-generation-natural-killer-cells-.html Thu, 24 Jan 2019 16:05:00 +0530 B-MoGen Biotechnologies, Inc. and CytoSen Therapeutics have announced a research collaboration to develop the next generation of gene-modified Natural Killer Cell (NK) therapies.  B-MoGen will utilize its expertise in genetic design and its patented non-viral gene delivery platform in conjunction with CytoSen's nanoparticle expansion platform to improve efficacy and reduce cost of NK cell therapeutics.  "We are very excited and look forward to teaming up with CytoSen to utilize our scientific expertise and engineering work with CARs and TCRs to help develop NK treatments in the human therapeutics space," said Jeff Liter, President and CEO of B-MoGen.  "CytoSen's innovation, science and pioneering technology is a perfect fit with B-MoGen's genome engineering experience and technology." Both companies are experiencing rapid growth by providing cutting edge science and technical know-how to help create life-changing human disease therapies.  This partnership looks to enable the creation and delivery of new NK cell therapies for cancer patients.  ]]> https://biospectrumindia.com/news/57/12586/pharmaseal-launches-clinical-trial-platform-for-integrated-governance.html https://biospectrumindia.com/news/57/12586/pharmaseal-launches-clinical-trial-platform-for-integrated-governance.html Thu, 24 Jan 2019 14:50:00 +0530 PHARMASEAL provides clinical trial management platform and governance solutions to enter the market, has launched Engility™ CTMS, the first product to be released from its Engility B2B platform. PHARMASEAL has industry expertise, innovative thinking and advanced automation to build and operate an integrated enterprise platform which allows biopharmaceutical and medical device companies to manage all of their clinical trials effectively. With a focus on usability and rapid implementation, this innovative new generation clinical trial management system (CTMS) has been designed to increase the level of governance and control that organisations demand from their management systems to enable effective oversight of their clinical trials. A key challenge to overcome in the design was to optimise the cost of software validation so that new innovations can be introduced easily for the benefit of customers. Engility CTMS is engineered for change and benefits from extensive automation to deliver new features in a regulated industry, faster than current products. With an intuitive interface and flexible cloud architecture, biopharmaceutical and medical device companies of all sizes can leverage affordable enterprise technology to fit their particular organisation model.   ]]> https://biospectrumindia.com/news/57/12584/servier-neurochlore-initiates-trial-to-evaluate-bumetanide-in-asd-children-.html https://biospectrumindia.com/news/57/12584/servier-neurochlore-initiates-trial-to-evaluate-bumetanide-in-asd-children-.html Thu, 24 Jan 2019 11:10:00 +0530 Servier, an independent, international pharmaceutical company, and Neurochlore, French biotechnology, announce the launch in Europe of phase 3 studies to evaluate the use of bumetanide in children suffering from Autism Spectrum Disorders (ASD). The pediatric investigation plan, which involves the use of an oral liquid formulation for children, has been approved by the Pediatric Committee of the European Medicines Agency. Two multicenter, randomized, double-blind, placebo-controlled clinical trials conducted by Servier are underway and will evaluate the efficacy and safety of bumetanide administered twice a day to children suffering from ASD aged 2 to 6 years and 7 to 17 years. The main aim of these trials is to evaluate the efficacy and safety of bumetanide, compared with placebo, on the core symptoms (persistent impairment in reciprocal social communication and interaction and restricted and repetitive patterns of behavior) of ASD after 6-month treatment. Overall the total duration of each of these two trials will be one year. Following the 6-month evaluation period versus placebo, all the patients will be treated with bumetanide for a period of 6 months. Each patient will thus have the opportunity to be on active treatment for at least 6 months. Servier has obtained the required authorizations to conduct these clinical trials in some European countries (France, Spain, Hungary, Germany, Italy, Poland and United Kingdom). Following additional regulatory approval, other European countries and countries outside Europe should be included as well in these trials. The objective is to recruit approximately 200 patients in each study. Bumetanide reduces the high concentrations of chloride observed in neurons in certain neurodevelopmental disorders like ASD. In 2017, Neurochlore published results supporting efficacy and safety from its phase 2b study with bumetanide in 6 centers in France in almost 90 children (aged2-18 years). Bumetanide’s favorable effects on several aspects of ASD allow to envision management of autism, particularly of its core symptoms. Professor Ben-Ari, President of Neurochlore, commented: “We are pleased with the launch of these phase 3 studies which are in the continuum of our ongoing research into autism, for which there is still no drug treatment." These clinical studies are in the frame of a partnership agreement signed in 2017 in which Servier will develop and commercialize bumetanide in Europe while Neurochlore will retain the rights for the rest of the world. ]]> https://biospectrumindia.com/news/57/12575/bioseros-software-automates-lab-ecosystem-.html https://biospectrumindia.com/news/57/12575/bioseros-software-automates-lab-ecosystem-.html Wed, 23 Jan 2019 14:55:00 +0530 Biosero, Inc. will introduce the latest release of its Green Button GoTM software platform at the 2019 Society for Laboratory Automation and Screening Conference (SLAS 2019). The breakthrough Green Button Go software integrates life science equipment to create a cohesive lab ecosystem that automates testing and discovery workflows. Green Button Go software is easy to set up and supports a vast library of device drivers, making it plug-and-play with a variety of lab equipment such as robotic arms, scanners, liquid handlers, washers and readers. It eliminates surprise costs associated with installations and setup, reduces downtime and provides a "future proof" aspect by being agnostic to any manufacturer's hardware or software. Using the drag-and-drop user interface of Green Button Go, scientists and lab technicians can set up and automate their workflows. Technicians can manage and schedule different methods to run simultaneously or at scheduled times. The platform provides a comprehensive view of the whole equipment network giving operators constant visibility into all aspects of their processes. Traditionally lab technicians have had to oversee workflows minute-by-minute to make sure they are running smoothly. Now, lab technicians can walk away while Green Button Go coordinates all the work. Technicians can even oversee the productivity of their workflows remotely. Four features of the latest release help labs save time and improve the reliability and repeatability of critical tasks. They include: Cloud-Based Downloads, Artificial Intelligence Enabled, Simulation and Run Analysis, Data Access, Integrity and Alerts.   ]]> https://biospectrumindia.com/news/57/12572/sanofi-partners-with-startup-creasphere.html https://biospectrumindia.com/news/57/12572/sanofi-partners-with-startup-creasphere.html Wed, 23 Jan 2019 13:25:00 +0530 Startup Creasphere, the first digital health innovation hub in Europe, has announced a partnership with the consumer healthcare business unit of Sanofi. Sanofi will partner with Startup Creasphere and other companies in creating the ultimate hub of digital health innovation in Europe, where forward-thinking corporations and disruptive startups can meet to pilot solutions and services, drive investments, learn and share experiences and facilitate international expansion. Startup Creasphere is supported by Plug and Play, a global innovation platform and venture fund from Silicon Valley, specializing in the development of early-to-growth stage technology startups. Startup Creasphere will run two sessions annually where hundreds of startups from across the globe will be evaluated, with the most promising selected by corporate partners, such as Sanofi, to join each session. In their first session, Sanofi will focus on working with startups in the nutritional health and allergy space. "Within Sanofi, we have strong expertise in bringing over the counter healthcare solutions to market, so we look forward to combining these strengths with the ingenuity and innovative mindset of startups to help consumers live healthier, fuller lives." said Oliver Freichel, Corporate Vice President Strategy & Business Development & Licensing, Consumer Healthcare, Sanofi ]]> https://biospectrumindia.com/news/57/12568/novo-holdings-invests-4-4m-euro-in-minerva-to-combat-amr.html https://biospectrumindia.com/news/57/12568/novo-holdings-invests-4-4m-euro-in-minerva-to-combat-amr.html Tue, 22 Jan 2019 22:05:00 +0530 MinervaX, a privately held Danish biotech company has announced that is has been awarded an investment of 3.6 mEUR from the Novo Holdings REPAIR Impact Fund for development of therapies to combat antimicrobial resistance (AMR). An additional investment of 0.8 mEUR was obtained from SunStone Capital. The funding will be used to help finalize Phase I development of the Company’s protein-only GBS vaccine, targeting pregnant women for the prevention of life-threatening infections in newborns. GBS is responsible for 50% of life-threatening infections in newborns and affects 0.5-3 in 1,000 babies, depending on the geographical region. At any given time, some 15-25% of women are spontaneously colonized with GBS, and they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS infection in the unborn child may lead to premature delivery or stillbirth, and GBS infection in the newborn child may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long-term disability or death. Annually, GBS is estimated to be responsible for some 57,000 cases of stillbirth, 319,000 cases of invasive neonatal disease, 7,000 cases of meningitis, and up to 3.5 million preterm deliveries globally. MinervaX is developing a GBS vaccine for maternal immunization, likely to have superior characteristics compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against almost 100% of GBS isolates. MinervaX has previously reported positive results from an initial Phase I trial completed in 240 healthy adult women with a single component vaccine. The vaccine was demonstrated to have a favorable safety profile, give rise to high levels of long-lasting antibodies, which are capable of killing GBS bacteria and prevent invasion of epithelial and endothelial cell barriers. The current funding will be used to conduct a short Phase I trial to expand the coverage of the vaccine to close to 100% of all colonizing and invasive strains of GBS, by inclusion of a second vaccine component. In addition, funding will be used for CMC development in preparation of Phase II clinical trials. The clinical trial was initiated in the UK on January 8, 2019. According to Per Fischer, D.Phil., Chief Executive Officer of MinervaX, “The award from the REPAIR Impact Fund, represents external validation and recognition of MinervaX’s GBS vaccine program by a group of key vaccine and bacteriology experts, and allows the company to advance the program towards Phase II clinical trials.” Group B Strep Support is the UK’s only charity dedicated to eradicating group B Strep infection in newborn babies. Chief Executive and Founder of the charity, Jane Plumb MBE, welcomes the news that Phase 1 program of MinervaX’s clinical trial of their GBS vaccine will now be finalised ahead of Phase II trials. “We welcome the news that MinervaX’s Phase 1 program of their group B Strep vaccine will be finalised thanks to funding from the REPAIR Impact Fund. Group B Strep is the most common cause of severe infection in newborn babies and of meningitis in babies under 3 months. A safe and effective vaccine is the ‘holy grail’ of preventing group B Strep infection and could protect more than any other prevention strategy. It is urgently needed and I’m delighted that the research into MinervaX’s vaccine candidate will continue.” Group B Strep International (GBSI) is a non-profit organization committed to promoting awareness and prevention of group B strep disease in babies during pregnancy through several months of age. Marti Perhach, CEO and Cofounder of GBSI, is glad to know that MinervaX has received funding from the REPAIR Impact Fund to finalize their Phase I clinical development of a GBS vaccine. “The current GBS disease prevention strategy of routine screening and indicated IV antibiotic treatment during labor and delivery adopted by many countries only targets GBS infections acquired during birth and, while highly effective, raises concerns about antibiotic overuse and how antibiotics affect the newborn’s microbiome. An effective GBS vaccine replacing this strategy would obviate these concerns as well as provide a measure of protective coverage for unborn babies nearing term and babies up to several months of age, both periods of susceptibility without health agency recommended prevention strategies.” Shortcomings of current GBS prevention. Current GBS intervention, involving antibiotic prophylaxis during childbirth (known as intra-partum antibiotic prophylaxis or IAP) in women colonized with GBS or otherwise at risk of transmitting the bacteria to the newborn, has reduced the incidence of Early Onset Disease (EOD) occurring within the first 6 days of life by some 80% since its introduction. However, IAP has failed to fully eradicate EOD for a number of practical reasons, and is not universally implemented in all countries, particularly in Europe and the developing world; Current use of IAP has no impact on GBS-induced premature delivery and stillbirth caused by infection of the unborn child as it is administered only during labor; IAP has no impact on Late Onset Disease occurring from 7 days to 3 months of age, where the burden of meningitis is highest. 50% of babies who recover from GBS meningitis have long-term sequelae, including brain damage, cerebral palsy, severe learning difficulties, hearing loss, and/or blindness; IAP is currently only available in high-income countries and is unlikely to be implemented in low-income countries; the efficacy of IAP is currently under threat from emerging antibiotic resistance in GBS, including the most commonly used antibiotics such as penicillin; the wide spread use of broad-spectrum prophylactic antibiotic in birthing women has led to an increase in antibiotic resistance amongst other bacteria, which also can infect newborns, particularly in preterm babies; and finally, wide-spread antibiotic prophylaxis in birthing women may negatively impact the developing intestinal microbiota of the newborn increasing the risk of eczema, asthma, ADHD, and learning disabilities. The development of an efficacious GBS vaccine for maternal immunization capable of reducing this wide-spread use of antibiotic prophylaxis in birthing women and preventing more GBS infections both of early and late onset therefore addresses two significant medical needs. ]]> https://biospectrumindia.com/news/57/12567/wockhardt-gets-usfda-nod-for-generic-cancer-drug.html https://biospectrumindia.com/news/57/12567/wockhardt-gets-usfda-nod-for-generic-cancer-drug.html Tue, 22 Jan 2019 21:50:00 +0530 Drug firm Wockhardt has said that it has received approval from the US health regulator for generic version of Gleevec used for treatment of cancers and tumours. Wockhardt has received approval from the United States Food & Drug Administration (USFDA) for an abbreviated new drug application (ANDA) for 100 mg and 400 mg tablets of Imatinib Mesylate, the company said in a BSE filing. Wockhardt's Imatinib Mesylate tablets are a generic version of Gleevec, marketed in USA and other countries by Novartis. "Wockhardt is building a portfolio of oncology products in the US and has several pending ANDA's for oncology products," Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said. Oncology and other specialty products have always been a priority area for our US business and this product will further boost this focus, he added. Wockhardt said it will launch this product in the United States, in a short period of time. ]]> https://biospectrumindia.com/news/57/12553/fiera-milano-to-host-cphi-worldwide-2020.html https://biospectrumindia.com/news/57/12553/fiera-milano-to-host-cphi-worldwide-2020.html Mon, 21 Jan 2019 17:50:00 +0530 CPhI Worldwide, the world’s largest pharma event, will return to the Fiera Milano venue (13 - 15 October) in 2020 bringing over 47,000 professionals and 2,600 exhibitors from more than 150 countries. The three-day exhibition, organized by UBM, part of Informa PLC, will bring the world’s pharma community to Milan and occupy over 250 thousand square meters. Fiera Milano has secured this premier global exhibition, and the largest in pharmaceuticals, ahead of a number of prominent international venues. Milan, and the Lombardy Region, were chosen thanks to the weight of the regional pharma industry and the caliber of its exhibition centre. The pharmaceutical industry in Italy is worth more than €30 billion, with Lombardy the largest regional hub. “Fiera Milano with this announcement is taking another important step towards the delivery of the strategic plan launched in May” commented Fabrizio Curci, CEO of Fiera Milano S.p.A. “Global international events such as CPhI Worldwide find Milan and its fair a unique platform”. CPhI Worldwide, which in 2020 will be hosting its thirty-first edition, covers the entire pharmaceutical supply chain and is by far the most comprehensive hub for global pharmaceuticals. It is a key networking and new business event driving forward the industry’s growth. Orhan Caglayan, Brand Director at CPhI Worldwide, added: “It’s been a particularly successful couple of years for CPhI Worldwide, as the world’s largest pharma event we have seen a remarkable growth in numbers. At the 2020 edition we anticipate 2600+ exhibitors and around 47,000 attendees, so the challenge we have, is to find a venue large enough with excellent infrastructure. Fiera Milano was an ideal choice, combining a comprehensive venue and a strong pharma industry. Italy is Europe’s second pharma market in terms of production, a major export hub, and Milan is the heart of this nation’s industry. As a result, we expect to attract substantial international attendees to one of Europe’s primary pharma manufacturing centres.”   ]]> https://biospectrumindia.com/news/57/12552/fda-approves-first-generic-version-of-sabril-to-treat-seizures.html https://biospectrumindia.com/news/57/12552/fda-approves-first-generic-version-of-sabril-to-treat-seizures.html Mon, 21 Jan 2019 17:15:00 +0530 The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments. "Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients. The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year,” said FDA Commissioner Scott Gottlieb, M.D. “We know there has been past interest in developing a generic alternative to this product. Earlier this year, we also highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. Today’s action demonstrates that there is an open pathway to approving products like this one. We’re especially focused on new policies aimed at making the generic review process more predictable, efficient and lower cost so we can entice more generic firms to enter this space, and help facilitate more generic drug launches after generic approvals. We know it’s not enough just to approve a record number of generic medicines. We also want to see firms launch these products so that patients can benefit from their availability, and we intend to take steps to advance these goals." Complex partial seizures, a common type of seizures, start in a specific area of the brain and can affect consciousness. Typically, complex partial seizures last between 30 and 90 seconds, and are often followed by a period of disorientation, confusion and/or fatigue. The FDA requires appropriate data and information to demonstrate that generic drugs meet the agency’s rigorous approval standards to ensure quality drug products that are as safe and effective as their brand name counterparts. As with brand-name drugs, the FDA also inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products. Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss. Teva’s generic vigabatrin tablets is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin to ensure the safe use of the product. Brand and generic drug makers are required to develop a single shared-system REMS program (unless FDA waives the single shared system requirement) when a generic drug seeks approval and the brand drug has a REMS associated with it.   ]]> https://biospectrumindia.com/news/57/12550/lilly-reports-results-of-announce.html https://biospectrumindia.com/news/57/12550/lilly-reports-results-of-announce.html Mon, 21 Jan 2019 16:15:00 +0530 Eli Lilly and Company has reported that the results of ANNOUNCE, the Phase 3 study of LARTRUVO (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS), did not confirm the clinical benefit of LARTRUVO in combination with doxorubicin as compared to doxorubicin, a standard of care treatment. Specifically, the study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population. LARTRUVO was well tolerated; there were no new safety signals identified and the safety profile was comparable between treatment arms. LARTRUVO in combination with doxorubicin previously showed an OS benefit in STS in a 133-patient, U.S.-only, randomized Phase 2 trial, which led to accelerated approval by the U.S. Food and Drug Administrationand conditional marketing authorization by the European Medicines Agency. Continued approval is contingent upon verification of clinical benefit in a confirmatory trial. As ANNOUNCE did not confirm clinical benefit, Lilly is working with global regulators to determine the appropriate next steps for LARTRUVO. While these discussions are ongoing, patients who are currently receiving LARTRUVO may, in consultation with their physician, continue their course of therapy if they are receiving clinical benefit. For patients who have not previously received LARTRUVO, the results of the Phase 3 trial do not support initiating treatment with LARTRUVO in patients with STS, outside of participation in a clinical trial. At this time, Lilly is suspending promotion of LARTRUVO. Anne White, president, Lilly Oncology said, "Lilly was surprised and disappointed that LARTRUVO did not improve survival for patients with advanced soft tissue sarcoma in this study. Lilly is committed to helping people who have soft tissue sarcoma and we will carefully study the detailed data in an effort to better understand the different results between the two trials. We are thankful for the patients and physicians who have participated in the ANNOUNCE study." LARTRUVO is also being studied in an ongoing global, randomized, double-blind, placebo-controlled Phase 2 trial in advanced STS in combination with gemcitabine and docetaxel. Lilly expects to incur a charge in the first quarter of 2019 related to LARTRUVO. The exact amount of the charge has not yet been determined, but is estimated to be in the range of $70 million to $90 million (pre-tax), or approximately $0.10 per share (after tax). In addition, the company expects this to have an impact of approximately $0.17 per share on Lilly's full-year 2019 earnings per share guidance. Lilly will provide a full update to its 2019 financial guidance, including the impact of the potential Loxo Oncology acquisition, when it announces Q4 2018 earnings. This announcement does not change Lilly's 2020 minimum financial goals. ]]> https://biospectrumindia.com/news/57/12539/kane-biotech-positions-dispersinb-for-wound-care-treatment-in-u-s-.html https://biospectrumindia.com/news/57/12539/kane-biotech-positions-dispersinb-for-wound-care-treatment-in-u-s-.html Fri, 18 Jan 2019 21:50:00 +0530 Kane Biotech has announced the kick-off of their new human health strategy. Efforts will be focused on development of a wound care hydrogel containing Kane’s patented enzyme DispersinB. Marc Edwards, Chief Executive Officer of Kane Biotech, stated, “I believe DispersinB could be a technology platform with a variety of applications in various fields. With DispersinB hydrogel, our aim is to not replace existing wound care treatments, but to greatly improve their activity and efficacy through the removal of bacteria biofilm. This first product, due to its unique impact on biofilms, has the potential to be the missing link in wound care.” This strategy is further fortified by the Corporation’s renewal of its exclusive worldwide license agreement with the University of Medicine and Dentistry of New Jersey, now part of Rutgers University, for all human, animal and industrial applications of the DispersinB enzyme. The discovery of DispersinB was made by Dr. Jeffrey Kaplan, Assistant Professor in the Department of Oral Biology at UMDNJ, who was able to show that the novel enzyme is responsible for the dispersal of bacterial biofilms.  Kane Biotech is delighted to be able to count on Dr. Kaplan’s continued support in the development of the DispersinB technology platform. Kane has taken a number of measures to accelerate the development and commercialization of the DispersinB technology including, the creation of a Scientific Advisory Board (S.A.B.) and the appointment of Dr. Gordon Guay as Chief Scientific Officer. Following a full technology review by their S.A.B., Kane Biotech identified DispersinB as the company’s key area of focus moving forward in human health. “DispersinB is a unique enzyme that is capable of greatly enhancing the efficacy of available wound care treatments by dissolving bacterial biofilm, which could significantly improve patient outcome and timelines,” added Dr. Gordon Guay, Chief Scientific Officer of Kane Biotech. Kane has also retained the services of the international regulatory consultant Amarex Clinical Research, a CRO with extensive experience in FDA submissions. With their help, Kane Biotech plans to conduct additional clinical studies and seek regulatory approval moving forward in 2019. Furthermore, Kane Biotech recently submitted a proposal under the Military Infectious Diseases Research Program (MIDRP) with Medical Technology Enterprise Consortium (MTEC) open concepts request for project information. MTECs mission is to assist the U.S. Army Medical Research and Materiel Command (USAMRMC) by providing cutting-edge technologies and supporting effective life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC has already given first stage approval to this project. “Our team worked very hard to put the proposal together and we are excited that it was well received, we are looking forward to further interactions with the U.S. Department of Defense,” stated Marc Edwards Chief Executive Officer of Kane Biotech. Wound care is currently the most expensive area of care with multiple complex solutions. Chronic wounds present a significant financial burden to the U.S. healthcare system. A 2018 study of Medicare data estimated the cost to treat these wounds at between $28 billion and $32 billion. The treatment of chronic wounds is a major challenge for health care providers, with a high failure rate leading to amputation, sepsis and deathi. One of the major reasons for this failure is the formation of bacterial biofilms, which are present in 60% of chronic woundsii,iii. Biofilm formation can make bacteria up to 1000 times more resistant to antibiotics, antimicrobial agents, disinfectants and the host immune systemiv.  Ultimately, anti-biofilm therapies have the potential to significantly increase the ability of healthcare providers to effectively treat wound infections.   ]]> https://biospectrumindia.com/news/57/12533/jj-to-initiate-research-study-with-apple-watch-.html https://biospectrumindia.com/news/57/12533/jj-to-initiate-research-study-with-apple-watch-.html Fri, 18 Jan 2019 11:05:00 +0530 Johnson & Johnson announced that Janssen Pharmaceuticals, Inc., member of the Johnson & Johnson Family of Companies, entered into a research study in collaboration with Apple Inc. to investigate whether a new heart health program using an app from Johnson & Johnson in combination with Apple Watch's irregular rhythm notifications and ECG app can accelerate the diagnosis and improve health outcomes of the 33 million people worldwide living with atrial fibrillation (AFib), a condition that can lead to stroke and other potentially devastating complications. In the U.S. alone, AFib is responsible for approximately 130,000 deaths and 750,000 hospitalizations every year. The study aims to analyze the impact of Apple Watch on the early detection and diagnosis of AFib, and the potential to improve outcomes including the prevention of stroke. A multi-year research program will be launched later in 2019. This large-scale program will occur in the U.S. only, and will be designed as a pragmatic randomized controlled research study for individuals age 65 years or older. The study's goals include: Measuring the outcomes of a heart health engagement program with irregular rhythm notifications on Apple Watch. Assessing the impact of a medication adherence program using an app from Johnson & Johnson. "We're excited about the potential of common, wearable technology to aid in the earlier detection and prevention of a frequent cause of stroke," said Paul Stoffels, M.D., Vice Chair of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "Too many people living with AFib are unaware of their risk, and earlier detection, diagnosis and treatment of AFib could significantly improve outcomes. Based on the insights generated through this research program, we may be able to develop new ways to detect other health conditions earlier in the future that also exhibit measurable physiological symptoms." "Through Apple Watch people have been able to learn more about their heart health, including discovering they have AFib. This kind of information empowers customers to follow up with the right treatment or even better, implement healthy habits aimed at prevention," said Jeff Williams, Chief Operating Officer, Apple Inc. "We're excited to work with Johnson & Johnson, a leader in the medical community, as we learn about the impact Apple Watch can have in delivering better health outcomes." Johnson & Johnson's recent mSTOPs (mHealth Screening to Prevent Strokes) study demonstrated that earlier screening leads to increased AFib detection. "Utilizing wristwatch-based optical heart sensor and ECG monitoring is a logical evolution of this research and may also lead to increased AFib diagnosis and improved clinical outcomes for patients," said Paul Burton, M.D., Ph.D., FACC, Vice President, Medical Affairs, Internal Medicine, Janssen Scientific Affairs, LLC. "This collaboration brings together Johnson & Johnson's depth of expertise and long heritage in treating cardiovascular disease with Apple's experience in utilizing cutting-edge technologies to improve the lives of consumers. Ultimately, we hope to improve the treatment of cardiovascular disease, and identify ways to prevent it."   ]]> https://biospectrumindia.com/news/57/12529/medical-marijuana-launches-real-scientific-hemp-oil.html https://biospectrumindia.com/news/57/12529/medical-marijuana-launches-real-scientific-hemp-oil.html Thu, 17 Jan 2019 17:00:00 +0530 Medical Marijuana, Inc. the first-ever publicly traded cannabis company in the United States, subsidiary  HempMeds announced today the release of its newest cannabidiol (CBD) product Real Scientific Hemp Oil™ (RSHO™) Maximum Strength. RSHO™ Maximum Strength is the company's most potent full-spectrum product, containing 4,500 mg of CBD in each 10-gram oral applicator to support overall wellness. This product features both CBD and CBDa in a proprietary blend of the company's premium hemp oils, including its RSHO™ Green Label raw CBD oil and RSHO™ Gold filtered CBD oil. It is also available in one-gram containers. "We developed Real Scientific Hemp Oil Maximum Strength because of our promise to continuously evolve and lead the industry with quality and innovation," said HempMeds® President Todd Morrow. "This product brings consumers a new level of full spectrum concentration to assist those who can benefit most from a higher concentration oral applicator product. We will continue to drive industry innovation and offer products that stand by our promise to deliver safe, high-quality and meaningful ingestible or topical formulations that can help make a difference for those who benefit from CBD."  HempMeds® was the first company to ever bring hemp-based CBD oil products to market in the U.S. in 2012 -- and the first to both make CBD products available in bulk for U.S. consumers and provide high-quality CBD hemp oil to customers around the world. HempMeds® was also the first-ever company to receive historic federal government import approvals for its CBD products in the nations of Argentina, Brazil, Mexico and Paraguay.   ]]> https://biospectrumindia.com/news/57/12522/nih-fitbit-launch-byod-project.html https://biospectrumindia.com/news/57/12522/nih-fitbit-launch-byod-project.html Thu, 17 Jan 2019 12:30:00 +0530 Global wearables brand, Fitbit and the National Institutes of Health (NIH) has launched the Fitbit Bring-Your-Own-Device (BYOD) project, the first digital health technology initiative for the All of Us Research Program. Fitbit users currently enrolled in the program can now choose to sync their Fitbit accounts to help researchers unlock deeper insights into the relationships between health indicators such as physical activity, heart rate, sleep and health outcomes. By consenting to sync their data with All of Us, Fitbit users have the opportunity to contribute to one of the world’s largest precision medicine studies and help build one of the most diverse data sets for scientific research. Fitbit is the first wearable to be included in the program. Launched nationally in May 2018, All of Us seeks to enroll one million or more participants, with the goal of improving the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics. Participants will be invited to share different types of health information over time through surveys, electronic health records, physical measurements, biosamples and digital health technologies. Data will be made accessible to researchers for a wide range of health studies, with strict safeguards in place to protect participant privacy. Eric Dishman, director of the All of Us Research Program said, “Collecting real-world, real-time data through digital technologies will become a fundamental part of the program. This information in combination with many other data types will give us an unprecedented ability to better understand the impact of lifestyle and environment on health outcomes and, ultimately, develop better strategies for keeping people healthy in a very precise, individualized way.” As a national leader in research using digital health technologies, Scripps Research is spearheading the program’s digital health effort. In 2017, Scripps Research selected Fitbit as the first wearable for use in the groundbreaking All of Us program, based on the popularity and credibility of its use in peer-validated clinical research. Adam Pellegrini, general manager, Fitbit Health Solutions said, “This is a tremendous opportunity for Fitbit users who choose to participate, to further contribute to one of the world’s largest research efforts by providing information that can help pave the way to a healthier future for all of us. Every day we learn more about the potential for wearable data to inform personalized healthcare and through All of Us, the research community will gain an even better understanding of the role wearable data can play in helping to prevent and treat disease.” A second All of Us research initiative using Fitbit devices will launch in 2019 that involves providing up to 10,000 Fitbit devices to a diverse set of participants randomly invited to take part. The study, which will be conducted by Scripps Research Translational Institute, will generate a unique data set for exploring the relationship between health indicators such as physical activity, heart rate and sleep in conjunction with other critical health outcomes that will be captured as part of All of Us. ]]> https://biospectrumindia.com/news/57/12523/nih-fitbit-launch-byod-project.html https://biospectrumindia.com/news/57/12523/nih-fitbit-launch-byod-project.html Thu, 17 Jan 2019 12:30:00 +0530 Global wearables brand, Fitbit and the National Institutes of Health (NIH) has launched the Fitbit Bring-Your-Own-Device (BYOD) project, the first digital health technology initiative for the All of Us Research Program. Fitbit users currently enrolled in the program can now choose to sync their Fitbit accounts to help researchers unlock deeper insights into the relationships between health indicators such as physical activity, heart rate, sleep and health outcomes. By consenting to sync their data with All of Us, Fitbit users have the opportunity to contribute to one of the world’s largest precision medicine studies and help build one of the most diverse data sets for scientific research. Fitbit is the first wearable to be included in the program. Launched nationally in May 2018, All of Us seeks to enroll one million or more participants, with the goal of improving the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics. Participants will be invited to share different types of health information over time through surveys, electronic health records, physical measurements, biosamples and digital health technologies. Data will be made accessible to researchers for a wide range of health studies, with strict safeguards in place to protect participant privacy. Eric Dishman, director of the All of Us Research Program said, “Collecting real-world, real-time data through digital technologies will become a fundamental part of the program. This information in combination with many other data types will give us an unprecedented ability to better understand the impact of lifestyle and environment on health outcomes and, ultimately, develop better strategies for keeping people healthy in a very precise, individualized way.” As a national leader in research using digital health technologies, Scripps Research is spearheading the program’s digital health effort. In 2017, Scripps Research selected Fitbit as the first wearable for use in the groundbreaking All of Us program, based on the popularity and credibility of its use in peer-validated clinical research. Adam Pellegrini, general manager, Fitbit Health Solutions said, “This is a tremendous opportunity for Fitbit users who choose to participate, to further contribute to one of the world’s largest research efforts by providing information that can help pave the way to a healthier future for all of us. Every day we learn more about the potential for wearable data to inform personalized healthcare and through All of Us, the research community will gain an even better understanding of the role wearable data can play in helping to prevent and treat disease.” A second All of Us research initiative using Fitbit devices will launch in 2019 that involves providing up to 10,000 Fitbit devices to a diverse set of participants randomly invited to take part. The study, which will be conducted by Scripps Research Translational Institute, will generate a unique data set for exploring the relationship between health indicators such as physical activity, heart rate and sleep in conjunction with other critical health outcomes that will be captured as part of All of Us. ]]> https://biospectrumindia.com/news/57/12520/international-stem-cell-corporation-granted-us-patent-for-anti-aging-business.html https://biospectrumindia.com/news/57/12520/international-stem-cell-corporation-granted-us-patent-for-anti-aging-business.html Thu, 17 Jan 2019 11:50:00 +0530 International Stem Cell Corporation, a California-based, clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that the United States Patent and Trademark Office (USPTO) has granted the Company US Patent No. 10,172,890 on the topical use of lysate from human parthenogenetic (non-embryonic) stem cells to visibly improve signs of skin aging. The patented stem cell lysate is encapsulated and delivered from protective liposomes, and is combined with antioxidants, vitamins and peptides to provide skin benefits including reducing the depth/number of facial fine lines and wrinkles, increasing skin elasticity/firmness, and improving skin hydration. This proven to be effective technology used in the products was developed by key ISCO scientists, who brought neural stem cells to the clinical trial for the treatment of Parkinson’s disease. “It is important that ISCO’s intellectual property portfolio continues to expand and we are excited to receive this US patent covering a technology used in Lifeline’s stem cell-based product line, which won various prestigious awards and has been receiving positive feedback both from consumers and well-known doctors since 2010 when we launched the product line” – commented Russell Kern, PhD, Co-Founder and CEO of Lifeline Skin Care, Inc.    ISCO’s wholly-owned subsidiary Lifeline Skin Care Inc. is a cosmeceutical business which develops, manufactures and markets anti-aging topical products using a proprietary extract derived from human parthenogenetic (non-embryonic) stem cells (hpSC) that has been shown to have a beneficial effect on skin cells. Currently Lifeline has developed and markets nineteen products. The products have been clinically tested by third party to ensure safety and efficacy. Lifeline Skin Care’s products are sold nationally and internationally through its own branded website, various e-tailers such as Amazon, as well as through dermatology and cosmetic surgery offices, medical, day and resort spas. The goal of Lifeline is to help individuals improve the look and feel of their skin by combining the latest discoveries in the fields of stem cell biology, nanotechnology and skin cream formulation technology to create the highest quality, scientifically tested and most effective skin care products.   ]]> https://biospectrumindia.com/news/57/12518/nih-researchers-prevent-blindness-in-animal-models-of-retinal-degeneration.html https://biospectrumindia.com/news/57/12518/nih-researchers-prevent-blindness-in-animal-models-of-retinal-degeneration.html Thu, 17 Jan 2019 11:40:00 +0530 Using a novel patient-specific stem cell-based therapy, researchers at the National Eye Institute (NEI) prevented blindness in animal models of geographic atrophy, the advanced "dry" form of age-related macular degeneration (AMD), which is a leading cause of vision loss among people age 65 and older. The protocols established by the animal study, published January 16 in Science Translational Medicine (STM), set the stage for a first-in-human clinical trial testing the therapy in people with geographic atrophy, for which there is currently no treatment. Kapil Bharti, Ph.D., a Stadtman Investigator and head of the NEI Unit on Ocular and Stem Cell Translational Research said, "If the clinical trial moves forward, it would be the first ever to test a stem cell-based therapy derived from induced pluripotent stem cells (iPSC) for treating a disease.” Bharti was the lead investigator for the animal-model study published in STM. The NEI is part of the National Institutes of Health. The therapy involves taking a patient’s blood cells and, in a lab, converting them into iPS cells, which can become any type of cell in the body. The iPS cells are programmed to become retinal pigment epithelial cells, the type of cell that dies early in the geographic atrophy stage of macular degeneration. RPE cells nurture photoreceptors, the light-sensing cells in the retina. In geographic atrophy, once RPE cells die, photoreceptors eventually also die, resulting in blindness. The therapy is an attempt to shore up the health of remaining photoreceptors by replacing dying RPE with iPSC-derived RPE. Before they are transplanted, the iPSC-derived RPE are grown in tiny sheets one cell thick, replicating their natural structure within the eye. This monolayer of iPSC-derived RPE is grown on a biodegradable scaffold designed to promote the integration of the cells within the retina. A specially designed surgical tool was built for the task of inserting the patch of cells between the RPE and the photoreceptors. In the STM paper, Bharti describes testing the approach in rat and pig models. Ten weeks after the human iPSC-derived RPE patches were implanted in the animals’ retinas, imaging studies confirmed that the lab-made cells had integrated within the animal retina. The investigators report the transplanted cells functioned properly. Immunostaining confirmed that the iPSC-derived RPE expressed the gene RPE65, suggesting the lab-made cells had reached a crucial stage of maturity necessary to maintain photoreceptor health. RPE65 is necessary for the regeneration of visual pigment within the photoreceptors and is an essential component for vision. Further tests showed that the transplanted RPE cells were pruning photoreceptors via phagocytosis, another RPE function that helps keep photoreceptors healthy. In addition, electrical responses recorded from photoreceptors rescued by RPE patches were normal; whereas photoreceptors treated with a control empty scaffold had died. The animal studies inform the processes for conducting a first-in-human clinical trial testing the treatment. Key to that workflow are good manufacturing practice (GMP) protocols, which were established to ensure that the iPSC-derived RPE were a safe and efficacious, clinical-grade product. GMP protocols are also crucial for making the therapy reproducible, a requirement for scaling up production and Food and Drug Administration approval. "Adhering to the protocols helps ensure that the transplanted cells function reliably, and that unintended consequences are minimized," Bharti said. A key concern with any stem cell therapy is its oncogenic potential: the ability for cells to multiply uncontrollably and form tumors. The researchers genetically analyzed the iPSC-derived RPE cells and found no genetic mutations linked to tumor growth. "The protocol also minimizes the chance of rejection by developing the iPSC-RPE with an individual’s autologous (own) blood cells," Bharti said. The planning of a Phase I clinical trial testing the safety of the iPSC-based therapy for geographic atrophy is underway and will be initiated after U.S. Food and Drug Administration approval. The preclinical study was funded by the NEI Intramural Research Program and by an NIH Common Fund Therapeutic Challenge Award     ]]> https://biospectrumindia.com/news/57/12517/regulatory-submission-of-tafamidis-by-pfizer-accepted-by-usfda.html https://biospectrumindia.com/news/57/12517/regulatory-submission-of-tafamidis-by-pfizer-accepted-by-usfda.html Thu, 17 Jan 2019 11:15:00 +0530 Pfizer has announced that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition. The tafamidis meglumine form (20 mg capsule) has been granted Priority Review. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The tafamidis free acid form (61 mg capsule) will be under Standard Review. This form is bioequivalent to the 80 mg tafamidis meglumine dose, which was administered as four 20 mg capsules in the pivotal trial; it was developed for patient convenience to enable a single capsule for daily administration. The target PDUFA action date for a decision by the FDA is in November 2019. Brenda Cooperstone MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development said, “The diagnosis of ATTR-CM is often delayed, primarily because disease awareness is low and patients often present with symptoms similar to more common causes of heart failure. In fact, we believe less than one percent of patients living with this disease are currently diagnosed. The FDA’s filing acceptance is an encouraging step toward our goal of further raising awareness and providing a treatment option for ATTR-CM patients who are in desperate need of an approved pharmacologic therapy. We look forward to working with the FDA to bring the first treatment for this deadly disease to patients.” The submission is based on findings from the pivotal Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study, which evaluated the efficacy, safety, and tolerability of tafamidis meglumine compared to placebo for the treatment of patients with ATTR-CM. ATTR-CM is a rare and progressive disease caused by destabilization of a transport protein called transthyretin, which is composed of four identical subunits (a tetramer). In ATTR-CM, heart failure occurs when unstable tetramers dissociate, resulting in misfolded proteins that aggregate into amyloid fibrils and deposit predominantly in the heart. Tafamidis is an oral, investigational product being evaluated as a potential treatment for ATTR-CM. Tafamidis is a small molecule that selectively binds at specific sites on the transthyretin tetramer to prevent destabilization of the transthyretin transport protein and formation of amyloid that causes ATTR-CM. It is not approved for any use in the United States.     ]]> https://biospectrumindia.com/news/57/12516/bridge-biotherapeutics-gets-fda-odd-for-bbt-877.html https://biospectrumindia.com/news/57/12516/bridge-biotherapeutics-gets-fda-odd-for-bbt-877.html Thu, 17 Jan 2019 11:00:00 +0530 South Korea based Bridge Biotherapeutics Inc., a clinical stage biotech company announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to BBT-877, a drug candidate under development for Idiopathic Pulmonary Fibrosis (IPF) treatment. BBT-877, a potent best-in-class Autotaxin (ATX) inhibitor deregulates ATX, the enzyme found to be engaging in inflammation and fibrosis by generating the lipid signaling molecule. The early-stage compound of BBT-877 had been originally discovered by LegoChem Biosciences and has been under the development process by the lead of Bridge Biotherapeutics since the company acquired the worldwide exclusive right for further developments in 2017. In August 2018, Bridge Biotherapeutics presented the results of the preclinical study on BBT-877 at the IPF Summit, attracting pulmonologists' interest on the efficacy and safety of the drug candidate. The data has demonstrated the best-in-class opportunity in comparison to a current development pipeline compound. Bridge Biotherapeutics will commence a Phase 1 study of BBT-877 in the U.S. next month to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug candidate in healthy volunteers. The planned study will be performed in two phases, a Single Ascending Dose (SAD) phase with 5 cohorts and a Multi Ascending Dose (MAD) phase with 3 cohorts. The estimated primary completion date is currently expected in late 2019. ]]> https://biospectrumindia.com/news/57/12512/roche-launches-upath-enterprise-software-for-digital-pathology-.html https://biospectrumindia.com/news/57/12512/roche-launches-upath-enterprise-software-for-digital-pathology-.html Wed, 16 Jan 2019 17:20:00 +0530 Roche has announced the launch of its innovative uPath enterprise software for digital pathology. Offering a new standard of personalization for pathology workflows, the uPath enterprise software improves on the previous version, known as VENTANA Virtuoso. uPath software enhances the user experience by drastically decreasing image rendering times, integrating automated image analysis and improving efficiency by enabling an improved workflow for sharing cases between pathologists.  To aid in the development of uPath software, Roche acquired the Leeds Virtual Microscope (LVM) technology from the University Of Leeds, U.K., and the Leeds Teaching Hospitals NHS Trust, U.K. With this technology, pathologists can diagnose a patient case more quickly by viewing all slides in a case in a single seamless view, as well as viewing all available patient information simultaneously.  Multiple slides appear on a canvas-like display, enabling pathologists to move seamlessly between hematoxylin and eosin (H&E), immunohistochemistry (IHC) and special stains in a single view, which is not possible with a standard microscope. The LVM technology operates on displays that range from laptops to ultra-high definition Powerwalls, to transform pathologists' ability to diagnose disease.  The uPath software offers pathologists, histotechnicians, and administrators a universal platform to manage all aspects of the pathology workflow through diagnosis. With the customization offered through uPath software's highly configurable interface and scalability, requesting second opinions and sharing cases take a fraction of the time that has traditionally been required, with no geographical limitations as compared to glass slides.   ]]> https://biospectrumindia.com/news/57/12507/invivo-therapeutics-appoints-richard-christopher-as-cfo.html https://biospectrumindia.com/news/57/12507/invivo-therapeutics-appoints-richard-christopher-as-cfo.html Wed, 16 Jan 2019 13:00:00 +0530 InVivo Therapeutics Holdings Corp, a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries (SCIs) has announced the appointment of Richard Christopher as its Chief Financial Officer and Treasurer, effective January 14, 2019. Prior to joining InVivo, Mr. Christopher was the Chief Financial Officer of iCAD, Inc., a Nasdaq-listed company with a focus on therapies and solutions for the early identification and treatment of cancer. Prior to iCAD, Inc., Mr. Christopher was Chief Financial Officer and Chief Operating Officer of Caliber Imaging & Diagnostics Inc., a medical technology company focused on cancer detection imaging solutions, with primary applications in dermatology. Prior to Caliber, Mr. Christopher held various positions of increasing responsibility at DUSA Pharmaceuticals, Inc., a Nasdaq-listed dermatology company focused on the treatment of precancerous skin lesions, where he ultimately served as Chief Financial Officer through its acquisition and integration into Sun Pharmaceuticals Industries Ltd. Mr. Christopher holds a Master of Science in Accounting from Suffolk University and a Bachelor of Science in Finance from Bentley University. Richard Toselli, M.D., InVivo’s President and Chief Executive Officer said, “Rich’s more than 25 years of invaluable financial experience, including at various publicly traded life science companies, make him a key asset in the navigation of InVivo’s goals. He has a proven track record in diverse financial management, financing transactions and strategic planning, and most significantly, Rich shares a passion for bringing treatments and therapies to patients in areas of unmet need. On behalf of the Board and Management, we welcome Rich to the InVivo team.” “It is an exciting time to join InVivo, especially during a transformative and pivotal stage in the company’s development. I look forward to working with the InVivo Board of Directors and Management Team to drive its mission of helping this underserved patient population and bringing value to shareholders,” stated Mr. Christopher. Inducement Grant under Nasdaq Listing Rule 5635(c)(4) In connection with the appointment of Mr. Christopher and in accordance with the terms of an employment agreement between Mr. Christopher and the company, the Board granted to Mr. Christopher a stock option to purchase up to 90,000 shares of InVivo’s common stock, vesting over three years, with one-third (1/3) of the shares underlying the stock option vesting on the first anniversary of Mr. Christopher’s start date with the company, one-third (1/3) vesting on the second anniversary of Mr. Christopher’s start date, and the remaining one-third (1/3) vesting on the third anniversary of Mr. Christopher’s start date, subject to Mr. Christopher’s continued employment by the company on each vesting date. The vesting of the option is subject to acceleration upon the termination of Mr. Christopher’s employment by the Company without cause or by Mr. Christopher for good reason within twelve months following a change of control. The option was granted effective January 14, 2019 as an inducement material to Mr. Christopher’s acceptance of employment with InVivo, in accordance with NASDAQ Listing Rule 5635(c)(4). The option has an exercise price per share equal to the closing price of a share of Common Stock on the Nasdaq Capital Market on January 14, 2019. ]]> https://biospectrumindia.com/news/57/12508/pharmacyte-biotech-announces-encapsulation-of-live-cells-for-clinical-trials-in-pancreatic-cancer.html https://biospectrumindia.com/news/57/12508/pharmacyte-biotech-announces-encapsulation-of-live-cells-for-clinical-trials-in-pancreatic-cancer.html Wed, 16 Jan 2019 13:00:00 +0530 PharmaCyte Biotech, a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box has announced PharmaCyte’s partner, Austrianova, has successfully encapsulated the live cells used in PharmaCyte’s therapy for its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC). The cells are now growing and dividing inside the Cell-in-a-Box capsules. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We are now in the process of monitoring the growth and division of the live cells as they spend more time in a ‘nutrient bath.’ This will allow the cells to continue to grow and divide and then completely fill the capsules. Once the capsules are completely full of live cells, they will be placed into syringes and frozen. Austrianova will then commence testing the capsules in the frozen syringes to finalize PharmaCyte’s clinical trial material.” Since its pre-production “engineering runs” in late 2018, Austrianova has further enhanced the manufacturing process and equipment. Once the testing of the syringes is successfully completed, the data and reports generated from this process will allow the completion of the Investigational New Drug application (IND) that must be submitted to the U.S. Food and Drug Administration (FDA) to apply for approval to begin a clinical trial in LAPC.   ]]> https://biospectrumindia.com/news/57/12506/merck-wins-life-science-industry-award.html https://biospectrumindia.com/news/57/12506/merck-wins-life-science-industry-award.html Wed, 16 Jan 2019 12:25:00 +0530 Merck has announced that it has been recognized by BioInformatics LLC with a 2018 Life Science Industry Award for best use of social media. Renee Connolly, head of Communications & Corporate Responsibility, Life Science, at Merck said, “This recognition reflects the opinions of our scientific customers and industry peers. Congratulations to our global Life Science Communications and Digital Marketing teams for creating and executing a top-notch social and digital strategy that clearly is working to engage our customers with content that educates and inspires them to solve their toughest problems.” Craig Overpeck, CEO of BioInformatics said, “Science has always depended on communicating important findings with others. Social media is changing the way we communicate with each other and Merck is exceling at using this always evolving medium.” Merck was selected for the award through a survey of more than 2,000 scientists from around the world who are engaged in all major life science facets of basic and pre-clinical research and pharmaceutical research and development.  The Life Science Industry Awards have been presented every other year since 2002. The scientists who voted are all members of The Science Advisory Board®, a global online community of scientific and medical professionals owned and managed by BioInformatics Inc. since 1997. ]]> https://biospectrumindia.com/news/57/12502/optima-life-science-at-ice-munich-2019.html https://biospectrumindia.com/news/57/12502/optima-life-science-at-ice-munich-2019.html Wed, 16 Jan 2019 11:10:00 +0530 Two leading players, one alliance: COMEDCO offers the perfect introduction to the production, assembly, and packaging of transdermal plasters (TDP) and oral dispersible films (ODF). To this end, Coatema and Optima Life Science have pooled their expertise in coating, converting, and service and have founded the COMEDCO alliance. Machine systems that cover all manufacturing and assembly processes can be seen live at the trade fair.  The COMEDCO alliance is a development and technology partner that supports pharmaceutical companies in efficiently bringing TDP and ODF products to market. COMEDCO has many years of experience and advice to offer. This is significant because TDP and ODF products require a certain amount of development work before they are ready for the market. This includes selecting film carrier materials and suitable application systems, for example. The field of application for the COMEDCO machine system ranges from laboratory level through to series production. The COMEDCO service network is also ready for use worldwide.   The booths of the alliance partners Coatema and Optima Life Science will showcase the combined process for an ODF product at ICE Munich. At Coatema, active ingredients will be applied to a carrier film and dried. The carrier film will then be cut and wound onto individual rolls. These rolls will then be processed further at the Optima Life Science booth where web processing will begin. Depending on the product, existing carrier films will be removed, new ones applied and films cut to size, separated, and packaged. This process will either be continuous or intermittent, depending on the performance requirements.  The Optima Life Science booth will provide information about some of the company’s other converting systems. These include high-speed systems with a capacity of up to 1,200 units/min. and ultra-flexible solutions. Packaging machines for four-side sealed pouches, such as the OPTIMA 4SS; complement Optima Life Science’s product range for converting products. ]]> https://biospectrumindia.com/news/57/12493/eu-research-consortium-selects-hd-wireless-to-treat-osteoarthritis.html https://biospectrumindia.com/news/57/12493/eu-research-consortium-selects-hd-wireless-to-treat-osteoarthritis.html Mon, 14 Jan 2019 17:45:00 +0530 H&D Wireless AB has been selected as an IoT partner in a European research consortium that aims to greatly reduce the disease of osteoarthritis. H&D Wireless will contribute with the Internet of things (IoT) solution based on the company's proprietary Griffin ® IoT Cloud platform. The agreement is worth SEK 5.5 million for H&D Wireless, half of which is paid at the start of the project in Q1 2019. The project is fully financed by the EU. Osteoarthritis is a population disease that affects approximately one in four Swedes over 45 years of age and in average 10% of the population. In total, the EU estimates that 40 million are affected, which is estimated to double within 10 years as a result of ageing populations and increased obesity. The market for osteoarthritis is expected to increase from 1.4 billion EUR 2016 to 3.1 billion EUR by GlobalData. The consortium that has chosen the H&D Wireless as partner has eight participating players under the leadership of one of Europe's most reputable universities in the field. In addition to customizing the Griffin-IoT platform for this application, H&D Wireless delivers radio communication for sensor reading and dosage, mobile app for both doctor and patient and a secure cloud platform for testing and prototyping. The project will be conducted within business unit LABS and is funded at 100% "That we have been selected as partners in an advanced research project for new healthcare shows how far ahead we are within IoT, but also that our solution is very versatile. Griffin is an IoT platform that is flexible and scalable and manages to handle a lot of data in a secure way and with this project we take a step forward to help digitize healthcare," says Pär Bergsten, CEO of H&D Wireless. The project will start in January 2019 and runs through December 2022. More detailed information regarding the project will be distributed in February 2019.   ]]> https://biospectrumindia.com/news/57/12492/amacathera-raises-3-25m-for-phase-i-trials.html https://biospectrumindia.com/news/57/12492/amacathera-raises-3-25m-for-phase-i-trials.html Mon, 14 Jan 2019 17:30:00 +0530 AmacaThera, Toronto-based company commercializing hydrogel-based drug delivery platforms, has already raised $3.25 million (CAD) in seed financing from Sprout BioVentures, Viva Biotech, and Grey Sky Venture Partners and welcomes additional investors. AmacaThera's founding technology was discovered at the University of Toronto by Dr. Molly Shoichet, a leading expert on polymer design and recent winner of the prestigious Killam Prize in Engineering. One of the key scientists involved in this research, Dr. Mike Cooke, will serve as the CEO of the new company. AmacaThera envisions their proprietary technology to allow sustained and controllable release of diverse therapeutic agents from injectable, biocompatible hydrogels. Their first product, AMT-143, targets superior post-operative pain control with the goal of eliminating opioid use following surgery. The funding raised in this round will be used to advance AmacaThera's drug delivery platform technology through Phase I clinical proof-of-concept. AmacaThera is excited about the initial close and is currently in discussions with additional investors and angels for a second closing, which is anticipated in the coming months. AmacaThera's financing round was co-led by Sprout BioVentures and Viva Biotech. Venture partner Mike Serrano-Wushared his excitement to work with AmacaThera: "We jumped at the chance to work with Molly and Mike and break open the field of hydrogel-encapsulated therapeutics. The unique inverse thermal gelling property of AMT-143 will lead to multiple opportunities for the AmacaThera platform to significantly improve patient care." Grey Sky Venture Partners have also joined the seed round. Todd McIntyre, partner at Grey Sky Venture Partners said: "Grey Sky is very pleased to work with the AmacaThera team to bring AMT-143 to market. There is a large unmet need for a non-opioid pain control following surgery, and AmacaThera's technology provides a unique solution to the sustained release of acute pain medications." AmacaThera was nurtured in Dr. Shoichet's laboratory with assistance from numerous accelerators, including the Creative Destruction Lab at the Rotman School of Management, University of Toronto Early-Stage Technology, the Ontario Biosciences Innovation Organization, MaRS Innovation, and the U of T Innovations & Partnership Office. ]]> https://biospectrumindia.com/news/57/12489/burst-biologics-joins-hands-with-adventist-health-system.html https://biospectrumindia.com/news/57/12489/burst-biologics-joins-hands-with-adventist-health-system.html Mon, 14 Jan 2019 12:10:00 +0530 US based Burst Biologics enters a new partnership with Adventist Health System, a faith-based health care organization centered on quality, safety, and patient satisfaction. This relationship will give distributors with Burst Biologics reliable access to a large number of surgical hospitals without the need to contract with each one at a local level. Adventist Health System has a heavy presence in Florida, Texas, and South Carolina. The organization includes a network with an estimated 41 owned hospital affiliates, 5 non-owned affiliates, and 481 owned ambulatory care centers. Burst Biologics plans to utilize the partnership to contract with new distributors throughout the network. "We're looking forward to our partnership with Adventist Health System. This represents a tremendous benefit to our surgical product distributors and surgeons, and at the same time helps more patients gain access to our cutting-edge neurosurgical technologies," said Christopher D. Jones, CEO of Burst Biologics. Burst Biologics is committed to expanding its distribution network and plans to establish additional relationships with group purchasing organizations (GPOs). Burst also supports its distributors with a range of marketing materials and peer-reviewed research studies. With new distribution opportunities, a prominent portfolio of products, and support from industry experts, Burst Biologics is a promising partner for a distributor business.   ]]> https://biospectrumindia.com/news/57/12488/univercells-brings-advanced-vaccine-manufacturing-platform.html https://biospectrumindia.com/news/57/12488/univercells-brings-advanced-vaccine-manufacturing-platform.html Mon, 14 Jan 2019 10:50:00 +0530 Univercells, a business-to-business provider focused on increasing the availability of affordable biologics to address global health challenges, announced the commercial launch of its proprietary NevoLine™ bioproduction system for vaccines. The system was initially developed as part of a $12M Grand Challenges grant awarded by the Bill &Melinda Gates Foundation to deliver affordable inactivated polio vaccine (sIPV). Leading the consortium, Univercells was responsible for the NevoLine system, Batavia Biosciences for the polio manufacturing process, and Merck for the purification membrane. After attaining its goals of delivering a very low Cost of Goods for a sIPV below $0.30 per trivalent dose, the consortium has now received a $4M grant extension to scale-up the manufacturing system and process in preparation for clinical and commercial application. The first NevoLine system will be installed in BataviaBiosciences’ polio dedicated Biosafety level 3 Facility in Leiden, the Netherlands. Based on novel process architecture, Univercells designed the automated NevoLine bioproduction system that facilitates safer, faster and closed bioprocessing in a much smaller footprint. Through intensification and chaining of unit steps into a continuous process, users achieve high yields with less time and money invested. The sIPV production process using the NevoLine system is capable of producing trivalent sIPV at less than $0.30/dose, representing a five-fold reduction compared to current manufacturing technologies. “This challenging two-year project aimed at delivering a new manufacturing system to drastically decrease cost, footprint and time to market for vaccine manufacturers, and we are pleased to have met these goals,” Hugues Bultot, CEO and co-founder of Univercells said. “The NevoLine system is self-contained into a 6m² series of isolators. A facility designed with four NevoLine units would deliver up to 50 million sIPV doses per year for an estimated capital cost of $20M. These breakthrough achievements further strengthen our dedication to innovating flexible, scalable and accessible vaccines and biotherapeutics manufacturing solutions.” Univercells remains more than ever dedicated to developing turnkey solutions for a series of vaccines and biotherapeutics, to be delivered at an affordable price.   ]]> https://biospectrumindia.com/news/57/12484/with-hiv-undetectable-equals-untransmittable-nih.html https://biospectrumindia.com/news/57/12484/with-hiv-undetectable-equals-untransmittable-nih.html Fri, 11 Jan 2019 17:10:00 +0530 In recent years, an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound, say officials from the National Institutes of Health. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others. Writing in JAMA, officials from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) review the scientific evidence underlying U=U and discuss the implications of widespread acceptance of the message. In the new commentary, Anthony S. Fauci, Director, NIAID and colleagues summarize results from large clinical trials and cohort studies validating U=U. The landmark NIH-funded HPTN 052 clinical trial showed that no linked HIV transmissions occurred among HIV serodifferent heterosexual couples when the partner living with HIV had a durably suppressed viral load. Subsequently, the PARTNER and Opposites Attract studies confirmed these findings and extended them to male-male couples. Validation of the HIV treatment as prevention strategy and acceptance of the U=U concept as scientifically sound have numerous behavioral, social and legal implications, the NIAID officials note. U=U can help control the HIV pandemic by preventing HIV transmission, and it can reduce the stigma that many people with HIV face. The success of U=U as an HIV prevention method depends on achieving and maintaining an undetectable viral load by taking ART daily as prescribed. Numerous factors, including lack of access to quality health care, can make ART adherence difficult. To enhance the overall success of U=U, the authors emphasize the importance of implementing programs that help patients remain in care and address the barriers to daily therapy.   ]]> https://biospectrumindia.com/news/57/12482/tela-bio-to-market-large-size-ovitex-rbs-.html https://biospectrumindia.com/news/57/12482/tela-bio-to-market-large-size-ovitex-rbs-.html Fri, 11 Jan 2019 16:50:00 +0530 TELA Bio®, Inc. and Aroa Biosurgery, the joint developers of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market large sizes of OviTex RBS. The OviTex Permanent product line is now commercially available in United States from TELA Bio in sizes up to 25x40 cm (1,000 cm2), which is a 150% surface area increase over currently available devices. "We are pleased to launch larger OviTex RBSs as we continue our mission to provide valuable solutions for a full range of hernia repairs and abdominal wall reconstructions, including the most complex cases," said Antony Koblish, president and CEO of TELA Bio. "Traditionally, large abdominal wall hernias can present a technical challenge for some surgeons. Our devices are now positioned to ensure that patients who are most at need have access to the most advanced technology to assist with their hernia repair."  A distinct class of surgical mesh, OviTex RBSs is the only devices available that reinforce biologic materials with polymer fibers in a unique embroidered construction that allows for functional tissue remodeling, as well as improved strength and handling. "The ability to cover a larger surface area could have many potential benefits for patients and surgeons in terms of securing the most complex hernia repairs properly and reducing the risk of recurrence," said Brian Ward, CEO of Aroa Biosurgery. "As a joint developer and the manufacturer of the Ovitex technology, it is encouraging to see growing demand and the continued expansion of our product portfolio. We provide a robust and comprehensive suite of accessible and affordable options that address the current shortcomings in surgical hernia repair solutions." ]]> https://biospectrumindia.com/news/57/12477/generex-biotechnology-acquires-pantheon-medical-manufacturers.html https://biospectrumindia.com/news/57/12477/generex-biotechnology-acquires-pantheon-medical-manufacturers.html Fri, 11 Jan 2019 12:50:00 +0530 Generex Biotechnology Corporation has announced that the company has entered into a letter of intent (LOI) to acquire Pantheon Medical – Foot & Ankle, a manufacturer of specialty orthopedic surgery products and tools. Under the terms of the deal, Generex will acquire all of the assets of Pantheon Medical including business operations, accounts receivable and inventory, contracts, and an FDA letter related to balanced plating system, on a debt free basis, for One Million Four Hundred Thousand Dollars ($1,400,000) worth of Generex (GNBT) stock, plus additional cash and stock consideration upon achieving certain sales and profit goals. Pantheon Medical – Foot & Ankle is a multi-million dollar company that began operations in 2014 with a physician friendly, “all-in-one,” integrated kit that includes plates, screws, and tools required for orthopedic surgeons and podiatrists conducting foot and ankle surgeries. Over the next three years, the Company will be developing and submitting several new product lines to the FDA which will include cannulated surgical screws and surgical staples, as well as a proprietary Hammertoe System. Travis H. Bird, CEO of Pantheon Medical, commented on the deal, “Partnering with Generex will enable us to expedite Pantheon’s ability to build a manufacturing company with proprietary product lines that offer convenience and cost effectiveness to physicians. We are already seeing significant uptake in the marketplace with our 'one stop shop' approach to orthopedic surgery, and the new product lines will expand our market reach.” “The acquisition of Pantheon expands the commercial product portfolio of Generex into the surgical field, adding revenues and profits with their current product line and significant upside opportunities for new FDA-approved product introductions over the next several years,” stated Joe Moscato, CEO of Generex. “Our MSO partners, many of whom are orthopedic surgeons and podiatrists, will immediately benefit from Pantheon’s Foot & Ankle surgery kit. The acquisition demonstrates Generex’s commitment to providing end-to-end solutions that enhance physician’s practice and improve outcomes for patients. We are in the process of completing the due diligence on the Pantheon acquisition, with plans to close the transaction in the coming weeks.” ]]> https://biospectrumindia.com/news/57/12476/insilico-elevian-to-discover-anti-aging-drugs.html https://biospectrumindia.com/news/57/12476/insilico-elevian-to-discover-anti-aging-drugs.html Fri, 11 Jan 2019 12:45:00 +0530 On the final day of the largest biotechnology and pharmaceutical partnering week at the Juvenescence Longevity Showcase two leading longevity biotechnology companies, Elevian and Insilico Medicine announced a research and development partnership to develop oral medications targeting the GDF11 pathway and associated targets. Elevian is an emerging biotech company developing medicines that restore youthful regenerative capacity, with the potential to treat and prevent the diseases of aging. Its first target is the GDF11 pathway. Insilico Medicine is an Artificial Intelligence (AI) company developing an end-to-end pipeline for automated target identification, small molecule generation, prediction of clinical trials outcomes and aging research. It is a leader in the fields of deep learning for drug discovery, biomarker development, and anti-aging interventions. The collaboration will take advantage of Insilico's generative adversarial networks (GANs) and reinforcement learning (RL) AI technologies to discover novel small molecules that target the GDF11 pathway, which has been demonstrated to play an important role in aging and age-related disease. "We are excited to partner with Insilico Medicine," said Mark Allen, MD, CEO of Elevian. "Not only will we leverage Insilico's advanced AI technology to accelerate drug development, but we also share a common mission: to eliminate age-related disease and promote healthy longevity." "We are looking forward to working with Elevian. GDF11 is an exciting pathway and Elevian's scientists are world leaders in this field coming from Harvard and other prestigious institutions. Their management has a solid vision and is committed to doing great research and turn it into the life-saving products in record time," said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine In order to succeed in this endeavor, the companies will utilize state of the art techniques in AI-enabled drug discovery. Based on biological and structural target data from Elevian, Insilico will identify small molecules that produce the intended biological actions utilizing deep learning technology. Starting out with existing libraries of compounds and molecular building blocks, based upon iterations of virtual and biological screenings, the scientists will narrow down the list of potential candidates. Subsequently, based on the results of previous iterations, Insilico will also provide a selection of novel de novo compound candidates, which will be synthesized by WuXi AppTec, a leading global pharmaceutical contract research and manufacturing organization. Using this approach, Insilico and WuXi have recently discovered novel small molecules for challenging targets. "My fund, BOLD Capital Partners, is a proud investor in both Elevian and Insilico. This partnership perfectly illustrates the convergence of biotechnology and AI, which together are shaping the future health of humanity," said Peter Diamandis, MD, Founder and Chairman of the XPRIZE Foundation and Partner at BOLD Capital Partners. "We are in the middle of a biotechnology revolution," said Jim Mellon, Chairman of Juvenescence Limited and investor in Insilico Medicine. "Within most people's lifetimes, the developments in the longevity biotechnology sector will allow us to live increasingly long and healthy lives, and provide one of the best investment opportunities ever." Insilico Medicine is an artificial intelligence company with R&D offices and resources in the US, Belgium, Russia, the UK, Taiwan, and Korea, sourced through hackathons and competitions. The company and its scientists are dedicated to extending human productive longevity and transforming every step of the drug discovery and drug development process through excellence in biomarker discovery, drug development, digital medicine, and aging research while Elevian is an emerging biotech company developing medicines that restore youthful regenerative capacity, with the potential to treat and prevent the diseases of aging. Elevian's scientific founders, working at the Harvard Department of Stem Cell and Regenerative Biology, discovered that replenishing the circulating factor GDF11 can regenerate the heart, brain, muscle and other tissues. Elevian has acquired exclusive, worldwide rights to Harvard's patent portfolio concerning circulating factors that regulate aging. ]]> https://biospectrumindia.com/news/57/12469/epilepsy-smartband-gets-fda-approval.html https://biospectrumindia.com/news/57/12469/epilepsy-smartband-gets-fda-approval.html Thu, 10 Jan 2019 17:25:00 +0530 Embrace by Empatica has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in children. Embrace is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. It is the first non-EEG based physiology signal seizure monitoring system to be cleared by the FDA for use in a pediatric population, highlighting the challenges and complicated processes that come with this type of testing for children. The clearance for children is not only positive development for families, but also for doctors, providing them with reliable technology that can assist in patient treatment and care. ]]> https://biospectrumindia.com/news/57/12465/clinigen-extends-european-clinical-trial-agreement-with-accord.html https://biospectrumindia.com/news/57/12465/clinigen-extends-european-clinical-trial-agreement-with-accord.html Thu, 10 Jan 2019 14:50:00 +0530 Clinigen Group plc, the global pharmaceutical and services company, announces that its Clinical Trial Service (‘CTS’) business has extended its exclusive European clinical trial supply agreement with Accord Healthcare. Clinigen is also offering pharma companies an ‘on demand’ service to Accord’s products, a first for the industry. Clinigen and Accord have been partnered since 2012 to deliver oncology Injectable Products, including carboplatin, cisplatin and paclitaxel, into clinical trials. The extended agreement now covers Accord’s European Solid Dose Products, including those in the central nervous system, autoimmune, diabetes and anti-viral therapy areas. The CTS team is the sole point of contact for all clinical trial supply enquiries, ensuring an effective and secure supply chain in the distribution of Accord’s European product portfolio to pharmaceutical manufacturers, contract research organisations (CROs), clinical trial contract packagers and other specialist service providers. The drugs are supplied for use as a comparator, co-therapy, rescue and adjunctive drugs in clinical trials. The ‘on demand’ supply service will be available for any Clinigen client running clinical trials. They will be offered instant access to key products from Accord's generic oncology Injectable Product portfolio. Products will be held in large batch sizes on consignment ready for instant dispatch to new and existing clinical trials. This is the first type of dedicated service providing instant access to products solely for clinical trials in the industry and directly tackles the constant timeline and flexibility challenges experienced when running clinical trials. Shaun Chilton, Group Chief Executive Officer of Clinigen, said: “This extended agreement builds on the strong partnership we have with Accord in providing access to its medicines for use in clinical trials. “The launch of our ‘on demand’ offering demonstrates the ability we have across the Group and the specialisms we have in the supply and distribution of medicines. These capabilities enable us to provide the best possible service to those running clinical trials.” Phill Semmens, Senior Vice President Commercial, Accord Healthcare, EMENA, said: “We are delighted that the strong collaboration Accord and Clinigen have built over the past six years continues to expand with the agreement to include solid dose oral products. “The scope of this partnership is a first for the industry, allowing us to ensure that our products are available as comparators in a variety of vital clinical trials, helping to further medical knowledge and the identification of new treatment options to improve patient care.”   ]]> https://biospectrumindia.com/news/57/12462/neosensory-announces-10m-series-a-financing-round.html https://biospectrumindia.com/news/57/12462/neosensory-announces-10m-series-a-financing-round.html Thu, 10 Jan 2019 10:20:00 +0530 Neosensory, a company that pioneers devices to send information to the brain non-invasively has announced that it has received $10 million of Series A financing.  Excel Venture Management and DigiTx Partners co-led the round, with participation from existing investors True Ventures, Tao Capital, and several angel investors. With total funding of $16 million since launch, Neosensory plans to release their first product -- a wristband called the Buzz -- later this year.  Excel's Juan Enriquez and DigiTx's David Kim will join Neosensory's Board of Directors. Co-founded by neuroscientists David Eagleman and Scott Novich, Neosensory develops consumer-friendly, non-invasive technology that was first introduced in a TED talk entitled Can we create new senses for humans? Their patented devices transform data streams into patterns of touch. One application relays sounds normally captured by the ear into vibrations on the skin, overcoming the cost and limitations of hearing aids and cochlear implants. Versions of Neosensory's technology were recently featured on National Geographic and in Season 2 of HBO's Westworld. "Neosensory's technology has the potential to extend our natural biological limitations," said Juan Enriquez, Managing Director at Excel Venture Management. "In the context of hearing loss, we believe the market is going to incorporate wearable devices such as Neosensory's wristband." Dr. David Kim, Managing Director of DigiTx Partners, added, "Dr. Eagleman and the Neosensory team are pushing the envelope in the field of sensory substitution. We are excited to support the transformation of the company from cutting-edge R&D to a strong commercial company serving the needs of millions of people." "We're just scratching the surface of how powerful sensory substitution can be when combined with well-designed wearables," said Eagleman, Neosensory's Chief Executive Officer. "The support and expertise of our investors will help us execute our vision rapidly and worldwide." ]]> https://biospectrumindia.com/news/57/12456/medidata-appoints-sastry-chilukuri-as-executive-vp-of-digital-and-ai-solutions.html https://biospectrumindia.com/news/57/12456/medidata-appoints-sastry-chilukuri-as-executive-vp-of-digital-and-ai-solutions.html Wed, 09 Jan 2019 15:25:00 +0530 Medidata has announced the addition of executive vice president of Digital and AI Solutions, Sastry Chilukuri to its senior leadership team. As the most used platform in life sciences, and with its comprehensive clinical data assets, Medidata applies artificial intelligence and advanced analytics to help clients deliver innovative therapies. Chilukuri will be responsible for accelerating the development, go-to-market, and delivery of these capabilities. Chilukuri brings 19 years of experience in healthcare technology. He most recently was a partner at McKinsey & Company, where he worked for 12 years advising bio-pharma, medical device, technology, public sector and regulatory clients around the world. Prior to that he worked for GE Healthcare in software engineering, product development and operations. “Sastry brings tremendous experience and vision to our team, and will work closely with our clients to deliver breakthrough therapies in the age of precision medicine,” said Tarek Sherif, chairman and chief executive officer, Medidata. “The breadth and depth of his thought leadership on the impact of digital and AI across the life sciences value chain is unmatched.” “I am excited to join the company leading the digital revolution in life sciences. I look forward to helping our clients accelerate their transformation, and maximize the value from AI and analytics,” said Chilukuri. Chilukuri holds a Master of Business Administration from the Kellogg School of Management, Northwestern University; a Master of Science from The Ohio State University and a Bachelor of Technology (B. Tech) from the Indian Institute of Technology (BHU), Varanasi, India. ]]> https://biospectrumindia.com/news/57/12450/forbius-announces-the-first-patient-dosed-in-a-phase-1-trial-of-avid200.html https://biospectrumindia.com/news/57/12450/forbius-announces-the-first-patient-dosed-in-a-phase-1-trial-of-avid200.html Wed, 09 Jan 2019 11:20:00 +0530 Forbius, a clinical-stage company developing biologics for the treatment of cancer and fibrosis, announced that the first patient was dosed in a Phase 1 clinical trial with AVID200. The trial will evaluate safety, pharmacokinetics, pharmacodynamics, and antitumor effects of escalating doses of AVID200 in patients with solid tumors. “Our goal is to significantly expand the number of cancer patients who benefit from checkpoint blockade and other immunotherapies. AVID200 was designed to have the potency and isoform selectivity to effectively counteract the highly immunosuppressive effects of TGF-beta in the tumor microenvironment and reverse resistance to immunotherapy,” commented Dr. Maureen O’Connor-McCourt, CSO of Forbius. AVID200 selectively neutralizes TGF-beta 1 & 3 with best-in-class pM potency, thus neutralizing the principal immunosuppressive TGF-beta isoforms. AVID200’s optimal selectivity was also designed to circumvent cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors. TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018). AVID200’s immuno-oncology mode of action focuses on the reversal of both immunosuppression and fibrosis in the tumor stroma. In syngeneic mouse tumor models, AVID200 treatment led to T-cell activation, increased immune cell infiltration, and increased efficacy of immune checkpoint agents. Forbius is a clinical-stage protein engineering company that designs, develops, and commercializes biotherapeutics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways. Our lead program targeting the TGF-beta pathway is AVID200. AVID200 is a rationally designed and highly potent TGF-beta 1 & 3 inhibitor. This TGF-beta isoform selectivity was chosen in order to achieve an optimal therapeutic index. The AVID200 program has been cleared by the FDA for two Phase 1b clinical trials in fibrotic indications, as well as a Phase 1 clinical trial in solid tumors. Additional clinical trials in fibrotic indications are planned for 2019. Forbius' lead program targeting the EGFR pathway is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate. This program has completed a Phase 1 clinical trial and has commenced Phase 2a clinical trials in EGFR overexpressing solid tumors. ]]> https://biospectrumindia.com/news/57/12445/generex-biotechnology-acquires-regentys-corporation.html https://biospectrumindia.com/news/57/12445/generex-biotechnology-acquires-regentys-corporation.html Tue, 08 Jan 2019 16:30:00 +0530 Generex Biotechnology Corporation has announced that the company has completed the acquisition of 51% of Regentys Corporation, a regenerative medicine company focused on developing novel treatments for patients with gastrointestinal (GI) disorders. The terms of the deal include the previously reported upfront payment of $400,000, plus $14.6 million to be paid according to a milestone-based schedule. Details of the transaction can be found in the Generex 8K filing with the SEC. The Regentys Extracellular Matrix Hydrogel is a first-in-class, non-pharmacologic, non-surgical treatment option for patients suffering from Ulcerative Colitis. ECMH is a proprietary, patented UC treatment that protects damaged tissue from waste flow and promotes tissue regeneration and healing rather than suppressing the immune system as other treatments currently do. The product has been developed with polymeric characteristics that transform ECMH from a liquid to gel form upon adherence to the mucosal lining of the diseased colon, providing a “Bio-Scaffold Bandage” to the affected area. The ECMH Bio-scaffold facilitates healing and functional repair of the colon lining, first by covering the ulcer to limit the inflammatory response, then by providing a framework to mobilize the body’s tissue repair mechanisms. Regentys has received guidance from FDA that the treatment can be approved through the FDA Office of Device Evaluation as a 510K de novo application, and the company will initiate the clinical studies necessary to obtain that approval by Q4 2019. Ulcerative Colitis, a disease that affects approximately 750,000 patients in the United States and 1.9 million patients worldwide, is a chronic, inflammatory disease that causes sores or ulcers in the lining of the large intestine (the colon). There are currently four biologics approved by FDA, including the top-selling antibody medicines Humira (adalimumab), Simponi (golimumab), Remicade (infliximab) and Entyvio (vedolizumab), all of which target the pro-inflammatory protein, TNF-α (Tumor Necrosis Factor Alpha). Even with the introduction of expensive biologics, more than half of all patients with ulcerative colitis [UC] do not achieve long-term remission. Many, because of disease progression, require colectomy surgery (Research and consulting firm GlobalData reports the global ulcerative colitis surgery space is set to rise from $5.64 billion in 2015 to over $6.58 billion by 2025).Future indications for the company’s product platform include Crohn’s Disease, an inflammatory bowel disease, as well as rectal mucositis, a condition arising from cancer radiation treatments, conditions that affect millions of patients. Joe Moscato, CEO of Generex commented on the acquisition, “The completion of this Regentys acquisition demonstrates our commitment to build a world-class regenerative medicine business by acquiring great companies with cutting-edge, patented technologies and exceptional management teams. Our direct investment in the clinical development of Regentys ECMH will provide long-term value to Generex investors as we achieve milestones on the path to commercialization in the billion dollar markets for ulcerative colitis and other inflammatory bowel diseases.” Rick Bulman, CEO of Regentys continued, “Our partnership with Generex provides Regentys with a number of advantages, and we are happy to join the NuGenerex family of subsidiary companies. The merger agreement offers not only the financing to advance our clinical development efforts, but the Generex corporate philosophy also promotes continuity by supporting our scientific, medical, and leadership team with resources, relationships and industry knowledge that will accelerate the commercial introduction of Regentys ECMH.” ]]> https://biospectrumindia.com/news/57/12439/tae-life-sciences-adds-seasoned-coo-.html https://biospectrumindia.com/news/57/12439/tae-life-sciences-adds-seasoned-coo-.html Tue, 08 Jan 2019 14:30:00 +0530 TAE Life Sciences, an oncology company pioneering a new treatment platform focused on addressing limitations in current cancer therapy has announced the appointment of Robert Hill as Chief Operating Officer. With expertise in technology development and clinical adoption in the field of Radiation Oncology, and a wealth of experience in commercializing medical technology, Hill's appointment furthers TAE Life Sciences' ability to scale its efforts to bring a compelling new technology for treating cancer patients around the world. "Rob's strength in the innovation and commercialization of medical technology will be a great advantage as we develop the market for our innovative approach to cancer treatment," said Bruce Bauer, CEO of TAE Life Sciences. "We are excited about the knowledge and energy he brings to our team." As Chief Operating Officer of TAE Life Sciences, Hill will use his extensive knowledge in the development of radiation oncology systems to amplify and accelerate the commercialization of a full clinical system for TAE Life Sciences' proprietary solution for Boron Neutron Capture Therapy (BNCT). TAE Life Sciences is leveraging unique accelerator-based neutron beam technology developed by TAE Technologies, Inc., the world's largest and most advanced private fusion energy company. TAE Life Sciences has exclusively licensed intellectual property from the fusion energy leader to bring promising treatment potential for head and neck, glioblastoma multiforme (GBM) and other cancers that are difficult or impossible to treat with traditional methods. Its development of low-energy neutron beams will be practical for installation in typical hospital settings. Hill joins from Accuray Incorporated, where he held a variety of executive level roles including Senior Vice President of R&D, Senior Vice President of Corporate Development, and Chief Product Officer. Over his tenure he led efforts in product development, innovation, mergers, acquisitions, partnerships, and intellectual property development. Hill was previously Vice President of Engineering at North American Scientific and held various research and development leadership roles at NOMOS Corporation, where he was an early innovator in the field of radiation therapy focusing on Intensity Modulated Radiation Therapy (IMRT), Image Guided Radiation Therapy (IGRT), tomotherapy, and Monte Carlo dose calculation. "I joined TAE Life Sciences because I believe its unique approach to cancer treatment will have a significant impact on the lives of individuals battling the most lethal cancers," said Hill. "I am honored to be joining a talented team working hard to give hope to patients and families who need new therapeutic solutions." ]]> https://biospectrumindia.com/news/57/12438/mynd-analytics-emmaus-life-sciences-announce-merger-and-spin-off-transaction.html https://biospectrumindia.com/news/57/12438/mynd-analytics-emmaus-life-sciences-announce-merger-and-spin-off-transaction.html Tue, 08 Jan 2019 14:20:00 +0530 MYnd Analytics, a predictive analytics company aimed at improving the delivery of mental health services through the combination of telemedicine and data analytics has announced that it has entered into a definitive stock-for-stock merger agreement with Emmaus Life Sciences, a leader in sickle cell disease treatment.  Pursuant to the merger agreement, Emmaus will become a wholly owned subsidiary of MYnd Analytics in exchange for MYnd Analytics’ issuance of common stock to Emmaus shareholders and other equity holders.  The exchange ratio will result in Emmaus security holders owning approximately 94% of the MYnd Analytics’ common stock on a fully diluted basis after the merger. The company expects to meet all applicable requirements for initial listing upon completion of the merger and, therefore, expects to continue to be listed on The Nasdaq Capital Market. The completion of the merger is subject to customary closing conditions, including receipt of approval from the shareholders of each company and Nasdaq approval. A.G.P./Alliance Global Partners is acting as a financial advisor to Emmaus in connection with this transaction. In connection with the transaction, MYnd Analytics intends to transfer all of its assets (including cash and its equity interest in Arcadian Telepsychiatry Services, LLC) and liabilities into its wholly-owned subsidiary, MYnd Analytics California, and to distribute the shares of MYnd Analytics California to MYnd Analytics’ shareholders as of a record date prior to the merger, which will be set prior to the merger effective time.  MYnd Analytics expects that the MYnd Analytics California subsidiary, following the spinoff, will commence trading as an independent company at a date to be announced. Under the leadership of its new CEO, Patrick Herguth, the MYnd Analytics California spin off intends to continue operating, integrating and growing its technology-enabled telepsychiatry and teletherapy businesses in order to provide enhanced access to behavioral health services, improve patient outcomes and help lower the costs associated with behavioral health issues. MYnd-Arcadian customers include major health plans, health systems, and community-based organizations. The parties do not expect there to be any disruption to the existing business or customers. Emmaus is a commercial stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, including those in the rare and orphan disease categories. Its lead prescription product, Endari, demonstrated positive clinical results in a completed Phase 3 clinical trial for sickle cell disease and received FDA approval in July 2017.  Yutaka Niihara, MD, MPH, CEO and Chairman of Emmaus, stated, “The merger with MYnd Analytics, and concurrent Nasdaq listing, will be a major milestone for the company, and builds on our recent progress, including the FDA approval of Endari, the publication of our Phase 3 results in The New England Journal of Medicine, Medicaid coverage, the addition of major pharmaceutical distributors, and a presentation at the American Society of Hematology (ASH) 2018 Annual Meeting.  Just as important as these accomplishments was the launch and market acceptance of Endari – the first medication (FDA approved) for sickle cell disease in almost 20 years. Endari addresses a $3 billion global market.  In addition to the treatment of sickle cell disease, we believe our platform technology has the potential to address other clinical indications such as diverticulosis.  Through this merger, we believe we can maximize value for shareholders and we are grateful to MYnd for this opportunity.” Robin Smith, Chairman of MYnd Analytics, commented, “We are excited to announce this definitive merger agreement with Emmaus, whereby the MYnd shareholders will own equity in Emmaus, and upon our expected spin-off, will continue to own 100% of the predictive analytics and telemedicine business, which we expect to begin operations as a new standalone public company.  We are quite encouraged by the outlook for the business and look forward to further integrating and accelerating the growth of our offerings under Patrick Herguth’s leadership.  We plan to provide further details on the new operational direction, branding, and growth strategy in the coming weeks and months.”    ]]> https://biospectrumindia.com/news/57/12436/holmusk-gets-residency-of-johnson-johnson-innovation-.html https://biospectrumindia.com/news/57/12436/holmusk-gets-residency-of-johnson-johnson-innovation-.html Tue, 08 Jan 2019 13:05:00 +0530 Holmusk became a resident company of Johnson & Johnson Innovation, JLABS (JLABS @ NYC), a premier life science incubator program. With its residency, Holmusk is excited to interact with other resident companies and looks forward to expanding its US footprint and deepening its relationship with partners and stakeholders within the pharma/life science hub of the US east coast. Holmusk's team at JLABS @ NYC will focus on building the world's largest real-world evidence (RWE) platform for behavioral health. This platform will incorporate the latest evidence from clinical trials and real-world data, brining insights to the point of care. Additionally, the platform will serve as a stepping stone to drive innovation among pharma companies to serve patients with unmet needs and allow quicker access to new drugs. Holmusk is proud to be a part of JLABS @ NYC, which provides an ideal stage to interact with the life science ecosystem. "Being part of JLABS is like being part of a world class network of entrepreneurs and thought leaders - we are excited to join the conversation," said Holmusk's Founder and CEO Nawal Roy. JLABS is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing health and wellness solutions to patients around the world. As a leader in innovation, JLABS helps entrepreneurs in pharmaceutical, medical device, consumer, and health tech bring healthcare solutions to patients and consumers.   ]]> https://biospectrumindia.com/news/57/12432/adagene-collaborates-with-nih-to-discover-novel-car-t.html https://biospectrumindia.com/news/57/12432/adagene-collaborates-with-nih-to-discover-novel-car-t.html Mon, 07 Jan 2019 18:30:00 +0530 Adagene, Inc., an innovative antibody discovery and engineering company, announced collaboration with Dr. Richard Childs, Chief of the Laboratory of Transplantation Immunotherapy at the National, Heart, Lung, and Blood Institute, part of the National Institutes of Health, to discover antibodies targeting a novel antigen expressed on the surface of tumor cells.  Dr. Childs's laboratory will convert these antibodies into a CAR-T, as they work to develop a non-major histocompatibility complex (MHC) restricted the immunotherapy approach to targeting an endogenous retrovirus with tumor-restricted expression. "We are very pleased to be collaborating with such an expert in the field of clinical cancer biology," said Peter Luo, CEO of Adagene. "At Adagene, our goal is to translate innovation and scientific research into life-saving medications. It is incredibly rewarding to have the opportunity to leverage our proprietary Dynamic Precision Library to develop antibodies against a disease with such highly unmet medical need." "Adagene has gone to great lengths to develop our leading antigen display technology," said Felix Du, Head of Technology Development at Adagene. "With our unique combination of antigen presentation technologies and having a very large, diverse and fully human antibody discovery library we were able to find the first antibodies targeting non-MHC restricted surface-expressed antigens against this class of challenging cancer targets."   ]]> https://biospectrumindia.com/news/57/12421/mit-lfe-with-informa-pharma-intelligence-launches-project-alpha.html https://biospectrumindia.com/news/57/12421/mit-lfe-with-informa-pharma-intelligence-launches-project-alpha.html Mon, 07 Jan 2019 10:50:00 +0530 The MIT Laboratory for Financial Engineering (LFE) and Informa Pharma Intelligence announced Project ALPHA (Analytics for Life-sciences Professionals and Healthcare Advocates), an initiative to provide timely and more accurate estimates of the risks and rewards of clinical trials to the entire biopharma ecosystem. The goal of Project ALPHA is to accelerate biomedical innovation by helping investors, regulators, payers, and biopharmaceutical companies better assess the opportunities of biomedical R&D, allowing all stakeholders to manage their investments more efficiently. "More accurate risk metrics will eventually lead to fewer big failures, faster approval times, cost savings to the entire healthcare system and more investment capital for developing breakthrough therapies," says Andrew W. Lo, Charles E. and Susan T. Harris Professor at the MIT Sloan School of Management and director of the LFE, "all of which means more, and better, therapies to patients sooner." The first set of analytics to be included as part of Project ALPHA are clinical success rate metrics, based on algorithms developed by MIT researchers.  Jointly developed by the LFE and Informa, these metrics will be made freely available. The article, "Estimation of Clinical Trial Success Rates and Related Parameters," leverages Informa's Citeline drug and clinical trials data sets, and assesses clinical success from pre-clinical to launch, across nine therapeutic groups, providing the most comprehensive view on clinical success rates ever published. Project ALPHA will distribute risk analytics via an LFE-hosted website, http://projectalpha.mit.edu, which will provide regularly updated aggregate clinical success rates and durations, as well as disaggregated estimates across trial features such as disease type, clinical phase, time, and lead indication status.   "We're excited to be collaborating with Andrew Loand the MIT Laboratory for Financial Engineering to leverage our data and biopharma expertise with their research capabilities in risk management and financial analytics," said Mark Gordon, president of product & innovation in Informa's business intelligence division. To encourage additional analyses using the metrics and the data behind them, Informa will make its commercial data sets available to academic researchers through an academic licensing program and a research proposal review process.   ]]> https://biospectrumindia.com/news/57/12423/md-anderson-cancer-center-4d-pharma-collaborate-to-evaluate-live-biotherapeutics-in-solid-tumors.html https://biospectrumindia.com/news/57/12423/md-anderson-cancer-center-4d-pharma-collaborate-to-evaluate-live-biotherapeutics-in-solid-tumors.html Mon, 07 Jan 2019 10:40:00 +0530 The University of Texas MD Anderson Cancer Center and 4D pharma has announced a strategic collaboration to evaluate 4D’s live biotherapeutic oncology pipeline across a range of cancer settings. The alliance brings together MD Anderson's translational medicine and clinical research capabilities with 4D’s expertise in the discovery and development of live biotherapeutics. The collaboration will initially assess the 4D’s lead oncology candidate, MRx0518, as a potential treatment for solid tumors. The first clinical trial, an open label Phase I study of MRx0518 in combination with Keytruda and conducted in collaboration with Merck & Co., Inc., Kenilworth, N.J., has been initiated and is due to open shortly. The study will enroll up to 132 patients with metastatic cancer across multiple histologies including non-small cell lung cancer, renal cell carcinoma, bladder cancer and melanoma, who have not responded to prior anti-PD-1 therapy. Subsequent studies are also being planned under the collaboration, including using MRx0518 in combination with stereotactic body radiotherapy (SBRT) for the treatment of pancreatic cancer. "This alliance, with one of the leading oncology research centers in the world, will provide a strong and long-term foundation for the development of 4D’s live biotherapeutics in cancer,” said Duncan Peyton, 4D’s chief executive officer. “The current study, which is one of the first live biotherapeutic programs to reach the clinic in the immuno-oncology space, represents an important step forward in the development of MRx0518 and 4D’s broader oncology franchise. We look forward to continuing to work with our partners at MD Anderson to progress this study and help bring this therapy to patients.”   ]]> https://biospectrumindia.com/news/57/12419/parkinsons-drug-apomorphine-set-to-enter-eastern-india.html https://biospectrumindia.com/news/57/12419/parkinsons-drug-apomorphine-set-to-enter-eastern-india.html Fri, 04 Jan 2019 18:00:00 +0530 Medica Superspecialty Hospital in association with Kings College, London and UK-based Britannia Pharmaceuticals, has launched a revolutionary treatment that will change the way Parkinson’s disease is being treated in eastern India. ‘Apomorphine Pen & Pump’ is the treatment that will radically change the life of a Parkinson’s patient. Dr Sunandan Basu, Consultant Neurosurgeon, Medica Superspecialty Hospital said, “Apomorphine is a highly selective Dopamine receptor emulator, which promotes the release of Dopamine in the brain from the nerve cells.” While explaining further, Prof Kalyan Bhattacharya, Consultant Parkinson’s Disease and Movement Disorders Specialist, Medica Superspecialty Hospital said, “DBS was not a choice for all ages & stages of Parkinson’s disease.  Hence there were limitations and there was a need for therapeutic options in moderately advanced Parkinson’s disease.” Dr. Laxmi Narayan Tripathy, Senior Vice Chairman; Director and Senior Consultant, Neuro & Spine Surgeon, Medica Superspecialty Hospital said, “Apomorphine is a wonderful option in treating Parkinson’s disease especially in advanced disease.” Dr. Alok Roy, Chairman, Medica Group of Hospitals said, “We are privileged to have Kings College, London and Britannia Pharmaceuticals, with us for the launch of Apomorphine PEN & PUMP. We wish to transfer the benefits of this medicines to our patients in eastern part of India.” Dr. Vinod Metta, Consultant Interventional Neurologist, Kings College Hospital, London, & Medical advisor to Britannia Pharmaceuticals India, told that, “Apomorphine pens work dramatically on patients within a couple of minutes and are very similar to usage to that of Insulin Pens.” Prof. Kallol Ray Chaudhuri, Director of National Parkinson’s Foundation Center, King’s College, United Kingdom, feels that “It was indeed a long overdue for Indian patients and these therapies will add significantly to the benefit of patient care and reducing caregiver burden.” Constantino Savinnidis, International lead & Business Director, Britannia Pharmaceuticals, UK, concluded: “Thanks are due in no small amount to the management team of Medica for inviting us today and it is a great privilege for us to collaborate with Medica Hospitals along with academic partner Kings College Hospital, London. It is a great honour for us to deliver Apomorphine pump and pen through Medica Hospitals for deserving patients in the entire eastern region.” The increase in life expectancy has led to a new set of medical disorders which are called as “Aging related Degenerative Diseases”. Among these disorders Alzheimer's and Parkinson’s disease are important. Parkinson’s disease is characterized by slowness, stiffness and tremors, the treatment for which is either oral medical treatment or expensive surgical options like Deep brain stimulation (DBS), a neurosurgical procedure involving the implantation of a medical device sometimes referred to as a brain pacemaker.   ]]> https://biospectrumindia.com/news/57/12412/jj-locus-bioscience-collaborate-to-develop-crispr-cas3-bacteriophage-therapeutics.html https://biospectrumindia.com/news/57/12412/jj-locus-bioscience-collaborate-to-develop-crispr-cas3-bacteriophage-therapeutics.html Fri, 04 Jan 2019 12:15:00 +0530 Locus Biosciences Inc., a biotechnology company developing precision antibacterial therapies, announced today that it has entered into an exclusive collaboration and license agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop, manufacture and commercialize CRISPR-Cas3-enhanced bacteriophage ("crPhage™") products targeting two key bacterial pathogens for the potential treatment of infections of the respiratory tract and other organ systems. Johnson & Johnson Innovation LLC facilitated the transaction. Under the terms of the agreement, Locus will receive $20 million in initial payments, and is eligible to receive up to a total of $798 million in potential future development and commercial milestone payments, and royalties on any product sales. Locus is the world leader in CRISPR-engineered phage therapeutics, uniquely leveraging the powerful Type I CRISPR-Cas3 system to specifically degrade the DNA of target bacteria cells, quickly destroying them. This patented DNA-shredding technology precisely and selectively removes unwanted bacteria from the human body while leaving the many other species of good bacteria unaffected (see video description at youtu.be/q88b6bgCZ6c). If proven safe and effective in clinical trials, these products could provide a turning point in the global battle against antibiotic resistant infections and other microbiome dysbiosis-related conditions. "Our collaboration with Janssen on the development of products to treat deadly infections and potentially other microbiome dysbiosis associated conditions reflects the importance of the crPhage platform and its potential to revolutionize the treatment of disease and extend human life," said Paul Garofolo, CEO of Locus Biosciences. "Our platform is uniquely positioned to selectively eradicate pathogenic bacteria of choice while preserving an otherwise healthy microbiome in patients, and this collaboration with Janssen will enable us to further develop products on the platform to help patients in need around the world." ]]> https://biospectrumindia.com/news/57/12411/takeda-announces-multiple-cell-therapy-collaborations-.html https://biospectrumindia.com/news/57/12411/takeda-announces-multiple-cell-therapy-collaborations-.html Fri, 04 Jan 2019 12:00:00 +0530 Takeda Pharmaceutical  has announced new research collaborations in immuno-oncology (I-O), an area of key strategic focus for the company. Through these collaborations, Takeda seeks to accelerate the discovery of next-generation cancer immunotherapies, including novel cell therapy approaches that may provide important opportunities for addressing the needs of patients with hard-to-treat cancers. “We are excited by the recent momentum in oncology R&D, especially around the curative potential of cell-based therapies through our growing partnership network,” said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. “We look forward to continuing to collaborate with some of the leading pioneers in the field to fuel research and discovery with the aim of targeting novel mechanisms of action in the cancer-immunity cycle to help us fulfill our aspiration to cure cancer.” Takeda will collaborate with Memorial Sloan Kettering Cancer Center (MSK) to discover and develop novel chimeric antigen receptor T-cell (CAR-T) products for the treatment of multiple myeloma, acute myeloid leukemia and additional solid tumor indications. The broad, multi-faceted collaboration will be co-led by CAR-T therapy pioneer Michel Sadelain, M.D., Ph.D., Director of the Center for Cell Engineering at MSK and scientific founder of Juno Therapeutics. Takeda exercised an option under its existing research collaboration with Noile-Immune Biotech Inc. (Noile), which originated in September 2017. Due to the success of the collaboration, Takeda exclusively licensed NIB-102 and NIB-103 for the treatment of various solid tumor indications, and will co-develop these CAR-T cell therapies with Noile utilizing the company’s proprietary “Prime” (proliferation inducing and migration enhancing) CAR-T platform. The company plans to gain regulatory approval for human testing of NIB-102 by the end of this year. Takeda’s exercised option for an exclusive oncology-targeted Humabody® license from Crescendo Biologics will allow Takeda to additionally evaluate these Humabody® VHs for the development of novel CAR-T therapeutics. The development will leverage the unique properties of single-domain tumor-targeted binders as an alternative to conventional single-chain variable fragment (scFv)-based approaches. Takeda’s diversification into next-generation cell therapy builds directly on its three strategic pillars in oncology: hematologic malignancies, lung cancer and immuno-oncology. Through collaboration with external partners and its newly established translational cell therapy engine, Takeda plans to deliver a rich pipeline of early-stage assets in the coming years. Takeda has established a new internal translational cell therapy engine with bioengineering, chemistry, manufacturing and control (CMC), clinical and translational expertise. The group aims to rapidly translate innovative and differentiated cell therapy concepts in to the clinic under the leadership of Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies. “There’s an incredible opportunity to combine promising external innovation with the power of a fit-for-purpose translational cell therapy engine to accelerate the development of truly novel cell therapies,” said Stefan Wildt. “We have assembled a very talented team with deep and relevant cell therapy development experience who will help us achieve this goal.” ]]> https://biospectrumindia.com/news/57/12410/jazz-pharma-codiak-biosciences-collaborates-for-hard-to-treat-cancers.html https://biospectrumindia.com/news/57/12410/jazz-pharma-codiak-biosciences-collaborates-for-hard-to-treat-cancers.html Fri, 04 Jan 2019 10:55:00 +0530 Jazz Pharmaceuticals plc and Codiak BioSciences, Inc. today announced that the companies have entered into a strategic collaboration agreement focused on the research, development and commercialization of exosome therapeutics to treat cancer. Codiak granted Jazz an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize therapeutic candidates directed at five targets to be developed using Codiak's engEx™ precision engineering platform for exosome therapeutics. The targets focus on oncogenes that have been well validated in hematological malignancies and solid tumors but have been undruggable with current modalities, including NRAS and STAT3. Under the terms of the agreement, Codiak is responsible for the execution of pre-clinical and early clinical development of therapeutic candidates directed at all five targets through Phase 1/2 proof of concept studies. Following the conclusion of the applicable Phase 1/2 study, Jazz will be responsible for future development, potential regulatory submissions and commercialization for each product.  Codiak has the option to participate in co-commercialization and cost/profit-sharing in the U.S. and Canada on up to two products. As part of the agreement, Jazz will pay Codiak an upfront payment of $56 million. Codiak is eligible to receive up to $20 million in preclinical development milestone payments across all five programs.  Codiak is also eligible to receive milestone payments totaling up to $200 million per target based on Investigational New Drug application acceptance, clinical and regulatory milestones, including approvals in the U.S., European Union and Japan, and sales milestones. Codiak is also eligible to receive tiered royalties on net sales of each approved product, with percentages ranging from mid-single digits in the lowest tier to high teens in the highest tier. Exosomes are naturally occurring, nanometer-sized vesicles that are released and received by nearly all cells in the body.  They serve as an efficient system of intercellular communication.  In the tumor microenvironment, exosomes have been shown to carry molecular messages between tumor and immune cells. Codiak has co-opted this process and, through its engEx™ platform, engineers potent drug molecules into the exosome to create bespoke therapeutic candidates which have shown potent preclinical antitumor activity.  With the engEx™ platform, Codiak has the ability to incorporate a range of therapeutic drug classes—including small molecules, proteins, peptides, cytokines and nucleic acids—onto the surface or in the lumen of its therapeutic exosomes.  engEx™ also enables precise modifications of the engineered exosomes to optimize potency and to alter or enhance tropism for directed delivery to desired cell types.  These flexible design features allow Codiak to create an optimized exosome therapeutic for the drug target and desired site of action. ]]> https://biospectrumindia.com/news/57/12401/ampel-biosolutions-brings-new-hope-for-patients-suffering-from-gout.html https://biospectrumindia.com/news/57/12401/ampel-biosolutions-brings-new-hope-for-patients-suffering-from-gout.html Thu, 03 Jan 2019 11:30:00 +0530 AMPEL Bio Solutions, a leading technology research firm based in Charlottesville, VA today announced the publication of new data in Arthritis Research and Therapy, co-authored by AMPEL Co-Founder Dr. Peter Lipsky, which demonstrates the effectiveness of Pegloticase (Horizon Pharma) in the resolution of urate depositions or tophi in people suffering from Gout. Gout is an ancient disease and the most common form of inflammatory arthritis in the US, with more than 8 million affected people. Gout is caused by the deposition of urate crystals into tissues. It is a genetically-based metabolic and inflammatory condition that can be worsened by diet, kidney disease and certain medications. Gout can cause inflammatory arthritis and is associated with many other diseases, including cardiovascular and kidney disease. The cardinal feature of Gout is the deposition of urate crystals into aggregates known as tophi, which can cause painful joint swelling. Numerous treatments are available to decrease urate levels, but most are very slow acting and take years to resolve urate build up and cause visible clinical benefits. In contrast, Pegloticase has been proven to rapidly degrade urate levels, giving hope for a new thorough and proactive treatment for Gout patients. It is an innovative treatment that acts as a replacement therapy for the uricase enzyme that humans lost through evolution. Acting as the uricase enzyme, Pegloticase rapidly and persistently decreases urate levels inside the body and simultaneously resolves visible tophi and joint swelling that result from those urate deposits. Dr. Brian Mandell, a steering committee member of Gout Study Group, said, "Other than for acute attacks, it is no surprise that physicians have a no rush approach to the treatment of Gout. This has been reinforced over the years by the absence of any effective therapy to rapidly dissolve these tophi. Yet some patients are profoundly incapacitated by the presence of tophi not associated with flare-ups, that cannot be seen by the naked eye, and that prevent the use of their hands, or drain through chronically infected sinus tracts. These patients, and those suffering from flare-ups can benefit enormously from rapid tophi resolution. In the current reanalysis of data from the initial trials of Pegloticase, there is proof of concept that by maintaining an extremely low serum urate level over the course of only months, tophi can be very rapidly and in many patients completely dissolved. By using its unique data mining capability, AMPEL was able to show that the administration of Pegloticase caused a complete resolution of all visible tophi in a mean of 9 months. This is dramatically faster than with other available urate-lowering drugs that work by other mechanisms and may take years to resolve tophi. Since tophi are associated with local bone damage, loss of function when affecting the hand and also a decreased quality of life, rapid resolution of tophi provides new hope for the many people suffering from gout." Dr. Peter Lipsky, Co-founder of AMPEL, said, "the results published today demonstrate and validate AMPEL's novel approach to data mining as a tool in understanding the effectiveness of a drug. In this case AMPEL's deep mining of data from the randomized controlled trials of Pegloticase, a U.S. approved treatment for chronic Gout, demonstrated that this treatment is proven to lower urate levels dramatically faster than the standard of care, given patients relief from both visible and lurking urate deposits."   ]]> https://biospectrumindia.com/news/57/12398/nih-developed-test-detects-protein-associated-with-alzheimers-and-cte.html https://biospectrumindia.com/news/57/12398/nih-developed-test-detects-protein-associated-with-alzheimers-and-cte.html Wed, 02 Jan 2019 16:35:00 +0530 An ultrasensitive test has been developed that detects a corrupted protein associated with Alzheimer’s disease and chronic traumatic encephalopathy (CTE), a condition found in athletes, military veterans, and others with a history of repetitive brain trauma. This advance could lead to early diagnosis of these conditions and open new research into how they originate, according to National Institutes of Health scientists and their colleagues. In their new study, published in Acta Neuropathologica, the researchers explain how they adapted a diagnostic test originally developed for prion diseases to detect abnormal clusters of tau protein. Like other proteins involved in neurological diseases, tau protein clusters can seed themselves and contribute substantially to the disease processes of Alzheimer’s and CTE. The study involved brain samples from 16 Alzheimer’s patients, two boxers with CTE, and numerous control cases involving other brain diseases. The test is extremely sensitive. For example, if a pinhead-sized sample of brain tissue from an Alzheimer’s patient were pulverized and diluted into a thousand gallons of liquid, the test still could detect tau seeds in a pinhead-sized volume of that dilution. The test is called AD RT-QuIC: Alzheimer’s disease real-time quaking induced conversion. Scientists at NIH’s National Institute of Allergy and Infectious Diseases developed RT-QuIC about a decade ago to detect Creutzfeldt-Jakob (CJD) and other prion diseases. Since then, they have repeatedly improved and adapted it to detect other neurological diseases, such as Parkinson’s and dementia with Lewy bodies. The test, which already is used in clinical settings to diagnose sporadic CJD, is noted for its rapid and accurate results. Their latest findings could be a major advance for Alzheimer’s diagnostics because the study points to tau seeds as potential biological “markers” for Alzheimer’s disease in the brain. Scientists are testing therapies to slow the accumulation of tau clusters and the progression of neurological disease. In these efforts, they need more sensitive and accurate tests to better select clinical trial participants and assess whether new therapeutic strategies work as hoped. Alzheimer’s affects about 5.7 million people in the United States alone at an estimated annual cost of $232 billion, according to the Alzheimer’s Association. ]]> https://biospectrumindia.com/news/57/12396/ai-predicts-cancer-patients-symptoms.html https://biospectrumindia.com/news/57/12396/ai-predicts-cancer-patients-symptoms.html Wed, 02 Jan 2019 14:35:00 +0530 Doctors could get a head start treating cancer thanks to new AI developed at the University of Surrey that is able to predict symptoms and their severity throughout the course of a patient’s treatment.  In what is believed to be the first study of its kind,researchers from the Centre for Vision, Speech and Signal Processing (CVSSP) at the University of Surrey detail how they created two machine learning models that are both able to accurately predict the severity of three common symptoms faced by cancer patients – depression, anxiety and sleep disturbance. All three symptoms are associated with severe reduction in cancer patients’ quality of life.  Researchers analysed existing data of the symptoms experienced by cancer patients during the course of computed tomography x-ray treatment. The team used different time periods during this data to test whether the machine learning algorithms are able to accurately predict when and if symptoms surfaced.  The results found that the actual reported symptoms were very close to those predicted by the machine learning methods.  This work has been a collaboration between the University of Surrey and the University of California in San Francisco (UCSF). The UCSF research in this joint collaboration is led by Professor Christine Miaskowski.  Payam Barnaghi, Professor of Machine Intelligence at the University of Surrey, said: “These exciting results show that there is an opportunity for machine learning techniques to make a real difference in the lives of people living with cancer. They can help clinicians identify high-risk patients, help and support their symptom experience and pre-emptively plan a way to manage those symptoms and improve quality of life.”   Nikos Papachristou, who worked on designing the machine learning algorithms for this project, said: “I am very excited to see how machine learning and AI can be used to create solutions that have a positive impact on the quality of life and well-being of patients.” ]]> https://biospectrumindia.com/news/57/12388/ocular-therapeutix-announces-completion-of-debt-refinancing.html https://biospectrumindia.com/news/57/12388/ocular-therapeutix-announces-completion-of-debt-refinancing.html Tue, 01 Jan 2019 15:50:00 +0530 Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has closed a refinancing of its existing debt by entering into a new $25.0 million term loan with MidCap Financial and Silicon Valley Bank. The 5-year term loan facility allows for an expansion of the Company’s prior $18 million credit facility to $25.0 million, all of which was drawn at closing. The proceeds from the loan were used to repay the approximately $12.3 million remaining balance under the prior facility and provide an additional $12.0 million of new funds, net of expenses and fees. The restated and amended agreement extends the term of the credit facility until December 21, 2023 and permits the Company to make interest-only payments until January 1, 2021. “We are pleased with the expansion and extension of our credit facility which not only strengthens our balance sheet with net new funds of $12.0 million but also improves near term cash flow through interest-only payments for the next 24 months, collectively extending the Company’s cash runway, based on current plans and forecasted expenses, into the third quarter of 2019,” said Donald Notman, Chief Financial Officer. ]]> https://biospectrumindia.com/news/57/12387/innovus-pharma-announces-3-17-million-private-placement.html https://biospectrumindia.com/news/57/12387/innovus-pharma-announces-3-17-million-private-placement.html Tue, 01 Jan 2019 15:35:00 +0530 Innovus Pharmaceuticals, an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, today announced that it has entered into a definitive agreement with a healthcare-dedicated institutional investor for the sale of 45,306,347 shares of common stock (or common stock equivalents), series A warrants to purchase up to 45,306,347 shares of common stock and series B warrants to purchase up to 45,306,347 shares of common stock in a private placement at a price of $0.07 per share and associated warrants for gross proceeds of approximately $3.17 million. The transaction is anticipated to close on or about January 3, 2019, subject to customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The series A warrants are exercisable immediately with a term of 18 months following the effectuation of a reverse stock split by the Company and an exercise price of $0.07 and the series B warrants are exercisable immediately with a term of 5½ years following the effectuation of a reverse stock split by the Company and an exercise price of $0.08 per share. The net proceeds from the offering are anticipated to be approximately $2.765 million. The Company intends to use the net proceeds for working capital and general corporate purposes. The Company has agreed to file a resale registration statement for the shares of common stock and the shares of common stock underlying the warrants issued in the offering within 30 days pursuant to a registration rights agreement. The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. ]]> https://biospectrumindia.com/news/57/12386/sarepta-therapeutics-grants-equity-awards.html https://biospectrumindia.com/news/57/12386/sarepta-therapeutics-grants-equity-awards.html Tue, 01 Jan 2019 15:30:00 +0530 Sarepta Therapeutics, a leader in precision genetic medicine for rare diseases, granted equity awards on December 31, 2018, that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to twenty-three individuals hired by Sarepta in December 2018. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The employees received, in the aggregate, options to purchase 40,950 shares of Sarepta's common stock, and in the aggregate, 13,500 restricted stock units (“RSUs”). The options have an exercise price of $109.13 per share, which is equal to the closing price of Sarepta's common stock on December 31, 2018 (the “Grant Date”). One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of the Grant Date and thereafter 1/48th of the shares underlying each employee’s option will vest monthly, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting dates. One-fourth of the RSUs will vest yearly on each anniversary of the Grant Date, such that the RSUs granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting date. About Sarepta Therapeutics Sarepta is at the forefront of precision genetic medicine, having built an impressive and competitive position in Duchenne muscular dystrophy (DMD) and more recently in Limb-girdle muscular dystrophy (LGMD), Charcot-Marie-Tooth (CMT) and CNS-related disorders, totaling over 20 therapies in various stages of development. The Company’s programs span across several therapeutic modalities, including RNA, gene therapy and gene editing. Sarepta is poised to be the most meaningful precision genetic medicine company in the world and make a profound difference in the lives of patients suffering from rare neuromuscular diseases and other rare diseases. ]]> https://biospectrumindia.com/news/57/12382/myriad-genetics-announces-result-on-development-of-the-adjusted-vectra-score.html https://biospectrumindia.com/news/57/12382/myriad-genetics-announces-result-on-development-of-the-adjusted-vectra-score.html Mon, 31 Dec 2018 15:45:00 +0530 Myriad Genetics, a global leader in personalized medicine has announced the results from a large commercial cohort and several clinical studies on development of the adjusted Vectra score that were published in the journal Rheumatology. The key findings are that the adjusted Vectra score significantly outperformed conventional measures of disease activity in predicting radiographic progression (new joint damage) in patients with rheumatoid arthritis (RA). “This study showed that the adjusted Vectra score was the strongest individual predictor of new radiographic joint damage over one year in patients with RA,” said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. “In these analyses, the adjusted Vectra score was three times more predictive of radiographic joint damage than DAS28-CRP and five times more predictive than DAS28* and was significantly better than other disease activity measures commonly used by clinicians today.” This large study included a cohort of more than 300,000 commercially tested patients with RA and 1,411 RA patients from a clinical trial/registry cohort. An adjusted Vectra DA score was developed to account for three factors known to impact inflammation: age, gender, and degree of adiposity proxied either by serum leptin level or body mass index (BMI). In addition, the adjusted Vectra scores were evaluated for their ability to predict radiographic progression (RP) and compared with other disease activity measures, including DAS28, DAS28-CRP, SDAI, and CDAI. The results showed that the leptin-adjusted Vectra score was 5.5 times more predictive of radiographic progression, the BMI-adjusted Vectra score was 4.6 times more predictive, and the original Vectra score was four times more predictive when compared to DAS28. Importantly, Vectra also outperformed the other common measures evaluated in this study. “The Vectra test allows one to identify patients with a high degree of inflammatory activity, which can lead to join damage progression,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Myriad Autoimmune. “This study showed that the adjusted Vectra score significantly improved ability to predict radiographic progression and thus, it provides valuable information to clinicians that they can incorporate into the individual patient treatment plans”. ]]> https://biospectrumindia.com/news/57/12368/nmpa-approves-innovents-tyvyt-to-market-in-china.html https://biospectrumindia.com/news/57/12368/nmpa-approves-innovents-tyvyt-to-market-in-china.html Fri, 28 Dec 2018 15:45:00 +0530  Innovent Biologics, and Eli Lilly and Company ("Lilly") jointly announce today that the co-developed Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL). The approval of Tyvyt® (sintilimab injection) highlights the emergence of China in the field of Immuno-Oncology. Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent, said, "Tyvyt® (sintilimab injection) is an example of our success with the National Mega Innovation Program, and its approval highlights our achievements in immunotherapy and contributions to China's efforts to deliver innovative medicines. Innovent has shown its ability to develop large molecule drug and this approval is also a validation and the recognition of Innovent's R&D capabilities. I have confidence that Tyvyt® (sintilimab injection), with its global quality and cost-effectiveness, will bring better treatment to cancer patients in China." Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, said, "The efficacy and safety profile of Tyvyt® (sintilimab injection) is well proven in the ORIENT-1 trial. The drug provides a new immuno-oncology treatment option for patients with relapsed/refractory classical Hodgkin's lymphoma (r/r cHL). Lilly will continue to collaborate with outstanding local pharmaceutical companies to bring more innovative medicines to patients and help in demonstrating local R&D capabilities in global oncology community." Currently, Tyvyt® (sintilimab injection) is being studied in more than twenty clinical trials, including studies in first line non-squamous non-small cell lung cancer (NSCLC), first line squamous NSCLC, second line squamous NSCLC, EGFR mutant NSCLC after EGFR TKI treatment failure, first line gastric cancer, first line liver cancer, first line esophageal cancer, and second line esophageal cancer.   ]]> https://biospectrumindia.com/news/57/12371/edwards-sapien-3-ultra-transcatheter-heart-valve-gets-fda-nod.html https://biospectrumindia.com/news/57/12371/edwards-sapien-3-ultra-transcatheter-heart-valve-gets-fda-nod.html Fri, 28 Dec 2018 15:45:00 +0530 Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery. "The advanced SAPIEN 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of SAPIEN 3 to further advance and improve patient care," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "We look forward to introducing the SAPIEN 3 Ultra system to U.S. patients." The SAPIEN 3 Ultra system builds on Edwards' decades of engineering and experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves.   ]]> https://biospectrumindia.com/news/57/12335/merck-pfizer-brings-update-on-javelin-ovarian-100-trial-of-avelumab-.html https://biospectrumindia.com/news/57/12335/merck-pfizer-brings-update-on-javelin-ovarian-100-trial-of-avelumab-.html Mon, 24 Dec 2018 10:55:00 +0530 Merck and Pfizer Inc. announced that data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of avelumab did not support the study's initial hypothesis, and therefore the alliance made the decision to terminate the trial in alignment with the independent Data Monitoring Committee. The Merck-Pfizer alliance was the first to test an immunotherapy in this indication, given the significant unmet need in the treatment of ovarian cancer. Four out of five women with ovarian cancer are diagnosed at advanced stages. Most women with advanced ovarian cancer ultimately die within five years due to refractory, resistant or recurrent disease. Topline results showed that the study, which is evaluating avelumab in combination with and/or following platinum-based chemotherapy in previously untreated patients with ovarian cancer, would not achieve superiority in the pre-specified primary endpoint of progression-free survival. While detailed analyses of the data are ongoing, no new safety signals were observed, and the safety profile for avelumab in this trial appears consistent with that observed in the overall JAVELIN clinical development program. The alliance has notified health authorities and trial investigators of the interim findings and the decision to discontinue the trial. Detailed results will be shared with the scientific community. The JAVELIN Ovarian PARP 100 study and earlier phase studies investigating avelumab in various combinations are ongoing. ]]> https://biospectrumindia.com/news/57/12330/ec-approves-sanofis-dengue-vaccine.html https://biospectrumindia.com/news/57/12330/ec-approves-sanofis-dengue-vaccine.html Fri, 21 Dec 2018 14:50:00 +0530 The European Commission (EC) has granted marketing authorization for Dengvaxia, Sanofi’s dengue vaccine. The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve use of the dengue vaccine in European endemic areas. Dengvaxia will be available in Europe to prevent dengue disease in individuals 9-45 years of age with a documented prior dengue infection and who are living in endemic areas. “In some of the European overseas territories where dengue recurs regularly, people who have had a dengue infection previously are at risk of being infected with the virus again,” explains Dr. Su-Peing Ng, Global Medical Head at Sanofi Pasteur, the vaccine unit of Sanofi. “As the second infection with dengue tends to be more severe than the first, it is important to be able to offer these people a vaccine that could help protect them against subsequent dengue infections.” According to the WHO, the global incidence of dengue has grown rapidly in recent decades and it now threatens half of the world’s population living in 128 countries. Dengue is endemic in several European territories located in tropical and sub-tropical climates prone to outbreaks of the disease particularly during the rainy season. Earlier this year, dengue outbreaks in La Reunion resulted in more than 6,000 people being made ill by the virus, which is spread by a day- biting mosquito that often lives in people’s homes. During past outbreaks of dengue in Guadeloupe and Martinique, more than 40,000 people reportedly contracted the fever. The dengue vaccine has been evaluated in studies involving more than 40,000 people from 15 countries with up to six years of follow-up from large-scale clinical safety and efficacy investigations. Dengvaxia is approved for use in several endemic countries in Latin America and Asia where reducing the human and economic burden of dengue is critical. The vaccine is currently under priority review by the US Food and Drug Administration (FDA) as it would be considered a significant medical advance in the prevention of dengue, which is considered an unmet medical need by the FDA. ]]> https://biospectrumindia.com/news/57/12327/merck-assigns-car-t-rights-to-intrexon.html https://biospectrumindia.com/news/57/12327/merck-assigns-car-t-rights-to-intrexon.html Fri, 21 Dec 2018 10:40:00 +0530 Merck, a leading science and technology company has announced that it has evolved its agreement with Intrexon Corporation for the development of Chimeric Antigen Receptor T-cell (CAR-T) therapies, genetically engineered T-cells with synthetic receptors that recognize a specific antigen expressed on tumor cells. The agreement with Intrexon and its wholly-owned subsidiary, Precigen, Inc., enables Merck to continue to implement its focused R&D strategy, while maintaining an investment in the future potential of next-generation CAR-T development. Under the terms of the agreement, Merck will assign its exclusive CAR-T development rights to Intrexon. Merck will receive shares of Intrexon common stock valued at $150 million in exchange for assigning Intrexon its CAR-T rights. "Merck is excited to maintain its interest in the potential of CAR-T technology, which may offer significant future benefits to patients fighting cancer," said Belen Garijo, Member of the Executive Board and CEO Healthcare, Merck. "The agreement is also illustrative of our efforts to enhance our focus on accelerating the delivery of our innovative clinical pipeline to patients." Merck first entered into a collaboration and license agreement with Intrexon in 2015 to develop and commercialize CAR-T cancer therapies utilizing Intrexon's proprietary RheoSwitch Therapeutic System and the Sleeping Beauty non-viral gene integration technology. The combination of these platforms enables regulation of gene expression and delivery with a non-viral approach and preclinical data indicate the potential to improve therapeutic safety and facilitate shortened manufacturing to improve time-to-treatment. As of December 31, 2017, these rights were considered intangible assets not yet available for use with a carrying amount of € 104 million. "Merck's leading immuno-oncology research and commitment to developing innovative medicines made them an ideal partner for us in advancing targeted and controllable CAR-T therapies," said Helen Sabzevari, PhD, President of Precigen. "We look forward to continued development of these promising treatments with the goal of delivering more cost-effective, powerful and precise therapies to patients in need." In addition to receiving $150 million of Intrexon common stock, this agreement also includes a further $25 million investment in Intrexon. In return, Merck will receive a $25 million convertible note, providing the option to receive either Precigen or Intrexon stock. The closing of the transactions contemplated by the agreement is subject to customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. ]]> https://biospectrumindia.com/news/57/12322/gilead-sciences-scholar-rock-unite-to-develop-remedies-for-fibrotic-diseases.html https://biospectrumindia.com/news/57/12322/gilead-sciences-scholar-rock-unite-to-develop-remedies-for-fibrotic-diseases.html Thu, 20 Dec 2018 17:25:00 +0530 Gilead Sciences, Inc. and Scholar Rock Holding Corporation announced that the companies have entered into a strategic collaboration to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases. Under the collaboration, Gilead has exclusive options to license worldwide rights to product candidates that emerge from three Scholar Rock TGFβ programs: inhibitors that target activation of latent TGFβ1 with high affinity and specificity, inhibitors that selectively target activation of latent TGFβ1 localized to the extracellular matrix, and a third TGFβ discovery program.  Scholar Rock is responsible for antibody discovery and preclinical research through product candidate nomination, after which, upon exercising the option for a program, Gilead will be responsible for the program’s preclinical and clinical development and commercialization. Scholar Rock retains exclusive worldwide rights to discover, develop, and commercialize certain TGFβ inhibitors for oncology and cancer immunotherapy. In connection with the collaboration agreement, Scholar Rock will receive $80 million in upfront payments, comprised of $50 million cash and $30 million purchase of Scholar Rock Holding Corporation common stock. In addition, Scholar Rock will receive a one-time milestone payment of $25 million upon the successful completion of specific preclinical studies and be eligible to receive up to an additional $1,425 million in potential payments aggregated across all three programs based on the successful achievement of certain research, development, regulatory and commercialization milestones. Scholar Rock would also receive high single-digit to low double-digit tiered royalties on sales of potential future products originating from the collaboration. Fibrosis is a debilitating pathological feature of many diseases that scars tissues and vital organs and is a major cause of morbidity and mortality. TGFβ-driven signaling is thought to be a central regulator of fibrosis. Inhibitors of TGFβ signaling discovered through Scholar Rock’s proprietary platform have been shown to selectively prevent the activation of the growth factor in the fibrotic matrix in vitro and in preclinical models. By targeting the disease microenvironment, these highly specific inhibitors of TGFβ activation may offer a novel approach to suppressing pro-fibrotic signaling in multiple organs.   ]]> https://biospectrumindia.com/news/57/12318/nextgen-healthcare-brings-cloud-based-data-collection-platform.html https://biospectrumindia.com/news/57/12318/nextgen-healthcare-brings-cloud-based-data-collection-platform.html Thu, 20 Dec 2018 12:40:00 +0530 NextGen Healthcare, Inc.the leading provider of ambulatory-only healthcare technology solutions, announces the launch of NextGen® Health Data HubÔ, a cloud-based Health Information Exchange (HIE) platform that supports the sharing and aggregation of patient health data. The ability of Health Data Hub to work with any data management interface allows it to connect disparate systems. This provides seamless interoperability so that clinicians and healthcare providers can streamline the process of sharing or receiving patient information, thereby improving clinical decision making at the point of care. Key features of Health Data Hub include: Clinical content management: Full support of clinical data types in use by ambulatory and inpatient systems; API: An API-first design enables complete data access and enhanced system integration points; User portal: A user-accessible front-end for the display and management of patient data; Consent & data protection: Secure patient data management for sharing and access permissions; and Cloud-hosting: Fully managed, continuously delivered solution leveraging Amazon Web Services. The latest addition to NextGen’s Connected Health offerings, Health Data Hub joins a suite of innovative health IT solutions designed to optimize data aggregation and provide users with relevant patient data from across the continuum of care. Health Data Hub is programmed to provide tailored solutions that give users the opportunity to create, manage and optimize their workflow. With the launch of Health Data Hub, NextGen Healthcare is at the forefront of interoperability data management solutions that help improve patient care. ]]> https://biospectrumindia.com/news/57/12314/mauseur-packaging-solutions-receives-dutch-innovation-award.html https://biospectrumindia.com/news/57/12314/mauseur-packaging-solutions-receives-dutch-innovation-award.html Thu, 20 Dec 2018 09:05:00 +0530 Mauser Packaging Solutions, a global leader in solutions and services across the packaging lifecycle, has launched the first medical waste container made of 100% recycled plastics generated from post-consumer packaging waste. The innovative concept has been awarded the 3rd prize in the 2018 NENnovation Award presented by the Dutch Standardization Institute NEN. The new WIVA Infinity Container combines the superior protection and handling of specific healthcare risk waste with the environmental benefits of using recycled plastic resin. Made of 100% recycled plastics, users in hospitals, clinics, laboratories, practices, nursing homes and pharmacies can expect a reduced CO2 footprint of over 50% with the new containers compared to those made of virgin plastic material. As Kees Vredevoort, Sales Manager Mauser Benelux, explains, “the new WIVA Infinity Container is available in sizes 30l, 50l and 60l complementing our well known WIVA Medical Waste Container range.” The recent development is a great example of how partners in the supply chain are teaming up on a joint vision of a circular economy to reduce the environmental impact of a specific product. Being the leading producer of medical waste containers in Europe, Mauser Packaging Solutions collaborated with QCP (Quality Circular Polymers) and SUEZ to develop new recycling plastics suitable to meet the highest quality standards applicable for packaging designed to handle healthcare risk waste. The new product concept was successfully tested according to the United Nations Dangerous Goods protocols. In close cooperation, and with the highly appreciated support from several Dutch authorities, such as the IL&T (Transport Inspection), the Ministry of Infrastructure and Transport and T&CPI (Testing Authority), Mauser Packaging Solutions gained a special permit allowing the container to be used in the Dutch market and on Dutch roads.  Prize-winning innovation for future-leading sustainability Honoring the supply chain initiative, WIVA Infinity Container received the 3rd prize in this year’s prestigious NENnovation Award organized by the Dutch Standardization Institute NEN. The jury recognized the uniqueness of the WIVA Infinity Container because it not only makes use of household plastic waste, but also significantly reduces the carbon footprint. Mauser Packaging Solutions is continuously looking for new ways to reduce the environmental impact of its packaging solutions and to support customers in reaching their sustainability goals. The company provides sustainability-oriented, full-cycle services from production to recycling. One of the main initiatives is the Infinity program which combines all efforts to produce packaging using recycled plastics. “Having installed recycling centers in the United States, Brazil and Europe, Mauser Packaging Solutions can generate high-quality post-industrial resin to manufacture a wide range of industrial packaging with a significantly lower carbon footprint,” outlines Axel Schaefer, Head of Product Management for Mauser's International Packaging Division. ]]> https://biospectrumindia.com/news/57/12312/ajinomoto-and-xl-protein-unite-to-develop-therapeutic-compounds.html https://biospectrumindia.com/news/57/12312/ajinomoto-and-xl-protein-unite-to-develop-therapeutic-compounds.html Wed, 19 Dec 2018 15:35:00 +0530 Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan and India.  Ajinomoto Bio-Pharma pleased to announce a Strategic alliance with XL-protein GmbH, a privately owned German biopharmaceutical company. Ajinomoto will apply its proprietary Corynex® expression system together with XL-protein's proprietary PASylation® technology for plasma half-life extension to develop a series of therapeutic compounds. Ajinomoto and XL-protein have established the efficient production of a PASylated proprietary GLP-1 variant with an extended half-life at laboratory scale yielding >3 grams soluble protein per liter bacterial culture including facile purification from the supernatant. The PASylated GLP-1 variant maintains high receptor affinity. In vivo pharmacokinetic studies in mice have revealed a drastically prolonged half-life, suggesting potentially weekly or biweekly dosing in human patients. Ajinomoto has started a partnering process for this molecule. Financial terms of the agreement have not been disclosed.   ]]> https://biospectrumindia.com/news/57/12309/adscs-uphold-results-after-fat-grafting.html https://biospectrumindia.com/news/57/12309/adscs-uphold-results-after-fat-grafting.html Wed, 19 Dec 2018 11:15:00 +0530 Nowadays, an approach based on adipose-derived stem cells (ADSCs) injection allows to maintain the breast volume achieved after fat grafting. The first ever evidences of ADSCs advantages come from the 16th Annual IFATS Meeting organized by the International Federation for Adipose Therapeutics and Science in Las Vegas (USA), where Bioscience Institute presented the results of a 4-years follow-up of patients subjected to autologous expanded ADSCs implant for breast augmentation. Breast volume MRI analysis was performed under the medical supervision of Bioscience Institute medical director, Roberto Viel, before and 4 years after ADSCs treatment, revealing that appropriate injection allows to maintain 100% of the volume achieved with fat grafting. When patient BMI increased, total breast volume increased too, reaching 109 to 135% of total breast volume achieved with fat injection, demonstrating fat graft behaves like fat in other parts of the organism. Such results have been made possible by Liposkill Plus, a body shaping approach based on expansion of autologous ADSCs to be injected in patient's breast to obtain a double aesthetic goal: improving breast volume without breast implants and eventually removing fat from undesired deposits (e.g. abdomen, tights). ADSCs expansion is fundamental for long-lasting results, allowing to get the minimum right dose of cells for injection (100-150 thousand cells/ml of fat for a volume between 400 to 800 ml).   ]]> https://biospectrumindia.com/news/57/12307/the-12th-edition-of-cphi-p-mec-india-expo-successfully-organized-at-india-expo-centre.html https://biospectrumindia.com/news/57/12307/the-12th-edition-of-cphi-p-mec-india-expo-successfully-organized-at-india-expo-centre.html Wed, 19 Dec 2018 10:45:00 +0530 UBM India organized the 12th edition of South Asia’s largest Pharma event, the CPhI & PMEC India expo which was a three day show happened from December 12th–14th, 2018, at the India Expo Centre, Greater Noida, Delhi-NCR. The signature expo has been comprehensively assisted in its endeavors by governing bodies such as Pharmexcil, CIPI and IDMA. This year's edition witnessed participation from more than 1,600 exhibitors from 42 countries. Special pavilions by Pharmaceuticals Export Promotion Council of India (Pharmexcil), China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and China Council for the Promotion of International Trade (CCPIT) formed an intrinsic part of the expo. The expo was inaugurated by Guests of Honour, Satish W. Wagh, Chairman- CHEMEXCIL; Dr. Dinesh Dua, Chairman, Nectar Life Sciences Ltd; Ravi Uday Bhaskar, Director General, Pharmexcil; KV Rajendranath Reddy, IPS, Director General, Drugs Control Administration, Government of Andhra Pradesh; Mr Michael Duck, Executive Vice President, UBM Asia Ltd; Yogesh Mudras, Managing Director, UBM India, Adam Andersen, Group Brand Director Pharma, Informa and Rahul Deshpande, Group Director, UBM India, amidst an august industry gathering.  The 3rd edition of the India Pharma Week (IPW), the week-long pharma celebration packed with a melange of events was started on December 9, with the event, Pharma Leaders Golf, taking place in Mumbai as a tribute to the city where it was born. Speaking at the inauguration of the expo, Yogesh Mudras  said, “With the 12 edition of the CPhI & P-MEC India expo along with the India Pharma Week shifting to Delhi-NCR region, an important chapter in the pharma industry has unfolded today. According to our worldwide reputation pharma report, the CPhI Global Pharma Index, India has taken huge strides in terms of its reputation with a 10.92 per cent rise in reputation. This is the maximum increase globally and extremely impressive given the quality and compliance issues it had faced previously. It also ranks no 1 in terms of pharma market growth potential and is in the top 3 countries in terms of competitiveness. A lot of it is the result of government initiatives focusing on improving the health infrastructure especially in the rural markets, providing fiscal incentives, and streamlined development procedures, based on recommendation by industry thought leaders.”  “With the key stakeholders of the pharma industry congregated under the giant umbrella of the IPW here, these are some of the subjects -- along with the business -- that we will take to the next level at the power-packed sessions and engagements of this unrivalled celebration of the pharma industry,” he added. Key exhibitors at the CPhI & P-MEC India expo included Thermo Fisher Scientific, ACG, Excellence United, Aurobindo Pharma, Nectar Lifesciences, Hoong-A Corporation, Supriya Lifesciences, IMA, GEA Group, Optel Group, Bosch, Bowman & Archer, Solace Engineers, Morepen Laboratories, Hetero Labs, Neogen Chemicals, Akums Drugs & Pharmaceuticals, Granules India, Acebright Pharma, Zim Laboratories, Nitika Pharmaceuticals Specialities, Scope Ingredients, Evonik India, Colorcon Asia, Pioma Chemicals, IMCD India, Accupack Engineering, Pharmalab India, Ace Technologies, Gerresheimer, Uflex, Nipro Pharma Packaging, and Indo German Pharma Engineers, among many more. "CPhI and PMEC India offer a great platform to showcase products to our customers and network with existing and new clients. Given the number of suppliers that participate every year, CPHI-PMEC India has established itself as a premiere event in this segment. Customers not just from India but also from Middle-east, Africa and surrounding Asian countries attend the show to view products and explore new technologies and suppliers. We at Thermo Fisher have been consistently exhibiting at this event over the past nine years and have always received a great response. We presented our solutions through two separate booths, one each in CPhI and PMEC respectively. While the CPhI booth showcases our range of laboratory chemicals, consumables and lab equipment, the booth in PMEC offers customers glimpse into our industry leading cutting-edge analytical solutions in chromatography, mass spectrometry, molecular and elemental spectroscopy, informatics and data management. The 2018 show was a great success and offered an opportunity to interact with prospective clients. Customers were excited to see the workflow approach and appreciated our initiatives to provide holistic solutions that align with our mission to enable our customers to make the world healthier, cleaner and safer", pointed out Amit Chopra, Managing Director and VP/ GM India and Middle East, Thermo Fisher Scientific. Onsite, several innovative engagement platforms such as Supplier Finder, CPhI TV, Live Streaming, Mobile Apps, Tech Walls, Matchmaking - Live Pharma Connect, Exhibitor Showcase, and Innovation Gallery among others made the visitor experience an engaging and memorable one.   ]]> https://biospectrumindia.com/news/57/12304/ifm-therapeutics-announces-discovery-of-new-immune-system-triggers.html https://biospectrumindia.com/news/57/12304/ifm-therapeutics-announces-discovery-of-new-immune-system-triggers.html Wed, 19 Dec 2018 09:50:00 +0530 IFM Therapeutics (IFM), a privately held biopharmaceutical company focused on developing therapies that modulate novel targets in the innate immune system has announced the discovery of new immune system triggers that are associated with certain inflammatory diseases. The study, published in the Journal of Immunology, was co-authored by IFM co-founder Eicke Latz, M.D., Ph.D., along with colleagues Bernardo Franklin, M.D., Ph.D. and Juan Francisco Rodriguez-Alcázar of the Institute of Innate Immunity at the University of Bonn. Charcot-Leyden Crystals (CLCs) are protein crystals that appear and persist in the tissues of patients with conditions such as asthma, allergic reactions, and fungal and parasitic diseases. Collectively, these are known as Eosinophilic diseases because of the marked increase of eosinophils, a part of the immune system consisting of a variety of white blood cells. Following immune stimulus, eosinophils degranulate, releasing an array of cytotoxic proteins. One of these proteins, Galectin-10, crystallizes to form CLCs. Higher levels of CLCs correlate with higher eosinophil activity, which is believed to contribute to disease severity.    In this study, Dr. Latz's team demonstrates that CLCs are engulfed by human macrophages in vitro, resulting in the release of the pro-inflammatory cytokine IL-1β. Additionally, CLCs were shown to promote inflammation in vivo, as evidenced by an increased tissue presence of IL-1β. Importantly, chemical inhibition and small interfering RNA (siRNA) knock-down of NLRP3 in primary human macrophages reduced IL-1B production in response to CLCs, suggesting that the inflammatory response occurs via the NLRP3 inflammasome pathway. "CLCs have been observed in patients for over 150 years. However, until recently, they were believed to be inert by-products of eosinophil activity with no immune activation," says Eicke Latz, M.D., Ph.D. "This study suggests that degradation of eosinophils leaves behind remnants that sustain immune activity. At a fundamental level, this supports the hypothesis that NLRP3 inhibition may be a therapeutically relevant approach for eosinophilic disorders, such as asthma and allergic disease." NLRP3 (NOD-, LRR- and pyrin domain-containing 3) is an intracellular innate immune signaling receptor that allows immune cells to detect the presence of foreign or endogenous molecules that signal infection or tissue damage. Abnormal activation of the NLRP3 inflammasome typically occurs without the presence of a foreign pathogen, and is known to cause negative downstream effects. "The work of our scientific founders, including Dr. Eicke Latz, further underscores the strong scientific rationale for targeting NLRP3 to treat chronic inflammation," said Martin Seidel, Ph.D., executive vice president of R&D at IFM. "By building on our vast knowledge of innate immune system pathways and their links to inflammatory processes, we are better equipped to lead the development of therapies for patients with serious inflammatory diseases." ]]> https://biospectrumindia.com/news/57/12299/kuehne-nagel-opens-global-distribution-centre-in-slovenia.html https://biospectrumindia.com/news/57/12299/kuehne-nagel-opens-global-distribution-centre-in-slovenia.html Tue, 18 Dec 2018 17:00:00 +0530 Kuehne + Nagel open a dedicated pharma & healthcare warehouse, one of the largest within its global KN PharmaChain network, expanding its standardised GxP compliant offering for the pharma & healthcare industry. The new facility, which is strategically located in close vicinity to the Ljubljana Airport, will carry out the distribution of finished products worldwide and will be used for the storage and distribution of production materials for the pharmaceutical industry. While eco-friendly built and equipped, the distribution centre complies with the highest security standards and state-of-the-art technology to increase current operational capacities. The facility provides an area of approximately 38,000 sqm, a capacity of about 65,000 pallet locations for the reception, storage and distribution of temperature-sensitive products and includes three cold chambers to handle temperature requirements of 15 to 25°C and 2 to 8°C. The new facility further underlines Kuehne + Nagel’s continuous commitment to expand its multi-modal and temperature-controlled forwarding and warehousing services worldwide. With a global network of currently close to 200 certified operations, 600,000 sqm of an industry dedicated warehousing space and a team of specially trained operators, KN PharmaChain addresses the need of pharma & healthcare customers for a standardised, reliable and compliant end-to-end logistics offering. At the same time, the company strengthens its presence in the Slovenian market, with an enhanced regional footprint.   ]]> https://biospectrumindia.com/news/57/12298/global-cannabis-partnership-expands-to-31-members-.html https://biospectrumindia.com/news/57/12298/global-cannabis-partnership-expands-to-31-members-.html Tue, 18 Dec 2018 16:20:00 +0530 The Global Cannabis Partnership (GCP) is pleased to announce the addition of seven new Members as it continues to grow internationally, bringing its total membership number to 31. The GCP welcomes Cannvas MedTech Inc., Compass Cannabis Clinic / Starbuds Canada, Constance Therapeutics, MediPharm Labs Corp., Nutrasource Pharmaceutical & Neutraceutical Services, StrainprintTM Technologies Ltd. and YSS by Solo. "There's a growing interest in the GCP as more stakeholders recognize the importance and value of working together on industry-wide CSR policies and programs," says Kim Wilson, Executive Director. "At a time when everyone is learning as they go, and as this nascent industry develops around the world, now is the time to work collaboratively, share insights and knowledge, and set the bar for socially responsible practices." The Member category is open to government agencies, licensed producers, national associations, industry partners and community groups from the global cannabis industry. Neither an advocacy nor a lobby group, the GCP represents a cross-section of organizations that play – or will play – a role in the legal, adult-use recreational cannabis supply chain. The GCP mirrors successful initiatives in other industry sectors, such as alcohol, gaming, pharmaceuticals and forestry. The GCP is working with two of its Founding Members, PwC Canada and McCarthy Tétrault, to establish itself as a non-profit legal entity, and finalize a governance structure led by a board of directors. The development of the Responsible Cannabis Framework, a worldwide social responsibility standard, is near completion and will be launched in 2019.   ]]> https://biospectrumindia.com/news/57/12297/arena-pharmaceuticals-brings-manmeet-s-soni-on-board-.html https://biospectrumindia.com/news/57/12297/arena-pharmaceuticals-brings-manmeet-s-soni-on-board-.html Tue, 18 Dec 2018 16:10:00 +0530  Arena Pharmaceuticals, Inc. has announced the appointment of Manmeet S. Soni as a non-executive director. Soni is a highly accomplished senior finance executive with extensive experience in the life sciences industry. "Manmeet brings deep financial and business expertise to the board, and we are thrilled to welcome him," said Tina Nova, Chairman of the Board of Directors of Arena. "His leadership abilities and senior finance experience within the life sciences industry will be instrumental as we strategically advance Arena towards its next stage of growth." Soni has served as Senior Vice President, Chief Financial Officer of Alnylam Pharmaceuticals, Inc. since May 2017. From March 2016 to February 2017, he was Executive Vice President, Chief Financial Officer and Treasurer of ARIAD Pharmaceuticals, Inc., a publicly-held biopharmaceutical company, when ARIAD was acquired by Takeda Pharmaceutical Company Limited. Previously, Soni served as Chief Financial Officer of Pharmacyclics, Inc., a publicly-held biopharmaceutical company, until its acquisition by AbbVie, Inc. in May 2015. He first joined Pharmacyclics in September 2012 as corporate controller and served in various increasingly senior roles prior to being appointed Chief Financial Officer and Treasurer in February 2014. Prior to joining Pharmacyclics, Soni worked at ZELTIQ Aesthetics Inc., a publicly held medical technology company, as well as PricewaterhouseCoopers, in the Life Science and Venture Capital Group and PricewaterhouseCoopers India, providing audit and assurance services. Mr. Soni currently serves as director of Pulse Biosciences, Inc. He is a certified public accountant and completed his Chartered Accountancy from the Institute of Chartered Accountants of India. Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in later-stage clinical programs in ulcerative colitis (UC) and Crohn's disease, as well as in programs for primary biliary cholangitis (PBC) and atopic dermatitis. Ralinepag (APD811) is being evaluated in a Phase 3 program for pulmonary arterial hypertension (PAH). Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure. In addition, Arena has several partnerships including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ - marketed product). ]]> https://biospectrumindia.com/news/57/12293/thailand-becomes-first-in-asia-to-introduce-tobacco-plain-packaging.html https://biospectrumindia.com/news/57/12293/thailand-becomes-first-in-asia-to-introduce-tobacco-plain-packaging.html Tue, 18 Dec 2018 11:15:00 +0530 As per Thailand’s new legislation, by September 2019 all tobacco products will have plain packaging. Thailand already has graphic health warnings covering 85% packaging of tobacco products. Introduction of plain packaging is expected to further boost the country’s tobacco control efforts targeting the current and new users. World Health Organization commended stronger tobacco control measures being adopted by Thailand which has become the first in Asia and the first low and middle-income country to adopt plain packaging for tobacco products. Dr Poonam Khetrapal Singh, Regional Director World Health Organization South-East Asia said, “Thailand’s bold steps against tobacco – the single most important cause of preventable deaths worldwide – is commendable and reflects the country’s earnest efforts in promoting health and well-being of its people.” The new legislative announcement on plain packaging is the latest effort of Thai government and adds to the Tobacco Control Act 2017 which enforces 20 years as the minimum age for purchasing tobacco, bans single stick sale and bans tobacco advertisement, promotion and sponsorship. Plain packaging of tobacco products restricts or prohibits the use of logos, colors, brand images or promotional information on packaging other than brand names and product names displayed in a standard color and font style. Plain packaging is an evidence-based policy being advocated by WHO Framework Convention on Tobacco Control (FCTC), a legal treaty that aims to protect present and future generation against the devastating health and socio-economic impact of tobacco use. Globally, tobacco kills more than seven million people every year - up to half of its users. Tobacco use is a key risk factor for major noncommunicable diseases such as heart attack, stroke, cancer, chronic respiratory diseases and diabetes. Noncommunicable diseases account for over 70% of all deaths in Thailand. Member countries in the Region are in the forefront in the fight against tobacco with four of them listed among the top five countries globally with largest graphic warning on tobacco product packs. ]]> https://biospectrumindia.com/news/57/12291/neuclone-discloses-its-sixth-biosimilar-candidate-of-pertuzumab-.html https://biospectrumindia.com/news/57/12291/neuclone-discloses-its-sixth-biosimilar-candidate-of-pertuzumab-.html Tue, 18 Dec 2018 10:40:00 +0530 NeuClone Pharmaceuticals Ltd. (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products has disclosed the sixth biosimilar being developed in its pipeline of monoclonal antibody (mAb) products. The product is a biosimilar candidate of Perjeta (pertuzumab) currently in preclinical development. Perjeta (pertuzumab) is FDA and EMA approved as a treatment for patients with HER2-positive early or metastatic breast cancer and is authorised for use only in combination with trastuzumab. In addition to the pertuzumab biosimilar, NeuClone is also developing a biosimilar of Herceptin (trastuzumab) currently in clinical development. NeuClone's Perjeta (pertuzumab) biosimilar is partnered with Serum Institute of India (Serum). Under the partnership, NeuClone and Serum are developing ten biosimilars for global markets. "We believe biosimilar combination therapies referencing Perjeta and Herceptin represent an exciting development in the future of biosimilars," stated Dr. Noelle Sunstrom, CEO of NeuClone. "Current combination treatments of mAbs, while often clinically superior to monotherapies, are extremely expensive when available. We are determined to dramatically expand the number of patients able to receive these life-changing combination therapies by offering lower-priced biosimilars of both mAbs." "Biosimilars are fast becoming a very important part of our pipeline," says Adar C. Poonawalla, CEO of Serum Institute of India. "NeuClone's biosimilar technology coupled with our low-cost, large-scale business model, will enable us to supply these critical antibody therapies to those previously unable to receive treatment." Pertuzumab is an IgG1 humanized mAb that targets human epidermal growth factor receptor 2 (HER2). Approximately 20% of women diagnosed with breast cancer test positively for HER2. According to La Merie, Perjeta recorded global sales of $2.3 billion in 2017. Dr. Noelle Sunstrom and other NeuClone representatives will be attending the 37th Annual J.P. Morgan Healthcare Conference in San Francisco from 7-10th January 2019. As part of NeuClone's strategy for biosimilar products the company is seeking commercialisation partners. ]]> https://biospectrumindia.com/news/57/12265/amgen-direct-relief-partner-to-help-cancer-patients-in-18-countries.html https://biospectrumindia.com/news/57/12265/amgen-direct-relief-partner-to-help-cancer-patients-in-18-countries.html Fri, 14 Dec 2018 11:55:00 +0530 Amgen and Direct Relief has announced a joint initiative in which Direct Relief will distribute $93 million worth of Amgen donated cancer treatments and supportive care medicines. This donation will provide cancer patients in 18 developing countries access to Neulasta® (pegfilgrastim), NEUPOGEN® (filgrastim) and Vectibix® (panitumumab). Patients will access the donated medicines through Direct Relief-partner hospitals and clinics in the following countries: Armenia, Cambodia, Dominican Republic, Ethiopia, Ghana, Haiti, Honduras, India, Jamaica, Malawi, Myanmar, Nepal, Nicaragua, Pakistan, Paraguay, Senegal, Tanzania and Uganda. "Amgen's mission is to serve patients around the world. We are pleased to work with Direct Relief, an organization with a strong network of high-quality cancer hospitals and clinics across the developing world, to make these innovative cancer medicines accessible to patients in need," said Joshua Ofman, M.D., senior vice president of Global Value, Access and Policy at Amgen. "Direct Relief is deeply appreciative to Amgen for its leadership and initiative in providing critical treatments to underserved cancer patients globally," said Thomas Tighe, president and chief executive officer of Direct Relief. "Cancer patients who would otherwise not be able to access many important therapies will be able to receive these advanced biologic medicines." The first shipments of the nearly 110,000 units of donated medicines have already reached cancer clinics in destination countries and are available to patients. Donated medicines will serve approximately 7,400 low-income patients. Amgen and Direct Relief will continue to seek opportunities to partner in the future to bring innovative biologics to patients in need. ]]> https://biospectrumindia.com/news/57/12264/minoryx-therapeutics-completes-phase-2-3-clinical-study-of-min-102-.html https://biospectrumindia.com/news/57/12264/minoryx-therapeutics-completes-phase-2-3-clinical-study-of-min-102-.html Fri, 14 Dec 2018 10:45:00 +0530 Minoryx Therapeutics, a company specializing in the development of new drugs for orphan diseases, announces that it has completed patient randomization of its phase 2/3 clinical trial of MIN-102 for the treatment of adrenomyeloneuropathy (AMN). The trial enrolled adult male patients affected by AMN, the most frequent phenotype of X-linked adrenoleukodystrophy (X-ALD).  The ADVANCE trial is a randomized, double-blind, placebo-controlled study designed to determine the efficacy and safety of MIN-102 with an open-label extension for patients completing the double-blind part of the trial. The primary objective of the clinical trial is to evaluate the efficacy of MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients, determined by a motor function test. Results of the study are expected at the end of 2020.  A total of 116 patients have been randomized in this study. 90 patients are being treated in Europe in a number of centers in Spain, France, Hungary, Germany, Italy, the United Kingdom and the Netherlands, while 26 are in the US in California, Maryland and Massachusetts. Enrolment was completed several months ahead of schedule.  “The strong interest in this AMN trial in the EU and US has resulted in exceeding the target enrolment ahead of schedule,” said Dr. Uwe Meya, chief medical officer of Minoryx. “We believe this highlights the very high unmet medical need in this area.”  MIN-102, the lead candidate in Minoryx’s pipeline, is a novel, orally bioavailable and selective PPAR gamma agonist with a superior profile for central nervous system-related diseases and good in-vivo efficacy. Phase 1 studies confirmed that MIN-102 is well tolerated and is able to cross the blood-brain barrier engaging the PPAR gamma in the CNS.  “On behalf of the company, I would like to take this opportunity to thank the patients and their families, the advocacy groups, and the caregivers and their staff for achieving this fast enrollment,” said Marc Martinell, CEO of Minoryx. “With the recent €21.3M Series B funding we are exploring the potential of MIN-102 in additional indications and plan to launch a new clinical study for a second orphan central nervous system indication.” ]]> https://biospectrumindia.com/news/57/12261/researchers-create-an-innovative-therapeutic-system-to-combat-cancer-.html https://biospectrumindia.com/news/57/12261/researchers-create-an-innovative-therapeutic-system-to-combat-cancer-.html Thu, 13 Dec 2018 17:35:00 +0530 A team of materials scientists from NUST MISiS together with a team of chemists from MIREA-Russian Technological University have managed to combine a photosensitizer molecule (a converter capable of transmitting the energy of light quanta, available in living tissues, into oxygen and turning it into an active form and highly active radicals, which have a cytotoxic effect) with a magnetic nanoparticle to create an innovative therapeutic system to combat cancer.  The nanoparticle is a controlled locomotive which researchers have learned to deliver locally to a tumor and track by MRI, and as a therapeutic component, the photosensitive molecule serves as an effective liquidator of pathology. The study results have already been tested in-vivo and published in the international scientific journal Journal of Colloid and Interface Science. "The photodynamic therapy is a cancer treatment method that uses a combination of special preparations-photosensitizers and light with waves of a certain length. The photosensitizers tend to accumulate in the tumor and when exposed to light with certain wavelengths they produce a special form of oxygen that destroys cancer cells. In addition to destroying cancer cells, photodynamic therapy destroys cancer in two other ways. First, photosensitizers can damage the blood vessels in the tumor, thus disrupting the flow of nutrients to it, and second, they can activate the immune system causing it to attack the cancer cells," said Mikhail Grin, the project co-author, a Doctor of Chemical Sciences, and head of the Department of Chemistry and Technology of Biologically Active Compounds at MIREA-Russian Technological University. However, this promising method has a natural limitation, as using a light source also directly affects the internal organ, leading to an uncontrollable accumulation of photosensitizers in the tissue. First, a photosensitizer is introduced into the patient`s body (intravenously or in a cavity). The drug is absorbed by cells throughout the body; at the same time, the photosensitizer accumulates in cancer cells in larger amounts than in healthy cells and also remains in them longer. Then, doctors irradiate the tumor "saturated" by the "light killers", a.k.a. the photosensitizers, with the help of optic fibers. Usually, laser installations are the light source for photodynamic therapy. The laser light using fiber optic cables should be immediately aimed at the tumor inside the body. The optical cable can be inserted through an endoscope into the stomach or any other natural openings. The drug, together with a photosensitizer, spreads throughout the body after being introduced into the body, but doctors can`t know for sure when its concentration will reach the desired maximum in a particular area or organ to immediate begin surgery. Logistically speaking, a patient can`t be kept under the lamps and the surgeon`s scalpel for several hours while simply waiting for the optimal momentum of light irradiation. That is why photodynamic therapy is mainly used only for treating skin cancer. The NUST MISIS research team has solved this problem with an innovative drug that includes bacteriochlorin molecules and magnetic nanoparticles. "We have managed to successfully combine the photosensitizer-bacteriochlorin and magnetite nanoparticles, which are both a drug deliverer and a contrast agent. We have obtained a new tool that allows us, using MRI, to effectively monitor the degree of accumulation of molecules in the affected organ, which provides the desired concentration and the shortest possible time of surgery. In general, this approach is promising for fine-tuning therapeutic complexes and significantly scales the method of photodynamic therapy," said Maxim Abakumov, the project co-author and Head of NUST MISiS`s Biomedical Nanomaterials Laboratory. The research team has already tested the new method in-vivo and has obtained good intermediate results - the "light killers" immobilized on magnetic nanoparticles were successfully delivered to cancer cells and caused the photo-induced death of cancer cells in lab mice. ]]> https://biospectrumindia.com/news/57/12249/mercks-bifunctional-immunotherapy-m7824-gets-fda-orphan-drug-designation.html https://biospectrumindia.com/news/57/12249/mercks-bifunctional-immunotherapy-m7824-gets-fda-orphan-drug-designation.html Wed, 12 Dec 2018 11:55:00 +0530 Merck, a leading science and technology company, has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer (BTC). The FDA orphan drug designation follows the recent presentation of the first clinical data for M7824 in BTC at the European Society of Medical Oncology (ESMO) congress in October. M7824 is an investigational bifunctional immunotherapy designed to combine co-localized blocking of the transforming growth factor-β and anti-PD-L1 immune escape mechanisms. BTC is a collective term for a group of rare and aggressive gastrointestinal cancers, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder carcinoma (GBC). Approximately 16,000 cases of BTC are estimated to occur every year in the US and collectively these cancers present late in the majority of patients.  Treatment options are limited and the median survival rate in the advanced setting is less than one year, objective tumor response with commonly used chemotherapy is typically less than 10% with short duration of response. "Biliary tract cancer is a rare, notoriously hard-to-treat tumor where existing treatment approaches, such as surgery or chemotherapy, are either not viable or simply don't deliver acceptable patient outcomes," said Luciano Rossetti, Head of Global Research & Development at the Biopharma business of Merck. "As the first regulatory designation for M7824, Merck is excited about the potential of this new class of immunotherapy in a number of challenging cancers and settings." FDA Orphan Drug Designation (ODD) is granted to medicines intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US, or those that affect more than 200,000 people but are unlikely to recover the costs of developing and marketing the drug. Medicines that meet the FDA's ODD criteria qualify for a number of incentives to help support advancement. M7824 is an investigational bifunctional immunotherapy that combines a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. Designed to combine co-localized blocking of the two immunosuppressive pathways, M7824 is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. M7824 is an important part of a novel combination approach that seeks to harness the power of the immune system and address the tremendously complex nature of difficult-to-treat tumors. ]]> https://biospectrumindia.com/news/57/12245/us-researchers-create-3dprinted-glucose-biosensors.html https://biospectrumindia.com/news/57/12245/us-researchers-create-3dprinted-glucose-biosensors.html Wed, 12 Dec 2018 10:00:00 +0530 A 3D‑printed glucose biosensor for use in wearable monitors has been created by Washington State University (WSU) researchers. The work could lead to improved glucose monitors for millions of people who suffer from diabetes. Using 3D printing, the WSU research team has developed a glucose monitor with much better stability and sensitivity than those manufactured through traditional methods. The researchers used a method called direct-ink-writing (DIW), that involves printing inks out of nozzles to create intricate and precise designs at tiny scales. The researchers printed out a nanoscale material that is electrically conductive to create flexible electrodes. The WSU team’s technique allows a precise application of the material, resulting in a uniform surface and fewer defects, which increases the sensor’s sensitivity. The researchers found that their 3D‑printed sensors did better at picking up glucose signals than the traditionally produced electrodes. The team is now working to integrate the sensors into a packaged system that can be used as a wearable device for long‑term glucose-monitoring. ]]> https://biospectrumindia.com/news/57/12248/roche-announces-appointment-of-william-bill-anderson-as-ceo-.html https://biospectrumindia.com/news/57/12248/roche-announces-appointment-of-william-bill-anderson-as-ceo-.html Wed, 12 Dec 2018 09:10:00 +0530 Roche has announced that Daniel O'Day, CEO Roche Pharmaceuticals and member of the Corporate Executive Committee, will be stepping down from his role as of 31 December 2018. Until the end of February 2019 and prior to assuming new responsibilities outside of Roche, he will provide his support to ensure a smooth transition of activities. William (Bill) Anderson, currently CEO of Genentech, will be appointed CEO Roche Pharmaceuticals effective 1 January 2019. He will be based in Basel, report to Severin Schwan, Roche Group CEO and become a member of the Corporate Executive Committee. Roche's CEO Severin Schwan said: "Dan has had an outstanding 31-year career at Roche and has played a key role in bringing a large number of new, innovative medicines to patients. Roche today has one of the strongest pipelines of medicines in the industry and is well positioned to shape digitalisation in healthcare. We are very grateful for all of Dan's contributions." Schwan added: "I am very pleased that with Bill Anderson we are appointing a new CEO of our Pharmaceuticals Division with an impressive track record. Bill brings both in-depth knowledge of our industry and extensive global leadership experience." Daniel O'Day began his career with Roche Pharmaceuticals in 1987 and held various roles in the United States before moving in 1998 to Basel, Switzerland in Global Marketing and then Lifecycle Management. In 2001, he was appointed Head of Corporate Planning for Roche Pharmaceuticals in Japan and subsequently became General Manager Pharma Denmark. He returned to the United States to head up Roche Molecular Diagnostics in 2006 before being appointed to lead the Diagnostics Division in 2010. He was appointed to lead the Pharmaceuticals Division in 2012. Bill Anderson joined Roche in 2006 leading the Immunology Business Unit in Genentech and then took responsibility for Oncology Sales and Marketing. In 2013, he was appointed Head of Global Product Strategy based in Basel before assuming his current role as CEO of Genentech in 2017. Bill Anderson holds Master of Science degrees in Management and Chemical Engineering from Massachusetts Institute of Technology. ]]> https://biospectrumindia.com/news/57/12247/roche-merck-partner-to-develop-a-companion-diagnostic-test.html https://biospectrumindia.com/news/57/12247/roche-merck-partner-to-develop-a-companion-diagnostic-test.html Wed, 12 Dec 2018 09:00:00 +0530 Roche has announced that it entered into a collaboration with Merck (known as MSD outside the United States and Canada) to develop a companion diagnostic test to identify patients eligible for anti-PD-1 therapy based on the status of a biomarker in advanced solid tumors. The companies will collaborate on the development of a pan-cancer companion diagnostic to detect mismatch repair deficiency (dMMR) in solid tumors. "We are excited to collaborate with Merck to develop a pan-cancer companion diagnostic test panel to detect mismatch repair deficiency," said Jill German, Head of Roche Tissue Diagnostics. "This new development could help change the way we identify patients best suited for immunotherapy treatment." Cancer treatment has been predominantly determined by the location in the body where the tumor originated. The development of an MMR immunohistochemistry (IHC) assay potentially paves the way for treatment decisions to be made based on biomarker expression within solid tumors originating from various parts of the body. "A key element of our strategy at Merck is focused on identifying those patients likely to benefit most from our medicines," said Dr. Eric Rubin, senior vice president, oncology clinical development, Merck Research Laboratories. "We look forward to working with Roche to develop a diagnostic test for mismatch repair deficiency." In May 2017, Keytruda, Merck's anti-PD-1 therapy, became the first cancer treatment approved by the US Food and Drug Administration for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no other alternative treatment options, or colorectal cancer that has progressed following treatment with certain chemotherapy drugs. Testing for MMR consists of the immunohistochemical detection of four MMR proteins (MLH1, MSH2, MSH6 and PMS2).[1,2] These assays, along with BRAF V600E, are currently used clinically to aid in the identification of a genetic predisposition for colorectal and other cancers called Lynch syndrome. This collaboration is expected to expand the utility of this panel to include selection of patients with solid tumors for immunotherapy. The companion diagnostic currently under development is an IHC test for use on the Roche BenchMark ULTRA instrument, which, as the most widely installed IHC/ISH (in situ hybridization) staining platform globally, will provide broad testing access to patients. ]]> https://biospectrumindia.com/news/57/12237/merck-genoway-form-crispr-cas9-strategic-alliance-to-develop-rodent-models.html https://biospectrumindia.com/news/57/12237/merck-genoway-form-crispr-cas9-strategic-alliance-to-develop-rodent-models.html Tue, 11 Dec 2018 10:25:00 +0530 Merck, a leading science and technology company and leader in genome editing, has announced a strategic alliance in the CRISPR/Cas9 rodent model market with France-based biotechnology company genOway. "We are committed to making our patented CRISPR technology broadly available to the global research and discovery community," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "Together with genOway, we will get the best research models out to the pharmaceutical and biotech industries as well as academic laboratories quickly, so we can help accelerate their research, shorten drug development timelines and treat previously untreatable diseases in faster and more targeted ways. We will continue to play an active role, responsibly and ethically, in ensuring that scientists have access to the latest CRISPR technologies." Through an exclusive worldwide license of Merck's foundational CRISPR integration patents, genOway will develop new models and solutions allowing non-profit and for-profit scientists to use CRISPR/Cas9 technology. Under the agreement, genOway will also develop a network of sublicensees in both the model creation and distribution businesses and preclinical services for all potential applications worldwide, with a strong focus in the United States, Asia and Europe. Financial details were not disclosed. Both Merck and genOway have identified research fields where they can combine their respective technologies and expertise to develop and validate new CRISPR/Cas9-related products and solutions. Merck's patented CRISPR integration technology is a strong entry point through which innovation can be developed and launched. At Merck, excellence and expertise in animal care, use and welfare are of the highest priority. In line with its mission to develop innovative medicines and chemicals based on scientific excellence and the established ethical standards, Merck is committed to conducting animal research activities only if no other method or testing is available for obtaining the result or product sought, not entailing the use of a live animal. "The CRISPR/Cas9 IP landscape has been complex and uncertain over the last years," said Alexandre Fraichard, CEO of genOway. "The situation has changed and the Merck IP portfolio is clearly central to CRISPR/Cas9-based eukaryotic genome-editing applications. This alliance, combining research and business, will enable us to provide the scientific community with more physiologically relevant models and the necessary intellectual property rights which will ultimately speed delivering better drugs to patients." ]]> https://biospectrumindia.com/news/57/12236/gilead-names-daniel-oday-as-chairman-and-ceo.html https://biospectrumindia.com/news/57/12236/gilead-names-daniel-oday-as-chairman-and-ceo.html Tue, 11 Dec 2018 08:55:00 +0530 Gilead Sciences Inc. a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need has announced that its Board of Directors has named Daniel O’Day Chairman of the Board and Chief Executive Officer, effective March 1, 2019. O’Day is currently the CEO of Roche Pharmaceuticals. He has held the position since 2012, and prior to that led Roche Diagnostics. His career spans three decades of diverse leadership roles across North America, Asia Pacific and Europe. The Board has also appointed Gregg Alton as interim Chief Executive Officer for the period of January 1, 2019 until O’Day’s start date of March 1, 2019. Alton has held a number of executive positions at Gilead over the past 20 years, with experience in legal, medical affairs, policy and commercial. He previously served as general counsel and in August of this year, was appointed Chief Patient Officer. “Following a comprehensive search, the Board became convinced that Dan is the right leader to bring Gilead into the future,” said John C. Martin, PhD, Chairman, Gilead Sciences Board of Directors. “He is uniquely qualified to take on this role given his track record of success in highly scientific and competitive therapeutic areas, deep understanding of the evolving healthcare environment around the world, and unwavering commitment to driving innovation across all aspects of a business, which will serve Gilead and our stakeholders well. Additionally, Dan brings expertise and values that are aligned with our organization, and I, along with Gilead’s entire Board, am confident in his ability to work alongside our talented leadership team and deliver on our ambitious goals.” After joining Roche Pharmaceuticals in 1987, O’Day held various positions in the United States before moving to Roche headquarters in Switzerland in 1998. During his time in Switzerland, he held leadership roles in Global Marketing and Lifecycle Management. In 2001, he moved to Tokyo to become Head of Corporate Planning for Roche Pharmaceuticals in Japan and later moved to Denmark to serve as General Manager. He became President of Roche Molecular Diagnostics in California in 2006 and subsequently returned to Roche headquarters to lead the Diagnostics Division before assuming his current position. He is a member of the corporate executive committee of F. Hoffmann La Roche AG and a member of the boards of Shanghai Roche Pharmaceuticals Ltd., Roche (China) Holding, Roche Pharma Schweiz AG, Genentech, Inc., Chugai Pharmaceuticals Co., Ltd., Flatiron Health, Inc., and Foundation Medicine, Inc. Additionally, he has served as a member of the board of the European Federation of Pharmaceutical Industries and Associations. O’Day holds a Bachelor of Science in Biology from Georgetown University in Washington, D.C. and an MBA from the Columbia Business School at Columbia University in New York. “I have long admired Gilead for its work to develop medicines that have fundamentally changed the way HIV and viral hepatitis are treated. The company has successfully grown into a global organization, providing access to people around the world, while maintaining its focus on innovative science,” said O’Day. “Together with the Board, leadership team and Gilead’s 11,000 employees, I look forward to building on this in ways that I believe will – in keeping with Gilead’s mission – transform the lives of millions of individuals.” As previously announced, Dr. Martin will step down from the company’s Board of Directors, effective March 1, 2019, O’Day’s first day of employment. Also as previously announced, John F. Milligan, PhD, will step down from his role as President and Chief Executive Officer and as a member of the Board at the end of 2018. ]]> https://biospectrumindia.com/news/57/12232/astrazeneca-cancer-research-uk-launch-functional-genomics-centre.html https://biospectrumindia.com/news/57/12232/astrazeneca-cancer-research-uk-launch-functional-genomics-centre.html Mon, 10 Dec 2018 18:20:00 +0530 AstraZeneca has announced a new collaboration with Cancer Research UK to launch a centre of excellence in genetic screening, cancer modelling and big data processing aimed at accelerating the discovery of new cancer medicines. The Functional Genomics Centre will further develop CRISPR technology to better understand the biology of cancer, creating biological models that may be more reflective of human disease, and advancing computational approaches to better analyse big datasets. These approaches are designed to inform new druggable targets in oncology by using clinical insights to better understand tumour disease and resistance mechanisms. The Functional Genomics Centre will be located at the Milner Therapeutics Institute at the University of Cambridge. AstraZeneca and Cancer Research UK will have independent use of the Centre’s facilities, and their scientists will work alongside each other to facilitate collaboration, technical innovation and scientific progress. At the Centre, scientists will have access to the next generation of CRISPR libraries for silencing or activating every gene in the genome, accessed through an extension of the existing collaboration between AstraZeneca and the Wellcome Sanger Institute. This collaboration includes access to the Wellcome Sanger Institute’s most recent versions of human and mouse genome-wide CRISPR/Cas9 knockout libraries, as well as Cas9 and dual gRNA expression vectors. This extends the application of CRISPR technology with vectors, providing enhanced sensitivity and specificity in gene editing, leading to easier targeting and identification. A separate collaboration between AstraZeneca and the California-based Innovative Genomics Institute (IGI) will aim to use CRISPR to uncover genes and disease pathway mechanisms involved in DNA Damage Response (DDR), a key process involved in many cancers and one of AstraZeneca’s four key platforms in oncology. Research will focus on identifying potential therapeutic strategies for DDR inhibitors, including combinations, in oncology. ]]> https://biospectrumindia.com/news/57/12226/researchers-develop-blood-test-to-diagnose-alzheimers-disease-accurately-.html https://biospectrumindia.com/news/57/12226/researchers-develop-blood-test-to-diagnose-alzheimers-disease-accurately-.html Mon, 10 Dec 2018 13:25:00 +0530 Scientists have developed a blood test that can accurately diagnose or even predict Alzheimer's disease before symptoms appear.  Currently the only way to definitively diagnose Alzheimer's disease in life is through brain scans and tests of cerebrospinal fluid that must be collected via lumbar puncture.  Researchers at Brigham and Women's Hospital are working to develop a blood test that could replace these procedures to accurately diagnose or even predict Alzheimer's disease before symptoms appear.   The tau protein has long been implicated in Alzheimer's, however, tau occurs as a family of related molecules which have subtly different properties.  The team took advantage of the complexity of tau and built assays to measure different forms of tau and identified a subset of tau proteins which are specifically elevated in Alzheimer's disease.  “A blood test for Alzheimer's disease could be administered easily and repeatedly, with patients going to their primary care office rather than having to go into a hospital," said corresponding author Dominic Walsh, PhD, of the Ann Romney Center for Neurologic Diseases at the Brigham. "Ultimately, a blood-based test could replace cerebrospinal fluid testing and/or brain imaging. Our new test has the potential to do just that. Our test will need further validation in many more people, but if it performs as in the initial two cohorts, it would be a transformative breakthrough."  Walsh and colleagues developed tests capable of detecting different populations of tau fragments in cerebrospinal fluid and blood. They applied these tests to participants who had donated both plasma and cerebrospinal fluid. They validated results in a second group of patients.  The team analysed five different tests for tau fragments, finding that one, known as the NT1 assay, showed sufficient ability to predict AD cases and exclude controls to pursue its use as a potential screening tool for Alzheimer's disease. This was confirmed in both sets of patients.  While performing the experiment twice - in two sets of patients with two different demographic backgrounds - provided important confirmation, the authors note that both groups of participants were small (65 participants and 86 participants, respectively).  Larger groups of participants will need to be studied. Researchers are also interested in studying patients over time to determine how tau levels in blood may change as the disease progresses and what those numbers may look like before the onset of symptoms.  "We've made our data and the tools needed to perform our test widely available because we want other research groups to put this to test," said Walsh. "It's important for others to validate our findings so that we can be certain this test will work across different populations."   ]]> https://biospectrumindia.com/news/57/12220/chryscapital-acquires-majority-stake-in-gebbs-healthcare-solutions.html https://biospectrumindia.com/news/57/12220/chryscapital-acquires-majority-stake-in-gebbs-healthcare-solutions.html Sat, 08 Dec 2018 04:50:00 +0530 GeBBS Healthcare Solutions, a leading national provider of Revenue Cycle Management (RCM) solutions for the healthcare industry has announced that ChrysCapital, a marquee Indian private equity fund with a global technology services footprint, has acquired a majority stake in the company. Founded in 2005, GeBBS Healthcare Solutions is one of the fastest-growing companies in the industry. Their cost containment solutions leverage the latest technology and help clients increase profitability and scalability. GeBBS will continue to be led by Mr. Nitin Thakor and Mr. Milind Godbole who, together with the existing management team, have been instrumental in driving the company’s growth. “We are excited to partner with ChrysCapital as we enter our next phase of growth.” said Nitin Thakor, President and CEO of GeBBS Healthcare Solutions. “We chose to partner with ChrysCapital because they bring with them a strong track record of building best-in-class businesses. Their deep domain expertise and strong network of relationships will complement our capabilities and drive additional value to our customers. We now have the resources to accelerate our growth and strategic objectives.” “ChrysCapital has a long tradition of successful partnerships with entrepreneurs, supporting their growth and expansion in a collaborative manner. We are excited to partner with Nitin, Milind and the existing management team to build the world’s leading healthcare business services company. With access to decades of experience with IT and BPO companies, ChrysCapital is confident that its investment in GeBBS will help differentiate the company and significantly accelerate its growth trajectory. We look forward to participating in GeBBS’ continued success." said Sanjay Kukreja, Partner at ChrysCapital. Houlihan Lokey acted as exclusive financial advisor to GeBBS Healthcare Solutions. Mundkur Law Partners and Clark Hill acted as legal advisors to GeBBS Healthcare Solutions. Shardul Amarchand Mangaldas & Co and Wilson Sonsini Goodrich & Rosati acted as advisors to ChrysCapital. GeBBS Healthcare Solutions is a leading technology-enabled provider of revenue cycle management (RCM) solutions. GeBBS’ innovative technology, combined with its over 6,000-strong global workforce, helps clients improve financial performance, compliance, and patient satisfaction. GeBBS’ solutions include Health Information Management (HIM), Revenue Cycle Management (RCM), Patient Access and Risk Adjustment Solutions. Headquartered in the Los Angeles, CA area, GeBBS has won numerous accolades, including being ranked in Modern Healthcare’s Top 15 Largest RCM Firms, Black Book Market Research’s Top 3 RCM Outsourcing Services for Health Systems, and Inc. 5000’s fastest growing private companies in the U.S. Founded in 1999, ChrysCapital is one of the largest and most successful India-focused private equity firms with over $3 billion in AUM across 7 funds. Since inception the firm has made over 80 investments and has delivered over 65 exits across a number of sectors including in Business Services, Financial Services, Pharmaceuticals, Healthcare and Consumer. ChrysCapital’s investors include global endowments, sovereign funds, family offices, foundations and fund of funds. The firm’s current and past investments include HCL Technologies, L&T Infotech, LiquidHub, Infogain, Mankind Pharma, Hero FinCorp and National Stock Exchange of India. ]]> https://biospectrumindia.com/news/57/12219/bluerock-therapeutics-strengthens-collaboration-with-mcewen-stem-cell-institute.html https://biospectrumindia.com/news/57/12219/bluerock-therapeutics-strengthens-collaboration-with-mcewen-stem-cell-institute.html Sat, 08 Dec 2018 04:35:00 +0530 BlueRock Therapeutics, LP, an engineered cell therapy company leveraging its novel Cell+Gene platform to develop regenerative medicines for intractable diseases, has announced the strengthening of its ongoing strategic collaboration with the McEwen Stem Cell Institute at the University Health Network (UHN) in Toronto. "Toronto is an incredible scientific ecosystem and a world-renowned center for stem cell biology and regenerative medicine," said Emile Nuwaysir, PhD, Chief Executive Officer of BlueRock Therapeutics. "The McEwen Stem Cell Institute at UHN is the epicenter of that ecosystem, and we have been very pleased with our relationship to date. The expansion of that partnership deepens the relationship, broadens our access to that foundational science and accelerates the development of our therapeutic programs." The partnership encompasses an operations and infrastructure expansion. BlueRock will be moving into an additional 14,000 square feet within UHN in Toronto's MaRS Discovery District, co-located with the McEwen Institute. The new lab will be in close proximity to the already established 7,000 square foot faculty housing BlueRock process development and manufacturing teams as well as the new pilot Good Manufacturing Practices (GMP) facility, which will open in early 2019. The strengthened partnership will also provide funding to support a BlueRock-endowed research chair in regenerative medicine for Dr. Stephanie Protze, PhD, principal investigator, McEwen Stem Cell Institute. While a post-doctoral fellow in Dr. Gordon Keller's lab, Dr. Protze successfully transformed human stem cells into functional pacemaker cardiac cells; these cells were able to elicit a rodent's heartbeat. Today her work is focused on further validating if these pacemaker cells can function as biological pacemaker using additional models and on using developmental biology-based approaches to establish strategies to guide the differentiation of hPSCs into the second type of pacemaker cell found in the heart. "The collaboration between BlueRock and the McEwen Institute at UHN will continue to greatly enrich and expedite the development of regenerative therapy approaches for cardiovascular disease," said Dr. Protze. "I am thrilled to have the opportunity to develop BlueRock's unique Cell+Gene therapy platform and translate its capabilities to new treatments." Additionally, BlueRock will increase the amount of funding and the breadth of sponsored research programs with Dr. Gordon Keller, PhD, Director, McEwen Stem Cell Institute, Dr. Protze and Dr. Michael Laflamme, MD, PhD, Principal Investigator. This funding will enable BlueRock to advance native and engineered cell programs in cardiac indications as well as additional areas. BlueRock Therapeutics is an engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock's Cell+Gene platform harnesses the power of cells for new medicines across neurology, cardiology and autoimmune indications. BlueRock's cell differentiation technology recapitulates the cell's developmental biology to produce native cell therapies which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function. BlueRock was founded in 2016 by Versant Ventures and capitalized with one of the largest-ever Series A financings in biotech history by Bayer AG and Versant. ]]> https://biospectrumindia.com/news/57/12218/trianni-macrogenics-enter-into-a-license-agreement.html https://biospectrumindia.com/news/57/12218/trianni-macrogenics-enter-into-a-license-agreement.html Sat, 08 Dec 2018 04:15:00 +0530 Trianni, Inc. and MacroGenics, Inc. has announced that they have entered into a license agreement for The Trianni Mouse, a best-in-class transgenic mouse R&D platform for the discovery of fully-human monoclonal antibodies, to support MacroGenics' discovery programs for monoclonal antibody-based therapeutics for the treatment of cancer. "With the Trianni Mouse in our discovery toolbox, MacroGenics now has the ability to incorporate fully human antibody sequences into molecules that are based on our Fc optimization and multi-specific DART® and TRIDENT™ platforms, further accelerating our discovery and candidate development processes," said Ezio Bonvini, M.D., Chief Scientific Officer of MacroGenics. "TRIANNI is very happy that MacroGenics has chosen the TRIANNI discovery platform," said Matthias Wabl, PhD, Chairman, President and CEO of TRIANNI. "We are confident that the cutting-edge genomic design of the TRIANNI discovery platform, which combines the complete human antibody repertoire with wild-type mouse immune responses to any target antigen, will be a great asset for MacroGenics' drug discovery programs." No financial details were disclosed. Trianni, Inc. is a privately held biotech company specializing in antibody discovery technology. TRIANNI's lead technology, The Trianni Mouse, is a powerful, next-generation platform enabling efficient generation of fully-human monoclonal antibodies. TRIANNI's transgenic platform leverages a novel approach to design made possible by advances in DNA synthesis and genomic modification technology, making it a best-in-class therapeutic antibody discovery platform. The company is headquartered in San Francisco, CA. MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. ]]> https://biospectrumindia.com/news/57/12209/pharmacyte-biotech-engages-cgmp-validation-to-assist-in-preparation-of-ind-for-pancreatic-cancer-trial.html https://biospectrumindia.com/news/57/12209/pharmacyte-biotech-engages-cgmp-validation-to-assist-in-preparation-of-ind-for-pancreatic-cancer-trial.html Fri, 07 Dec 2018 03:35:00 +0530 PharmaCyte Biotech, a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box has announced that it has engaged cGMP Validation L.L.C. (cGMP Validation) to assist in the preparation of the Investigational New Drug application (IND) that must be submitted to and approved by the U.S. Food and Drug Administration (FDA) before PharmaCyte can begin its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC). cGMP Validation is playing a pivotal role for PharmaCyte and will continue to do so as it moves forward with the preparation of its IND. The role of cGMP Validation and its President and Chief Executive Officer, Jesse Gillikin, in particular, is to ensure that each and every step of the manufacturing process of PharmaCyte’s encapsulated cells completely complies with the FDA’s cGMP regulations and all other FDA requirements requested by the U.S. drug regulatory agency. In addition to ensuring that PharmaCyte’s clinical trial product meets regulatory compliance throughout the production process, cGMP Validation will also serve as a resource to Austrianova in its manufacturing process related to cGMP requirements with which it must adhere. For example, cGMP Validation will examine cGMP required documents prepared by Austrianova that concern all “production runs” of the manufacturing process and work with Austrianova to ensure compliance in every respect. cGMP Validation will also serve, on behalf of PharmaCyte, as the agent for the “release” of the final product that will be implanted into patients before the chemotherapy prodrug ifosfamide is given during the planned clinical trial in LAPC. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are extremely fortunate to have been able to retain cGMP Validation as our outside cGMP compliance/validation expert and to have Mr. Gillikin work directly with us and the principals at Austrianova to make certain that the very important manufacturing portion of our IND is complete and compliant with the FDA’s stringent cGMP regulations. As I mentioned in an interview last summer, we’re almost there. Our checklist of items to be completed has been whittled down to just a few remaining items, and cGMP Validation provides us with the confidence moving forward to get across the finish line. It is imperative that our submission of the IND to the FDA is done flawlessly; therefore, cGMP Validation’s efforts will play a major role in ensuring that the IND we plan to submit to the FDA is as complete and accurate as possible.” cGMP Validation was established in 1997 as a full-service validation/compliance firm offering services for the pharmaceutical, biotechnology, biologics, medical device and medical diagnostic sectors. It has served new and repeat clients across the U.S., Puerto Rico and Canada and has international experience in Europe, Egypt, Korea, Indonesia and Vietnam. cGMP is headquartered in North Carolina, and it has an operational office in Missouri. Mr. Gillikin is a co-founder of cGMP Validation and serves as its President and Chief Executive Officer. He has been in the pharmaceutical industry since 1978 and has experience in validation, managing QC laboratories, field auditing, and compliance, including interactions with the FDA and international regulatory agencies. His experience has included working with numerous companies in establishing validation and compliance practices. Mr. Gillikin’s experience enables him to provide clients with a wide array of validation resources, such as manufacturing equipment validation, process validation, cleaning validation and computer validation. His extensive work with other companies, as well as his long-standing relationship and experience with the FDA, also enables him to provide auditing, compliance/validation program building and the writing/execution of validation protocols. Because of the intense efforts that PharmaCyte, cGMP Validation, and PharmaCyte’s clinical team of consultants are currently engaged in with respect to the preparation of the IND, as well as difficulty in coordinating and scheduling travel with everyone involved during the holiday season, PharmaCyte has decided to postpone its planned shareholder meeting until the first quarter of 2019. ]]> https://biospectrumindia.com/news/57/12199/philips-recognized-by-frost-sullivan-for-its-pmas-system.html https://biospectrumindia.com/news/57/12199/philips-recognized-by-frost-sullivan-for-its-pmas-system.html Thu, 06 Dec 2018 13:25:00 +0530 Based on its recent analysis of the North American medication adherence market, Frost & Sullivan recognizes Philips, a global leader in health technology, with the 2018 North American Enabling Technology Leadership Award for creating a connected ecosystem that allows payers and providers to track their patients' health. The Philips Medication Adherence Solution (PMAS) features spencer®, an enterprise-grade medication dispenser, which finds special application in managing medication for high acuity and chronic disease patients. With this solution, pharmacists, caregivers, patients, and providers are connected on a single platform, making it a vastly superior solution to mere pill dispensing devices. "The PMAS eases traceability and follow-ups, and supports patients' compliance with treatment protocols. It is designed with a patient-friendly interface, as well as an alert system and connected app that offers timely notifications for pharmacists and clinicians if a patient misses a dose," said Divyaa Ravishankar Industry Principal. "With its remote patient monitoring capability, digital tools, and door-to-door delivery, the company has innovated the caregiving pathway from hospital to home." The World Health Organization (WHO) requires a patient's compliance to be at 80 percent, but the PMAS has an average patient adherence level of 98 percent. Many long-term care centers in the United States use spencer® to help elderly and chronically ill patients better manage their health. The solution enables the patient's caregivers to keep close watch on their adherence, as its automated dispensing service is linked to the phone line and issues alerts to caregivers. Additionally, the device can even function during power outages, dispense medication in advance if a patient is scheduled to travel, and set both audio and visual reminders to ensure no doses are missed. Providers contracted by Philips offer PMAS units to their patients at no direct cost, and every spencer®-certified pharmacist verifies coverage details before transferring and packaging prescriptions to the device. One of the most significant value-added features in the device is the spencer® Assist app, which facilitates information sharing between patients and their family caregivers. It ensures stability and transparency for high-acuity patients and is one of the best tools to monitor patients suffering from opioid addiction. "At an enterprise level, the device can potentially improve the Medicare STAR rating for health systems," noted Ravishankar. "By boosting medication adherence, the PMAS reduces unnecessary hospitalizations and helps all stakeholders save healthcare costs. Its 4x doses per day and provision of a subscription model have positioned it ahead of its competitors and made Philips richly deserving of the 2018 North American Enabling Technology Leadership Award." Each year, Frost & Sullivan presents this award to a company that has developed a pioneering technology that not only enhances current products, but also enables the development of new products and applications. The award recognizes the high market acceptance potential of the recipient's technology. ]]> https://biospectrumindia.com/news/57/12185/biotage-ab-acquires-phynexus-at-21-5m.html https://biospectrumindia.com/news/57/12185/biotage-ab-acquires-phynexus-at-21-5m.html Wed, 05 Dec 2018 11:10:00 +0530 PhyNexus, Inc., a privately held California corporation, announces today an agreement to be acquired by Biotage AB, strengthening its position for world-wide sales and marketing of automated lab-scale purification technology of biomolecules. Biotage AB will acquire all outstanding shares in PhyNexus, for a total purchase price of approx. US$ 21.5 million (corresponding to approx. SEK 195 million) financed through a combination of newly issued shares in Biotage and existing cash at hand.  Together, PhyNexus and Biotage will be able to provide their global customers an enabling automation platform based on Dual Flow Chromatography and patented tip technology for high throughput purification of biomolecules such as proteins, plasmids and antibodies at the lab-scale.    The companies will fully address the growing multi-billion USD market, including purification and manipulation of biomolecules. PhyNexus and Biotage believe that the combination of technology and resources will also enable the development of new approaches for clinical, forensic, food and environmental testing. PhyNexus technology enables miniaturized and parallel automated work-flows to address different laboratory purification processes. The company's Dual Flow Chromatography tip technology has the ability to draw up samples, process them and re-deposit them into sample wells. The processed samples are ready for use or, if desired, may be processed with additional tips to bring the sample to the desired form in a completely automated work-flow. The platform technology delivers high throughput purification capability with improved results across multiple applications in biologics drug discovery, research and development, and diagnostic applications. ]]> https://biospectrumindia.com/news/57/12180/domain-therapeutics-signs-multi-target-research-collaboration-with-boehringer-ingelheim-.html https://biospectrumindia.com/news/57/12180/domain-therapeutics-signs-multi-target-research-collaboration-with-boehringer-ingelheim-.html Wed, 05 Dec 2018 10:30:00 +0530 Domain Therapeutics announces a multi-target drug discovery collaboration and licensing agreement with Boehringer Ingelheim on orphan G Protein-Coupled Receptors (GPCRs) in the Central Nervous System (CNS) disease area.  The collaboration combines the expertise of Domain Therapeutics, a French and Canadian biopharmaceutical company, in the discovery of GPCR targeting drugs in CNS, oncology and immuno-oncology, with Boehringer Ingelheim’s expertise in the discovery and clinical development of therapeutics on multiple indications.  Domain Therapeutics will use its proprietary platforms, DTect-All™ and bioSens-All™, which enable a comprehensive characterization of small molecule GPCR binders for the screening and characterization of potential lead compounds. In addition, Domain brings on board its extensive network of leading GPCR experts to provide additional knowledge and insight to the discovery phase (Prof. Brigitte Kieffer, Douglas Institute – Montreal, Canada and Prof. Michel Bouvier, IRIC Institute - Montreal, Canada).  Domain will be eligible for an upfront payment, discovery, development and commercial milestone payments as well as royalties on sales. Financial details are not disclosed. ]]> https://biospectrumindia.com/news/57/12174/beckman-coulter-diagnostics-teams-up-with-sepsis-alliance.html https://biospectrumindia.com/news/57/12174/beckman-coulter-diagnostics-teams-up-with-sepsis-alliance.html Tue, 04 Dec 2018 11:25:00 +0530 Beckman Coulter, a global leader in the clinical diagnostics industry, has announced that it is joining forces with Sepsis Alliance, the nation's leading sepsis organization, to support the Sepsis Coordinator Network. Sepsis is the body's life-threatening reaction to infection and the leading cause of death in hospitals in the United States, taking a life every two minutes. As the first of its kind, online, peer-to-peer association for healthcare professionals, the Sepsis Coordinator Network is committed to helping save lives by improving patient outcomes. The Sepsis Coordinator Network is led by experts in the field of nursing with critical experience in caring for sepsis patients. A complementary team of healthcare professionals from across the continuum of care serve as clinical advisors in specialized areas. They include physicians, pharmacists and mental health specialists, among others. ]]> https://biospectrumindia.com/news/57/12171/fda-approves-first-diagnostic-test-to-detect-herpes-virus-in-newborns.html https://biospectrumindia.com/news/57/12171/fda-approves-first-diagnostic-test-to-detect-herpes-virus-in-newborns.html Mon, 03 Dec 2018 16:30:00 +0530 Today the U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. "Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies," said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child." According to the Centers for Disease Control and Prevention, more than half of adults by age 40 have been infected with CMV. Most people infected with CMV show no signs or symptoms of infection. However, CMV infection can cause serious health problems for people with weakened immune systems and for some newborns. Congenital CMV occurs when a baby is infected with CMV during pregnancy. Although most babies with CMV will not have any signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems. The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information. The FDA evaluated the analytical and clinical performance of the device. Data from a prospective clinical study showed that 1,472 saliva samples out of 1,475 samples collected from newborns were correctly identified by the device as negative for the presence of CMV DNA. Three samples were incorrectly identified as positive when they were negative. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA. The FDA also reviewed data from a testing of 34 samples of archived specimens from babies known to be infected with CMV in which all the archived specimens were correctly identified by the device as positive for presence of CMV DNA. The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which determines the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience, Inc. ]]> https://biospectrumindia.com/news/57/12153/the-native-antigen-company-launches-new-zika-immunoassays-.html https://biospectrumindia.com/news/57/12153/the-native-antigen-company-launches-new-zika-immunoassays-.html Fri, 30 Nov 2018 11:15:00 +0530 The Native Antigen Company has launched a series of ground-breaking immunoassays for Zika virus, offering researchers in academia, public health and drug discovery the capability to work with unprecedented levels of specificity and sensitivity. Unlike previous methods, the new assays have little or no cross-reactivity with other flaviviruses, including Dengue, West Nile, Yellow Fever, Japanese Encephalitis, Tick-Borne Encephalitis and Usutu virus.   The Native Antigen Company Zika Virus NS1 ELISA assay is a highly sensitive and specific assay suitable for the quantitative detection of Zika Virus NS1 in a range of biological samples, with no cross-reactivity with other flaviviruses. Present in human serum during the early stages of infection, the NS1 protein provides an early marker of viral replication following infection. This ELISA assay can detect NS1 antigen at levels as low as 5 pg/ml and enables researchers to measure the level of Zika NS1 protein in infected patients, offering value in epidemiology studies.   The Native Antigen Company Zika Virus IgG/IgM/IgA ELISA assay is designed for the detection of Zika-specific antibodies in human serum. It is minimally cross-reactive with antibodies to Dengue virus and so can be used to distinguish human anti-Zika antibodies from other flavivirus and infectious disease antibodies. Previous assays have been time-consuming, cumbersome and have been unable to reliably distinguish between Zika and Dengue. However, the Zika Virus ELISA has an assay time of only 2 hours, with specificity and sensitivity both in excess of 90%, even in regions endemic with Dengue. Due to the novel assay format, the test may also be used in any species, making it of particular value for studying animal models of Zika infection. In an independent assessment of the Zika Virus IgG/IgM/IgA ELISA kit, external researchers reported a sensitivity of 90.3% and specificity of 92.1%. This compared favourably with direct testing against a market-leading IgG assay that exhibited only 69.4% specificity.  In addition to the kits, The Native Antigen Company also offers an extensive range of Zika virus antigens, both expressed as recombinant proteins in a mammalian expression system and as native viral preparations. Further products include NS1 proteins (from both the prototypic Uganda strain and from the Suriname strain responsible for the major outbreak in 2016) and Zika Virus-like particles (VLPs). ]]> https://biospectrumindia.com/news/57/12152/measles-cases-spike-globally-due-to-gaps-in-vaccination-coverage-who.html https://biospectrumindia.com/news/57/12152/measles-cases-spike-globally-due-to-gaps-in-vaccination-coverage-who.html Fri, 30 Nov 2018 11:10:00 +0530 According to the new report by WHO, reported measles cases spiked in 2017, as multiple countries experienced severe and protracted outbreaks of the disease. Because of gaps in vaccination coverage, measles outbreaks occurred in all regions, while there were an estimated 110 000 deaths related to the disease.  Using updated disease modelling data, the report provides the estimates of measles trends over the last 17 years. It shows that since 2000, over 21 million lives have been saved through measles immunizations. However, reported cases increased by more than 30 percent worldwide from 2016.  Measles is a serious and highly contagious disease. It can cause debilitating or fatal complications, including encephalitis (an infection that leads to swelling of the brain), severe diarrhoea and dehydration, pneumonia, ear infections and permanent vision loss. Babies and young children with malnutrition and weak immune systems are particularly vulnerable to complications and death. The Americas, the Eastern Mediterranean Region, and Europe experienced the greatest upsurges in cases in 2017, with the Western Pacific the only World Health Organization (WHO) region where measles incidence fell. Dr Soumya Swaminathan, Deputy Director General for Programmes at WHO said, “The resurgence of measles is of serious concern, with extended outbreaks occurring across regions, and particularly in countries that had achieved, or were close to achieving measles elimination. Without urgent efforts to increase vaccination coverage and identify populations with unacceptable levels of under-, or unimmunized children, we risk losing decades of progress in protecting children and communities against this devastating, but entirely preventable disease.” The disease is preventable through two doses of a safe and effective vaccine. For several years, however, global coverage with the first dose of measles vaccine has stalled at 85 percent. This is far short of the 95 percent needed to prevent outbreaks, and leaves many people, in many communities, susceptible to the disease. Second dose coverage stands at 67 percent. Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance said, The increase in measles cases is deeply concerning, but not surprising. Complacency about the disease and the spread of falsehoods about the vaccine in Europe, a collapsing health system in Venezuela and pockets of fragility and low immunization coverage in Africa are combining to bring about a global resurgence of measles after years of progress. Existing strategies need to change: more effort needs to go into increasing routine immunization coverage and strengthening health systems. Otherwise we will continue chasing one outbreak after another.” Dr Robert Linkins, Branch Chief of Accelerated Disease Control and Vaccine Preventable Disease Surveillance at the U.S. Centers for Disease Control and Prevention (CDC) and Measles & Rubella Initiative Management Team Chair said, “Sustained investments are needed to strengthen immunization service delivery and to use every opportunity for delivering vaccines to those who need them.” Responding to the recent outbreaks, health agencies are calling for sustained investment in immunization systems, alongside efforts to strengthen routine vaccination services.   ]]> https://biospectrumindia.com/news/57/12149/merck-receives-ec-approval-for-hiv-drugs.html https://biospectrumindia.com/news/57/12149/merck-receives-ec-approval-for-hiv-drugs.html Thu, 29 Nov 2018 20:15:00 +0530 Merck, known as MSD outside the United States and Canada, has announced that the European Commission (EC) has approved DELSTRIGO and PIFELTRO for the treatment of HIV-1 infection. DELSTRIGO is a new once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). It is indicated in the European Union for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of antiviral agents, lamivudine or tenofovir. PIFELTRO (doravirine, 100 mg) is a new, once-daily NNRTI indicated (in the EU) in combination with other antiretroviral medicines for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the NNRTI class. The approval allows for marketing of DELSTRIGO and PIFELTRO in all 28 European Union member states, plus Iceland, Lichtenstein and Norway, and follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency announced on Sept. 20, 2018. Marketing authorization applications for DELSTRIGO and PIFELTRO are also under review in other countries, including Australia and Switzerland. The U.S. Food and Drug Administration approved DELSTRIGO and PIFELTRO on Aug. 30, 2018. Health Canada approved PIFELTRO on Oct. 12, 2018 and DELSTRIGO on Nov. 9, 2018. Availability for DELSTRIGO and PIFELTRO in the EU is anticipated to begin in the first half of 2019.     ]]> https://biospectrumindia.com/news/57/12146/hookipa-and-darwinhealth-enter-into-a-research-collaboration-.html https://biospectrumindia.com/news/57/12146/hookipa-and-darwinhealth-enter-into-a-research-collaboration-.html Thu, 29 Nov 2018 18:00:00 +0530 HOOKIPA Pharma Inc. (“HOOKIPA”), a clinical stage biopharmaceutical company developing a new class of immuno-therapeutics targeting infectious diseases and cancers based on its proprietary technology platform, announced today that it entered into a research collaboration and license agreement with DarwinHealth to develop novel immunotherapies based on the systematic discovery and prioritization of the next generation of immunogenic, tumor-specific cryptic antigens.  DarwinHealth is a precision-focused cancer medicine company, utilizing systems-biology derived algorithms to identify appropriate therapies for cancer patients and to systematically discover and prioritize the next generation of immunogenic, tumor-specific antigens. Under the terms of the agreement, DarwinHealth will utilize a combined single-cell transcriptome analysis and bioinformatics-based approach using both mouse and human cancerous and non-cancerous tissues to identify the next generation of shared “off-the-shelf” tumor-specific antigens. HOOKIPA will perform the validation experiments and be granted exclusive rights to the development, manufacturing and commercialization of products arising from the collaboration. “Immunotherapy is one of the areas of greatest potential for future cancer treatment. Arguably, all antigen-specific immunotherapy is limited by the scarcity of known antigens. The current group of shared tumor self-antigens has been established for many years, and while more recent efforts have been aimed at identifying patient-specific neo-antigens, systematic attempts to identify the next generation of tumor self-antigens have not been pursued as aggressively,” said Dr. Igor Matushansky, Chief Medical Officer and Global Head of Research and Development of HOOKIPA.  “This is why the primary objective of our next generation, antigen discovery program - entitled HIDE [Human Immunotranscript Discovery initiativE]” - with DarwinHealth is to identify a novel constellation of shared self-antigens for multiple tumor subtypes. Our goal is that following a successful completion of the two-year program, antigens with validated immunogenicity will be deployed clinically as antigen-specific, vector-mediated immunotherapy using our TheraT®* vector.” “DarwinHealth utilizes proprietary, systems biology-generated algorithms to match cancer patients with the drugs and drug combinations that are most likely to produce a successful treatment outcome. These same algorithms can also be used to prioritize investigational drugs and compound combinations of unknown potential against a full spectrum of human malignancies, as well as novel cancer targets,” explained Andrea Califano, Dr. co-founder of DarwinHealth and Clyde and Helen Wu Professor of Chemical Systems Biology and Chair, Department of Systems Biology at Columbia University, “and importantly, for immuno-oncology applications, DarwinHealth can apply proprietary bioinformatics- and experimentally-based methodologies to identify human, cryptic immunogenic transcripts ]]> https://biospectrumindia.com/news/57/12145/marinomed-demonstrates-the-benefits-of-its-patented-marinosolv-technology.html https://biospectrumindia.com/news/57/12145/marinomed-demonstrates-the-benefits-of-its-patented-marinosolv-technology.html Thu, 29 Nov 2018 17:00:00 +0530 Marinomed Biotech AG (Marinomed) – an established Viennese biopharmaceutical company with a global presence – has published the results of scientific investigations that clearly demonstrate the benefits of its Marinosolv® technology platform. The study, which is available to read now in the European Journal of Pharmaceutics and Biopharmaceutics, shows that the solubility of the immunomodulator tacrolimus is 200 times greater in Marinosolv® than in water. This higher solubility could offer significant advantages for producers of tacrolimus-based medicines as well as patients – advantages which Marinomed is already exploiting with the development of Tacrosolv, its product candidate for the treatment of allergic conjunctivitis and dry eye syndrome. Marinomed’s Chief Executive Officer Dr. Andreas Grassauer commented: “These are important results in terms of demonstrating the effectiveness of our Marinosolv® technology platform. This is the basis of our two product candidates Budesolv and Tacrosolv which we are developing for rapidly growing billion-dollar markets.” Budesolv, a solubilized version of the corticosteroid budesonide developed for the treatment of allergic rhinitis, is already being tested in a pivotal clinical phase III trial, and Tacrosolv is expected to reach the phase II trial stage for the treatment of conjunctivitis in 2019. The next step for Tacrosolv will then be a pivotal phase III trial for allergic conjunctivitis and dry eye syndrome. The Marinosolv® platform behind both product candidates was developed by Marinomed in 2015. At present, 40% of approved medicines and nearly 90% of therapeutic molecules currently in the research pipelines of pharmaceutical companies are poorly soluble.* Marinosolv® makes it possible to improve the water solubility of otherwise hardly soluble compounds – resulting in a lower drug dosage and a faster action. The Marinosolv® platform therefore opens up opportunities for the development of products that offer improved local availability of active ingredients in sensitive parts of the body such as the eyes and nose. The impact on the rest of the body is subsequently lower, meaning side effects could be reduced. Marinosolv® also enables preservative-free products to be manufactured with lower production costs. The data on solubilized tacrolimus published by Marinomed’s research team demonstrates how effectively Marinosolv® can function. Commenting on Marinomed’s development objectives for its proprietary platforms, Dr. Grassauer said: “We are planning to capitalize on Marinosolv® to enter the multi-billion-dollar market for the treatment of allergies and eye diseases. All over the world, products from our other platform Carragelose® have already proved successful in treating the causes of colds and flu-like symptoms. We are going to expand both platforms to further strengthen our positions in extremely promising growth markets.” ]]> https://biospectrumindia.com/news/57/12154/80-adolescents-a-day-will-still-die-of-aids-by-2030-despite-slowdown-in-epidemic-un.html https://biospectrumindia.com/news/57/12154/80-adolescents-a-day-will-still-die-of-aids-by-2030-despite-slowdown-in-epidemic-un.html Thu, 29 Nov 2018 12:55:00 +0530 In a report ‘Children, HIV and AIDS: The World in 2030’,current trends indicate AIDS-related deaths and new infections are slowing, but the downward trajectory is not happening fast enough. Henrietta Fore, Chief, UNICEF said, “The report makes it clear, without the shadow of a doubt, that the world is off track when it comes to ending AIDS among children and adolescents by 2030.” The end of AIDS is an ambitious goal envisioned by the UN agency coalition established to tackle the epidemic, known as the UNAIDS, Fast-Track strategy. The report reveals that, “More than half of those children known to be dying of AIDS won’t reach the age of five.” Prevention and infection treatment efforts, Henrietta Fore noted, are still missing the mark, specifically when it comes to “HIV transmission from mothers to babies,” she said. Henrietta Fore added, “Prevention and infection treatment efforts, noted, are still missing the mark, specifically when it comes to HIV transmission from mothers to babies. Programmes to treat the virus and prevent it from spreading among older children are nowhere near where they should be.” The number of mother-to-child infections have fallen by around 40 percent in the last eight years, but girls still account for two-thirds of all adolescent HIV infections, and rates of infection among older children are the slowest to decline, according to current data. Furthermore, the report cites a global target reduction in the number of HIV-infected children by 2030 to 1.4 million, while the projected number today of 1.9 million, shows that the world is off-track by around 500,000. Currently, 3 million persons 19 years and younger, are infected with HIV worldwide. “We can’t win the fight against HIV if we don’t accelerate progress in preventing transmission to the next generation,” said Fore. Two million new infections could be averted by 2030, if global targets are met—this means providing adequate access to HIV prevention, care and treatment services, and testing and diagnoses. The major shortfalls show slow progress in prevention among the young, and a failure to address the key drivers of the epidemic. Many infected children and adolescents are unaware of their illness, and even when tested HIV-positive, rarely adhere to proper treatment.   ]]> https://biospectrumindia.com/news/57/12131/merck-grabs-two-rd-100-awards.html https://biospectrumindia.com/news/57/12131/merck-grabs-two-rd-100-awards.html Wed, 28 Nov 2018 10:25:00 +0530 Merck, a leading science and technology company has won two R&D 100 Awards. The 56th annual R&D 100 Awards program, honoring the 100 most innovative and significant technologies introduced in the past year, recognized Merck for its BioReliance® Viral and Gene Therapy Assay Portfolio and proxy-CRISPR technology. Merck has received nine R&D 100 Awards in the past six years. "We are honored to receive two R&D 100 Awards, one recognizing our continuous focus on making gene therapy more widely accessible to patients in need by developing and implementing our BioReliance®Viral and Gene Therapy assays rapidly," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. He stated further, “The second award highlights Merck as a market leader in gene editing — the result of our longstanding R&D focus on CRISPR technology. I am immensely proud of our teams, who, every day, live our purpose to solve the toughest problems in life science." Merck's BioReliance® Viral and Gene Therapy Assay Portfolio won a R&D 100 Award in the Analytical/Test category. The BioReliance® Viral and Gene Therapy Assay Portfolio is a platform of assays that allows the timely release of viral and gene therapy vectors, cutting testing time nearly in half, while providing accurate and reliable results. Merck developed the assays specifically for viral gene therapy product characterization, purity, potency, safety and release testing. Merck's proxy-CRISPR technology won a Special Recognition Market Disruptor --Products award. Market disruptor awards are given to those that have the potential to be "game changers," disrupting established technologies and transforming their respective industry. Proxy-CRISPR is a new genome-editing tool for improving the performance of other newly discovered CRISPR proteins. This technology makes CRISPR more efficient, flexible and specific by opening up the DNA helix so researchers can make targeted sequence changes in previously inaccessible regions of the genome. Merck's proxy-CRISPR provides a rapid and simple method to increase usability without the laborious need to re-engineer native CRISPR proteins. The R&D 100 Awards are among the most prestigious innovation awards, honoring research and development pioneers.   ]]> https://biospectrumindia.com/news/57/12124/drc-initiates-first-ever-multi-drug-ebola-trial.html https://biospectrumindia.com/news/57/12124/drc-initiates-first-ever-multi-drug-ebola-trial.html Tue, 27 Nov 2018 11:30:00 +0530 First-ever multi drug trial for an Ebola treatment has been announced by The Ministry of Health of the Democratic Republic of the Congo (DRC). This randomized control trial has begun to evaluate the effectiveness and safety of drugs used in the treatment of Ebola patients. It will form a part of multi-outbreak, multi-country study agreed to by partners under a World Health Organization (WHO) initiative. Dr Tedros Adhanom Ghebreyesus, Director-General, WHO said, “While our focus remains on bringing this outbreak to an end, the launch of the randomized control trial in DRC is an important step towards finally finding an Ebola treatment that will save lives. Until now, patients have been treated under a compassionate use protocol, with drugs that showed promise and had a good safety profile in laboratory conditions. The giant step DRC is taking now will bring clarity about what works best, and save many lives in years to come. We hope to one day say that the death and suffering from Ebola is behind us.”    The current trial is coordinated by WHO, and led and sponsored by the DRC’s National Institute for Biomedical Research (INRB), in partnership with the DRC Ministry of Health, the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the United States’ National Institutes of Health, The Alliance for International Medical Action (ALIMA) and other organizations. Until now, over 160 patients have been treated with investigational therapeutics under an ethical framework developed by WHO, in consultation with experts in the field and the DRC, called the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). The MEURI protocol was not designed to evaluate the drugs. Now that protocols for trials are in place, patients will be offered treatments under that framework in the facilities where the trial has started. In others, compassionate use will continue up to the time when they join the randomization. Patients will not be treated noticeably differently from before, though the treatment they receive will be decided by random allocation. The data gathered will become standardized and will be useful for drawing conclusions about the safety and efficacy of the drugs. Dr. Olly Ilunga, Minister of Health of the DRC said, “Our country is struck with Ebola outbreaks too often, which also means we have unique expertise in combatting it. These trials will contribute to building that knowledge, while we continue to respond on every front to bring the current outbreak to an end.”   WHO conducted a meeting of international organizations, United Nations partners, countries at risk of Ebola, drug manufacturers and others to agree on a framework to continue trials in the next Ebola outbreak in the month of October. Over time, this will lead to an accumulation of evidence that will help to draw robust conclusions across outbreaks about the currently available drugs, and any new ones that may come along. ]]> https://biospectrumindia.com/news/57/12116/akelos-inc-completes-seed-financing-for-neuropathic-pain-treatment.html https://biospectrumindia.com/news/57/12116/akelos-inc-completes-seed-financing-for-neuropathic-pain-treatment.html Tue, 27 Nov 2018 10:15:00 +0530 Akelos Inc., a biopharmaceutical company focused on the development of new drugs for neuropathic pain, has completed a $295,000 seed financing to provide initial funds for research collaboration with Well Cornell Medicine to develop and commercialize a novel, non-opioid anti hyperalgesic drug to treat chronic and neuropathic pain. The pre-clinical laboratory research that gave rise to the underlying technology was enabled through prior support provided by Weill Cornell Medicine’s Daedalus Fund for Innovation, an “accelerator” type program that provides gap funding for select research projects at Weill Cornell Medicine with manifest commercial potential. Weill Cornell Medicine’s Office of BioPharma Alliances and Research Collaborations, which leads the Daedalus Fund for Innovation, catalyzed and negotiated the Agreement with Akelos. Dr. Peter Goldstein, a professor of anesthesiology at Weill Cornell Medicine and a principal investigator in the C.V. Starr Laboratory for Molecular Neuropharmacology in the institution’s Department of Anesthesiology, will participate on the Scientific Advisory Board of Akelos. “The unprecedented opioid epidemic has made it all the more important to develop new medications that relieve pain without the addictive qualities that can lead to dependency. Our collaboration with Weill Cornell Medicine researchers, led by Dr. Goldstein, is a critical step to realizing that goal,” said Dr. Steven Fox, chairman of Akelos. ]]> https://biospectrumindia.com/news/57/12109/lunit-fujifilm-unite-with-salud-digna-to-provide-medical-ai-solution-.html https://biospectrumindia.com/news/57/12109/lunit-fujifilm-unite-with-salud-digna-to-provide-medical-ai-solution-.html Mon, 26 Nov 2018 11:20:00 +0530 Medical AI company, Lunit announced its corporate partnership with FUJIFILM Medical Systems USA, Inc. and Salud Digna in a joint AI project to provide a medical AI solution for the local population in Mexico. Lunit's medical AI solution for chest radiography and mammography, Lunit INSIGHT, will be integrated into Fujifilm Synapse PACS system, which will then be evaluated by 20 radiologists in Salud Digna, one of the largest diagnostic service providers in Mexico. Upon the evaluation, Lunit and FUJIFILM Medical Systems USA, Inc. will seek to further develop the application and technology for more effective implementation on site. The project also includes an evaluation of worklist prioritization feature which could help to improve productivity in diagnosis. "We're happy to have Fujifilm and Salud Digna as our partners in beginning the onsite installation of Lunit's AI solutions for medical imaging," said Brandon Suh, CEO of Lunit. "Mexico is one of the countries that experience constraint in the number of radiologists—4,000 radiologists at 7,000 medical facilities, serving 130 million patients—that is less than one radiologist per facility. This is one of the situations that we had been hoping to contribute with our technology and we are confident that our medical AI solution can present a great opportunity to improve productivity." According to a recent study published in <Radiology>, Lunit's AI solution surpassed physicians of all level in accuracy. It also has been proven to increase the performance level of non-radiology physicians as much as 20% when used as a second reader. Lunit says its AI solution for chest x-ray has an accuracy level of 97-99% and 97% for mammography. "Fujifilm is very excited about the opportunities to have clinicians at Salud Digna evaluate our open AI platform in conjunction with Lunit's AI solutions," said Tak Shimomura, Chief Technical Officer of Medical Informatics at FUJIFILM Medical Systems, U.S.A., Inc. Salud Digna healthcare network has 94 clinics around 24 states in Mexico. It had screened and diagnosed more than 182,000 images only in October, of which 108,450 were computed radiography and 63,880 were mammography cases. ]]> https://biospectrumindia.com/news/57/12107/who-eu-to-accelerate-progress-on-health.html https://biospectrumindia.com/news/57/12107/who-eu-to-accelerate-progress-on-health.html Mon, 26 Nov 2018 10:30:00 +0530 Dr Tedros commended the fruitful cooperation between the European Commission and the World Health Organisation (WHO), particularly in the fields of antimicrobial resistance, strengthening health systems and preparedness for outbreaks of communicable diseases in developing countries. President Juncker confirmed the support of the European Commission to the Global Action Plan on Health and Well Being to accelerate progress to achieve Sustainable Development Goals, including goal number 3, related to healthy lives and well-being at all ages. President Juncker and Dr Tedros also spoke about the importance of focusing on air pollution and agreed to jointly organize a Global Vaccination Summit, building on initiatives to increase vaccination and improve vaccination confidence in the EU, with the aim of avoiding unnecessary deaths from preventable diseases. Dr Tedros met separately with Commissioner Vytenis Andriukaitis responsible for Health and Food Safety; Commissioner Neven Mimica, responsible for international cooperation and development; Commissioner for Humanitarian aid and crisis management, Christos Stylianides and Commissioner Karmenu Vella, in charge of the Environment, Fisheries and Maritime Affairs;, as well as with Director-General for Research, Science and Innovation Jean Paquet. On the occasion of the 70th anniversaries of WHO and of the Universal Declaration of Human Rights , Dr Tedros emphasized that “Both WHO’s Constitution and the Universal Declaration of Human Rights assert that health is a human right, rather than a privilege for those who can afford it. But we must remember that the right to health is not a given. It takes renewed political commitment and leadership in every generation – including ours.” “The right to health “has been a platform for major health improvements” in the past 70 years. Globally, life expectancy has increased by 25 years. Smallpox has been eradicated and polio is on the brink”, he added. However, Dr Tedros warned of the rise of new health threats and the need for “unrelenting political commitment” to achieve Universal health coverage and the Sustainable Development Goals. ]]> https://biospectrumindia.com/news/57/12088/roquette-chooses-barentz-as-a-preferred-distributor-in-europe.html https://biospectrumindia.com/news/57/12088/roquette-chooses-barentz-as-a-preferred-distributor-in-europe.html Thu, 22 Nov 2018 15:25:00 +0530 Roquette, a global leader in plant-based ingredients for Food, Nutrition and Health markets, has appointed Barentz as the preferred distribution partner for Roquette’s pharmaceutical product range in Europe. Barentz and Roquette have been successfully working together for many years in several European countries by developing distribution channels backed by a strong technical expertise. This appointment is driven by Roquette’s strategic plan to implement a new high performance distribution network to support its position as a world leading pharmaceutical excipients’ company. Having worked together successfully at the logistics and strategic levels for many years, the preferred distributor status is a logical step in the cooperation between Roquette and Barentz. Laurent Cousin, Head of Global Distribution Management at Roquette says: “Roquette is committed to providing its customers with high quality plant-based ingredients as well as an excellent level of service and we have strong growth ambitions to better serve our customers worldwide. Barentz has been a key partner for years with added value in terms of their specialized expertise, research teams and local labs. Thanks to their knowledge of our products and strategy, we are able to operate together in perfect harmony.” Anthony Litchfield, Director of the Pharmaceutical Division at Barentz, is also proud of the deeper collaboration: “We are pleased and proud that we will be supplying and providing solutions to more customers in even more European countries with Roquette’s comprehensive and high quality product range for Pharma and Nutra companies. We see it as the next chapter in our alliance.” High quality products available in almost all European countries The collaboration between Roquette and Barentz is expanding to countries including Austria, Cyprus, France, Iceland, Ireland, Malta, Switzerland and the United Kingdom. This is in addition to the Baltic States, Belgium, Bosnia, Bulgaria, Croatia, the Czech Republic, Finland, Germany, Greece, Hungary, Macedonia, the Netherlands, Poland, Romania, the Scandinavian countries, Serbia, Slovakia, Slovenia and Turkey. This means that Barentz will soon be able to offer and supply Roquette’s extensive product range to customers in most European countries. Between now and the end of 2018 both companies will work together to ensure alignment in all countries with the exception of the UK, Ireland and France where co-operation will officially start from the 1st of July 2019. ]]> https://biospectrumindia.com/news/57/12081/nih-explains-behavioral-reaction-to-painful-experiences.html https://biospectrumindia.com/news/57/12081/nih-explains-behavioral-reaction-to-painful-experiences.html Wed, 21 Nov 2018 18:15:00 +0530 Researchers at the National Centre for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, have identified activity in the brain that governs the reactions that are generated due to exposure to uncomfortable sensations. Using heat as the source of discomfort, experiments conducted by the center’s intramural program showed that bodily responses to pain are controlled by a neural pathway involving heightened activity in the spinal cord and two parts of the brainstem. Alexander T. Chesler, Stadtman Investigator at NCCIH and senior author of the study said, “Much is known about local spinal cord circuits for simple reflexive responses, but the mechanisms underlying more complex behaviors remain poorly understood. We set out to describe the brain pathway that controls motor responses and involuntary behaviors when the body is faced with painful experiences.” Experiments showed that the parts of a brainstem involved in this circuit are the parabrachial nucleus (PBNI) and the dorsal reticular formation in the medulla (MdD). A specific group of nerve cells in the PBNI is activated by standing on a hot surface, triggering escape responses through connections to the MdD. These PBNI cells express a gene called Tac1, which codes for substances called tachykinins that participate in many functions in the body and contribute to multiple disease processes. The MdD cells involved in this circuit also express Tac1. A different group of cells in the PBNI participates in the aspects of the response to noxious heat that involve the forebrain. Arnab Barik, postdoctoral fellow at NCCIH and one of the study’s authors said, “Our data provide evidence that the PBNI produces streams of information with distinct functional significance. The brainstem-spinal cord pathway identified in this study selectively controls pain response and elicits appropriate behaviors based on sensory input.” “This kind of feed-forward circuitry is unique because it is an upward spiral. The more this pathway is activated by harmful activity, the more it reacts, leading to dramatic behavioral responses”, added Chesler With this knowledge of the brain activity, NIH provides new insight into how the body responds to harmful, painful stimuli. The mechanism described in this study can help researchers better understand how pain is encoded in the brain. Further investigation of this circuit may increase understanding of how responses to pain are coordinated with other biological needs, such as feeding and reproduction. These findings may also offer opportunities to understand how the body becomes dysregulated during chronic pain. ]]> https://biospectrumindia.com/news/57/12080/3d-images-from-worlds-first-full-body-scanner.html https://biospectrumindia.com/news/57/12080/3d-images-from-worlds-first-full-body-scanner.html Wed, 21 Nov 2018 15:50:00 +0530 Images from the world's first full-body 3D medical scanner named EXPLORER have been released. This scanner is developed by scientists from UC Davis, the scanner combined positron emission tomography (PET) and X-ray computed tomography (CT) to capture the entire body at once. Scientists Simon Cherry and Ramsey Badawai believe the technology will have "countless applications" from improving diagnostics through to drug research and tracking disease progression. The first images of human scans from the EXPLORER are to be presented at a meeting of the Radiological Society of North America on 24 November in Chicago. "While I had imagined what the images would look like for years, nothing prepared me for the incredible detail we could see on that first scan," said Mr Cherry, distinguished professor in the UC Davis department of biomedical engineering. EXPLORER will have a profound impact on clinical research and patient care because it produces higher-quality diagnostic PET scans than have ever been possible, they said. It also scans up to 40 times faster than current PET scans and can produce a diagnostic scan of the whole body in as little as 20-30 seconds, according to the researchers. "While there is still a lot of careful analysis to do, I think we already know that EXPLORER is delivering roughly what we had promised." Mr Badawi, chief of nuclear medicine at UC Davis Health and vice-chair for research in the department of radiology, said he was dumbfounded when he saw the first images. The level of detail was astonishing, especially once we got the reconstruction method a bit more optimised," he said. "We could see features that you just don't see on regular PET scans. And the dynamic sequence showing the radiotracer moving around the body in three dimensions over time was, frankly, mind-blowing." "There is no other device that can obtain data like this in humans, so this is truly novel added.I don't think it will be long before we see at a number of EXPLORER systems around the world,” Mr Badawi added. ]]> https://biospectrumindia.com/news/57/12074/lack-of-gut-bacteria-may-lead-to-type-2-diabetes-.html https://biospectrumindia.com/news/57/12074/lack-of-gut-bacteria-may-lead-to-type-2-diabetes-.html Tue, 20 Nov 2018 17:55:00 +0530 Researchers reported that old mice have less Akkermansia muciniphila bacteria than young mice do. That loss triggers inflammation, which eventually leads cells to ignore signals from the hormone insulin. Such disregard for insulin’s message to take in glucose is known as insulin resistance and is a hallmark of type 2 diabetes. Researchers have suspected that bacteria and other microbes in the gut are involved in aging, but how the microbes influence the process hasn’t been clear. Monica Bodogai of the U.S. National Institute on Aging in Baltimore and colleagues examined what happens to mice’s gut bacteria as the rodents age. The mice lose A. muciniphila, also called Akk, and other friendly microbes that help break down dietary fiber into short-chain fatty acids, such as butyrate and acetate. Those fatty acids signal bacteria and human cells to perform certain functions. Losing Akk led to less butyrate production, Bodogai’s team found. In turn, loss of butyrate triggered a chain reaction of immune cell dysfunction that ended with mice’s cells ignoring the insulin. Treating old mice and elderly rhesus macaques with an antibiotic called enrofloxacin increased the abundance of Akk in the animals’ guts and made cells respond to insulin again. Giving old animals butyrate had the same effect, suggesting that there may be multiple ways to head off insulin resistance in older people in the future. ]]> https://biospectrumindia.com/news/57/12072/amgen-becomes-a-new-member-of-cqdm-.html https://biospectrumindia.com/news/57/12072/amgen-becomes-a-new-member-of-cqdm-.html Tue, 20 Nov 2018 16:30:00 +0530 CQDM is pleased to welcome Amgen as a new member of its biopharmaceutical research consortium established to identify and invest in highly innovative biopharmaceutical research projects in Quebec and Canada with the ultimate goal of enabling the development of better treatments for patients. This announcement was made at CQDM's 10th Anniversary Forum in the presence of over 300 stakeholders of the life sciences industry.  "The Québec government firmly believes in the importance of coordinating biopharmaceutical research and will continue to support partnership initiatives that establish Québec as an important player in the development of innovative treatments.  Bringing Amgen on board with CQDM is in line with our desire to encourage partnerships and increase the economic spinoffs associated with the innovations that result." "We are delighted to welcome Amgen at CQDM. It is world-leading biopharmaceutical companies who will bring key expertise to the development of the next generation of innovative technologies that are essential to the growth of our economy," said Diane Gosselin, President, and CEO of CQDM. "We are thrilled to be officially joining CQDM's biopharmaceutical research consortium," stated Philip Tagari, Amgen's Vice President of Therapeutic Discovery. "Amgen has long recognized the high-quality research that emerges out of Quebec. In fact, some of the clinical science that supported the development of Amgen's most recent cardiovascular drug, Repatha®, was undertaken at the Montreal Clinical Research Institute. From regenerative medicine, to stem cell manufacturing, to artificial intelligence, Quebec is leading in many ways and we are excited about the partnership opportunities that CQDM offers." "The Government of Quebec has long recognized the importance of the biopharmaceutical industry to its economy," said Francesco Di Marco, Vice President and General Manager of Amgen Canada. "Our investment in CQDM is recognition of the importance of Quebec as a partner in growing the life sciences sector in Canada. CQDM's research consortium brings together local emerging companies, great science and the resources of multinational enterprises for the benefit of the patients we serve. We are extremely excited about what we can accomplish together." ]]> https://biospectrumindia.com/news/57/12066/forbion-leads-40m-series-b-financing-in-inflazome.html https://biospectrumindia.com/news/57/12066/forbion-leads-40m-series-b-financing-in-inflazome.html Tue, 20 Nov 2018 13:10:00 +0530 Forbion, a leading European life science venture capital firm has announced that it has led a Series B financing round of €40 million ($46 million) in Inflazome, a pioneering inflammasome company developing small molecule drugs that block harmful inflammation. Forbion invested from its recently launched Forbion IV Fund. Longitude Capital and founding investors, Novartis Venture Fund and Fountain Healthcare Partners also participated in the round. Clinical and scientific data indicates that the NLRP3 inflammasome, a compelling biological target that regulates our innate immune response, is overactive in a broad range of serious medical conditions driven by harmful inflammation. These include neurological disorders such as Alzheimer’s and Parkinson’s, cardiovascular diseases, arthritis, liver inflammation and asthma; conditions often inadequately treated by current therapies. Inflazome is developing potent and selective small-molecule inhibitors of the NLRP3 inflammasome, to stop the cycle of chronic inflammation that drives such diseases. The Series B proceeds will be used to advance the Company’s first-in-class NLRP3 inflammasome inhibitors into multiple clinical trials in 2019, with next-generation compounds following thereafter. Following the completion of the financing round, Dr Marco Boorsma, a General Partner at Forbion, and Dr David Hirsch, a Managing Director and Founder of Longitude Capital, have joined Inflazome’s Board of Directors. Dr Marco Boorsma, General Partner at Forbion Capital Partners, commented: “Recognizing the important role of the inflammasome in many major diseases, we intensively screened the universe of companies active in this space. We decided to back Inflazome because of their leading position, deep understanding of inflammasome biology, foundational IP position and advanced and diversified pipeline of NLRP3 modulators. We were also highly impressed with the experience and knowledge of the Company’s Management Team and Board.” Dr Matt Cooper, Co-Founder and CEO of Inflazome, commented: “We are very pleased to have secured a new partnership with leading EU and US investors Forbion and Longitude and additional support from our founding investors, Novartis Venture Fund and Fountain Healthcare Partners. Both Forbion and Longitude have excellent track records of working closely with biotechs to drive R&D programs to successful clinical outcomes.” ]]> https://biospectrumindia.com/news/57/12065/sandoz-pear-therapeutics-announce-launch-of-reset.html https://biospectrumindia.com/news/57/12065/sandoz-pear-therapeutics-announce-launch-of-reset.html Tue, 20 Nov 2018 13:05:00 +0530 Sandoz, a Novartis division, and Pear Therapeutics, Inc., has announced the commercial launch of reSET for patients with Substance Use Disorder (SUD). reSET, the first and only FDA-authorized prescription digital therapeutic, is immediately available. Study results from a multicenter, randomized clinical trial showed that reSET, when used with outpatient therapy and contingency management, significantly improved abstinence in substances of abuse and increased retention as compared to outpatient therapy alone. The reSET therapeutic content was validated in a randomized clinical trial through the National Institute of Drug Abuse (NIDA) Clinical Trial Network. reSET is a 12-week (90-day) prescription digital therapeutic to be used in conjunction with outpatient clinician-delivered care. reSET offers interactive treatment modules that deliver cognitive behavioral therapy and fluency training to reinforce proficiency. Within the clinician dashboard, clinicians can follow patient-reported substance use, cravings, and triggers to facilitate transparency and deeper interaction between patients and clinicians at face-to-face meetings. “We all have a role to play in helping find solutions that work for patients, families and communities as we fight the substance abuse epidemic,” said Richard Francis, CEO, Sandoz. “Adding reSET to outpatient therapy enhances behaviors associated with recovery. It leverages new technology to help patients improve abstinence in substances of abuse and stay in treatment programs longer than outpatient therapy alone.” “Patients with Substance Use Disorder deserve access to more effective, convenient, and innovative treatment options,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “reSET has been clinically validated to significantly improve outcomes for patients, while also providing patients a discreet way to access care when and where they need it. Prescription digital therapeutics will help redefine the treatment of serious diseases like Substance Use Disorder, providing improved patient outcomes, and driving clinical insights for clinicians.” To support patients and clinicians, Pear Therapeutics has also launched the reSET Connect Patient Service Center. A specialist is available to provide access to reSET, walk patients and clinicians through the steps for downloading and using reSET, troubleshoot any issues with reSET, and work with the patient’s insurance company to ensure a seamless treatment experience. In April, Sandoz entered into a collaboration with Pear Therapeutics, Inc. to commercialize and continue development of reSET – designed to effectively augment clinicians and improve clinical outcomes for patients. The collaboration brought together Sandoz expertise in launching and commercializing treatments with Pear's leading experience in prescription digital therapeutics design, development, and implementation. SUD is a chronic, relapsing disease caused by the recurrent use of alcohol or drugs – or both. For people with SUD, treatment has typically meant resource-intensive, face-to-face interactions in a specialized setting. Inconsistent quality in treatment, disparities in payment for behavioral health services, and limited accessibility has led to poor treatment outcomes, including low rates of abstinence and high dropout rates. This collaboration is part of the Sandoz and Novartis strategic effort to work with innovative digital health leaders to drive the next wave of medical innovation. Sandoz and Novartis are collaborating to develop technologies to monitor patient data in real-time, detect day-to-day behavioral and biological changes in condition, improve patient adherence, and ultimately enhance treatment outcomes by helping patients to take a more active role in their own healthcare. Pear is a leader in developing prescription digital therapeutics, developing the first FDA-authorized prescription digital mobile medical application with both a safety and effectiveness label to help treat patients with SUD. ]]> https://biospectrumindia.com/news/57/12064/who-and-partners-launch-new-country-led-response-for-malaria.html https://biospectrumindia.com/news/57/12064/who-and-partners-launch-new-country-led-response-for-malaria.html Tue, 20 Nov 2018 11:35:00 +0530 In order to scale up prevention and treatment, and increased investment, to protect vulnerable people from Malaria, WHO and partners are joining a new country-led response. According to new malaria report 2018, reductions in malaria cases have stalled after several years of decline globally. Annual report produced by WHO reveals a plateauing in numbers of people affected by malaria. In 2017, there were an estimated 219 million cases of malaria, compared to 217 million the year before. But in the years prior, the number of people contracting malaria globally had been steadily falling, from 239 million in 2010 to 214 million in 2015. Dr Tedros Adhanom Ghebreyesus, WHO Director-General says, “Nobody should die from malaria. But the world faces a new reality: as progress stagnates, we are at risk of squandering years of toil, investment and success in reducing the number of people suffering from the disease. We recognise we have to do something different – now. So today we are launching a country-focused and -led plan to take comprehensive action against malaria by making our work more effective where it counts most – at local level.” In 2017, approximately 70% of all malaria cases (151 million) and deaths (274 000) were concentrated in 11 countries: 10 in Africa (Burkina Faso, Cameroon, Democratic Republic of the Congo, Ghana, Mali, Mozambique, Niger, Nigeria, Uganda and United Republic of Tanzania) and India. There were 3.5 million more malaria cases reported in these 10 African countries in 2017 compared to the previous year, while India, however, showed progress in reducing its disease burden. The report highlights that despite marginal increases in recent years in the distribution and use of insecticide-treated bed nets in sub-Saharan Africa – the primary tool for preventing malaria. In 2017, an estimated half of at-risk people in Africa did not sleep under a treated net. Also, fewer homes are being protected by indoor residual spraying than before, and access to preventive therapies that protect pregnant women and children from malaria remains too low. In line with WHO’s strategic vision to scale up activities to protect people’s health, the new country-driven “High burden to high impact” response plan has been launched to support nations with most malaria cases and deaths. Targets set by the WHO Global technical strategy for malaria 2016–2030 to reduce malaria case incidence and death rates by at least 40% by 2020 are not on track to being met. Catalyzed by WHO and the RBM Partnership to End Malaria, “High burden to high impact” builds on the principle that no one should die from a disease that can be easily prevented and diagnosed, and that is entirely curable with available treatments. Dr Kesete Admasu, CEO of the RBM Partnership said, “There is no standing still with malaria. The latest World malaria report shows that further progress is not inevitable and that business as usual is no longer an option. The new country-led response will jumpstart aggressive new malaria control efforts in the highest burden countries and will be crucial to get back on track with fighting one of the most pressing health challenges we face.” Dr Matshidiso Moeti, WHO Regional Director for Africa says, “When countries prioritize action on malaria, we see the results in lives saved and cases reduced. WHO and global malaria control partners will continue striving to help governments, especially those with the highest burden, scale up the response to malaria.” In 2018, WHO certified Paraguay as malaria free making it the first country in the Americas to receive this status in 45 years. Three other countries – Algeria, Argentina and Uzbekistan – have requested official malaria-free certification from WHO. India – a country that represents 4% of the global malaria burden – recorded a 24% reduction in cases in 2017 compared to 2016. Also in Rwanda, 436 000 fewer cases were recorded in 2017 compared to 2016. Ethiopia and Pakistan both reported marked decreases of more than 240 000 in the same period. ]]> https://biospectrumindia.com/news/57/12062/abbott-launches-new-system-to-treat-chronic-pain.html https://biospectrumindia.com/news/57/12062/abbott-launches-new-system-to-treat-chronic-pain.html Mon, 19 Nov 2018 20:40:00 +0530 Abbott has announced the launch of the new DRG Invisible Trial System, which is approved by the U.S. Food and Drug Administration (FDA) and received CE Mark in Europe. People battling complex chronic pain conditions can now use the DRG Invisible Trial System to try Abbott's dorsal root ganglion (DRG) stimulation—a clinically proven, non-opioid treatment option for targeted chronic pain management. Patients who find adequate pain relief with DRG therapy can then have Abbott's Proclaim DRG system implanted, empowering them to manage their pain with familiar Apple consumer technology. A form of neurostimulation, Abbott's DRG therapy specifically targets the dorsal root ganglion—a structure adjacent to the spinal cord densely populated with sensory nerves that transmit chronic pain to the central nervous system. The therapy helps people living with neuropathic pain conditions by blocking pain signals with electrical pulses transmitted over the DRG. Clinical research, such as the ACCURATE study, has demonstrated that DRG therapy can provide superior pain relief when compared to traditional spinal cord stimulation (SCS) therapy for patients with persistent neuropathic focal pain conditions. Focal chronic pain conditions, including complex regional pain syndrome (CRPS), are some of the most prevalent and under-treated forms of chronic pain around the world. ]]> https://biospectrumindia.com/news/57/12055/mobilehelp-healthcare-expands-diabetes-management-platform.html https://biospectrumindia.com/news/57/12055/mobilehelp-healthcare-expands-diabetes-management-platform.html Mon, 19 Nov 2018 12:35:00 +0530 MobileHelp® Healthcare, a leader in personal and enterprise healthcare technology solutions, announced expanded diabetes management capabilities through a new business relationship with Polymap Wireless. The collaboration between MobileHelp Healthcare and Polymap Wireless will allow healthcare providers to monitor patient glucose levels in addition to other vital signs such as blood pressure and weight through the MobileVitals® remote patient monitoring (RPM) platform.  The Polytel® Wireless Glucose Meter Accessory 3 (GMA3) is a Bluetooth Smart (BLE) adapter, configured to transfer medical data wirelessly from an in-home glucose monitor of the patient's choice to the MobileHelp Touch tablet base station, the communication hub of the MobileVitals system. The data is then seamlessly transferred to professional caregivers for review and feedback to the patient. "Millions of patients have glucose meters they like to use, but they don't have the built-in connectivity they need to communicate with a smart monitoring device," said Pierre Landau, Founder and President of Polymap Wireless. "Our GMA3 adapter makes it easy and secure to incorporate those legacy glucose meters into a diabetes monitoring system, such as the MobileVitals RPM solution." The GMA3 adapts to the following in-home glucose monitors: GMA3-LS for LifeLifeScan OneTouch® Ultra® Ultra® 2, and UltraMini, UltraEasy, Select GMA3-BY for Bayer Contour®, Contour® TS, Contour® Next EZ, Contour® XT and Breeze2® GMA3-AB for Abbott FreeStyle® Lite and FreeStyle® Freedom® Lite GMA3-NI for Nipro / Trividia TRUEresultTM, TRUEmetrixTM, TRUEtrackTM and TRUEbalanceTM GMA3-US for Accu-Chek Aviva Connect The Polytel Wireless GMA3 adapters will be available as part of the MobileVitals RPM platform . ]]> https://biospectrumindia.com/news/57/12039/nbe-therapeutics-appoints-dr-anthony-tolcher-on-scientific-advisory-board-.html https://biospectrumindia.com/news/57/12039/nbe-therapeutics-appoints-dr-anthony-tolcher-on-scientific-advisory-board-.html Fri, 16 Nov 2018 12:20:00 +0530 NBE Therapeutics AG, a biopharmaceutical company developing next-generation immune-stimulatory antibody-drug conjugates (iADCs™) for improved cancer therapy, today announces the appointment of Dr. Anthony Tolcher to NBE's Scientific Advisory Board (SAB). Dr. Tolcher is a Board certified Medical Oncologist from San Antonio, TX, U.S.A., with significant experience in performing early-stage clinical trials with Antibody Drug Conjugates (ADCs). Dr. Tolcher was previously co-founder and a leading member of START (South Texas Accelerated Research Therapeutics), managing a network of global clinical trial centers across the U.S., Europe and Asia. Currently, Dr. Tolcher is founder and CEO of NEXT-Oncology in San Antonio, TX, U.S.A, a clinical research organization dedicated to advance highly innovative cancer medicines to first-in-human clinical trials. Dr. Tolcher is a renowned key opinion leader in the field of clinical development of ADCs and advises NBE-Therapeutics on its strategies to advance NBE's late-stage preclinical development pipeline of iADCs™ to early stage clinical validation in cancer patients (phaseI/II clinical trials). Dr. Tolcher said, "Having performed a comprehensive review of NBE's late-stage preclinical data for NBE-Therapeutic's iADC programs, and in particular NBE's lead program NBE-002 targeting ROR-1 to treat difficult solid tumors, like triple negative breast cancer (TNBC), sarcoma and lung cancer, I am very excited to support NBE-Therapeutics to advance its iADC programs to the clinic. There are tremendous opportunities of NBE's platform to lead to advancements in the treatment of many cancers and as a combination with current and future immune checkpoint inhibitors.” ]]> https://biospectrumindia.com/news/57/12035/gofire-launches-data-driven-health-tracking-app.html https://biospectrumindia.com/news/57/12035/gofire-launches-data-driven-health-tracking-app.html Thu, 15 Nov 2018 17:15:00 +0530 Gofire, a Denver-based digital healthcare company, has released a groundbreaking app and scannable DoseCode technology as part of its comprehensive health suite for plant-based medicine. The app allows patients to find products, anonymously contribute and access reviews within the community, track personal dosages and document outcomes. The Gofire DoseCode is a branded QR code attached to exclusive plant-based medical products found in hundreds of retailers across Colorado. After downloading the Gofire app, patients use their phone to scan a DoseCode on edibles, topicals, tinctures and extracts, which pulls the chemical profile of that product validated from a third-party testing lab. The patient rates how each dose worked for their relief, anonymously tracking every session to discover trends and create a consistent, repeatable experience. When patients download the Gofire app, they join a community of like-minded individuals searching for a similar type of relief. The app gives patients access to education and anonymous product ratings from other community members. This enables them to determine which products and dose sizes will work best for their needs and then drives them to a map where they can find specific products at retailers in the area. ]]> https://biospectrumindia.com/news/57/12005/nosopharm-appoints-dr-sarah-gould-as-chief-development-officer.html https://biospectrumindia.com/news/57/12005/nosopharm-appoints-dr-sarah-gould-as-chief-development-officer.html Mon, 12 Nov 2018 16:15:00 +0530 Nosopharm, a France-based biotechnology company dedicated to the research and development of new anti-infective drugs, announces today the appointment of Dr Sarah Gould as chief development officer. In this post, she will oversee the translation of Nosopharm’s R&D programs from the pre-clinical to the clinical development stage. Dr Sarah Gould brings over 20 years’ experience in non-clinical pharmacology and toxicology. She was previously at Adocia, where she was non-clinical director for pharmacology and toxicology. Prior to this, Dr Gould worked as senior director for non-clinical safety at Sanofi Pasteur and held several positions at AstraZeneca UK. She has a PhD in Biological Sciences from Victoria University of Manchester.  "We are thrilled to welcome Dr Sarah Gould as chief development officer. We have reached a crossroads in the development of NOSO-502. Sarah has the proven track record to make this first-in-class antibiotic progress towards the next step: entry into the first-in-human clinical studies,” said Philippe Villain-Guillot, co-founder and chief executive officer of Nosopharm. “I’m delighted to have this opportunity. I’ve worked for many years in big pharma, where I gained a lot of experience in drug and vaccine development. To now take that expertise to Nosopharm, an evolving biotech, and to use it to develop a much-needed antibiotic is a pleasure. It will no doubt be a challenge but I hope to continue to learn as biotech companies reshape the pharmaceutical drug development model and learn how to keep the creativity and flexibility that they bring,” said Dr Sarah Gould. Nosopharm’s lead candidate, NOSO-502, is the first clinical candidate in the novel antibiotic class called Odilhorhabdins (ODLs). It inhibits the bacterial ribosome with a new mechanism of action and is intended for the treatment of nosocomial infections caused by Enterobacteriaceae, including polymyxin- and carbapenem-resistant Enterobacteriaceae (CRE). NOSO-502 has proven to be effective in vivo in several Enterobacteriaceae infection models and demonstrated antibacterial activity in vitro against multi-drug resistant clinical isolates (KPC, NDM, and OXA among others). Nosopharm expects IND-enabling studies to start in 2019 and to launch first-in-human studies with NOSO-502 in 2020. ]]> https://biospectrumindia.com/news/57/12004/retipharma-to-develop-treatments-of-degenerative-eye-disorders.html https://biospectrumindia.com/news/57/12004/retipharma-to-develop-treatments-of-degenerative-eye-disorders.html Mon, 12 Nov 2018 15:50:00 +0530 Denmark based RetiPharma, focusing on the development of products for the treatment of degenerative eye disorders based on an in vivo platform for translation from in vivo models to humans, is pleased to announce that it has secured funding from the Novo Nordisk Foundation’s BioInnovation Institute (BII). The funding will be used to prepare its lead drug RP001 for a clinical proof-of-concept study in patients with retinal detachment as well as to in source additional compounds using RetiPharma’s unique translational platform.  RP001 is a new peptide drug for intravitreal [eye] injection that already has demonstrated functional improvement of the sight as well as neuroprotection in several in vivo models. The BII has provided EUR 1.3 million as funding in a convertible note which paid in tranches according to achievement of agreed milestones. “RetiPharma has a skilled team with lots of passion for their exciting new concept that addresses an unmet medical need in treating degenerative eye disorders. “We are glad to have RetiPharma in our newly opened incubator,” says Thomas Nagy, Director of BII. “We are very pleased to have secured funding which offers a perfect platform for further development of RetiPharma. We have already started the process to prepare for the next financing round to strengthen our program” says Henrik Vissing, CEO. RetiPharma is supported by a strong scientific and clinical team lead by David Woldbye, MD and Kristian Klemp, MD Chief Physician, specialised in retinal detachment surgery at Rigshospitalet. David has been working with NPY at the University of Copenhagen for decades and RetiPharma is the second company based on his research. “We are always very happy and proud to see our researchers start new companies and get their inventions developed into promising treatments for patients”, says Trine Winterø, Vice Dean for Innovation at the University of Copenhagen. Assuming the positive in vivo effects of RP001 can be demonstrated in patients with retinal detachment, it will open up a potential to explore this novel target in other degenerative eye disorders, such as Retinal Vein Occlusion (RVO), Acute Glaucoma, Diabetic Macular Edema (DME) and Age-related Macular Degeneration (AMD). The translational in vivo platform has been developed in parallel with the groundwork of RP001 that have already demonstrated effect on end-points that are relevant for clinical studies in man. End-points are measured by the same equipment used in the clinic adding to the comfort of seeing the effects translated in patients. RP001 could reach the market under an accelerated regulatory process as early as 2024, “The initiative taken by the Novo Nordisk Foundation to establish the BII is an amazing contribution to the Nordic /Danish community of life science start-ups. We in RetiPharma have been very pleased with the collaboration and to see RetiPharma entering the spot light of promising companies”, says Morten Albrechtsen, Chairman. ]]> https://biospectrumindia.com/news/57/12001/smart-drainage-device-may-help-glaucoma-patients.html https://biospectrumindia.com/news/57/12001/smart-drainage-device-may-help-glaucoma-patients.html Mon, 12 Nov 2018 12:05:00 +0530 Scientists have developed a smart drainage device that may help patients with glaucoma, one of the leading causes of blindness in the world save their eyesight. Glaucoma can be treated only with medications or surgical implants, both of which offer varying degrees of success in helping to improve sight and to relieve pressure buildup inside the eye. Implantable glaucoma drainage devices have grown in popularity over the past years, but only half of the devices are still operational after five years because microorganisms accumulate on the device during and after implantation. This problem is known as biofouling. "We created a new drainage device that combats this problem of buildup by using advances in microtechnology," said Hyowon Lee, an assistant professor from Purdue University in the US. "It is able to clear itself of harmful bio-buildup. This is a giant leap toward personalised medicine," said Lee, who led the research team. The glaucoma drainage device is built with microactuators that vibrate when a magnetic field is introduced. The vibrations shake loose the biomaterials that have built up in the tube. "We can introduce the magnetic field from outside the body at any time to essentially give the device a refresh. Our on-demand technology allows for a more reliable, safe and effective implant for treating glaucoma," said Lee. The device can vary flow resistance, which allows the drainage technology to customise treatment for each patient at different stages of glaucoma with varying degrees of pressure buildup inside the eye. ]]> https://biospectrumindia.com/news/57/11989/kane-biotech-senior-management-purchases-1-9-m-shares.html https://biospectrumindia.com/news/57/11989/kane-biotech-senior-management-purchases-1-9-m-shares.html Wed, 07 Nov 2018 23:40:00 +0530 Kane Biotech Inc., has announced that Marc Edwards, Chief Executive Officer, and Ray Dupuis, Chief Financial Officer of Kane Biotech recently completed the purchases, from the open market, of a combined total of approximately 1.9 million shares of Kane Biotech's common stock. Marc Edwards, Kane Biotech's Chief Executive Officer, stated, "I strongly believe in the future potential of our business, intellectual property and the world-class team we have assembled to take us there. I feel confident in investing in Kane Biotech as we begin solidifying commercial opportunities for the significant expansion and implementation of our anti-biofilm technologies. Biofilm is a very expensive problem in a wide variety of industries, there is no clear leader in the Biofilm space, and we're determined to take on that leadership position." ]]> https://biospectrumindia.com/news/57/11988/fda-approves-bmy-therapy-for-previously-treated-multiple-myeloma.html https://biospectrumindia.com/news/57/11988/fda-approves-bmy-therapy-for-previously-treated-multiple-myeloma.html Wed, 07 Nov 2018 23:25:00 +0530 Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.  In ELOQUENT-3, a randomized, open-label, Phase 2 trial, EPd demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) and overall response rate (ORR) versus pomalidomide and dexamethasone (Pd). “Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving health care professionals an effective new tool to tackle this relentless cancer,” said Joseph E. Eid, M.D., senior vice president and head of Medical, Bristol-Myers Squibb. “Today’s approval reinforces the importance of Immuno-Oncology in blood cancers and expands the role of Empliciti to address the needs of relapsed or refractory multiple myeloma patients.” Empliciti with pomalidomide and dexamethasone is associated with Warnings and Precautions related to: infusion reactions, infections, secondary primary malignancies, hepatotoxicity, interference with determination of complete response, pregnancy/females and males of reproductive potential and adverse reactions.  “Relapse can be overwhelming and extremely challenging for multiple myeloma patients, particularly after they have already tried several therapies,” said Paul Giusti, president and chief executive officer of the Multiple Myeloma Research Foundation. “Empliciti, in combination with pomalidomide and dexamethasone, is an exciting new option for patients with relapsed or refractory myeloma.” Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. ]]> https://biospectrumindia.com/news/57/11985/uk-to-open-new-ai-medical-centres.html https://biospectrumindia.com/news/57/11985/uk-to-open-new-ai-medical-centres.html Wed, 07 Nov 2018 12:00:00 +0530 The UK Government has announced plans to open five new centres of excellence focused on the use of artificial intelligence (AI) for digital pathology and medical imaging. In line with the country’s Industrial Strategy, the new initiative aims to accelerate disease diagnosis with advances in medical technology. The detection of diseases at an earlier stage is expected to improve patient outcomes. The new AI medical centres will receive a total of £50 million of funding under the government’s Industrial Strategy Challenge Fund. They are set to be led by some of the country’s biggest medical companies such as GE Healthcare, Siemens, Philips, Leica, Canon and Roche Diagnostics. Doctors, businesses and academics will join these facilities to create digital technology-based products for medical use. These products will be designed to enable more personalised treatment. ]]> https://biospectrumindia.com/news/57/11964/lifescan-upgrades-diabetes-management-app.html https://biospectrumindia.com/news/57/11964/lifescan-upgrades-diabetes-management-app.html Mon, 05 Nov 2018 09:00:00 +0530 Blood glucose monitoring solutions provider LifeScan has launched a new version of its diabetes management mobile app OneTouch Reveal which now has new features. OneTouch Reveal is designed to enable the wireless monitoring of blood sugar. Users will also be able to share the results with their healthcare team. The new version comes with functionality to automatically identify recurring highs or lows in the blood sugar and alerts users on their smartphones. In addition, the new OneTouch Reveal allows patients to set and track their personalised goals for blood glucose tests, carbohydrates logging and other daily activities. The app is currently available for use in a total of 24 countries, including Belgium, Canada, France, Germany, India, the US, Italy, Ireland, Spain, the UAE, Poland and the UK. ]]> https://biospectrumindia.com/news/57/11954/abbvie-recieves-ec-approval-of-venclyxto-in-combination-with-rituximab.html https://biospectrumindia.com/news/57/11954/abbvie-recieves-ec-approval-of-venclyxto-in-combination-with-rituximab.html Thu, 01 Nov 2018 12:50:00 +0530 AbbVie, a research-based global biopharmaceutical company has announced that the European Commission (EC) has approved the type-II variation application for VENCLYXTO (venetoclax) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. This approval allows more patients to receive VENCLYXTO in the second-line setting and gives healthcare providers the ability to prescribe this medicine to a broader population of patients with R/R CLL than the previously approved indication for VENCLYXTO as monotherapy in the European Union (EU). The approval is valid in all 28 member states of the EU, as well as Iceland, Liechtenstein and Norway. The EC approval is based on results from the MURANO Phase 3 randomized clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with rituximab compared to bendamustine in combination with rituximab, an established standard of care chemoimmunotherapy regimen for patients with R/R CLL. At the time of the primary analysis, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death2) in patients who received VENCLYXTO plus rituximab, resulting in an 83 percent reduction in the risk of disease progression or death (hazard ratio [HR]:0.17; 95% confidence interval [CI]: 0.11-0.25; P<0.0001) and prolonged overall survival (OS) compared to the standard of care chemoimmunotherapy (HR: 0.48; 95% CI: 0.25-0.90; overall survival data are not yet mature). In the MURANO Phase 3 clinical trial, undetectable minimal residual disease (uMRD) was a secondary endpoint assessed at the end of combination therapy (nine-month assessment1,3). The majority of patients in the trial who received VENCLYXTO plus rituximab achieved uMRD in the peripheral blood, with 62.4 percent of patients achieving uMRD versus 13.3 percent with bendamustine in combination with rituximab.1 uMRD is an objective measure defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment. Earlier prospective clinical trials have provided evidence that achieving uMRD in CLL patients is associated with improved clinical outcomes. "Chronic lymphocytic leukemia can relapse and become refractory to first-line treatment, and there is a need for better therapies to treat these patients who otherwise have limited options," said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of Cancer Medicine at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia. "The venetoclax plus rituximab combination provides these patients with an alternative treatment option that is superior to a type of chemoimmunotherapy and can achieve deep responses, as shown by MRD negativity rates in the peripheral blood and bone marrow, allowing for a fixed duration of treatment without the need for chemoimmunotherapy." CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.4 CLL accounts for approximately one third of new leukemia diagnoses. In September 2018, AbbVie announced the European Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the Marketing Authorization Application for VENCLYXTO plus rituximab for the treatment of patients with R/R CLL. "The approval of VENCLYXTO in combination with rituximab is an important step forward in providing patients with relapsed/refractory chronic lymphocytic leukemia a strong chance to live longer without their disease progressing," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to bringing VENCLYXTO to more patients with chronic lymphocytic leukemia, while continuing to further the research and development of therapies with the potential to transform the standards of care in blood cancers." VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. ]]> https://biospectrumindia.com/news/57/11952/selvita-to-present-its-oncology-data-at-sitc-2018.html https://biospectrumindia.com/news/57/11952/selvita-to-present-its-oncology-data-at-sitc-2018.html Thu, 01 Nov 2018 12:20:00 +0530 Selvita a clinical stage drug discovery and development company focused on innovative medicines for oncology patients, will publish the most recent data from its oncology programs at the 33rd Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC), which will take place on November 7–11, 2018 at the Walter E. Washington Convention Center in Washington, D.C., USA. Data presented at the conference will include recent results from Selvita’s discovery phase project targeting cancer immunometabolism a dual A2A/A2B adenosine receptor antagonist, as well as cancer immunotherapy – a novel class of small molecule direct STING agonists. “We look forward to present new results from our early discovery projects. We see our immunometabolism and immunooncology programs as key assets in Selvita’s pipeline. Therefore we are excited to share the data demonstrating potent, next-generation small molecule STING agonists as well as a series of dual A2A/A2B antagonists retaining its nanomolar potency in tumor-like adenosine rich environment” said Krzysztof Brzózka, Chief Scientific Officer at Selvita. SITC 2018 brings together a unique and international mix of pharmaceutical and biotech companies, leading universities and clinical research institutions in the cancer immunotherapy area.  It provides a multidisciplinary educational and interactive environment focused on improving outcomes for current and future patients with cancer by incorporating strategies based on basic and applied cancer immunotherapy. ]]> https://biospectrumindia.com/news/57/11950/fda-announces-plant-and-animal-biotechnology-innovation-plan.html https://biospectrumindia.com/news/57/11950/fda-announces-plant-and-animal-biotechnology-innovation-plan.html Thu, 01 Nov 2018 11:35:00 +0530 The US FDA is taking new steps to foster innovation in the emerging space of plant and animal biotechnology. The FDA has announced a new Plant and Animal Biotechnology Innovation Action Plan. The new plan identifies priorities in three important areas: Advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways Strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology Increasing engagement with domestic and international partners on biotechnology issues The FDA also stated that many of the priorities identified in the Action Plan are well underway. It further stated that it will be seeking public input as appropriate, over the coming year, with the expectation of continuing implementation and making meaningful progress on the Action Plan’s commitments in the months and years ahead. The FDA has announced that as a first step, the FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them. This modern, flexible framework will advance the agency’s commitment to safety while promoting innovation in this space. Their shared goal is to help usher in new, beneficial and safe products to consumers and animals as quickly and safely as possible. As part of this effort, the agency intends to publish two guidance documents over the next year. These new guidances will provide more clarity on how the FDA is applying its regulatory oversight to evaluate new animal biotechnology products based on the risk profile of various products. The FDA is also piloting a new Veterinary Innovation Program (VIP) for developers of intentionally genetically altered (IGA) animals and animal cells, tissues and cell- or tissue-based products (ACTPs) that are seeking the FDA’s approval of a new animal drug application. The program will provide intensive assistance for developers of IGA animals or ACTPs that benefit human or animal health, animal well-being or food production. The goal of the VIP is to facilitate advancements in the development of innovative animal products by enhancing certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to market for certain, innovative animal products. Building on the agency’s more than 25 years of world-class plant biotechnology evaluations, the FDA also intends to publish guidance to clarify our regulatory approach for plant biotechnology products for human and animal food. The FDA has evaluated the safety of food from more than 180 varieties of genetically engineered plants. Many of these products are consumed by Americans every day. The guidance will provide the clarification necessary to help small and medium size firms understand their responsibilities under our regulatory framework so that they’re better able to navigate the regulatory pathway toward bringing safe, innovative plant biotechnology products to market. Another key focus of their Action Plan is a robust communications and engagement strategy designed to continue collaborations with a wide range of stakeholders to understand their views on how the FDA can best support safe innovation in plant and animal biotechnology while addressing and appropriately considering any potential risks. Such outreach is crucial to help ensure that the FDA is fostering innovation while at the same time helping the agency uphold its mission of protecting and promoting public health.  It has also announced that the FDA is dedicated to increasing this coordination with all stakeholders, including small developers, in order to improve their understanding of the FDA’s regulatory approaches, to develop and advance new approaches, and to take all steps necessary to help ensure that products developed using biotechnology meet the FDA’s safety standards. We’re also committed to continued collaboration with our federal partners, including the Environmental Protection Agency and the U.S. Department of Agriculture, as it evaluates ways to make more transparent, predictable and efficient our oversight of products developed using genome editing and other new plant and animal development techniques. As the final element of our Action Plan, the FDA remains committed to efforts with domestic and international partners to foster efficiency and regulatory cooperation and enhance regulatory science. For example, we hope to engage in a dialogue about how transformative biotechnology tools, such as genome editing, may eventually be used to help address vector-borne diseases like the Zika virus. We believe that our actions in plant biotechnology regulation will further establish the FDA as a global leader in the regulation of plant biotechnology products, while also positioning us to set the standard in discussions with our international partners regarding appropriate regulatory oversight of plant biotechnology food products. The Action Plan is intended to help the agency ensure the safety of plant and animal biotechnology products, foster continued public confidence in the FDA’s regulation of these products, and avoid unnecessary barriers to future innovations that align with our mission. FDA is looking forward to collaborating with all biotechnology stakeholders to promote efficient and clear regulatory pathways that enable these novel products to enter the marketplace and ensure that they meet applicable safety standards. ]]> https://biospectrumindia.com/news/57/11949/1drop-raises-4-25-m-to-develop-next-gen-diagnostics.html https://biospectrumindia.com/news/57/11949/1drop-raises-4-25-m-to-develop-next-gen-diagnostics.html Thu, 01 Nov 2018 10:30:00 +0530 1DROP, a life science company developing and commercializing an easy to use, laboratory quality, portable medical diagnostic testing platform, has announced the successful closing of a $4.25 million Series A equity financing round. From a single drop of blood applied to a biochip, 1DROP offers a complete panel of diagnostic test results within 15 minutes. The Boston, Massachusetts and Neuchatel, Switzerland based company raised the new equity funding from a number of professional investors. The deal was led by Christian Wildmoser (former partner CVC Capital Partners & Swiss Startup Group Investor). Major private investors of the Swiss Startup Group including Dr. Hans-Peter Strebel (owner of On Your Marks, the competence center for top athletics and research) joined the round. Beat Schillig (IFJ Institute for Young Entrepreneurs) and Jean-Philippe de Toledo (CEO of Pharmacie Principale) invested. This financing round was supported by VentureLab. 1DROP plans to use the financing to expand research and development and to commercialize the medical diagnostics platform. The company plans to perform clinical studies to demonstrate the device's suitability for near-patient use and to develop additional panels of tests. 1DROP plans to obtain the appropriate regulatory approvals and integrate diagnostic test results with electronic medical records. Machine learning will establish patterns of disease evolution and clinical outcomes. ]]> https://biospectrumindia.com/news/57/11955/genesis-biotechnology-partners-with-yale-university.html https://biospectrumindia.com/news/57/11955/genesis-biotechnology-partners-with-yale-university.html Wed, 31 Oct 2018 13:55:00 +0530 Genesis Biotechnology Group (GBG) and its CRO arm Genesis Drug Discovery & Development (GD3) has announced that it has entered into a partnership with Yale University to offer an integrated portfolio of drug discovery services from "target validation" to "lead optimization" to the awardees of the Blavatnik Fund for Innovation. The partnership is a part of GD3's efforts to offer early drug discovery-based services to Yale's researchers, allowing their breakthrough research to get to the market as new drugs and treatments. "We are delighted to partner with Yale University to accelerate the transition of fundamental biomedical discoveries into commercialization opportunities," said Olesia Buiakova, M.D., Ph.D., Chief Scientific Officer of GD3. "Our partnership with Yale is an important step forward for this program and we look forward to developing a strong and mutually beneficial relationship with the Blavatnik Fund and Office of Cooperative Research at Yale." This partnership was made possible by a grant from the Blavatnik Family Foundation. This multi-year grant supports the Blavatnik Fund for Innovation at Yale, which was designed to bridge the gap between life science research and business and support faculty in the commercialization of applied research and technology. The fund's recent commitment of $25 million has created new opportunities for emerging ventures and biotech companies. "Genesis Biotechnology Group has been a true collaborator for innovation. Since initiating this relationship, GBG has invested an unparalleled level of engagement with our investigators and we are excited to see this collaboration grow for years to come," said William Wiesler, Ph.D., M.B.A., Director of the Blavatnik Fund and Director of New Ventures at the Yale Office of Cooperative Research (OCR). "We're incredibly excited about the work ahead to advance drug discoveries and we're looking forward to the increase in opportunities for ventures in life sciences as afforded by the Blavatnik Fund." ]]> https://biospectrumindia.com/news/57/11945/fda-declares-action-plan-to-improve-innovation-in-biotech-.html https://biospectrumindia.com/news/57/11945/fda-declares-action-plan-to-improve-innovation-in-biotech-.html Wed, 31 Oct 2018 13:15:00 +0530 The FDA announces its Plant and Animal Biotechnology Innovation Action Plan aimed at supporting advances in the space while ensuring product safety. The plan focuses on three key priorities: Advancing public health by promoting innovation. The agency intends to update and clarify its policies, when appropriate, to ensure that its regulatory processes are efficient, predictable and risk-proportionate. It plans to refine its comprehensive policy framework to support the development and oversight of animal biotech products, including those derived from genetically altered animals. It is launching a new pilot program, the Veterinary Innovation Program, aimed at providing technical and programmatic assistance for developers seeking approval for products based on intentionally genetically altered animals, animal cells, tissues, cell-based products or tissue-based products. The new guidance will be issued in 2019 that will clarify the agency's approach. The draft guidance will also be issued in 2019 clarifying the FDA's approach in plant biotech, building on the knowledge gained in its 25 years' experience overseeing foods from genetically edited crops. Strengthening public outreach and communication. It intends to actively engage with stakeholders to promote understanding of its regulatory approaches together with making the information more accessible online. Increasing engagement with domestic and international partners. Execute coordinated actions aimed at promoting regulatory alignment and efficiency while enhancing the regulatory science to inform decisions. For example, it will continue to work with the U.S. EPA and USDA on regulatory approaches to genetically altered products as well as international authorities to share information and achieve more consistency in global regulatory processes.   ]]> https://biospectrumindia.com/news/57/11941/grunenthal-acquires-market-rights-for-nexium-vimovo-.html https://biospectrumindia.com/news/57/11941/grunenthal-acquires-market-rights-for-nexium-vimovo-.html Tue, 30 Oct 2018 15:05:00 +0530 Grunenthal has agreed to acquire AstraZeneca's European rights to Nexium and the global (ex US and Japan) rights to Vimovo for a total consideration of up to US$ 922 m (€ 811 m). Nexium (esomeprazole) is a proton pump inhibitor (PPI) that helps to reduce the amount of acid produced by the stomach in patients with gastroesophageal reflux conditions and ulcers. It has a number of indications, including the prevention and treatment of gastric ulcers induced by pain-relieving non-steroidal anti-inflammatory drugs (NSAIDs). Vimovo is a fixed-dose combination tablet of naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and esomeprazole, the same gastroprotective active ingredient as in Nexium. It is indicated for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing NSAID-associated gastric and/or duodenal ulcers. "This acquisition is the biggest single investment in Grünenthal's history and an important step in pursuing our vision of creating a world free of pain for patients," explained Grunenthal CEO Gabriel Baertschi. Under the terms of the agreement, Grunenthal will acquire the exclusive rights to market Nexium for the approved indications in 33 European countries. Nexium continues to generate significant revenues despite having lost exclusivity. Total prescription Nexium 2017 sales for in-scope markets were US$ 248 m (€ 220 m). Grunenthal will obtain Vimovo global commercialization rights with the exception of the US and Japan. Vimovo is available in over 30 countries and is patent protected in most European markets until 2025. Vimovo achieved revenues of US$ 79 m (€ 70 m) in in-scope markets in 2017. With this acquisition, Grunenthal is expected to double its EBITDA performance. Moreover, Grunenthal will significantly enhance its business across multiple pain-related therapeutic categories and geographies. The transaction is subject to approval from the relevant antitrust authorities, with closing expected in December 2018. The financing for Grunenthal has been secured by the underwriting banks BBVA, BNP Paribas, Commerzbank and ING. ]]> https://biospectrumindia.com/news/57/11927/voluntis-astrazeneca-win-prestigious-prix-galien-medstartup-award.html https://biospectrumindia.com/news/57/11927/voluntis-astrazeneca-win-prestigious-prix-galien-medstartup-award.html Mon, 29 Oct 2018 15:05:00 +0530 Voluntis, a company specialized in digital therapeutics, and AstraZeneca has announced that they have been awarded the 2018 Prix Galien – MedStartUp Award for Best Patient Engagement Technology for eCO. The award recognizes outstanding partnerships between French and North American entities to improve health care. It was presented at a ceremony in New York City on October 25, 2018. Pierre Leurent, CEO of Voluntis said “We are honored to receive this prestigious award, which recognizes eCO as a significant achievement in improving patients’ lives. It is also an acknowledgement of the strength of our partnership with AstraZeneca and the National Cancer Institute. We have been delighted to work with them in developing eCO as we bring our respective expertise and passion for patients. As they say at Prix Galien, ‘Actors win Oscars, innovators win the Prix Galien.’” eCO is a companion digital therapeutic developed by Voluntis, in partnership with AstraZeneca and the National Cancer Institute, for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of Cediranib plus Olaparib. It aims to help these women manage symptoms sometimes associated with their treatment in collaboration with their care teams via a patient app and clinician web portal. In a feasibility study, published in the Journal of Clinical Oncology (JCO®) Clinical Cancer Informatics, patients had statistically significant, positive responses to the use of the eCO application. Patients indicated that using eCO made them feel more involved in their care and better connected to their healthcare team. Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team that so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia and Diabeo in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance. ]]> https://biospectrumindia.com/news/57/11926/voluntis-astrazeneca-win-prestigious-prix-galien-medstartup-award.html https://biospectrumindia.com/news/57/11926/voluntis-astrazeneca-win-prestigious-prix-galien-medstartup-award.html Mon, 29 Oct 2018 15:00:00 +0530 Voluntis, a company specialized in digital therapeutics, and AstraZeneca has announced that they have been awarded the 2018 Prix Galien – MedStartUp Award for Best Patient Engagement Technology for eCO. The award recognizes outstanding partnerships between French and North American entities to improve health care. It was presented at a ceremony in New York City on October 25, 2018. Pierre Leurent, CEO of Voluntis said “We are honored to receive this prestigious award, which recognizes eCO as a significant achievement in improving patients’ lives. It is also an acknowledgement of the strength of our partnership with AstraZeneca and the National Cancer Institute. We have been delighted to work with them in developing eCO as we bring our respective expertise and passion for patients. As they say at Prix Galien, ‘Actors win Oscars, innovators win the Prix Galien.’” eCO is a companion digital therapeutic developed by Voluntis, in partnership with AstraZeneca and the National Cancer Institute, for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of Cediranib plus Olaparib. It aims to help these women manage symptoms sometimes associated with their treatment in collaboration with their care teams via a patient app and clinician web portal. In a feasibility study, published in the Journal of Clinical Oncology (JCO®) Clinical Cancer Informatics, patients had statistically significant, positive responses to the use of the eCO application. Patients indicated that using eCO made them feel more involved in their care and better connected to their healthcare team. Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team that so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia and Diabeo in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance. ]]> https://biospectrumindia.com/news/57/11924/pfizer-enters-into-an-agreement-with-novartis-to-advance-the-treatment-of-nash.html https://biospectrumindia.com/news/57/11924/pfizer-enters-into-an-agreement-with-novartis-to-advance-the-treatment-of-nash.html Mon, 29 Oct 2018 14:40:00 +0530 Pfizer Inc. has announced that it has entered into a non-exclusive clinical development agreement with Novartis to investigate one or more combination therapies for the treatment of non-alcoholic steatohepatitis (NASH). Non-alcoholic steatohepatitis (NASH) is a serious, progressive form of non-alcoholic fatty liver disease caused by a buildup of fat in the liver accompanied by inflammation, liver cell scarring and damage. Due to its lack of symptoms, NASH is often unrecognized and underdiagnosed, but it is believed to affect at least three to five percent of the global adult population. With no currently available treatments, NASH is expected to be the leading cause of liver transplants within the next decade. Pfizer is committed to researching multiple pathways to treat NASH at different stages of its progression with monotherapies, or combinations of medicines, to address different aspects of the disease. The companies will conduct both non-clinical and Phase 1 clinical studies of Pfizer’s investigational therapies, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in Phase 2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, Phase 1) and a Ketohexokinase (KHK) Inhibitor (PF-06835919, Phase 2), together with Novartis’s tropifexor, a non-bile acid, Farnesoid X receptor (FXR) agonist. With three assets in development, and several first-in-class pre-clinical candidates under investigation, Pfizer is building a robust NASH program, which was entirely developed in-house and targets NASH through multiple, diverse pathways of the disease. The collaboration with Novartis helps Pfizer to explore combination approaches at an early stage. “This is an exciting collaboration with Novartis that furthers our approach to this complex disease by exploring different and potentially complementary mechanisms of action,” said Morris Birnbaum, MD, PhD, Senior Vice President and Chief Scientific Officer, Pfizer Internal Medicine. “Our research in NASH dates back more than a decade and stems directly from how we have developed medicines to address conditions that put patients at risk for NASH, including Type 2 diabetes and cardiovascular disease. We are confident that by drawing from our history and deep understanding of the close interplay between metabolic, inflammatory and cardiovascular conditions, we can potentially uncover treatments that truly meet patient needs.” ]]> https://biospectrumindia.com/news/57/11920/amgen-invests-66-m-in-oxford-nanopore-tech.html https://biospectrumindia.com/news/57/11920/amgen-invests-66-m-in-oxford-nanopore-tech.html Sat, 27 Oct 2018 11:10:00 +0530 Amgen and Oxford Nanopore Technologies Ltd. has announced Amgen's equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology. Oxford Nanopore has developed and brought to market a proprietary sequencing technology that uses many nanopores (nano-scale holes made by proteins contained within a synthetic membrane) in combination with electronics to perform direct, real-time sequencing of DNA and RNA. The technology ranges in scale from pocket-sized to very high throughput benchtop devices and can sequence very long fragments of DNA or RNA, which has a number of benefits in genomic analysis. The investment in Oxford Nanopore aligns with Amgen's strategic focus on using human genetics to deliver new medicines to patients. Amgen subsidiary deCODE Genetics, a world leader in human genetics, uses Oxford Nanopore's sequencing technologies to conduct genome research, including the identification and validation of new targets.   "The study of human genetics continues to uncover insights into the diseases we face as a society," said Kári Stefánsson, founder of deCODE Genetics. "Oxford Nanopore's long-read sequencing capability creates a window into parts of the genome that have been out of reach, as well as giving us a much better handle on structural variants that confer risk of a wide variety of diseases. We have used Oxford Nanopore technology to sequence several hundred human genomes and continue to see the promise of this emerging technology." "As a biotechnology pioneer, Amgen has demonstrated what can be achieved for society through innovation and a deep understanding of genetics," said Gordon Sanghera, chief executive officer of Oxford Nanopore. "We are delighted to welcome them as a shareholder." Nanopore technology is uniquely scalable. MinIONTM, the only pocket-sized sequencer, can be used to sequence in any location. In addition, Oxford Nanopore has developed benchtop, on-demand, high-throughput devices such as PromethIONTM designed for very large projects or large numbers of samples. This investment will be effected through the purchase of $66 million of ordinary shares in Oxford Nanopore based on the same price per share as the primary fundraising announced in March 2018. ]]> https://biospectrumindia.com/news/57/11915/cristal-therapeutics-initiates-ph-2-clinical-trial-of-cripec-for-ovarian-cancer.html https://biospectrumindia.com/news/57/11915/cristal-therapeutics-initiates-ph-2-clinical-trial-of-cripec-for-ovarian-cancer.html Fri, 26 Oct 2018 15:20:00 +0530 Cristal Therapeutics, a clinical stage pharmaceutical company developing unique nanomedicines for the treatment of cancer and other diseases, has announced the first patient has been dosed in its Phase 2 clinical trial of lead nanomedicine candidate CPC634 for patients with platinum-resistant ovarian cancer. CPC634 is a new drug modality. It combines CriPec nanoparticles with docetaxel (Taxotere), a clinically validated chemotherapy, as its therapeutic payload. This nanomedicine candidate has been designed to enable enhanced tumour accumulation and localised drug release at the target site, with the goal of boosting therapeutic efficacy. In addition, it is anticipated that CPC634 will overcome the shortfalls associated with current docetaxel products, including toxic systemic side effects. Dr Joost Holthuis, Cristal Therapeutics’ CEO and co-founder said, “Results from our Phase 1 NAPOLY study demonstrated that CPC634 can be administered safely and was well tolerated by patients with advanced solid tumours. CPC634 also demonstrated encouraging signs of efficacy and reduction in systemic side effects commonly seen with docetaxel.” Professor Jonathan Ledermann, BSc MD, FRCP, UCL Cancer Institute, London, and Principal Investigator added: “Treatment of platinum-resistant ovarian cancer is an area of high unmet medical need and this trial will give us the opportunity to assess both the therapeutic efficacy of CPC634 and its potential to reduce toxic systemic side-effects such as neutropenia and alopecia, seen with the current standard of care.” The primary objective of the trial will be to determine the response rate as measured by RECIST, a standard unbiased method for assessing whether a tumour shrinks, stays the same, or gets bigger, with CPC634 monotherapy. The clinical study will be conducted in 10 centres across the UK, Belgium, Netherlands, and Spain.   ]]> https://biospectrumindia.com/news/57/11910/researchers-to-develop-sensing-technologies-to-measure-circadian-rhythm.html https://biospectrumindia.com/news/57/11910/researchers-to-develop-sensing-technologies-to-measure-circadian-rhythm.html Thu, 25 Oct 2018 15:00:00 +0530 Deepak Ganesan and Tauhidur Rahman at the University of Massachusetts Amherst, as part of a multi-institution team, have received a three-year grant from the National Science Foundation (NSF) to explore how work performance may be affected by shift work and disrupted circadian rhythm, the 24-hour internal body clock that cycle between sleepiness and alertness.  Among other outcomes, cognitive performance, lost productivity and an increased incidence of accidents at work have been associated with shift work and disrupted sleep/wake patterns. This research is part of NSF's "Future of Work at the Human-Technology Frontier" program. Ganesan and Rahman of UMass Amherst's College of Computer and Information Sciences expect to receive about $630,000 for the study, which they'll conduct with colleagues at Rice and Cornell.  Approximately 20 percent of the labor force engages in shift work, which often leads to inadequate and poor sleep, the researchers say, and may lead to other complications including a higher likelihood for cardiovascular disease, cancer, obesity and mental health problems. They plan to design and develop a suite of on- and off-body sensing technologies that can infer the cognitive and biological state of shift workers.  As Ganesan points out, there has been considerable research on understanding the effect of circadian rhythms, but scientists lack sensing technologies that can continuously monitor these rhythms in natural settings. He and Rahman plan to use specialized facilities at UMass Amherst's Institute for Applied Life Sciences' Center for Personalized Health Monitoring to develop the sensors and carry out studies that will bridge this gap and produce valuable insight into how such disruptions affect people in real-world settings.  They will build on earlier work in which "smart" eyeglasses detect fatigue and pain and contactless radar sensors monitor sleep rhythms. Using such sensors, they plan to analyze characteristics such as alertness, fatigue, stress and sleep that are subject to circadian misalignment due to irregular sleeping schedule, multiple jobs or economic and social burdens.  The team intends to provide personalized feedback to enhance users' cognitive ability and well-being. As Ganesan explains, "The ability to continuously measure an individual's circadian rhythm is an important ingredient of personalized medicine. There has been much work on just-in-time health interventions with mobile devices in recent years and I suspect that the efficacy of such interventions can improve greatly if we also account for an individual's rhythm."  ]]> https://biospectrumindia.com/news/57/11908/vetter-further-expands-secondary-packaging.html https://biospectrumindia.com/news/57/11908/vetter-further-expands-secondary-packaging.html Thu, 25 Oct 2018 11:50:00 +0530 Vetter is a global leading solution provider of prefilled drug-delivery systems and a specialist for a wide range of packaging solutions. In addition to labelling, blister packing, cartoning as well as serialization, the company offers its customers further technically sophisticated packaging solutions such as the assembly of pens, auto-injectors and safety devices.  Because they facilitate self-medication for many users, the demand for these systems is continuously increasing. For example, diabetes patients benefit from the ease of handling and exact dosage during application. Vetter includes the production of these user-friendly and secure but complex packaging solutions among its core competencies.  Due to its many years of experience and expert knowledge of its staff, the company is at the position to meet the different requirements that authorities, customers and patients demand in a product. “Thanks to the modular use of manual, semi-automatic and fully automatic machines, we are able to individually package anything from small clinical to large commercial quantities and, therefore, react flexibly to changing customer structures and requirements”, said Bernd Stauss, Senior Vice President Production and Engineering.  At the  Ravensburg site, various syringes, cartridges and vials, some with highly complex requirements, are currently packed on state-of-the-art lines. In addition to the existing area of approximately 6000 m2, an additional 2900 m2 will be available in a new building by 2020, enabling continued flexible planning of secondary packaging well into the future.  The extension also includes investments in modern testing and analysis methods. In addition to standard release and stability tests, e.g. syringes with a needle shield, the pharmaceutical service provider will be at the position to offer its customers even more extensive tests for autoinjectors beginning in March 2019. This development was achieved through the efforts of a team of specialized engineers that worked on the development of a testing machine, enabling application simulations and digital documentation on auto-injectors. Vetter is setting a new standard for testing machines for autoinjectors in the pharmaceutical industry. “State-of-the-art technologies and extensive know-how are bundled at Vetter. In this way, we create real value for our customers – high quality, compliance with regulatory requirements and user-friendly administration systems”, explained Wolfgang Weikmann, Senior Vice President Quality.   This high level of quality is well received by customers. The ever-increasing demand means that Vetter will continue to expand its offering for complete solutions in the future and contribute with user-friendly solutions for patient safety, as well as convenience and compliance.   ]]> https://biospectrumindia.com/news/57/11891/polyganics-begins-first-in-human-trial-of-its-self-adhesive-patch-liqoseal.html https://biospectrumindia.com/news/57/11891/polyganics-begins-first-in-human-trial-of-its-self-adhesive-patch-liqoseal.html Mon, 22 Oct 2018 14:55:00 +0530 Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced that it has initiated enrollment of patients into a first-in-human clinical trial of LIQOSEAL®, its dura sealant patch. The self-adhesive patch has been developed to reduce cerebrospinal fluid (CSF) leakage following brain surgery.  The trial, titled ‘ENCASE’, is a single-arm, open-label study, evaluating safety and performance of LIQOSEAL® in reducing CSF leakage following elective cranial surgery. Up to 40 adult patients will be recruited at three sites across the Netherlands and Switzerland, with follow-up spanning a 90-day period.  CSF leakage is a common complication of neurosurgical procedures and can lead to life-threatening infections such as meningitis. LIQOSEAL®, developed using Polyganics’ bioresorbable polymers, is designed as an adjunct to closure of the outer protective membrane (‘dura’) surrounding the brain after brain surgery, thereby minimizing leakage of cerebrospinal fluid (CSF). The patch has been engineered to encourage regeneration of the dura and to degrade naturally and safely within the body over time, once the membrane has healed.   ]]> https://biospectrumindia.com/news/57/11888/sanofi-announces-positive-chmp-opinion-for-dengue-vaccine.html https://biospectrumindia.com/news/57/11888/sanofi-announces-positive-chmp-opinion-for-dengue-vaccine.html Sun, 21 Oct 2018 15:55:00 +0530 The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Sanofi’s dengue vaccine. The vaccine, known as Dengvaxia, is currently licensed in 20 countries for the prevention of dengue. The indication for the dengue vaccine recommended by the CHMP is for use in prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas. European Commission approval of the vaccine is expected in December 2018. "This is good news for people living in dengue-endemic parts of the European territories where frequent outbreaks could put them at risk of re-infection with another dengue virus serotype, which is often more severe than the first infection," said Su-Peing Ng, global medical head at Sanofi Pasteur. "Sanofi is committed to ensuring access to dengue vaccination as part of integrated prevention efforts to reduce the burden of this disease in endemic populations around the world." ]]> https://biospectrumindia.com/news/57/11887/nia-releases-national-recruitment-strategy-to-spur-dementia-based-research-.html https://biospectrumindia.com/news/57/11887/nia-releases-national-recruitment-strategy-to-spur-dementia-based-research-.html Sat, 20 Oct 2018 15:35:00 +0530 Recruitment and retention in clinical studies for Alzheimer’s disease remains one of the biggest hurdles in the path to a cure or prevention for this devastating disease. From strict eligibility requirements and invasive and time-consuming procedures, to the need for study partners for people already with dementia to encouraging people without symptoms to participate, the challenges are substantial. To set a path forward to address these challenges, NIA has released Together We Make the Difference: National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research. With co-facilitation by the Alzheimer’s Association and many other organizations and experts, the strategy is the culmination of more than two years of dedication and work to outline practical, proactive approaches to help study sites engage a wider, more diverse number of volunteers. The strategy focuses on four larger themes: Increase awareness and engagement at a broad, national level Build and improve capacity and infrastructure at the study site level Engage local communities and support participants Develop an applied science of recruitment   ]]> https://biospectrumindia.com/news/57/11884/apceth-biopharma-announces-positive-results-for-apceth-201-in-mouse-models.html https://biospectrumindia.com/news/57/11884/apceth-biopharma-announces-positive-results-for-apceth-201-in-mouse-models.html Fri, 19 Oct 2018 17:40:00 +0530 apceth Biopharma GmbH, a company with the mission of improving patients’ lives with next generation cell therapies has announced positive results for apceth-201 in mouse models for acute graft-versus-host disease (aGvHD). The data was highlighted in a poster presentation at the Annual Congress of the European Society of Gene and Cell Therapy in Lausanne on October 16-19. “We are very excited with these results that clearly show the transformative therapeutic potential of apceth-201 in an immune-mediated disease with high unmet medical need and few treatment options”, said Dr Christine Guenther, CEO of apceth Biopharma. “Based on these promising and impressive data, we are currently preparing to initiate a phase 1/2 clinical study assessing the safety and efficacy of apceth-201 in adult steroid-refractory GvHD patients.” Acute graft-versus-host disease is a frequent complication associated with allogeneic hematopoietic stem cell transplantation (HSCT). Immunosuppressants are used to manage aGvHD; however, steroid-refractory aGvHD develops in many cases and has an extremely poor prognosis. apceth-201 significantly improved clinical score and overall survival in two aGvHD models apceth-201 are allogeneic human mesenchymal stromal cells (MSCs) that have been genetically modified to express alpha-1 antitrypsin (AAT), a protease inhibitor exerting potent anti-inflammatory and tissue-protective functions to further augment the immunomodulatory potential of MSCs. In vitro assays demonstrated that apceth-201 efficiently suppresses T-cell proliferation, the maturation of dendritic cells, and also polarizes macrophages to an anti-inflammatory M2 type. The in vivo efficacy of apceth-201 was assessed in two different mouse models for aGvHD. In a humanized model vehicle-treated control animals succumbed quickly to GvHD, whereas median survival was doubled in apceth-201-treated animals. Mice receiving apceth-201 showed significantly improved clinical scores, a striking amelioration of bone marrow cellularity, and reduced levels of inflammatory markers. apceth-201 was further tested in a GvHD model system which closely mimics haploidentical HSCT. Vehicle-treated control animals again succumbed quickly to GvHD, whereas treatment with apceth-201 resulted in long-term survival of 57 % of the mice. Initially, all apceth-201-treated animals exhibited clinical scores comparable to the control animals. However, within a period of 25 days after the second cell injection, the clinical scores had returned to baseline, indicating complete resolution of GvHD. This promising data has led to planning of a phase 1/2 study using apceth-201 for the treatment of steroid-refractory aGvHD in adults. ]]> https://biospectrumindia.com/news/57/11882/acticor-biotech-raises-15-3m-in-series-b-financing.html https://biospectrumindia.com/news/57/11882/acticor-biotech-raises-15-3m-in-series-b-financing.html Fri, 19 Oct 2018 15:25:00 +0530 Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including stroke and pulmonary embolism has announced that it has completed a €15.3 million Series B round of financing from European and Asian investors. This new funding will enable the company to finance its first phase II in acute ischemic stroke with its lead candidate ACT017. The Series B was led by Newton BioCapital, a Belgium venture capital fund, followed by Mirae Capital, a Korean fund, CMS Medical Venture Investment Limited and A&B (HK), these last two funds are based in Hong Kong. Existing investors including CapDecisif Management also participated into this round. This Series B might be completed by an additional financing of up to €5M in order to finance additional clinical developments with ACT017 in other indication. Alain Parthoens, Managing Director of Newton Biocapital will now join the Board of Directors and commented: “We are excited to lead the current round of investors in Acticor Biotech and look forward to advancing ACT017 into its first phase II clinical development in acute ischemic stroke.” Hyun Tae Kim, General Manager, Head of Bio Investment Team of Mirae Asset Capital, a subsidiary of Mirae Asset Financial Group, who will now join the Board of Director as observer, commented: “Our presence as investor in Europe is relatively new but we have been convinced by the potential of ACT017, the new target GPVI and the management team”. Catherine Boule, Managing Partner at CapDecisif Management commented: “We have reinforced our investment into the company who is pursuing its clinical development at a fast pace and on time”. Gilles Avenard, President of Acticor Biotech, commented: “We are delighted to have raised new equity from specialised healthcare investors who will enable us to grow and demonstrate the full potential of the company into thrombotic diseases”. Agile Capital Markets and Cukierman Life Sciences acted as financial advisors for Acticor Biotech. ]]> https://biospectrumindia.com/news/57/11877/novartis-to-acquire-endocyte-in-2-1b-deal.html https://biospectrumindia.com/news/57/11877/novartis-to-acquire-endocyte-in-2-1b-deal.html Fri, 19 Oct 2018 11:05:00 +0530 Novartis AG will acquire U.S.-based cancer drugmaker Endocyte Inc for $2.1 billion in cash as the Swiss drugmaker expands its radiopharmaceuticals business. The $24-per-share offer represents a premium of 54 percent to Endocyte's Wednesday closing price. Endocyte said the deal will help develop a broader role for radioligand therapies in cancer treatment. The deal will also enable Novartis to investigate the potential development of a drug candidate for use in earlier lines of prostate cancer therapy. Endocyte will be merged with a newly formed Novartis subsidiary. The transaction is expected to be completed in the first half of 2019 and Endocyte will continue to operate as a separate and independent company until then. Novartis said in September that it will cut 2,550 jobs in Switzerland and Britain over four years, as it strives to boost profits and focus on new medicines. ]]> https://biospectrumindia.com/news/57/11873/congenica-to-provide-worlds-first-national-genomic-medicine-service.html https://biospectrumindia.com/news/57/11873/congenica-to-provide-worlds-first-national-genomic-medicine-service.html Wed, 17 Oct 2018 15:45:00 +0530 Congenica has been awarded a multi-year contract by Genomics England, to be a provider of Diagnostic Decision Support Services for them to deliver for the world leading NHS Genomic Medicine Service. Genomics England carried out a rigorous evaluation of all the leading providers of diagnostic decision support solutions for genomics from across the globe, during a formal competitive tender process. Features including usability, clinical accuracy, case throughput and commercial value were all tested and Congenica’s platform Sapientia emerged as the clear leader. Professor John Mattick, Chief Executive of Genomics England, commented: “By working with Congenica from the start of the 100,000 Genomes Project, we’ve been able to provide high quality variant interpretation of genome sequences to the NHS, helping deliver benefits to patients at scale. Now that we are embarking on the next exciting step in our journey to embed genomic medicine in healthcare, Congenica will continue to play an important role with Genomics England in delivering results to clinicians and diagnoses to patients.” The NHS is establishing the national Genomic Medicine Service inclusive of a network of Genomic Laboratory Hubs around the country serving patients with a wide variety of needs. Initially, patients who suffer from rare and inherited diseases and cancer will be able to access genomic testing - an area of focus for the Sapientia platform. The service began mobilising in October 2018 and will continue to provide valuable clinical information to 100,000s of patients. Congenica’s CEO, Dr David Atkins said: “Genomics England and the NHS have done extraordinary work in building the foundations for the Genomic Medicine Service. We feel privileged to continue to be part of this initiative and to be a contributor to the world’s first service of this kind. While we have many other customers who have subjected us to rigorous evaluation, we are particularly proud to have beaten a very competitive field in this competition.” Sapientia has already been extensively validated on approximately 10,000 genomes during the 100,000 Genomes Project. During this time, Congenica’s clinical scientists used Sapientia for clinical analysis and genomic interrogation, to generate comprehensive, actionable clinical reports. Genomics England was established by the UK Department of Health and Social Care to deliver the 100,000 Genomes Project, which is expected to complete before the end of 2018. The learnings from this project have enabled the NHS to advance a service which transforms the way that people are cared for in the UK, bringing genomics to the clinic and improving the quality and efficiency of the healthcare system. ]]> https://biospectrumindia.com/news/57/11870/dnanexus-launches-improved-platform-for-clinico-genomic-data-.html https://biospectrumindia.com/news/57/11870/dnanexus-launches-improved-platform-for-clinico-genomic-data-.html Wed, 17 Oct 2018 12:10:00 +0530 DNAnexus, the global leader in biomedical informatics and data management, has announced DNAnexus Apollo, an enhanced platform for clinico-genomic data science exploration, analysis, and discovery. Global pharmaceutical research and development (R&D) teams can leverage DNAnexus Apollo in their translational informatics research to rapidly test multiple hypotheses and gain valuable insight into mechanisms of action, biomarkers, and targets. Moving from the initial stages of target identification through clinical development remains a significant challenge for biopharmaceutical companies. In order to achieve actionable insights, pharmaceutical R&D teams need access to massive volumes of combined clinical and genomic data paired with a robust informatics strategy to interrogate the data for targets and biomarkers of disease progression and therapy response. To address these challenges DNAnexus Apollo provides a scalable cloud environment, flexible data models, and intuitive analysis and visualization tools to simplify research workflows for R&D teams globally. Working with clinical data requires specialized capabilities to maintain privacy; DNAnexus Apollo leverages the same best-in-class DNAnexus security and privacy framework, which includes compliance in accordance with HIPAA, CLIA, GxP, and FedRAMP, among others.  “The key to improving productivity is improved understanding and use of data, and this requires the massive integration of multi-omic and biomedical datasets,” said Richard Daly, Chief Executive Officer at DNAnexus. “By integrating clinically relevant data into the research process, mechanisms and targets with low probability of advancement can be rejected earlier in the process. This is critical to accelerate and improve decision support for the identification of drug targets and markers of disease progression and drug response.” A DNAnexus workshop titled Leveraging Translational Informatics for the Advancement of Drug Discovery and Improved Clinical Outcomes will take place on Thursday, October 18th, between 12:30-1:45 PM at the San Diego Convention Center, upper level, room 30E. The workshop will be hosted by Vice President of Strategy Brady Davis, who will be discussing the new DNAnexus Apollo cloud platform. ]]> https://biospectrumindia.com/news/57/11868/sqz-biotech-roche-to-develop-apc-for-immune-oncology.html https://biospectrumindia.com/news/57/11868/sqz-biotech-roche-to-develop-apc-for-immune-oncology.html Wed, 17 Oct 2018 11:20:00 +0530 SQZ Biotechnologies, a cell therapy company developing novel treatments for multiple therapeutic areas, has announced the expansion of its collaboration with Roche in cellular therapy. The expanded partnership furthers the synergistic combination of SQZ's innovation and expertise in cell therapy with Roche's cancer immunotherapy expertise. Under the terms, SQZ and Roche will jointly develop and commercialize certain products based on antigen presenting cells (APCs) created by the SQZ platform for the treatment of oncology indications. Under the collaboration, SQZ may receive up to $125 million in upfront payment and near-term milestones. SQZ could earn up to $250 million in clinical, regulatory and sales milestones per product that emerges from the collaboration. In addition, SQZ may receive development milestone payments of over $1 billion.  Within the collaboration, SQZ and Roche could share commercial rights for certain approved products. SQZ APCs leverage native immune functions to spark target-specific killer (CD8) T cell responses in vivo. Through effective presentation of antigens on MHC-I, SQZ APCs can directly stimulate CD8 T cell activity and potentially drive powerful anti-tumor effects that address antigens inaccessible by other adoptive cell-based cancer immune therapy strategies. In addition to their broad targeting potential, the SQZ APC engineering and manufacturing process requires no cellular expansion or genetic modification by viruses or editing agents, thereby dramatically improving the anticipated safety profile, cutting production time, and cost. ]]> https://biospectrumindia.com/news/57/11866/acme-clinical-trials-launches-an-ai-powered-database.html https://biospectrumindia.com/news/57/11866/acme-clinical-trials-launches-an-ai-powered-database.html Tue, 16 Oct 2018 23:55:00 +0530 The number of registered clinical studies has skyrocketed in the last two decades, growing from just under 1,300 in 2000 to more than 290,000 today. With this growth comes a host of benefits for patients, families, and the medical community as a whole -- every trial and every study represents new opportunities to both find answers and help those living with these diseases, disabilities, and chronic conditions.   Bridging the Patient/Access Gap   That said, while the trials and the data emerging from these cutting-edge studies exists, information and access isn’t readily available, even to those who need it most. This not only leaves patients in the dark, but keeps researchers and other key industry insiders from unpacking the data coming from clinical studies -- stakeholders who could help advance these causes and accelerate success.   Silicon Valley startup Acme Clinical Trials (ACT) is working to bridge this gap. The nonprofit and its comprehensive digital destination AClinicalTrials.com brings together more than 300,000 trials, with thousands added daily from researchers and physicians around the globe. To ensure patients, families, and researchers connect with the right intel and insights quickly and easily, ACT leverages an artificial intelligence- (AI) powered guided search feature.   “Right now the information is out there, but it’s fragmented and housed on government sites -- sites that are confusing and cumbersome to navigate,” says ACT Founder Nofel Izz. “Our guided search makes finding the right studies easy.” When they find relevant studies, patients can submit their medical information to several at a time, using ACT’s blockchain-enabled platform to share their medical information with trial hosts.   Driving Research Ahead   In addition to supporting potential trial participants, ACT will also help researchers, physicians, and patients to tap into data emerging from these high-value studies.   “We’ll cull analytics and demographics of disease types along with pharmaceuticals taken,” Nofel explains. “Using AI, we’ll identify links between health conditions, medications, and trials, helping establish critical connections and from there, establish more clear-cut success rates for specific diseases and treatment plans.”   Like the clinical trial landscape, this emerging data is out there but is often difficult to find, access, and leverage. ACT not only democratizes this essential data but, with automated filtering and authentication, ensures the 15,000-plus new records added daily are error-free.   A Lifetime of Entrepreneurship   ACT isn’t the first game-changing venture for Nofel. A renowned entrepreneur, Nofel is currently involved with 19 startups -- and counting.  With a strong computer science background and MBA from University of Cambridge, Nofel has long leveraged his diverse professional and academic experiences to build innovative new businesses. Much of his work centers on bringing cutting-edge technology to the mainstream.   ACT, Nofel explains, was an idea he initially pitched to fellow Cambridge alumni Wassel Al Fakhoury, an M&A attorney and entrepreneur Xuhua Ji. “I wanted to create a new clinical trials platform that would leverage AI and neural networks to overcome common patient and researcher obstacles,” he adds. Despite the radical nature of Nofel’s space elevator and other innovative launches he’s pioneered, he says ACT is by far the most complex and the most high-potential. “The technology we’re using for ACT is far more complicated than rocket science,” he says. “The fact is, rockets work,” Nofel explains. “AI and neural networks -- what we’re leveraging for ACT -- still have a long way to go.”   Gaining Global Traction & Support   Though still in its infancy, ACT has gained significant traction and interest from worldwide investors. To date, the nonprofit is seeking $30 million in seed investments but, already, has received letters of intent and interests from premier investment companies in the Gulf region and Saudi Arabia -- as well as Chinese investors such as China International Capital Corporation (CiCC), Tasly Pharma, and Industrial and Commercial Bank of China. These and future funds raised will enable ACT to remain free for all users.   “We want to ensure individuals in developing countries -- people in dire need of treatments, transplants, and insights can access ACT,” says Nofel. “This network enables these users to find relevant trials and studies, while disseminating information and helping advance our collective quest for cures.”   In addition to investors, ACT has also invited 70,000 medical specialists from around the world to add input, articles, and questionnaires to the platform. This, Nofel explains, will help patients better search and explore clinical trials, with the option to connect to participating specialists for further guidance and support.   “Our goal was to establish a powerful clinical trial and medical analytics platform free of cost and open to the public,” Nofel adds. “Now, one year later, ACT is the single largest database of active and completed clinical trials in the world.”   ]]> https://biospectrumindia.com/news/57/11862/researcher-discovers-apt-cure-for-treatment-resistant-hypothyroidism.html https://biospectrumindia.com/news/57/11862/researcher-discovers-apt-cure-for-treatment-resistant-hypothyroidism.html Tue, 16 Oct 2018 12:05:00 +0530 A new "metal-coordinated" drug-delivery technology potentially could be used to supplement the standard therapy for hypothyroidism, which affects nearly 10 million Americans, and many more patients worldwide, according to results of a study published in the journal Thyroid this month. Researchers at Rush University Medical Centre have been pursuing an improved treatment for the minority of hypothyroid patients who don't respond well to the standard therapy. Now, their investigations into the way thyroid hormones given in tablets are absorbed and metabolized by the body suggest that a metal-coordinated molecule could prove to be a more effective therapy for all hypothyroid patients, according to Dr. Antonio Bianco. He is a professor of medicine at the University of Chicago who was formerly a researcher and clinician at Rush, where the work detailed in the Thyroid paper was completed. The new drug, poly-zinc-liothyronine (PZL), worked well in laboratory studies, Bianco said. Safety tests in animals and clinical trials in humans must still be conducted, and funding must be obtained to support that work. If all goes well, though, PZL could be offered to patients in only a few years, according to Bianco. "We know enough about thyroid physiology in rats and humans that we feel confident that this drug is ready for prime time" in terms of working as well in humans as it has in the lab, he said. The standard treatment for hypothyroidism is levothyroxine (L-T4), a synthetic version of the thyroid hormone thyroxine (T4), which in a healthy person is secreted by the thyroid gland. However, about 10 to 15 percent of L-T4-treated patients continue to have symptoms of the condition when treated, including weight gain, fatigue, lethargy, mood fluctuations, and problems with memory. While investigating why minorities of hypothyroid patients still have symptoms even while adhering to the standard L-T4 therapy, these investigators discovered that, in rat models, a steady supply of liothyronine (L-T3) is necessary to "normalize" functional thyroid levels in the blood, and in such tissue areas as the brain, muscles and liver. That discovery gave new urgency to the hunt for a way to effectively deploy L-T3 over time in patients with hypothyroidism. "A sustained-release L-T3 has been sort of the Holy Grail" in the field, Bianco said -- specifically, one that would perform well in clinical trials. PZL appears to solve that key problem and could be used in combination therapy. Bianco said. "When you take L-T3 alone, it's immediately absorbed. PZL isn't." With PZL, T3 levels in the blood are "sustained over time with a delayed, but more desirable biological response," the study reported. As a result, PZL "minimizes post-dose peaks in circulating T3 typically seen with L-T3 administration." In other words, not only is PZL effective, but it also is less of a shock to the body. If [PZL] is deemed to be safe and ready for clinical trial in humans, such trials can help determine if combination therapy can improve the signs and symptoms of hypothyroidism. ]]> https://biospectrumindia.com/news/57/11860/sanofi-genzyme-perkinelmer-offer-free-dx-testing-for-lsd.html https://biospectrumindia.com/news/57/11860/sanofi-genzyme-perkinelmer-offer-free-dx-testing-for-lsd.html Tue, 16 Oct 2018 10:45:00 +0530 Sanofi's Genzyme subsidiary and PerkinElmer Genomics, the molecular genetics laboratory of PerkinElmer, have launched a program called the Lantern Project to provide no-cost diagnostic testing to patients in the US who suffer from certain lysosomal storage disorders (LSDs). Through the project physicians will be able to arrange for screening of certain suspected LSDs as well as confirmatory DNA testing and phlebotomy services for their patients. Physicians will be able to refer patients who may be suffering from Gaucher disease, Fabry disease, Pompe disease, mucopolysaccharidosis type I (MPS I), or acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease types A and B. Additionally, patients have the option of undergoing testing with an enzyme panel for seven mucopolysaccharidoses and a 105-gene panel for limb-girdle muscular dystrophies (LGMD) and other myopathies. LSDs comprise a group of more than 40 genetic diseases that are frequently characterized by a range of symptoms. Disease progression and symptom severity can vary widely. One of the benefits of the Lantern Project is the LGMD panel, which is able to sequence 105 genes known to be associated with LGMDs and other myopathies, a heterogeneous group of muscular weakness disorders that vary in severity and age of onset. The panel uses NGS technology to sequence multiple genes simultaneously, testing for multiple LGMD disorders at once in addition to other diseases that may cause similar symptoms, including Pompe disease and spinal muscular atrophy. ]]> https://biospectrumindia.com/news/57/11842/survey-discloses-emotional-impact-of-multiple-sclerosis.html https://biospectrumindia.com/news/57/11842/survey-discloses-emotional-impact-of-multiple-sclerosis.html Fri, 12 Oct 2018 12:05:00 +0530 Merck, a leading science and technology company, has announced the publication of results from a global Merck-sponsored multiple sclerosis (MS) carer survey, as well as the premiere of the #MSInsideOut documentary film, Seeing MS from the Inside Out, executive produced by Shift.ms, a social network for people with multiple sclerosis, at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS), in Berlin, Germany. The 'Living with Multiple Sclerosis: The Carer's Perspective report was developed in collaboration with The International Alliance of Carer Organizations (IACO) and Eurocarers to examine the experiences of 1,050 multiple sclerosis (MS) carers across seven countries (US, Canada, UK, France, Germany, Italyand Spain). The survey found that almost half (48%) of those surveyed became MS carers when they were below the age of 35, and nearly one in three had been caring for somebody for 11 years or more. Additional key findings from the carer survey included: 43% and 28% of carers surveyed reported an impact on their emotional/mental health and physical health respectively 34% said being an MS carer impacted their financial situation, more than a third (36%) stated they had to take time off work, and as a result, 84% of those carers reported their work and career being impacted Only 15% of carers surveyed connected with other carers or patient organisations to help cope with the challenges of their role As part of the #MSInsideOut campaign, an initiative aimed at providing a deeper understanding of MS, the MS Inside Out documentary film, 'Seeing MS from the Inside Out', will be premiered. Developed with Shift.ms as executive producers, it is the first global documentary film to pair artists and people from across the MS community, with a view to interpreting the experiences and perspectives of those impacted by MS through art. "In line with our broader mission at Shift.ms, the aim of this documentary is to highlight the individual stories in a unique and innovative way across the MS community, digging deeper into the elements of MS that remain under-represented with a view of interpreting the unmet needs of those impacted by MS through art," said George Pepper, Co-founder and CEO, Shift.ms. "By bringing these stories out into the open we will be able to address those challenges that remain, opening lines of communication and ultimately raising awareness of MS." The documentary follows three stories: Maria Florencia, a person living with MS from Argentina, Jon Strum, a caregiver from the US, and Dr. Luigi Lavorgna, a healthcare professional from Italy. Each was paired with a local visual artist to bring their stories to life through an emotional interpretation not bound by words but through art, reflecting the often difficult-to-explain nature of MS. "At Merck, we are extremely proud to highlight the unmet needs in the community through our work with Shift.ms, IACO and Eurocarers which expose the experiences of different members of the MS community, including the perspective of MS carers, whose voices have traditionally not been heard as strongly," said Andrew Paterson, Senior Vice President, Global Head of Neurology and Immunology, at the biopharma business of Merck. "Forming part of our ongoing company-wide commitment to carers, and connecting with the broader Embracing Carers initiative, the outcomes from both the survey and documentary film highlight the need for additional support and awareness. We therefore encourage and call upon the MS community to take these findings and identify ways in which they can better assist both MS carers and patients."   ]]> https://biospectrumindia.com/news/57/11838/myriad-initiates-commercialization-plan-with-pfizer.html https://biospectrumindia.com/news/57/11838/myriad-initiates-commercialization-plan-with-pfizer.html Fri, 12 Oct 2018 10:30:00 +0530 Diagnostic tests provider Myriad Genetics has included a commercialisation plan into its ongoing companion diagnostic agreement with pharmaceutical giant Pfizer. As part of the existing arrangement, Myriad is seeking the US Food and Drug Administration (FDA) approval for its BRACAnalysis CDx device as a companion diagnostic for Pfizer’s talazoparib therapy. Under the new plan, each company will be responsible for the commercialisation of its respective product. However, the companies will partner on select commercial activities associated with the use of BRACAnalysis CDx to detect patients for potential treatment with talazoparib, following the FDA approval. BRACAnalysis CDx is an in-vitro diagnostic device designed to qualitatively detect and classify variants in the protein coding regions and intron or exon boundaries of the BRCA1 and BRCA2 genes. For the testing, the device uses genomic DNA extracted from whole blood specimens collected in EDTA. On the other hand, Talazoparib is an investigational, poly ADP ribose polymerase (PARP) inhibitor being developed for the treatment of various cancer types characterised by DNA damage repair (DDR) deficiencies. ]]> https://biospectrumindia.com/news/57/11836/iavi-to-start-phase-i-trial-for-hiv-vaccine-candidate.html https://biospectrumindia.com/news/57/11836/iavi-to-start-phase-i-trial-for-hiv-vaccine-candidate.html Thu, 11 Oct 2018 20:35:00 +0530 The International AIDS Vaccine Initiative (IAVI) announces the start of a Phase I clinical trial (IAVI G001) to test a novel vaccine candidate designed to stimulate the immune system to initiate a key first step in the generation of potent proteins, known as broadly neutralizing antibodies (bNAbs), against HIV. The trial will evaluate the safety of the candidate and the immune responses it is able to induce. The candidate, known as eOD-GT8 60mer, represents an important step forward in the quest to develop an HIV vaccine. Researchers widely agree that a vaccine that induces bNAbs will likely be the best way to confer durable protection against the virus. bNAbs are desirable because in laboratory experiments, they are effective against many of the genetically diverse strains of HIV, and in animal studies, they can block infection of a virus similar to HIV. “The world urgently needs new ways to prevent HIV infection, and chief among these is a vaccine,” said Mark Feinberg, M.D., Ph.D., president and CEO of IAVI. “Fortunately, a new generation of HIV immunogen candidates, including eOD-GT8 60mer, is entering clinical trials. These candidates are being developed using highly sophisticated and elegant vaccine science and provide a precedent for vaccine strategies targeting the induction of specific immune responses believed to be critical in protecting against HIV infection.” Over the past 15 years, scientists have gained an unprecedented understanding of the structure of HIV’s outermost envelope protein, which is the target of all bNAbs. From large cohort studies of HIV-infected volunteers, researchers isolated and characterized many bNAbs that develop naturally, but only rarely, during the course of HIV infection, and identified where they bind to the virus. These sites of vulnerability on the virus were then used to design vaccine immunogens, using what is referred to as a structure-based vaccine design approach. The eOD-GT8 60mer candidate is based on one of these sites targeted by bNAbs. The candidate was developed in the laboratory of Dr. William Schief, director of vaccine design for IAVI’s Neutralizing Antibody Center (NAC) at Scripps Research and professor at Scripps. It is the first candidate to enter clinical trials that was designed using a structure-based vaccine approach, and it is the first in a sequence of engineered vaccine candidates that Dr. Schief and his colleagues are developing. “In this trial, our goal is to prove that it is possible to induce responses from special, targeted B cells,” said Dr. Schief. “We’ll have a promising outcome if some of the vaccine recipients produce B cells expressing a specific type of antibody, whereas placebo recipients do not. This would confirm that we are able to induce the desired initial immune response, and the next step will be making technical refinements to improve performance.” There are several steps involved in the development of bNAbs, and in animal studies, the eOD vaccine candidate successfully elicited antibodies that are precursors to the much more specialized antibodies that scientists classify as broadly neutralizing. It is envisioned that eOD or a similar engineered vaccine candidate would be the first in a series of vaccinations that would elicit the bNAbs believed to be needed to protect against HIV infection. “This is a big moment, not just for HIV vaccines, but for vaccine science as a whole,” said Dr. Dennis Burton, scientific director of the NAC and chair of the Scripps Research Department of Immunology and Microbiology. “This trial is going to tell us how much control we can have over the immune responses induced by a targeted vaccine candidate. If this type of vaccine engineering is successful, it can be applied more broadly, bringing about a new day in vaccinology. If we can really drive immune responses in predictable ways, we can make better, more effective vaccines, not just for HIV but for other viruses, too.” The IAVI G001 trial will enroll 48 healthy adult volunteers who will receive two doses of eOD-GT8 60mer, along with the AS0B1 adjuvant developed by the pharmaceutical company GSK, or placebo. Adjuvants are substances used to enhance immune responses induced by a vaccine, and the AS01 adjuvant is used in licensed vaccines. The doses are spaced two months apart and are administered through intramuscular injection. The trial is taking place at two sites: George Washington University (GW) in Washington, D.C., and the Fred Hutchinson Cancer Research Center in Seattle, Washington. At GW, the trial is led by Dr. David Diemert, associate professor in the Department of Medicine, who will serve as the principal investigator at this site, and Dr. Jeffrey Bethony, professor in the Department of Microbiology, Immunology, and Tropical Medicine, who will direct the specimen processing and biorepository aspects of the trial at GW. At the Fred Hutchinson Cancer Research Center, the trial is led by Dr. Julie McElrath, senior vice president and director of the Vaccine and Infectious Disease Division. The Collaboration for AIDS Vaccine Discovery (CAVD) Comprehensive T-Cell Vaccine Immune Monitoring Consortium/The Dale and Betty Bumpers Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH), the CAVD Comprehensive Antibody Vaccine Immune Monitoring Consortium, and the Fred Hutchinson Cancer Research Center will be performing key analytical assays in support of the trial, to assess whether the targeted immune response is elicited. The CAVD Vaccine Immunology Statistical Center played a major role in the study design and analytical methods to evaluate the data. Results of the IAVI G001 trial are expected in late 2019. IAVI developed the eOD-GT8 60mer candidate with support from the Bill & Melinda Gates Foundation, the Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID) at NIAID at the NIH, and Scripps Research. Research at the NAC that contributed to the development of eOD-GT8 60mer was also made possible by the generous support of the American people through the United States Agency for International Development (USAID). USAID administers the U.S. foreign assistance program providing economic and humanitarian assistance in more than 120 countries worldwide. The contents are the responsibility of IAVI and do not necessarily reflect the views of USAID or the United States government. ]]> https://biospectrumindia.com/news/57/11832/cphi-declares-winners-of-pharma-awards.html https://biospectrumindia.com/news/57/11832/cphi-declares-winners-of-pharma-awards.html Thu, 11 Oct 2018 15:50:00 +0530 CPhI Worldwide, organized by UBM (part of Informa PLC), has announced the winners of the prestigious 2018 CPhI Pharma Awards. The awards, in their 15th edition, welcomed 365 guests on October 9 in Madrid, Spain to celebrate outstanding achievements in pharma across 17 different categories. Among the awards presented, ‘CEO of the Year’ went to Laurent Levy, PhD, the founder and CEO of Nanobiotix who has propelled the company to the forefront of oncological nanomedicine development. Nanobiotix also received the award for ‘Pharma Company of the Year’. The company is pioneering new approaches in cancer treatment and fast becoming the leading nanomedicine company. Scientist.com was chosen as the winner of the ‘Regulatory Procedures and Compliance’ award in recognition of its new regulatory and compliance framework, COMPLi, and West Pharmaceutical Services, Inc was granted the ‘Corporate Social Responsibility’ award for delivering good corporate citizenship particularly its recent achievements in environmental sustainability. In the ‘Patient Centricity’ category, SRS Life Sciences won, thanks to the Unistraw Delivery System, a child focussed approach to pharmaceuticals and supplements delivery. Qualit-e Cloud GmbH received the ‘IT, mHealth & Digitilization’ award for its new web portal. This innovation enables pharmaceutical raw material producers to upload their quality documents and authorise customers and distributors to download. The 2018 CPhI Pharma Award winner by category: Excellence in Pharma: API Development – Artemisinin, Ipca Labs Limited Excellence in Pharma: Formulation – Micelle Inside Solubilisation, MiVital AG Excellence in Pharma: Excipients - Parteck® MXP Excipient, Merck Excellence in Pharma: Manufacturing Technology and Equipment – AqVida filling line, AqVida GmbH Excellence in Pharma: Bioprocessing & Manufacturing - Simplification of Fed-Batch Processes Using Modified Amino Acids, Merck Excellence in Pharma: Analysis, Testing, and Quality Control - HyperFlux™ PRO Plus, Tornado Spectral Systems Excellence in Pharma: Drug Delivery Devices - e-NOVELIA, the smart ophthalmic add-on, Nemera. Highly commended – IQ-Dose, Stiplastics Excellence in Pharma: Packaging - Dual-Mix®, TECHNOFLEX. Highly commended - QuickFlip™, Aptar Pharma Excellence in Pharma: Supply Chain, Logistics & Distribution - UniSecure®, Systech International Excellence in Pharma: Contract Services & Outsourcing - Development of a novel bio-catalysed manufacturing route for a generic API, CatSci Ltd. Highly commended - Continuous Flow Centre of Excellence, Cambrex  Excellence in Pharma: Regulatory and Compliance Framework, COMPLi– Scientist.com Excellence in Pharma: Corporate Social Responsibility - Delivering on the Promise of Good Corporate Citizenship, West Pharmaceutical Services, Inc. Excellence in Pharma: CEO of the Year - Laurent Levy, Nanobiotix Excellence in Pharma: Pharma Company of the Year - Nanobiotix Excellence in Pharma: OTC - Excilor 2-in-1 Wart Treatment Device, Medical Brands and Vemedia  Excellence in Pharma: Patient Centricity - SRS Unistraw Delivery System, SRS Life Sciences Pte Ltd Excellence in Pharma: IT, mHealth & Digitalisation - Qualit-e Cloud, Qualit-e Cloud GmbH   ]]> https://biospectrumindia.com/news/57/11830/ime-medical-with-amor-enters-into-development-cooperation-.html https://biospectrumindia.com/news/57/11830/ime-medical-with-amor-enters-into-development-cooperation-.html Thu, 11 Oct 2018 13:35:00 +0530 Medical Technology company IME Medical Electrospinning, developer, producer and scientific partner in the field of biomedical electrospinning processes and equipment,  announced that it has entered into a new collaboration with Amor (Suzhou) Medical Sci-Tech Co., Ltd. of Jiangsu Province, P.R China, a new Sino-Foreign joint venture founded in 2017 by a team of business leaders from the People’s Republic of China and a team of scientists from the University of Freiburg in Germany to provide systematic regenerative medical solutions. The collaboration aims at optimizing Amor’s production of a novel resorbable Medical Device Class III product for the treatment of full-thickness wounds in oral cavities. Amor (Suzhou) Medical is on the path of becoming a leader in tissue regeneration in China, Europe, US and Asia by developing and placing its novel resorbable implant product, an invention originating from the University of Freiburg/Germany, in the respective markets. IME has set the worldwide standard in the co-development and production of scalable and reproducible nanometer and micrometer scaffolds that enable scientists to develop medical implants, helping the human body to repair itself, such as heart valves, blood vessels, nerves, tendons, skin and bone. Recently the company commissioned its brand new high-end GMP Laboratory and set of cleanrooms. With this IME is now able to not only develop and manufacture its top-end proprietary electrospinning machines but to also produce the actual scaffolds for the intended medical implants for their customers. The cleanroom facilities enable the production of Class I, II and III medical devices. IME's technological solutions are able to mimic the natural human extracellular matrix for implants in the human body in nanometer and micrometer format, applying specific polymers. Human cells attach to this matrix leading to new body tissue. This is in contrast to implants of traditional structures, which are seen as foreign and therefore can lead to scar tissue or rejection phenomena. ]]> https://biospectrumindia.com/news/57/11826/medincell-lists-on-euronext-paris-raises-30m.html https://biospectrumindia.com/news/57/11826/medincell-lists-on-euronext-paris-raises-30m.html Wed, 10 Oct 2018 16:50:00 +0530 Euronext welcomed MedinCell, a Pharma tech company that develops injectable drug delivery solutions, to listing in compartment C of Euronext Paris. MedinCell is hoping to improve patient compliance with medication regimes by injecting them with a drug-infused gel. Patient compliance with taking medication can be as low as 30% and non-compliance is costly for healthcare systems. The French company’s tech, called BEPO, consists of a gel with which it can mix drugs already on the market. Once injected into patients, the drug-infused gel degrades and releases the drug automatically for up to a year. According to the company, you can fine tune how quickly the drug is released just by altering the gel’s ingredients. MedinCell’s lead project is being tested in a US Phase III trial for the treatment of schizophrenia. In partnership with Teva, the biotech combined its BEPO tech to allow the slow release of the antipsychotic risperidone. The biotech is also running a Phase II trial in the US for treating postoperative pain and inflammation. For this trial, it partnered up with the orthopedic surgery company AIC to test BEPO with the anti-inflammatory drug celecoxib. In addition to its IPO, Medincell received a €20M loan from the European Investment Bank in March this year. With the funding, the company plans to develop and expand its portfolio. Other companies in Europe are also injecting cash into slow-release technology. Danish biotech Ascendis hopes to achieve the slow release of hormones such as growth hormone by injecting them with protective carrier molecules. Ascendis aims to reduce the frequency that patients need growth hormone injections and is testing this lead application in a Phase III trial. ]]> https://biospectrumindia.com/news/57/11823/fda-approves-hemlibra-without-factor-viii-inhibitors-for-hemophilia-a.html https://biospectrumindia.com/news/57/11823/fda-approves-hemlibra-without-factor-viii-inhibitors-for-hemophilia-a.html Wed, 10 Oct 2018 12:30:00 +0530 Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has approved Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously (under the skin) and at multiple dosing options (once weekly, every two weeks or every four weeks). This approval is based on positive results from the Phase III HAVEN 3 and HAVEN 4 studies. Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis (primary endpoint) and across all other bleed-related endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4 study.  “Many preventative treatment options for people with hemophilia A without factor VIII inhibitors require intravenous infusions several times a week. Even then, people can still experience bleeds, and there has been a need for more treatment options,” said Michael Callaghan, M.D., hematologist, Children’s Hospital of Michigan. “The approval of Hemlibra is an important advancement for the entire hemophilia A community, as we now have a new class of medicine for the first time in nearly 20 years. Hemlibra can reduce bleeds, and it offers a new subcutaneous administration once weekly, every two weeks or every four weeks.” “Today’s approval of Hemlibra reflects our commitment to groundbreaking science and the development of medicines with the potential to redefine the standard of care,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Hemlibra is now the only FDA-approved medicine for people with hemophilia A with and without factor VIII inhibitors, based on the efficacy and safety profile demonstrated across four pivotal studies. We want to thank the hemophilia community for their partnership in helping us bring this new option to everyone living with hemophilia A.” In the Phase III HAVEN 3 study, adults and adolescents aged 12 years or older with hemophilia A without factor VIII inhibitors who received Hemlibra prophylaxis once weekly (n=36) or every two weeks (n=35) experienced a 96 percent (95 percent CI: 92.5; 98.0, p<0.0001) and 97 percent (95 percent CI: 93.4; 98.3, p<0.0001) reduction in treated bleeds, respectively, compared to those who received no prophylaxis (n=18). Hemlibra is the first medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, which has been the recommended standard of care, as demonstrated by a statistically significant reduction of 68 percent (95 percent CI: 48.6; 80.5, p<0.0001) in treated bleeds in a prospective intra-patient comparison (n=48) of people who previously received factor VIII prophylaxis in a non-interventional study and switched to Hemlibra prophylaxis. In the single-arm Phase III HAVEN 4 study of adults and adolescents aged 12 years or older with hemophilia A with factor VIII inhibitors (n=5) and without factor VIII inhibitors (n=36), Hemlibra prophylaxis every four weeks (n=41) led to clinically meaningful control of bleeding. The most common adverse reactions occurring in 10 percent or more of people treated with Hemlibra in pooled studies (n=391) were injection site reactions (n=85), headache (n=57) and joint pain (arthralgia; n=59). Hemlibra is now available to people in the U.S. who have hemophilia A without factor VIII inhibitors. Genentech is committed to helping people with hemophilia A access Hemlibra and offers comprehensive services to help minimize barriers to access and reimbursement. Patients can call (866) HEMLIBRA (436-5427) for more information. For people who qualify, Genentech also offers patient assistance programs through Genentech Access Solutions. Hemlibra was granted Breakthrough Therapy Designation by the FDA for hemophilia A without factor VIII inhibitors. It was also granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease. Submissions to other regulatory authorities around the world are ongoing. Hemlibra was approved by the FDA in November 2017 for adults and children with hemophilia A with factor VIII inhibitors. It has been studied in one of the largest pivotal clinical trial programs in people with hemophilia A with and without factor VIII inhibitors, including four pivotal HAVEN studies (HAVEN 1, HAVEN 2, HAVEN 3 and HAVEN 4). ]]> https://biospectrumindia.com/news/57/11821/wave-life-sciences-to-develop-programs-in-rare-genetic-eye-diseases.html https://biospectrumindia.com/news/57/11821/wave-life-sciences-to-develop-programs-in-rare-genetic-eye-diseases.html Wed, 10 Oct 2018 11:10:00 +0530 Wave Life Sciences, a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases has announced plans to design and advance stereopure oligonucleotide therapeutics for the potential treatment of rare, inherited eye diseases. Wave's research in ophthalmology will initially focus on the following four inherited retinal diseases which commonly lead to progressive vision loss typically starting in childhood or adolescence: retinitis pigmentosa due to a P23H mutation in the RHO gene, Stargardt disease, Usher syndrome type 2A and Leber congenital amaurosis 10. The company expects to announce its first ophthalmology development candidate in the second half of 2019. "We have long believed that oligonucleotides have the potential to be particularly effective and durable in the eye and are energized by our latest research that provides additional validation of our precisely designed stereopure oligonucleotides," said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. "Our aim is to move quickly to develop long-acting, intravitreally injected, disease-modifying therapies to address the enormous need across a spectrum of rare, genetically-defined eye diseases." Wave's decision to expand its therapeutic pipeline into ophthalmology is supported by its data presented at the 14th Annual Meeting of the Oligonucleotide Therapeutics Society on October 1, 2018 in Seattle, Washington. The data demonstrate that a single intravitreal injection of stereopure oligonucleotide in the eye of non-human primates resulted in greater than 95% knockdown of a target RNA in the retina for at least four months. Based on these data, the company is working to design development candidates that could achieve a therapeutic effect with only two doses per year. Inherited retinal dystrophies are a wide range of heterogeneous, rare eye disorders characterized by progressive loss of vision and/or eventual blindness caused by inherited genetic mutations. These conditions affect approximately 200,000 people in the U.S. There are currently no cures or treatments for this category of diseases, except for one approved disease-modifying therapeutic in the U.S. for patients with biallelic RPE65 mutation-associated retinal dystrophy. Wave's research will assess four genetic targets, RHO P23H, USH2A, ABCA4 and CEP290 to address four rare, inherited retinal diseases. The company estimates that approximately 10,000 U.S. patients could potentially be treated by Wave's approach to addressing the four diseases which are Retinitis pigmentosa, Usher syndrome type 2A, Stargardt disease and Leber congenial amaurosis 10. ]]> https://biospectrumindia.com/news/57/11820/ai-can-guess-alzheimers-risk-5-years-in-advance.html https://biospectrumindia.com/news/57/11820/ai-can-guess-alzheimers-risk-5-years-in-advance.html Wed, 10 Oct 2018 10:40:00 +0530 Researchers from the University of Toronto have designed an algorithm that learns signatures from magnetic resonance imaging (MRI), genetics, and clinical data. The research titled Modeling and Prediction of Clinical Symptom Trajectories in Alzheimer’s Disease Using Longitudinal Data uses artificial intelligence algorithm which can accurately predict whether a person’s cognitive decline will lead to Alzheimer’s disease in the next five years or not. The research by Indian-origin scientists Nikhil Bhagwat, M Mallar Chakravarty, and Joseph D Viviano and Aristotle N Voineskos, talks about their AI methodology could work symbiotically as a “doctor’s assistant”.  "At the moment, there are limited ways to treat Alzheimer's and the best evidence we have is for prevention. Our AI methodology could have significant implications as a 'doctor's assistant' that would help stream people onto the right pathway for treatment," said Mallar Chakravarty, an assistant professor in McGill University in Canada. For example, one could even initiate lifestyle changes that may delay the beginning stages of Alzheimer's or even prevent it altogether," said Chakravarty. The researchers trained their algorithms using data from more than 800 people ranging from normal healthy seniors to those experiencing mild cognitive impairment, and Alzheimer’s disease patients. ]]> https://biospectrumindia.com/news/57/11819/philips-to-focus-on-medication-adherence-monitoring.html https://biospectrumindia.com/news/57/11819/philips-to-focus-on-medication-adherence-monitoring.html Tue, 09 Oct 2018 20:05:00 +0530 Royal Philips has signed a Memorandum of Understanding (MoU) with Ypsomed, a self-medication systems maker, to co-develop and deploy new digital services for the monitoring of medication adherence. The new SmartServices will be backed by Philips’ Cloud-based HealthSuite digital platform, which offers tools and services for easy integration, management and end-to-end security. SmartServices will comprise a set of digital services to address device-related challenges and support self-medication for patients with chronic diseases such as diabetes and rheumatoid arthritis. The deal will facilitate the integration of Ypsomed’s smart medical devices into Philips HealthSuite digital platform thereby improving therapy-specific care pathways. ]]> https://biospectrumindia.com/news/57/11804/alnylam-launches-first-ever-rnai-therapeutic-in-germany.html https://biospectrumindia.com/news/57/11804/alnylam-launches-first-ever-rnai-therapeutic-in-germany.html Mon, 08 Oct 2018 11:50:00 +0530 Alnylam Pharmaceuticals, Inc., the leading RNA interference (RNAi) therapeutics company has announced that ONPATTRO (patisiran) is now available in Germany. ONPATTRO has been developed to meet a significant unmet need for patients with hereditary ATTR amyloidosis, a devastating, chronic and often fatal disease. Hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. ONPATTRO is based on Nobel Prize-winning science and is the first-ever RNAi therapeutic to be approved in the European Union. Alnylam plans to launch ONPATTRO in additional markets in Europe throughout 2018 and 2019. “The launch of ONPATTRO in Germany, just over a month after being granted approval by the European Medicines Agency, is a demonstration of our commitment to deliver innovative medicines with the potential to transform the lives of patients suffering from hATTR amyloidosis and our recognition of the urgency of unmet medical needs in this patient community,” said Hannes Schmeil, Country General Manager, Alnylam Germany. “Up until now, patients in Germany lacked medical treatment options with the potential to halt the progression of their disease. ONPATTRO will provide physicians, patients and their families with a new treatment option that we hope will make a meaningful difference to patients’ lives, restoring their hope for the future.” The European Commission decision was based on the evaluation of the effects of patisiran in hATTR amyloidosis patients with polyneuropathy and its safety profile as demonstrated in the APOLLO Phase 3 study, the largest-ever study in hATTR amyloidosis patients with polyneuropathy. Results from the APOLLO study were published in the July 5, 2018, issue of The New England Journal of Medicine. The Summary of Product Characteristics (SmPC) includes data from APOLLO on primary and secondary endpoints, as well as exploratory cardiac endpoints. The SmPC allows for the administration of patisiran in the home setting under the supervision of a healthcare professional provided infusions are being tolerated well by the patient. The European Medicines Agency reviewed patisiran under the accelerated assessment procedure that is granted to medicines judged to be of major interest for public health and therapeutic innovation. ]]> https://biospectrumindia.com/news/57/11803/us-researchers-develop-a-universal-vaccine-platform.html https://biospectrumindia.com/news/57/11803/us-researchers-develop-a-universal-vaccine-platform.html Sun, 07 Oct 2018 13:15:00 +0530 Researchers at The University of Texas Medical Branch at Galveston, US have developed a less expensive way to produce vaccines that cuts the costs of vaccine production and storage by up to 80 per cent without decreasing safety or effectiveness. The research team engineered a live-attenuated Zika vaccine in the DNA form. Once the DNA is delivered into the body, it launches the vaccine in the cells, leading to antibody production and other protective immunity. With this production method, there is no need to manufacture the vaccine in cell culture or eggs at factories. Because DNA molecules are shelf stable, the vaccine will not expire at warm temperatures and could be stockpiled at room temperature for years. Using this model, the research group showed that the DNA platform worked very efficiently in mice. After a single low dose, the DNA vaccine protected mice from Zika virus infection, mother-to-fetus transmission during pregnancy and male reproductive tract infection and damage. This is the first study to demonstrate that, after a single low dose, a DNA vaccine could induce saturated protective immunity. The team intends to continue testing this promising Zika vaccine platform and then apply the platform to other viruses. ]]> https://biospectrumindia.com/news/57/11797/merck-opens-m-lab-collaboration-centre-in-brazil.html https://biospectrumindia.com/news/57/11797/merck-opens-m-lab-collaboration-centre-in-brazil.html Fri, 05 Oct 2018 10:35:00 +0530 Merck, the vibrant science and technology company, has officially opened a state-of-the-art M Lab Collaboration Centre in Brazil, serving the Latin America region. The centre will provide Life Science customers with a shared, exploratory environment where they can closely collaborate with Merck scientists and engineers to solve their toughest challenges and accelerate development and production of new therapies. At Merck's new M Lab Collaboration centre, customers will benefit from the company's deep technical expertise to develop processes for manufacturing drugs faster, safer and more effectively "With a rapidly growing biopharmaceutical industry in Brazil and Latin America, and demand for novel and cost-effective therapies worldwide, there is a need for full end-to-end process development support," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "At our M Lab Collaboration centre, customers will benefit from Merck's deep technical expertise to develop processes for manufacturing drugs faster, safer and more effectively than in the past." The 1,000-square meter lab facility includes non-GMP pilot and bench scale labs for customers to engage in process development support, troubleshooting, demonstrations and hands-on training. It is one of nine such centres around the world, each of which allows pharmaceutical manufacturers to explore new ways to increase productivity, improve processes and mitigate risks. Each year, more than 1,500 customers visit Merck's M Lab Collaboration centres, where they work alongside Merck's team of experts and get access to sizing and simulation tools and methodologies as well as analytical and modeling support. Formal bioprocessing courses are also available, including traditional classroom-style training and interactive, hands-on sessions. Other M Lab Collaboration centre locations include China, Singapore, Japan, South Korea, India, France and the United States. Merck opened its first customer-facing laboratory in 1995 in Massachusetts, USA. The global network has steadily grown over the years, not only to meet the training and process development needs of customers in local regions, but also to allow and ensure successful technology transfer between countries for global customers. In 2015, Merck began reimagining these labs as the M Lab Collaboration centres with a focus on customers. ]]> https://biospectrumindia.com/news/57/11792/novartis-to-develop-novel-anti-infective-drug-candidates.html https://biospectrumindia.com/news/57/11792/novartis-to-develop-novel-anti-infective-drug-candidates.html Thu, 04 Oct 2018 11:05:00 +0530 Novartis has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug candidates that are part of the Novartis Infectious Diseases portfolio, which have the potential to address the need for new agents to treat antibiotic resistant Gram-negative infections. Under the terms of the agreement, Boston Pharmaceuticals acquired worldwide rights to two complementary candidates targeting carbapenem-resistant enterobacteriaceae (CRE) and one candidate targeting Pseudomonas infections. Novartis will receive an upfront payment and is entitled to royalties and milestone payments for successfully commercialized medicines. In addition, Novartis will receive an equity stake in two new companies formed together with Boston Pharmaceuticals to further develop and commercialize these programs. Financial terms of the agreement were not disclosed. The programs in this agreement include: LYS228 is a potential best-in-class monobactam which has entered clinical development and which has demonstrated activity against CRE with resistance caused by serine beta-lactamases (SBLs) and/or metallo beta-lactamases (MBLs); IID572 is a novel beta-lactamase inhibitor that may be used in combination with LYS228 or other beta-lactam antibiotics to expand their use against difficult-to-treat infections caused by a broader spectrum of CRE; and MAK181 is an oral, first-in-class LpxC inhibitor for Pseudomonas infections. ]]> https://biospectrumindia.com/news/57/11782/us-scientists-invent-biofuel-based-diagnostic-sensor-.html https://biospectrumindia.com/news/57/11782/us-scientists-invent-biofuel-based-diagnostic-sensor-.html Wed, 03 Oct 2018 10:25:00 +0530 A team of scientists from Washington State University (WSU) in the US has developed a new biofuel-based sensor that can be implanted into the body for tracking biological signals in order to diagnose diseases. The sensor has been designed to run on sugar by harvesting glucose from body fluids. It comprises electronics to process both physiological and biochemical signals. Though the electronics in the sensor require less power, they are said to be highly sensitive. As the biofuel-based sensor depends on body glucose, it eliminates the need for recharging. The scientists have already tested the sensor in the lab and are planning to assess and demonstrate it in blood capillaries, after potentially obtaining the necessary regulatory approval. Furthermore, the team intends to improve and enhance the power output of the biofuel sensor. ]]> https://biospectrumindia.com/news/57/11774/eppendorf-announces-applications-for-award-2019-for-young-scientists.html https://biospectrumindia.com/news/57/11774/eppendorf-announces-applications-for-award-2019-for-young-scientists.html Mon, 01 Oct 2018 10:55:00 +0530 From October 1, 2018, until January 15, 2019, young researchers not older than 35 years, with an advanced degree, who are working in Europe can apply for the Eppendorf Award for Young European Investigators. This highly prestigious 20,000 EUR prize acknowledges outstanding contributions to biomedical research in Europe based on methods of molecular biology, including novel analytical concepts. The winner is selected by an independent expert committee chaired by Reinhard Jahn (Max Planck Institute for Biophysical Chemistry, Göttingen, Germany). The Award winner 2019 will receive >        A prize money of 20,000 EUR >        An invitation to the prize ceremony at the EMBL Advanced Training Centre in Heidelberg, Germany, on June 27, 2019 >        An invitation to visit Eppendorf AG in Hamburg, Germany >        Coverage of his/her work by Nature in print and online (including a podcast)  Full details on the Eppendorf Award for Young European Investigators, the selection criteria and Award winners since 1995 can be found at www.eppendorf.com/award. Only online applications are accepted. The official online registration portal will accept applications as of October 1, 2018 at www.eppendorf.com/award/application. The Eppendorf award for Young European Investigators is presented in partnership with Nature. ]]> https://biospectrumindia.com/news/57/11773/bioconjugation-expertise-and-increased-productivity-over-next-5-years-forecasts-a-biolive-report.html https://biospectrumindia.com/news/57/11773/bioconjugation-expertise-and-increased-productivity-over-next-5-years-forecasts-a-biolive-report.html Mon, 01 Oct 2018 10:50:00 +0530 Ahead of the inaugural edition of bioLIVE, the bioprocessing and manufacturing event opening October (9-11) in Madrid, CPhI Worldwide announces the bio findings of its annual report, which foresees much greater efficiency in biomanufacturing and an increased exchange of ideas across small and large molecule industries. CPhI Annual report expert, Mike Ultee of Ulteemit BioConsulting projects great strides being made in improving bioprocessing techniques and, in particular, cell line productivity for recombinant proteins. He predicts that over the next 5-years productivity of fusion proteins and enzymes will move towards the 2-5g/l range. The consequence of which is that we are likely to see continued moves towards smaller bioreactors. Ultee also argues that the rise in the use of continuous bioprocessing will see the return of perfusion bioreactors aided by inline new filtration technologies – ultrafiltration, diafiltration and concentration equipment. In fact, high-efficiency perfusion techniques will also enable extremely high densities (~ 108cells/mL) in small volumes. Most excitingly, the pipeline of CAR-T and gene therapies will now come to market in increasing numbers as bioprocessing techniques have proved reliable in bringing products through clinical and commercial production. “In 5-years time we will have been through a golden period, with game changing improvements made in upstream, downstream and continuous bioprocessing. The market will by then also boast much greater numbers of biosimilars and new applications for cell and gene therapies. The industry is collectively maturing extremely quickly from big pharma and biosimilars to CDMOs,” added Ultee. Kent Payne, CEO of Socorro Pharmaceuticals LLC explores in his analysis how demand is now outstripping supply for qualified bio professionals in the big bio hubs – notably Boston and San Francisco – and increasingly we will see small molecule professionals moving across, especially in areas like conjugation and ADCs where there is directly transferable expertise. However, his conclusion was that as bio manufacturing enters its maturation stage, especially amongst the smaller nimble biotechs, they will increasingly look borrow from practices already established in the small molecule segment rather than by ‘any means to market’. “There are lessons to be learned from Pharma peers to drive enhanced productivity and quality, whilst simultaneously lowering costs. The processes and skills that have been honed at larger companies to drive operational excellence are key to the smaller companies’ growth and profitability prospects. As small companies reach a tipping point in their life cycle, they must move beyond the ‘just get it done by any means’ mode to a ‘growth by design’ mode in order to be prepared for commercialization and beyond” commented Payne. In particular, it is in the supply chain and management systems where there are likely to be great efficiencies yet to be discovered. Payne concluded “over the last decade or so, many of the larger biomanufacturing players have implemented more sophisticated production management systems to provide real monitoring and optimization. Nevertheless, in comparison to small molecule counterparts, there is still much room for improvement.” Rutger Oudejans, Brand Director at UBM for bioLIVE: “The findings in our Annual Report clearly support the need for introducing an event like bioLIVE – one that supports the benefits of the growing exchange of ideas across small molecule and bio manufacturing. What is most exciting is that in an age of renewed innovation and with drug attrition rates falling that we might also be able to bring these new biologics to market much cheaper. It’s one of the central themes of this year’s inaugural event, ‘how to help transition the growing workforce needed in bio’ and, of course, ‘how we can make manufacturing more efficient and bring medicine to patients faster’. The synergies we are seeing with small and large molecule in the long-term will help both industries innovate and commercialize better in the future.”   ]]> https://biospectrumindia.com/news/57/11768/who-reappoints-bloomberg-as-global-ambassador-for-ncds-.html https://biospectrumindia.com/news/57/11768/who-reappoints-bloomberg-as-global-ambassador-for-ncds-.html Fri, 28 Sep 2018 16:55:00 +0530 Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), has renewed the appointment of Michael R. Bloomberg as WHO Global Ambassador for Non-communicable diseases (NCDs) and Injuries. During his second term as Global Ambassador, Bloomberg will continue to support global, national, and local efforts to protect people from NCDs and injuries. Many of the work streams from the first appointment will continue, including building the Partnership for Healthy Cities and promoting investment in NCD and injury prevention. Bloomberg served as the 108th Mayor of the City of New York, from 2002 to 2013.  He launched his foundation, Bloomberg Philanthropies, in 2006. Most recently at the 17th World Conference on Tobacco or Health in March 2018, Bloomberg Philanthropies announced the global tobacco industry watchdog STOP – Stopping Tobacco Organizations and Products – which will aggressively monitor deceptive practices to undermine public health. ]]> https://biospectrumindia.com/news/57/11763/plexus-technology-announces-ios-12-support-for-anesthesia-touch.html https://biospectrumindia.com/news/57/11763/plexus-technology-announces-ios-12-support-for-anesthesia-touch.html Fri, 28 Sep 2018 10:55:00 +0530 Plexus Technology Group, LLC (Plexus TG), a market-leading, best-of-breed provider of anesthesia information management systems (AIMS), is pleased to announce that Anesthesia Touch™ is ready for Apple's iOS 12. Clients that wish to upgrade their devices to iOS 12 should coordinate with Plexus TG support. "As a professional, mission critical application, we want to ensure Anesthesia Touch on iOS works with the latest version from Apple. This ensures our customers benefit from the significant performance improvements in the release and continued security enhancements," said Tony Mira, CEO of Plexus Technology Group. Doug Marcey, CTO, continues, "Because Anesthesia Touch works across iOS, Windows and a cloud-hosted server environment, our Development and Quality Assurance teams are always working to ensure we support these major releases in tandem as quickly as possible. We want to ensure customers can update their devices to take advantage of the new software." ]]> https://biospectrumindia.com/news/57/11760/3-million-deaths-globally-per-year-are-by-air-pollution-whf.html https://biospectrumindia.com/news/57/11760/3-million-deaths-globally-per-year-are-by-air-pollution-whf.html Thu, 27 Sep 2018 12:50:00 +0530 This year, on 29 September, the World Heart Federation (WHF) is raising awareness of an increasingly important CVD risk factor: air pollution. The latest scientific evidence by  Nature warns that exposure to nitrogen dioxide and fine particulate matter air pollution is clearly linked to CVD mortality. Poor air quality is also ranked as the 4th cause of Disability-Adjusted Life Year (DALY) - one lost year of 'healthy life' - according to latest Global Burden of Disease Study. Professor David Wood, WHF President said," On World Heart Day, we are raising awareness of poor outdoor and household air quality as an increasingly important risk factor, and bringing together all those involved in cardiovascular health from every country in the world in the fight to reduce CVD." My Heart, Your Heart Created and led by WHF, World Heart Day aims to combat the rising number of people with cardiovascular disease (CVD), by promoting the importance of living a heart-healthy lifestyle. On 29 September, people all around the world will unite to fight CVD by holding awareness activities, sharing the campaign video, organizing fundraising activities for their local heart foundation and illuminating iconic landmarks and buildings. Our campaign, in partnership with Manulife and Philips, includes a simple call to action: Make your heart promise. A promise to eat more healthily, to do more exercise and to say no to smoking. A promise as a healthcare professional to continue working to reduce the impact of CVD. A promise as a politician to implement a noncommunicable diseases action plan. A simple promise for MY HEART, for YOUR HEART, for ALL OUR HEARTS. ]]> https://biospectrumindia.com/news/57/11753/c-cit-sensors-to-provide-biosensors-for-zurich-project-liver4life.html https://biospectrumindia.com/news/57/11753/c-cit-sensors-to-provide-biosensors-for-zurich-project-liver4life.html Wed, 26 Sep 2018 16:00:00 +0530 Liver4Life is a project of Wyss Zurich, a joint research and development center of the ETH Zurich and the University of Zurich in the fields of Regenerative Medicine and Robotics. The project is aiming at developing a liver perfusion device. C-CIT Sensors AG supplies single-use biosensors for applications in the field of normothermic ex-vivo organ perfusion. The challenging aim of the Liver4Life project at Wyss Zurich is to extend the viability of liver tissue outside of the body (ex-vivo) up to five days and allow its growth. The perfusion system will provide necessary nutrients and oxygen supply and is monitoring the functional capacity of the liver. Putting one focus on the glucose metabolism is important for the overall mission’s success. As a company with its main competence in electrochemistry and in developing and manufacturing single-use sensors for the in-situ and continuous measurement of metabolically relevant parameters in aqueous solutions such as blood, cell culture media or sweat, C-CIT Sensors contributes an important feature to the Liver4Life perfusion machine. Because the glucose metabolism is an important task of the liver, the team around Professor Philipp Rudolf von Rohr successfully evaluated C-CIT Sensors’ glucose monitoring technology as part of an artificial pancreas within the Liver4Life system. “We are happy about the latest achievements we made together with C-CIT Sensors and to continue our innovation process in this exciting field of liver regeneration”, said Professor Rudolf von Rohr. “C-CIT Sensors’ single-use in-situ glucose sensor technology is a valuable tool for identifying the optimal process parameters to allow extended organ perfusion under normothermic conditions. Continuous information on changing blood glucose levels help stabilize the organ on the machine." Dr Andreas Koch, Business Development Manager with C-CIT Sensors is looking forward to continuing this experimental phase together with Liver4Life. “The results obtained so far are highly encouraging and confirm the broad applicability of our technology within different fields of Biopharmaceutical production, Cell Therapy and Regenerative Medicine.” ]]> https://biospectrumindia.com/news/57/11752/verastems-copiktra-gets-u-s-fda-nod.html https://biospectrumindia.com/news/57/11752/verastems-copiktra-gets-u-s-fda-nod.html Wed, 26 Sep 2018 14:25:00 +0530 Verastem, Inc. focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients has announced that the U.S. Food and Drug Administration (FDA) has approved COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. COPIKTRA is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. "With today's FDA approval of COPIKTRA, Verastem Oncology is delivering upon our commitment to patients with cancer by bringing a new oral medicine to market," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "We are pleased to be able to introduce COPIKTRA during National Blood Cancer Awareness Month. At Verastem Oncology, we are driven by the strength and courage of those battling cancer, and we are committed to advancing therapies such as COPIKTRA with the potential to make a significant impact for patients, their caregivers and physicians. We are immensely grateful to the many patients who participated in the duvelisib clinical trial program over the years leading to this pivotal moment." "COPIKTRA is an important addition to the evolving treatment paradigm for patients with CLL/SLL and FL," said Ian Flinn, MD, PhD, Director of the Lymphoma Research Program at Sarah Cannon Research Institute and lead investigator of the DYNAMO™ and DUO™ studies. "The approval of COPIKTRA for the treatment of relapsed or refractory CLL/SLL after at least two prior therapies, or relapsed or refractory FL after at least two prior systemic therapies, is based on clinical trial data gathered from the treatment of over 400 adult patients. COPIKTRA is a significant addition to physicians' treatment armamentarium that I believe will address an unmet need for patients who have limited options once they have progressed after two prior therapies." Lymphoma is the most common blood cancer, and CLL/SLL and FL are common types of indolent non-Hodgkin lymphomas (iNHL). There are an estimated 681,000 people living with non-Hodgkin lymphoma in the US alone, including nearly 350,000 cases of CLL/SLL or FL. Many of these patients will eventually relapse or develop refractory disease. "Each lymphoma patient's experience is unique, and today's approval offers patients with CLL/SLL and FL a new treatment option and a new opportunity for hope," said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. "We applaud the FDA, Verastem and the patients who participated in the clinical trials for their roles in advancing treatment options for people living with CLL/SLL and FL." The New Drug Application for COPIKTRA received Priority Review. Priority Review is reserved for medicines that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA had previously granted COPIKTRA Fast Track Designation in CLL and FL as well as Orphan Drug Designation for CLL/SLL and FL. For the indication of FL, COPIKTRA was approved under FDA regulations for accelerated approval. "We are excited to offer a new treatment that can allow patients to manage their disease with an oral monotherapy," said Joseph Lobacki, Executive Vice President and Chief Commercial Officer of Verastem Oncology. "We continue to hear from physicians and patients that there is a great need for additional treatment options to fight chronic cancers such as CLL/SLL and FL. In preparation for this approval, we have assembled an experienced oncology commercial team, established our distribution network, and we are ready to make COPIKTRA commercially available to patients." COPIKTRA will be available in the U.S. market immediately. Verastem Oncology is committed to helping patients with CLL/SLL and FL access COPIKTRA through our Verastem Cares program. Verastem Cares is a comprehensive, personalized program designed to provide information and assistance to patients who have been prescribed COPIKTRA. ]]> https://biospectrumindia.com/news/57/11749/minoryx-therapeutics-obtains-21-3m-in-series-b-round.html https://biospectrumindia.com/news/57/11749/minoryx-therapeutics-obtains-21-3m-in-series-b-round.html Wed, 26 Sep 2018 12:10:00 +0530 Minoryx Therapeutics, a company specializing in the development of new drugs for orphan diseases, announces the completion of a Series B funding round of €21.3M. The proceeds will enable the company to expand the list of indications for its lead compound, MIN-102, as well as to conduct a new clinical trial for a second orphan central nervous system (CNS) indication. The funding round was led by Fund+, joined by SFPI, S.R.I.W. and Sambrinvest, in addition to all Series A investors (Ysios Capital, Kurma Partners, Roche Venture Fund, Idinvest Partners, Chiesi Ventures, Caixa Capital Risc and HealthEquity). MIN-102 is a novel, orally bioavailable and selective PPAR gamma agonist with a superior profile for central nervous system-related diseases. It is currently in phase 2/3 clinical trial for the treatment of adrenomyeloneuropathy (AMN). The trial enrolls adult male patients affected by AMN, the most frequent phenotype of X-linked adrenoleukodystrophy (X-ALD), in Europe and the US, with results expected in 2020. “The proceeds of the round will allow the company to demonstrate the potential of MIN-102 in new indications,” said Marc Martinell, co-founder and CEO of Minoryx. “These indications for MIN-102 include neuroinflammatory conditions such as cerebral ALD (cALD) as well as multiple neurodegenerative diseases.” Following this Series B funding round, two new members will join the Board of Directors of Minoryx: Philippe Monteyne and Gery Lefebvre, representing Fund+ and S.R.I.W., respectively. “On behalf of the board of directors, it is my great pleasure to welcome Philippe Monteyne and Gery Lefebvre, whose expertise and experience will be a valuable addition to the board as the company progresses its ambitious development plans over the next 18-24 months”, said Khalid Islam, chairman of the board of directors at Minoryx Therapeutics.   ]]> https://biospectrumindia.com/news/57/11743/novartis-to-file-lucentis-for-retinopathy-in-premature-babies-.html https://biospectrumindia.com/news/57/11743/novartis-to-file-lucentis-for-retinopathy-in-premature-babies-.html Tue, 25 Sep 2018 15:50:00 +0530 Novartis has revealed its intent to file anti-VEGF therapy Lucentis for retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness. The move follows data from the Phase III Rainbow trial, which showed that, despite marginally missing statistical significance for the primary endpoint of showing superiority of the drug to laser surgery, Lucentis (ranibizumab) was found to be “an efficacious, safe and well-tolerated treatment for infants with ROP”. “With 80% of patients achieving treatment success with 0.2mg Lucentis versus 66% with laser, these data are clinically relevant,” the firm stressed. "Laser surgery, the current standard of care, works by destroying the tissue in the eye that contributes to the elevation of VEGF. While it is an effective treatment, there is a clear unmet need for innovative ways to treat ROP without destroying retinal tissue,” noted Professor Andreas Stahl, senior physician in Retinal Surgery and Head of the Angiogenesis Research Group at the Eye Center, University of Freiburg, Germany. “Lucentis demonstrated in the Rainbow study that it is an efficacious and well tolerated option for the treatment of ROP that may offer new hope to parents of this vulnerable patient population”.   ]]> https://biospectrumindia.com/news/57/11741/mylan-atomo-diagnostics-to-expand-access-to-hiv-self-testing-.html https://biospectrumindia.com/news/57/11741/mylan-atomo-diagnostics-to-expand-access-to-hiv-self-testing-.html Tue, 25 Sep 2018 11:10:00 +0530 Global pharmaceutical company Mylan and medical device company Atomo Diagnostics have announced a strategic partnership to commercialize CE-Marked in vitro HIV rapid diagnostic tests for self-testing in low- and middle-income countries. The tests will allow individuals to confidently screen themselves in the privacy of their own homes with a device engineered for simplicity and accuracy. The tests are designed to detect the presence or absence of HIV antibodies in a single drop of blood obtained from a fingertip. Results are delivered in just 15 minutes, which is essential for access to early treatment and care. While in some countries, like the U.S. and in Europe, HIV self-tests are readily available in pharmacies, HIV testing in low- and middle-income countries remains dependent on the diagnostic test being conducted in formal settings by trained professionals. Scaling up self-testing globally requires a simple and reliable product. Atomo is partnering with Mylan to supply all-in-one test devices that offer improved functionality and ease-of-use compared to current multi-component rapid diagnostic tests. Under the terms of the agreement, Mylan has exclusive rights to commercialize the products in more than 100 countries in Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS) and Latin America. Mylan plans to launch the Mylan HIV Self-Test in global markets in early 2019. ]]> https://biospectrumindia.com/news/57/11737/skeletal-stem-cells-may-grow-bones-and-cartilage-.html https://biospectrumindia.com/news/57/11737/skeletal-stem-cells-may-grow-bones-and-cartilage-.html Mon, 24 Sep 2018 13:25:00 +0530 Scientists found the stem cells, which give rise to bones, cartilage and the spongy bone that harbors bone marrow, in fetal bones, adult bones and fat. The researchers also reprogrammed adult cells into skeletal stem cells. A ready supply of such cells could one day help doctors repair or replace joint cartilage, heal broken bones more quickly, build up bone in osteoporosis patients and even grow new bone and cartilage for reconstructive surgeries. Those applications are still far in the future, says Clifford Tabin, a developmental geneticist at Harvard Medical School who was not involved in the study. “The current study is an extremely important advance,” he says, “but there is work to be done before [skeletal stem cells] can contribute to changing the landscape of orthopedic medicine.”   Other stem cells collected from fat and cartilage can be coaxed into making bone or cartilage under special circumstances, but those cells are not the dedicated skeletal cells discovered in the new study, says co-author Michael Longaker, a plastic surgeon at Stanford University School of Medicine. Longaker’s team found skeletal stem cells in the rapidly growing portion of a fetal femur and transferred them to lab dishes where they could multiply. Continued self-renewal is an important characteristic of stem cells. To determine whether the cells could make more of themselves indefinitely, researchers performed a series of stem cell transplants into mice under the outer layer of the rodents’ kidneys. The transplanted human skeletal stem cells grew into bones on the mice’s kidneys. Stem cells from those newly grown bones were transplanted into another mouse, where the stem cells again made bones. The skeletal stem cells could form bone, cartilage and spongy bone, but didn’t make fat or other tissues. That result shows these stem cells are specific to the skeleton.  Longaker’s team tracked down adult skeleton stem cells by cataloging the types of RNA produced in the fetal skeletal stem cells. Different types of RNA are copies of genetic instructions encoded in DNA, which determine a cell’s identity and function. Skeletal stem cells in adult bones and fat that make the same RNAs also made bone, cartilage and spongy bone when transplanted into mice.    The team also manipulated embryonic-like stem cells, or induced pluripotent stem cells, into becoming the skeletal stem cells. The ability to grow skeletal stem cells in a dish “is particularly promising, as you can grow as many of these as you wish,” Tabin says.   ]]> https://biospectrumindia.com/news/57/11728/plexis-healthcare-systems-and-santch-enter-into-partnership.html https://biospectrumindia.com/news/57/11728/plexis-healthcare-systems-and-santch-enter-into-partnership.html Fri, 21 Sep 2018 15:45:00 +0530 PLEXIS Healthcare Systems, a global provider of core payer technologies for healthcare claims administration, and Santéch, a leading provider of innovative solutions through the I-Network platform for agile provider network management capabilities, announced a strategic partnership to empower provider network management and claims administration for payers across the country and beyond. "Payer organizations increasingly demand a modern solution to manage provider networks, provider recruitment, provider directories, and value-based contracts. Santéch's I-Network platform is a proven solution validated by leading payer organizations and industry analysts," said Sean Garrett, Chief Operating Officer of PLEXIS. "Our partnership with Santéch will empower our clients to leverage the I-Network platform for cost-saving operational efficiencies and numerous additional capabilities." "We are thrilled to partner with PLEXIS Healthcare System. PLEXIS has deep expertise in payer administration, and the PLEXIS payer platform leads the industry in core administration and claims management. We appreciate PLEXIS' recognition of payers' increasing demand for efficient provider network management and I-Network as the solution for these needs," said Neeraj K. Sharma, COO of Santéch. "This partnership creates seamless capabilities for faster provider recruitment, credentialing, contracting, directory validations, and ease of provider content integration with the claims system for streamlined claims administration." Santéch's provider management platform has garnered endorsements and attention from a growing number of payer/provider organizations and industry analysts as a disruptive solution for managing provider data and networks. This partnership capitalizes on Santéch's innovative solutions for payers and providers while maximizing the competency of PLEXIS' core administration and claims management payer platform, facilitating seamless solutions for payer organizations. ]]> https://biospectrumindia.com/news/57/11725/pierre-fabre-gets-eu-approval-for-braftovi-mektovi-.html https://biospectrumindia.com/news/57/11725/pierre-fabre-gets-eu-approval-for-braftovi-mektovi-.html Fri, 21 Sep 2018 15:05:00 +0530 Pierre Fabre, the 2nd largest dermo-cosmetics laboratory in the world, announced that the European Commission (EC) has granted marketing authorisation for the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test. The EC decision is applicable to all 28 European Union (EU) member states plus Liechtenstein, Iceland and Norway. "We are extremely pleased that European patients with advanced BRAF-mutant melanoma will now have the combination of BRAFTOVI and MEKTOVI as a new treatment option", said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. "All of us at Pierre Fabre are driven to make a real difference for patients.  Bringing more than 30 years of oncology experience and our heritage in dermatology to our partnership with Array, we have been able to harness our expertise in order to help men and women living with this devastating disease. Today's news inspires us to continue pursuing new innovations that will benefit patients". The EC decision, which follows the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July, is based on results from the Phase 3 COLUMBUS trial.  This trial demonstrated that the combination of BRAFTOVI 450 mg once daily and MEKTOVI 45 mg twice daily significantly improved median progression-free survival (PFS), compared with vemurafenib alone 960 mg twice daily (14.9 months versus 7.3 months, respectively: hazard ratio [HR] 0.54, 95% confidence interval [CI], 0.41-0.71; two-sided p<0.0001). Treatment with BRAFTOVI and MEKTOVI achieved a median overall survival (OS) of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as a monotherapy (HR 0.61, 95% CI, 0.47-0.79; p<0.0001) in the planned analysis of OS in the COLUMBUS trial.    ]]> https://biospectrumindia.com/news/57/11720/st-jude-tessa-therapeutics-announce-strategic-collaboration.html https://biospectrumindia.com/news/57/11720/st-jude-tessa-therapeutics-announce-strategic-collaboration.html Fri, 21 Sep 2018 11:35:00 +0530 St. Jude Children’s Research Hospital (St. Jude), the U.S. hospital leading the way the world understands, treats and cures childhood cancer and other life-threatening diseases, together with Tessa Therapeutics (Tessa), a clinical stage biopharmaceutical company has announced the establishment of a strategic collaboration focusing on the development of novel cellular immunotherapies that could lead to new treatment options for children with brain cancer.  The goal of the partnership is to accelerate the preclinical development of CAR-expressing Virus-Specific T cells (VSTs) leading to clinical testing in the near future. Stephen Gottschalk, M.D., chair of the St. Jude Department of Bone Marrow Transplantation and Cellular Therapy, leads the St. Jude team of investigators, which also includes Giedre Krenciute, Ph.D., and Jean-Yves Metais, Ph.D.  “The strategic collaboration will advance our understanding of how CARs work in VSTs,” Gottschalk said. “The gained knowledge will be critical for optimizing CAR VSTs targeting multiple tumor antigens expressed in pediatric high-grade gliomas.”  For the collaboration’s first project, the research teams of Gottschalk and John E. Connolly, Ph.D., Chief Scientific Officer of Tessa Therapeutics, will develop a new treatment for pediatric high-grade gliomas, an aggressive form of brain cancer in children, which currently has very few treatment options.  “We are excited to team up with St. Jude in the fight against childhood cancer,” said Andrew Khoo, Tessa Therapeutics CEO and Co-Founder. “St. Jude, one of the leading pediatric cancer hospitals in the U.S., shares our vision of working toward a cure for cancer. We believe our joint effort will accelerate advances in cellular immunotherapy and lead us a step closer to achieving this vision. Together, we aim to bring new hope to children suffering from cancer in the U.S. and around the world.”  Notably, the teams at Tessa and St. Jude will explore a new approach to cellular immunotherapy by targeting multiple tumor antigens with CARs using Tessa’s VST platform. This novel multi-CAR VST approach carries the potential to improve survival rates in children as well as reduce the chance of tumor escape, a phenomenon where cancer evolves to evade a successful treatment.  “If successful,” Gottschalk said, “multi-CAR VSTs could be adapted to other pediatric cancers that cannot be cured with conventional therapies.”  Connolly added, “High-grade glioma is a tumor where in some cases, we have seen a reduction in tumor volume following cell therapy treatment. However, after some time the tumor starts growing again. One reason could be that current therapies only target single tumor antigens. Over time, cancer cells may mutate and stop displaying the target antigen. Targeting multiple antigens should prevent the cancer from taking this escape strategy. The promise of the multi-CAR VST approach we are taking together with St. Jude is incredibly exciting.”  Cellular immunotherapy is a new cancer treatment that harnesses the patient’s immune system to fight the disease. It is widely considered one of the most promising advances toward a cure for cancer. T cells are removed from the patient’s blood and re-engineered to recognize the cancer cells. The T cells are then expanded to large numbers and infused back into the patient where the T cells seek out and destroy the cancer cells. ]]> https://biospectrumindia.com/news/57/11716/lonza-expands-ibex-solutions-for-complete-product-lifecycle-in-one-location.html https://biospectrumindia.com/news/57/11716/lonza-expands-ibex-solutions-for-complete-product-lifecycle-in-one-location.html Thu, 20 Sep 2018 15:05:00 +0530 Lonza is one of the world's leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. Lonza announces the addition of two new Ibex™Solutions offerings to Lonza's 100,000 m2 (1.1 million ft2) biopark in Visp (CH). In July 2017 Ibex™Dedicate, a modular, technology-agnostic biomanufacturing concept, was launched as the first Ibex™Solutions offering. Ibex™ Dedicate offers an innovative facility concept with reduced CAPEX and accelerated timelines, enabling speed to market or allowing biopharma companies to delay investment decisions to decrease financial risk. The two new Ibex™ Solutions, Ibex™ Design and Ibex™ Develop, announced today are designed to meet the evolving needs of biotech companies with antibody therapies, from the preclinical stage through to commercialization. Together with Ibex™ Dedicate, the new investment allows Lonza to offer complete product lifecycle management in one site. Ibex™ Design covers the early stages of creating a new biologic, from gene through to clinical phase I. The offering comprises a pioneering fixed-price gene-to-vial package with terms under which Lonza will deliver drug product based on at least 1 kg drug substance within 12 months. The package also includes the reservation of a manufacturing slot for clinical resupply. Ibex™ Design allows aspiring companies to start clinical trials earlier while reducing uncertainty. Ibex™ Develop helps companies seamlessly and rapidly transition from clinical phase II to commercialization. The offering enables biologics license applications (BLAs) to be submitted within 22 months from the start of process characterization. Eliminating the need for tech transfers, allowing process optimizations and creating operational efficiencies are expected to accelerate the path to market. Ibex™ Design and Ibex™ Develop draw on Lonza's R&D and operational experience from more than 30 years in biomanufacturing. Proven platform technologies, such as the GS Gene Expression System® and expertise in drug product development, are an integral part of the new offerings. The application of single-use technologies and a high degree of automation further increase the efficiency of Ibex™ Design and Ibex™ Develop. In addition, customers of all three Ibex™ Solutions can benefit from the ability to scale-up or scale-out to other sites in the established Lonza network in Europe, America or Asia. "We looked at every step in the development and manufacturing process and asked how we could transform the path to commercialization for customers," said Marc Funk, COO Lonza Pharma & Biotech. "The result strengthens our capabilities from the early stages of drug development all the way through to commercialization. It will help biotech companies deliver life-saving medicines to patients faster." Ibex™ Design and Ibex™ Develop will become operational from 2020 and provide a full range of manufacturing options from early development through to full commercialization.   ]]> https://biospectrumindia.com/news/57/11709/1st-wireless-handheld-ultrasound-device-to-offer-live-demos.html https://biospectrumindia.com/news/57/11709/1st-wireless-handheld-ultrasound-device-to-offer-live-demos.html Wed, 19 Sep 2018 13:10:00 +0530 Healcerion announced the SONON 300L will be unveiled to the US market with live demos at booth #722 in the New Exhibitor Pavilion at FMX Family Medicine Experience Show 2018, October 9-13, Ernest N. Morial Convention Center, New Orleans, LA. Dr. Benjamin Ryu, CEO and Founder of Healcerion and creator of the SONON 300L says, "Today, the stethoscope is a symbol of the medical profession. It is the most ubiquitous, recognized diagnostic instrument worldwide. Thanks to wireless technology and innovation, we now have a world-class ultrasound device that fits easily in your hand or your pocket." Dr. Ryu adds, "Primary Care Physicians and other clinicians can try the new SONON 300L wireless, handheld ultrasound device at FMX, and learn how to accelerate diagnosis, gain deeper insight into patient health and provide a richer patient experience, while increasing revenue." This family medicine event is the AAFP's (American Academy of Family Physicians) largest annual meeting. Attendees will gain valuable new family medicine knowledge through exclusive opportunities to engage with the latest developments in health care, patient expectations, treatment guidelines, and technology including the newly launched SONON 300L wireless, handheld ultrasound device. SONON 300L is smaller and easier to use than any other ultrasound in the US market. It removes the barriers of space and budgetary constraints for an acquisition of a diagnostic ultrasound device. As a result, practitioners and patients both benefit. The SONON 300L costs approximately 1/10 of a traditional ultrasound unit. It uses easy touch-screen controls with an app downloaded from the Google Play or Apple App Store. It pairs with a tablet or smartphone as a display, and images can be analyzed and shared quickly. The device weighs only 13 ounces (370 grams) and has a rechargeable lithium-ion battery with industry-leading 3-hour continuous run-time, Wi-Fi connectivity and 3G/LTE cellular capability. ]]> https://biospectrumindia.com/news/57/11697/biocity-wins-contract-to-provide-support-to-scottish-companies.html https://biospectrumindia.com/news/57/11697/biocity-wins-contract-to-provide-support-to-scottish-companies.html Tue, 18 Sep 2018 13:10:00 +0530 Life sciences incubator, BioCity, has won a contract tendered by Scottish Enterprise to provide specialist support and advice to all its life science start-ups in Scotland. The minimum three-year contract will see BioCity provide specialist coaches and consultants to help and support the next generation of life science start-ups in Scotland to achieve their potential. BioCity is already providing key support to a number of Scottish start-ups through programmes at its sites near Glasgow and in Aberdeen. This new initiative will allow BioCity to broaden its reach, using its highly commercial approach and unparalleled network in the sector to provide support for life science and healthcare start-ups chosen for support by Scottish Enterprise (SE). To support the programme, BioCity has teamed up with highly experienced and connected individuals from across the life sciences industry, who will be coaches to the Scottish start-ups. Commenting on the team of specialist coaches, Toby Reid, Managing Director of BioCity Group, said: “These guys have been there and done it. They want to put something back and are keen to use their experience and connections to promote growth and success within Scotland’s life sciences start-ups.” Programme coach and Founder and Director of TherapeutAix, Darcey Black said: “I am really excited to be working with BioCity on this SE initiative. There are many innovative ideas being developed by start-ups within the life sciences sector in Scotland. “Together with the other coaches and specialists, I am looking forward to sharing my knowledge and experience with fledgling companies to help them to succeed and bring effective therapies to patients”. Elaine Baxter, a programme coach and Director of Boutique Innovation added: “This is a fantastic opportunity for me use my experience in consumer goods product design and innovation to help the next generation of Scottish life-science start-ups.  There is a real focus on innovation in Scotland right now and being part of the team to help drive it to commercialisation is a great privilege.” Bill Blair, Venture Capital Fund Adviser and Business Specialist for the programme, said: “I am delighted to support BioCity and Scottish Enterprise in this initiative, which will better equip Scottish life sciences companies in attracting the finance required to become world leaders in their sector.”   ]]> https://biospectrumindia.com/news/57/11689/new-ai-device-to-monitor-patients-health-through-walls.html https://biospectrumindia.com/news/57/11689/new-ai-device-to-monitor-patients-health-through-walls.html Mon, 17 Sep 2018 15:30:00 +0530 Dina Katabi, a professor at the Massachusetts Institute of Technology (MIT) has developed a device that can monitor your health using radio signals and machine learning, even through walls. The device can help people living with conditions like Parkinson's, Alzheimer's, depression, and pulmonary diseases and enable their physicians to wirelessly monitor their health.  Katabi built the gadget to track breathing, heart rate, sleep, gait and more as you live your life at home. According to her, the novel device will be able to replace the array of expensive, bulky, uncomfortable gear we currently need to get clinical data about the body. It transmits a low-power wireless signal throughout a space the size of a one- or two-bedroom apartment (even through walls), and the signal reflects off people's bodies.  The device then uses machine learning to analyse those reflected signals and extract physiological data.  The gadget looks like a box and works like a Wi-Fi router; the low-power wireless signals reflect off nearby people's bodies and carry information back to the box, the MIT tech review said. The box analyzes the information and offers up health data. The device senses your movements, even if you're just breathing, by recording changes in the electromagnetic field around you. It can accurately monitor sleep, including individual sleep stages, in a person's own bed, with no changes to the way they sleep or what they wear.  Because the device would be installed in a home, it could track the resident over time, too, which could be useful for watching sleep-disrupting conditions like Alzheimer's or depression, she said. The data is collected only about specific traits and only with a person's consent. In addition, it is encrypted and is limited to certain designated recipients. ]]> https://biospectrumindia.com/news/57/11683/nih-to-accelerate-genetic-therapies-for-sickle-cell-disease.html https://biospectrumindia.com/news/57/11683/nih-to-accelerate-genetic-therapies-for-sickle-cell-disease.html Mon, 17 Sep 2018 11:00:00 +0530 The National Institutes of Health (NIH) has announced the launch of a new initiative to help speed the development of cures for sickle cell disease, a group of inherited blood disorders affecting at least 100,000 people in the United States and 20 million worldwide. The Cure Sickle Cell Initiative will take advantage of the latest genetic discoveries and technological advances to move the most promising genetic-based curative therapies safely into clinical trials within five to 10 years. The initiative and its research partners will establish a national data warehouse of genetic therapies for sickle cell disease and conduct comparative analyses of therapeutic approaches to assess both clinical and cost effectiveness. They will also establish national networks to make it easier for patients and providers to learn and engage with the research, clinical trials, and other activities happening across the country. The Cure Sickle Cell Initiative seeks to develop cures for a far broader group of individuals with the disease, and it is initially focusing on gene therapies that modify the patient’s own hematopoietic stem cells (HSCs), which make red and other blood cells. These modified HSCs can then be given back to the patient via a bone marrow transplant, making a cure available to more patients who lack a matched donor. This patient-focused Initiative builds on the legacy of National Heart, Lung, and Blood Institute (NHLBI) supported research that has contributed to improving clinical care for patients who have sickle cell disease. It also complements the Institute’s broader sickle cell disease research investment, which includes basic, clinical, translational, and implementation science research. ]]> https://biospectrumindia.com/news/57/11675/rostec-to-build-unique-oncology-treatment-centre-in-russian-far-east.html https://biospectrumindia.com/news/57/11675/rostec-to-build-unique-oncology-treatment-centre-in-russian-far-east.html Fri, 14 Sep 2018 15:35:00 +0530 State Corporation Rostec and the administration of the Primorsky Krai, a federal subject in the Russian Far East, have signed an agreement to establish an oncology centre of proton therapy in the Primorsky region. The health clinic shall admit its first patients in 2022, its annual capacity shall be over 1000 patients.  The health centre which is unique for Russia shall be provided with advanced medical equipment allowing detection of diseases at early stages and precision sparing therapy. The agreement has been signed by Vasily Brovko, Director for Special Commissions of Rostec, and Andrey Tarasenko, acting governor of the Primorsky Krai, at the Eastern Economic Forum in Vladivostok. Only few countries have comparable clinics: these include the USA, Japan and China. The centre shall be established within the project for construction of similar clinics in the Russian regions, the aim of which is to improve availability of modern methods of diagnosis and cancer treatment. The project shall be implemented in two stages. On the first stage Rostec shall provide a medical complex under construction in the territory of the Far Eastern Federal University (FEFU) with the following diagnostic equipment: PET and CT modular scanners and a modular cyclotron. This equipment shall allow detecting of neoplasms at early stages and timely prevent the disease progression. On the second stage, under the aegis of FEFU, a modern proton therapy centre shall be built. "Rostec is an active participant of the Healthcare National Project, one of the key directions of which is cancer control. Today, there is only one high-technology diagnostic and therapy centre per every 2 million people in Russia. And there is only one PET/CT scanner allowing most accurate cancer detection per every 5 million Russians. The project we implement in cooperation with the regions and country's leading universities is aimed at the fundamental solution of these problems. Russian proton therapy centres shall be provided with the unique equipment," says Director for Special Commissions of Rostec Vasily Brovko. Proton therapy is currently one of the most effective methods for cancer treatment which allows surgery to be avoided. The therapy requires special accelerator that produces a narrow beam of protons and by it locally impacts on a tumor without affecting neighbouring organs. It is planned to establish the network of proton centres with such equipment in Moscow, Novosibirsk and Obninsk. ]]> https://biospectrumindia.com/news/57/11669/researchers-in-canada-design-wearable-ultrasound-scanner.html https://biospectrumindia.com/news/57/11669/researchers-in-canada-design-wearable-ultrasound-scanner.html Fri, 14 Sep 2018 10:40:00 +0530 A team of researchers from the University of British Columbia (UBC), Canada has created a new ultrasound transducer that is wearable, portable, cost-effective and can be powered by a smartphone. The new wearable ultrasound consists of tiny vibrating drums that are made of polymer resin. These are called polymer capacitive micro-machined ultrasound transducers (polyCMUTs) and are cheaper to manufacture. The new ultrasound scanner is expected to potentially slash the device cost to $100. Also, the new transducer only requires 10 volts for operation and hence can be powered using a smartphone. The researchers are currently working towards developing different prototypes of their transducer, with plans to investigate its use in various clinical applications in the future. ]]> https://biospectrumindia.com/news/57/11664/fsd-pharma-issues-40000k-stock-options-to-director-dr-raza-bokhari-.html https://biospectrumindia.com/news/57/11664/fsd-pharma-issues-40000k-stock-options-to-director-dr-raza-bokhari-.html Wed, 12 Sep 2018 12:40:00 +0530 FSD Pharma Inc. announces that pursuant to its Stock Option Plan, the Board approved the grant of 3,000,000 stock options for class B subordinate voting shares of the Company (the "Options") on August 14, 2018 to Dr. Raza Bokhari following his appointment as a Director. The Options vest immediately and are exercisable at a price of $0.13 for a period of five years. The Company has also cancelled 15,000,000 stock options that had been previously issued at $0.05.  The Board has also approved an additional grant of 40,000,000 Options to Dr. Bokhari exercisable at a price of $0.74 for a period of five years. The Options shall only vest and become exercisable upon the completion of the following conditions: The Company becomes listed on the NASDAQ stock exchange, or merges with a NASDAQ-listed company to the satisfaction of the Board; and Adequate financing is arranged for the listing of the Company on the NASDAQ stock exchange or merger of the Company with a NASDAQ-listed company referenced above, to the satisfaction of the Board. Stock Option Plan The Company's stock option plan was approved by the Board on February 19, 2018 (the "Stock Option Plan"). The Stock Option Plan provides that the aggregate number of securities reserved for issuance will be 10% of the number of common shares of the Corporation issued and outstanding from time to time. The Stock Option Plan was established to provide an incentive to qualified parties to increase their proprietary interest in the Corporation and thereby encourage their continuing association with the Corporation. Management proposes stock option grants to the Board based on such criteria as performance, previous grants, and hiring incentives. All grants require Board approval. The Stock Option Plan is administered by the Board and provides that options will be issued to directors, officers, employees or consultants of the Corporation or a subsidiary of the Corporation. The Board has full and final authority with respect to the granting of all options under the Stock Option Plan.   ]]> https://biospectrumindia.com/news/57/11653/hp-partners-with-parmatech.html https://biospectrumindia.com/news/57/11653/hp-partners-with-parmatech.html Tue, 11 Sep 2018 11:15:00 +0530 At the 2018 International Manufacturing Technology Show (IMTS), HP Inc. launched HP Metal Jet, the world’s most advanced 3D printing technology for the high volume manufacturing of production-grade metal parts. Providing up to 50 times more productivity at a significantly lower cost than other 3D printing methods, HP Metal Jet is being deployed by manufacturing leaders GKN Powder Metallurgy and Parmatech for the factory production of final parts. Customers placing orders include global stalwarts Volkswagen and Wilo and innovative vertical market leaders such as Primo Medical Group and OKAY Industries. As part of its mission to transform the way the world designs and manufactures, HP has also launched the Metal Jet Production Service, enabling customers around the world to rapidly iterate new 3D part designs, produce final parts in volume, and integrate HP Metal Jet into their long-term production roadmaps.  “We are in the midst of a digital industrial revolution that is transforming the $12 trillion manufacturing industry. HP has helped lead this transformation by pioneering the 3D mass production of plastic parts and we are now doubling down with HP Metal Jet, a breakthrough metals 3D printing technology,” said Dion Weisler, CEO and President, HP Inc. “The implications are huge – the auto, industrial, and medical sectors alone produce billions of metal parts each year.  HP’s new Metal Jet 3D printing platform unlocks the speed, quality, and economics to enable our customers to completely rethink the way they design, manufacture, and deliver new solutions in the digital age.” HP Metal Jet is a groundbreaking, voxel-level binder jetting technology leveraging more than 30 years of HP printhead and advanced chemistries innovation. With a bed size of 430 x 320 x 200mm, 4x the nozzle redundancy and 2x the printbars, and significantly less binder by weight, HP Metal Jet delivers greater productivity and reliability at a low acquisition and operational cost compared to other metals 3D printing solutions. HP Metal Jet will start with stainless steel finished parts, delivering isotropic properties that meet or exceed ASTM and MPIF Standards Reinventing Healthcare With HP Metal Jet To serve the medical industry, HP is also partnering with Parmatech, an ATW Company, to expand mass production of Metal Jet parts for customers including OKAY Industries, Primo Medical Group, and others.  Parmatech is a world leader in metal injection molding and has been a metals manufacturing pioneer for more than 40 years, specializing in producing low-cost, high-volume metal parts for the medical and industrial sectors. “HP Metal Jet represents the first truly viable 3D technology for the industrial-scale production of metal parts.  Our customers demand extreme performance, quality, and reliability and HP’s advanced technology and heritage of market disruption give us the confidence to deliver beyond expectations,“ said Rob Hall, President of Parmatech. “We are excited to deploy HP Metal Jet in our factories and begin manufacturing complex parts, such as surgical scissors and endoscopic surgical jaws, and new applications and geometries not possible with conventional metal fabrication technologies. HP Metal Jet technology will play a key role in our mission to develop innovative solutions for the unique challenges of our customers.” ]]> https://biospectrumindia.com/news/57/11652/us-scientists-invent-new-blood-pressure-app.html https://biospectrumindia.com/news/57/11652/us-scientists-invent-new-blood-pressure-app.html Tue, 11 Sep 2018 10:35:00 +0530 A team of scientists at Michigan State University (MSU) has invented a proof-of-concept blood pressure app that can give accurate readings using an iPhone - with no special equipment. With the combination of a smartphone and add-on optical and force sensors, the team produced a device that rivaled arm-cuff readings, the standard in most medical settings. According to the lead scientist, Prof Ramakrishna Mukkamala, MSU electrical and computer engineering department, the app could be available in late 2019. The application still needs to be validated in a standard regulatory test. ]]> https://biospectrumindia.com/news/57/11644/samsung-opens-new-ai-centre-in-new-york.html https://biospectrumindia.com/news/57/11644/samsung-opens-new-ai-centre-in-new-york.html Mon, 10 Sep 2018 11:45:00 +0530 Samsung Electronics is all set to open a new artificial intelligence (AI) research centre in New York City, U.S., to strengthen its AI capabilities. With cooperation from a leading authority in neuroscience-based AI technologies, H. Sebastian Seung, Executive Vice President of Samsung Research, the New York AI Centre will spearhead the advanced AI research in robotics. As the Chief Research Scientist of Samsung Electronics, Seung will also advise Samsung on advanced AI research in developing future business growth opportunities. Samsung has announced plans to expand its advanced AI research capabilities to employ about 1,000 specialists by 2020. This will be Samsung’s sixth AI centre around the world, and it will work in partnership with Samsung’s other AI research facilities. The additional AI centers are located in Korea, the U.K., Canada, Russia, and Silicon Valley, the U.S. ]]> https://biospectrumindia.com/news/57/11642/menarini-lunaphore-to-bring-ultra-rapid-tissue-staining-solution-.html https://biospectrumindia.com/news/57/11642/menarini-lunaphore-to-bring-ultra-rapid-tissue-staining-solution-.html Mon, 10 Sep 2018 11:00:00 +0530 Lunaphore Technologies SA, a Swiss Company developing innovative next-generation devices for cancer tissue diagnostics, and A. Menarini Diagnostics S.r.l., one of Europe’s leading diagnostic solution providers and part of the Menarini Group, jointly announced the start of a strategic partnership bringing to the market a new and innovative system, using Lunaphore’s technology. LabSat™ Frozen is an ultra-rapid automated tissue staining solution performing immunohistochemistry (IHC) assays in a few minutes. Thanks to this breakthrough technology, patients will be able to benefit from a faster, better and more personalized treatment starting in the operating room. Shorter turnaround times may provide clinical pathologists with higher degrees of responsiveness for urgent testing and enable IHC consultation during biopsy procedures. The partnership between A. Menarini Diagnostics and Lunaphore Technologies opens a new era of the anatomical pathology field, paving the way to one-day diagnosis.   ]]> https://biospectrumindia.com/news/57/11635/tezepelumab-gets-breakthrough-therapy-label-to-treat-severe-asthma.html https://biospectrumindia.com/news/57/11635/tezepelumab-gets-breakthrough-therapy-label-to-treat-severe-asthma.html Fri, 07 Sep 2018 12:15:00 +0530 Amgen and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) have granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines. The Breakthrough Therapy Designation is supported by the tezepelumab Phase 2b PATHWAY data. The trial showed a significant reduction in the annual asthma exacerbation rate compared with placebo in a broad population of severe asthma patients independent of baseline blood eosinophil count or other type 2 (T2) inflammatory biomarkers. Currently available biologic therapies only target T2 driven inflammation. Tezepelumab is a potential first-in-class new medicine that blocks thymic stromal lymphopoietin (TSLP), an upstream modulator of multiple inflammatory pathways. "The Phase 2b PATHWAY trial data demonstrated tezepelumab's promise as a novel therapeutic option for a broad population of patients with severe asthma, including those ineligible for currently approved biologic therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The Breakthrough Designation will give us the opportunity to work closely with the FDA to bring tezepelumab to patients as quickly as possible." Tezepelumab is currently in development in the Phase 3 PATHFINDER clinical trial program. ]]> https://biospectrumindia.com/news/57/11629/biospain-attracts-biotech-professionals-in-europe.html https://biospectrumindia.com/news/57/11629/biospain-attracts-biotech-professionals-in-europe.html Thu, 06 Sep 2018 13:50:00 +0530 The Spanish Bioindustry Association (ASEBIO) and the Regional Government of  Andalusia have announced a collaboration agreement naming Seville as the site of the ninth BIOSPAIN biennial fair. Between 25 and 27 September 2018, the FIBES Exhibition & Congress Centre will thus be the stage for BIOSPAIN, a forum to exchange knowledge, ideas and experiences among all the actors from the biotech sector, which has become the leading platform to enhance the international standing of Spanish biotechnology. In the 2016 event, BIOSPAIN attracted 1,750 delegates representing 800 companies from 29 countries, (28% of those attending came from abroad), 233 exhibitors, 50 international investors, 49 breakout sessions and also featured 3,000 one-to-one meetings. These numbers have made BIOSPAIN the world's fifth largest biotechnology event by business meetings and the most important country-based event in Europe. The event is structured as a trade fair, a partnering system which facilitates one-to-one meetings, a conference programme and an investor's forum which brings together the globe's most important investors from the field of life sciences. As of today, BIOSPAIN already have 25 confirmed investors from seven countries, including Ysios Capital Partners, Andera Capital (previously Edmond de Rothschild), Biogeneration Ventures and Johnson & Johnson Innovation. This year's BIOSPAIN programme gives special weight to the biomedical area, although a good part of the conference will also be dedicated to agri-food and industrial biotechnology, mainly in the bioeconomy field. Financing sessions will also have a prominent place. The fair will also feature the plenary speaker Philippe Monteyne, a partner of Fund+. Among the main topics to be discussed in this ninth edition are: Alzheimer's disease, advanced therapies, agri-food, biobanks, financing programmes, circular economy, artificial intelligence, gene editing, immunotherapy, antibiotic resistance, precision medicine, etc. Additionally, as a new aspect this year, BIOSPAIN wants to encourage  researchers, academics and representatives from intermediary bodies to  participate with a special registration policy. In the poll conducted among the participants after finishing the event, 84.81% of those polled in 2016 stated that they identified real business opportunities. The event was classified as good or very good by 76.92% of the people attending. As of today, users can download the BIOSPAIN 2018 APP on the iOS and Android marketplaces. The app is easy to use and will provide extensive support for participants throughout their experience in the convention. The app makes it easier for participants to be independent, to network and to have all the relevant information available in the palm of their hand. ]]> https://biospectrumindia.com/news/57/11625/syneron-candela-acquires-ellipse.html https://biospectrumindia.com/news/57/11625/syneron-candela-acquires-ellipse.html Thu, 06 Sep 2018 11:25:00 +0530 Syneron Candela, a leading global aesthetic device company, announces the acquisition of Ellipse, a Danish medical device company that manufactures and markets Intense Pulsed Light (IPL) and laser-based platforms for a wide variety of medical and aesthetic skin treatments. Financial terms of the agreement were not disclosed. "The acquisition of Ellipse allows Syneron Candela to strengthen its footprint in the multi-application space and provide our customers a comprehensive portfolio. Syneron Candela's best-in-class laser and energy-based technologies are now coupled with a trusted IPL technology that is well respected by physicians," states Geoffrey Crouse, Chief Executive Officer of Syneron Candela. "Ellipse platforms will provide aesthetic practices with a fully scalable multi-application, multi-technology device. We look forward to Ellipse strengthening our portfolio as we continue to deliver our brand promise of Science, Results, Trust to our physicians and patients worldwide. The Ellipse product portfolio is consistent with our commitment to scientifically proven technologies backed by consistent clinical outcomes." Ellipse's key products include Nordlys, a multi-application, multi-technology IPL and Nd: YAG platform for vascular and pigmented lesions, as well as hair removal. The Nordlys also offers a fractionated 1550 nm handpiece for skin resurfacing. Other products include an IPL-only system used for skin rejuvenation, facial veins and hair removal, as well as a fractional non-ablative laser system used for skin resurfacing. Ellipse's Selective Waveband Technology (SWT®) uniquely utilizes dual filtering on all IPL handpieces to focus on effective wavelengths and selectively deliver precise energy to the targeted area, using sub-millisecond pulses for some applications. "We are excited to join forces with Syneron Candela and market our strong technology platforms via Syneron Candela's expansive global footprint, along with its commitment to clinical excellence, quality and innovation," says Jacob Kildegaard Larsen, Chief Executive Officer at Ellipse. "Syneron Candela and Ellipse are both physician acknowledged leaders in their respective categories. Bringing the companies together will herald a new era in device innovation that elevates patient care," concludes Christine Dierickx, M.D, a Luxembourg based dermatologist, specializing in laser surgery and cosmetic dermatology. ]]> https://biospectrumindia.com/news/57/11622/rxhealth-raises-1-8m-seed-round-launches-bulk-prescription-.html https://biospectrumindia.com/news/57/11622/rxhealth-raises-1-8m-seed-round-launches-bulk-prescription-.html Wed, 05 Sep 2018 12:15:00 +0530 Digital medicine platform Rx.Health, a Mount Sinai Health System spinoff and provider of RxUniverse has recently announced that it has raised $1.8 million in seed funding. The funding will be used to diversify Rx.Health's client base and support its first-to-market Bulk Prescription digital therapeutics and patient engagement tool. Rx.Health's Bulk Prescription allows health care teams to prescribe digital therapeutics and patient-centered care plans to entire cohorts of patients through a single click. The feature will be initially launched for the treatment and monitoring of various chronic diseases, including respiratory, cardiovascular, and gastroenterological illnesses. Patients who do not have their symptoms under control can simultaneously receive immediate access to education, digital therapeutics, or remote monitoring via smartphone or email. Incoming patient data is then integrated into electronic health records (EHR) and care management dashboards, ensuring that providers are streamlining care processes while meeting quality and outcome metrics. "We've seen a tremendous increase in the demand for our services and the landscape of potential clients has broadened. By integrating multiple evidence-based solutions under one digital medicine platform, we're making digital transformation simple and affordable," noted Rx.Health Chief Operating Officer Andy Pfau. "In addition to health systems, we're now able to capitalize on the advanced discussions we're having with payers and accountable care organizations. These discussions always change the application of your products, which in turn naturally fuels R&D." Rx.Health curates digital solutions that are clinically proven to improve patient health, lowering the cost for health systems as they transition to value-based care. According to Shrawan Patel, MD, Vice President and Head of Clinical Transformation for Rx.Health, U.S. health systems are losing nearly $100 million per year by failing to engage patients through digital solutions. Rx.Health's flagship product RxUniverse is the first enterprise-level, app-prescribing platform that provides an efficient prescription mechanism built into a health system's EHR, becoming part of an evolving, bundled care plan that provides real-time feedback to providers. The platform gained recognition over the last year after scoring in the 96th percentile on the System Usability Score based on the results of RxUniverse's eight-week pilot study and facilitated a 40 percent reduction in readmissions for patients of chronic heart failure. RxUniverse is live in several U.S. health systems, with additional implementations currently underway. "Rx.Health is expanding the model for patient care by extending care outside of the clinical setting and allowing health care systems to harness the power of digital health," said Erik Lium, PhD, Executive Vice President of Mount Sinai Innovation Partners. "Rx.Health is a prime example of the innovative, patient-first discoveries valued by the Mount Sinai Health System and I look forward to seeing its expansion as a leader in digital medicine." ]]> https://biospectrumindia.com/news/57/11588/tb-alliance-launches-clinical-trial-for-new-tb-drug.html https://biospectrumindia.com/news/57/11588/tb-alliance-launches-clinical-trial-for-new-tb-drug.html Fri, 31 Aug 2018 11:25:00 +0530 TB Alliance, a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis (TB) has initiated a pivotal clinical trial, SimpliciTB that will evaluate whether a new four-drug regimen can treat most types of tuberculosis (TB) including multidrug-resistant TB (MDR-TB) more quickly and effectively than currently-available treatments. The first patients have been enrolled at the National Center for Tuberculosis and Lung Disease in Tbilisi, Georgia. SimpliciTB is expected to enroll 450 people with TB, including up to 150 with MDR-TB* across at least 26 centers in 10 countries in Africa, Asia, Europe and Latin America. SimpliciTB will test the efficacy of a four-month treatment with the BPaMZ regimen, consisting of the drugs bedaquiline, pretomanid, moxifloxacin and pyrazinamide, in people with drug-sensitive TB. Outcomes will be compared against the standard six-month treatment regimen of isoniazid, rifampicin, pyrazinamide and ethambutol (HRZE), to determine whether BPaMZ may be able to shorten the duration of therapy for drug-sensitive TB by a third. The trial will also assess BPaMZ’s potential to treat MDR-TB in six months. Currently, treatment for drug-resistant TB is extremely complicated, expensive, and lengthy, involving a wide variety of medicines that have debilitating side-effects, injectable drugs, and are administered for nine months to two years or longer. Today, people with MDR-TB often go untreated, and of those who do receive treatment only about half are cured. “As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in six months or less, regardless of their resistance profile,” said Mel Spigelman, president and CEO of TB Alliance. “If proven successful in SimpliciTB, the BPaMZ regimen would represent a major step toward this goal.” The BPaMZ regimen was previously studied in the Phase 2b study called NC-005, in which people with MDR-TB who were treated with the BPaMZ regimen cleared TB bacteria from their lungs up to three times faster than drug-sensitive TB patients treated with the standard (HRZE) treatment. NC-005 was an eight-week trial conducted at 10 sites across Uganda, South Africa and Tanzania. SimpliciTB builds on these results, testing BPaMZ over a longer duration, in more people and across more sites, and against both drug-sensitive and MDR-TB. According to the World Health Organization’s most recent Global Tuberculosis Report, there is growing resistance to available drugs, which means the disease is becoming more deadly and difficult to treat. WHO estimates that in 2016 there were 600,000 new cases with resistance to rifampicin – the most effective first-line drug—of which 490,000 had MDR-TB. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, United Kingdom Department for International Development, United Kingdom Department of Health, United States Agency for International Development, and the United States Food and Drug Administration. ]]> https://biospectrumindia.com/news/57/11578/shires-takhzyro-gets-fda-nod-for-the-treatment-of-hereditary-angioedema.html https://biospectrumindia.com/news/57/11578/shires-takhzyro-gets-fda-nod-for-the-treatment-of-hereditary-angioedema.html Thu, 30 Aug 2018 15:05:00 +0530 Shire plc, the leading global biotechnology company focused on rare diseases has announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved TAKHZYRO (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body. “HAE attacks are painful, debilitating, and potentially life threatening. TAKHZYRO provides the HAE community with a new option for the prevention of HAE attacks,” said Anthony J. Castaldo, President, U.S. Hereditary Angioedema Association. “We are grateful for the time and effort put forth by the patients and researchers who participated in the clinical trial program that enabled this important addition to the HAE treatment landscape.” TAKHZYRO is the only monoclonal antibody (mAb) that provides targeted inhibition of plasma kallikrein, an enzyme which is chronically uncontrolled in people with HAE, to help prevent attacks. The recommended starting dose of TAKHZYRO is 300 mg every two weeks. A dosing interval of 300 mg every four weeks is also effective and may be considered if the patient is well-controlled (e.g., attack free) for more than six months. In the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study supporting FDA approval, TAKHZYRO reduced the number of monthly HAE attacks an average of 87% (n=27) vs. placebo (n=41) when administered at 300 mg every two weeks and 73% (n=29) vs placebo (n=41) when administered at 300 mg every four weeks (Adjusted P<0.001).5 In the 26-week clinical study, which included 125 people with HAE, patients taking TAKHZYRO 300 mg every 2 weeks also had 83% fewer moderate to severe attacks, and 87% fewer attacks that needed on-demand treatment. A pre-specified, exploratory analysis showed that 44% of patients (n=27) receiving TAKHZYRO 300 mg every two weeks had zero attacks compared to placebo (2%, n=41) for the 26-week treatment period from Day 0 to Day 182. Additionally, in a post hoc analysis of the 16-week period from Day 70 to Day 182, 77% of patients (n=26) treated with TAKHZYRO in the same dosage arm of the trial were attack-free compared to placebo (3%, n=37). TAKHZYRO has a half-life of approximately two weeks and is administered as one subcutaneous self-injection every two weeks at the recommended starting dose. In clinical trials, the majority of patients took one minute or less to complete the injection.5 The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire said: “With the approval of TAKHZYRO, HAE patients have an innovative treatment that works differently than current options to help prevent attacks. Based on an exploratory and post hoc analysis, after six doses of TAKHZYRO 300 mg every two weeks, 77% or nearly 8 of 10 patients had zero attacks. This approval reinforces our ongoing commitment to developing novel therapies that have a meaningful impact on patients. Looking to the future, we continue to work towards our goal of a world in which those living with HAE can aim for zero attacks.” The FDA approval of TAKHZYRO was based on data from four clinical trials, including the HELP Study, the largest prevention study conducted to date in HAE. Of the patients who completed the HELP Study who received TAKHZYRO, 97% opted in to an ongoing open-label extension study designed to evaluate the long-term safety and efficacy of TAKHZYRO. Shire added TAKHZYRO to its HAE portfolio with the acquisition of Dyax Corp., which was completed in January 2016 in an all cash transaction valued at approximately $5.9 billion. Under the terms of the acquisition, the non-tradable contingent value right (CVR) received by Dyax shareholders will now pay $4.00 in cash per Dyax share as a result of the FDA approval of TAKHZYRO (formerly DX-2930). ]]> https://biospectrumindia.com/news/57/11577/researchers-identify-potential-therapeutic-targets-for-nephrotic-syndrome.html https://biospectrumindia.com/news/57/11577/researchers-identify-potential-therapeutic-targets-for-nephrotic-syndrome.html Thu, 30 Aug 2018 12:25:00 +0530 Nephrotic syndrome is one of the most common kidney disorders, characterised by excessive protein in the urine, swelling in the legs, feet and ankles, and increased levels of albumin and lipids in the blood of patients. It has a high level of incidence in Asian countries, particularly amongst children (9-16 per 100000 children every year). Now, in a massive international collaborative effort, researchers from India, Germany, the United States, Saudi Arabia, Egypt, Japan, Serbia, Switzerland, Austria, Kazakhstan and Canada have identified variants in six novel genes which may be responsible for causing this disorder. In patients of nephrotic syndrome, damage to the glomeruli lets proteins and red blood cells leak into the urine. The conventional treatment regimen consists of administration of steroids, which have limited effectiveness. Based on whether or not patients respond to steroid treatment, the disorder is classified as Steroid Sensitive Nephrotic Syndrome (SSNS) and Steroid Resistant Nephrotic Syndrome (SRNS). Previous studies have found mutations in more than 40 genes to be associated with steroid-resistant nephrotic syndrome. These studies also suggest that many of these gene products localize to podocytes, cells in the kidney that help flush out toxins from the blood. However, only one gene has till date been shown to monogenetically cause steroid-sensitive nephrotic syndrome, and the mechanism of steroid resistance remains a mystery. In this new study, researchers analysed multiple families with nephrotic syndrome and identified mutations in six novel genes (MAGI2, CDK20, TNS2, DLC1, ITSN1 and ITSN2) as causative factors in 17 families with partially treatment-sensitive nephrotic syndrome (which falls somewhere in the border between steroid-resistant and steroid-sensitive variants of the disease). To understand the role these genes play in the pathophysiology of the nephrotic syndrome, the researchers evaluated the effect of overexpression and knockdown of all six genes in cell lines. They observed that the proteins encoded by these genes interact to regulate the activity of Rho like small GTPases - a class of proteins that has previously been implicated in the pathogenesis of nephrotic syndrome. The mutant variants of these genes found in the partially treatment-sensitive patients, however, lacked this effect. Interestingly, steroid treatment abolished the effect of two of these genes (DLC1 and CDK20) on Rho like small GTPases in cell lines as well as in cultured human podocytes. This suggests that regulation of this activity may be a possible mechanism for beneficial steroid action. “This study provides insight into the possible molecular basis of nephrotic syndrome as well as opens doors to explore newer therapeutics targeting Rho signaling activity,” said Dr Anil Vasudevan, Head of Pediatric nephrology at the St. Johns medical college hospital, Bangalore. “The weak correlations between genotype and phenotype exhibited in this study also reinforce the emerging paradigm that nephrotic syndrome may not be a classical ‘monogenic’ disease inherited in a Mendelian fashion,” he added. This study included researchers from Jamia Millia Islamia and All India Institute of Medical Sciences (AIIMS), New Delhi, and the Institute of Child Health and Hospital for Children, Chennai. The results of this study lend support to an ongoing study funded by the Department of Biotechnology to examine the genetic basis of steroid-resistant nephrotic syndrome. This new study will help in understanding the relevance of the TNS2 gene in Indian children with steroid-resistant nephrotic syndrome by using the whole-exome sequencing approach.   ]]> https://biospectrumindia.com/news/57/11563/us-scientists-develop-drugs-to-help-smokers-quit.html https://biospectrumindia.com/news/57/11563/us-scientists-develop-drugs-to-help-smokers-quit.html Tue, 28 Aug 2018 15:45:00 +0530 Researchers at Washington State University created more than a dozen candidate drugs with the potential to curb smokers' desire for nicotine by slowing how it is broken down in the body. They hoped that the substances could help people reduce their consumption of tobacco, if not quit altogether. The discovery targets a liver enzyme, called CYP2A6, which metabolizes nicotine. Researchers found that people who have fewer copies of a gene for the enzyme tend to smoke less and are less likely to be addicted to smoking. Nicotine triggers the release of dopamine and serotonin, two pleasure-causing chemicals produced by the body. But as it gets metabolized, users can experience withdrawal symptoms like tingling in the hands and feet, sweating, anxiety, and irritability. Denton and Philip Lazarus, co-corresponding author of the paper and Boeing distinguished professor of pharmaceutical sciences, designed dozens of molecules that bind to CYP2A6 and inhibit its ability to metabolize nicotine. Once the Food and Drug Administration verifies a drug's safety, clinical trials would begin to see how it works in a human. "If you inhibit CYP2A6, it shouldn't bother your overall health. If we could specifically target this enzyme, people should be fine, and it will possibly help them stop smoking or at least decrease their amount of smoking," said Philip Lazarus, co-author of the study. ]]> https://biospectrumindia.com/news/57/11559/study-reveals-reasons-of-death-after-non-cardiac-surgery.html https://biospectrumindia.com/news/57/11559/study-reveals-reasons-of-death-after-non-cardiac-surgery.html Tue, 28 Aug 2018 11:20:00 +0530 The main reasons why people die after non-cardiac surgery are revealed in a study of more than 40,000 patients from six continents presented in a late breaking science session at ESC Congress 2018. Myocardial injury, major bleeding, and sepsis contributed to nearly three-quarters of all deaths. “There’s a false assumption among patients that once you’ve undergone surgery, you’ve ‘made it’,” said study author Dr Jessica Spence, of the Population Health Research Institute (PHRI), a joint institute of Hamilton Health Sciences (HHS) and McMaster University, Hamilton, Canada. “Unfortunately, that’s not always the case, and now we have a much better sense of when and why people die after non-cardiac surgery. Most deaths are linked to cardiovascular causes.” The VISION study included 40,004 patients aged 45 years or older undergoing non-cardiac surgery and remaining in hospital for at least one night. Patients were recruited from 27 centers in 14 countries in North and South America, Asia, Europe, Africa, and Australia, and monitored for complications until 30 days after their surgery. The researchers found that 715 (1.8%) patients died within 30 days after non-cardiac surgery. Of those, 505 (71%) died in hospital (including four [0.6%] in the operating room), and 210 (29%) died after discharge from hospital. Dr. Spence said: “One in 56 patients died within 30 days of non-cardiac surgery and nearly all deaths occurred after leaving the operating room, with more than a quarter occurring after hospital discharge.” Eight perioperative complications – including five cardiovascular – were associated with death within 30 days postoperatively. The top three complications, which contributed to nearly three-quarters of all deaths, were myocardial injury after non-cardiac surgery (MINS; 29%), major bleeding (25%), and sepsis (20%). “We’re letting patients down in postoperative management,” said principal investigator Professor Philip J. Devereaux, director of cardiology at McMaster University. “The study suggests that most deaths after non-cardiac surgery are due to cardiovascular causes, so cardiologists have a major role to play to improve patient safety. This includes conducting blood and imaging tests to identify patients at risk then giving preventive treatment, including medications that prevent abnormal heart rhythms, lower blood pressure and cholesterol, and prevent blood clots.” Earlier findings from the VISION study showed that a simple blood test can identify MINS, enabling clinicians to intervene early and prevent further complications. (3) The blood test measures a protein called high-sensitivity troponin T which is released into the bloodstream when injury to the heart occurs. Regarding cardiovascular complications, MINS occurred in 5,191 (13%) patients and independently increased the risk of 30-day mortality by 2.6-fold; major bleeding occurred in 6,238 (16%) patients and increased risk by 2.4-fold; 372 (0.9%) patients had congestive heart failure, which raised risk by 1.6-fold; 152 (0.4%) patients had deep venous thrombosis which raised risk by 2.1-fold; and 132 (0.3%) patients had a stroke, which increased risk by a factor of 1.6. Regarding non-cardiovascular complications associated with 30-day mortality, sepsis occurred in 1,783 (4.5%) patients and independently increased risk by 5.7-fold; infection occurred in 2,171 (5.4%) patients and raised risk by 1.9-fold; and 118 patients (0.3%) had acute kidney injury resulting in new dialysis, which increased risk by 4.7-fold. “Combined, these discoveries tell us that we need to become more involved in care and monitoring after surgery to ensure that patients at risk have the best chance for a good recovery,” said Dr Spence, who is also an anesthesiologist at HHS and a PhD candidate at McMaster University. SOURCES OF FUNDING:  Roche Diagnostics provided the troponin T assays as well as financial support for the VISION Study. Funding for this study came from more than 60 grants for VISION and its sub studies. Australia: National Health and Medical Research Council Program. Brazil: Projeto Hospitais de Excelencia a Servico do SUS (PROADI-SUS) grant from the Brazilian Ministry of Health in partnership with Hcor (Cardiac Hospital Sao Paulo-SP); National Council for Scientific and Technological Development (CNPQ) grant from the Brazilian Ministry of Science and Technology. China: Public Policy Research Fund (grant CUHK-4002-PPR-3), Research Grant Council, Hong Kong SAR; General Research Fund (grant 461412). Research Grant Council, Hong Kong SAR: Australian and New Zealand College of Anaesthetists (grant 13/008). Canada: Canadian Institutes of Health Research (7 grants); Heart and Stroke Foundation of Ontario (2 grants); Academic Health Science Centers Alternative Funding Plan Innovation Fund Ontario; Population Health Research Institute; CLARITY Research Group; McMaster University Department of Surgery Surgical Associates; Hamilton Health Science New Investigator Fund; Hamilton Health Sciences; Ontario Ministry of Resources and innovation; Stryker Canada; McMaster University, Department of Anesthesiology (2 grants); St. Joseph’s Healthcare, Department of Medicine (2 grants); Father Sean O’Sullivan Research Centre (2 grants); McMaster University Department of Medicine (2 grants); Roche Diagnostics Global Office (5 grants); Hamilton Health Sciences Summer Studentships (6 grants); McMaster University Department of Clinical Epidemiology and Biostatistics; McMaster University, Division of Cardiology; Canadian Network and Centre for Trials Internationally: Winnipeg Health Sciences Foundation; University of Manitoba Department of Surgery (2 grants); Diagnostic Services of Manitoba Research; Manitoba Medical Services Foundation; Manitoba Health Research Council; University of Manitoba Faculty of Dentistry Operational Fund; University of Manitoba Department of Anesthesia; University Medical Group, Department of Surgery, University of Manitoba, Start-up Fund. Colombia: School of Nursing, Universida Industrial de Santander; Grupo de Cardiologia Preventiva, Universidad Autonoma de Bucaramanga: Fundacion Cardioinfantil-Instituto de Cardiologia; Alianza Diagnostica SA. France: Universite Pierre et Marie Curie. Department d’anesthsie Reanimation, Pitie-Salpetriere, Assistance Publique-Hopitaux de Paris. India: St. John’s Medical College and Research Institute: Division of Clinical Research and Training. Malaysia: University of Malaya (grant RG302-14AFR); University of Malaya, Penyelidikan Jangka Pendek. Poland: Polish Ministry of Science and Higher Education (grant NN402083939). South Africa: University of KwaZulu-Natal. Spain: Instituto de Salud Carlos III; Fundacio La Marato de TV3. United States: America Heart Association; Covidien. United Kingdom: National Institute for Health Research. ]]> https://biospectrumindia.com/news/57/11557/evotec-centogene-to-work-on-rare-genetic-diseases.html https://biospectrumindia.com/news/57/11557/evotec-centogene-to-work-on-rare-genetic-diseases.html Tue, 28 Aug 2018 11:00:00 +0530 German companies Evotec and Centogene have entered into a global strategic collaboration agreement for joint drug discovery projects, developing compounds to treat rare genetic diseases. Centogene and Evotec initiated the collaboration to develop a strategic high-throughput platform for testing novel small molecules in rare hereditary metabolic diseases. The collaboration brings together Evotec's leading induced pluripotent stem cell (iPSC) platform and broad drug discovery capabilities with Centogene's unique medical and genetic insights. In particular, detailed genotype-phenotype data enables rapid biomarker development using patient primary cells. "The identification and development of innovative small molecules to treat rare, hereditary conditions is particularly challenging because of the absence of adequate cellular models and the general lack of specific biomarkers to monitor the different diseases. With this innovative collaboration between Evotec and Centogene, we can accelerate the development of new drugs. Centogene is fully committed to explore any given opportunity to discover new ways of helping patients and their families, together with its partners," said Dr Arndt Rolfs, Chief Executive Officer, Centogene. ]]> https://biospectrumindia.com/news/57/11558/gastric-cancer-foundation-launches-new-clinical-trials-navigator-.html https://biospectrumindia.com/news/57/11558/gastric-cancer-foundation-launches-new-clinical-trials-navigator-.html Tue, 28 Aug 2018 10:55:00 +0530 The Gastric Cancer Foundation has launched its new website this month and has introduced an online clinical trials navigator to help patients more easily identify clinical trials matched with their specific diagnosis, stage, and treatment history. A special grant from Stupid Strong Charitable Foundation, a Texas organization established by Jeff and Candace Netzer, is enabling Gastric Cancer Foundation to bring this new service to gastric cancer patients. The impetus for the Foundation came from JP Gallagher, a Silicon Valley marketing executive, who was diagnosed with stomach cancer at age 37 and could not find reliable information about the disease. He battled the disease for six years before passing in 2013, leaving behind a wife and three young children. Gallagher along with other families affected by the disease formed the Foundation to encourage more research funding and to give patients and families a place to turn to find resources.    The service is named in memory of Candace Netzer who lost her battle with the disease in November 2017. Jeff Netzer is a member of the Gastric Cancer Foundation's board of directors. According to Jeff Netzer, "It was difficult for my wife and me to quickly identify and connect with clinical trials once her initial lines of treatment failed. Access to this type of compassionate and knowledgeable navigator would have lessened anxiety and fear during a critical time. Stupid Strong is proud to partner with Gastric Cancer Foundation on this project. I know Candace would be thrilled that the Foundation is able to provide this much needed service to patients and families now, and to support research towards better treatment alternatives in the future." "One of the most frustrating experiences for patients battling gastric cancer is trying to find appropriate clinical treatment trials among the burgeoning national database of trials," noted Alice Leung, Gastric Cancer Foundation Co-Chair. "At the same time, researchers frequently report that they cannot enroll enough participants in their investigative trials. With this new navigator, we hope to match more gastric cancer patients with trials that can make a difference in their treatment while furthering promising research," explained Leung. Patients and their families are encouraged to review the navigator and learn how they can easily participate by filling out a short online survey. The clinical trial database is hosted by EmergingMed and includes all treatment trials from clinicaltrials.gov along with updates reported directly by trial sponsors and sites. For more than a decade, EmergingMed has facilitated clinical trial searches for nearly 500,000 patients. The Foundation's Board of Directors was most impressed with this navigator's commitment to privacy and its ability to provide patients with personalized guidance to find clinical trials that match their diagnosis and treatment history. The service can also update patients when new trials and sites open that match their profiles. "This clinical trials navigator is one more tool to further our mission of education, research, and advocacy for gastric cancer patients," said Foundation Board Co-Chair Paul Gottsegen.       Gastric Cancer Foundation has granted more than $2 million for gastric cancer research, elevating research funding for this cancer that receives only .04% of all federal funding for cancer research.  Additionally, it created the first HIPAA-compliant Gastric Cancer Registry and a perpetual Research Scholar Award to fund talented young scientists who are pursuing research on this often-neglected disease. Since 2009, the Foundation has established a successful track record of strategic investments in early stage research efforts that have made breakthrough discoveries.   ]]> https://biospectrumindia.com/news/57/11555/freyr-wins-excellence-award-for-exceptional-services.html https://biospectrumindia.com/news/57/11555/freyr-wins-excellence-award-for-exceptional-services.html Tue, 28 Aug 2018 10:35:00 +0530 Freyr, a leading, niche, full-service global Regulatory Solutions and Services Company which is headquartered in New Jersey, USA and has a Global Delivery Center in Hyderabad, India and has regional offices across UK, Germany, UAE, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia has won the Excellence Award for its exceptional performance as a pharma and life sciences Regulatory services, solutions and consulting company. The GHP (Global Health & Pharma) International Life Science Awards 2018 recognize rapidly evolving companies at all levels & aspects of healthcare and pharmaceutical sector with emphasis on end-to-end functioning and unmatchable quality.   As a leading full-service global Regulatory solutions and services provider, Freyr has been successful in catering compliant Regulatory services amid growing competition and rapid technological advancements. With 550+ dynamic Regulatory experts assisting the clients with a specialized focus on end-to-end compliance, Freyr has supported more than 250 global clients since its inception, which stand a proven factor for its excellence. “This is a momentous achievement for Freyr. The recognition reflects on the continuous efforts of Freyr to deliver the best solutions focusing on the entire Regulatory value chain,” said Suren Dheenadayalan, Co-CEO Freyr. “With a due credit to our in-house experts, who are benchmarking the best of compliant standards for the betterment of life sciences, we believe that Freyr’s responsibility to evolve and provide hi-end compliant solutions and services has increased further with this win,” he added. Freyr is supporting large, medium and small size global life sciences companies in their entire regulatory value-chain; ranging from regulatory strategy, intelligence, dossiers, submissions etc. to post- approval or legacy product maintenance, labeling, artwork change management and other related functions. ]]> https://biospectrumindia.com/news/57/11554/novartiss-kymriah-gets-ec-approval-to-treat-blood-cancer.html https://biospectrumindia.com/news/57/11554/novartiss-kymriah-gets-ec-approval-to-treat-blood-cancer.html Mon, 27 Aug 2018 14:55:00 +0530 Drugmaker Novartis announced that the European Commission (EC) has approved Kymriah®(tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah developed in collaboration with the University of Pennsylvania (Penn)   is a ground-breaking one-time treatment that uses a patient's own T cells to fight cancer, and the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration (FDA). Novartis will continue to build out facilities to manufacture Kymriah, which costs up to $475,000 for children and young adults with B-cell acute lymphoblastic leukemia and $373,000 for adults with B-cell lymphoma in the United States.   ]]> https://biospectrumindia.com/news/57/11550/uta-bioengineer-to-develop-hydrogel-for-heart-tissue-repair.html https://biospectrumindia.com/news/57/11550/uta-bioengineer-to-develop-hydrogel-for-heart-tissue-repair.html Mon, 27 Aug 2018 12:15:00 +0530 A UTA (University of Texas, Arlington) bioengineering professor has won a new $460,000 grant from the National Institutes of Health to develop a biodegradable and bioactive hydrogel to repair heart tissue after heart attacks. "Heart attacks, or myocardial infarction, are a leading cause of morbidity and mortality worldwide," said UTA bioengineering professor Yi Hong, who is leading the research project. "We are working on a new biodegradable and bioactive hydrogel material that could be injected into the heart to promote cardiac repair after a heart attack." Recent research has shown that the injection of a hydrogel derived from heart tissue with the cells removed can promote the development of new heart muscle cells and also help restore heart function. This scaffold material is called the extracellular matrix. "My collaborators and I aim to take this one step further and develop a blended injectable biogel that combines the scaffolding and repair properties of the extracellular matrix with nanoparticle-based drug delivery technologies," Hong said. "Our projected outcome is to significantly increase the recruitment of stem cells to the heart, accelerate cardiac repair and improve cardiac function after a heart attack." Hong is collaborating with UTA bioengineering professor Kytai Nguyen and UTA bioengineering associate professor Jun Liao, as well as Ge Zhang, associate professor of biomedical engineering at the University of Akron. Michael Cho, UTA's chair of bioengineering, congratulated Hong and the team on attaining this highly competitive grant. "Dr. Hong's research in biomaterials and especially biogels is positioning UTA at the forefront of this burgeoning field," Cho said. "This new project will provide a platform for cross-institutional collaboration in Dallas-Fort Worth area and strengthen our position even further in biomedical engineering research and potential clinical applications." Earlier this year, Hong developed a highly elastic biodegradable hydrogel for bioprinting materials that mimic natural human soft tissues. Bioprinting uses live cells within the scaffolding of the new tissues and could potentially transform cell printing. A provisional patent application has been filed on this new elastic material, which will be able to generate multiple types of human soft tissues, including skin, skeletal muscles, blood vessels and heart muscles. ]]> https://biospectrumindia.com/news/57/11547/bhf-launches-30-m-funding-for-cardiovascular-research.html https://biospectrumindia.com/news/57/11547/bhf-launches-30-m-funding-for-cardiovascular-research.html Mon, 27 Aug 2018 10:30:00 +0530 The British Heart Foundation (BHF) has launched the Big Beat Challenge, a unique research funding award that will bring together world-leading researchers and innovators to identify and solve any of the biggest problems in heart and circulatory disease. Unveiled at this year's European Society of Cardiology Congress in Munich, the £30 million award will be one of the largest and most ambitious of its kind; a challenge to scientists, clinicians, innovators and entrepreneurs to look beyond incremental gains and accelerate breakthroughs that could transform lives across the globe. The Big Beat Challenge will push the international research community to identify a real world challenge, significant unmet need or opportunity for game-changing innovation in heart and circulatory science or medicine. A problem or opportunity, which if solved or seized at scale, would mean major progress towards real patient benefit.   ]]> https://biospectrumindia.com/news/57/11541/pfizer-exact-sciences-to-co-market-colorectal-cancer-diagnostic-test.html https://biospectrumindia.com/news/57/11541/pfizer-exact-sciences-to-co-market-colorectal-cancer-diagnostic-test.html Fri, 24 Aug 2018 10:20:00 +0530 Molecular diagnostics company Exact Sciences and Pfizer have signed a multi-year agreement to co-market the Cologuard test for diagnosing colorectal cancer in the US. Cologuard is one of the only US Food and Drug Administration (FDA) approved and non-invasive stool DNA screening diagnostics for cancer. By promoting the test, Exact Sciences and Pfizer intend to boost colorectal cancer screening rates. Exact Science’s sales force, the science of Cologuard and a direct-to-consumer marketing campaign will be combined with Pfizer’s health systems network and marketing expertise. Exact Sciences will continue to carry out all manufacturing and laboratory operations of the test. Pfizer will evenly share gross profits and marketing costs above an agreed baseline. ]]> https://biospectrumindia.com/news/57/11532/systech-avows-blockchain-solutions-for-pharma-supply-chain.html https://biospectrumindia.com/news/57/11532/systech-avows-blockchain-solutions-for-pharma-supply-chain.html Wed, 22 Aug 2018 14:25:00 +0530 Systech, a global technology leader in consumer safety, brand protection, and product authentication, along with representatives from leading healthcare industry companies and associations, came together to explore the use of blockchain technology to support Drug Supply Chain Security Act (DSCSA) compliance. Hosted by the Center for Supply Chain Studies, the "DSCSA & Blockchain" study team explored whether blockchain technology can be used to address the full data sharing requirement of the DSCSA's future mandate that states interoperable, electronic tracing of product at the package level should go into effect. The study team set goals for establishing a blockchain-based electronic connection between global trading partners, sharing required data without exposing proprietary information, designing for expansion beyond DSCSA compliance, and funding the architecture. Moving beyond schematics, several scenarios were simulated to test their theories, with results shared and verified by the team. The Drug Supply Chain Security Act and Blockchain white paper published June 21, 2018, documents and provides an opportunity to further explore the study and the team's work. "We identified several challenges and potential design alternatives in readying supply chain stakeholders and solution providers to define the interoperable system needed to satisfy the requirements of the "Enhanced Drug Distribution System" outlined in the DSCSA," says Bob Celeste, Founder of C4SCS. "The next steps are to move from a simulated ReferenceModel environment to a testing stage where the technology can be further explored and provide clarity on implementation conditions."   ]]> https://biospectrumindia.com/news/57/11526/researchers-develop-test-for-checking-substandard-antibiotics.html https://biospectrumindia.com/news/57/11526/researchers-develop-test-for-checking-substandard-antibiotics.html Wed, 22 Aug 2018 12:55:00 +0530 A group of researchers from Colorado State University in the US, has created a paper-based test that can quickly determine whether an antibiotic sample is of appropriate strength, or diluted with filler substances like baking soda. Similar to the mechanism of a home pregnancy test, a strip of paper turns a distinctive color if a falsified antibiotic is present. For the test, the researchers used the bacterial enzyme, called beta-lactamase, to empower their device to detect the presence of antibiotics in a given sample. Bacteria naturally produce this enzyme that can give them resistance to antibiotics by chemically binding to portions of the antibiotic molecule. With a good antibiotic dose, there is little color change in the paper strip, but in a falsified or weakened antibiotic, the paper goes red, because the enzyme instead reacts with a molecule called nitrocefin present in the paper. In short, yellow means good (appropriate strength antibiotic); red means bad (diluted antibiotic). ]]> https://biospectrumindia.com/news/57/11522/mit-scientists-design-gps-system-to-track-tumours-.html https://biospectrumindia.com/news/57/11522/mit-scientists-design-gps-system-to-track-tumours-.html Tue, 21 Aug 2018 18:25:00 +0530 A team of scientists at the Massachusetts Institute of Technology (MIT) has developed an in-body GPS system, called ReMix, which can identify the location of ingestible implants inside the body via low-power wireless signals. The team expects that such implants can be used to track tumours by monitoring even slight movements. In the future, the implants may also help in dispensing drugs to a specific area in the body. ReMix is being developed by MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) in alliance with Massachusetts General Hospital (MGH). The in-body GPS system is based on a wireless technology that MIT previously developed to detect heart rate, breathing and movement. Further studies are required to improve the system’s accuracy and address any associated challenges. ]]> https://biospectrumindia.com/news/57/11520/researchers-develop-predictor-for-immunotherapy-response-in-melanoma.html https://biospectrumindia.com/news/57/11520/researchers-develop-predictor-for-immunotherapy-response-in-melanoma.html Tue, 21 Aug 2018 14:30:00 +0530 In a new study, researchers developed a gene expression predictor that can indicate whether melanoma in a specific patient is likely to respond to treatment with immune checkpoint inhibitors, a novel type of immunotherapy. The predictor was developed by Noam Auslander, Ph.D., with other researchers in the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), part of the National Institutes of Health, and colleagues at Harvard University, Cambridge, Massachusetts; the University of Pennsylvania, Philadelphia; and the University of Maryland, College Park. The study was published Aug. 20, 2018 in Nature Medicine. “There is a critical need to be able to predict how cancer patients will respond to this type of immunotherapy,” said Eytan Ruppin, M.D., Ph.D., of NCI’s newly established Cancer Data Science Laboratory, who led the study. “Being able to predict who is highly likely to respond and who isn’t will enable us to more accurately and precisely guide patients’ treatment.” Treatment with checkpoint inhibitors is effective for some patients with late-stage melanoma and certain other types of cancer. However, not all patients with melanoma respond to this treatment, and it can have considerable side effects.. But developing a predictor of response has been challenging, partly because of the limited number of patients who have received this relatively new form of treatment. In this study, the investigators developed a predictor by first looking for clues in cases where the immune system appears to mount an unprompted, successful immune response to cancer, causing spontaneous tumor regression. They analyzed neuroblastoma, a type of cancer that frequently undergoes spontaneous regression in young children, and were able to define gene expression features that separated patients with non-regressing disease from those with regressing disease. These features enabled the researchers to compute what they called an IMmuno-PREdictive Score (IMPRES) for each patient sample. The higher the IMPRES score for a sample, the more likely it was to undergo spontaneous regression. To see if IMPRES could be used to predict melanoma patients’ responses to checkpoint inhibitors, the authors analyzed 297 samples from several studies. They found that the predictor could identify nearly all patients who responded to the inhibitors and more than half of those who did not, making it significantly superior to all other existing published predictors. Importantly, unlike other existing predictors, IMPRES was accurate across many different melanoma patient data sets. “We now know that immunotherapy works, but we do not understand well why a particular therapy will work for some patients but not others,” said Tom Misteli, Ph.D., director of CCR at NCI. “This study is a step forward in developing tools to address this challenge, which is of practical importance to patients.” Dr. Ruppin said that while the results obtained are encouraging, they will need to be carefully evaluated in additional patient datasets. The authors also wrote that further study of this kind of predictor is now warranted in other cancer types for which checkpoint inhibitors have been approved. ]]> https://biospectrumindia.com/news/57/11512/stanford-team-develops-effective-imaging-technique-for-tb.html https://biospectrumindia.com/news/57/11512/stanford-team-develops-effective-imaging-technique-for-tb.html Mon, 20 Aug 2018 10:45:00 +0530 A research team at Stanford University School of Medicine has developed an imaging technique that can diagnose live tuberculosis (TB) in an hour and help monitor the efficacy of treatments. The new method is easier and cheaper to carry out than current methods, meaning the technology could be useful in cash-strapped healthcare systems. It requires the use of fluorescent microscopes, which nearly all hospitals have, and no special training. The technology relies on a newly created two-piece fluorescent probe. The probe is combined with the spit sample and is activated when it comes in contact with TB bacteria. When one part of the probe detects TB it then glows and the second part localises the glow to the bacterium. This concentrated fluorescence allows researchers to track the distribution of the bacteria in infected host cells. The probe can also determine the appropriate drug for a patient by showing which bacteria are still alive in the patient sample. The research team hopes that the technique could help scientists develop new TB drugs for different strains of the disease. The team is planning to test the probe and obtain approval from the US Food and Drug Administration (FDA). ]]> https://biospectrumindia.com/news/57/11510/fda-approves-first-generic-version-of-epipen.html https://biospectrumindia.com/news/57/11510/fda-approves-first-generic-version-of-epipen.html Fri, 17 Aug 2018 18:20:00 +0530 The U.S. Food and Drug Administration has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, M.D. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages. The path to developing generic drug-device combination products like this one is challenging. We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines. Many of these steps were outlined in our Drug Competition Action Plan, announced last year. We’re especially committed to the development of generic copies of complex products. These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval. We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.” Life-threatening allergies can include reactions to insect bites or stings, foods, medications, latex or other causes. Anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death. Anaphylaxis occurs in approximately one in 50 Americans. People who have had an anaphylaxis episode always face the risk of another one. Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand. The EpiPen is intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names. An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product. Epinephrine auto-injector products are known as “combination products” because they consist of a drug (epinephrine) and a device (the auto-injector). This epinephrine injection (auto-injector) is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins. The most common side effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache and/or respiratory difficulties. Rare cases of serious skin and soft tissue infections have been reported following use of the drug. In patients with heart disease, use of epinephrine injection may cause chest pain (angina pectoris) or abnormal heart beats (ventricular arrhythmias). Following use of epinephrine injection, patients should seek immediate medical or hospital care. Epinephrine should not be injected into the vein, buttock, fingers, hands or feet. To minimize risk of injection-site injury, movement of the leg should be limited during injection. ]]> https://biospectrumindia.com/news/57/11506/ubiquigent-receives-innovate-uk-grant-.html https://biospectrumindia.com/news/57/11506/ubiquigent-receives-innovate-uk-grant-.html Fri, 17 Aug 2018 12:55:00 +0530 Ubiquigent Limited, a company focused on enabling and supporting ubiquitin system targeted drug discovery, announced today that it was awarded a new grant from Innovate UK as part of its Investor Accelerator Pilot to support a project entitled; ‘The development of novel compounds to seed a neurodegeneration drug discovery programme’.  The programme provides simultaneous grant funding and venture capital investment for early-stage projects led by UK companies. As part of the award, Ubiquigent received further investment from IP Group plc and a group of experienced life science investors led by Ubiquigent’s senior management team to support the ongoing growth of the business. Ubiquigent’s Managing Director, Jason Mundin commented: "This latest grant and investment provides additional support for the advancement of one of our key programmes. The programme is now well underway, and we look forward to reaching our endpoint of developing novel compounds in this disease area much sooner than originally planned. The team is now even better placed to support our existing and new partners focused on ubiquitin system drug discovery."    ]]> https://biospectrumindia.com/news/57/11498/merck-foundation-commits-to-improve-cancer-care-in-africa.html https://biospectrumindia.com/news/57/11498/merck-foundation-commits-to-improve-cancer-care-in-africa.html Thu, 16 Aug 2018 14:45:00 +0530 Merck Foundation, the philanthropic arm of Merck KGaA Germany continues their long term commitment to improve access to cancer care and to build capacity through their Merck Access Program in Africa. Dr. RashaKelej, CEO of Merck Foundation met the First Lady of Gambia, H.E. Fatoumattah Bah-Barrow, First Lady of Lesotho, H.E. MaesiahThabane, First Lady of Botswana, H.E. Neo Masisi and First Lady of Zimbabwe, H.E. AuxilliaMnangagwa to discuss Merck Cancer Access Program and Merck Foundation long term partnership to build capacity in their countries in the fields of cancer, fertility and diabetes. “We are committed to lead Africa to a better future through changing the landscape of Cancer care in the continent. Our meeting today was an effort in the same direction. Merck Foundation has been actively working to realize our vision and achieve our objectives of building professional capacity with the aim to increase the limited number of oncologists in more than 17 African countries. We will now strengthen our efforts in more countries,” emphasized Dr. RashaKelej. So far, more than 30 candidates from Niger, Chad, Guinea, Kenya, Ethiopia, Rwanda, Uganda, Liberia, Botswana, South Africa, Gambia, Senegal, Zambia, Namibia, Mauritius and Ghana have been enrolled in the one year and two year Oncology Fellowship Program in partnership with African ministries of health and First Ladies offices to be conducted in the University of Nairobi, Kenya, Tata Memorial Centre, India, University of Malaya, Malaysia, and Cairo University, Egypt. Merck Cancer Access Program builds cancer care capacity, supports the implementation and development of specialized healthcare solutions and is augmented by community awareness campaigns to contribute to the reduction of cancer incidences and improve survival rates. The lack of financial means is not the only challenge in Africa and developing countries, but a scarcity of trained health care personnel capable to tackle the prevention, early diagnosis and management of cancer at all levels of the health care systems is even a bigger challenge. Therefore, Merck Foundation has conducted the Merck Oncology Fellowship Program focuses on building professional cancer care capacity with the aim to increase the limited number of oncologists in Africa and Developing Countries. ]]> https://biospectrumindia.com/news/57/11484/mylan-brings-first-generic-for-adcirca-tablets.html https://biospectrumindia.com/news/57/11484/mylan-brings-first-generic-for-adcirca-tablets.html Tue, 14 Aug 2018 12:00:00 +0530 Global pharmaceutical company Mylan N.V.  has announced the U.S. launch of Tadalafil Tablets USP, 20 mg, the first generic version of the reference listed drug, Eli Lilly and Company's Adcirca®.   Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) and was awarded 180 days of marketing exclusivity for this product, which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. U.S. sales for Tadalafil Tablets USP, 20 mg, were approximately $510 million for the 12 months ending May 31, 2018, according to IQVIA. Currently, Mylan has 192 ANDAs pending FDA approval representing approximately $88.3 billion in annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $44.9 billion in annual brand sales, for the 12 months ending December 31, 2017, according to IQVIA.   ]]> https://biospectrumindia.com/news/57/11482/scientists-devise-a-technique-to-detect-hundreds-of-proteins-in-a-single-sample.html https://biospectrumindia.com/news/57/11482/scientists-devise-a-technique-to-detect-hundreds-of-proteins-in-a-single-sample.html Tue, 14 Aug 2018 10:55:00 +0530 New technology developed by a team of McGill University scientists shows potential to streamline the analysis of proteins, offering a quick, high volume and cost-effective tool to hospitals and research labs alike. Proteins found in blood provide scientists and clinicians with key information on our health. These biological markers can determine if a chest pain is caused by a cardiac event or if a patient has cancer. Unfortunately, the tools used to detect such proteins haven't evolved much over the past 50 years - despite there being over 20,000 proteins in our body, the vast majority of protein tests run today target only a single protein at-a-time. Now, PhD candidate Milad Dagher, Professor David Juncker and colleagues in McGill's Department of Biomedical Engineering have devised a technique that can detect hundreds of proteins with a single blood sample. Part of their work, just published in Nature Nanotechnology, describes a new and improved way to barcode micro-beads using multicolour fluorescent dyes. By generating upwards of 500 differently coloured micro-beads, their new barcoding platform enables detection of markers in parallel from the same solution--for example, a blue barcode can be used to detect marker 1, while a red barcode can detect marker 2, and so on. A laser-based instrument called a cytometer then counts the proteins that stick to the different coloured beads. Though this kind of analysis method has been available for some time, interference among multicolour dyes has limited the ability to generate the right colours. Now, a new algorithm developed by the team enables different colours of micro-beads to be generated with high accuracy--much like a colour wheel can be used to predict the outcome of colour mixing. Professor Juncker's team is hoping to leverage its platform for improved analysis of proteins. "Current technologies hold a major trade-off between the number of proteins that can be measured at once, and the cost and accuracy of a test", Dagher explains. "This means that large-scale studies, such as clinical trials, are underpowered because they tend to fall back on tried-and-true platforms with limited capabilities." ]]> https://biospectrumindia.com/news/57/11474/researchers-develop-ai-technique-to-treat-cancer.html https://biospectrumindia.com/news/57/11474/researchers-develop-ai-technique-to-treat-cancer.html Mon, 13 Aug 2018 13:30:00 +0530 MIT researchers, including one of Indian-origin, have developed novel machine-learning techniques to improve the quality of life for patients by reducing toxic chemotherapy and radiotherapy dosing for an aggressive form of brain cancer. Glioblastoma is a malignant tumour that appears in the brain or spinal cord, and the prognosis for adults is no more than five years. Patients are generally administered maximum safe drug doses to shrink the tumour as much as possible, but they still remain at risk of debilitating side effects. The new “self-learning” machine-learning technique could make the dosing regimen less toxic but still effective. It looks at the treatment regimen currently in use, and finds an optimal treatment plan, with the lowest possible potency and frequency of doses that should still reduce tumour sizes to a degree comparable to that of traditional regimen, the researchers said. “We kept the goal where we have to help patients by reducing tumour sizes but, at the same time, we want to make sure the quality of life, the dosing toxicity doesn’t lead to overwhelming sickness and harmful side effects,” said Pratik Shah, principal investigator from the Massachusetts Institute of Technology (MIT) in Boston, US. The findings will be presented at the 2018 Machine Learning for Healthcare conference at Stanford University in California, US. In simulated trials of 50 patients, the model comprising of artificially intelligent “agents”, designed treatment cycles that reduced the potency to a quarter or half of nearly all the doses while maintaining the same tumour-shrinking potential. Many times, it skipped doses altogether, scheduling administrations only twice a year instead of monthly. However, the researchers also had to make sure the model does not just dish out a maximum number and potency of doses. Whenever the model chooses to administer all full doses, it gets penalized, so instead it chooses fewer, smaller doses. “If all we want to do is reduce the mean tumour diameter, and let it take whatever actions it wants, it will administer drugs irresponsibly,” Shah said. “Instead, we need to reduce the harmful actions it takes to get to that outcome.” ]]> https://biospectrumindia.com/news/57/11467/researchers-highlight-ebola-vaccine-progress.html https://biospectrumindia.com/news/57/11467/researchers-highlight-ebola-vaccine-progress.html Mon, 13 Aug 2018 10:50:00 +0530 Despite promising advances, important scientific questions remain unanswered in the effort to develop a safe and effective Ebola vaccine, according to members of an international Ebola research consortium. In a Viewpoint published in The Lancet, the experts review the current field of Ebola vaccine candidates and clinical trials and highlight key gaps in knowledge that need to be addressed by future research. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are among the Viewpoint's authors. All authors are with the Partnership for Research on Ebola VACcination (PREVAC). In addition to NIAID, the partnership, established in 2017, comprises experts from the French National Institute of Health and Medical Research (Inserm), the London School of Hygiene & Tropical Medicine (LSHTM), the West African Clinical Research Consortium and their collaborators. PREVAC is currently conducting a Phase 2 clinical trial in Guinea, Liberia, Sierra Leone and Mali to evaluate three Ebola vaccination strategies in people one year and older. Ebola virus disease remains a public health threat-the Democratic Republic of the Congo (DRC) already has experienced two Ebola outbreaks in 2018-underscoring the need for continued efforts to develop an effective vaccine. The authors note that 36 trials of Ebola vaccine candidates have been completed and another 14 are active, according to clinicaltrials.gov. The rVSV-ZEBOV experimental vaccine, which has been deployed in the DRC, is the only candidate with some clinical efficacy data, which were obtained in a clinical trial in Guinea conducted during the 2014-2016 Ebola outbreak in Guinea. After reviewing the status of four additional vaccine candidates under study (Ad26.ZEBOV, MVA-BN-Filo, chAd3-EBO-Z, and the GamEvac-Combi vaccine), the authors highlight areas where more research is required. Specifically, they note the need for more data in pregnant women, children and immunocompromised populations, including people infected with HIV and the elderly. Additionally, they say more research is needed on the durability and rapidity of immune responses generated by various vaccine approaches. The experts also call for studies to identify reliable correlates of protection (the specific and measurable part of an immune response that would indicate a person is protected from Ebola) as well as large-scale trials to fully evaluate the safety and efficacy of experimental vaccines. The authors conclude by underscoring the value of embedding social science research in clinical trial design to help build trust and engagement with the affected communities. They note that in addition to the need to investigate various vaccines and vaccination strategies to respond more effectively to future outbreaks, improving the global capacity to conduct clinical research and forming collaborative partnerships, such as PREVAC, are crucial for success. ]]> https://biospectrumindia.com/news/57/11456/scientists-use-nanoparticles-to-detect-deep-tissue-cancers.html https://biospectrumindia.com/news/57/11456/scientists-use-nanoparticles-to-detect-deep-tissue-cancers.html Thu, 09 Aug 2018 18:25:00 +0530 Australian and Chinese scientists have developed a method using coded nanoparticles to detect and help diagnose disease.    The research team from Macquarie University and Fudan University hopes that their study will lead to less invasive disease detection.    "Currently for many more disease diagnosis such as for cancer, they rely on medical imaging but ultimately need to take tissue out for testing, we would like to move that to a different approach using optical imaging." said research author Dr. Yiqing Lu from the Centre of Excellence for Nanoscale BioPhotonics (CNBP) at Macquarie University.    In its current level of laboratory testing, the method has been successful in detecting multiple forms of breast cancer in mice.   "This technique has the potential to provide a low-invasive method of determining if breast cancer is present, as well as the form of breast cancer, without the need to take tissue samples via biopsy," joint-lead author Prof. Fan Zhang from China's Fudan University said.   Up until now it has been very difficult for the method to detect multiple biomarkers, or different forms of disease.    Light absorbing and scattering elements such as blood, muscle and cartilage produce too much interference making it difficult to determine if a range of disease biomarkers are present.    The team's solution was to engineer special nanoparticles which emit light for set periods of time.    It is the duration of the light-emission and the biomarker reaction to this timed amount of light that produces a clearly identifiable molecular signature.    "This enables high-contrast optical biomedical imaging that can detect multiple disease biomarkers all at the one time."Prof. Jim Piper, CNBP node leader at Macquarie University described the research as a major breakthrough.   "Next steps in our research collaboration are to further refine the nanoparticles, to examine issues related to a clinical roll-out of the technology and to explore further applications and disease areas where this technique could be best utilised," Piper said.   ]]> https://biospectrumindia.com/news/57/11447/eurocine-vaccines-immunosetm-flu-shows-good-safety-in-older-adults.html https://biospectrumindia.com/news/57/11447/eurocine-vaccines-immunosetm-flu-shows-good-safety-in-older-adults.html Wed, 08 Aug 2018 14:25:00 +0530 Eurocine Vaccines announced good safety and tolerability in older adults, in the second clinical phase I/II study including their quadrivalent influenza vaccine candidate.   Immunose™ FLU is a novel nose drop formulation based on the company´s technology Endocine™ and inactivated split influenza antigens.   I am very happy that we have once again confirmed good safety, this time in older adults, a population in need of better influenza vaccines.   Now we look forward to the immunological results, which are expected in October, says Dr. Anna-Karin Maltais, CSO, Vice President R&D.   The study was conducted during the influenza season 2017/2018 with the purpose to evaluate safety and tolerability, as well as serological and mucosal immune responses to four influenza strains in older adults aged 50-75.   A total of 298 subjects, with a mean age of 63 years, were divided into seven treatment groups and the study was conducted at five locations throughout Sweden. The compliance was high, with 99% of the subjects completing the clinical part of the study.   No serious adverse event was reported in the Immunose™ FLU groups. The reported adverse events were mostly mild or moderate. A tolerability evaluation measuring discomfort at the administration site showed mild and transient experiences, lasting less than two hours.   With this study, the safety database has expanded to a total of over 400 subjects for the platform technology Endocine™.   The data put us exactly where we want to be for our further development and in our hunt for the next vaccine project, says Dr. Hans Arwidsson, CEO. ]]> https://biospectrumindia.com/news/57/11445/alternate-health-signs-pact-to-increase-lab-biz.html https://biospectrumindia.com/news/57/11445/alternate-health-signs-pact-to-increase-lab-biz.html Wed, 08 Aug 2018 12:50:00 +0530 Alternate Health Corp., an international leader in software solutions for the medical cannabis industry, announced that the Company signed a binding contract to provide laboratory services for a large multistate laboratory provider.   Alternate Health expects to begin testing samples in August and is targeting a ramp up to a monthly sample rate of 25,000 - 30,000 by December 2018. August is forecasted to begin with approximately 5,000 to 6,000 samples monthly with an increase of 5,000 to 6,000 additional samples per month.   The assumptions on sample volumes, both to start in August and the December projections were made after carefully reviewing the current needs and future growth projected by the referring entity.   Regional fees per sample run between US$50.00 to US$250.00, with averages falling into the US$130 to US$150 range. Costs and expenses associated with performing the tests certainly vary with volume, with Alternate Health's historical numbers falling between US$35.00 to US$70.00 per sample.   In late 2017 through 2018, the Company completed a program of upgrades at Alternate Health Lab's San Antonio facility. As a result, Alternate Health Labs now has the capacity to run blood, toxicology, allergy, pharmacogenetics, respiratory pathogen panels and women's health panels.   "With this agreement, Alternate Health will benefit from the investments we have made in our laboratory business," says Dr. Murphy. "We are excited to build a stable financial foundation to move forward with our mission to be the technology leader in the international cannabis industry." ]]> https://biospectrumindia.com/news/57/11438/sotera-health-completes-the-sale-of-medical-isotopes-biz-to-bwxt.html https://biospectrumindia.com/news/57/11438/sotera-health-completes-the-sale-of-medical-isotopes-biz-to-bwxt.html Tue, 07 Aug 2018 10:50:00 +0530 Sotera Health LLC, the world's leading, fully integrated protector of global health, today announced the closing of the sale of the Medical Isotopes segment within its Nordion business to BWX Technologies, Inc. (BWXT).   With the sale, BWXT now owns Nordion's former medical isotopes business, including the radiochemical and contract manufacturing operations in Kanata, Ontario, and the isotope production facility in Vancouver, British Columbia, along with the transfer of approximately 150 employees.   Nordion retains ownership of its gamma technologies business as well as its state-of-the-art licenced facility in Kanata. Separately, the companies also signed a long-term lease agreement that will allow BWXT to continue operating from Nordion's Kanata facility.   ]]> https://biospectrumindia.com/news/57/11437/agilent-appoints-new-cfo.html https://biospectrumindia.com/news/57/11437/agilent-appoints-new-cfo.html Tue, 07 Aug 2018 10:45:00 +0530 Agilent Technologies has announced that Didier Hirsch, senior vice president and chief financial officer (CFO), has decided to retire on 31 October 2018. The company has appointed Robert McMahon, currently chief financial officer of the medical technology company Hologic, as his successor. McMahon has joined Agilent, as senior vice president, and will become CFO from 1 September 2018, when Hirsch will step down. Hirsch will continue as an active member of the executive staff until his retirement date at the end of the fiscal year, focused on working with McMahon to ensure a smooth transition. Hirsch has led Agilent’s global finance organization as CFO since 2010. Before that he had oversight of the corporate controllership and tax functions. He joined Agilent at its inception in 1999 as VP of treasury and investor relations. He held various international finance positions at HP, Agilent’s predecessor, from 1989 until joining Agilent.   ]]> https://biospectrumindia.com/news/57/11433/tissue-diagnostics-firms-focus-on-automation-and-partnerships.html https://biospectrumindia.com/news/57/11433/tissue-diagnostics-firms-focus-on-automation-and-partnerships.html Mon, 06 Aug 2018 14:55:00 +0530 Clinical laboratories' intensifying demand for a robust solution to manage data and the declining availability of skilled pathologists is making a strong case for the automation of tissue diagnostic systems.   Innovations in the automation of staining equipment and novel platforms such as digital immunohistochemistry (IHC) will be significant as automation and the use of an advanced laboratory information system (LIS) are emerging key differentiators in the global market.   There will also be strong investment activity in digitization, as digital formats can be integrated within the health information systems and made easily available for diagnostics purposes.   Frost & Sullivan's recent analysis, Global Tissue Diagnostics Market, Forecast to 2022, highlights key market participants, customer segments, and restraining factors such as liquid biopsy and reimbursement cuts.   It segments the market by pre-analytical staining, advanced staining, and APLIS across the United States, Western Europe, Asia-Pacific, and Rest of the World. This market is expected to register a CAGR of 7.9% from $4.7 billion in 2017 to $6.9 billion in 2022 due to its evolving role in companion diagnostics and use of automation.   Global Tissue Diagnostics Market, Forecast to 2022 is part of Frost & Sullivan's global Life Sciences Growth Partnership Service program.   ]]> https://biospectrumindia.com/news/57/11429/aobiome-therapeutics-announces-expansion-of-its-bod.html https://biospectrumindia.com/news/57/11429/aobiome-therapeutics-announces-expansion-of-its-bod.html Mon, 06 Aug 2018 11:35:00 +0530 AOBiome Therapeutics, Inc. ("AOBiome"), a world-leading clinical-stage microbiome company focusing on research and development of therapeutics for inflammatory conditions, central nervous system disorders and other systemic diseases. The company announced the expansion of its Board of Directors with the appointments of (i) Professor Klaus Dugi, Executive Vice President and Chief Medical Officer of Ferring Pharmaceuticals, (ii) Dr. Anna Lisa Jenkins, MBBS, FRCP, Chief Executive Officer of PlaqueTec Ltd. and (iii) Mr. Doug Rosefsky, partner of Prudentia Capital S.A.S., as independent non-executive directors.  Mr. Rosefsky will lead the audit committee and Dr. Jenkins will lead the remuneration committee. "We are very excited to announce the additions of Klaus, Anna Lisa and Doug to the AOBiome Board of Directors," said Mr. Todd Krueger, President and Chief Executive Officer of AOBiome. "These industry veterans bring to AOBiome a broad range of expertise in clinical development, medicine, finance and business management experience. We look forward to benefiting from their strategic insights that will be invaluable to the future direction of the Company."   ]]> https://biospectrumindia.com/news/57/11421/pfizer-announces-ec-approval-of-its-oncology-biosimilar.html https://biospectrumindia.com/news/57/11421/pfizer-announces-ec-approval-of-its-oncology-biosimilar.html Fri, 03 Aug 2018 11:30:00 +0530 Pfizer Inc. has announced that the European Commission (EC) has approved TRAZIMERA(trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018. “TRAZIMERA has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease,” said Professor Diana Lüftner, Charité Campus Benjamin Franklin and Member of the Presidency of the German Society of Hematology and Medical Oncology. “Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy and safety.” Richard Blackburn, Global President, Pfizer Essential Health Europe, Africa/Middle East and Biosimilars said “The approval of TRAZIMERA, Pfizer’s first oncology biosimilar, is another significant step in our quest to introduce more treatment options for patients in Europe. Pfizer is investing in developing and launching a range of biosimilars which can help to reduce healthcare costs and increase patient access to important medicines.” The EC approval is based on a comprehensive submission package which demonstrated a high degree of similarity for TRAZIMERA and the originator product. The data included results from the REFLECTIONS B327-02 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between TRAZIMERA and originator product in patients with first line HER2 overexpressing metastatic breast cancer. TRAZIMERA is Pfizer’s fourth biosimilar, and the first oncology biosimilar, to receive European approval. Pfizer’s biosimilars pipeline consists of 9 distinct Pfizer and legacy Hospira biosimilar molecules in various stages of development.   ]]> https://biospectrumindia.com/news/57/11413/google-glass-helps-autistic-children-to-socialize-with-others.html https://biospectrumindia.com/news/57/11413/google-glass-helps-autistic-children-to-socialize-with-others.html Thu, 02 Aug 2018 17:05:00 +0530 A new smartphone app that pairs with a Google Glass headset uses facial recognition software to give the wearer real-time updates on which emotions people are expressing. In a pilot trial, 14 children with autism spectrum disorder used this program at home for an average of just over 10 weeks. After treatment, the kids showed improved social skills, including increased eye contact and ability to decode facial expressions.   Dennis Wall, a biomedical data scientist specializing in pediatrics at Stanford University, and colleagues built the new Google Glass program to offer children with autism at-home, on-demand behavioral therapy.   The headset’s camera records the faces of people in the child’s field of view and feeds that information to a smartphone app. The app, trained on hundreds of thousands of face photos, is designed to recognize eight core expressions: happiness, sadness, anger, disgust, surprise, fear, contempt and calm.   When the app recognizes an expression of one of these feelings, it sends the information to the Google Glass wearer either by naming the emotion through the headset speaker or by displaying an emoticon on a small screen in the corner of the right spectacle frame.   In the pilot trial, children ages 3 to 17 with autism used this Google Glass program around their families for at least three 20-minute sessions per week. Before and after treatment, parents completed questionnaires that rated their children’s social skills.   On this Social Responsiveness Scale, scores below 60 fall within the “normal” range, whereas scores 60 to 65, 65 to 75, and above 75 indicate mild, moderate and severe autism, respectively. Over the course of treatment, the children’s average score dropped from 80.07 to 72.93.   Wall and his team are currently working on one such experiment with 74 children ages 6 to 12.  If the Google Glass therapy performs well in future clinical trials and is cleared for widespread use, it could be a powerful learning aid for many children with autism which affects an estimated 1 in 59 children in the United States, according to the U.S. Centers for Disease Control and Prevention.   ]]> https://biospectrumindia.com/news/57/11412/lg-to-open-ai-research-lab-in-canada.html https://biospectrumindia.com/news/57/11412/lg-to-open-ai-research-lab-in-canada.html Thu, 02 Aug 2018 14:55:00 +0530 Global innovator LG Electronics Inc. (LG) is poised to define the future of artificial intelligence (AI) for consumers and businesses in the years ahead with the establishment of a major new AI research presence in North America in collaboration with leaders in academia and start-ups. This week marks the launch of the new LG Electronics AI Research Lab in Canada, an extension of the newly expanded LG Silicon Valley AI Lab in Santa Clara, California. Supporting LG’s vision of AI as a key future growth engine, the North American labs further enhance LG’s global research capabilities, which include AI labs in South Korea, India and Russia. In addition, LG is entering into a new research partnership with the University of Toronto, which is recognized worldwide for its AI and machine learning expertise, particularly in the area of deep learning. “AI will ultimately touch everybody’s lives, transforming the way we live, work and play,” said LG Electronics President and Chief Technology Officer Dr. I.P. Park. “Early implementations of AI in connected devices today are setting the stage for tomorrow’s smart cities, smart homes, smart businesses and smart devices, all with capabilities that no one has even dreamed of yet.” He said the North American labs and LG’s research partnership with the University of Toronto will play a key role in developing source technologies defining that future. Under its five-year, multi-million-dollar research partnership with the University of Toronto, LG will build on its Open Platform-Open Partnership-Open Connectivity strategy to expand the AI ecosystem. The new lab will capitalize on the expertise of researchers at the University of Toronto who will now have the opportunity to work collaboratively with LG’s growing U.S. and Canadian AI R&D teams. Complementing this work, LG intends to collaborate with and invest in North American start-ups. University of Toronto President Meric Gertler views LG as an exciting new partner for AI research. “The University of Toronto looks forward to partnering with an innovative global company like LG as our researchers continue to advance the boundaries of artifi-cial intelligence. The presence of such leading, multi-national firms in our innovation ecosystem strengthens opportunities for our faculty, students and start-up companies across a whole range of disciplines.” Echoing President Gertler’s views, Dr. Park said, “AI solutions based on deep learning will revolutionize how we interact with the world around us, in new seamless ways that use contextual data from things like biometrics, emotions, gestures and of course voice.” He went on to explain the three main pillars of LG’s AI strategy: “The first is the ability to evolve with time, so the more you use our products, the better they evolve to meet your specific needs. The second is the ability to integrate AI into diverse touchpoints – to have a seamless, consistent user experience across the entire LG product portfolio, from connected appliances and TVs to connected cars and smartphones. The third is openness; our strategy is to provide the best AI experience for LG customers, leveraging the complementary capabilities of leading partners across the ecosystem,” Dr. Park explained. ]]> https://biospectrumindia.com/news/57/11411/2-million-grant-for-sepsis-research-in-africa.html https://biospectrumindia.com/news/57/11411/2-million-grant-for-sepsis-research-in-africa.html Thu, 02 Aug 2018 14:45:00 +0530 Liverpool School of Tropical Medicine is to lead a new multinational project on sepsis following a £2 million award from the National Institute of Health Research (NIHR). The African Research Collaboration on Sepsis (ARCS) has been set up as a Global Health Research Group and is led by LSTM's Dr Shevin Jacob and Dr Jamie Rylance, working across Malawi, Uganda and Gabon, working with academic, clinical and government partners in each country. Dr Rylance said: "ARCS is about bridging Africa and UK clinical research outfits and establishing long-term and equitable partnerships. It's very exciting to be involved at the very start of this process for such an important public health problem." Sepsis is a life-threatening condition that arises when the body's response to infections causes injury to its own tissues and organs. It affects more that 31 million people each year resulting in 6 million deaths worldwide. ARCS brings together African and UK expertise across the applied health spectrum to tackle this common problem, learning from the UK's experience in reducing sepsis mortality through the NHS focus on quality of care and patient safety. Creating sustainable partnerships between research and clinical organisations, Ministries of Health, on-government organisations, and commercial sectors, ARCS will establish a network across the three counties and focus on the following four aims: to deliver high quality sepsis research training; to establish commonly agreed sepsis care quality indicators for Africa which could form the bedrock of monitoring and evaluation programmes; to pilot test innovative sepsis care interventions; and to test the feasibility of novel clinical trial platforms for answering key sepsis questions for Africa. Dr Jacob said: "Due to multiple factors including a high burden of infection, diminished health system capacity, and limited awareness of how best to recognize and treat sepsis, Africa shoulders the greatest burden of sepsis in terms of global morbidity and mortality. We are thrilled that NIHR has funded ARCS to help build African research capacity on sepsis and, ultimately, add to our growing knowledge of how best to identify and treat sepsis within the African context." ]]> https://biospectrumindia.com/news/57/11410/dna-discovery-reverses-wrinkles-and-hair-loss-.html https://biospectrumindia.com/news/57/11410/dna-discovery-reverses-wrinkles-and-hair-loss-.html Thu, 02 Aug 2018 11:30:00 +0530 New experiments with mice show that by treating a mutation-based imbalance in mitochondrial function, animals that looked physically aged regrew hair and lost their wrinkles restoring them to a healthy, youthful appearance in just weeks.   "To our knowledge, this observation is unprecedented," says geneticist Keshav Singh from the University of Alabama at Birmingham.   One of the focal points of anti-ageing research is investigating the so-called mitochondrial theory of ageing, which posits that mutations in the DNA of our mitochondria – the 'powerhouse of the cell' – contribute over time to defects in these organelles, giving rise to ageing itself, associated chronic diseases, and other human pathologies.   To investigate these mechanisms, Singh and fellow researchers genetically modified mice to have depleted mitochondrial DNA (mtDNA).   They did this by adding the antibiotic doxycycline to the food and drinking water of transgenic mice. This turned on a mutation which causes mitochondrial dysfunction and depletes their healthy levels of mtDNA.   In the space of eight weeks, the previously healthy mice developed numerous physical changes reminiscent of natural ageing: greying and significantly thinning hair, wrinkled skin, along with slowed movements and lethargy.     The depleted mice also showed an increased numbers of skin cells, contributing to an abnormal thickening of the outer layer of their skin, in addition to dysfunctional hair follicles, and an imbalance between enzymes and inhibitors that usually prevents collagen fibres from wrinkling skin.   But once the doxycycline was no longer fed to the animals, and their mitochondria could get back to doing what they do best, the mice regained their healthy, youthful appearance within just four weeks.   Effectively, they reverted to the animals they were before their mitochondrial DNA content was tampered with – which could mean mitochondria are reversible regulators of skin ageing and hair loss.   "It suggests that epigenetic mechanisms underlying mitochondria-to-nucleus cross-talk must play an important role in the restoration of normal skin and hair phenotype," says Singh.   "This mouse model should provide an unprecedented opportunity for the development of preventative and therapeutic drug development strategies to augment the mitochondrial functions for the treatment of ageing-associated skin and hair pathology and other human diseases in which mitochondrial dysfunction plays a significant role." Researchers said. ]]> https://biospectrumindia.com/news/57/11405/new-armband-sensor-technology-to-quit-smoking.html https://biospectrumindia.com/news/57/11405/new-armband-sensor-technology-to-quit-smoking.html Wed, 01 Aug 2018 16:20:00 +0530 Researchers at Case Western Reserve University are using wearable sensor technology to develop an automatic alert system to help people quit smoking.   The smart-phone app, initially limited to android-based operating systems, automatically texts 20- to 120-second video messages to smokers when sensors detect specific arm and body motions associated with smoking.   According to the researchers, the mobile alert system that they are testing may be the first that combines an existing online platform with mindfulness training and a personalized plan for quitting smoking.   two armband sensors to detect smoking motions, a technology that demonstrated more than 98-percent accuracy in differentiating “lighting up” from other similar motions and a personalized text-messaging service that reminds the user of either their own plan to quit, or sends video messages that stress the health and financial benefits of quitting.   The system was conceived, developed and tested over the course of the last year by a team of Electrical Engineering and Computer Science researchers at the Case School of Engineering and a high school intern in collaboration with a clinical psychologist at the Case Western Reserve School of Medicine.   The researchers said most previous studies have relied on smokers self-reporting how often they smoked, while the Case Western Reserve system more accurately tracked smoking activity based on the sensors.   “We’ve been able to differentiate between a single motion, which could be confused with eating or drinking, and a sequence of motions more clearly linked to the act of smoking a cigarette,” said Ming-Chun Huang, an assistant electrical engineering and computer science professor who led the technical aspect of the study.   ]]> https://biospectrumindia.com/news/57/11399/puma-biotechnology-files-nds-for-nerlynx-in-canada.html https://biospectrumindia.com/news/57/11399/puma-biotechnology-files-nds-for-nerlynx-in-canada.html Wed, 01 Aug 2018 10:45:00 +0530 Puma Biotechnology, Inc., a biopharmaceutical company has announced that Health Canada has accepted for review the Company’s New Drug Submission (NDS) for the medicinal product NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. The NDS recently passed the mandatory validation period by Health Canada, the country’s federal regulator for drugs and health products, and has now entered the review period. “Health Canada’s acceptance of our NDS represents another important regulatory milestone in our commitment to increasing access to NERLYNX around the world to reduce disease recurrence following trastuzumab therapy in patients with early stage HER2-positive breast cancer,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “We look forward to working with Health Canada during their review of our submission.” Neratinib, an oral irreversible pan-HER kinase inhibitor, was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX. The drug also received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) in June 2018 and is being reviewed by the European Commission, which has the authority to approve medicines for the European Union.   ]]> https://biospectrumindia.com/news/57/11396/abbott-gets-usfda-nod-to-market-glucose-monitoring-system-in-u-s-.html https://biospectrumindia.com/news/57/11396/abbott-gets-usfda-nod-to-market-glucose-monitoring-system-in-u-s-.html Tue, 31 Jul 2018 15:05:00 +0530 Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle® Libre 14 day Flash Glucose Monitoring system, which allows people with diabetes to wear the sensor up to 14 days with high accuracy. This approval makes Abbott's revolutionary continuous glucose monitor (CGM) the longest lasting self-applied personal glucose sensor available on the market.   "At Abbott, we are continuously pushing for new innovations that minimize the daily burden of managing diabetes," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "With the new FreeStyle Libre 14 day system, people with diabetes will now have extended access to their glucose data with a high degree of accuracy, which will improve their experience and help empower them to better manage their condition." ]]> https://biospectrumindia.com/news/57/11382/gsks-nucala-wins-positive-opinion-from-ema-for-treatment-of-children-with-severe-asthma.html https://biospectrumindia.com/news/57/11382/gsks-nucala-wins-positive-opinion-from-ema-for-treatment-of-children-with-severe-asthma.html Mon, 30 Jul 2018 11:25:00 +0530 GlaxoSmithKline has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. If approved it would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in paediatric patients in Europe. Dr. Hal Barron, Chief Scientific Officer and President, R&D GSK said: “Ensuring our medicines have the broadest possible label is very important, as it allows us to help the greatest number of patients who may benefit. If approved Nucala could provide an additional option for younger patients in Europe who still struggle to control their asthma despite taking inhaled steroids and other controller medications. These are patients who are at high risk of asthma attacks, which can be a very frightening experience for anyone, especially young children.” Asthma is the commonest chronic disease in childhood and severe asthma that is poorly responsive to current standard of care asthma treatments has been reported in approximately 4.5% of children with asthma. A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission.  About severe asthma and eosinophilic inflammation Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy. Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs that can affect the airways, limiting breathing and increasing the frequency of asthma attacks. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. About Nucala (mepolizumab) Mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of white blood cells called eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophils. Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been approved (under the brand name Nucala) in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with severe eosinophilic asthma and is the leading biologic in this indication. In the US, Japan and Canada it is approved as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA).  This paediatric licence application is supported by a partial extrapolation approach agreed with the EU Paediatric Committee of the European Medicines Agency which utilised the efficacy and safety data available in paediatric patients and its well-documented positive benefit to risk profile in adult patients. Existing data was used from adolescent participants in the mepolizumab severe asthma pivotal programme in addition to new data from children in the pharmacokinetic (PK)/ pharmacodynamic (PD) study 200363. Part A, completed in children 6-11 years old with severe eosinophilic asthma, collected uncontrolled safety and limited efficacy data and showed that subcutaneous PK data in children 6 to 11 years is consistent with adults after adjustment for bodyweight and bioavailability and that mepolizumab blood eosinophil count reduction in adults is predictive of the blood eosinophil count reduction in paediatric patients. The safety profile of mepolizumab in children and adolescents with severe asthma appears similar to that of adolescents and adults from the Phase III placebo controlled severe eosinophilic asthma studies. No new safety concerns were identified for paediatrics when compared with the overall adolescent and adult data from the Phase III placebo controlled severe eosinophilic asthma studies. The adult application was supported with data from the mepolizumab phase II/III clinical development programme, which involved nine studies and a total of 915 patients with severe refractory eosinophilic asthma. Patients received either a subcutaneous or an intravenous dose of mepolizumab during clinical studies of 24 to 52 weeks duration. Three key clinical trials – DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) – have established the efficacy and safety profile of Nucala for severe refractory eosinophilic asthma patients. The European Marketing Authorisation Application for Nucala in patients over 18 was submitted to the EMA on 21 November 2014 and was approved on 2 December 2015. GSK’s commitment to respiratory disease GSK has led the way in developing innovative medicines to advance the management of asthma and COPD for nearly 50 years. Over the last five years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment.     ]]> https://biospectrumindia.com/news/57/11377/uk-group-develops-a-lamp-to-treat-chronic-ulcers.html https://biospectrumindia.com/news/57/11377/uk-group-develops-a-lamp-to-treat-chronic-ulcers.html Fri, 27 Jul 2018 15:45:00 +0530 A group of researchers at the University of Manchester and Salford Royal NHS Trust has developed a lamp for the treatment of chronic ulcers. The Arthritis Research UK-funded trial was led by Dr Michael Hughes who tested the therapy, which combines infrared, red and ultraviolet light, on finger ulcers caused by systemic sclerosis, a condition which causes the immune system attacks the body’s fingers and toes. The new therapy can be administered at home with SIM card technology to remotely monitor patient progress. The lamp has 32 different bulbs that emit infrared, red or ultraviolet light. According to the research group, the results of the trial were very significant and the device could be a potential treatment for other ulcers, including diabetic and venous ulcers. ]]> https://biospectrumindia.com/news/57/11376/mesa-biotech-provides-corporate-update.html https://biospectrumindia.com/news/57/11376/mesa-biotech-provides-corporate-update.html Fri, 27 Jul 2018 15:35:00 +0530 Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, provides an update on notable accomplishments and corporate priorities for the remainder of 2018. "In 2017, we focused on preparing our Accula Test System for commercialization, strengthening key corporate partnerships that will build the foundation for our global distribution channel strategy, expanding manufacturing capacity, and building an experienced team. In the first half of 2018 we launched our first product in both the EU and US and secured additional funding to execute on our mid-term and long-term strategic plans," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. "We are now positioned to further expand manufacturing capacity and move our pipeline products forward." 2017 and Early 2018 Highlights 2017 was a year of pre-commercial preparation for Mesa Biotech. To facilitate global expansion, the company received an internationally recognized ISO quality certification. This designation marked the completion of a critical step for commercialization of Mesa Biotech's novel Accula System in the European Union (EU) and the United States (US). The company hired Steven Sepulveda for the vital role of Vice President Global Business Development and Channel Management. Sepulveda is directing and overseeing all aspects of global commercial sales, business development, strategic alliances and distributor management. Rounding out 2017, Sekisui Diagnostics became a strategic partner and exclusive distributor for Mesa Biotech products in the US and Canada, ensuring immediate access to established distribution in North America due to their market strength and excellent reputation among distributors and healthcare providers. The first quarter of 2018 was pivotal for Mesa Biotech. The company obtained CE Mark in the EU for its Accula System. The first available test in the EU market was the company's Flu A/Flu B Test. Several weeks later, Mesa received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for their Accula Flu A/Flu B test. The CLIA waiver is significant as it allows for use and commercialization in the wider segment of alternate care including the physician office lab (POL) market. Mesa Biotech raised $20 million in a Series B financing round in early July, following a $3 million Series A financing from earlier in the year. These two rounds bring the company's total year funding to $23 million, leaving Mesa debt free. 2018 Priorities With a solid foundation, Mesa Biotech is well-positioned for continued progress in the second half of 2018. The company intends to invest recent funding in new assay development, increased production capacity, commercialization activities, facilities expansion and key hires. "Unlike other available molecular POC products in the market, our Accula System has a low-cost entry point and operating cost, requires no calibration or refrigeration of components and minimal maintenance. These are significant benefits for a point of care clinician," said Cai. "Our POC product solution offers the simplicity, convenience and procedural familiarity of traditional rapid immunoassays; while delivering the excellent sensitivity, specificity and information of laboratory-based PCR testing." Near term, the company is planning to further develop its respiratory infectious disease product portfolio as well as expand into sexually transmitted diseases and women's health. Mesa has completed the RSV (respiratory syncytial virus) assay clinical trial and expects to obtain CE Mark later this summer and launch in time for the EU's RSV 2018-2019 season. In the US, a dual submission for 510(k) clearance and CLIA-waiver for the Accula RSV test has been submitted to the FDA. ]]> https://biospectrumindia.com/news/57/11370/xleratehealth-accelerator-selects-ten-companies-for-incoming-sixth-cohort.html https://biospectrumindia.com/news/57/11370/xleratehealth-accelerator-selects-ten-companies-for-incoming-sixth-cohort.html Thu, 26 Jul 2018 14:10:00 +0530 XLerateHealth, an enterprise-focused healthcare accelerator that helps early-stage healthcare companies has announced it has selected ten companies to participate in this year’s cohort of companies: Airis Health develops artificially intelligent physician workflow solutions for hospitals to yield lower overall costs and higher reimbursements. Like Siri or Alexa for physicians, Airis acts as a virtual assistant, aiding physicians in often-frustrating tasks such as locating and communicating with staff. Astarte Medical Partners has created an AI-driven analytics platform for the neonatal intensive care unit (NICU) including NICUtrition Guidance, a compliance tool to help hospitals standardize the practice of infant feeding in the NICU, and NICUtrition MAGI which uses predictive analytics to help identify infants at risk for gut inflammation. CloverLeaf Learning provides unique video-based learning content for healthcare students, workers, and healthcare facilities. The company’s flagship product, RadTechBootCamp, is becoming an industry standard for Radiology-based educational content. Concussion Triage Network has developed a real-time assessment and referral network for athletic team coaches when a player has a suspected head injury on the playing field. This tool includes protocols for assessing the player’s risk at the point and time of injury and provides a real-time connection to a national network of concussion specialists and neurologists for assessment and referral to the appropriate level of treatment. Desicorp is a biotechnology company focused on developing a new method to extend the shelf-life of blood by drying it to powder for applications in disaster relief situations, battlefield settings, and in remote rural emergency rescue situations where blood for transfusions is in limited supply and/or is difficult to store due to limited availability of refrigeration. EnMed MicroAnalyticshas developed a proprietary method for detecting very low concentrations of lead and other heavy metals collected from a single finger-or-heel stick. According to the CDC, almost all U.S. children are at risk for lead poisoning. This technology will enable routine (and ideally universal) screening of every pregnant woman and newborn, and selected pediatric patients for exposure to lead and other heavy metals. MendUX provides nursing homes and assisted living facilities with a proactive solution to help solve problems related to cognitively-impaired patients (e.g. Alzheimer's) wandering away from the caregiving facility and potentially becoming lost or injured. By discretely placing biosensors to learn the patient’s normal patterns of behavior, predictive analytics can alert caregivers to signs of wandering and can then locate and redirect the person. nQ Medical is a digital diagnostic for neurological disorders which captures functional decline and allows for precise monitoring of small changes in neurodegeneration. Using AI, nQ evaluates passive data captured 24/7 to detect pathological signs of disease earlier than current tools, track disease progression, and measure the impact of therapy. Used in Pharma clinical trials, it has been clinically validated as a diagnostic tool for Parkinson's and is engaged in Alzheimer's trials with the Cleveland Clinic. Telasightis a telehealth company providing real-time practitioner to practitioner consults via phone, video-conference, text, and email. When a patient presents with an unfamiliar or uncommon condition, a practitioner can now get a real-time consultation from an up-to-date expert in their field to receive the current standard of care and determine the best treatment and management plan. VB Healthis a Primary Care-Centered, Clinically Integrated Organization (“CIO”) specializing in the delivery of comprehensive disease management and physician services to Medicare Advantage Plans (“MA”), Medicaid Care Organizations (“MCO”), and other risk-bearing entities including Accountable Care Organizations (“ACO”) for the clinical management of their high-risk membership. XLerateHealth has received sponsorship support from the Kentucky Cabinet for Economic Development – Office of Commercialization & Innovation, Louisville Metro Government, The U.S. Small Business Administration (SBA), the VOGT Invention & Innovation Fund, and ID&A Office and Interior Design. Venture capital sponsors include Kentucky Enterprise Fund/KSTC (Lexington), OCA Ventures (Chicago), TriStar Ventures (Nashville), River Cities Capital (Cincinnati), and Chrysalis Ventures (Louisville). In-kind sponsors include Frost Brown Todd and Argi. ]]> https://biospectrumindia.com/news/57/11368/merck-gets-approval-in-21-eu-countries-for-euthyrox-formulation.html https://biospectrumindia.com/news/57/11368/merck-gets-approval-in-21-eu-countries-for-euthyrox-formulation.html Thu, 26 Jul 2018 13:00:00 +0530 Merck, a leading science and technology company announced that the German Federal Institute for Drugs and Medical Devices has recommended to approve Merck's new formulation of Euthyrox® (levothyroxine) in 21 EU countries. National approvals will be issued following this recommendation.   The German BfArM decision to recommend the approval of the new formulation of Euthyrox® across 21 EU states was based on a study demonstrating bioequivalence between the old and new formulations.   Levothyroxine is a synthetically produced hormone that corresponds to the natural thyroid hormone Thyroxin (T4). It is used to treat hypothyroidism, goiter and to suppress TSH in the post-treatment of differentiated thyroid cancer.   The new formulation came at the request of several health authorities worldwide. It was introduced in France in March 2017 and Switzerland in April 2018. Turkish authorities have approved the new formulation and Merck expects to launch the medicine there in the course of 2018.   For thyroid drugs a small dosage variation might impact the patient's thyroid balance. Prescribing doctors are therefore encouraged to monitor patients closely when prescribing the new formulation and to adjust the individual dosage if medically required.   Along with Health Authorities, Merck recommends that all patients do not switch or stop their treatment without medical advice and refer to their prescribing physician to potentially adjust the medication dose to their individual need during the transition phase.   ]]> https://biospectrumindia.com/news/57/11358/new-research-suggests-saliva-test-for-detecting-diabetes.html https://biospectrumindia.com/news/57/11358/new-research-suggests-saliva-test-for-detecting-diabetes.html Wed, 25 Jul 2018 10:55:00 +0530 A new study conducted by a team of researchers at the National and Kapodistrian University of Athens, Greece suggests that a simple saliva test can replace the blood sugar level test for diabetes assessment. The study finds that proteins in saliva reflect high blood sugar and associated disease processes in young patients with type 1 diabetes, long before the appearance of clinical symptoms. This could lead to better prediction and prevention of long-term complications of the disease. The researchers found that young type 1 diabetics with good blood sugar control had similar saliva protein profiles to non-diabetics. In contrast, young people with poorly controlled type 1 diabetes showed a very different saliva protein profile. Researchers envision that in the near future diagnosis and monitoring of therapeutic strategies in diabetes will be possible with only a drop of saliva, through ultra-sensitive and highly specific techniques such as the Multiple Reaction Monitoring as well as real-time, non-invasive, salivary glucose monitoring devices. ]]> https://biospectrumindia.com/news/57/11356/healthway-medical-rebrands-itself.html https://biospectrumindia.com/news/57/11356/healthway-medical-rebrands-itself.html Tue, 24 Jul 2018 16:40:00 +0530 Healthway Medical Corporation Limited has announced a refreshed look and tagline to complement the Company’s vision of creating a technology-enabled, hospitality-led network of clinics that will empower patients in Singapore. The new brand reflects HMC’s goal of empowering healthier lives through a renewed focus on a patient-centric approach, where patients are always at the centre of HMC’s care ecosystem. HMC has identified four key thrusts of its new brand identity – trusted care, hospitality excellence, accessibility, and technology. Dr Stephen Riady, Non-Executive Non-Independent Director of HMC, said, “The rebranding of the Company retains our established values while adopting a timely update reflecting our renewed commitment to, and focus on, our patients. Our rebranding is guided by our goal to deliver the highest quality of healthcare services to our patients, while ensuring our enhanced processes and methods support and nurture our staff and doctors. This is an exciting milestone for us, and we look forward to serving our communities better.” HMC’s strategy going forward is anchored on patient-empowerment through digital innovation. As part of its digital transformation, HMC will progressively develop and deliver a host of targeted digital healthcare solutions to patients. It will also continue to improve patient accessibility to care through its vast network of clinics. The healthcare company with 100 clinics islandwide across Singapore, will also focus on educating its patients on the importance of preventive healthcare, given the rapidly ageing population. A Trusted Brand Most recently, HMC was awarded the Gold Award in the Singapore edition of the Reader’s Digest Trusted Brands Asia Awards 2018, under the category of Family Clinics. The award signifies a strong vote of confidence from a sizeable pool of consumers, with the award criteria focusing heavily on the areas of healthcare expertise, brand reliability and trustworthiness, and a strong local connection. Strategic and Community Partnerships Over the past 12 months, HMC has announced a series of initiatives anchored on boosting its innovative capabilities and enhancing its community healthcare services. HMC inked strategic partnership agreements with South Korea’s SK Telecom, the Seoul National University Bundang Hospital, HealthConnect, and Hong Kong-based United Medical Practice, thereby bolstering HMC’s network of partners and depth of expertise across the region. In April 2018, HMC further strengthened its commitment to providing quality healthcare services to the community by forming an advisory board aimed at providing relevant insights on key market trends and other developments in the medical field. Mr Tan Chuan-Jin, Speaker of Parliament and Member of Parliament (MP) for Kembangan-Chai Chee, Marine Parade Group Representation Constituency (GRC), chairs the advisory board. Also on the board are Jalan Besar GRC MP Lily Neo and Professor Bernard Yeung, Dean and Stephen Riady Distinguished Professor of Finance, Strategy and Policy at the National University of Singapore Business School. ]]> https://biospectrumindia.com/news/57/11351/medical-cannabis-market-to-grow-13-6-in-2022.html https://biospectrumindia.com/news/57/11351/medical-cannabis-market-to-grow-13-6-in-2022.html Tue, 24 Jul 2018 13:20:00 +0530 Frost & Sullivan's recent analysis on medical cannabis finds that the total revenue of this market in the United States is expected to grow from $5.32 billion in 2017 to $10 billion in 2022, at a compound annual growth rate (CAGR) of 13.6%.   Even though the Food and Drug Administration (FDA) has approved only a few medical marijuana-derived products, there will be a strong growth trajectory over the next few years. Much of the current medical cannabis revenue is currently generated in states where the use of marijuana plant products for medical indications has been legalized.   Revenue projections suggest that the medical segment of the market may surpass the recreational revenue segment in the next four years, as patients in states where marijuana is legal look for alternatives to opioids to treat their chronic pain.   Cannabinoid targeted small-molecule drugs, such as Cesamet, Marinol and Sativex, have been approved for the treatment of numerous medical conditions. In some US states where medical marijuana has been legalized, prescription pain drug use has reduced, especially opioids. Medical cannabis-derived products have the potential to treat pain, which could significantly curb the out-of-control opioid epidemic gripping the nation.   Future growth opportunities in this market include:   Health Canada, the department of the government responsible for national public health, covers the use of medical cannabis for pain and diseases like epilepsy, and will be a reference for future US coverage; Billions of dollars are being invested in cannabis research across the globe to study the effects of cannabis on different medical conditions; and Big pharma companies have the capital and regulatory expertise to get CBD-based drugs approved. Restraints in this market include the risk of patient medical registry data where medical use is permitted and the lack of understanding from physicians about cannabis since they might not have completed medical cannabis coursework in medical school.   One of the major concerns of the United States Food and Drug Administration (FDA) is that the lack of standardized testing of cannabis plants (marijuana) is making it impossible to evaluate, with scientific rigor, the test results that are normally required for drugs that are approved for human use.  Nevertheless, healthcare companies are willing to invest.   US Medical Marijuana Market, Forecast to 2022 is part of Frost & Sullivan's Transformation Health – Life Sciences Growth Partnership Service program. ]]> https://biospectrumindia.com/news/57/11346/azafaros-announces-closing-of-seed-funding-round.html https://biospectrumindia.com/news/57/11346/azafaros-announces-closing-of-seed-funding-round.html Mon, 23 Jul 2018 13:20:00 +0530 Azafaros, a spin-off from Leiden University and Amsterdam UMC, focusing on the development of new therapies in the field of rare metabolic disorders, has announced the closing of a seed financing round. BioGeneration Ventures (BGV) is the founding investor. Rare metabolic disorders such as lysosomal storage disorders (LSDs) represent a broad class of severe and sometimes life-threatening inherited diseases, presenting significant unmet medical needs, with only few approved therapies. With its proprietary small molecule compounds, Azafaros will concentrate on new treatments for patients suffering from LSDs and LSD-related diseases. These compounds interfere with the metabolism of glycolipids that is disturbed in these patients and are intended to counteract the underlying pathological effects. Azafaros holds an exclusive license from Leiden University and Amsterdam UMC (location AMC) to a library of novel compounds and patents that were discovered by Professor Hans Aerts and his co-workers at Amsterdam UMC and Leiden University. Through a broad research collaboration Azafaros will benefit from the vast experience of the group led by Professor Hans Aerts to progress the technology. Olivier Morand, Ph.D. and IMD alumnus, is joining Azafaros as Chief Executive Officer (CEO) and member of the Board of Directors. Olivier Morand, a senior leader in pharma strategic development for early- and late-phase products, brings many years of hand-on experience and know-how in rare metabolic disorders and orphan drugs. He has a very strong industry track record most recently at Idorsia Pharmaceuticals, and before that at Actelion Pharmaceuticals and Hoffmann-La Roche. In his early career, he held various roles in academic institutions such as INSERM Paris, the University of Wisconsin Madison, the Hadassah Medical School Jerusalem and the Mount Sinai Medical School New York. With this, Olivier Morand brings a broad scientific, clinical and regulatory experience as well as business insights to the Azafaros team. Olivier Morand, CEO, says: “I feel very privileged to lead Azafaros. I anticipate that with our focused efforts the company will be able to develop high performing drugs out of the Leiden University and Amsterdam UMC compound library, supported by a solid patent position, and based on strong scientific rationale and sound clinical approaches.” Edward van Wezel, managing partner at BGV and member of the Board of Directors, comments: “We are very excited to be able to support the development of new treatment modalities for LSDs with a founding team that has strong scientific and business experience in a field with clear unmet medical needs. We strongly believe that these new compounds have the potential to offer better clinical outcome for patients in the future.” ]]> https://biospectrumindia.com/news/57/11344/life-sciences-at-the-heart-of-uk-economy.html https://biospectrumindia.com/news/57/11344/life-sciences-at-the-heart-of-uk-economy.html Mon, 23 Jul 2018 12:10:00 +0530 The UK Government, last week, hosted the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary were amongst those that met with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable focused on: how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy ensuring that the UK is ‘open for business’ with a positive business environment our ambitions
for a comprehensive agreement with the EU on our future relationship the development and implementation of our independent trade policy To date, the government has engaged significantly with the sector, including the launch of the Life Sciences Industrial Strategy and Sector Deal, the Prime Minister and Cabinet Ministers’ Davos meeting with global Life Sciences executives and the inaugural meeting of the Life Sciences Council at 10 Downing Street in May. The UK remains the number one destination for life sciences inward investment in Europe, ranks number two globally behind the US, and has also grown a thriving domestic industry with more than 5,600 companies and some of the strongest R&D capability in Europe. Health and Social Care Secretary Matt Hancock said: “From the discovery of DNA to the 100,000 genomes project, the UK has always been at the forefront of ground-breaking research and development with the potential to transform the lives of millions of people. The life sciences sector is incredibly important to the UK, not only for the hundreds of thousands of people employed and its £70bn turnover, but also so NHS patients continue to have access to pioneering new treatments as part of our long term plan for the NHS.” Business Secretary Greg Clark said: “Partnerships between government and industry are essential in helping us work towards our common goal of ensuring the UK continues to be a global leader in life sciences. That is why government has placed health and life sciences at the centre of our modern Industrial Strategy. Through the Life Sciences Sector Deal and our Grand Challenge missions in AI and Ageing Society, we have committed to working together with industry and overseas investors, to ensure that the UK remains the go-to destination for launching new businesses, new discoveries and new techniques to a wider market.” The UK has one of the strongest and most productive Life Sciences sectors in the world, attracting the most inward investment in Europe which supports 2,40,000 UK jobs and generates a turnover of around £70 billion per year.  Alongside this, the attractiveness of the UK markets is demonstrated by the fact that all of the top 25 global pharmaceutical companies, and the top 30 global medical technology companies, operate in the UK, utilising a world-renowned bank of R&D knowledge. A recent example of the ground-breaking work being done in the UK by the sector is the 1,00,000 Genomes Project which has revolutionised the way genetics data is held and used. The project has led to the UK becoming the only nation in the world to have a large scale whole genome dataset which will lead to new genomic discovery, advancements in precision medicine and healthcare globally. ]]> https://biospectrumindia.com/news/57/11336/-laurel-vc-alpine-complete-sale-divestiture-of-gsnor-assets.html https://biospectrumindia.com/news/57/11336/-laurel-vc-alpine-complete-sale-divestiture-of-gsnor-assets.html Fri, 20 Jul 2018 12:55:00 +0530 Laurel Venture Capital, a life science focused venture capital fund based in Hangzhou, Zhejiang Province, China, and Alpine Immune Sciences, Inc., a company focused on discovering and developing innovative, protein-based immunotherapies to treat cancer, autoimmune/inflammatory, and other diseases, announced the completion of the sale and transfer of global rights to the S-Nitrosoglutathione Reductase (GSNOR) assets from Alpine to Laurel Venture Capital. The assets include broad intellectual property around small molecule GSNOR inhibitors, including the most clinically advanced orally active GSNOR inhibitor, cavosonstat, a product candidate for severe asthma and chronic obstructive pulmonary disease (COPD) demonstrating compelling safety and efficacy in preclinical and clinical studies. As a result of the transaction, Alpine will receive an upfront payment and is eligible for potential approval milestone and royalty payments. Alpine acquired the GSNOR assets as part of its merger with Nivalis Therapeutics, Inc. in 2017. GSNOR serves a pivotal role in controlling nitric oxide availability within tissues and plays an important regulatory role in smooth muscle tone, immune function, inflammation and neuronal development. Disregulation of GSNOR has been implicated in disease and studies have shown pharmacologic GSNOR inhibition attenuates lung and systemic inflammation, decreases airspace enlargement in models of COPD and improves bronchoconstriction in asthma. Following completion of the acquisition, Laurel Venture Capital will incorporate a new entity in China to maintain the acquired assets. The management team of this newly formed entity will work toward expansion of a Phase II clinical study of cavosonstat to a global multi-centre clinical program and explore prospective new indications. This phase II clinical study of cavosonstat will be sponsored by the National Institutes of Health (NIH) for severe asthma in the United States. ]]> https://biospectrumindia.com/news/57/11335/kite-gadeta-unites-for-novel-solid-tumor-therapies.html https://biospectrumindia.com/news/57/11335/kite-gadeta-unites-for-novel-solid-tumor-therapies.html Fri, 20 Jul 2018 12:35:00 +0530 Kite, a Gilead Company and Gadeta B.V., a privately-held company focused on the discovery and development of novel cancer immunotherapies based on gamma delta T cell receptors (TCRs), have entered into a strategic collaboration to develop novel gamma delta TCR therapies in various cancers. Under the financial terms, Kite will provide research and development (R&D) funding for the collaboration and Gadeta will be eligible to receive future payments upon achievement of certain regulatory milestones.  In addition, Kite will make an upfront purchase of equity in Gadeta from Gadeta’s shareholders and may acquire additional equity in Gadeta upon achievement of certain R&D milestones. Kite will have the exclusive option to acquire Gadeta. Gadeta has developed a proprietary technology to engineer alpha beta T cells with gamma delta TCRs, called TEGs, for the potential treatment of various hematological cancers and solid tumors. This platform has the potential to combine the advantages of conventional T cells, which express alpha and beta TCR chains, with TCRs derived from gamma delta T cells that recognize novel targets in cancer cells, according to preclinical models evaluating the lead TEG candidates. Unlike alpha beta T cells, gamma delta TCRs do not require expression of cell surface proteins (major histocompatibility complex (MHC) molecules) for target recognition, and their ability to recognize novel targets under stress or metabolic conditions offer an attractive approach to develop potentially effective cell therapies in solid tumors. ]]> https://biospectrumindia.com/news/57/11331/who-identifies-new-antifungal-class-by-granting-ibrexafungerp-to-scynexis.html https://biospectrumindia.com/news/57/11331/who-identifies-new-antifungal-class-by-granting-ibrexafungerp-to-scynexis.html Thu, 19 Jul 2018 15:45:00 +0530 SCYNEXIS a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, announced that the World Health Organization's (WHO) International Non-proprietary Name (INN) group has assigned the generic name "ibrexafungerp" for its lead candidate SCY-078, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family. SCYNEXIS is developing ibrexafungerp for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. "For nearly two decades, only three drug classes have encompassed all FDA-approved antifungal treatments. Ibrexafungerp has the potential to represent the first new antifungal class approved since 2001, providing unique benefits of critical importance given the rapidly rising rates of antifungal resistance to many standards of care therapies," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. The INN system was established to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients in a unique, globally-recognized manner. Obtaining a non-proprietary, or generic, name is a required step in bringing a new drug to market. Generic names of pharmacologically-related substances demonstrate their relationship by using a common "stem," allowing medical practitioners and pharmacists to recognize substances having similar pharmacological activity. This is important for the clear identification, safe prescription and dispensing of medicines to patients. The generic name ibrexafungerp includes a new stem, "-fungerp," which indicates that SCY-078 is unlike any previously-approved drug, and reflects its first-in-class nature.   ]]> https://biospectrumindia.com/news/57/11328/researchers-design-the-worlds-first-3d-color-x-rays.html https://biospectrumindia.com/news/57/11328/researchers-design-the-worlds-first-3d-color-x-rays.html Thu, 19 Jul 2018 15:15:00 +0530 Scientists in New Zealand have designed an x-ray scanner capable of capturing human bodies in full color and three dimensions, which could give doctors a clearer picture for diagnosing cancer and other diseases, minimizing the need for invasive surgeries. The new scanner has its origins in a tool that contributed to research into the universe’s fundamental particles and functions much like a camera. It counts subatomic particles as they meet pixels when its electronic shutter is open. That allows it to generate high-resolution images of soft tissues, including minute disease markers. “We can make out details of various tissues, like bones, fats, water and cartilage, all functioning together inside the human system,” said Anthony Butler, a radiologist at Otago University in New Zealand, who developed the scanner with his father, Phil Butler, a physicist. Whereas traditional scanners send x-rays through the body and show only two colors, white where bone tissue has absorbed the beams, and black where soft tissues have not, the new machine is sensitive enough to detect specific types of tissue (such as bone, cartilage, fat, and water) by analyzing individual light particles. The new scanner matches individual X-ray photon wavelengths to specific materials, such as calcium. It then assigns a corresponding color to the scanned objects. The tool then translates the data into a three-dimensional image. The tissue data are then used to construct a full color reconstruction of the body. The scanning technology was adapted from a tool that physicists used at CERN, the European particle physics laboratory near Geneva, Switzerland, to detect particles moving through the Large Hadron Collider. ]]> https://biospectrumindia.com/news/57/11326/puma-biotechnology-enters-into-a-collaborative-agreement-with-strata-oncology.html https://biospectrumindia.com/news/57/11326/puma-biotechnology-enters-into-a-collaborative-agreement-with-strata-oncology.html Thu, 19 Jul 2018 11:05:00 +0530 Puma Biotechnology, Inc., a biopharmaceutical company, and Strata Oncology, Inc., a precision oncology company, have entered into a collaborative agreement to accelerate patient enrollment in Puma’s ongoing Phase II SUMMIT trial of PB272 (neratinib). The SUMMIT trial is a global, multi-histology, open-label, precision-medicine ‘basket’ study evaluating the safety and efficacy of neratinib in patients with a wide variety of solid tumors with activating EGFR, HER2 or HER4 mutations. Neratinib, an oral irreversible pan-HER kinase inhibitor, was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX®. Data published in the journal Nature earlier this year showed neratinib has activity across multiple tumor types with HER2-activating mutations. Under the terms of the agreement, Strata will exclusively refer HER2-mutated advanced cancer patients identified through the Strata Trial for consideration of enrollment to Puma’s SUMMIT Trial for neratinib. The Strata Trial is a screening protocol providing comprehensive tumor molecular profiling to advanced cancer patients at no cost and proactive enrollment support for a portfolio of pharma-sponsored precision therapy trials. Tumor profiling through the Strata Trial is provided as part of routine care to solid tumor patients across the Strata Precision Oncology Network, a network of 11 leading health systems representing more than 85,000 new cancer patients annually. This large network of trial-ready health systems with fully pre-screened advanced cancer populations enables rapid and predictable enrollment of precision therapy trials. “We are pleased to partner with Puma Biotechnology to accelerate the path to new approvals for neratinib,” said Dan Rhodes, Ph.D., CEO of Strata Oncology. “We frequently identify HER2-mutant patients across the Strata Precision Oncology Network and we believe this partnership will greatly facilitate patient access to this promising clinical trial.” “Puma’s ultimate goal is to deliver new treatment options and improve the lives of patients with various types of cancer,” said Alshad S. Lalani, V.P., Translational Medicine of Puma Biotechnology. “We believe Puma’s partnership with Strata will help us reach patients with multiple tumor types who may not otherwise know about the SUMMIT study, giving them a chance to participate in research that’s designed to provide important new information for future treatment.” ]]> https://biospectrumindia.com/news/57/11320/orion-biotech-awarded-a-2m-grant.html https://biospectrumindia.com/news/57/11320/orion-biotech-awarded-a-2m-grant.html Wed, 18 Jul 2018 11:15:00 +0530 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, today announced that its European subsidiary, Orion Biotechnology Polska Sp. z o.o., was awarded a grant of $2M US dollars by the National Center for Research and Development. The grant will fund a project to advance development of the company’s innovative microbicide candidate (OB-002H). Designed to prevent the transmission of HIV, OB-002H has the potential to address an urgent and growing need for an HIV prevention product that is affordable, appealing to use, and easily integrates into the lifestyles of people at risk for HIV infection regardless of age, sex or gender. The project is co-financed by the National Center for Research and Development under the InnoNeuroPharm program - Measure 1.2: Sectoral R & D programs of the Intelligent Development Operational Program 2014-2020. Orion Biotechnology will use the grant to complete IND enabling studies, advance OB-002H to the clinic and complete a Phase 1 clinical trial. “This additional investment will help accelerate our efforts to bring our novel microbicide to market,” said Dr. Ian McGowan, Chief Scientific Officer for Orion Biotechnology. “Armed with sufficient capital and a robust preclinical data package, Orion is now positioned to advance OB-002H into the clinic.” Mark Groper, President and CEO of Orion Biotechnology, added: “We are honoured to have been successful in the comprehensive and highly competitive selection process conducted by the National Center for Research and Development. It is further endorsement of our world-class team of experts as well as the therapeutic and commercial promise of our innovative HIV microbicide product.”   ]]> https://biospectrumindia.com/news/57/11319/zavation-gets-510k-clearance-of-the-normandy-vbr-system.html https://biospectrumindia.com/news/57/11319/zavation-gets-510k-clearance-of-the-normandy-vbr-system.html Wed, 18 Jul 2018 11:00:00 +0530 Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products has received 510(k) clearance from the FDA to market Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage).   The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy.    The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients.    The device can be adjusted to the required height after implantation.   The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer.   Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.   The Normandy VBR System is indicated for use in the cervical spine (C2-C7) and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.   The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion.   The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. ]]> https://biospectrumindia.com/news/57/11315/polares-medical-announces-closing-of-25m-financing.html https://biospectrumindia.com/news/57/11315/polares-medical-announces-closing-of-25m-financing.html Tue, 17 Jul 2018 16:55:00 +0530 Polares Medical SA, a preclinical stage medical technology company focused on the development of a unique trans-catheter mitral valve hemi-replacement system to treat patients suffering from mitral regurgitation (MR), has announced the closing of a $25 million financing led by Decheng Capital (Menlo Park and Shanghai) together with Endeavour Vision (Geneva), IDO Investments (Muscat), Earlybird Venture Capital (Berlin) and Wellington Partners (Munich). Polares Medical’s solution to MR is based on the original concept of hemi-replacement of the mitral valve, i.e. the replacement of the posterior leaflet with a prosthetic leaflet designed to enhance coaptation with the native anterior leaflet. “Hemi-replacement represents a new treatment paradigm for mitral regurgitation, between repair and total replacement. We believe this approach has the potential to provide an effective addition to the armamentarium for the percutaneous treatment of MR,” said Decheng Principal Nick Pliam, MD, Ph.D. Polares Medical was created as a spin-off of Symetis SA to develop the mitral technology that Symetis obtained through its acquisition of Middle Peak Medical GmbH, prior to Boston Scientific Corporation’s acquisition of Symetis in 2017. “This investment allows Polares to bring our technology to clinical evaluation, and to unleash its potential as a game-changer in MR treatment.” said Jacques Essinger, Ph.D, Chairman and CEO.   ]]> https://biospectrumindia.com/news/57/11311/new-als-therapy-in-clinical-trials.html https://biospectrumindia.com/news/57/11311/new-als-therapy-in-clinical-trials.html Tue, 17 Jul 2018 12:10:00 +0530 About 20,000 people in the United States are living with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The invariably fatal disease kills the nerve cells that control walking, eating and breathing. Few people survive more than three years after diagnosis. Now, new research led by Washington University School of Medicine in St. Louis indicates an investigational therapy for an inherited form of ALS extends survival and reverses signs of neuromuscular damage in mice and rats. The findings, published July 16 in The Journal of Clinical Investigation, have led to a phase one/two clinical trial to investigate whether the drug could benefit people with ALS whose disease is caused by mutations in a gene called SOD1. "This drug had an impressive effect in mice and rats with just one or two doses," said Timothy Miller, MD, PhD, the David Clayson Professor of Neurology at Washington University. "We don't know yet if this works in people, but we're very hopeful. We've completed the first phase of safety testing, and now we're working on finding the right dose." About 10 percent of ALS cases are inherited. Of those, about a fifth are caused by mutations in SOD1. Such mutations cause the SOD1 protein to be overly active, which suggests that reducing protein levels might help ALS patients with SOD1 mutations. Patients with ALS have few options for treatment. Only two drugs have been approved by the Food and Drug Administration (FDA) for ALS, and both only modestly slow the course of the disease. In collaboration with Ionis Pharmaceuticals, Miller and colleagues tested DNA-based compounds that block the body from making SOD1 protein. Miller and colleagues at Ionis tested two such compounds - known as antisense oligonucleotides, or oligos for short - in mice and rats. The animals were genetically modified to carry a mutated form of the human SOD1 gene. By a few months old, such animals start having trouble walking and feeding themselves. Mice were given an anti-SOD1 oligo or a placebo at day 50, and a second dose about six weeks later. The mice that received the active drug maintained their weight 26 days longer and lived 37 days longer than those given the placebo, an increase in life span of 22 percent. As a comparison, the researchers also tested the treatment in rats. The rats that received an active oligo fared much better than the ones that received the placebo. They maintained their weight more than nine weeks longer and survived eight to nine weeks longer. The oligos also reversed signs of neuromuscular damage in the animals. By nine weeks old, mice that carry the mutant SOD1 gene are already showing molecular signs of deteriorating neuromuscular function. To find out whether the drug could reverse this decline, researchers treated 9-week-old mice with an anti-SOD1 oligo or a placebo. Muscle function steadily improved over the next eight weeks in the mice that received the active drug, while it continued to decline in the placebo group. A sign of neurological damage rose in both groups, but it rose more than twice as quickly in the mice that received the placebo than the ones given the active oligo. Miller's colleague at the School of Medicine, Robert Bucelli, MD, PhD, an associate professor of neurology, leads a phase one/two clinical trial based on Miller's research. The trial is designed to evaluate the safety of using the oligos in people. Initial safety testing did not identify any obvious hazards. Now, they are testing different doses and regimens to find the most effective way to reduce SOD1 levels without causing unacceptable side effects. "The phase one/two trial is really still a safety trial," Miller said. "There are not enough patients in it to really be able to accurately see an effect on disease. But we're on the cusp of testing the hypothesis that people with ALS caused by mutations in SOD1 can benefit from this treatment. We predict the effect will be good, but we can't know until we test it." ]]> https://biospectrumindia.com/news/57/11310/invokana-effective-to-treat-ckd-and-type-2-diabetes-.html https://biospectrumindia.com/news/57/11310/invokana-effective-to-treat-ckd-and-type-2-diabetes-.html Tue, 17 Jul 2018 11:30:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson  announced that the Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) clinical trial, evaluating the efficacy and safety of INVOKANA® (canagliflozin) versus placebo when used in addition to standard of care for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), is being stopped early based on the achievement of pre-specified efficacy criteria. The decision is based on a recommendation from the study's Independent Data Monitoring Committee (IDMC) that met to review the data during a planned interim analysis. This recommendation was based on demonstration of efficacy, as the trial had achieved pre-specified criteria for the primary composite endpoint of end-stage kidney disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular (CV) death, when used in addition to standard of care. CREDENCE is the first dedicated renal outcomes trial in patients with CKD and T2D on the background of standard of care, including angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). This randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial evaluates the efficacy and safety of canagliflozin versus placebo in preventing clinically important renal and CV outcomes in patients with T2D and established kidney disease. The trial enrolled approximately 4,400 patients with T2D, estimated glomerular filtration rate ≥30 to <90 mL/min/1.73 m2, and albuminuria (urinary albumin: creatinine ratio >300 to ≤5,000 mg/g). All patients were required to be on the maximum labeled or tolerated dose of an ACE inhibitor or ARB for more than four weeks prior to randomization. At this time, INVOKANA® is contraindicated for patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end-stage renal disease (ESRD), or patients on dialysis. In addition, INVOKANA® is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2. ]]> https://biospectrumindia.com/news/57/11307/aetna-announces-partnership-with-mind-hk.html https://biospectrumindia.com/news/57/11307/aetna-announces-partnership-with-mind-hk.html Mon, 16 Jul 2018 17:50:00 +0530 Global health care benefits provider Aetna International has announced that it will work with non-profit organization, Mind HK, to promote awareness of mental health issues among Hong Kong residents. This relationship comes hot on the heels of Aetna’s launch of its new Hong Kong health insurance company, Aetna Insurance (Hong Kong) Limited, on July 16 2018. One of the first joint efforts of this relationship is a study of the current perceptions around people who suffer from mental illness in Hong Kong today, and the stigma that people facehere. The study will be undertaken in conjunction with the Hong Kong University, King’s College London, as well as London-based non-profit, Time to Change UK. “If you look at the figures, one in six people in Hong Kong at any one time have a diagnosable mental health problem. And the problem is likely a lot bigger than that, as it’s still very much taboo to discuss mental health and emotional issues here,” said Dr. Hannah Reidy, Chief Executive Officer of Mind HK. “I’m hopeful that when Hong Kong catches on that the solution to mental health is to start talking about it, everyone will start doing this, and make it easier for people to ask for help when they need it.” Aetna and Mind HK will also work to introduce to Hong Kong best practices from places that have spent more time trying to improve mental health care on a population basis - countrieslike the United Kingdom and Australia. Today, Aetna’s award-winning Summit health plans for employers offer a built-in Employee Assistance Program - at no additional cost – to help companies support the mental wellbeing of their employees. With the program, Aetna members get access to confidential counselling from behavioural health experts in 180 countries around the world; by phone call, email, web and even chat messaging via an app. “As we work to raise awareness for mental health issues, we’re also equally focused on developing solutions for people who need help,” says Kevin Jones, Chief Executive of AetnaInsurance (Hong Kong) Limited. “We’re looking into ways to drive early intervention – things like enhancing primary care offerings and using technology to make access to help more widely and easily available.” As a leader in international health insurance, Aetna International also regularly publishes content on its website to help the globally mobile manage the stresses of transitioning to a new country. The Aetna Explore Hub is publicly available and boasts resources such as country guides, moving checklists and guides on adapting to new cultures andenvironments. ]]> https://biospectrumindia.com/news/57/11306/healthcap-invests-in-modus-therapeutics.html https://biospectrumindia.com/news/57/11306/healthcap-invests-in-modus-therapeutics.html Mon, 16 Jul 2018 14:20:00 +0530 Karolinska Development announces that HealthCap with an investment of SEK 60 million becomes a new shareholder of Modus Therapeutics. At the same time, convertible notes held by current shareholders will also be converted into shares. The new investment together with the conversion, amount to a total of just above SEK 140 million in Series A preference shares. The transaction will increase the book value of Karolinska Development's holding in Modus Therapeutics.  As a consequence, a positive effect on earnings by approximately SEK 35 million will be reported in the income statement for the second quarter of 2018, to be published on the 16th of August. HealthCap is a European venture capital firm with a focus on investments in breakthrough therapies of diseases with highly unmet medical needs. Modus Therapeutics' most advanced drug candidate  sevuparin, a potential new treatment for sickle cell disease (SCD), is currently being evaluated in a Phase II clinical study. "HealthCap is one of Europe's leading and most reputable investors within life science. We view their investment in Modus Therapeutics as a clear acknowledgment of the quality and innovative depth of our portfolio company's pipeline project," says Karolinska Developments CEO, Viktor Drvota. SCD is caused by a mutation that causes red blood cells to sickle. The sickled red blood cells clump together, thereby restricting blood supply to organs, which can lead to episodes of severe pain and a need for immediate medical care. SCD may result in life-threatening conditions and life expectancies for men and women with the disease are just 42 and 48 years respectively. Aside from analgesics, there is currently no treatment available for the acute pain experienced with SCD. "HealthCap sees ample opportunities for Modus Therapeutics' orphan drug candidate sevuparin to be an important treatment for SCD. We look forward to the next important step in the company's development, which is the completion of the ongoing Phase II study that aims to deliver proof of concept," says HealthCap's Partner Mårten Steen.   ]]> https://biospectrumindia.com/news/57/11305/novartis-inks-a-deal-with-cdmo-to-make-car-t-cell-therapy.html https://biospectrumindia.com/news/57/11305/novartis-inks-a-deal-with-cdmo-to-make-car-t-cell-therapy.html Mon, 16 Jul 2018 13:50:00 +0530 In anticipation of Kymriah’s regulatory approval in Europe, Novartis has signed a deal with CELLforCURE. The bio production laboratories at French contract manufacturer CELLforCURE could soon be crafting Novartis' cancer cell therapies for clinical and potential commercial use, pending a technology transfer that's planned for 2019.  Manufacturing at CELLforCURE 's site in Les Ulis, a city southwest of Paris, would mimic the processes Novartis has in place at its Morris Plains, New Jersey hub, which currently produces Kymriah for sale in the U.S. Currently, manufacturing of the bespoke cell treatment is handled in Morris Plains and at the Leipzig, Germany-based Fraunhofer Institut, which is dedicated to supporting clinical trials.  Adding in CELLforCURE would give Novartis additional capacity and help it manage the supply challenges involved with shipping live patient cells from hospitals to production hubs and back again, a journey that can span hundreds or even thousands of miles depending on where a patient is treated. CELLforCURE will be responsible for producing CAR-T therapies which are considered the embodiment of personalized medicine. Unlike traditional treatments each dose is tailored individually to, and manufactured for, each patient using their own blood cells. In the near term, however, manufacturing support will be largely run from the Morris Plains site, as production won't be set up at CELLforCURE’s site until 2019 at the earliest. The pharma already has experience supplying Kymriah across international borders through its pivotal clinical studies ELIANA and JULIET, which involved sites in the U.S., Europe, Canada, Australia and Japan.    ]]> https://biospectrumindia.com/news/57/11303/univercells-raises-16-million-led-by-ghif.html https://biospectrumindia.com/news/57/11303/univercells-raises-16-million-led-by-ghif.html Mon, 16 Jul 2018 12:55:00 +0530 Univercells SA (‘Univercells’) and Global Health Investment Fund (‘GHIF’) are pleased to announce the closing of a €16 million ($18.8M) Series B equity financing. Investment proceeds will support the continued development of Univercells’ game-changing biomanufacturing technology, which has the potential to dramatically reduce the capital expenditure, physical footprint and operating costs required to produce a variety of complex biologics. The financing, which was heavily over-subscribed, is anchored by institutional commitments from prominent investment funds on three continents. In addition to GHIF (a public health-focused R&D fund based in New York), the Series B syndicate includes Seoul-based Korea Investment Partners, a leading technology investor in Asia and two Belgian technology investors: The Innovation Fund, supporting innovative chemistry and life sciences companies, and Inventures II, a leading impact venture capital fund. Rodolphe de Spoelberch, a Belgium-based independent private equity investor with a long-term horizon, is welcomed as an incoming Univercells board observer, while a variety of prominent private investors were federated by TheClubDeal, a private investment holding. The Series B financing was catalyzed by new validations of the breakthrough biologics manufacturing solutions being pioneered at Univercells. The company’s flagship Sabin inactivated polio vaccine (sIPV) program recently achieved a 40-fold increase in polio D-antigen productivity compared to the benchmark process and manufacturing cost estimates are within striking distance of the original goal of $0.15 per dose. With continued process development and high-efficiency fill-finish operations, the Univercells sIPV technology could enable a 10-fold reduction of the current public-sector sales price. On the heels of these milestones, Univercells is concluding technology transfer negotiations with a number of established biologics manufacturers and healthcare providers in China, India and Latin America. In parallel, Univercells will be demonstrating the versatility of its technology platform by developing turn-key manufacturing solutions for two additional public health vaccines. With the current financing in place, Univercells has the resources to commercialize a diversified portfolio of technology solutions for a variety of vaccines, monoclonal antibodies and enzyme replacement therapies, with the first products available for human use as soon as 2019.     ]]> https://biospectrumindia.com/news/57/11298/accenture-named-a-leader-in-life-sciences-rd-bpo-services.html https://biospectrumindia.com/news/57/11298/accenture-named-a-leader-in-life-sciences-rd-bpo-services.html Fri, 13 Jul 2018 12:55:00 +0530 Accenture has been named a Leader in an IDC Health Insights IDC MarketScape vendor assessment covering business process outsourcing (BPO) across the life sciences research and development (R&D) industry. This is the third consecutive time Accenture Life Sciences has achieved this prestigious ranking.  The report, “IDC MarketScape: Worldwide Life Science R&D BPO 2018 Vendor Assessment" examines the current life sciences R&D BPO landscape, including industry and market trends, comparing major vendors against the criteria most important for life sciences companies to consider when selecting a service provider. Alan Louie, Ph.D, research director for IDC Health Insights Life Sciences practice, notes in his report, “Accenture has extensive experience working with life science companies across all three sections of the industry: pharmaceutical, biotech, and medical devices. Building on an aggressive growth and acquisition strategy, Accenture has diversified significantly beyond its traditional big pharma focus and has grown its presence among emerging and mid-tier life science companies in recent years. Relative to other vendors discussed in this study, and based on feedback from multiple customer references, Accenture received high marks for transparent integration into client teams, working as a vested partner, and helping the client improve operational efficiencies across a widening portfolio of efforts.” Kevin Julian, senior managing director in Accenture’s Life Sciences practice, said, “This leadership positioning in the IDC MarketScape emphasizes our focus on providing best-in-class solutions to top global and emerging pharmaceutical, biotech and medical device companies. We’re pleased to be recognized for the third consecutive time by IDC as a high-quality BPO service provider, demonstrating the breadth of our understanding of this dynamic industry across company-specific, strategic and tactical levels.” In naming Accenture Life Sciences as a Leader, the IDC MarketScape looked at: Breadth of services offered, depth of related project experience, and number of customers Accenture serves; Geographical footprint and global delivery capabilities, level of priority and focus by Accenture on the life sciences R&D sector, and the pace of investment in related life sciences capabilities; Life sciences' industry-specific expertise, corporate financial stability, and ability to accommodate different types and sizes of life sciences clients; Customer references to examine vendor capabilities surrounding project management, IT technical skills, account management, and overall value delivery to clients. For the purposes of this analysis, IDC Health Insights divided potential key measures for success into two primary categories: capabilities and strategies. The assessment includes client references. ]]> https://biospectrumindia.com/news/57/11296/antabio-raises-12-5m-from-series-a-funding.html https://biospectrumindia.com/news/57/11296/antabio-raises-12-5m-from-series-a-funding.html Fri, 13 Jul 2018 11:25:00 +0530 Antabio SAS, a biopharmaceutical company developing novel antibacterial treatments in areas of highest unmet needs has extended its Series A financing round with an additional €5.2 million subscribed by investment funds Omnes, BNP Paribas Development, and Sham Innovation Santé (Turenne Capital). Existing shareholder Galia Gestion also participated in this extension. In October 2017, Antabio announced the first closing of its Series A financing round for €7.3 million subscribed by investment funds iXO Private Equity, IRDI SORIDEC Gestion, Galia Gestion and Antabio’s historical investor and former President of OM Pharma Christophe Ricard. The second closing brings the total raised in Series A to €12.5 million. The new funding will be used to accelerate the development of Antabio’s novel inhibitor of bacterial metallo ß-lactamases (“MBLs”) which will be combined with a carbapenem to fill an important gap in the treatment of drug-resistant infections. Superbugs carrying MBLs (such as NDM-1) are spreading worldwide and cause life-threatening drug-resistant infections that are deemed a critical medical priority by the WHO. There are currently no marketed inhibitors of MBLs. The €12.5 million series A financing complements the CARB-X grant of up to $8.9 million awarded to Antabio in July 2017 to support the company’s Pseudomonas Elastase Inhibitor program (PEI) for the treatment of chronic Pseudomonas infections in Cystic Fibrosis patients. ]]> https://biospectrumindia.com/news/57/11286/new-wearable-patch-to-detect-heart-ailments.html https://biospectrumindia.com/news/57/11286/new-wearable-patch-to-detect-heart-ailments.html Wed, 11 Jul 2018 15:40:00 +0530 Researchers have found a wearable patch that acts like a sensor can effectively improve the diagnosis rate for heart rhythm disorder without interfering with routine activities. The US Food and Drug Administration (FDA) approved wearable patch acts like a sensor and perform active electrocardiography (ECG) screening to detect irregular heart rhythm condition as well as recent heart attacks. The device resulted in more people receiving critical preventive therapies, which might have gone undiagnosed, said the researchers while emphasising the use of digital medicine technologies to identify undiagnosed Afib disorder in at-risk populations. Atrial fibrillation (Afib) disorder is characterised by increased or irregular heart rhythm that increases the risk of stroke, heart failure and other cardiovascular diseases. "Our study shows an almost threefold improvement in the rate of diagnosis of AFib in those actively monitored compared to usual care," said Steven Steinhubl, Director of digital medicine at Scripps Translational Science Institute (STSI) in California, US. The study was done on 5,214 individuals for one year, with one third of the group being assigned to the monitored cohort and the rest being observational controls. The participants self-applied the wearable sensor patch for two weeks and returned it for analysis. The team found that six per cent of the group developed Afib and nearly three per cent among the controls developed the disease. "This study demonstrates the utility of a digital approach not only to diagnosing asymptomatic AFib, but to the clinical research field as a whole," Steinhubl explained. ]]> https://biospectrumindia.com/news/57/11281/duke-university-collaborates-with-microsoft-for-research.html https://biospectrumindia.com/news/57/11281/duke-university-collaborates-with-microsoft-for-research.html Wed, 11 Jul 2018 11:05:00 +0530 Duke University has announced a new collaboration with Microsoft in several areas including research and cognitive services using Microsoft Azure -a cloud computing platform. To support the effort, Microsoft is committed to building a dedicated "Innovation Hub" in the Chesterfield building in downtown Durham, where it will be near researchers from Duke's schools of medicine and engineering and the Duke Clinical Research Institute, the university said in a statement on Monday. Duke already uses Microsoft cloud technology, but the new collaboration will accelerate the use of Azure to advance healthcare research, educational programs, and university operations. "We can leverage all of the work they have done and we can build on it. For example, Microsoft's efforts to improve radiology with data science can be built upon and advanced by Duke radiologists and data scientists," said Lawrence Carin from Duke University. Azure has in place the data protections needed to maintain health records privacy, Carin said. Azure cognitive services would include speech-to-text, natural language processing, and machine vision. Cloud computing offers several advantages for the researchers and staff. It has essentially limitless data storage and processing power, along with the flexibility to apply the right computing resources to any given problem. "With Microsoft's support, we will also enable graduate students in research labs to access the rich set of Microsoft Azure services. The computational power that this will bring to our research endeavor is immense," Carin added.   ]]> https://biospectrumindia.com/news/57/11277/probiogen-pionyr-starts-another-immuno-oncology-project.html https://biospectrumindia.com/news/57/11277/probiogen-pionyr-starts-another-immuno-oncology-project.html Tue, 10 Jul 2018 15:20:00 +0530 ProBioGen AG, a premier service and technology provider for complex therapeutic glycoproteins, and Pionyr Immunotherapeutics, an immuno-oncology company which develops next generation antibody-based therapeutics that target the tumor microenvironment, announced a second service and license agreement to develop novel antibody therapeutics. Under the terms of the agreement, ProBioGen will perform process development and GMP manufacturing on a second antibody from the Pionyr pipeline using their high performance CHO.RiGHT® expression platform. Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline, enabling a rapid advance to clinical trials. “We developed a strong collaboration with Pionyr Immunotherapeutics on their initial antibody candidate, and we are enthusiastic about advancing a second antibody candidate into development. We consider Pionyr’s Myeloid Tuning™ approach to be ideally suited to target solid tumors and look forward to contributing to multiple programs with our CHO.RiGHT® development and manufacturing platform. We have established a seamless team working across the two companies and are very pleased to expand our collaboration”, said Dr René Brecht, VP Process Science and Manufacturing.   ]]> https://biospectrumindia.com/news/57/11275/national-biotechnology-board-unveiled-in-zimbabwe.html https://biospectrumindia.com/news/57/11275/national-biotechnology-board-unveiled-in-zimbabwe.html Tue, 10 Jul 2018 15:05:00 +0530 Higher and Tertiary Education, Science and Technology Development Minister of Zimbabwe Professor Amon Murwira has unveiled the new National Biotechnology Authority Board in Harare. According to the news reported by The Herald, while assigning the new appointees their duties, Prof Murwira challenged the board to put national development at the top of their agenda. “There is need for you to be selfless in discharging your new duties. Whenever someone gets a chance to serve their country, they should do so with humility and pride. Ten names were submitted to President, but only seven got the nod. “Some of the people whose names were submitted to the President for approval did not make it, but yours were selected. This means that the country trusts your competence, we expect the NBA to answer national questions. Knowledge that cannot be translated to product is not helpful” said Prof Murwira. In line with constitutional requirement, 10 names were submitted to President Mnangagwa recently from which he appointed the seven academics and professionals from various sectors who will serve as board members of the NBA. The board members are Ms Rungano Karimanzira, Dr Jonathan Mufandaedza (the current NBA chief executive), Dr Fungayi Chatiza, Professor Mhosisi Masocha, Mr Zephania Dhlamini, Mr Elisha Moyo and University of Zimbabwe Professor Florence Mutambanengwe. Prof Mutambanengwe will chair the board during its three-year tenure, deputised by corporate lawyer Mr Moyo. Accepting their new role, Prof Mutambanengwe promised to deliver on expected results. “We are grateful to President Mnangagwa and the Minister for bestowing confidence and trust in us, for which we are honoured and humbled to accept,” Prof Mutambanengwe said. “I have to say that along with everyone here present, I was pleasantly surprised by your consideration to be on this board.” The NBA is an independent research institution established through the National Biotechnology Authority of Zimbabwe NBA Act of 2006 Section 14:31. Its role is to regulate and lead the development of biotechnology for the benefit of Zimbabweans, as well as the creation of knowledge.   ]]> https://biospectrumindia.com/news/57/11256/transmedtech-medteq-collaborate-for-research-innovation.html https://biospectrumindia.com/news/57/11256/transmedtech-medteq-collaborate-for-research-innovation.html Fri, 06 Jul 2018 11:35:00 +0530 The TransMedTech Institute is collaborating with MEDTEQ with the aim of bringing new medical technologies into the Canadian health system by simplifying and accelerating the steps taken by their researchers and the project selection process. The two organisations are joining forces so they can co-manage collaborative research and innovation projects eligible for funding from both organisations. This co-management will be made possible by the sharing of expertise, infrastructure and human resources. MEDTEQ’s scientific committee will evaluate joint projects as well as projects eligible for TransMedTech funding only. The agreement also confirms the implementation of a project co-financing system as TransMedTech and MEDTEQ have developed complementary skills in this field. Their alliance will enable collaborative research and innovation projects eligible for funding from both organisations to be funded first by TransMedTech, and then to access MEDTEQ funding once they have reached a certain level of technological maturity. ]]> https://biospectrumindia.com/news/57/11244/unsw-students-pioneering-artificial-intelligence-boosts-ivf-success.html https://biospectrumindia.com/news/57/11244/unsw-students-pioneering-artificial-intelligence-boosts-ivf-success.html Wed, 04 Jul 2018 16:50:00 +0530 A problem first posed in a UNSW lecture has driven a current Medicine student to design a pioneering artificial intelligence system that is now helping women become pregnant via IVF. Aengus Tran, 24, is in the final year of his undergraduate studies but has already joined forces with his brother Dimitry – an AGSM @ UNSW Business School Executive MBA alumnus – to set up a company called Harrison-AI which is improving embryo selection in IVF clinics. The spark came from a visiting lecture by Dr Simon Cooke, the Scientific Director at IVF Australia, who explained how embryologists have traditionally manually assessed groups of embryos based on physical appearance at a limited number of critical development check points, before selecting which one they felt would be most likely to result in a pregnancy. Aengus Tran identified that artificial intelligence could be used to make those decisions faster and also better – based on machine learning from thousands of previous successful and unsuccessful embryos – and ultimately designed a system that is now known as Ivy. Ivy is a self-improving artificial intelligence that continuously learns from the embryos it analyses via a comprehensive three-dimensional assessment of the growth of the embryos through all stages of development in an incubator. It then relates this data to whether a fetal heart has developed or not. “Ivy has taught itself how to select out the embryo with the highest potential to create a fetal heart,” explains Tran, who is Chief Data Scientist at Harrison-AI. “It starts off with a completely blank canvas and it's not influenced by any previous human knowledge or bias. It has learned directly from thousands of embryos that have had a known fetal heart outcome and has slowly and steady improved itself to become better and better at selecting embryos.” Harrison-AI is now in partnership with Virtus Health, one of Australia’s leading providers of assisted reproductive services, which is poised to introduce Ivy technology in IVF Australia clinics nationwide and also across Europe later this year. About University of New South Wales (UNSW) UNSW, Australia’s global university ranked among the top 50 Universities in the world offers programs in engineering, business, law, architecture, art and design, medicine and science. Located in Sydney, a safe and student friendly city, UNSW is home to more than 52,000 students from nearly 130 countries. UNSW has been attracting a growing number of bright Indian students for undergraduate and post graduate studies. As one of the world's leading research and teaching universities UNSW's cutting edge research and innovation facilitated by 3000 faculty is known for acceptance and successful commercialisation. ]]> https://biospectrumindia.com/news/57/11243/electronic-skin-patches-to-reach-over-10bn-per-year-by-2023.html https://biospectrumindia.com/news/57/11243/electronic-skin-patches-to-reach-over-10bn-per-year-by-2023.html Wed, 04 Jul 2018 15:00:00 +0530 IDTechEx Research's latest market research report Electronic Skin Patches 2018-2028 covers the entire product ecosystem for smart skin patches. With coverage across 26 application areas, >85 companies, 95 different product case studies, historic market data and market forecasts to 2028, it is the most comprehensive study compiled for this emerging product area. It reveals significant opportunity, with a forecast for total annual revenues in electronic skin patches to reach over $10bn per year by 2023 and approaching $15bn per year by 2028. But the case for skin patches must be understood relative to the capabilities of other wearable devices. After all, why bother with a potentially messy, uncomfortable adhesive when a strap or clip onto clothing could be more practical? Firstly, skin patches offer much greater choice in terms of device positioning; as long as there is an area for the patch to be attached, they can be placed there. This is particularly relevant when the sensor requires position close to a certain part of the body (e.g. on the upper chest for sensing the heart, around the head for monitoring concussions, etc.). Secondly, a patch allows for a more consistent means for contact between the device and the body. This may be required for the use of an invasive component such as a microneedle, or in offering a more consistent electrical interface for stable sensor readings. These advantages are particularly relevant in the two largest application sectors for electronic skin patches today: cardiovascular monitoring and diabetes management. The report looks at both of these sections in detail, characterizing the features of the electronic skin patch products being used, the major players, competitive product options and market outlook. In cardiovascular monitoring, mobile cardiac telemetry (MCT) devices sit alongside Holter monitors and cardiac event monitors, each of which can be deployed as a skin patch. They allow for different levels of ambulatory monitoring, enabling at-risk patients to avoid the risks associated with remaining as an inpatient but providing a higher quality of data that can be achieved by other devices such as a smartwatch. In diabetes management, challenges in the markets around traditional self-monitoring of blood glucose via test strips are driving innovation. Leading players have developed continuous glucose monitoring devices (CGM) which can give a longer term picture of blood glucose levels, and are even achieving approval to work directly with insulin pumps, moving towards "closed-loop" systems. Both CGM devices and insulin pumps can be deployed using different types of skin patch, and are covered in detail in the report.   Electronic Skin Patches 2018-2028 covers both sections in detail, including details on product types, technology and a comparison of strategies from players in the space. The report includes a mixture of primary and secondary research, combining executive interviews, extensive conference visits and site visits with companies alongside supporting information from literature and other sources.   IDTechEx's experienced analyst team brings decades of experience and coverage of key parallel or supporting industry and technology sectors to assemble the most comprehensive report on the commercialization of electronic skin patches. ]]> https://biospectrumindia.com/news/57/11233/health-canada-gives-clearance-to-wat-medicals-innovative-devices-.html https://biospectrumindia.com/news/57/11233/health-canada-gives-clearance-to-wat-medicals-innovative-devices-.html Tue, 03 Jul 2018 11:45:00 +0530 Shortly after WAT Medical's leading product to treat nausea-induced vomiting, EmeTerm, received its FDA clearance earlier in April, it has now also received official clearance from Health Canada. Health Canada ensures all of its certified medical products are of the highest quality and are able to provide the best care for patients to improve their lives. WAT Medical has reached the long-awaited milestone and is thrilled to introduce its innovative technology to Canada. The product is effective for a wide range of treatments, including all types of motion sickness induced by travelling and morning sickness. EmeTerm allows its users to be free from medication side effects like dizziness, drowsiness and thickened lung secretions. EmeTerm's technology is called neuro modulation, which is Health Canada cleared and clinically proven. The electric current is sent by the peripheral nervous system via P6 acupuncture point on the underside of the wrist. The electric pulses are delivered to their targets in the brain and precisely block the emesis signals from brain to stomach. EmeTerm is currently used by consumers in over 20 counties worldwide, including all of Europe, the United States and Australia. EmeTerm is the winner of 2017 iF Design Award for its innovative design and usability. The patented electrodes design enhances the transfer of electric pulses from device to skin. No conduct gel is needed, which increases convenience and affordability to consumers. WAT Medical's anti-migraine device, HeadaTerm, also received Health Canada clearance, and is going to enter the Canadian market along with EmeTerm. HeadaTerm also uses neuromodulation by sending precise electric impulse to targeted area in the brain responsible for endorphin release. HeadaTerm reduces migraine pain within minutes after it occurs, and also works as an effective preventative measure by reducing the frequency and intensity of migraine episodes. Unlike any anti-migraine technology before it, HeadaTerm is a disposable device at an affordable price. Its small and lightweight design allows it to be extremely portable, offering consumers fast and convenient migraine treatment. ]]> https://biospectrumindia.com/news/57/11230/merck-launches-new-technologies-for-fertility-labs.html https://biospectrumindia.com/news/57/11230/merck-launches-new-technologies-for-fertility-labs.html Tue, 03 Jul 2018 11:00:00 +0530 Merck, a leading science and technology company, today announces the launch of QBOX IVF, and the new Geri Assess 2.0, in its continued drive to serve the needs of its customers and to become the preferred treatment partner for all IVF stakeholders and assisted reproductive treatment (ART) clinics. "Our priority is to understand our customers' specific needs and then make continuous improvements to our technologies based on new insights," says Rehan Verjee, Chief Marketing and Strategy Officer at Merck's Biopharma Business. "We incorporated key user feedback to develop QBOX IVF and GeriAssess 2.0 and are proud to launch these two state-of-the-art products for ART." Merck is committed to support healthcare professionals (HCPs) throughout every step in the fertility treatment. With lab processes getting increasingly complex, a clear need exists for increased efficiencies and automation of lab procedures while ensuring high quality and precision as well as reduction of the risk for human error. Setting a strong basis for connectivity in the ART clinic, Merck introduces QBOX IVF, a hub that enables two-way unidirectional automated information transfer between Merck's clinic devices Gidget and Geri Connect & Assess (including Geri Assess 2.0 and Eeva) and industry-leading Electronic Medical Record (EMR) providers, thus improving standardization and automation. QBOX IVF is an integrated information management hub, recently developed in collaboration with Planet Innovation, Australia. Offering a simple single integration for multiple systems and reducing manual entry for users, the software minimizes the potential for human error and allows ART events to be automatically synchronized, streamlining patient data transfer during treatments across systems. Major EMR providers partnering with Merck for the QBOX IVF 1.1 release include BabySentry, DMDC, eIVF and MediTEX. Merck already works to expand functionality and connectivity of the QBOX IVF hub. Integration of the first third party product, XiltriX, a network-based laboratory monitoring, data logging and alarm system by IKS International, is currently being evaluated. In addition, Merck and Genea Biomedx, Australia, through their joint development hub ARTinnovations, developed a new module that extends the embryo assessment offering within the Geri Connect & Assess platform. While Geri Assess 1.0 provided user defined scoring systems to assess and grade embryos, Geri Assess 2.0 provides automated cell event tracking using latest Artificial Intelligence (AI) technology and even allows for custom applied scoring algorithms for embryo assessment and grading. The new module helps clinics simplify embryo assessment, improve consistency across users and reduce the time spent in annotations by automatically detecting key events in embryo and blastocyst development. This new version of Geri Assess maintains the focus on the embryo from a functional perspective and brings higher levels of automation and customization. ]]> https://biospectrumindia.com/news/57/11209/elsevier-preprints-with-the-lancet-launches-on-ssrn.html https://biospectrumindia.com/news/57/11209/elsevier-preprints-with-the-lancet-launches-on-ssrn.html Fri, 29 Jun 2018 11:30:00 +0530 SSRN, Elsevier's world leading preprint server and early stage research platform has announced the launch of 'Preprints with The Lancet' - a new preprint series for sharing early stage health and medical research.   The collaboration brings together SSRN with The Lancet as part of a six-month pilot to assess whether the health and medical community are ready for this form of early research sharing.   Preprints are research papers that are at the submission stage or can be described as on-going research. By sharing online, authors widen the opportunity for receiving comments on their work by other researchers with the goal of an improved final peer-reviewed publication and for the exchange of research areas with the future potential for collaboration.   Preprints are primarily intended for research use; they have not been through the important steps of peer review and experienced editorial scrutiny and guidance that is part of the publishing process.   All papers on 'Preprints with The Lancet' will be free to upload and download.   Authors of all research papers submitted to any Lancet family journal, will be asked at submission whether they would like their paper to be posted - as a preprint, an opt-in that all co-authors must agree to. Authors can also submit their papers through SSRN directly.   Submitted papers will be subject to SSRN's usual checks to ensure that the paper is part of the scholarly discourse, in a subject area covered by one or more of SSRN's networks.   A Lancet editor will then check the paper and ensure the authors have provided a statement about the funding of the study; a summarized declaration of interests for all authors; a statement on ethics approval or why the research was exempted; and if the research is a randomized trial, confirmation that it has been prospectively registered along with the trial registration number.   Once a final version of a preprint paper is peer-reviewed and published and becomes part of the scientific evidence as the version of record, authors are encouraged to link to the preprint of the published paper.   Gregg Gordon, Managing Director of SSRN, added: "It's fantastic The Lancet has decided to embrace preprints and launch this new series. We have over 20 years' experience helping researchers from across the world, and from all scientific disciplines, collaborate and share their early stage research. With the new Sneak Peek series from Cell Press recently launched on SSRN, we have two of the world's leading journals from Elsevier working in partnership with us." ]]> https://biospectrumindia.com/news/57/11202/babylon-ai-achieves-equivalent-accuracy-with-human-doctors-.html https://biospectrumindia.com/news/57/11202/babylon-ai-achieves-equivalent-accuracy-with-human-doctors-.html Thu, 28 Jun 2018 11:45:00 +0530 Babylon Health has announced a world-first during a presentation streamed live from London's Royal College of Physicians: The company's AI, in a series of robust tests (including the relevant sections of the MRCGP exam), has demonstrated its ability to provide heath advice which is on-par with practicing clinicians.   The MRCGP exam is the final test for trainee General Practitioners (GPs), set by the Royal College of General Practitioners (RCGP).   Trainee GPs who pass this assessment have demonstrated their competence and clinical skills to a level which is sufficiently high enough for them to undertake independent practice.   A key part of this exam tests a doctor's ability to diagnose.   Babylon's technology provides health information, rather than a medical diagnosis, for regulatory reasons. The tests carried out relate to the diagnostic exams taken by doctors as a benchmark for accuracy, however, Babylon's AI service remains an information service, rather than a medical diagnosis.   Babylon took a representative sample-set of questions testing diagnostic skills from publicly available RCGP sources, as well as independently published examination preparation materials, and mapped these to the current RCGP curriculum in order to ensure the questions resembled actual MRCGP questions as closely as possible.   The average pass mark over the past five years for real-life doctors was 72%. In sitting the exam for the first time, Babylon's AI scored 81%.   As the AI is continues to learn and accumulate knowledge, Babylon expects that subsequent testing will produce significant improvements in terms of results.   Important though exams are, doctors are presented with a much wider range of illnesses and conditions in their daily practice.   Therefore, to further test the AI's capabilities, Babylon's team of scientists, clinicians and engineers next collaborated with the Royal College of Physicians, Dr Megan Mahoney (Chief of General Primary Care, Division of Primary Care and Population Health, Stanford University), and Dr Arnold DoRosario (Chief Population Health Officer, Yale New Haven Health) to test Babylon's AI alongside seven highly-experienced primary care doctors using 100 independently-devised symptom sets (or 'vignettes').    Babylon's AI scored 80% for accuracy, while the seven doctors achieved an accuracy range of 64-94%.   The accuracy of the AI was 98% when assessed against conditions seen most frequently in primary care medicine. In comparison, when Babylon's research team assessed experienced clinicians using the same measure, their accuracy ranged from 52-99%.   As the RCGP does not publish past papers, Babylon used example questions some published directly by the College, some which were sourced from publicly available resources (which all are referenced) - during its AI exam preparation and testing.   Average CSA pass mark by trainee GPs was calculated using publicly available RCGP test result data from the period 2012 - 2017.   Crucially, the safety of the AI was 97%. This compares favourably to the doctors, whose average was 93.1%. ]]> https://biospectrumindia.com/news/57/11201/lumicks-teams-up-with-az-uc-to-set-up-coe.html https://biospectrumindia.com/news/57/11201/lumicks-teams-up-with-az-uc-to-set-up-coe.html Thu, 28 Jun 2018 11:15:00 +0530 LUMICKS, a world leader in dynamic single-molecule analysis, has partnered with AstraZeneca and the University of Cambridge Biochemistry Department to form the 'centre of Excellence for Dynamic Single-Molecule Analysis for Accelerated Drug Discovery and Biology', the first of its kind worldwide. As part of the collaboration, a C-Trap optical tweezers-fluorescence microscope has been installed at the University of Cambridge and will be used by AstraZeneca, University of Cambridge research groups and LUMICKS, to provide new insights in biology and early-stage drug discovery research. LUMICKS' technology allows for analysis of complex dynamic details related to the behavior and interaction of single molecules, allowing the centre to investigate both the fundamental cause of diseases and potential for drug optimization. This collaboration aims to generate data that will validate the use of dynamic single-molecule technology for biomedical and pharmaceutical research and potential applications for accelerating drug discovery. ]]> https://biospectrumindia.com/news/57/11190/siemens-healthineers-launches-new-ultrasound-system.html https://biospectrumindia.com/news/57/11190/siemens-healthineers-launches-new-ultrasound-system.html Wed, 27 Jun 2018 11:20:00 +0530 German medical technology company Siemens Healthineers has introduced a new general imaging ultrasound system called the Acuson Sequoia to enable imaging of different sized patients with consistent clarity. The new device is equipped with a new high-powered architecture Deep Abdominal Transducer (DAX) and other upgrades to elastography and contrast-enhanced ultrasound. It can produce penetration of up to 40cm to offer high-resolution imaging adapting to patients’ personal characteristics to enable better diagnosis. The new Acuson Sequoia system is designed to adapt to the ‘BioAcoustic Variations’ of every patient with different tissue density, stiffness and absorption levels. It is capable of providing high-resolution InFocus imaging throughout the field of view in real-time, eliminating the need to adjust the focal point of the scan. ]]> https://biospectrumindia.com/news/57/11191/ge-plans-to-divest-healthcare-unit.html https://biospectrumindia.com/news/57/11191/ge-plans-to-divest-healthcare-unit.html Wed, 27 Jun 2018 11:20:00 +0530 General Electric Co said on Tuesday it will spin off its healthcare business and divest its stake in oil-services firm Baker Hughes, effectively breaking up the 126-year-old conglomerate which was once the most valuable U.S. corporation and a global symbol of American business power.   The slimmed-down company will focus on jet engines, power plants and renewable energy, which GE hopes will reward battered shareholders who have seen the stock lose more than half its value over the past 20 years.   GE said its plan will strengthen its balance sheet by reducing debt, building up cash and further shrinking GE Capital. Shareholders will receive 80 percent of the value of GE Healthcare as a tax-free distribution of shares.   GE shares jumped 8.7 percent to $13.86, on track for their best day in three years.   GE will likely either need to hold an initial public offering of Baker Hughes, organize numerous block trades of shares to institutional investors, or find an entirely new investor to acquire its holding since the only two strategic buyers of its stake, Schlumberger NV and Halliburton Co, would have major antitrust risks in the oilfield services market, analysts said.   GE said its plan to divest $20 billion in assets “is substantially complete,” leaving a “simpler and stronger” company that it hopes will boost growth, operating profits and shareholder returns.   Major shareholder Trian Fund Management supports GE’s plans and believes that the initiatives will create “substantial value for shareholders,” it said in a statement.   ]]> https://biospectrumindia.com/news/57/11184/inthera-bioscience-ag-expands-management-team.html https://biospectrumindia.com/news/57/11184/inthera-bioscience-ag-expands-management-team.html Tue, 26 Jun 2018 13:15:00 +0530 Inthera Bioscience AG, a pre-clinical stage oncology company targeting the inhibition of protein-protein interactions with innovative small molecule chemistry, today announced that three senior Pharma and Biotech Industry members joined its management team.   Bernd Hentsch joins the company as Chief Development Officer, Ralph Lindemann as Chief Scientific Officer and Monique Schiersing as Chief Operating Officer.   The company is also pleased to announce that it secured the second tranche of its Series A financing, bringing the total amount to €9.6 million.   Bernd Hentsch, Ph.D. has held various senior positions in the European Biotech industry. Prior to joining Inthera Bioscience he was Chief Development Officer at 4SC AG, a German clinical stage oncology company and TopoTarget A/S, a Danish clinical stage oncology company.   Prior to TopoTarget A/S, Bernd has held other R&D related positions, e.g. in Germany at Merck KGaA, Darmstadt, the German Cancer Research Center, Heidelberg, and at the Walter and Eliza Hall Institute in Melbourne, Australia.   Ralph Lindemann, Ph.D. joins Inthera Bioscience from Merck KGaA, Darmstadt, Translational Innovation Platform Oncology. He has 15 years of experience in translational research and drug discovery and an academic track record in chromatin-based therapeutics.   Monique Schiersing, M.Sc., MBA served previously as Investment Director at the Roche Venture Fund, F. Hoffmann–La Roche AG’s corporate venture fund. In this role Monique served as Director on the board of various Biotech companies in the US as well as in Europe, amongst others Macrolide Pharmaceuticals, Inc., Minoryx Therapeutics S.L., or mySugr GmbH. Prior to this role, Monique held positions as Principal at BankInvest in Copenhagen and Global Alliance Director at Roche Pharma Partnering in Basel. ]]> https://biospectrumindia.com/news/57/11183/a-new-mobile-app-offers-all-clinical-services-.html https://biospectrumindia.com/news/57/11183/a-new-mobile-app-offers-all-clinical-services-.html Tue, 26 Jun 2018 12:50:00 +0530 The new ClinicAll App helps to make patients and hospitals independent of stationary bedside terminals. Now, clinic services can be accessed directly from any mobile device.   One of the main advantages of the ClinicAll App is integration. Several software providers have already developed clinic-specific functions but it's not feasible for users to install yet another separate app on their device for each new function.   This is where the ClinicAll App comes into play because it integrates all these functions by use of appropriate interfaces into one single app.   If you are a patient in a hospital, open the ClinicAll App on your device and login and you're ready to use TV, Internet, or retrieve all hospital information: Treatment data, your next lunch meal. You can also control room lighting and your bed.   Doctors and staff inform you via push messages about upcoming activities, dates or rounds. Nurse call is also accessible. Any communication is as easy and simple as possible.   The ClinicAll App runs on iOS and Android devices. A central server provides full access control for all users. There is no need anymore for stationary computer terminals at every patient's bedside radically decreasing cost and effort for installation. ]]> https://biospectrumindia.com/news/57/11173/new-enzyme-may-prevent-virus-growth.html https://biospectrumindia.com/news/57/11173/new-enzyme-may-prevent-virus-growth.html Mon, 25 Jun 2018 11:55:00 +0530 Dr. Almo and his colleagues at Einstein and Pennsylvania State University have identified how a naturally occurring enzyme in humans and other mammals prevents viruses from multiplying, an advance that may pave the way for new antiviral drugs.   The enzyme viperin, known to have antiviral effects on a wide variety of viruses, including West Nile, hepatitis C, rabies, and HIV, facilitates a reaction that produces the molecule ddhctp, which prevents viruses from copying their genetic material and thus from multiplying.   The discovery could allow researchers to develop a drug that induces the human body to produce this molecule and could act as a broad-spectrum therapy for a range of viruses.   “We knew viperin had broad antiviral effects through some sort of enzymatic activity, but other antivirals use a different method to stop viruses,” said Craig Cameron, a professor at Pennsylvania State University in the US.   The current study reveals that viperin catalyzes the conversion of a nucleotide called CTP (cytidine triphosphate) into a structurally similar compound, or analog: the nucleotide ddhCTP--a previously undescribed molecule that sabotages viral replication.   Researches decoded the effects of ddhctp on a virus’ ability to replicate its genetic material.   “The molecule acts in a similar manner to drugs that were developed to treat viruses like HIV and hepatitis C. With a better understanding of how viperin prevents viruses from replicating, we hope to be able to design better antivirals,” said Cameron. ]]> https://biospectrumindia.com/news/57/11161/oxitec-bmgf-team-up-for-global-malaria-control.html https://biospectrumindia.com/news/57/11161/oxitec-bmgf-team-up-for-global-malaria-control.html Fri, 22 Jun 2018 11:55:00 +0530 Oxitec, Ltd., a wholly owned subsidiary of Intrexon Corporation, is entering into a cooperative agreement with the Bill & Melinda Gates Foundation (BMGF) to develop a new strain of Oxitec's self-limiting Friendly Mosquitoes to combat a mosquito species that spreads malaria in the Western Hemisphere. The parties will build on Oxitec's successful deployment of Friendly Aedes mosquitoes to reduce the vector that spreads dengue, Zika and other diseases and apply the self-limiting and male-selecting technology to anopheline vectors that can spread malaria in endemic regions in the Americas, eastern Africa and South Asia. This collaboration will fund the development of a new self-limiting Friendly Anopheles mosquito strain designed to suppress wild malaria vector populations. This first Friendly Anopheles strain will build on the strengths of Oxitec's self-limiting insect technology developed and tested over the last decade, and transfer the skills and know-how into an anopheles strain for use in vector control efforts to combat malaria. ]]> https://biospectrumindia.com/news/57/11152/health-organizations-collaborate-with-industry-to-combat-diabetes.html https://biospectrumindia.com/news/57/11152/health-organizations-collaborate-with-industry-to-combat-diabetes.html Thu, 21 Jun 2018 11:35:00 +0530 The American Heart Association (AHA) and the American Diabetes Association (ADA) has announced the start of a new multi-year collaborative initiative supported by founding sponsors Boehringer Ingelheim, Eli Lilly and Company, and Novo Nordisk. The initiative's goal is to help people with type 2 diabetes reduce their risk of disability and death due to cardiovascular events such as heart attack and stroke. Additional support for the initiative is provided by national sponsor Sanofi. The new initiative will enhance consumer awareness, patient education, healthcare provider training, and quality improvement measures for clinics, practices and hospitals treating people with type 2 diabetes. Together, the AHA and ADA bring strong credentials to this effort, with more than 30 million volunteers, members and healthcare professionals with a combined 170 years of expertise. The AHA is the world's leading voluntary organization working to build lives free of cardiovascular disease and stroke. The ADA is the nation's leading voluntary health organization working to prevent, cure and improve the lives of those affected by diabetes. ]]> https://biospectrumindia.com/news/57/11147/trinity-has-received-worlds-largest-autism-grant.html https://biospectrumindia.com/news/57/11147/trinity-has-received-worlds-largest-autism-grant.html Wed, 20 Jun 2018 15:15:00 +0530 The largest research grant ever given for neurodevelopmental conditions has been awarded by the Innovative Medicines Initiative to an international consortium academically led by the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London. Trinity College Dublin forms part of the research consortium which includes 48 universities and research institutions, industry partners and autism charities.    The €115 million grant, titled Autism Innovative Medicine Studies-2-Trials (AIMS-2-Trials), will increase our understanding of autism and help develop new therapies to improve health outcomes and quality of life for autistic people.    AIMS-2-Trials brings together autistic people and their families, academic institutions, charities and pharmaceutical companies to study autism and provide an infrastructure for developing and testing new therapies. In line with the autism community’s priorities, the consortium will also focus on why some autistic people develop additional health problems that severely impact both quality and length of life.   All autistic people are different which makes identifying and testing new therapies challenging. AIMS-2-Trials will take a precision medicine approach aimed at tailoring therapies to a person’s biological profiles. Achieving this will require developing tests that can predict how a person’s autism may progress throughout development and their likelihood of developing additional mental health problems.   AIMS-2-Trials will create the first European clinical trials network for autism, as well as allowing for international collaborations with charities, government agencies and industry to rapidly determine if therapies are effective. Partnership with autistic people, their families and carers will be a crucial part of developing therapies that achieve the outcomes which matter most to autistic people.   Researchers at Trinity College Dublin will contribute to the advancement of personalised approaches to therapies for Autism Spectrum Disorder. This project builds on our ongoing research investigating rare genetic changes that are associated with autism symptoms. In AIMS-2- Trials, Trinity researchers will focus on investigating individuals who carry deletions in genes specifically related to the structure and function of brain synapses (or brain cells).   They aim to find biomarkers that can help identify specific biological pathways involved in brain development.  The researchers will be engaging in a pan-European clinical trials network to investigate new therapies specifically targeting disabling symptoms and improving quality of life while also retaining unique autistic strengths.   Through the Innovative Medicines Initiative, European Union funding matches in-kind contributions from autism charities and the pharmaceutical industry, with nearly €60 million provided by charities, and €2.5 million from the European Federation of Pharmaceutical Industries and Associations (EFPIA).   ]]> https://biospectrumindia.com/news/57/11142/kallyope-novo-nordisk-tie-up-to-treat-diabetes-obesity.html https://biospectrumindia.com/news/57/11142/kallyope-novo-nordisk-tie-up-to-treat-diabetes-obesity.html Tue, 19 Jun 2018 16:00:00 +0530 Kallyope Inc. and Novo Nordisk A/S have entered into a research collaboration and option agreement to discover novel peptide therapeutics to treat obesity and diabetes. Kallyope will receive an upfront payment and research support for activities conducted in the collaboration. Under the terms of the agreement, Novo Nordisk has an option to license exclusive worldwide rights to develop and commercialize up to six products discovered in the collaboration.   Kallyope will receive a license fee if Novo Nordisk chooses to exercise an option to a therapeutic discovered and validated in the joint research plan and potential research, development, and sales milestones. In addition, Kallyope will receive royalties on worldwide product sales of licensed products. Kallyope has developed an innovative platform to interrogate the gut-brain axis and discover new medicines in multiple therapeutic areas. The platform integrates single-cell sequencing, bioinformatics, functional and anatomical circuit mapping, and organoids. It has enabled the discovery of new biological mechanisms, including multiple potential secreted products from the gut-brain axis that may play a role in metabolism. Under a joint research plan, Kallyope and Novo Nordisk will collaborate on in vitro and in vivo studies to validate a number of product candidates. Following validation and option exercise, Novo Nordisk will assume responsibility for further preclinical and clinical development, manufacturing, and commercialization. ]]> https://biospectrumindia.com/news/57/11134/teva-provides-update-on-clinical-trial-of-fremanezumab.html https://biospectrumindia.com/news/57/11134/teva-provides-update-on-clinical-trial-of-fremanezumab.html Mon, 18 Jun 2018 13:00:00 +0530 Teva Pharmaceutical Industries Ltd. announced a change in the clinical development program of fremanezumab in chronic cluster headache.   The ENFORCE Phase III clinical development program includes a chronic cluster headache study, an episodic cluster headache study, and a long-term safety study.   A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met. There were no safety concerns observed with fremanezumab treatment in the trial.   Based on the study meeting the futility criteria, the Company will discontinue the trial for chronic cluster headache. Chronic Cluster Headache patients who participate in the long-term safety study, will discontinue their participation in the long-term safety study as well. The episodic cluster headache study is not affected and continues as planned.   “While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide (CGRP) plays a contributory role in their pathophysiology.   We would like to thank the patients and investigators for their participation in the Chronic Cluster Clinical Trial,” said Tushar Shah, M.D., Senior Vice President, Head of Global Specialty Clinical Development at Teva.   Fremanezumab is currently under review by the U.S. Food and Drug Administration (FDA), with an action date of September 16, 2018, and by the European Medicines Agency (EMA), as a quarterly or monthly injection for the preventive treatment of migraine in adults. ]]> https://biospectrumindia.com/news/57/11132/scientists-discover-new-subtype-of-prostate-cancer.html https://biospectrumindia.com/news/57/11132/scientists-discover-new-subtype-of-prostate-cancer.html Mon, 18 Jun 2018 12:20:00 +0530 The subtype is characterized by loss of the gene CDK12. It was found to be more common in metastatic prostate cancer compared to early stage tumors that had not spread.   Tumors in which CDK12 was inactivated were responsive to immune checkpoint inhibitors, a type of immunotherapy treatment that has overall had limited success in prostate cancer.   Researchers at the Rogel Cancer Center will lead a multisite clinical trial to assess checkpoint inhibitors as a treatment for metastatic prostate cancer with CDK12 loss.   In this study, published in Cell, researchers looked at DNA and RNA sequencing data from 360 tumor samples from patients with metastatic castration-resistant prostate cancer.   This is an aggressive, advanced form of the disease in which the cancer has spread throughout the body and no longer responds to traditional hormone-based treatments.   Tumor samples were from U-M's Mi-ONCOSEQ program and from samples collected through the Stand Up to Cancer-Prostate Cancer Foundation Dream Team.   Researchers found the loss of CDK12 in only about 1 percent of early prostate cancer samples. That jumped to 7 percent for metastatic cancer, which indicates a more-aggressive form of the disease.   "It suggests that those early stage patients who have CDK12 loss are the ones who will develop metastatic disease. This could be a harbinger in early cancer," Chinnaiyan says.   By following the mechanism of how CDK12 loss impacts the cell, researchers found a process in which cells create neoantigens that are foreign to the immune system. This boosts immune-fighting T-cells, which may explain why these patients benefit from immune checkpoint blockade.   This suggests that a precision medicine approach to prostate cancer could help better direct immunotherapy treatment. It could also explain why some prostate cancer patients have had exceptional responses to immunotherapy while the treatment has had lackluster results overall in prostate cancer.   The team had first recognized a possible role for CDK12 in a 2015 paper that evaluated the genomic landscape of advanced prostate cancers. CDK12 has also been linked to ovarian cancer.   Little is known about CDK12 on a molecular basis but scientists do know that CDK12 regulates several critical cellular processes and is essential for development. Eliminating it is likely lethal to most cell types.   So why can tumors lose CDK12 and survive? Researchers suspect cancer must inherit something that allows it to grow in the face of CDK12 loss. More study is needed to understand this.   "This very promising study suggests that CDK12 loss may be a biomarker for identifying prostate cancer patients who may respond to checkpoint immunotherapy," says Howard Soule, Ph.D., executive vice president and chief science officer of the Prostate Cancer Foundation. ]]> https://biospectrumindia.com/news/57/11126/2018-bio-international-convention-makes-history.html https://biospectrumindia.com/news/57/11126/2018-bio-international-convention-makes-history.html Fri, 15 Jun 2018 12:35:00 +0530 The 2018 BIO International Convention (BIO 2018) recently wrapped up four days of programming under the theme of “Make History.” Hosted by the Biotechnology Innovation Organization (BIO), BIO 2018 attracted thousands of U.S. and international attendees, celebrated innovations that have shaped the past 25 years and recognized the companies, patient groups, academic centers and investors that continue to advance novel solutions to the world’s toughest challenges. The Convention drew 18,289 biotechnology industry leaders – the most attendees in the last 10 years – from 49 states, the District of Columbia, Puerto Rico and 67 countries. To encourage students to attend BIO and learn more about careers in the biotechnology industry, BIO 2018 included the first Free Student Day. Eligible participants got a one-day Exhibition Access registration and the opportunity to meet with representatives from the biotechnology community. The breadth and depth of offerings and the networking opportunities afforded to thousands of industry stakeholders and students continues to make the Convention the premiere event for the biotechnology industry. BIO 2018 drew companies, academic centers, patient groups, researchers and investors working to advance innovation in key areas such as drug development, brain health, digital health, oncology, opioids, renewable fuels and agriculture. Celebrities also made a presence at BIO, with stories of triumphs over illnesses such as cancer and addiction. Robin Roberts, a cancer survivor and an award-winning journalist, and Rob Reiner, an actor, director and advocate, delivered keynote addresses that emphasized the challenges faced by patients, the importance of patient advocacy and the need for continued innovation to address unmet needs. Setting a Guinness World Record for “The Largest Business Partnering Event,” BIO 2018 hosted 46,916 partnering meetings, facilitated by BIO’s One-on-One Partnering system — a 13% increase over 2017. These invaluable connections form the foundation of innovative industry collaborations and scientific breakthroughs. BIO 2018 also included over 1,800 exhibitors, more than a thousand speakers, 180 sessions, 17 plus super sessions and fireside chats and 19 education tracks. Special programming, such as the Start-Up Stadium, also provided a forum for up and coming companies to receive invaluable advice to accelerate their growth and potential. ]]> https://biospectrumindia.com/news/57/11118/google-to-open-ai-research-centre-in-ghana.html https://biospectrumindia.com/news/57/11118/google-to-open-ai-research-centre-in-ghana.html Thu, 14 Jun 2018 13:40:00 +0530 Google plans to open an artificial-intelligence research centre in Accra, Ghana, the latest in a string of investments the tech company has made in Africa. The research centre will focus on using AI in areas such as healthcare, agriculture and education, Google said. "We're committed to collaborating with local universities and research centres, as well as working with policy makers on the potential uses of AI in Africa," the company said in a blog post on Wednesday, reported Business Insider. The new AI centre in Ghana will open later this year and include machine learning researchers and engineers, Google said, thought it did provide details on the number of staff it will hire. Google CEO Sundar Pichai promised last year during a visit to Lagos that Google would continue raising its profile on the continent. At the time, Pichai announced new investments in African startups as part of the company's Launchpad Accelerator in Africa. The company also launched a special version of YouTube built for users with slow internet connections. Google's interest in Africa comes at a time when a lot of international money is being spread around the continent. In 30 years, the United Nations expects Africa to be home to 25 percent of the world's 9 billion population. Not only does that represent a huge market but investors are planning for the day that Africa's developing economies hit their stride. Last month, Facebook opened a technology hub in Lagos, which will host a start-up incubator. The social network has made numerous other investments there, including launching satellites to help deliver internet access to sub-Sahara Africa. According to recent reports, Russia is eyeing investments in East Africa and the Chinese have spent billions on infrastructure and other projects there.   ]]> https://biospectrumindia.com/news/57/11113/innovative-automated-robotic-device-for-faster-blood-testing.html https://biospectrumindia.com/news/57/11113/innovative-automated-robotic-device-for-faster-blood-testing.html Wed, 13 Jun 2018 14:40:00 +0530 Researchers from Rutgers University, New Brunswick, US have created an automated blood drawing and testing device that provides rapid results, potentially improving the workflow in hospitals and other health-related institutions to allow health care practitioners to spend more time treating patients.   Diagnostic blood testing is the most commonly performed clinical procedure in the world, and it influences most of the medical decisions made in hospitals and laboratories.   However, the success rate of manually drawing blood samples depends on clinicians' skill and patient physiology, and nearly all test results come from centralised labs that handle large numbers of samples and use labour-intensive analytical techniques.   The research team created a device that includes an image-guided robot for drawing blood from veins, a sample-handling module and a centrifuge-based blood analyser.   Their device provides highly accurate results from a white blood cell test, using a blood-like fluid spiked with fluorescent microbeads. The testing used artificial arms with plastic tubes that served as blood vessels.   The device could provide rapid test results at bedsides or in ambulances, emergency rooms, clinics and doctors' offices.    "With our relatively simple chip design and analysis techniques, the device can be extended to incorporate a broader panel of tests in the future," said Max Balter, who led the study. ]]> https://biospectrumindia.com/news/57/11111/world-health-organization-certifies-paraguay-malaria-free.html https://biospectrumindia.com/news/57/11111/world-health-organization-certifies-paraguay-malaria-free.html Wed, 13 Jun 2018 11:50:00 +0530 The World Health Organization (WHO) has certified Paraguay as having eliminated malaria, the first country in the Americas to be granted this status since Cuba in 1973. “It gives me great pleasure to certify that Paraguay is officially free of malaria,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General, in a recorded statement. “Success stories like Paraguay’s show what is possible. If malaria can be eliminated in one country, it can be eliminated in all countries.” In 2016, WHO identified Paraguay as one of 21 countries with the potential to eliminate malaria by 2020. Through the “E-2020 initiative,” WHO is supporting these countries as they scale up activities to become malaria-free. Other E-2020 countries in the Americas include Belize, Costa Rica, Ecuador, El Salvador, Mexico and Suriname.  From 1950 to 2011, Paraguay systematically developed policies and programmes to control and eliminate malaria, a significant public health challenge for a country that reported more than 80 000 cases of the disease in the 1940s. As a result, Paraguay registered its last case of Plasmodium falciparum malaria in 1995, and P. vivax malaria in 2011. A five-year plan to consolidate the gains, prevent re-establishment of transmission and prepare for elimination certification was launched in 2011. Activities focused on robust case management, engagement with communities, and education to make people more aware of ways to prevent malaria transmission, and about diagnosis and treatment options.  In 2016, in the next phase of the elimination drive, the Ministry of Health launched a three-year initiative to build Paraguay’s front-line health workers’ skills. Backed by The Global Fund to Fight AIDS, Tuberculosis and Malaria, the country strengthened its capacity to prevent disease, identify suspected malaria cases, accurately diagnose malaria and provide prompt treatment – key strategies to tackle the on-going threat of malaria importation from endemic countries elsewhere in the Americas and sub-Saharan Africa.  WHO is also releasing a progress update on elimination efforts in E-2020 countries, providing – for the first time – preliminary malaria case numbers for 2017. Ten more countries are on track to eliminate malaria by 2020. However, eight other E-2020 countries saw increases in indigenous malaria cases in 2017, reflecting the global malaria trends reported in the latest WHO World malaria report. WHO is publishing country briefs for the 21 eliminating countries, offering an overview of progress, key malaria data and an assessment of what is needed to reach the 2020 elimination target.  ]]> https://biospectrumindia.com/news/57/11095/innovative-seqfish-technique-can-image-above-10k-genes-at-once.html https://biospectrumindia.com/news/57/11095/innovative-seqfish-technique-can-image-above-10k-genes-at-once.html Mon, 11 Jun 2018 13:05:00 +0530 In a breakthrough, scientists have developed a new technique that enables them to image 10,421 genes at once within individual cells.   The technique, called intron seqFISH (sequential fluorescence in situ hybridisation), is a major advance in being able to identify what goes on across the genome in hundreds of different cells at once.   "This technique can be applied to any tissue," said Long Cai, research professor at California Institute of Technology in the US.   "Intron seqFISH can help identify cell types and also what the cells are going to do, in addition to giving us a look at the chromosome structure in the same cells," said Cai.   Previously, researchers could only image four to five genes at a time in cells with microscopy.   Scaling seqFISH up to a genomic level now enables the imaging of over 10,000 genes - about half of the total number of genes in mammals - within single cells, according to the research published in the journal Cell.   In order for genetic instructions to be turned into an actual functioning protein, a process called transcription must first occur. This process often occurs in pulses, or "bursts."   First, a gene will be read and copied into a precursor messenger RNA, or pre-mRNA, like jotting a quick, rough draft. This molecule then matures into a messenger RNA, or mRNA, akin to editing the rough draft.   During the "editing" process, certain regions called introns are cut out of the pre-mRNA.   The team chose to focus on labelling introns because they are produced so early in the transcription process, giving a picture of what a cell is doing at the precise moment of gene expression.   Using the newly developed intron seqFISH technique, each intron is labelled with a unique fluorescent barcode, enabling it to be seen with a microscope.   Seeing introns reveals which genes are currently turned on in individual cells, how strongly they are expressed, and where they are located. 10,421 introns - and therefore 10,421 genes - can be imaged at once.   Previous work that developed the barcoding technique focused on labelling mRNA itself, providing a measurement of how gene expression changed over several hours as the mRNA developed.   Looking at introns enabled the researchers to examine, for the first time, so-called nascent transcriptomes - newly synthesised gene expression.   This led them to discover that the transcription of genes oscillates globally across many genes on what Cai calls a "surprisingly short" timescale - only about two hours - compared to the time it takes for a cell to divide and replicate itself, which takes from 12 to 24 hours.   This means that over the course of a two-hour period, many genes within a cell will burst on and off. ]]> https://biospectrumindia.com/news/57/11082/apple-to-introduce-digital-health-feature-in-ios-12-.html https://biospectrumindia.com/news/57/11082/apple-to-introduce-digital-health-feature-in-ios-12-.html Thu, 07 Jun 2018 18:30:00 +0530 Just after the announcement of Digital Wellbeing by Google to help monitor and in effect reduce smartphone usage with the upcoming Android P operating system, it seems like Apple is planning to release a similar sort of update on iOS 12. According to media reports, Apple is planning to introduce a feature which will ensure that you spend less time on the iPhone. The feature is speculated to be called Digital Health, will be part of the iOS 12 package. As part of its WWDC 2018 announcements, where Apple will be laying the foundation for the operating systems across its platforms for the coming year, Apple will also highlight its digital wellness feature. The Digital Health features are expected to be bundled inside the Settings menu on iOS 12 according to people who are familiar with the matter. This comes right at the time when Apple has faced a lot of criticism for the addictive nature of the iPhone and iOS apps. In January, there was news about two major Apple shareholders expressing concerns about iPhone's addictive usage on public health, especially among children. A former senior Apple executive, Tony Fadell, who had worked on the original iPhone and iPod, had also stated that Apple needs to do more to fight smartphone addiction. "There is no consensus on what constitutes healthy device usage. We need more data so that we can establish useful recommendations," said Fadell in his Wired editorial on the matter. According to him, we had the tools and data to allow us to understand how we consumed digital media, it just needed to be refined so that we could draw conclusions from that data. Nothing else is known about the Digital Health feature at the moment, but it seems like a step in the right direction. Like Fadell said, Apple iPhones are quite powerful to give you deep insights into how you use your devices and even suggest measures to avoid toxic usage of your devices.   ]]> https://biospectrumindia.com/news/57/11079/thermo-fisher-opens-precision-medicine-centre-in-us.html https://biospectrumindia.com/news/57/11079/thermo-fisher-opens-precision-medicine-centre-in-us.html Wed, 06 Jun 2018 23:30:00 +0530 Thermo Fisher Scientific Inc., the world leader in serving science, has officially opened its U.S. Precision Medicine Science centre (PMSC) in Cambridge, Mass. The centre offers access to advanced "omics" technologies and expertise to help collaborators develop analytical workflows that generate precise molecular profiles of patients. This information will ultimately be used in clinical settings to more effectively treat disease. In addition to providing access to the industry's most advanced analytical technologies, the PMSC's team of in-house scientists helps partners develop standard protocols that enable them to compress R&D timelines and quickly progress from biomarker discovery to assay development. The team includes Thermo Fisher experts in biochemistry, mass spectrometry, molecular biology and data science. The PMSC offers access to advanced technologies spanning genomic, proteomic and metabolomic analysis. From analyzing genomic data with next-generation sequencers to identifying proteins and metabolites using advanced mass spectrometry, collaborators can rapidly move from research to clinical workflow development.  ]]> https://biospectrumindia.com/news/57/11076/glenmark-gets-usfda-nod-for-contraceptive-drugs-.html https://biospectrumindia.com/news/57/11076/glenmark-gets-usfda-nod-for-contraceptive-drugs-.html Wed, 06 Jun 2018 15:40:00 +0530 Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hailey 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1.5 mg/30 mcg) and Hailey Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets, 1.5 mg/30 mcg), The approved products are generic versions of Allergan Pharmaceuticals' Loestrin 21 1.5/30 and Loestrin Fe 1.5/30 tablets. For the 12 months to April 2018, the Loestrin 21 1.5/30 and Leostrin Fe 1.5/30 tablets market achieved annual sales of approximately $ 24.2 million and $ 41.3 million respectively, The company's current portfolio consists of 137 products authorised for distribution at the US marketplace and 61 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA. ]]> https://biospectrumindia.com/news/57/11069/labcorp-unilabs-to-enhance-companion-diagnostics.html https://biospectrumindia.com/news/57/11069/labcorp-unilabs-to-enhance-companion-diagnostics.html Tue, 05 Jun 2018 15:35:00 +0530 Life sciences firm LabCorp has entered a strategic collaboration with clinical laboratory testing services company Unilabs to enhance development and delivery of companion diagnostics globally for improving precision medicine. The partners will expand the network of laboratories that help biopharmaceutical organisations in developing and commercialising these diagnostics. In addition, commercialisation access will be enhanced in North America and Europe, with focus on diagnostics developed as well as validated by LabCorp and its drug development unit Covance. The companies also intend to simplify technical, regulatory and clinical complications related to the assays using globally harmonised processes, which will initially be applied for oncology. ]]> https://biospectrumindia.com/news/57/11055/amgen-md-anderson-collaborate-for-early-stage-oncology-therapies.html https://biospectrumindia.com/news/57/11055/amgen-md-anderson-collaborate-for-early-stage-oncology-therapies.html Sun, 03 Jun 2018 19:05:00 +0530 The University of Texas MD Anderson Cancer Center and Amgen have announced two multi-year collaboration agreements aimed at accelerating development of a variety of Amgen's early-stage oncology therapies for patients with leukemia, myelodysplastic syndromes, multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies. The agreements combine Amgen therapies nearing clinical development or those that have already begun the process with MD Anderson's translational medicine capabilities. The collaborations will focus on Amgen's bispecific T cell engager (BiTE), chimeric antigen receptor (CAR) T cell and small molecule programs. Amgen is advancing both types of T cell therapies against different targets and, in some cases, the same target.  The five-year collaboration will begin with Phase 1 clinical studies for BiTE antibody constructs and CAR T cell therapies for multiple myeloma and small cell lung cancer. The second agreement spans four years and will study BiTEantibody constructs, CAR T and small molecule treatments in leukemia and myelodysplastic syndromes. The collaboration includes multi-institutional pre-clinical and clinical trials, some of which will be led by MD Anderson, which may offer the potential for identifying new biomarkers. ]]> https://biospectrumindia.com/news/57/11050/scientists-develop-blood-test-to-detect-liver-damage.html https://biospectrumindia.com/news/57/11050/scientists-develop-blood-test-to-detect-liver-damage.html Fri, 01 Jun 2018 12:10:00 +0530 Scientists from University College London (UCL) in collaboration with the University of Massachusetts in the US have developed a new blood test to identify liver damage within one hour. The test is designed to detect the damage even before the appearance of symptoms and so addresses the need for the early diagnosis of liver diseases. Validated in clinical samples, the test was found to differentiate samples from healthy individuals and those with different degrees of liver damage. The University of Massachusetts researchers devised a sensor that uses polymers coated with fluorescent dyes, which bind to blood proteins and change in brightness and colour based on the composition of the sample. When tested using small blood samples from 65 subjects, the sensor was able to detect different protein level patterns in their serum. The blood test demonstrated the capability to distinguish fibrotic samples from healthy ones 80 per cent of the time, compared to 60 per cent in the case of differentiating mild-to-moderate and severe fibrosis. With plans for assessment in larger populations, the team intends to refine the test’s effectiveness. ]]> https://biospectrumindia.com/news/57/11043/startup-mou-signed-between-india-and-singapore-to-foster-collaboration.html https://biospectrumindia.com/news/57/11043/startup-mou-signed-between-india-and-singapore-to-foster-collaboration.html Thu, 31 May 2018 14:30:00 +0530   Singapore startups can now gain faster entry to India’s vibrant startup ecosystem to form partnerships and co-innovate with Indian startups after a state-owned enterprise has signed a Memorandum of Understanding with one of the largest global entrepreneurship organisations of Indian-origin. The MoU between Enterprise Singapore (ESG) and The Indus Entrepreneurs (TiE) Singapore was signed on Wednesday, a day before Prime Minister Narendra Modi’s arrival in the country on a three-day visit. The MoU kick-starts an incubation programme that aims to foster collaboration between Singapore and Indian start-ups through jointly organised networking events, workshops and sessions with in-market mentors. Singapore startups can now gain faster entry to India’s vibrant startup ecosystem to form partnerships and co-innovate with Indian startups, said ESG in a statement. The MOU with TiE Singapore, one of the largest global entrepreneurship organisations of Indian-origin which began in Silicon Valley and boast of strong funding muscles and deep pockets, kickstarts the “Singapore – India Incubation Programme” by Startup SG1, led by Enterprise Singapore, with the support of Trade Associations and Chambers and startup partners. As a start, TiE Singapore will be running a startup mission in July with 10 Singapore startups to meet with Indian startups, corporates, mentors and investors to partner and co-innovate solutions in fintech, e-services and deeptech. With a network of 11,000 members globally, India currently constitutes one third of TiE’s global membership. TiE was formed by Silicon Valley-based Indian technologists. Tan Soon Kim, Assistant Chief Executive Officer of Enterprise Singapore, said, “India is an up-and-coming hotspot for global startups and businesses. The growth of India’s startup landscape has been remarkable.” “The Singapore - India Incubation Programme aims to introduce ideas and concepts between the ecosystems of both countries and foster collaboration between companies in each other’s markets and in Southeast Asia. Over time, we aim to establish a series of key innovation nodes within India to form an innovation network for Singapore companies to tap on,” said Tan. Puneet Pushkarna, Chairman of TiE, said, “The strategic collaboration between TiE and Enterprise Singapore would strengthen the bridge between India and Singapore’s startup ecosystem, which today are amongst the most vibrant in the world.” “With 19 chapters in India alone, TiE provides the fattest pipe of entrepreneurial connectivity between the two countries and we hope to enhance market access opportunities for startups on both sides. We are confident that the platform would further proliferate networking amongst innovators and allow for the development and adoption of ideas, flow of capital and implementation of technically challenging solutions for the betterment of the society at large,” said Pushkarna. In line with the “Singapore – India Incubation Programme” by Startup SG, Enterprise Singapore will be organising an iAdvisory Seminar: “Startups in India” on June 12 2018, to help Singapore companies understand the startup landscape in India, opportunities and how to enter the market. India’s startup ecosystem ranks third globally, with over 4,750 startups. Its key focus areas include e-commerce, fintech, healthtech and edutech. The number of startups in India grew 12 per cent in 2016 and is expected to cross 10,000 by 2020. In 2017, the value of startup funding amounted to approximately USD 13.7 billion, significantly higher than the USD 4.06 billion of 2016 and the USD 8.4 billion of 2015, said the statement, citing industry data. The growth is fuelled by increased Government support through startup schemes that eased registration and gave Indian startups priority in Government-led projects and rising middle class which led to a boom in startups tapping into the consumer space, it said.   ]]> https://biospectrumindia.com/news/57/11044/thrombolytic-science-to-participate-in-2018-bio-international-conference.html https://biospectrumindia.com/news/57/11044/thrombolytic-science-to-participate-in-2018-bio-international-conference.html Thu, 31 May 2018 14:30:00 +0530 Thrombolytic Science, LLC (TSI), a clinical stage vascular health company developing biotechnology products to treat thrombotic diseases such as myocardial infarction (MI, or heart attack) and stroke, today announced that it will meet with potential partners at the 25th BIO International Conference from June 4th to June 7th in Boston, Mass. TSI recently completed a Phase I clinical trial of its treatment regimen, a next-generation clot-dissolving therapy that mimics nature’s safe and efficient fibrinolytic system in the treatment of clot-induced diseases. A first-in-human, randomized, double-blind, placebo-controlled study demonstrated the overall safety and tolerability of its treatment regimen in healthy adults. TSI is now preparing to enter human proof-of-concept trials in patients experiencing ischemic stroke and MI. The only treatment currently available for ischemic stroke is tissue plasminogen activator (tPA), which requires to be administrated within a 0-to-4.5-hour time window, and which carries a risk of brain hemorrhage. The main treatment for heart attacks is primary percutaneous coronary intervention (PCI, or balloon angioplasty), an invasive procedure that may cause smaller clots to break off and occlude smaller vessels downstream of the initial blockage, thereby increasing risk of future events. “We are excited to participate in the 2018 BIO International Conference and share our vision and plans regarding the potential for changing treatment standards in blood clot-related diseases,” said Alexis Wallace, President and Chief Executive Officer of TSI. “We encourage BIO guests to use the One-on-One Partnering platform to schedule meetings with TSI representatives.” ]]> https://biospectrumindia.com/news/57/11040/who-joins-hands-with-whf-for-world-no-tobacco-day.html https://biospectrumindia.com/news/57/11040/who-joins-hands-with-whf-for-world-no-tobacco-day.html Thu, 31 May 2018 11:25:00 +0530 For World No Tobacco Day 2018, WHO has joined with the World Heart Federation to highlight the link between tobacco and cardiovascular diseases (CVD), the world’s leading causes of death, responsible for 44% of all NCD deaths, or 17.9 million deaths annually. Tobacco use and second-hand smoke exposure are major causes of cardiovascular diseases, including heart attacks and stroke, contributing to approximately 3 million deaths per year. But evidence reveals a serious lack of knowledge of the multiple health risks associated with tobacco. "Most people know that using tobacco causes cancer and lung disease, but many people aren’t aware that tobacco also causes heart disease and stroke – the world’s leading killers," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. "This World No Tobacco Day, WHO is drawing attention to the fact that tobacco doesn’t just cause cancer, it quite literally breaks hearts."  While many people are aware tobacco use increases the risk of cancer, there are alarming gaps in knowledge of the cardiovascular risks of tobacco use. In many countries, this low awareness is substantial; for example in China, over 60% of the population is unaware smoking can cause heart attacks, according to the Global Adult Tobacco Survey. In India and Indonesia, more than half of adults do not know smoking can cause stroke. "Governments have the power in their hands to protect their citizens from suffering needlessly from heart disease," says Dr Douglas Bettcher, WHO Director for the Prevention of NCDs. "Measures that reduce the risks to heart health posed by tobacco include making all indoor public and workplaces completely smoke-free and promoting use of tobacco package warnings that demonstrate the health risks of tobacco." Tobacco kills over 7 million people each year, despite the steady reduction in tobacco use globally, as shown in WHO’s new Global Report on Trends in Prevalence of Tobacco Smoking 2000-2025. The report shows that worldwide, 27% smoked tobacco in 2000, compared to 20% in 2016. However, the pace of action in reducing tobacco demand and related death and disease is lagging behind global and national commitments to reduce tobacco use by 30%  by 2025 among people aged 15 and older. If the trend continues on the current trajectory, the world will only achieve a 22% reduction by 2025. Dr Svetlana Axelrod, WHO’s Assistant Director-General for NCDs and mental health, says: "We know what policies and actions can increase tobacco quit rates, prevent people from starting using tobacco, and reduce demand. We must overcome obstacles to implementing measures like taxation, marketing bans and implementing plain packaging. Our best chance of success is through global unity and strong multisectoral action against the tobacco industry." ]]> https://biospectrumindia.com/news/57/11038/uk-researchers-first-to-3d-print-human-corneas.html https://biospectrumindia.com/news/57/11038/uk-researchers-first-to-3d-print-human-corneas.html Thu, 31 May 2018 10:40:00 +0530 Researchers at Newcastle University in the UK have been the first to 3D-print human corneas, using a technique that could ensure an unlimited supply of corneas in the future. The proof-of-concept research for the new 3D-printing technique reports how human corneal stromal cells were taken from a healthy donor cornea and mixed together with alginate and collagen to create a ‘bio-ink’ solution that could be printed. Using a low-cost 3D bio-printer, the bio-ink was successfully printed in concentric circles to form the shape of a human cornea in less than 10 minutes. The stem cells were then shown to culture. The scientists also demonstrated that they could build a cornea to match unique patient specifications. The dimensions of the printed tissue were originally taken by scanning a patient’s eye and using the data to rapidly print a cornea which matched the size and shape. ]]> https://biospectrumindia.com/news/57/11029/mit-researchers-create-ingestible-sensor-for-gi-bleeding.html https://biospectrumindia.com/news/57/11029/mit-researchers-create-ingestible-sensor-for-gi-bleeding.html Wed, 30 May 2018 11:35:00 +0530 A team of researchers from the Massachusetts Institute of Technology (MIT) in the US has developed an ingestible sensor that features genetically engineered bacteria to diagnose bleeding in the stomach or other gastrointestinal (GI) problems. The ‘bacteria-on-a-chip’ device combines sensors made from living cells with ultra-low-power electronics to convert the bacterial response into a wireless signal that can be read by a smartphone. The newly developed sensors respond to heme, a component of blood, and have shown their ability to work in pigs. In order to focus the initial demonstration on bleeding in the GI tract, the researchers have created a probiotic strain of E. coli to express a genetic circuit that causes bacteria to release light when they encounter heme. The researchers have also developed an Android app that can be used to evaluate the data provided by the new approach. ]]> https://biospectrumindia.com/news/57/11023/dxterity-diagnostics-receives-ce-mark-for-the-redi-dx-test.html https://biospectrumindia.com/news/57/11023/dxterity-diagnostics-receives-ce-mark-for-the-redi-dx-test.html Tue, 29 May 2018 12:30:00 +0530 DxTerity Diagnostics has declared conformity with the requirements of the European In Vitro Diagnostic Directive (98/79/EC) and has applied the CE mark to the REDI-Dx® Radiation Biodosimetry Test for the quantitative estimation of the absorbed ionizing radiation dose after a nuclear event.   A radiological event, from the use of a nuclear weapon or improvised nuclear device, could potentially expose thousands of individuals to high or moderate levels of radiation that would require immediate medical intervention. REDI-Dx measures the biological response to radiation and provides individualized estimates of absorbed radiation from a peripheral blood sample. Physicians can use the estimate, in conjunction with radiation dispersal monitoring and clinical signs and symptoms, to prioritize the highly and moderately exposed individuals from the concerned public for medical treatment.   According to Bob Terbrueggen, CEO and Founder of DxTerity, "REDI-Dx fulfills a critical unmet need for responding to a mass scale nuclear event. It is the first CE-IVD assay for radiation biodosimetry and is designed to integrate into existing clinical testing infrastructure and read-out on the installed base of ABI 3500 Dx CE instruments."   The dicentric chromosome assay is the current "gold standard" in Europe and Asia; however, the limited testing capacity, lack of standardization, and 72-hour time to result limits its practicality. REDI-Dx overcomes these limitations with ambient sample shipping, 6-hour assay processing time, and a standardized CE-IVD kit for high throughput testing.   REDI-Dx is the result of a multi-year collaboration between DxTerity, Duke University, the University of Arizona, and Thermo Fisher Scientific; as well as patients and researchers from City of Hope Cancer Center and University of California Los Angeles. ]]> https://biospectrumindia.com/news/57/11022/tobacco-is-responsible-for-more-than-one-in-ten-deaths-whf-.html https://biospectrumindia.com/news/57/11022/tobacco-is-responsible-for-more-than-one-in-ten-deaths-whf-.html Tue, 29 May 2018 10:55:00 +0530 World No Tobacco Day is a World Health Organization initiative that will be held on 31 May and this year will focus on raising awareness of the link between tobacco and cardiovascular disease (CVD). Tobacco is associated with around 7 million deaths worldwide every year, directly related to the consumption of and indirect exposure to smoke.   Smoking damages blood vessels and thickens blood. It increases blood rate and blood pressure and replaces oxygen, making it an important risk factor in the development of coronary disease, stroke and peripheral vascular disease. Furthermore, it is the second most prevalent cause of CVD after hypertension. Given that CVDs constitute the number one cause of death in the world, the World Heart Federation (WHF) applauds this initiative by the World Health Organization (WHO).   Despite the general public being familiar with the impact that tobacco causes on health, the WHO highlights the fact that it is rarely thought of as being one of the main causes for CVD.   According to WHF President Professor David Wood: "Tobacco consumption constitutes the main avoidable risk for cardiovascular health. Because of this, it is our duty to help our patients with heart disease to quit smoking, and for those patients at high risk of having a heart attack or stroke to help them quit as well. By doing so we can help all our patients to reduce their risk but even more importantly we need to raise awareness and educate the general public about the impact tobacco on our hearts and crucially the importance of children and young people never starting."   Almost 80% of the one billion smokers around the world live in average and lower income countries where the burden of illness and death associated with tobacco is much greater. With this in mind, WHF through its "Because every heartbeat matters" policy is promoting an agenda of greater access to care and the prevention, control and management of cardiovascular illnesses for everyone, regardless of status or circumstance, with the objective of extending and improving quality of life.   "We firmly believe in the need to continually highlight the risks of tobacco to the health of our hearts and circulation. By bringing together healthcare professionals, governments, institutions, industry and the general public around a common cause we can continue to educate people about the dangers of tobacco and unhealthy lifestyles, and promote the need for universal access to care," adds Prof. Wood. To aid this education, WHF will soon be releasing two fact sheets on smoking cessation: one for the general public and one for professionals.   On 29 September, WHF will be celebrating World Heart Day with the objective of raising awareness about the importance of good cardiovascular health. One of their key messages is around the immediate and long-term health benefits brought about by quitting smoking: Within just 20 minutes, heart rate and blood pressure drops 12 hours after stopping smoking, the carbon monoxide levels in blood drops and returns to normal levels Between 2 and 12 weeks, circulation will have improved and pulmonary function increased Over the first 9 months, coughing and breathlessness diminishes One year after quitting smoking, the risk of contracting a coronary disease is approximately half that of a smoker Between 5 and 15 years after quitting smoking, the risk of suffering from a cerebrovascular accident drops to that of a non-smoker 15 years after having quit smoking, the risk of suffering from a coronary disease equates to that of a non-smoker ]]> https://biospectrumindia.com/news/57/11018/bariatric-surgery-devices-market-to-reach-2-16b-by-2023.html https://biospectrumindia.com/news/57/11018/bariatric-surgery-devices-market-to-reach-2-16b-by-2023.html Mon, 28 May 2018 12:30:00 +0530 According to a new market research report "Bariatric Surgery Devices Market by Type (Minimally Invasive (Stapling, Suturing), Non-Invasive), Procedure (Sleeve Gastrectomy, Gastric Bypass, Revision Surgery, Adjustable Gastric Banding, Mini Gastric Bypass) - Global Forecast to 2023", published by MarketsandMarkets™, the market is expected to reach USD 2.16 Billion by 2023 from an estimated USD 1.64 Billion in 2018, at a CAGR of 5.7%.  By type, the minimally invasive surgical devices are expected to account for the largest share of the market in 2018 On the basis of type, the Bariatric Surgery Devices Market is broadly segmented into minimally invasive surgical devices and non-invasive surgical devices. The minimally invasive surgical devices segment is further subdivided into stapling devices, energy/vessel sealing devices, suturing devices, and accessories. In 2018, the minimally invasive surgical devices segment is expected to account for the largest share of this market. The high growth in this segment can be attributed to the rising obesity rates and the increasing preference for minimally invasive procedures.  By procedure, the sleeve gastrectomy segment is expected to command the largest share of the market in 2018 On the basis of procedure, the market has been segmented into sleeve gastrectomy, gastric bypass, revision bariatric surgery, non-invasive bariatric surgery, adjustable gastric banding, mini-gastric bypass, and biliopancreatic diversion with duodenal switch. The sleeve gastrectomy segment is expected to command the largest share of the market in 2018. The large share of this segment can be attributed to the advantages of sleeve gastrectomy safety, effectiveness, and affordability and limited complications as compared to other bariatric procedures. North America to dominate the market in 2018  North America is expected to account for the largest share of the Bariatric Surgery Devices Market in 2018, followed by Europe. The large share of this segment can be attributed to the rapidly growing obese population and rise in the number of bariatric surgeries. ]]> https://biospectrumindia.com/news/57/11014/research-depression-leads-to-brain-ageing.html https://biospectrumindia.com/news/57/11014/research-depression-leads-to-brain-ageing.html Fri, 25 May 2018 13:00:00 +0530 Researchers at the University of Sussex in the UK conducted a robust systematic review of 34 longitudinal studies, with the focus on the link between depression or anxiety and decline in cognitive function over time. The study combined and reviewed evidence from over 71,000 participants, and included people who presented with symptoms of depression as well as those that were diagnosed as clinically depressed. Researchers looked at the rate of decline of overall cognitive state - encompassing memory loss, executive function (such as decision making) and information processing speed - in older adults. The study found that people with depression experienced a greater decline in cognitive state in older adulthood than those without depression. As there is a long pre-clinical period of several decades before dementia may be diagnosed, the findings are important for early interventions as currently there is no cure for the disease. "This study is of great importance - our populations are ageing at a rapid rate and the number of people living with decreasing cognitive abilities and dementia is expected to grow substantially over the next thirty years," said Darya Gaysina from the University of Sussex. "Our findings should give the government even more reason to take mental health issues seriously and to ensure that health provisions are properly resourced”. "We need to protect the mental wellbeing of our older adults and to provide robust support services to those experiencing depression and anxiety in order to safeguard brain function in later life," Gaysina said. ]]> https://biospectrumindia.com/news/57/11013/esmo-prioritize-cancer-on-global-health-agenda-at-wha.html https://biospectrumindia.com/news/57/11013/esmo-prioritize-cancer-on-global-health-agenda-at-wha.html Fri, 25 May 2018 12:30:00 +0530 ESMO advocated the strengthening of health systems to achieve Universal Health Coverage and to provide essential secondary healthcare services to the millions of cancer patients who die prematurely due to lack of access to appropriate treatment. The widespread availability of secondary healthcare services to cancer patients depends on the presence of sufficient numbers of well-trained oncology professionals with sustainable access to the resources required to perform surgery, deliver radiotherapy, administer cancer treatments, provide supportive and palliative care. ESMO is active in many of these areas and able to support individual Member States' efforts. Alexandru Eniu, ESMO Global Policy Committee Chair: "ESMO has worked with the WHO for over 15 years to improve cancer care worldwide. The platform we were given to talk about cancer illustrates how prominent the topic is becoming on the global health agenda and confirms the relevance of our continued collaboration." ESMO President Josep Tabernero: "It was a privilege for us to be able to speak directly to the international community about the pressing global health issue that is cancer. ESMO is ready to support the WHO and Member States in strengthening the medical oncology workforce and in identifying the most cost-effective interventions and treatments that can immediately help reduce the number of cancer deaths worldwide." ]]> https://biospectrumindia.com/news/57/11012/us-researchers-develop-portable-early-malaria-detection-device.html https://biospectrumindia.com/news/57/11012/us-researchers-develop-portable-early-malaria-detection-device.html Fri, 25 May 2018 10:25:00 +0530 A team of researchers at the USC Viterbi School of Engineering in the US has developed a prototype for a portable device capable of early-stage malaria detection. This device could play a key role in solving the global malaria crisis as malaria therapeutics are most effective after early-stage diagnosis. The device can detect a by-product generated by all species of the malaria parasite and offers the prospect of rapid screening for all malaria strains. The device can analyse an unprocessed, whole blood sample in 10-15 minutes and only requires five to seven drops of blood to provide a diagnosis. The technology relies on the detection of heme, a byproduct produced by the malarial parasite as it digests haemoglobin. The device has been designed using inexpensive, off-the-shelf components and does not require reagents so all parts are readily accessible and easily replaced. The researchers are currently working on the next iteration of the device, with the aim of reducing the sample volume to one or two drops of blood. They also want the device to be able to operate for 30 hours with an external battery pack or be hand-powered. ]]> https://biospectrumindia.com/news/57/11008/lunaphore-vitro-unite-to-develop-ish-protocols-for-rna-dna-targets.html https://biospectrumindia.com/news/57/11008/lunaphore-vitro-unite-to-develop-ish-protocols-for-rna-dna-targets.html Thu, 24 May 2018 15:15:00 +0530 Lunaphore Technologies SA, a next generation tissue diagnostics company, and Vitro SA, a manufacturer in the field of Pathology and Biomedical Research, announce a collaboration agreement to develop In Situ Hybridization (ISH) protocols for RNA and DNA targets in tissue using reagents provided by Vitro on Lunaphore’s rapid autostaining platform*. ISH hybridization techniques not only require the implementation of protocols with long overnight incubation times, but also the protocol automation is challenging. The partnership is aiming to further facilitate the development of ISH applications for Lunaphore’s platform* with shorter turnaround times using one of the latest automation technologies. Lunaphore’s CEO, Ata Tuna Ciftlik, said: “Vitro and Lunaphore have a very good strategical fit to address ISH applications, which are a large portion of the tissue diagnostics market. Our partner Vitro can provide access to key know-how as well as quality ISH reagents, while Lunaphore has a unique automation technology”, and added: “While Lunaphore has so far focused on immunohistology, ISH applications have always remained strategically important. This collaboration indeed proves the potential of our technology to address this highly attractive market segment”.       ]]> https://biospectrumindia.com/news/57/11002/fda-approves-mercks-drug-for-most-common-lung-cancer-type.html https://biospectrumindia.com/news/57/11002/fda-approves-mercks-drug-for-most-common-lung-cancer-type.html Thu, 24 May 2018 10:35:00 +0530 The FDA has approved the use of Keytruda in combination with chemotherapy as a first-line treatment for the most common type of lung cancer. Last year, the FDA approved it for lung cancer patients whose tumors produce a high amount of the protein PD-L1, which covered only a fraction of the total cases of lung cancer. The FDA approval for pembrozlizumab (Keytruda) to treat metastatic non-squamous non-small cell lung cancer widens the use of the immunotherapy. The Merck drug blocks the signals that some cancers use to evade attack by the immune system. FDA decision approves a combined use of pembrolizumab and the chemotherapy pemetrexed (Almita) to treat lung cancer patients whether or not their tumors express PD-L1. There are more than 200,000 new cases of lung cancer each year in the U.S., and it is the leading cause of cancer death, according to the American Cancer Society. According to media reports, the FDA granted accelerated approval of the combination after a study in 123 patients showed it had an effect on 55 percent of them, nearly double the effect in the pemetrexed-only group. Among patients treated with the combination, 93 percent showed a response to the drug for six months or more, compared to 81 percent of patients treated with only chemotherapy. The study also was based on the patients’ progression-free survival, which is a measure of time after treatment that a patient lives without the cancer worsening. Median progression-free survival was 13 months in the combination treatment group, compared to 8.9 months in the chemotherapy group. Pembrolizumab is also approved for certain kinds of skin cancer, head-and-neck cancer, and Hodgkin lymphoma. ]]> https://biospectrumindia.com/news/57/10988/artificial-intelligence-for-early-cancer-diagnosis.html https://biospectrumindia.com/news/57/10988/artificial-intelligence-for-early-cancer-diagnosis.html Tue, 22 May 2018 14:30:00 +0530 The British government has announced ambitious plans to prevent an estimated 22,000 cancer deaths by 2033, through the use of artificial intelligence to predict those individuals at greater risk of developing the disease. The research into the application of artificial intelligence aids with the early diagnosis of cancer. The platforms being developed under funding from the British government are targeted at prostate, lung and bowel cancer. The specific aim of the platform is to detect individuals at a greater risk from these types of cancers earlier by assessing the millions of data points held by the National Health Service (NHS), drawing upon information contained in patient records, such as genetic information, and lifestyle factors. With lifestyle factors, this could include social media profiles. This will help to determine which patients to screen and when to refer people for medical assessments. The collection and analysis of information has been made much easier through the adoption of electronic health records by the NHS. To make use of the information, machine learning is required. Overtime the accuracy of predictions should increase as the predictions are reviewed alongside patient survival statistics. The intention is to assist medical professionals, rather than to replace them. The artificial intelligence commitment, which was announced by the Prime Minister Teresa May, is also set to create hundreds of jobs, especially around technology clusters located in Edinburgh, Leeds and Oxford. These technologies also pave the way for personalized medicines. This is a shift from anti-cancer drugs aimed at a specific type of cancer (or cancers) intended for a general population pool, and towards medicines tailored towards an individual’s own genetic profile. Artificial intelligence is also being used in other ways in healthcare, such as through image analysis. Many tumors are transparent, which makes detecting them more difficult; moreover, there are over three hundred different types of tumors. An example of an image detection system in development is a new microscope from Google (which has been profiled on Digital Journal “Google microscope uses AI and AR for cancer detection”). Artificial intelligence is also being applied to cardiovascular issues. Here measurements are assessed in order to predict the likelihood or otherwise of heart conditions. AI scanning systems can provide recommendations based on an assessment of cardiovascular event risk, with the inquiries drawn from databases that expand over time. ]]> https://biospectrumindia.com/news/57/10985/french-surgeon-builds-windpipes-from-arteries.html https://biospectrumindia.com/news/57/10985/french-surgeon-builds-windpipes-from-arteries.html Tue, 22 May 2018 12:55:00 +0530 French surgeon Emmanuel Martinod has helped people whose windpipes have been ravaged by cancer and other diseases to live and breathe normally again. Since 2009, Martinod and his team at Avicenne Hospital near Paris have carried out more than a dozen trachea transplants using donor aortas reinforced with custom-made internal scaffolding, called stents. Hailed by one US throat surgeon as a "major advance", the reconstructive technique was detailed in the Journal of the American Medical Association (JAMA), and presented at a medical congress in San Diego, California. Previous efforts to rebuild the windpipe and airways from scratch had focused on using artificial tubes seeded with the patient's own stem cells. According to the news reported by AFP, Martinod struck on the idea of using aortas, the largest artery in the body from deceased donors to replace damaged sections of trachea, the roughly 10-centimetre (four-inch) tube of cartilage and tissue that connect the larnyx to bronchial tubes feeding into the lungs. The thick walls of aortas are designed to withstand a lifetime of pressure, chaneling blood pumped by the heart. Harvested from donors, the arteries can be frozen to minus 80 degrees Celsius (minus 112 degrees Fahrenheit) and stored, ensuring an ample supply.The freezing process, Martinod discovered, had another huge advantage: it removed the need for a life-long regimen of medications to prevent the immune system from rejecting a transplanted organ or body part. Follow-ups on the first patients to receive new windpipes brought even more good news. "We went from surprise to surprise, because we saw a regeneration of epithelium," he told AFP. The inside of a healthy trachea is lined with a thin film, called epithelium that moistens and protects the airways. It also functions as a barrier to disease and foreign particles transported toward the mouth by tiny, hair-like cilia. Unexpectedly, this crucial layer had appeared on the inner surface of the repurposed aortas. New cartilage had also begun to form. "That was the ultimate surprise -- the aorta transforming itself into a trachea," said Martinod. "It's not magic, but no one really believed it could happen that way." Eric Volery might disagree about the magic. The 40-year old Frenchman suffered from an acute narrowing of the windpipe called tracheal stenosis, and he was slowing choking to death. A tracheotomy, a hole cut through his throat directly into a less constricted part of his windpipe was keeping him alive. "I had to put a finger over the hole to talk," he recalled. "I'll never forget the doctor who told me: 'Mister, your working days and love life are finished'." Martinod operated on Volery in 2011, replacing his trachea and reinforcing it with a stent. Within a few years, an epithelium has formed and the stent was removed. "He's in perfect health, and is fond of taking 45 or 50-minute runs," the surgeon said. Peers have reacted favorably to the findings. "This represents a major advance in the management of diseases affecting the central airways," commented Valerie Rusch, a surgeon at Memorial Sloan Kettering Cancer Center in New York, writing in JAMA. "This approach provides an elegant solution to challenges that have long bedeviled the field of tracheal surgery." In the study, Martinod and colleagues described the outcomes for 13 transplant patients: five tracheas, seven bronchi and one carina, which is where the trachea divides. The carina transplant patient died sometime after surgery. The other 12 are all survived at least 90 days, and 10 of them were alive after nearly four years. Eight of these ten are breathing normally. All the stents were removed, on average 18 months after the surgery.   ]]> https://biospectrumindia.com/news/57/10986/new-algorithm-predicts-life-expectancy-after-heart-failure.html https://biospectrumindia.com/news/57/10986/new-algorithm-predicts-life-expectancy-after-heart-failure.html Tue, 22 May 2018 12:55:00 +0530 A new algorithm, developed from deep learning, can accurately predicts who is most likely to survive heart failure, and for how long. The platform can also determine whether or not a patient will receive a heart transplant. The algorithm has been devised at University College London, and it enables medical professionals to make more accurate and, most importantly, personalized assessments of people who are awaiting heart transplants. This boost in predictive analytics could enable health care providers to make more informed choices about the use of limited life-saving resources. This may come across as quite stark, but if there is only one heart available for transplant and two candidate patients, the medic will have the option to authorize the transplant for the patient who is more likely to survive, based on the data analysis. This, therefore, has the potential to reduce health care costs. With the algorithm, termed the Trees of Predictors, machine learning is used. Here the system effectively "learns" from additional new data over time. The system analyzes 53 data points, such as age, gender, body mass index, blood type and blood chemistry, in order to assess the complex differences among people waiting for heart transplants. From this it draws inferences about the compatibility between potential heart transplant recipients and donors. Research into the new algorithm has been published in the journal PLOS One, with the paper titled "Personalized survival predictions via Trees of Predictors: An application to cardiac transplantation." This reflects improvements in technology allowing medical researchers to cross-talk, mine big data and tackle unsolved problems relating to heart health. Perhaps of greatest importance is cloud computing, which provides "a powerful environment of analytical tools and state-of-the-art software to researchers who are analyzing large datasets for scientific insights." ]]> https://biospectrumindia.com/news/57/10982/us-approves-first-drug-that-prevents-migraines.html https://biospectrumindia.com/news/57/10982/us-approves-first-drug-that-prevents-migraines.html Mon, 21 May 2018 13:05:00 +0530 The first drug aimed at preventing the headaches has gained U.S. Food and Drug Administration approval. It was found that the injected drug called Aimovig or erenumab can prevent migraines if other treatments have failed to do so. "Aimovig provides patients with a novel option for reducing the number of days with migraine," Dr. Eric Bastings, deputy director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "We need new treatments for this painful and often debilitating condition," he added. The drug, Aimovig, is taken by patients once a month through self-injection. The drug blocks a key brain "neurotransmitter" chemical that sends out pain signals, explained a team of researchers who presented their study findings last month at the annual meeting of the American Academy of Neurology (AAN) in Los Angeles. Working with a group of people with tough-to-treat migraine, the "study found that [Aimovig] reduced the average number of monthly migraine headaches by more than 50 percent for nearly a third of study participants," lead researcher Dr. Uwe Reuter, of The Charite University Medicine Berlin in Germany, said in an AAN news release. In the study by Reuter and colleagues, which was funded by drug maker Novartis, the investigators tested Aimovig on 246 people with treatment-resistant migraine. Of these participants, 39 percent had already failed to respond to two available migraine medications, 38 percent were treated with three other medications and 23 percent had tried four different medications to help control their migraines. On average, these migraine sufferers experienced nine migraine headaches each month and took an acute migraine drug to stop an attack five times each month. During the study, each person received injections of either 140 milligrams of Aimovig or a "dummy" placebo once per month for three months. After three months, those treated with Aimovig were almost three times as likely to have fewer days with migraine pain, compared to people who'd only gotten the placebo. Days with migraine headaches were reduced by at least 50 percent compared to those who were given the placebo. In addition to fewer days with headaches, these patients also took acute migraine drugs less often. Of all the participants, 30 percent treated with Aimovig said their migraine frequency dropped by half. The same was true for only 14 percent in the placebo group. The drug was also not associated with significant side effects. All of this "can greatly improve a person's quality of life," Reuter said. "Our results show that people who thought their migraines were difficult to prevent may actually have hope of finding pain relief. " The FDA said after studying the effectiveness of Aimovig in three clinical trials, they learned most patients who used the drug experienced at least one less migraine per month. One study involved 955 people with episodic migraine who were given either Aimovig or a placebo for six months. In that trial, use of the drug was tied to one to two fewer migraine days per month. In the second study, 577 patients with episodic migraine were given Aimovig or a placebo for three months. Again, those on the drug had at least one less day of headache in a month. Similar results were found in a third, three-month study involving 667 patients—this time, Aimovig users had 2.5 fewer migraine days per month, the FDA said. The most common side effects were some injection-site reactions and constipation. The estimated cost of the drug is $7,000 annually and may be covered by insurance, according to published reports. According to Reuter, "more research is now needed to understand who is most likely to benefit from this new treatment." The researchers added that larger studies are also needed to evaluate the long-term safety and effectiveness of the medication.   ]]> https://biospectrumindia.com/news/57/10979/applying-machine-learning-to-challenges-in-the-pharmaceutical-industry.html https://biospectrumindia.com/news/57/10979/applying-machine-learning-to-challenges-in-the-pharmaceutical-industry.html Mon, 21 May 2018 12:00:00 +0530 MIT continues its efforts to transform the process of drug design and manufacturing with a new MIT-industry consortium, the Machine Learning for Pharmaceutical Discovery and Synthesis. The new consortium already includes eight industry partners, all major players in the pharmaceutical field, including Amgen, BASF, Bayer, Lilly, Novartis, Pfizer, Sunovion, and WuXi. A large number of these have a research presence in Cambridge or the surrounding areas, allowing for close cooperation and the creation of a center for artificial intelligence (AI) applications in pharmaceuticals. The drug discovery process can often be exceedingly expensive and time-consuming, but machine learning offers tremendous opportunities to more efficiently access and understand vast amounts of chemical data — with great potential to improve both processes and outcomes. The consortium aims to break down the divide between machine learning research at MIT and drug discovery research; bringing MIT researchers and industry together to identify and address the most significant problems. As part of the broader initiative to bring together machine learning and drug research, in April, MIT hosted a summit led by Regina Barzilay, the Delta Electronics Professor of Computer Science, and Dina Katabi, the Andrew and Erna Viterbi Professor of Electrical Engineering and Computer Science. The summit gathered MIT researchers with leaders of technology, biotech, and regulatory agencies to engage in ways digital technologies and artificial intelligence can help address major challenges in the biomedical and health care industries. The earliest seeds for the consortium began with software and technology funded by the Defense Advanced Research Projects Agency (DARPA) “Make-It” program, which has the goal of integrating machine learning with automated systems for chemical synthesis. MIT researchers discussed the potential for a consortium with pharmaceutical industry contacts, initially meeting with company representatives in May 2017 and again in September 2017 at which time there was great interest from both industry and MIT researchers in working together. Since then, through work with the MIT Office of Sponsored Programs (OSP) and the MIT Technology Licensing Office (TLO), the consortium has been officially formed. A consortium meeting on May 3 brought together industry members and MIT researchers. “The enthusiasm of the member companies and the potential of machine learning create a tremendous opportunity for advancing the toolbox for medical scientists in the chemical and pharmaceutical industries,” says Klavs Jensen, the Warren K. Lewis Professor of Chemical Engineering and professor of materials science and engineering.  The May 3 meeting aimed to introduce the industry members to fundamentals of machine learning through tutorials and joint research projects. Toward this goal, Barzilay taught the first tutorial on the basics of supervised learning; the tutorial covered neural models and focused on representation learning with the goal of preparing participants for technical presentations in the afternoon.  “The application of machine learning tools provides an opportunity to augment and accelerate drug discovery and development — and get new medicines to patients more quickly,” says Shawn Walker, director of process development of pivotal drug substance technologies at Amgen. “We are excited to participate in this MIT machine learning consortium, along with our other industry partners,” says José Duca, head of computer aided drug discovery in global discovery chemistry at the Novartis Institutes for BioMedical Research.“This consortium will tackle the challenge of efficient and targeted route-planning using state-of-the-art machine learning approaches. Ultimately, we hope this accelerates our ability to make safer, more potent drugs against human disease.” ]]> https://biospectrumindia.com/news/57/10976/who-releases-list-of-essential-diagnostic-tests-to-improve-diagnosis-and-treatment-outcomes.html https://biospectrumindia.com/news/57/10976/who-releases-list-of-essential-diagnostic-tests-to-improve-diagnosis-and-treatment-outcomes.html Mon, 21 May 2018 11:55:00 +0530 Many people are unable to get tested for diseases because they cannot access diagnostic services. Many are incorrectly diagnosed. As a result, they do not receive the treatment they need and, in some cases, may actually receive the wrong treatment. For example, an estimated 46% of adults with Type 2 diabetes worldwide are undiagnosed, risking serious health complications and higher health costs. Late diagnosis of infectious diseases such as HIV and tuberculosis increases the risk of spread and makes them more difficult to treat. To address this gap, WHO has published its first Essential Diagnostics List, a catalogue of the tests needed to diagnose the most common conditions as well as a number of global priority diseases. “An accurate diagnosis is the first step to getting effective treatment,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “No one should suffer or die because of a lack of diagnostic services, or because the right tests were not available.” The list concentrates on in vitro tests - i.e. tests of human specimens like blood and urine. It contains 113 products: 58 tests are listed for detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening and management of patients.  The remaining 55 tests are designed for the detection, diagnosis and monitoring of “priority” diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.  Some of the tests are particularly suitable for primary health care facilities, where laboratory services are often poorly resourced and sometimes non-existent; for example, tests that can rapidly diagnose a child for acute malaria or glucometers to test diabetes.  These tests do not require electricity or trained personnel.  Other tests are more sophisticated and therefore intended for larger medical facilities. “Our aim is to provide a tool that can be useful to all countries, to test and treat better, but also to use health funds more efficiently by concentrating on the truly essential tests,” says Mariângela Simão, WHO Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals. “Our other goal is to signal to countries and developers that the tests in the list must be of good quality, safe and affordable.” For each category of test, the Essential Diagnostics List specifies the type of test and intended use, format, and if appropriate for primary health care or for health facilities with laboratories. The list also provides links to WHO Guidelines or publications and, when available, to prequalified products. Similar to the WHO Essential Medicines List, which has been in use for four decades, the Essential Diagnostics List is intended to serve as a reference for countries to update or develop their own list of essential diagnostics. In order to truly benefit patients, national governments will need to ensure appropriate and quality-assured supplies, training of health care workers and safe use. To that end, WHO will provide support to countries as they adapt the list to the local context. The Essential Diagnostics List was developed following an extensive consultation within WHO and externally. The draft list was then considered for review by WHO’s Strategic Advisory Group of Experts on In-Vitro Diagnostics – a group of 19 experts with global representation. WHO will update the Essential Diagnostics List on a regular basis. In the coming months, WHO will issue a call for applications to add categories to the next edition. The list will expand significantly over the next few years, as it incorporates other important areas including antimicrobial resistance, emerging pathogens, neglected tropical diseases and additional non-communicable diseases.   ]]> https://biospectrumindia.com/news/57/10975/uk-trial-approves-breath-test-for-cancer-detection.html https://biospectrumindia.com/news/57/10975/uk-trial-approves-breath-test-for-cancer-detection.html Mon, 21 May 2018 10:40:00 +0530 A new clinical trial by the Imperial College London has validated the use of their breath test as a first-line diagnostic to identify oesophageal and gastric cancer. The test has been designed to detect chemical compounds called volatile organic compounds (VOC), which produce a distinctive smell and can be detected in the patient’s exhaled breath. According to the researchers the non-invasive test can detect cancer from benign diseases with 85% accuracy. They hope that their test can aid clinicians in deciding if a patient needs further investigations. The researchers expect that as a first-line diagnostic, the test will help some patients to avoid unnecessary invasive procedures. The team is working on further improving the test and planning a larger trial to confirm the findings in GP surgeries, where the test is intended to be used. The team also wants to evaluate the test for other cancers. ]]> https://biospectrumindia.com/news/57/10973/who-raises-high-ebola-health-risk-in-dr-congo.html https://biospectrumindia.com/news/57/10973/who-raises-high-ebola-health-risk-in-dr-congo.html Fri, 18 May 2018 15:40:00 +0530 The World Health Organization (WHO) is to hold an emergency meeting to discuss the risk of Ebola spreading from the Democratic Republic of Congo. A panel will decide whether to declare a “public health emergency of international concern,” which would trigger a larger response. At least 44 people are believed to have been infected in the current outbreak and 23 deaths are being investigated, reports BBC. Cases emerged in a rural area with one now confirmed in the city of Mbandaka. Mr Salama, the WHO's deputy director-general for emergency response, said Mbandaka's location on the Congo river raised the prospect of Ebola spreading to Congo-Brazzaville and the Central African Republic, as well as downstream to Kinshasa, which has a population of 10 million. "This puts a whole different lens on this outbreak and gives us increased urgency to move very quickly into Mbandaka to stop this new first sign of transmission," he said. The 2014-16 West Africa outbreak became particularly deadly when it spread to the capitals of Guinea, Sierra Leone and Liberia. WHO says that of the 44 Ebola cases reported, three are confirmed, 20 are probable, and 21 are suspected. They were recorded in Congo's Equateur province. Mbandaka is the provincial capital. Mr Salama said that isolation and rudimentary management facilities had been set up in Mbandaka. He said the disease could have been taken there by people who attended the funeral of an Ebola victim in Bikoro, the south of Mbandaka, before travelling to the city. On Wednesday more than 4,000 doses of an experimental vaccine sent by the WHO arrived in Kinshasa with another batch expected soon. These would be given as a priority to people in Mbandaka who had been in contact with those suspected of carrying the Ebola virus before people in any other affected area, Mr Salama said. The vaccine, from pharmaceutical firm Merck, is unlicensed but was effective in limited trials during the West Africa outbreak. It needs to be stored at a temperature of between -60 and -80 C. Electricity supplies in Congo are unreliable. WHO said health workers had identified 430 people who may have had contact with the disease and were working to trace more than 4,000 contacts of Ebola patients who had spread across north-west DR Congo. Many of these people were in remote areas, Mr Salama said. ]]> https://biospectrumindia.com/news/57/10962/glenmark-launches-generic-version-of-asthma-drug-in-denmark.html https://biospectrumindia.com/news/57/10962/glenmark-launches-generic-version-of-asthma-drug-in-denmark.html Wed, 16 May 2018 19:05:00 +0530 Glenmark Pharmaceuticals Europe Ltd has launched a generic version of Seretide Accuhaler used to treat asthma in Denmark. Developed by Celon Pharma, Glenmark has marketing and distribution rights for the product across 15 European countries. "This is Glenmark's first inhaled respiratory product launch in Europe. Glenmark is the first generic company to receive regulatory approval for substitution in Denmark for its generic of Seretide Accuhaler," Glenmark Pharmaceuticals Ltd said in a BSE filing. Fluticasone/Salmeterol dry powder inhaler is a combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD), it added. Glenmark said it has already received National Marketing Authorizations for the product in Sweden, Finland, Norway and Iceland, reports Firstpost. Quoting IQVIA data, Glenmark Pharma said Fluticasone/Salmeterol dry powder Inhaler (DPI) had sales of $ 864 million in Europe in the 12 month period ending September 2017. ]]> https://biospectrumindia.com/news/57/10953/new-insights-into-hookipas-theratr-replicating-viral-vector-platform-.html https://biospectrumindia.com/news/57/10953/new-insights-into-hookipas-theratr-replicating-viral-vector-platform-.html Wed, 16 May 2018 15:00:00 +0530 Hookipa Biotech AG, a clinical stage biotech company pioneering an innovative class of active immunization therapies for oncology and infectious diseases, announces the publication of a new preclinical study of its TheraT® replicating viral platform in the May edition of the prestigious international peer-reviewed journal Immunity.  The study was led by Professor Doron Merkler, M.D., and his team at the Department of Pathology and Immunology at the University of Geneva, Switzerland. CD8+ cytotoxic T lymphocytes (CTLs) are important in the body’s defense against infection and cancer and, in addition, contribute to the pathogenesis of several autoimmune diseases. In this study a mouse model of central nervous system autoimmune disease was used to investigate how priming by distinct microbes may enable CTLs to destroy self-tissues.  The study demonstrated that TheraT®-induced CD8+ T cells have a unique transcriptional profile, characterized by expression of the master transcription factor thymocyte selection-associated HMG-box protein (TOX). TOX expression unleashes the tissue-destructive potential of CD8+ T cells by repressing the immune checkpoint 2B4/CD244. Expression of TOX, which is selectively induced by TheraT®, enables CD8+ T cells to establish long-lasting interactions with their target cells inside solid tissues and kill them.  Professor Daniel D. Pinschewer, M.D., Hookipa’s Chief Scientific Officer and a co-author of the paper, said, “These data are very encouraging. They show that TOX expression enables TheraT®-induced CD8+ T cells to attack and destroy "self" tissue. A limitation of other immunization approaches has been that cancer also being a “self” tissue avoids immune mediated destruction. This feature of TheraT®-induced CD8+ T cells is of paramount importance in the immune response against cancer, which in essence represents an autoimmune attack that is desired and beneficial to the patient as it is directed specifically to and effective against the cancer”. Hookipa is performing IND-enabling studies for HB-201/TheraT® to be tested in Human papillomavirus positive (HPV+) head and neck squamous cell carcinoma. A Phase 1 trial is scheduled to start in 2019 as a monotherapy. In 2020, HB-201 will be combined with a checkpoint inhibitor and later with HB-202, a complementary TheraT®-based product in preclinical development.   ]]> https://biospectrumindia.com/news/57/10950/who-publishes-first-essential-diagnostics-list.html https://biospectrumindia.com/news/57/10950/who-publishes-first-essential-diagnostics-list.html Wed, 16 May 2018 11:35:00 +0530 World Health Organisation (WHO) has published its first Essential Diagnostics List, a catalogue of the tests needed to diagnose the most common conditions as well as a number of global priority diseases. “An accurate diagnosis is the first step to getting effective treatment,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “No one should suffer or die because of a lack of diagnostic services, or because the right tests were not available.” The list concentrates on in vitro tests - i.e. tests of human specimens like blood and urine. It contains 113 products: 58 tests are listed for detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening and management of patients.  The remaining 55 tests are designed for the detection, diagnosis and monitoring of “priority” diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.  Some of the tests are particularly suitable for primary health care facilities, where laboratory services are often poorly resourced and sometimes non-existent; for example, tests that can rapidly diagnose a child for acute malaria or glucometers to test diabetes.  These tests do not require electricity or trained personnel.  Other tests are more sophisticated and therefore intended for larger medical facilities. “Our aim is to provide a tool that can be useful to all countries, to test and treat better, but also to use health funds more efficiently by concentrating on the truly essential tests,” says Mariângela Simão, WHO Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals. “Our other goal is to signal to countries and developers that the tests in the list must be of good quality, safe and affordable.” For each category of test, the Essential Diagnostics List specifies the type of test and intended use, format, and if appropriate for primary health care or for health facilities with laboratories. The list also provides links to WHO Guidelines or publications and, when available, to prequalified products. Similar to the WHO Essential Medicines List, which has been in use for four decades, the Essential Diagnostics List is intended to serve as a reference for countries to update or develop their own list of essential diagnostics. In order to truly benefit patients, national governments will need to ensure appropriate and quality-assured supplies, training of health care workers and safe use. To that end, WHO will provide support to countries as they adapt the list to the local context. The Essential Diagnostics List was developed following an extensive consultation within WHO and externally. The draft list was then considered for review by WHO’s Strategic Advisory Group of Experts on In-Vitro Diagnostics – a group of 19 experts with global representation. WHO will update the Essential Diagnostics List on a regular basis. In the coming months, WHO will issue a call for applications to add categories to the next edition. The list will expand significantly over the next few years, as it incorporates other important areas including antimicrobial resistance, emerging pathogens, neglected tropical diseases and additional noncommunicable diseases. ]]> https://biospectrumindia.com/news/57/10948/krf-invites-collaborations-for-bowel-disease-research.html https://biospectrumindia.com/news/57/10948/krf-invites-collaborations-for-bowel-disease-research.html Tue, 15 May 2018 18:45:00 +0530 The Kenneth Rainin Foundation will accept proposals for its Synergy Awards program from May 21 through September 17, 2018. These awards fund new, cross-disciplinary research collaborations to accelerate progress in the study of Inflammatory Bowel Disease (IBD) around the world. "The Rainin Foundation invests in groundbreaking and unconventional methodologies that prioritize patient impact," said Laura Wilson, PhD, Director of Health Strategy and Ventures for the Rainin Foundation. "Our Synergy Awards encourage partnerships between researchers, clinicians and industry that are aimed at improving the prediction and prevention of IBD and encouraging innovative approaches." The awards support teams of up to three individuals for a maximum of $100,000 per investigator, up to $300,000 per project. Teams need not have worked together prior to their proposal, but must demonstrate that the proposed research could not be achieved without the collaboration. The Rainin Foundation supports projects that engage in a combination of basic, clinical and translational science. "This award makes it possible for researchers to forge unprecedented collaborations and pursue novel ideas in IBD research," said Wilson. Proposals will be accepted through the Foundation's online application system. Researchers from any scientific discipline at both nonprofit and for-profit institutions worldwide can apply for the Synergy Award. Projects that demonstrate significant progress toward their research goal after one year may be eligible for additional funding. View complete program information, eligibility requirements and proposal guidelines. ]]> https://biospectrumindia.com/news/57/10945/ge-healthcare-collaborates-with-kenya-cardiac-society.html https://biospectrumindia.com/news/57/10945/ge-healthcare-collaborates-with-kenya-cardiac-society.html Tue, 15 May 2018 14:55:00 +0530 General Electric (GE) and the Kenya Cardiac Society (KCS) have entered into a two-year collaboration to offer echocardiography training to physicians and technicians in public and private hospitals in the country. The training will enable the physicians and technicians to better offer primary baseline assessment for patients with identified cardiac illnesses. The trainings, which will be held in six-month cohorts, will enrich participants with technical skills on cardiac imaging with focus to anatomy, physiology and hemodynamics as well as sonographic measurement and probe manipulation skills. The training will include several practical sessions led by professional sonographers and physician cardiologists. GE Healthcare has a long history in supporting education and training to drive improved health outcomes. In 2016, GE inaugurated a healthcare training and skills institute in Kenya designed to train health professionals. Over 1900 professionals have benefited from the institute since its launch. ]]> https://biospectrumindia.com/news/57/10933/innovative-synthetic-nanofibre-may-reverse-atherosclerosis.html https://biospectrumindia.com/news/57/10933/innovative-synthetic-nanofibre-may-reverse-atherosclerosis.html Mon, 14 May 2018 12:15:00 +0530 A single shot of synthetically designed nanofibres might one day help break up as well as reverse the arterial plaque  a hallmark of atherosclerosis, said researchers led by one of an Indian-origin.  Atherosclerosis is characterised by a narrowing of arteries and blood vessels caused by a build-up of a hard, waxy substance called plaque, which is rich in cholesterol.  Targeting the vessel wall with peptide-based nanofibres developed in the laboratory can non-invasively and non-surgically, halt and reverse the disease, the researchers said.  The results "demonstrate that a novel targeted nanofibre binds specifically to atherosclerotic lesions and reduces plaque burden after a short treatment," said lead author Neel A. Mansukhani, an integrated vascular surgery fellow at Northwestern University in Chicago, US.  The findings were presented at the American Heart Association's Vascular Discovery: From Genes to Medicine Scientific Sessions 2018 in San Francisco.  The tiny fibres contained an amino acid sequence that promotes the cholesterol to dissolve and helped remove deposits from the plaque in the artery walls.  To test the noninvasive therapy, mice were genetically modified to rapidly develop atherosclerosis, then fed high fat diets for 14 weeks and after which the mice received biweekly injections of either the peptide amphile nanofibre or saline for 8 weeks.  After 8 weeks of treatment, plaque area in the arteries of the male mice was reduced by 11 per cent and in the female mice by 9 per cent. However, more research is needed before this new approach can be tested in humans, he noted. ]]> https://biospectrumindia.com/news/57/10927/nigeria-us-sign-mou-to-conduct-health-survey.html https://biospectrumindia.com/news/57/10927/nigeria-us-sign-mou-to-conduct-health-survey.html Sun, 13 May 2018 22:00:00 +0530 The Federal Government, Nigeria has signed a Memorandum of Understanding (MoU) with the United States (U.S.) to conduct national health indicator and impact survey to determine the accurate number of people infected with HIV in Nigeria. The Minister of Health, Dr Isaac Adewole, the Director-General, National Agency for the Control of AIDS, Dr Sani Aliyu and the US Ambassador to Nigeria, Stuart Symington, signed the agreement in Abuja. The survey, which will be the largest HIV research to be conducted in the whole world, will involve 170,000 people. It will also cover Hepatitis B and C and will also assess the uptake of HIV services among the population and estimate the prevalence of HIV related risks behaviour in the 36 states of the federation and the Federal Capital Territory (FCT). The National HIV and AIDS Indicator and Impact Assessment Survey is scheduled to start from June.   ]]> https://biospectrumindia.com/news/57/10915/uk-and-india-extend-health-partnership-to-deal-with-global-health-risks.html https://biospectrumindia.com/news/57/10915/uk-and-india-extend-health-partnership-to-deal-with-global-health-risks.html Thu, 10 May 2018 19:10:00 +0530 The United Kingdom and India will share research, knowledge and technology in areas of anti-microbial resistance, low cost health products and high yield crops. Prime Minister Theresa May, and Prime Minister Narendra Modi, at the meeting in UK on 18 April agreed to step up the health partnership between the UK and India. The UK-India Statement of Intent on Partnership for Cooperation in Third Countries will be extended, with the aim of improving the health and wealth of both countries. Health research will be expanded in the areas of: anti-microbial resistance low cost health products high yield crops The UK government will invest £1 million in an Artificial Intelligence (AI) project that will support India’s national health programmes. UK-based companies with innovative healthcare technologies will be able to participate in this project, which will generate around £50 million of business for the UK’s digital health industry. There are also plans to develop up to 5,000 diagnostic centres in India using NHS expertise, equipment and suppliers. Eleven new ‘medicities’ are already being developed in India, with related: hospitals nursing and medical colleges research and innovation centres The medicities programme is run by the Indo UK Institute of Health (IUIH) in partnership with leading UK hospitals, the first of which is King’s College Hospital.  Secretary of State for Health and Social Care Jeremy Hunt said: “I am proud that our NHS will be used as an example of gold standard healthcare in India – it is only right that our world-leading knowledge and expertise is shared across the globe. Global disease, infection and antimicrobial resistance are real threats to us at home and abroad – this partnership will enable us to tackle 21st century threats together." Health Minister Steve Brine said: “Health expertise and research is a global issue – if we act alone in tackling virulent diseases and long term health threats, we will fail.” This partnership between Britain and India represents a firm trajectory for healthcare into the modern world. Through new research, shared expertise and attention to ground-breaking technologies, both nations can continue to lead the world in health and care.   ]]> https://biospectrumindia.com/news/57/10877/reputed-institutes-battle-over-crispr-technology.html https://biospectrumindia.com/news/57/10877/reputed-institutes-battle-over-crispr-technology.html Fri, 04 May 2018 15:35:00 +0530 Some of the most well-known research institutions in the world including University of California at Berkeley and the Broad Institute which is affiliated with the Massachusetts Institute of Technology and Harvard University will face off in an appeals court on Monday over the question of who invented the CRISPR technology. CRISPR or Clustered Regularly Interspaced Short Palindromic Repeats has created a revolution by making it easier to manipulate living organisms. CRISPR-Cas9, a naturally occurring enzyme used by bacteria to rid itself of viruses was discovered decades ago. According to the news reported by Bloomberg, researchers with UC Berkeley and the University of Vienna were first to find ways to guide molecular scissors to targeted locations on the genome and say their work could be used for any living thing. They filed their patent application in 2012. The Broad Institute in Massachusetts has said that the UC Berkeley team only showed how the technology would work in a test tube. They said their research team proved CRISPR-Cas9 could work in plants and animals, including humans. The arguments before the U.S. Court of Appeals for the Federal Circuit involve the race to patent CRISPR technology. By paying an extra $70 fee, Broad got an accelerated review of its patent applications, which were issued while the application from UC Berkeley was still pending. UC Berkeley has objected this by telling the patent office that its application covered all the work Broad claims to have invented. Last year, the patent office disagreed, saying the inventions were different enough that both could get patents. UC Berkeley appealed to this order and a decision is expected later this year. UC Berkeley’s lawyer Donald Verrilli said in a statement that Broad’s team, led by Feng Zhang, were among six groups including UC that used “conventional, off-the-shelf tools to employ CRISPR-Cas9” in plant and animal cells. UC Berkeley scientist and co-inventor Jennifer Doudna described the patent office ruling after it was released as saying “our patent will be for all tennis balls and Broad’s will be for green tennis balls.” The reason UC Berkeley objects is because those green tennis balls could be where the money is. “At the end of the day, there’s so much potential with the CRISPR platform to treat so many diseases and have a tremendous effect on the patients,” said Samarth Kulkarni, chief executive officers of Crispr Therapeutics AG, which is developing a treatment for sickle-cell anemia. So far, the patent question hasn’t hindered work by companies like Crispr Therapeutics to develop new treatments. “Our primary focus is to develop therapeutics, so I don’t let the intellectual property things distract from the mission,” Kulkarni said. Still, “it would be a shame if these IP wars get in the way. There is plenty of room for people to coexist.” ]]> https://biospectrumindia.com/news/57/10870/wales-introduces-new-screening-test-for-downs-syndrome.html https://biospectrumindia.com/news/57/10870/wales-introduces-new-screening-test-for-downs-syndrome.html Thu, 03 May 2018 14:45:00 +0530 The Welsh Government has launched a new screening programme to provide non-invasive prenatal testing (NIPT) for detecting the risk of Down’s, Edward’s and Patau’s syndromes. Pregnant women in Wales will now be offered the new test along with the existing antenatal screening to identify any abnormalities associated with these genetic disorders during the first three months of expecting. NIPT is intended to acts as a safer and accurate alternative to invasive tests that are said to possess a small risk of miscarriage. To be assessed over a period of three years, the NIPT currently offers combined screening for Edward’s and Patau’s in women expecting one baby, and combined screening for Down’s, Edward’s and Patau’s for those having twins. However, the test does not provide a complete diagnosis but is designed to inform the associated risks, reported BBC. A positive NIPT result has to be further confirmed by an invasive test. ]]> https://biospectrumindia.com/news/57/10858/biogen-neurimmune-announce-option-exercise-for-aducanumab.html https://biospectrumindia.com/news/57/10858/biogen-neurimmune-announce-option-exercise-for-aducanumab.html Wed, 02 May 2018 11:20:00 +0530 Biogen and Neurimmune announced that Biogen has exercised its option to further reduce the previously negotiated royalty rates payable on potential future sales of aducanumab, Biogen’s Phase 3 investigational treatment for early Alzheimer’s disease.  Biogen will make a one-time $50 million payment to Neurimmune in exchange for a 5% reduction in the original royalty rates on potential commercial sales of aducanumab, which follows the 15% reduction in royalty rates announced in October 2017.  The reduced royalty rates on potential commercial sales of aducanumab will be in the high single digits to low-teens. Biogen licensed the worldwide rights to aducanumab from Neurimmune in 2007.   ]]> https://biospectrumindia.com/news/57/10854/agilent-announces-executive-appointments.html https://biospectrumindia.com/news/57/10854/agilent-announces-executive-appointments.html Tue, 01 May 2018 16:30:00 +0530 Agilent Technologies Inc. has announced that Jacob Thaysen, currently, senior vice president, Agilent and president, Diagnostics and Genomics Group (DGG), has been named president of Agilent’s Life Sciences and Applied Markets Group (LSAG), replacing Patrick Kaltenbach, who left the company on April 20, 2018. Sam Raha, currently senior vice president, Agilent Strategy and Corporate Development, will become president of DGG. Thaysen’s and Raha’s appointments as business presidents are effective immediately, and both will continue to report to president and chief executive officer, Mike McMullen. Jacob Thaysen is a recognized industry leader in life sciences and diagnostics markets. Since joining Agilent in 2012 as part of the acquisition of Dako, a Denmark based cancer diagnostics company, Thaysen has been an integral part of Agilent’s transition into a life sciences company. Sam joined Agilent to lead the Strategy and Corporate Development team that would help the company create its first long range strategy and more aggressively seek acquisitions that strategically enhance Agilent’s offerings to customers. ]]> https://biospectrumindia.com/news/57/10831/new-radiotherapy-may-help-treat-liver-cancer.html https://biospectrumindia.com/news/57/10831/new-radiotherapy-may-help-treat-liver-cancer.html Wed, 25 Apr 2018 13:15:00 +0530 A novel technique that delivers high doses of radiation to tumours while sparing the surrounding normal tissue may help treat patients with early-stage liver cancer, according to a study published. Curative treatment options for early-stage hepatocellular carcinoma (HCC), the most common type of liver cancer, include surgery, liver transplantation and radiofrequency ablation, said researchers from the Northwestern University Feinberg School of Medicine in the US. However, many patients are not candidates for these therapies due to the presence of other conditions. Radiation segmentectomy (RS) is a minimally invasive option that uses the radioisotope yttrium-90 (Y90) to destroy tumours. The isotope is embedded into tiny beads that are delivered through a catheter into a blood vessel in the liver. They then travel to the site of the tumour, where they come to rest and deliver their radioactive effect while sparing much of the surrounding healthy tissue. The procedure's name derives from the fact that surgeons divide the liver into a number of segments. Using an imaging approach called cone beam CT, interventional radiologists gain a detailed view of the complex liver vasculature and can focus delivery of the Y90 to the relevant segment. "Cone beam CT has revolutionised our ability to perform segmental injections isolated to very small tumours, sparing the majority of normal tissue," said Riad Salem from the Northwestern University Feinberg School of Medicine. "Before cone beam CT, we had the ability to focus radiation, but not with this level of accuracy," said Salem, senior author of the study published in the journal Radiology. Salem and colleagues studied long-term outcomes in 70 early-stage HCC patients who had undergone RS between 2003 and 2016. They analysed the patients' responses to treatment based on two commonly used sets of criteria. RS controlled the target tumour, slowed the time to disease progression and improved survival outcomes at rates comparable to radiofrequency ablation, surgery and transplantation for early-stage HCC patients. Almost three-quarters of patients had no progression of cancer in the target tumour five years after treatment, researchers said. Median overall survival was 6.7 years, and one, three-, and five-year survival probabilities were 98 per cent, 66 per cent and 57 per cent, respectively, they said. One-, three-, and five-year overall survival probability was 100 per cent, 82 per cent and 75 per cent in patients with a baseline tumour size of 3 centimeters or less. "The results show that we are able to impart curative outcomes to these patients," Salem said. "Our numbers with radiation segmentectomy match or outperform those of other curative treatments in terms of tumour control, survival rate and recurrence," he said. ]]> https://biospectrumindia.com/news/57/10829/weltec-biopower-expands-plant-lineup-in-northern-ireland.html https://biospectrumindia.com/news/57/10829/weltec-biopower-expands-plant-lineup-in-northern-ireland.html Wed, 25 Apr 2018 11:45:00 +0530 German biogas specialist WELTEC BIOPOWER is currently building three anaerobic digestion plants in Northern Ireland. All three 500-kW plants will shortly be completed and will go live in summer 2018. Two of them are being set up in County Antrim in north-east Northern Ireland. Another plant is being built in Benburb in County Tyrone. Thus, WELTEC will soon account for nine of a total of about 40 biogas plants in Northern Ireland. In recognition of this strong overseas commitment, WELTEC BIOPOWER recently qualified for the second place in the ranking of the German Foreign Trade Award.  At first glance, the three new 500-kW plants look similar. Henceforth, all biogas plants will largely be charged with slurry and pig, cattle and poultry manure as well as a small amount of renewable raw materials. Nevertheless, the WELTEC engineers have developed an individual concept for each plant, as the substrate composition and retention times vary. For example, the plant in County Antrim will only have one 2,625-m3 stainless-steel digester. The second plant, which is located nearby, provides for two digesters with a capacity of 2,625 m3 each. The plant in Benburb will use a slightly larger stainless-steel digester in order to extract as much energy as possible from the substrates. The strong market position of WELTEC in the United Kingdom has a solid basis. From the outset, the company from Lower Saxony has played a key role in the field of AD plant construction. On 19 April 2018, the award was conferred for the 10th time. The ceremony was conducted at the end of the German Foreign Trade Day by Dr. Carsten Sieling, mayor of Bremen, and Harald Emigholz, Chairman of the Bremen Chamber of Commerce.              Specifying the reasons for the bestowal of the award, the jury pointed out that WELTEC BIOPOWER started engaging in foreign trade as early as a year after its foundation in 2001. Today, more than 300 WELTEC plants exist in 25 countries on five continents. At present, additional energy plants are being built in Uruguay, France, Croatia and Greece. The export of German regenerative energy know-how has greatly contributed to WELTEC's sales and earnings performance. True to its convictions, WELTEC has retained the main elements of its value chain in the region and in Germany. In this way, the company provides its customers around the globe in various industries with a consistent quality level. ]]> https://biospectrumindia.com/news/57/10827/novartis-launches-ophthalmic-digital-research-platform-.html https://biospectrumindia.com/news/57/10827/novartis-launches-ophthalmic-digital-research-platform-.html Wed, 25 Apr 2018 10:55:00 +0530 Novartis has recently announced the launch of its FocalView app, an ophthalmic digital research platform created with ResearchKit. FocalView aims to allow researchers to track disease progression by collecting real-time, self-reported data directly from consenting patients. By adapting the design of clinical trials to suit the daily routine of patients, the app may reduce barriers to participation, leading to a more nuanced understanding of ophthalmic diseases and potentially accelerating the development of novel treatments. Data capture in traditional ophthalmic clinical trials can be inflexible and infrequent, making it difficult for researchers to monitor patients' disease activity and capture real-world patient experiences.   FocalView aims to help patients complete various assessments, gaining feedback on their visual function, including any changes over time. At the same time, the app could provide researchers with a greater volume of real-world, patient-reported data, creating more flexible and accessible clinical trial designs. ]]> https://biospectrumindia.com/news/57/10819/thermo-fisher-to-invest-50m-for-enhancing-capabilities.html https://biospectrumindia.com/news/57/10819/thermo-fisher-to-invest-50m-for-enhancing-capabilities.html Tue, 24 Apr 2018 10:55:00 +0530 Thermo Fisher Scientific is planning to invest $50 million in its St. Louis, Missouri site which is one of the company's Centers of Excellence (COE) for Biological Commercial Manufacturing. The investment is part of a deliberate strategy to continue expansion of the company's global network of biologic drug substance capabilities for clinical and commercial supply. The project includes expansion to the existing manufacturing building #2 by 64,000 square feet, which will double its manufacturing capacity and will be operational in 2019.  The expansion will take advantage of the Thermo Fisher bioproduction eco-system for bioreactors, consumables and factory automation.  With this capacity expansion, Thermo Fisher will have the second largest base of single-use bioproduction capacity at a Contract Development and Manufacturing Organization (CDMO) in the world. The investment will also allow for further expansion in the future. Approximately 80 new technical jobs are expected to be added. The St Louis site currently provides process development, clinical cGMP manufacturing and commercial manufacturing using both fed batch and perfusion processes. The St. Louis COE, with more than a decade of manufacturing experience, has in-house analytical capabilities for Quality Assurance and Quality Control. ]]> https://biospectrumindia.com/news/57/10818/phenomenex-introduces-biozen-series-for-biotherapeutics.html https://biospectrumindia.com/news/57/10818/phenomenex-introduces-biozen-series-for-biotherapeutics.html Mon, 23 Apr 2018 12:50:00 +0530 Phenomenex Inc., a global leader in the research and manufacture of advanced technologies for the separation sciences, introduces bioZen, a new series of LC solutions for bioseparations in pharmaceutical, biopharmaceutical and academic research. The series encompasses both proven and entirely new media spanning two particle platforms; core-shell and thermally modified fully porous along with new biocompatible titanium hardware. The initial bioZen product line features seven chemistries for the UHPLC and HPLC characterization of biotherapeutics such as monoclonal antibodies, antibody-drug conjugates and biosimilars. The offering includes specific LC chemistries for the analysis of aggregates and total mAb, intact mass and fragments, peptide mapping and quantitation, and glycan mapping. As an added benefit, all bioZen media, particle sizes and phases are available in Phenomenex’s new biocompatible titanium hardware, which minimizes secondary reactions, carryover and other recovery issues to provide better overall reproducibility than stainless steel hardware. It also minimizes the amount of time typically spent on column priming and does not interfere with protein or peptide integrity. The bioZen thermally modified fully porous media is produced with Phenomenex’s proprietary post-synthetic thermal treatment process, which improves particle mechanical strength and inertness, providing significantly better peak shape and fewer unwanted secondary interactions than traditional LC media. The thermally modified media pairs well with high-efficiency bioZen Core-Shell Technology media which delivers increased resolution and sensitivity inshorter retention time windows. Both particle platforms undergo stringent QC testing to ensure consistent high quality, while all individual bioZen columns have QC protocols for specific biologic applications to confirm product performance and reproducibility.   ]]> https://biospectrumindia.com/news/57/10817/us-researchers-develop-blood-test-for-detecting-multiple-myeloma.html https://biospectrumindia.com/news/57/10817/us-researchers-develop-blood-test-for-detecting-multiple-myeloma.html Mon, 23 Apr 2018 12:35:00 +0530 A new type of blood test has been developed by a group of researchers at the University of Kansas in the US, which employs a plastic chip to detect a form of cancer known as multiple myeloma. The test is also able to aid treatment decisions and is expected to replace the existing standard bone-biopsy or surgical procedures, which can be invasive and painful for patients. According to the researchers, the test helps to identify the stage of the disease and the most effective drug for its treatment, in addition to facilitating monitoring for any signs of recurrence in case of remission. Researchers are currently using the new diagnostic method to test for tumour cells in blood samples that have been obtained from paediatric acute leukaemia patients. The team hope that the test can be used to improve the diagnosis and precision treatment of various other tumours as well. ]]> https://biospectrumindia.com/news/57/10799/mundipharma-expands-partnership-with-caris-life-sciences.html https://biospectrumindia.com/news/57/10799/mundipharma-expands-partnership-with-caris-life-sciences.html Wed, 18 Apr 2018 13:30:00 +0530 Mundipharma is partnering with Caris Life Sciences, a leading US biotechnology company, to provide the exclusive sales, promotion, marketing and distribution of its tumor profiling service, Caris Molecular Intelligence, in Mexico. Caris Molecular Intelligence is a patented and proprietary service that uses a combination of technologies, including Next-Generation Sequencing (NGS), to examine each tumour at the various biological stages of cancer, which provides individualised data about a patient’s cancer. This information enables oncologists to make informed treatment decisions based on the unique molecular characteristics of each patient’s cancer. Providing nuanced understanding of tumour profiling studies helps identify patients who will benefit most from targeted therapies. This move expands the portfolio of cancer care medicines Mundipharma will provide in Mexico. More importantly, the service has the potential to make a real difference to patients’ lives by empowering healthcare professionals to more quickly identify treatment options, from all that are available, especially for rare and aggressive cancers. Mundipharma already has a successful partnership in place with Caris Life Sciences to provide this service in Malaysia and the two organisations are exploring other countries in which they could work together to benefit cancer patients. Mundipharma CEO, Raman Singh, said “As well as making new medicines available via our own research and development pipeline, Mundipharma is constantly exploring strategic partnerships that will bring patients access to important treatments. “While cancer treatments have significantly advanced over the years, current cancer care options are still failing too many patients. With the introduction of Caris Molecular Intelligence, we’re proud that oncologists will now able to recommend better personalized treatments to specifically target patients’ cancer. We believe this is a game-changer for oncology in Mexico.” ]]> https://biospectrumindia.com/news/57/10798/hitachi-to-experiment-worlds-first-urine-test-to-spot-cancer.html https://biospectrumindia.com/news/57/10798/hitachi-to-experiment-worlds-first-urine-test-to-spot-cancer.html Wed, 18 Apr 2018 12:05:00 +0530 A Japanese firm is trying to carry out the world's first experiment to test for cancer using urine samples, which would greatly facilitate screening for the deadly disease. Engineering and IT conglomerate Hitachi developed the basic technology to detect breast or colon cancer from urine samples two years ago. It will now begin testing the method using some 250 urine samples, to see if samples at room temperature are suitable for analysis. Research published earlier this year demonstrated that a new blood test has shown promise towards detecting eight different kinds of tumours before they spread elsewhere in the body. The Hitachi technology centres around detecting waste materials inside urine samples that act as a "biomarker" a naturally occurring substance by which a particular disease can be identified, the company said in a statement. The experiment will start this month until through September in cooperation with Nagoya University in central Japan.   ]]> https://biospectrumindia.com/news/57/10790/ge-launches-new-facility-for-viral-vector-based-therapeutics.html https://biospectrumindia.com/news/57/10790/ge-launches-new-facility-for-viral-vector-based-therapeutics.html Tue, 17 Apr 2018 17:40:00 +0530 GE Healthcare is launching a ready-to-run factory-in-a-box to speed up the production of viral vector based therapeutics, including viral vector based vaccines, oncolytic viruses and gene and cell therapies. The new, prefabricated and modular KUBio biomanufacturing facility is designed, constructed, assembled and fully fitted-out to current good manufacturing practice (cGMP) standards significantly faster that is required to build a traditional, stick-built manufacturing facility. This makes it possible to build capacity quickly and easily, allowing drug manufacturers to adapt to market requirements. The factory is also pre-engineered so that it can be expanded at a later stage to offer increased manufacturing output according to the drug demand.  Viral vectors are modified viruses that are being used as vehicles (or ‘carriers’) to deliver genetic material into target cells. They protect the new gene from degradation, while delivering it to the target cells that start using the new genetic code to cure or treat a certain disease. GE’s newest KUBio is designed for products requiring a biosafety level 2 (BSL2) environment such as viral vector based therapies, but even monoclonal antibody (mAb) and multi-product manufacturers can use the facility. The standard KUBio BSL2 includes a FlexFactory single-use biomanufacturing platform, where the recommended bioreactor size is between 200 and 1,000 liters. The facility can be extended with a larger, or additional manufacturing suite according to the market need. As a part of the project, GE provides end-to-end bioprocessing support including manufacturing equipment, a prefabricated modular facility and accompanying suite of services, including installation, financial guidance, project coordination, qualification and equipment maintenance services. GE already offers a prefabricated manufacturing solution, KUBio for the production of monoclonal antibodies (mAbs), a FlexFactory biomanufacturing platform for a variety of biologics and most recently, a scalable FlexFactory platform for cell therapy. Three KUBios and over 40 FlexFactories have already been purchased globally.   ]]> https://biospectrumindia.com/news/57/10787/sanofi-to-sell-generics-arm-to-advent-for-2-4b.html https://biospectrumindia.com/news/57/10787/sanofi-to-sell-generics-arm-to-advent-for-2-4b.html Tue, 17 Apr 2018 15:25:00 +0530 French healthcare group Sanofi is in exclusive talks to sell its Zentiva European generics drugs arm to private equity firm Advent International for 1.9 billion euros ($2.4 billion). Sanofi said the sale was expected to be completed before the end of the year, and Advent's offer was binding and fully financed. The 1.9 billion euros price is an enterprise value, including equity and debt. The planned Zentiva sale follows a move by UK group Shire this week to sell its oncology business to unlisted French drugmaker Servier for $2.4 billion.  Sanofi has been reshaping its business in recent months, spending more than $16 billion to buy biotech company Ablynx and U.S. haemophilia specialist Bioverativ, but also selling off some assets. This week, it sold some brands to Charterhouse Capital Partners' Cooper-Vemedia drugs manufacturing arm for 158 million euros. Zentiva operates in 50 markets and has a strong presence in Eastern Europe, particularly in the Czech Republic, Slovakia and Romania. ]]> https://biospectrumindia.com/news/57/10783/thermo-fisher-launches-childhood-oncology-network-.html https://biospectrumindia.com/news/57/10783/thermo-fisher-launches-childhood-oncology-network-.html Tue, 17 Apr 2018 10:30:00 +0530 To address the global issue of cancer, Thermo Fisher Scientific has established the International Childhood Oncology Network (ICON). It has also launched Oncomine Childhood Cancer Research Assay, a comprehensive, next-generation sequencing (NGS) panel it developed in collaboration with Children's Hospital Los Angeles that specifically targets mutations associated with pediatric and young adult cancers. Thermo Fisher's ICON is a resource to develop a global community spanning academic and clinical researchers who collaborate by sharing data, best practices and experiment protocols to drive deeper understanding of pediatric, childhood and young adult cancers. Membership in ICON is available through a registration process enabling access to data sets that are uploaded by network members to the ICON database. Thermo Fisher's new Oncomine Childhood Cancer Research Assay combines specific mutations, gene amplification and fusions in a single panel. The assay, designed by leading scientists and pediatric oncologists, interrogates 203 unique genes representing multiple gene classes and 1,700 fusion transcripts in two DNA and two RNA pools using a seamless NGS workflow. ]]> https://biospectrumindia.com/news/57/10778/scientists-in-france-develop-poc-hcv-assay.html https://biospectrumindia.com/news/57/10778/scientists-in-france-develop-poc-hcv-assay.html Mon, 16 Apr 2018 12:15:00 +0530 A group of researchers at the Institut Pasteur and Inserm in France have partnered with UK-based firm genedrive for the development and validation of a rapid, point-of-care (POC) assay for hepatitis C virus (HCV). The new diagnostic test is intended to allow early treatment for patients suffering from hepatitis C, a liver disease caused by the virus and characterised by complications such as cirrhosis and liver cancer. The new assay initially tests for specific HCV antibodies, followed by a polymerase chain reaction (PCR) assay to identify HCV RNA in the blood in order to confirm the presence or absence of a chronic infection. A miniaturised, less expensive device is employed for the PCR and can analyse 40 successive reaction cycles. The new assay is expected to cater to even countries with limited resources and delivers results in around one hour.   ]]> https://biospectrumindia.com/news/57/10757/fda-approves-ai-device-for-detecting-diabetic-retinopathy.html https://biospectrumindia.com/news/57/10757/fda-approves-ai-device-for-detecting-diabetic-retinopathy.html Thu, 12 Apr 2018 10:45:00 +0530 The U.S. Food and Drug Administration (FDA) has permitted marketing of the first medical device to use artificial intelligence (AI) to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. The device, called IDx-DR, is a software program that uses an AI algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400. A doctor uploads the digital images of the patient’s retinas to a cloud server on which IDx-DR software is installed. If the images are of sufficient quality, the software provides the doctor with one of two results: (1) more than mild diabetic retinopathy detected: refer to an eye care professional or (2) negative for more than mild diabetic retinopathy; rescreen in 12 months. IDx-DR is the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care. ]]> https://biospectrumindia.com/news/57/10725/aleafia-initiates-battle-against-opioid-crisis.html https://biospectrumindia.com/news/57/10725/aleafia-initiates-battle-against-opioid-crisis.html Thu, 05 Apr 2018 12:25:00 +0530 Aleafia Health Inc. announced that it has launched a new opiate replacement program across its 23 Aleafia/Canabo clinic network. As the opioid health-crisis continues across North America, Aleafia believes that its new initiative puts it ahead of the curve in the battle against this life-destroying epidemic. In light of new studies released by the American Medical Association that suggest cannabis may play a role in reducing some patients' need for opioids, Aleafia's opiate-replacement program is designed to: Increase the pace of Aleafia's previously announced 1,000-patient study on the use of medical cannabis to reduce opioid addiction, Conduct extensive outreach to local and regional patients and physicians announcing Aleafia/Canabo program to substitute opioids with medical cannabis, and Boost clinic education initiatives about the potential positive outcomes of replacing opioids with medical cannabis within Aleafia's patient-focused, physician-led and research-based environment. "From the very beginning, our goal at Aleafia was to provide evidence-based support for patients and their caregivers by introducing an effective alternative to the dangerous opioid option," added Aleafia's Executive Chairman, the Honourable Julian Fantino. "Today, we are ably positioned to make a meaningful difference with a large team of cannabinoid medicine experts, an established, cross-country clinic infrastructure, a much-sought-after, lucrative observational database, and an ambitious plan to grow our knowledge into more targeted, effective strains of medical cannabis for our patients." ]]> https://biospectrumindia.com/news/57/10724/prioritize-universal-health-coverage-who.html https://biospectrumindia.com/news/57/10724/prioritize-universal-health-coverage-who.html Thu, 05 Apr 2018 12:20:00 +0530 The World Health Organization has called upon countries in its South-East Asia Region to step-up efforts towards universal health coverage, to provide quality health services to all people when and where they need them, without having to suffer financial hardship. Dr Poonam Khetrapal Singh, Regional Director of WHO South-East Asia said, “Universal health coverage is central to improving health and well-being – a fundamental human right. It is also imperative for a country’s well-being as healthier populations create more productive economies. Universal health coverage (UHC) is a flagship programme of WHO in the Region since 2014. In recent years, all Member States have taken several initiatives which have helped improve access to essential health services. However, challenges remain. Nearly half of the WHO South-East Asia Region’s population still lacks full coverage of essential health services. Significant inequalities persist. Poorer people, and those in rural areas, have lower access than richer people, and those living in urban areas. Some 65 million are pushed into extreme poverty, mainly due to paying out-of-pocket for medicines, especially for non-communicable diseases such as heart disease, diabetes etc, and other common ailments. Dr Khetrapal said, “More efforts are needed to increase human resources for health, enhance skills of health workers and aid staff retention in rural and hard-to-reach area, to ensure quality health services are available for everyone, everywhere.” Health services must be planned around the needs of the people, she said, highlighting that by 2020 more of the Region’s population will be over 60 than under-five. Hence, ageing population, reversing the growing burden of non-communicable diseases, and early detection and timely treatment of infectious diseases, should be the focus of frontline services. Increasing access to quality and affordable essential medicines is also fundamental. Paying out-of-pocket for medicines is the leading cause of financial hardship from health care spending in this region, the Regional Director said. UHC includes the full spectrum of essential, quality health services, from health promotion to prevention, treatment, rehabilitation, and palliative care. Ensuring universal health coverage will help strengthen health security by making it easier to contain the spread of infectious diseases and respond effectively to natural disasters that the WHO South-East Asia Region is prone to. Countries in the Region have committed to monitor who is not being covered by health services and why, and review annually progress on UHC and SDG3 health goal until 2030.  UHC is feasible and can be achieved progressively, sometimes with rapid, ground-breaking strides; sometimes via gradual though crucial reform, the Regional Director said.   ]]> https://biospectrumindia.com/news/57/10721/research-shows-how-muscles-regulate-their-oxygen-consumption.html https://biospectrumindia.com/news/57/10721/research-shows-how-muscles-regulate-their-oxygen-consumption.html Wed, 04 Apr 2018 15:00:00 +0530 After exercise muscles consume oxygen to produce energy, until the level of oxygen drops below a particular threshold. Subsequently, energy is generated by the process of anaerobic metabolism, which does not require oxygen. However, this leads to the production of lactic acid and eventually exhaustion and cramping. In a new study, researchers demonstrate that the enzyme FIH (Factor Inhibiting HIF) is a key to how this switch-over happens. “We’ve discovered that the muscles regulate oxygen consumption in a very precise way using the oxygen-sensitive enzyme FIH,” says principle investigator Professor Randall Johnson at the Department of Cell and Molecular Biology, Karolinska Institutet. “The enzyme makes sure that the muscles can use a more effective oxygen-based metabolism for as long as possible and then promotes a very quick transition to anaerobic metabolism.” Using mice in which the production of the enzyme was blocked, the researchers found that mice lacking FIH in their muscles require more oxygen than normal when exercising. “We were able to show that without FIH, the muscles use much more oxygen than is otherwise the case,” says Professor Johnson. “This could be of great significance to elite athletes, who, according to an earlier study of ours, have uncommonly high levels of muscular FIH.” “No one’s entertained the idea of developing a drug that affects FIH before, but I think our study will lead to greater examination of that possibility,” says Professor Johnson.  “Here you’re able to affect the metabolism itself, perhaps mainly in the muscles, but possibly in other parts of the body too. This can be important in other contexts, such as diabetes and obesity.”   ]]> https://biospectrumindia.com/news/57/10720/new-technique-makes-heart-valve-replacement-safer-.html https://biospectrumindia.com/news/57/10720/new-technique-makes-heart-valve-replacement-safer-.html Wed, 04 Apr 2018 12:30:00 +0530 Scientists at National Institutes of Health have developed a novel technique that prevents coronary artery obstruction during transcatheter aortic valve replacement (TAVR), a rare but often fatal complication. The method, called Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA), will increase treatment options for high-risk patients who need heart valve procedures. TAVR, a procedure used to treat aortic valve stenosis, involves threading a long, thin, flexible tube, called a catheter, through the femoral artery in the leg to the heart. Aortic valve stenosis is a fatal narrowing of the valve controlling blood leaving the heart to the rest of the body. This narrowing reduces blood flow to vital organs, resulting in shortness of breath, chest pain, blackouts, and heart failure. For elderly or frail patients, TAVR offers an effective and less invasive alternative to open heart surgery. However, a small subset of these patients may develop coronary artery obstruction during the TAVR procedure. For more than half the patients who experience coronary artery obstruction during the TAVR, this complication has been fatal. BASILICA was developed by Jaffar M. Khan, M.D., at the National, Heart, Lung, and Blood Institute (NHLBI), part of NIH, to increase the safety of TAVR for this subset of patients. Robert J. Lederman, M.D., the senior investigator in NHLBI’s Division of Intramural Research who led the study with Khan said, “These patients are either not eligible for conventional TAVR, or they are at high risk for it.” Lederman explained that during TAVR, the surgeon places a catheter inside the heart and uses a balloon to open a new valve inside the aortic valve. However, in some patients whose hearts have uncommon structures, such as unusually large valve leaflets or small aortic roots, the large leaflets block the flow of blood to the coronary arteries as the new valve’s scaffolding opens. “There is no good treatment or prevention strategy for TAVR-induced coronary obstruction,” said Lederman. “The previous technique of using a stent to open the coronary artery appears to have poor long-term outcomes”, he added. BASILICA offers a solution to the problem of coronary obstruction during TAVR. The interventional cardiologist weaves an electrified wire the size of a sewing thread through a catheter and uses it to split the original leaflet in two so that it cannot block the coronary artery once it has been pushed aside by the transcatheter heart valve. In the current study, the researchers report the success of the BASILICA procedure in seven gravely ill patients who qualified for compassionate use of the technique — then untested in humans — because no other care options were available. “All patients had a successful TAVR with no coronary obstruction, stroke or any major complication. They were doing well as they reached the 30-day-mark after the procedure”, Lederman added.                 ]]> https://biospectrumindia.com/news/57/10718/hgs-acquires-axispoint-health.html https://biospectrumindia.com/news/57/10718/hgs-acquires-axispoint-health.html Wed, 04 Apr 2018 11:20:00 +0530 Hinduja Global Solutions Limited (HGS) has announced that its subsidiary, HGS Population Health LLC, USA, has acquired CMH Services Subsidiary LLC, USA, operating under the trade name of AxisPoint Health, a leading population health management company. "The acquisition of AxisPoint Health adds a strategic capability to our healthcare portfolio by strengthening our presence in the clinical services segment, and specifically in the population health management space. Combined with our existing services, we see a huge opportunity to cross-sell solutions to the payer industry," said Partha DeSarkar, Chief Executive Officer, HGS. Ramesh Gopalan, President – Global Healthcare and Head of India Business, HGS said, "The population health management segment is an attractive market, with healthcare payers looking to simplify and personalize the care experience while reducing costs and improving health outcomes. HGS already has a significant presence in the US healthcare market, and we see a lot of synergies with AxisPoint Health's portfolio of services." HGS' acquisition of, and new investment in, AxisPoint Health's services will allow the latter to further strengthen its offerings. ]]> https://biospectrumindia.com/news/57/10713/tfs-international-appoints-andrew-copestake-as-cco.html https://biospectrumindia.com/news/57/10713/tfs-international-appoints-andrew-copestake-as-cco.html Tue, 03 Apr 2018 15:25:00 +0530 TFS International is a leading, mid-size clinical Contract Research Organization providing global clinical development solutions. TFS International is delighted to announce that Dr Andrew Copestake has accepted the position of Chief Commercial Officer and Executive Vice President, Global Business Development. Dr Copestake is an entrepreneurial, commercially focused, senior executive with over 25 years’ experience in the pharmaceutical, biotechnology and CRO industry. His most recent role was with Julius Clinical, a science-driven CRO based in the Netherlands, where he held the position of Chief Business Development Officer.  Previous roles have included a number of senior leadership positions in business development and general management, including six years as CEO of a Swedish biotechnology company. The majority of Andrew’s experience has been in international roles and he has lived and worked in the UK, US, Japan, Sweden and the Netherlands. He has managed diverse business development teams, and is proud of his record of achieving growth. Andrew has proven leadership skills with an ability to manage businesses through significant change whilst achieving key operational and financial performance targets. Andrew said of this new role, “I am very excited to be joining TFS.  As one of the leading mid-sized, global CROs, TFS is well placed to take advantage of the significant growth opportunity in this sector.  As we see many CROs increasing in scale, our customers are failing to experience increasing levels of service, whilst simultaneously facing rising costs, and reduced market choice.  By offering excellent customer experience combined with global capabilities and competitive pricing, TFS can present a truly differentiated service, which will result in significant benefits for clients, patients and employees. It will be my responsibility to help guide TFS through this exciting phase of development and I am grateful to János, the TFS board and the leadership team for offering me this wonderful opportunity.” ]]> https://biospectrumindia.com/news/57/10711/ge-healthcare-to-sell-it-biz-for-1-05b.html https://biospectrumindia.com/news/57/10711/ge-healthcare-to-sell-it-biz-for-1-05b.html Tue, 03 Apr 2018 11:20:00 +0530 General Electric (GE) Co. is selling its financial management, ambulatory care and workforce management software unit from its healthcare business to private equity firm Veritas Capital for $1.05 billion in cash. The transaction is expected to close during the third quarter of 2018. Morgan Stanley and Keval Health are GE's financial advisers, while Goldman Sachs & Co. and William Blair & Co advised Veritas Capital. The company intends to sharpen its focus on smart diagnostics and connected devices. The divestiture comes as GE is making an effort to slim down its offerings under new CEO John Flannery and refocus its work.    ]]> https://biospectrumindia.com/news/57/10681/nhs-urges-teens-to-take-part-in-meningitis-b-vaccine-trial.html https://biospectrumindia.com/news/57/10681/nhs-urges-teens-to-take-part-in-meningitis-b-vaccine-trial.html Wed, 28 Mar 2018 14:50:00 +0530 The NHS is attempting to recruit 24,000 teenagers in a bid to test the first new vaccines for adolescents against the most common form of meningitis following a public outcry. Recent breakthroughs have offered up two new candidate drugs which scientists believe will provide near total protection from meningitis B. However, by testing them on such a large cohort they also want to establish if the drugs are capable of preventing the spread of the potentially deadly bacteria from protected to unprotected teens, thereby building ‘herd immunisation’. In 2016 more than 400,000 people signed a petition calling for all children to be given a meningitis vaccine. All 16 to 18-year-olds taking part in the study will receive two doses of one of the new vaccines, 8,000 in the 4CMenB (Bexsero) arm, with the same number taking MenB-fHBP (Trumbenba). A further 8,000 will act as a control group and not be given the vaccine. Throat swabs will be taken 12 months apart to assess to what extent they are carrying the bacteria. Dr Matthew Snape, from the University of Oxford’s Vaccine Groups, said: “Participants will not only get a vaccine that reduces their risk of meningitis but also help us understand if we can prevent the bug being carried and potentially spread to others.” Participants are being recruited through schools in 14 towns and cities in England, Scotland and Wales. ]]> https://biospectrumindia.com/news/57/10663/global-health-partners-adopt-bioinformatics-platform-for-tb-diagnosis.html https://biospectrumindia.com/news/57/10663/global-health-partners-adopt-bioinformatics-platform-for-tb-diagnosis.html Tue, 27 Mar 2018 10:55:00 +0530 The World Health Organization (WHO), the Foundation for Innovative New Diagnostics (FIND) and the Critical Path Institute (C-Path), recently announced that the Relational Sequencing for Tuberculosis (ReSeqTB) Platform, a global TB knowledgebase for predicting TB drug resistance, will be adopted as the WHO bioinformatics platform for surveillance of drug-resistant TB (DR-TB). The development of ReSeqTB has been supported by the Bill & Melinda Gates Foundation, and renewed funding has been applied for to support integration into the WHO Sequencing-based TB Drug Resistance Surveillance Programme. The platform will also serve as a resource for the development of global policies on new TB diagnostics and will ultimately support clinical management of DR-TB. ReSeqTB serves a diverse TB community to rapidly evaluate phenotypic antimicrobial resistance from raw sequence data from Mycobacterium tuberculosis (Mtb) in clinical samples – enabling large-scale, culture-free surveillance of TB drug resistance and informing development of new diagnostics and treatment regimens. It is designed to capture, analyse and report in-country data on mutations associated with TB drug resistance based on an expert-graded mutations list. In this new project phase, the ReSeqTB platform will support surveillance and global policy development for sequencing-based clinical diagnosis of DR-TB. It could also serve as a model for the broader goals of establishing global antimicrobial resistance surveillance and clinical diagnosis networks for WHO high-priority pathogens. ]]> https://biospectrumindia.com/news/57/10649/ping-an-technology-wins-recognition-yet-again.html https://biospectrumindia.com/news/57/10649/ping-an-technology-wins-recognition-yet-again.html Fri, 23 Mar 2018 17:55:00 +0530 The results of the Indian Diabetic Retinopathy Image Dataset (IDRiD) fundus analysis competition organized by the IEEE International Symposium on Biomedical Imaging (ISBI) were recently announced. Ping An Technology's PAMIA (Ping An Medical Imaging Assistant) performed head and shoulders above its peers, including a world first in EX (hard exudates) image segmentation, world second in HE (bleeding) segmentation and world third in MA (microaneurysm) segmentation task.  This is the second time this year that Ping An Technology has garnered awards in a world-class competition in the medical imaging research sector, heralding another milestone for the company in artificial intelligence. Earlier in the year, PAMIA had set a new record for nodule detection with an accuracy rate of 95.1 percent, and beat its own previous record for false positive reduction with an accuracy rate of 96.8 per cent in the international authoritative Lung Nodule Analysis (LUNA) rankings for medical imaging. PAMIA ranks first worldwide when it comes to EX, the most difficult yet most important lesions segmentation challenge, while ranking among the top three globally for the segmentation of other lesions. The fundus image is different from other image scenarios, as these lesions only occupy a few dozen pixels. PAMIA, in order to ensure the detection sensitivity, combined its comprehensive advantages in the field of medical diagnosis and deep learning with its experience of setting new world records in the LUNA competition at the beginning of the year to design a new segmentation network that used deep and transfer learning theories to identify suspected lesions quickly and achieve boundary segmentation. At present, the marking and segmentation of lesions can be completed in a few seconds, greatly improving the reading speed and accuracy rate. Ping An Technology has achieved several milestones in the intelligent film reading field since 2016 when it entered the medical imaging sector. These achievements reflect the company's leadership and dominant position in the technologies related to medical imaging. With this award as a new milestone, PAMIA plans to devote itself to furthering its research on medical artificial intelligence, helping to achieve a strategic development goal for China's artificial intelligence sector. ]]> https://biospectrumindia.com/news/57/10648/revolutionary-drug-test-uses-fingerprint-detection.html https://biospectrumindia.com/news/57/10648/revolutionary-drug-test-uses-fingerprint-detection.html Fri, 23 Mar 2018 16:05:00 +0530 A fingerprint test published in AACC's Clinical Chemistry journal can tell whether someone has taken heroin or cocaine, and accurately distinguishes between drug users versus individuals who were exposed to drug residue in the environment. This breakthrough study brings fingerprint drug testing one step closer to clinical adoption, which could revolutionize drug testing by making it both simpler and nearly impossible to cheat.  Traditional drug tests have many limitations, though. Blood tests, for example, are invasive and require trained staff to collect samples, urine test samples are extremely easy to adulterate, and saliva tests—though noninvasive and more tamper-resistant have a short window of detection. A team of researchers led by Melanie Bailey, PhD, of the University Of Surrey, U.K. developed a test that overcomes these issues by using a fingerprint to detect cocaine use. With this latest study, Bailey's team has improved on their 2017 test by developing a new fingerprint test protocol for both cocaine and heroin that uses the gold standard drug testing method, liquid chromatography-mass spectrometry (LC-MS), and that is minimally impacted by environmental contamination.  To develop this method, Bailey's team collected fingerprints before and after handwashing from 50 non-drug users and from 25 individuals who testified to taking either cocaine (13) or heroin (12) in the past 24 hours. The researchers took corresponding saliva samples for comparison. Additionally, to make sure the method accounted for environmental contamination, the researchers collected a third set of fingerprints from the non-drug users after they shook hands with the drug users. After analyzing the fingerprints with LC-MS for both heroin and the heroin metabolite 6monoacetylmorphine, the researchers found that this protocol identified 100% of heroin users even after handwashing and only gave a false positive for one non-drug user who shook hands with a drug user. The researchers also used LC-MS to test for cocaine and its metabolite benzoylecgonine, which identified 85% of cocaine users after handwashing and produced no false positives for the non-drug users who came in contact with drug users. Significantly, for both heroin and cocaine the fingerprint test correctly identified more drug users than saliva testing. The test could help bring about a huge change in drug testing and diagnostic sector and ultimately leads major contribution in healthcare industry. ]]> https://biospectrumindia.com/news/57/10637/nihr-launches-new-national-standards-for-research.html https://biospectrumindia.com/news/57/10637/nihr-launches-new-national-standards-for-research.html Thu, 22 Mar 2018 12:15:00 +0530 A set of national standards in order to improve the quality and consistency of public involvement in research was launched at the 2018 Patients First Conference which was jointly hosted by the AMRC and the ABPI – and at the Involving People Network Annual Meeting 2018. Una Rennard, NIHR INVOLVE Advisory Group member said: “Patients and the public bring a unique perspective to research, improving accessibility, quality and relevance by, for example, helping to ensure the language and content of study information is appropriate. As a public contributor I want to ensure proposed research is asking questions that are important to patients and is acceptable to potential participants.” The standards aim to provide people with clear, concise benchmarks for effective public involvement alongside indicators against which improvement can be monitored. They are intended to encourage approaches and behaviours that will support this. They have been developed through a UK-wide partnership over the last 18 months building on previous work in this area. The partnership brings together members of the public with representatives from the National Institute for Health Research (England), the Chief Scientist Office (Scotland), Health and Care Research Wales and the Public Health Agency (Northern Ireland), working with an independent expert. Dr Dan Venables, Head of Public Involvement & Engagement, Health and Care Research Wales said: “We know that the quality of public involvement varies greatly across research projects and organisations. The national standards clearly describe a vision for excellent public involvement that we expect all research to aspire to, whilst also enabling us to identify and celebrate existing good practice” The six standards are a description of what good public involvement looks like, designed to encourage self-reflection and learning. They are not designed as rules, or to provide fixed ideas about public involvement in research. Simon Denegri, NIHR Director of Patients, Carers and The Public said: “I am absolutely delighted to see the Public Involvement Standards reach the next milestone in their development at the Patients First conference today. My congratulations and thanks to those organisations who will be 'test beds' for the standards over the next 12 months. They will be playing a really important role in making them roadworthy for future users. “In the future, we want the standards to be seen by groups and organisations large and small; public, private and charitable as an essential tool in guiding their public involvement. I firmly believe the pioneering partnership that has been at the heart of these standards all along can only strengthen their case in this regard.” The focus is on testing these standards in the coming year. The partnership will be working with ten pilot sites across the UK as they put the standards to practical use in their own working environment. These sites will be based at the Asthma UK Centre for Applied Research, Sheffield Teaching Hospitals NHS Foundation Trust, Keele University, the Kidney Patient Involvement Network, Queen’s University Belfast, the University of Glasgow, the Royal College of Obstetricians and Gynaecologists Women’s Network, the Royal College of Speech and Language Therapists, Manchester University NHS Foundation Trust and the Wales School for Social Care Research and CADR (The Centre for Ageing and Dementia Research). Beyond this the partnership is encouraging as many groups and organisations as possible to use the standards in their workplace and share learning and experiences. With over 50 organisations applying to be pilot sites it is clear that, across the entire UK health research system, there is now a real commitment to involve patients, carers and the public so that research is done with their interests and priorities in mind. Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI) said: “Researching and developing new, life-changing medicines is best when done collaboratively. Today’s announcement from the NIHR sets out clear standards for how the pharmaceutical industry should work with patients to develop better vaccines and medicines. “With 7000 new medicines in development by our members, the future of medicine is exciting. These standards will help ensure patients are at the heart of cutting-edge clinical research for much-needed diseases like cancers, diabetes and Alzheimer’s.” Aisling Burnand MBE, Chief Executive, Association of Medical Research Charities said: “We welcome the addition of these standards for public involvement in research. They provide a degree of consistency across different R&D sectors and articulate the responsibilities on all of us to strive towards meeting them. I particularly welcome the fact that they accentuate what good public involvement looks like. “Until relatively recently, public involvement was still unheard of as a concept in many fields of research. I am proud that AMRC members are now leading the charge in this area. Patients First provides us with an opportunity to become advocates for pioneering partnerships that put patients at the centre of all we do. These standards are a helpful framework allowing us to do that.” In a recent NIHR-funded feasibility study to help patients manage their epilepsy, involving a group of people with learning disabilities was key to success, reports NIHR website. Epilepsy is hard to control with drugs and 60-70% of people with learning disabilities will continue to have seizures despite medication. With very few alternatives available, Books Beyond Words - which provides books, services and training for people who find pictures easier to understand than words - became the focus of a Hertfordshire Partnership University NHS Foundation Trust study, as the team set out to evaluate the resources for people with epilepsy. The team involved the public and patients from the beginning, at which point they presented to groups and gathered input into the study design. This process led to a number of changes in the initial plans and this was just the start. During the study, the team really began to reap the rewards of involving patients and the public in their project. They found patients and the public added a pragmatic element that enabled the team to make changes throughout the study. Dr Silvana Mengoni, researcher on the study said: “Patients have a valuable voice that often isn’t heard in research. Often patient and public involvement happens at the beginning of a study to help design it, and then at the end for disseminating results but it can be largely overlooked during the running of a study. This was a crucial time for us to be engaging with our reference group and our study changed in a number of ways as a result of their input.”   ]]> https://biospectrumindia.com/news/57/10623/semaglutide-injection-as-a-solution-for-obesity.html https://biospectrumindia.com/news/57/10623/semaglutide-injection-as-a-solution-for-obesity.html Tue, 20 Mar 2018 12:20:00 +0530 Adults with obesity treated with semaglutide 0.4 mg administered once-daily via subcutaneous injections lost up to 13.8% of their body weight after 52 weeks in a phase 2 trial, significantly more than those treated with placebo who lost 2.3% of their body weight. An oral presentation of data from this trial investigating the safety and efficacy of semaglutide as a potential treatment for adults with obesity took place at the Endocrine Society's annual meeting in Chicago (ENDO).  The results were from a phase 2, 52-week double blind dose-ranging study of once-daily semaglutide versus placebo and liraglutide 3 mg as active control. All trial participants also received dietary and physical exercise counselling. In the trial, 83% of people treated with semaglutide 0.4 mg lost greater than or equal to 5% of their body weight (compared to 23% with placebo and 66% with liraglutide 3 mg) and 65% lost greater than or equal to 10% (compared to 10% with placebo and 34% with liraglutide 3 mg). "In line with our long-term commitment, we plan to start the STEP phase 3 clinical development programme later this year to explore the potential of once-weekly semaglutide as a treatment for people with obesity," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.  ]]> https://biospectrumindia.com/news/57/10616/merz-pharma-unveils-anti-aging-therapies-on-110th-anniversary.html https://biospectrumindia.com/news/57/10616/merz-pharma-unveils-anti-aging-therapies-on-110th-anniversary.html Mon, 19 Mar 2018 11:00:00 +0530 Merz Pharma, an international healthcare company specializing in the fields of dermatology, neurology and metabolic disorders recently celebrated its 110th anniversary. Merz is a global leader in the pharmaceutical industry headquartered at Frankfurt, Germany. Merz anniversary celebration event was to align everyone to the fact that Merz Pharma completes 110 years, Merz India completes 3 years and Merz India has all the products for the Indian doctors to achieve the most well-proportioned face in people and making them more beautiful. Mr. Raymond Ong, Regional commercial director-Merz APAC, Dr David Chang, Senior manager-Merz medical affairs, Manju Garg, Country Head-Merz India and Noorin Sha who is an actor, last seen in the movie ABCD who has facial measurements as per the golden ratio were a part of the celebration. Dr Sonja Sattler, a doctor from Germany who has wide experience in using botulinum toxins and finds merit in the use of PURE incobotulinum toxin i.e. Xeomin was the guest of honour. The event also showcased a wide-ranging portfolio of aesthetic products offered by Merz India which includes Ultherapy, the only U.S. FDA-cleared non-invasive skin lifting and tightening ultrasound device, Xeomin (IncobotulinumtoxinA), Belotero (hyaluronic acid dermal filler) that enables physicians in India to meet the aesthetic needs of patients. “Ulthera has more than 1 million users globally” says Manju Garg, country head, Merz India. The pure truth of anti-ageing therapies was unveiled at the celebration with 4 key messages about Xeomin: Truly effective treatment performance: XEOMIN results are clinically proven. Efficacy and safety is well established and significant improvements are seen when the treatment is used for glabellar lines. Highly purified: Xeomin is a botulinum neurotoxin uniquely free from complexing proteins thus providing the lowest possible risk of antibody formation. The unique manufacturing process of Xeomin removes complexing proteins which are not needed for therapeutic effect. Xeomin is distinct from other products as Xeomin is a purified neurotoxin which does not come with complexing proteins. Complexing proteins are foreign proteins, with the potential to stimulate neutralising antibodies. These neutralising antibodies act against the neurotoxin and may result in partial or complete treatment failure. This assumption is backed by recently released clinical data as in aesthetic practice, secondary treatment failure is being recognized more frequently. Five practices reported cases of treatment failure linked to neutralising antibody formation after the administration of conventional botulinum toxin containing complexing proteins. Thus, choosing a neurotoxin free from complexing protein provides low risk More than a decade of trust and value: US FDA approved. Highly stable – This is an added advantage for the physicians since there is no need for refrigeration for shipping and storage. “We are focused on constant innovation and product development” said Mr Raymond Ong, Regional commercial director, Merz APAC. Merz Aesthetics serves the Indian practitioners more than just products. Merz Aesthetics is the 1st Pharma company to launch a new medical guideline to help aesthetic doctors achieve well-proportioned faces in Asians. “I am very happy to be in India for the 110th anniversary of Merz Pharma. Xeomin is a superior and the purest toxin available in the world at the moment” said Dr Sonja Sattler. ]]> https://biospectrumindia.com/news/57/10609/proteostasis-therapeutics-receives-fda-approval-for-cystic-fibrosis-drug.html https://biospectrumindia.com/news/57/10609/proteostasis-therapeutics-receives-fda-approval-for-cystic-fibrosis-drug.html Fri, 16 Mar 2018 13:55:00 +0530 Proteostasis Therapeutics, Inc. , a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for PTI-428, the Company’s cystic fibrosis transmembrane conductance regulator (CFTR) amplifier drug candidate.  “This is the second important regulatory designation PTI-428 has been granted from the FDA this week, highlighting our amplifier’s potential to provide clinical benefit in the treatment of CF,” said Meenu Chhabra, president and chief executive officer of Proteostasis Therapeutics." The FDA Office of Orphan Products Development grants Orphan Drug Designation to novel drugs or biologics that are intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the United States. The designation allows the sponsor of the drug to be eligible for various incentives, including a seven-year period of U.S. marketing exclusivity upon regulatory approval of the drug, as well as tax credits for clinical research costs, annual grant funding, clinical trial design assistance, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees. About PTI-428 PTI-428 is an investigational CFTR amplifier in development for the treatment of CF in patients who are homozygous for the F508del mutation in the CFTR gene as an add-on therapy to approved CFTR modulators or as part of PTI’s proprietary triple combination regimen that includes PTI-808, a potentiator, and PTI-801, a corrector. PTI-428 has been shown to work early during CFTR biogenesis to increase levels of newly synthesized CFTR protein, suggesting potential therapeutic benefits in combination with CFTR correctors and potentiators. In addition to Orphan Drug Designation, PTI-428 has been granted Breakthrough Therapy Designation as well as Fast Track Designation from the FDA. In December, Proteostasis announced the results from a Phase 2, randomized, placebo controlled study of PTI-428, in 24 CF subjects on background Orkambi therapy which showed that treatment with PTI-428 led to mean absolute improvement in percent predicted forced expiratory volume in 1 second (ppFEV1) of 5.2 percentage points from baseline through Day 28 compared to placebo (p<0.05). Proteostasis plans to initiate a triple combination CF Study of PTI-428 with PTI-801, its third generation corrector, and PTI-808, its potentiator, in the second quarter of 2018, with preliminary results anticipated in the second half of 2018. The Company is also planning an additional study of PTI-428 in CF Subjects on Symdeko™, with initial data anticipated in early 2019. ]]> https://biospectrumindia.com/news/57/10607/mda-collaborates-with-iqvia-to-expand-disease-registry.html https://biospectrumindia.com/news/57/10607/mda-collaborates-with-iqvia-to-expand-disease-registry.html Fri, 16 Mar 2018 12:55:00 +0530 The Muscular Dystrophy Association (MDA) is enhancing and expanding its disease registry into a comprehensive data hub as part of a new initiative with IQVIA (NYSE: IQV), a company known worldwide for its expertise in cutting-edge information management, analytics and technology. The new initiative will be called the MOVR (NeuroMuscular ObserVational Research) Data Hub. The enhancements will capitalize on improvements in health care information technology and systemically unify and aggregate both clinical and genetics data with patient-reported information. The updated technology platform will roll out in 2018 and become fully implemented at 50 MDA Care Centers in 2019. During this time, MDA will add three additional diseases to the four already covered in MOVR: amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD). The three new diseases will be identified later in 2018. "MDA is excited to partner with IQVIA as we ramp up our efforts to advance research and transform care to improve outcomes and bring innovative and life-changing solutions to individuals living with neuromuscular disease. Within the next year, MOVR will be the most comprehensive neuromuscular disease resource in the nation for patient and genetic data," said MDA President and Chief Executive Officer Lynn O'Connor Vos. "We are rapidly approaching the day when people will be able to benefit from personalized medicine, and MDA and IQVIA insights and data will provide the foundation and support for the advanced research it will take to get us there for so many of these patients." MDA's alliance with IQVIA will improve the ability for researchers and health care providers to identify precision medicine treatments, enhancing options for care. The new infrastructure will broaden research opportunities focused on the development of novel drugs. MOVR's digital health module will expand patient and clinical data collection methods, allowing for patient-reported outcomes to be captured via smartphone and rapidly integrated with clinical data obtained during patient and telemedicine visits. Tens of thousands of individuals living with neuromuscular disease will benefit from MOVR initially, with the full scope likely to grow as diseases are added. "Transforming rare disease care and research requires a more ambitious approach to the real-world evidence generation," said Brian Kelly, M.D. and president, Payer & Provider Solutions, IQVIA. "A central Data Hub that allows the collection of clinical information, patient-reported outcome data, and allows for the integration of that data with genomic and other data types will accelerate improvements in drug development and clinical care." MDA looks forward to fostering cross-sector collaborations with both the academic and private sectors to leverage this initiative. Two major areas of focus for MOVR will be clinical care and drug development, with specific emphasis on benchmarking quality of care, safety and effectiveness of new treatments, natural history of disease and genotype-phenotype correlation. "MOVR will help reduce barriers to therapy development by serving as a resource for patient recruitment to clinical trials and creating a global unique identifier (GUID) for patients matching longitudinal data to other data repositories," said Grace Pavlath, Ph.D., MDA senior vice president and scientific director. "MDA is eager to implement some of the more promising uses of the new system, including the ability of MOVR to capture clinical data for patients using newly approved drugs, as well as for pre-symptomatic infants identified through newborn screening programs." The collaboration between MDA and IQVIA will expand on the pilot registry, which was established in 2013 by MDA. The registry database originated with clinician-entered data from visits to a subset of MDA Care Centers and was populated with a range of clinical data including diagnostic tests, clinical measures and interventions. Since the pilot phase, this data has been used by neuromuscular disease specialists and researchers to progress in the field.   ]]> https://biospectrumindia.com/news/57/10602/arsanis-gets-patent-from-uspto-for-asn100.html https://biospectrumindia.com/news/57/10602/arsanis-gets-patent-from-uspto-for-asn100.html Thu, 15 Mar 2018 17:50:00 +0530 Arsanis, Inc.,a clinical-stage biopharmaceutical company focused on applying monoclonal antibody immunotherapies to address serious infectious diseases, announced that the United States Patent and Trademark Office ("USPTO") issued U.S. Patent No. 9914767 to the company. This patent broadly claims composition of matter for antibodies that cross-neutralize Staphylococcus aureus alpha hemolysin (Hla) and up to four additional S. aureus leukocidins targeted by ASN-1, one of the two antibodies in the company’s lead product candidate, ASN100. ASN100 is a combination of two fully human monoclonal antibodies (mAbs) that together neutralize the six cytotoxins critical to S. aureus pneumonia pathogenesis, including toxins that damage lung tissue and destroy human immune cells. This patent grants intellectual property protection in the United States through 2033. “The USPTO granting of this important patent follows similar patents for the composition-of-matter for these cross-reactive antibodies, including patent grants issued by the European Patent Office in 2015, and by the Japan Patent Office and IP Australia in 2017,” said Michael Gray, chief operating officer and chief financial officer of Arsanis. “We plan to continue our efforts to strengthen our intellectual property portfolio for ASN100 and our other pipeline programs.” ]]> https://biospectrumindia.com/news/57/10595/who-south-east-asia-countries-commit-to-end-tb-by-2030.html https://biospectrumindia.com/news/57/10595/who-south-east-asia-countries-commit-to-end-tb-by-2030.html Wed, 14 Mar 2018 21:35:00 +0530 Tracking progress to eliminate tuberculosis, Member countries of WHO South-East Asia Region committed to further intensifying efforts to ensure rapid and concrete progress to End TB by 2030. In a statement adopted at the Delhi End TB Summit held recently, member countries unanimously agreed to actualizing and intensifying essential actions agreed to in the Delhi Call to Action which was adopted in March last year to accelerate efforts to End TB in the Region, host to one fourth of the global population but a disproportionate 46% of the global TB burden. Dr Tedros Adhanom Ghebreyesus, Director-General, World Health Organization said, “Progress against TB in this Region will have a major impact on the progress globally. Too much is at stake, we cannot afford to fail. We must remember that the war against TB will be won in communities. It will be won by nurses, doctors, community health workers and others at the frontlines. We must give them the resources they need to find every last person with TB, to diagnose them, to treat them, and to cure them.” Welcoming the statement, Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia, said, “it gives shape to our momentum and aspirations, and does so by setting out a series of strategic priorities which include establishing strong leadership of TB programmes at the national level; increasing budgetary and human resource allocations to TB programmes from domestic and global sources; enabling each and every TB patient to access the best possible care available; and supplementing medical care for TB with social and financial protection.” Hosted by the Ministry of Health and Family Welfare, Government of India, the World Health Organization and the Stop TB Partnership, the Delhi End TB Summit 2018 was inaugurated recently by the Prime Minister of India. Reviewing efforts being made to end TB since the adoption of the Delhi Call for Action on 16 March 2017, Member countries noted that though efforts have been strengthened with increased attention, investments and initiatives; the stepped-up response was falling short of what was required to reach the critical thresholds for ending TB. The Member countries of the Region stressed their firm intent to collectively reach out to 2 million missing TB cases and 150 000 multidrug-resistance cases by 2020 and implement a response that is demonstrably adequate for ending TB. In the statement, the countries committed to multisectoral and empowered national initiatives, reporting to the highest levels of government, to lead the TB programme. The Member countries committed to increasing budgetary and human resource allocations by governments as well as by their global, domestic and other partners so as to ensure that national TB plans are fully funded. They also committed to universal access to comprehensive, integrated TB care and prevention services, to achieve universal health coverage as committed to in the Sustainable Development Goals, by enabling the best possible care to each and every person, including migrants, the aged and other high-risk populations, living with any form of TB including drug-resistant TB and TB-HIV co-infections. To address the challenge of TB in a holistic manner, the Member countries agreed to supplement medical care for TB with social and financial protection in both high and lower incidence countries. As member countries committed to ‘working together to end TB’, WHO reiterated that it stands with the Stop TB Partnership and all partners to make that vision a reality. Dr Lucica Ditiu, The Stop TB Partnership’s Executive Director and Peter Sands, Global Fund’s Executive Director were among the prominent health leaders attending the week-long meeting. The health ministers of a number of countries including Sri Lanka, Indonesia, Bangladesh, Nigeria, Mozambique, Zimbabwe, Kazakhstan and Peru also participated. The Summit sets the stage for the September 2018 United Nations High-Level Meeting on TB. For the first time TB will be discussed in the UN General Assembly at the Heads of State level. The UN high-level meeting is expected to endorse an ambitious set of goals to put the world on course to ending TB. ]]> https://biospectrumindia.com/news/57/10593/agc-biologics-sign-up-new-sr-vice-presidents-of-bd.html https://biospectrumindia.com/news/57/10593/agc-biologics-sign-up-new-sr-vice-presidents-of-bd.html Wed, 14 Mar 2018 15:15:00 +0530 AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced the appointment of Axel Schleyer as Senior Vice President of Business Development, North America, and Christoph Winterhalter as Senior Vice President of Business Development, Europe. Mr. Schleyer and Mr. Winterhalter will report to Robert Broeze, Chief Business Officer.  Mr. Schleyer brings more than 17 years of leadership experience in business development and key account management for pharmaceutical, biotechnology, and contract manufacturing organizations. Along with his deep industry expertise, he holds a demonstrated track record of building and leading high-performance teams, spearheading international business development initiatives, and designing and implementing strategic business plans across the globe. He most recently served as Vice President of Business Development - Americas & Asia/Pacific at Boehringer Ingelheim, where he was responsible for driving business efforts and strategic direction with an emphasis on the US and Asia, as well as establishing strong operational presence and strengthening international market awareness.  Mr. Winterhalter brings more than 20 years of business development leadership experience within Life Sciences organizations throughout Europe and the US. He has a strong background in assembling and managing successful teams, and implementing strategic global business development plans within diverse and multicultural environments. He most recently served as Senior Vice President at Rentschler Biotechnologie GmbH, where he was responsible for global strategy development and execution, development of new business models, account management, and cultivation of key alliances.  Under the AGC Biologics name, and with the support of Mr. Schleyer and Mr. Winterhalter, the company will maintain and grow its global presence with microbial and mammalian capabilities, fulfilling early-phase through commercial production, both at small and large-scale. ]]> https://biospectrumindia.com/features/57/10588/multi-specific-antibodies-to-target-hiv-1-virus-strains.html https://biospectrumindia.com/features/57/10588/multi-specific-antibodies-to-target-hiv-1-virus-strains.html Wed, 14 Mar 2018 11:30:00 +0530 A team of researchers at IBBR, led by Dr. Yuxing Li, Associate Professor at the University Of Maryland School Of Medicine, Baltimore, and Principal Investigator at the Institute for Bioscience and Biotechnology Research (IBBR), Rockville, is showing how engineered multi-specific antibodies appear to be highly effective at preventing infection across a broad range of HIV-1 virus strains.  Effective treatment of HIV infection currently involves using combinations of antiretroviral drugs (ARV).  While ARV treatment can improve the overall quality of life of HIV-positive individuals, better alternative treatments are needed since they can cause undesirable side effects and patients can become resistant to ARV therapy.  Immunotherapeutics, molecules derived from the immune system, can be used to specifically target and neutralize HIV-1 virus particles.  Several of these broadly neutralizing antibodies (bNAbs) are being developed and preliminary trials indicate that these individual bNAbs are safe, well-tolerated, and can reduce HIV-1 infection early on. However, treatment is not associated with long-term reductions in virus levels and, due to HIV's ability to rapidly mutate, resistant strains can emerge.  Additionally, the risk of transmission still exists.  Dr. Li's laboratory successfully created a bispecific antibody (bi-NAb) combining two bNAbs and tested it on a panel of 208 strains of HIV virus that are prevalent in humans.  The bi-NAb neutralized 95% of the circulating HIV-1 viruses, which is superior to any single agent.  "We further improved antiviral potency by engineering a tri-NAb and found that it can inhibit 99.5% of circulating HIV-1 viruses." said Dr. Li. This technology could lead to development of the broadest-spectrum anti-HIV-1 immunotherapeutic and preventive treatment that exist worldwide. This work was supported, in part, by the University of Maryland Strategic Partnership: MPowering the State and by a Maryland Innovation Initiative (MII) award from the Maryland Technology Development Corporation (TEDCO) to Dr. Yuxing Li. ]]> https://biospectrumindia.com/news/57/10567/jonathan-goff-step-up-the-ladder-to-vp-and-youlin-pan-named-senior-research-fellow-at-gelest.html https://biospectrumindia.com/news/57/10567/jonathan-goff-step-up-the-ladder-to-vp-and-youlin-pan-named-senior-research-fellow-at-gelest.html Thu, 08 Mar 2018 11:15:00 +0530 Dr. Jonathan Goff has been promoted to Vice President of Research & Development at Gelest, Inc., and Dr. Youlin Pan has been named Senior Research Fellow, adding to his current title of Senior R&D Manager. Dr. Goff will broaden his role as a strategic partner in facilitating customer relationships, research initiatives and operational efficiencies. He will continue to manage the Polymer Development and Technical Services groups and to help lead the Silanes & Metal-Organics and Research Engineering groups. An 8-year veteran of Gelest, Dr. Goff has been an integral part of the Research & Development team’s growth. Dr. Pan is Senior Research & Development Manager of Silanes & Metal Organics, and Senior Research Fellow. In addition to continuing to manage his research & development group, Dr. Pan will broaden his role in developing and expanding the capabilities of Gelest Research & Development and overall operations. He has been with Gelest for over 21 years, and is a trusted resource for silicon and metal-organic chemistry expertise. ]]> https://biospectrumindia.com/news/57/10560/zimmer-biomet-displays-their-innovative-products-at-aaos-2018.html https://biospectrumindia.com/news/57/10560/zimmer-biomet-displays-their-innovative-products-at-aaos-2018.html Wed, 07 Mar 2018 12:00:00 +0530 Zimmer Biomet Holdings, Inc. a global leader in musculoskeletal healthcare. It design, manufacture and market orthopedic reconstructive products. The company has announced it will be showcasing its latest commercial offerings and previewing its next generation of technological innovations at the American Academy of Orthopedic Surgeons (AAOS) Annual Meeting, March 6-10 in New Orleans, Louisiana. Zimmer Biomet has the most expansive and comprehensive portfolio of products and services in the industry. The company will connect with orthopedic professionals from around the world at AAOS. Newly FDA-Cleared Persona® Partial Knee System, Persona® Trabecular Metal™ Tibia, Comprehensive® Augmented Baseplate and Sidus® Stem-Free Shoulder Featured Onsite and Highlighted as a Part of Educational Series ]]> https://biospectrumindia.com/news/57/10523/us-researchers-develop-saliva-based-test-for-zika-virus.html https://biospectrumindia.com/news/57/10523/us-researchers-develop-saliva-based-test-for-zika-virus.html Fri, 02 Mar 2018 15:45:00 +0530 Researchers at New York University College of Dentistry (NYU Dentistry) and Rheonix in the US are developing a new test that uses saliva to detect nucleic acids and antibodies of the Zika Virus. Based on an existing test model created by the firms for fast detection of HIV, the Zika test is said to identify the viral diagnostic markers much quicker than existing tests. A blood sample processed with real-time polymerase chain reaction (RT-PCR) is commonly used to test for the Zika virus, followed by a separate step for detecting antibodies. As the virus in the blood sample disappears in seven to 14 days but stays longer in saliva, researchers believe that the new test could be a better, non-invasive and cost-effective alternative to test for both the virus and antibodies. The researchers also adopted isothermal amplification that is said to detect virus’ nucleic acids in just 20 minutes and antibodies within an hour by using Zika-specific antigens. ]]> https://biospectrumindia.com/news/57/10513/roche-and-takeda-to-use-organ-chip-technology-for-their-rd.html https://biospectrumindia.com/news/57/10513/roche-and-takeda-to-use-organ-chip-technology-for-their-rd.html Thu, 01 Mar 2018 15:25:00 +0530 Roche and Takeda have announced that they will be using organ-chip technology in their R&D Programs through partnerships with Emulate, the biotech startup behind organs-on-a-chip. Emulate and Roche have formed a three-year partnership to use organ-chips for testing the efficacy and safety of new antibody therapeutics and combination therapies.  Working in a jointly-run lab, researchers hope to use the chips to gain further insight into disease mechanisms and to increase predictability and early detection of biomarkers. The collaboration will initially use lung-chips and brain-chips with the possibility of using other organ-chips.  The partnership with Takeda will use Emulate’s intestine-chip in the R&D of drugs to treat gastrointestinal (GI) diseases. The intestine-chip can be used to recreate the mechanisms of the intestinal lining, which is understood to be associated with many GI diseases.        ]]> https://biospectrumindia.com/news/57/10505/astrazeneca-to-focus-on-autoimmune-diseases-with-new-drugs.html https://biospectrumindia.com/news/57/10505/astrazeneca-to-focus-on-autoimmune-diseases-with-new-drugs.html Thu, 01 Mar 2018 10:10:00 +0530 British drugmaker AstraZeneca will be spinning off six early-stage experimental drugs into a new $250 million standalone biotech company Viela Bio, focused on severe autoimmune diseases. AstraZeneca will retain a significant interest as Viela Bio's largest minority shareholder. Viela Bio's potential new medicines include inebilizumab for neuromyelitis optica, a rare disease affecting the optic nerve and spinal cord of around five in 100,000 people. The drug has orphan drug status and could be filed for approval in late 2019 or early 2020. However, the deal does not include anifrolumab, a promising treatment in final-stage clinical testing that AstraZeneca is developing for lupus, a chronic autoimmune disease with limited treatment options. Viela Bio will be based in Gaithersburg, Maryland, and will be funded with $250 million from a consortium of investors led by Boyu Capital, 6 Dimensions Capital and Hillhouse Capital. The new company's chief executive is Bing Yao, currently head of respiratory, inflammation and autoimmunity at AstraZeneca's MedImmune innovative medicines unit. ]]> https://biospectrumindia.com/news/57/10495/study-reveals-low-magnesium-levels-make-vitamin-d-ineffective.html https://biospectrumindia.com/news/57/10495/study-reveals-low-magnesium-levels-make-vitamin-d-ineffective.html Tue, 27 Feb 2018 12:50:00 +0530 A review published in The Journal of the American Osteopathic Association found Vitamin D can't be metabolized without sufficient magnesium levels, meaning Vitamin D remains stored and inactive for as many as 50 percent of Americans. "People are taking Vitamin D supplements but don't realize how it gets metabolized. Without magnesium, Vitamin D is not really useful or safe," says study co-author Mohammed S. Razzaque, MBBS, PhD, a professor of pathology at Lake Erie College of Osteopathic Medicine. Razzaque explains that consumption of Vitamin D supplements can increase a person's calcium and phosphate levels even if they remain Vitamin D deficient. The problem is people may suffer from vascular calcification if their magnesium levels aren't high enough to prevent the complication.  Deficiency in either of these nutrients is reported to be associated with various disorders, including skeletal deformities, cardiovascular diseases, and metabolic syndrome. Researchers say the magnesium consumption from natural foods has decreased in the past few decades, owing to industrialized agriculture and changes in dietary habits. ]]> https://biospectrumindia.com/news/57/10490/a-new-brain-mapping-technique-will-tell-who-you-are-thinking-about-.html https://biospectrumindia.com/news/57/10490/a-new-brain-mapping-technique-will-tell-who-you-are-thinking-about-.html Tue, 27 Feb 2018 11:25:00 +0530 Scientists have developed a new mind-reading technology that analyses brain waves to recreate the facial image a user is thinking about.  The technique, developed by Dan Nemrodov, a postdoctoral fellow at the University of Toronto Scarborough, is able to digitally reconstruct images seen by test subjects based on electroencephalography (EEG) data. “When we see something, our brain creates a mental percept, which is essentially a mental impression of that thing. We were able to capture this percept using EEG to get a direct illustration of what’s happening in the brain during this process,” said Mr. Nemrodov.  For the study, published in the journal eNeuro, test subjects hooked up to EEG equipment were shown images of faces. Their brain activity was recorded and then used to digitally recreate the image in the subject’s mind using a technique based on machine learning algorithms.  The study provides validation that EEG has potential for this type of image reconstruction, something many researchers doubted was possible given its apparent limitations. ]]> https://biospectrumindia.com/news/57/10476/texas-cardiac-arrhythmia-institute-to-host-eplive-2018.html https://biospectrumindia.com/news/57/10476/texas-cardiac-arrhythmia-institute-to-host-eplive-2018.html Mon, 26 Feb 2018 12:20:00 +0530 On March 1 and 2, 2018, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center will host its fourth international symposium on complex arrhythmias, EPLive 2018. EPLive is an intensive, two-day educational meeting for practicing clinical cardiac electrophysiologists, electrophysiologist fellows and general cardiologists who have an interest in treating complex arrhythmias, a condition in which the heart beats with an irregular or abnormal rhythm.  This event draws leaders in the field of electrophysiology from across the globe and gives the opportunity to shape physician practices and expand the scope of electrophysiology treatment options available to all patients.  EPLive is designed to help attendees gain a better understanding of techniques used to treat atrial and ventricular arrhythmias, implant complex devices and extract malfunctioning devices.  EPLive consists of four sections: Atrial Fibrillation (A Fib) ablation, Ventricular Tachycardia (VT) ablation, Devices and New Technology. The sessions consist of a combination of live and recorded cases from some of the world's premier centers. Cases include procedures such as A Fib ablation, ventricular tachycardia (VT) ablation, epicardial and endocardial VT ablation, left atrial appendage closures, lead extraction and venoplasty. EPLive will also feature new technology pioneered by physicians at TCAI. The conference will also focus on a variety of objectives, including: Evaluating techniques used to map and ablate atrial and ventricular arrhythmias Identifying processes to reduce complications and promote safety measures for the patient during ablation of A Fib and ventricular arrhythmias Applying interventional approaches learned in ablation of complex ventricular arrhythmias Demonstrating an understanding of the latest evidence and guidelines in arrhythmia management and treatment with new technology Applying interventional approaches that best utilize the new technologies demonstrated to maximize clinical outcomes. ]]> https://biospectrumindia.com/news/57/10471/philips-launches-focuspoint-to-reduce-costs-improve-operational-productivities.html https://biospectrumindia.com/news/57/10471/philips-launches-focuspoint-to-reduce-costs-improve-operational-productivities.html Mon, 26 Feb 2018 10:50:00 +0530 Royal Philips, a global leader in health technology, introduces FocusPoint, a network application management system to help improve biomedical and IT department productivity. The new technology provides operational alerts and statistical data to support the entire health ecosystem, from the IT department to the biomedical staff, allowing providers to increase system uptime and reduce costs associated with maintaining and servicing Philips medical devices, applications and networks. As the centerpiece of Philips remote-enabled services, FocusPoint builds on Philips’ leadership in patient monitoring with solutions tailored to specific customer needs, and integrating with the provider’s existing IT and biomedical systems and procedures.  As the shift toward value-based care continues, health systems are choosing to incorporate IT solutions into their hospital staff’s workflow to help support better use of resources, improve outcomes and optimize care. FocusPoint acts as a central point for the provider, showing which solutions are installed and running on the customer’s network. FocusPoint will be available in the US in the first half of 2018. ]]> https://biospectrumindia.com/news/57/10450/urgent-need-to-scale-up-health-services-in-coxs-bazar-who.html https://biospectrumindia.com/news/57/10450/urgent-need-to-scale-up-health-services-in-coxs-bazar-who.html Wed, 21 Feb 2018 15:05:00 +0530 Calling for continued efforts to further scale up health services for nearly 1.3 million people in Cox’s Bazar, Rohingyas and their surrounding host communities, the World Health Organization informed that six months after the start of the refugee crisis, the vulnerable populations remain at risk of several diseases and in need of critical services for survival. Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia said, “Commendable efforts have been made by the Government of Bangladesh and partner agencies to provide health services; prevent diseases such as cholera; and rapidly control outbreaks of measles and diphtheria. However, the challenges are huge, multiple and evolving. The magnitude of the crisis requires continued efforts and generous contributions by all partners to scale up health services for the vulnerable population.” An estimated 688, 000 Rohingyas crossed over to Cox’s Bazar from Myanmar beginning 25 August 2017, joining nearly 212 500 others who had arrived in earlier waves, in one of the largest population movement in the shortest span. While majority of the refugees are living in Kutapalong and Balukhali mega camps and 11 other clusters of small and big settlements, about 79 000 are living with the host population. The mega camps are currently one of the world’s biggest refugee settlement areas and also one of the world’s most densely populated areas. The health needs of this population continue to be immense. Women and young mothers need reproductive health services. An estimated 60 000 children are expected to be born in the camps in the next one year. Besides newborns, pregnant and young mothers; children, adults and the elderly need basic health services and that for injuries, trauma and various non-communicable diseases such as heart disease, diabetes, and importantly, psychosocial support. Stressing the need to accelerate efforts to address the key determinants of health on a priority the Regional Director said, “Water and sanitation, and shelter continues to be far from optimum, increasing the risk of rapid spread of several communicable and water borne diseases.” The upcoming rainy season and the risk of cyclone and floods, increase the vulnerability of these people to waterborne diseases such as diarrhea and hepatitis, and vector borne diseases such as malaria, dengue and chikungunya. For keeping a close watch on the situation, WHO established the Early Warning and Response System (EWARS), early as the crisis started, to rapidly detect and respond to disease outbreak to minimize death and disease. Additionally, WHO has been periodically carrying out risk assessments to enable Ministry of Health and partners take measures to detect potential health risks and take timely and appropriate measures. The EWARS and risk assessments helped Bangladesh’s decision to carry out large scale vaccination campaigns with cholera, measles and rubella, polio and diphtheria vaccines. WHO has been working with the Ministry of Health and partners to plan, roll out and monitor vaccination campaigns to ensure all children are protected. “The Government of Bangladesh has been extremely generous and forthcoming in hosting and providing for the Rohingyas. However, the health sector is grossly under-funded and grappling to meet the needs of the affected population,” Dr Khetrapal Singh said Reiterating WHO’s committed to work with the Ministry of Health and Family Welfare and partners to address health issues of the vulnerable population, the Regional Director said concerted efforts by both national and international community is the need of the hour to strengthen and reinforce health services for both the Rohingyas and their host population in Cox’s Bazar. ]]> https://biospectrumindia.com/news/57/10441/egalets-guardian-technology-receives-us-patent.html https://biospectrumindia.com/news/57/10441/egalets-guardian-technology-receives-us-patent.html Wed, 21 Feb 2018 11:35:00 +0530 Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, has received a US patent for its proprietary Guardian Technology. The patent covers the Guardian Technology two-component tablet architecture which provides precise drug delivery and can confer abuse-deterrent properties. The United States Patent and Trademark Office (USPTO) have issued patent number 9,884,029 covering Egalet-002. The patent offers protection through March 2024. Egalet has been granted a total of 20 US patents and 59 patents outside of the US that cover Guardian Technology and its product candidate ]]> https://biospectrumindia.com/news/57/10439/google-researchers-use-eye-scan-to-detect-heart-risk.html https://biospectrumindia.com/news/57/10439/google-researchers-use-eye-scan-to-detect-heart-risk.html Tue, 20 Feb 2018 14:15:00 +0530 Eye scans using deep learning technique are all that one may soon need to gauge whether he or she is prone to heart ailments in near future, according to a study by scientists at Google Research, Verily Life Sciences and Stanford School of Medicine.  The researchers of the study, said that they would be able to identify new indicators of heart disease risk present in pictures of retinas by analysing them with artificial intelligence. Traditionally, medical discoveries are often made through a sophisticated form of guess and test making hypotheses from observations and then designing and running experiments to test the hypotheses. However, with medical images, observing and quantifying associations can be difficult because of the wide variety of features, patterns, colours, values and shapes that are present in real images. Deep learning, can generate very accurate models without us having to tell the system what to look for. For the study, the scientists developed deep learning models using retinal fundus images of nearly 3, 00,000 people available from two countries; the UK and the US and validated them using those from another 13,000 patients. It brings down the prediction time-frame to 5 years as against 10 years typically associated with the clinical risk predictors currently in use.  The researchers however, cautioned that while the system achieved good results that matched the accuracy of a standard blood test-based technique for estimating the risk of heart failure commonly used in Europe called SCORE a dataset of less than 300,000 patients is still small for AI, and should be tested further. ]]> https://biospectrumindia.com/news/57/10419/individualized-supportive-care-key-to-positive-childbirth-experience-who.html https://biospectrumindia.com/news/57/10419/individualized-supportive-care-key-to-positive-childbirth-experience-who.html Thu, 15 Feb 2018 18:20:00 +0530 WHO has issued new recommendations to establish global care standards for healthy pregnant women and reduce unnecessary medical interventions. Worldwide, an estimated 140 million births take place every year. Most of these occur without complications for women and their babies. Yet, over the past 20 years, practitioners have increased the use of interventions that were previously only used to avoid risks or treat complications, such as oxytocin infusion to speed up labour or caesarean sections. Dr Princess Nothemba Simelela, WHO Assistant Director-General for Family, Women, Children and Adolescents said, “We want women to give birth in a safe environment with skilled birth attendants in well-equipped facilities. However, the increasing medicalization of normal childbirth processes are undermining a woman’s own capability to give birth and negatively impacting her birth experience.” “If labour is progressing normally, and the woman and her baby are in good condition, they do not need to receive additional interventions to accelerate labour,” she says. Childbirth is a normal physiological process that can be accomplished without complications for the majority of women and babies. However, studies show a substantial proportion of healthy pregnant women undergo at least one clinical intervention during labour and birth. They are also often subjected to needless and potentially harmful routine interventions. The new WHO guideline includes 56 evidence-based recommendations on what care is needed throughout labour and immediately after for the woman and her baby. These include having a companion of choice during labour and childbirth; ensuring respectful care and good communication between women and health providers; maintaining privacy and confidentiality; and allowing women to make decisions about their pain management, labour and birth positions and natural urge to push, among others. They also recognizes that every labour and childbirth is unique and that the duration of the active first stage of labour varies from one woman to another. In a first labour, it usually does not extend beyond 12 hours. In subsequent labours it usually does not extend beyond 10 hours. To reduce unnecessary medical interventions, the WHO guideline states that the previous benchmark for cervical dilation rate at 1 cm/hr during the active first stage of labour (as assessed by a partograph or chart used to document the course of a normal labour) may be unrealistic for some women and is inaccurate in identifying women at risk of adverse birth outcomes. The guideline emphasizes that a slower cervical dilation rate alone should not be a routine indication for intervention to accelerate labour or expedite birth. Ian Askew, WHO Director, Department of Reproductive Health and Research said, “Many women want a natural birth and prefer to rely on their bodies to give birth to their baby without the aid of medical intervention. Even when a medical intervention is wanted or needed, the inclusion of women in making decisions about the care they receive is important to ensure that they meet their goal of a positive childbirth experience.” Unnecessary labour interventions are widespread in low-, middle- and high-income settings, often putting a strain on already scarce resources in some countries, and further widening of the equity gap. As more women give birth in health facilities with skilled health professionals and timely referrals, they deserve better quality of care. About 830 women die from pregnancy- or childbirth-related complications around the world every day – the majority could be prevented with high-quality care in pregnancy and during childbirth. Achieving the best possible physical, emotional, and psychological outcomes for the woman and her baby requires a model of care in which health systems empower all women to access care that focuses on the mother and child. Health professionals should advise healthy pregnant women that the duration of labour varies greatly from one woman to another. While most women want a natural labour and birth, they also acknowledge that birth can be an unpredictable and risky event and that close monitoring and sometimes medical interventions may be necessary. Even when interventions are needed or wanted, women usually wish to retain a sense of personal achievement and control by being involved in decision making, and by rooming in with their baby after childbirth. ]]> https://biospectrumindia.com/news/57/10396/who-publicizes-third-edition-of-widely-used-resource-on-family-planning.html https://biospectrumindia.com/news/57/10396/who-publicizes-third-edition-of-widely-used-resource-on-family-planning.html Tue, 13 Feb 2018 17:40:00 +0530 Family planning is considered a development "best buy" and a life-saving intervention for millions of women and girls. Crucial to the success of family planning efforts worldwide is a well-educated and trained health workforce. In support of the global family planning workforce, a new edition of Family Planning: A Global Handbook for Providers, commonly known as the Global Handbook, will be released on February 15 in New Delhi, India, at the 2018 Regional Consortium Meeting of the Implementing Best Practices (IBP) Initiative.  Written in plain terms and organized for quick review, the Global Handbook has served as the world's standard reference on family planning methods and related topics since its first publication in 2006. To date, more than 500,000 copies have been distributed in 13 languages. This will be the third edition published jointly by the Johns Hopkins Bloomberg School of Public Health and the World Health Organization (WHO), with support from the United States Agency for International Development (USAID) and its Knowledge for Health (K4Health) Project. The Global Handbook is endorsed by more than 125 organizations worldwide, many of them members of the IBP Initiative. The new edition includes information about available and new methods, including the LNG-IUD and implants, long-acting reversible methods; subcutaneous depot medroxyprogesterone acetate (DMPA-SC), with the potential for self-injection; and the new progesterone-releasing vaginal ring for breastfeeding women.  New recommendations from WHO, including guidance on topics such as intimate partner violence, task sharing, and serving clients with disabilities. A new section on how family planning providers should respect, protect, and fulfill the human rights of their clients. New job aids on whether to use the pregnancy checklist or a pregnancy test and on counseling women who want progestin-only injectable where HIV risk is high.  The third edition of the Global Handbook is available in English and will soon be translated into French and Spanish. ]]> https://biospectrumindia.com/news/57/10383/niaid-researchers-reveal-ebola-virus-infects-reproductive-organs-in-monkey.html https://biospectrumindia.com/news/57/10383/niaid-researchers-reveal-ebola-virus-infects-reproductive-organs-in-monkey.html Mon, 12 Feb 2018 16:20:00 +0530 Ebola virus can infect the reproductive organs of male and female macaques, according to a study published in The American Journal of Pathology, suggesting that humans could be similarly infected. Prior studies of survivors of the 2014-2016 Ebola outbreaks in West Africa have revealed sexual transmission of Ebola virus, and that viral RNA (Ebola virus genetic material) can persist in semen following recovery. While little is known about viral persistence in female reproductive tissues, pregnant women with Ebola virus disease have a maternal death rate of more than 80 percent and a fetal death rate of nearly 100 per cent. In this study, investigators from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and from Thomas Jefferson University infected four female and eight male macaques with the Makona variant of Ebola virus, the variant responsible for the recent West Africa outbreak. All the macaques succumbed to Ebola virus disease and were euthanized six to nine days after infection. The scientists then took reproductive tissue samples from each macaque and analyzed the samples for signs of Ebola virus infection, organ and tissue damage, and immune responses. They found widespread Ebola virus infection of reproductive organs with minimal tissue immune response or signs of disease.  Based on the findings, the authors hypothesize that Ebola virus can persist in these tissues in human survivors, and that the virus may reach seminal fluid in men by infecting immune cells called tissue macrophages. However, it is unclear if the detection of Ebola virus RNA in semen documented in human studies means that infectious virus is present. The authors note that additional research is needed to learn how Ebola virus persists in these sites, to determine if drugs and vaccines can cure or prevent such infections, and to understand the mechanisms of sexual transmission, including why it appears to occur only rarely in people. To do this, NIAID scientists are developing a new nonhuman primate model of Ebola virus disease in which monkeys survive infection. Few macaques survive in the current model, making it difficult to study virus persistence and its long-term impacts. ]]> https://biospectrumindia.com/news/57/10366/university-of-surrey-prepares-for-cancer-research-uks-grand-challenge-award.html https://biospectrumindia.com/news/57/10366/university-of-surrey-prepares-for-cancer-research-uks-grand-challenge-award.html Fri, 09 Feb 2018 11:15:00 +0530 Cancer Research UK's Grand Challenge is the most ambitious cancer research grant in the world. A multi-disciplinary team of scientists led by the University of Surrey and National Physical Laboratory (NPL) in London has been shortlisted to the final stages of Cancer Research UK's Grand Challenge. The team has acquired a chance of securing £20m of global grants to help improve early diagnosis rates of cancer.  The team, made up by researchers from University of Surrey, NPL, Maastricht University, University of Stirling, University of Cambridge and industry experts from Microsoft Research, and Maastro Clinic Center, have proposed a novel method to identify early signs cancers by analysing people’s consumer and behavioural habits. Early symptoms of cancer are often mistaken for other health ailments and patients often unknowingly self-manage symptoms before seeking medical advice.  Working with cancer patients and survivors, as well as experts from across a number of fields including cancer health, psychology, 5G and nutrition, researchers will examine early symptoms of cancer and how self-management of symptoms impacts upon patients behavioural and consumer routines. If successful, the team will develop software tools to encourage individuals to seek medical care if their behavioural habits (such as shopping) match the profile of someone with early signs of cancer. The team will receive seed-funding of up to £30,000 to draft their full research proposal, and the winning proposal will be announced in autumn 2018. The Grand Challenge award aims to revolutionise how we diagnose, prevent and treat cancer by providing international multi-disciplinary teams the freedom to try novel approaches, at scale, in the pursuit of life changing discoveries. ]]> https://biospectrumindia.com/news/57/10346/probiogen-and-teva-team-up-for-human-artificial-lymph-node-technology.html https://biospectrumindia.com/news/57/10346/probiogen-and-teva-team-up-for-human-artificial-lymph-node-technology.html Wed, 07 Feb 2018 15:00:00 +0530 ProBioGen, a leading specialist for contract development and manufacturing of complex glycoproteins announced the signature of a non-exclusive license agreement on its proprietary human Artificial Lymph Node (HuALN) platform technology with TEVA. The unique human Artificial Lymph Node model was developed by ProBioGen as superior 3D-micro-organoid model for analyzing substance effects on the human immune system in vitro. It is based on a patented, miniaturized and perfused bioreactor for long-term cultivation of immune cells. Human blood-derived dendritic cells, T & B lymphocytes and Mesenchymal Stem Cells (MSC)-derived stromal cells are inoculated into the bioreactors’ 3-dimensional hydrogel matrix which is perfused with cell culture medium and aerated, just as in a real human lymph node. Upon antigen-stimulation the cells’ self-organize into immune-competent micro-organoid structures within the 3D matrix. The perfused bioreactor is typically operated for 4 weeks and thus allows multiple and repeated expositions of the immune cells to the test compounds. Under the terms of the agreement the technology platform will be transferred to TEVA as a predictive tool to assist in the assessment of TEVA’s biopharmaceutical drug candidates. ]]> https://biospectrumindia.com/news/57/10338/somalia-receives-around-89500-packages-of-drugs-from-gnh-india.html https://biospectrumindia.com/news/57/10338/somalia-receives-around-89500-packages-of-drugs-from-gnh-india.html Tue, 06 Feb 2018 16:50:00 +0530 Somalia received a not-for-profit aid shipment of over 89,500 packages of drugs from GNH India. The majority of the drugs are basic medicinal aid such as multi-vitamins antibiotics, dietary supplements for infants, Multi-vitamins, minerals and trace Elements, pain killers and general anesthetics. Two decades of war has left the country deprived of medicinal aid and where basic medicines are scarce and desperately needed in Somalia. Seeing the situation in his country, the Managing Director of one of the Somalia based pharma companies approached private companies to request for aid. "My country is under serious distress; not just politically, but socially and economically as well”, he said. Elevating the grief of his people was on his top most agenda, “My mission upon reaching India was to find a wholesaler willing to hear my cause. We are grateful to GNH India and team for all the hard work they have put in to provide some respite to my people.” Dr. Piyush Gupta, Associate Director, GNH India-"When we were approached by the Somali delegate, we could not possibly have turned them away. Our standing policy at GNH India is humanity over profit and this becomes part of the plethora of transactions that we have done. The shipment sent to them was at a low manufacturing cost and there was no profit involved. A similar shipment was done in Yemen as well.” Somalia is a tough market to crack as there are US trade sanctions on them, moreover, they are not financially stable therefore doing business there is not a sound decision. But GNH India kept the profit motive aside to ensure that the weak, hungry, and particularly vulnerable men women and children of Somalia received access to basic medicines. ]]> https://biospectrumindia.com/news/57/10333/offshoot-company-of-oxford-university-to-develop-a-vaccine-to-fight-every-type-of-flu.html https://biospectrumindia.com/news/57/10333/offshoot-company-of-oxford-university-to-develop-a-vaccine-to-fight-every-type-of-flu.html Tue, 06 Feb 2018 15:50:00 +0530 A biotech spun out of Oxford University is aiming to develop a universal flu vaccine and phase 2 trials will be completed by the end of next year.  Vaccitech says the vaccine unlike those now found on the market does not target surface antibodies. Instead, it works from the center of the virus where there are few components which can change the virus strain. The vaccine takes a novel approach.  Vaccitech's strategy has not been tested to work against the flu before, but company has started trials involving thousands of people.  The tests mark the first time that a universal flu vaccine has progressed beyond phase 1 clinical testing and Vaccitech aims to complete phase 2B testing by the end of next year, he said. Recently, the biotech start-up raised 20 million pounds (about $28 million) from investors including GV, the venture capital arm of Google parent Alphabet. ]]> https://biospectrumindia.com/news/57/10332/high-levels-of-antibiotic-resistance-found-worldwide-who-data.html https://biospectrumindia.com/news/57/10332/high-levels-of-antibiotic-resistance-found-worldwide-who-data.html Tue, 06 Feb 2018 15:35:00 +0530 WHO’s first release of surveillance data on antibiotic resistance reveals high levels of resistance to a number of serious bacterial infections in both high- and low-income countries. WHO’s new Global Antimicrobial Surveillance System (GLASS) reveals widespread occurrence of antibiotic resistance among 500 000 people with suspected bacterial infections across 22 countries. The most commonly reported resistant bacteria were Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, and Streptococcus pneumoniae, followed by Salmonella spp. The system does not include data on resistance of Mycobacterium tuberculosis, which causes tuberculosis (TB), as WHO has been tracking it since 1994 and providing annual updates in the Global tuberculosis report. Among patients with suspected bloodstream infection, the proportion that had bacteria resistant to at least one of the most commonly used antibiotics ranged tremendously between different countries – from zero to 82%. Resistance to penicillin – the medicine used for decades worldwide to treat pneumonia – ranged from zero to 51% among reporting countries. And between 8% to 65% of E. coli associated with urinary tract infections presented resistance to ciprofloxacin, an antibiotic commonly used to treat this condition. Dr Marc Sprenger, director of WHO’s Antimicrobial Resistance Secretariat said, “The report confirms the serious situation of antibiotic resistance worldwide. Some of the world’s most common – and potentially most dangerous – infections are proving drug-resistant,” adds Sprenger. “And most worrying of all, pathogens don’t respect national borders. That’s why WHO is encouraging all countries to set up good surveillance systems for detecting drug resistance that can provide data to this global system.” To date, 52 countries (25 high-income, 20 middle-income and 7 low-income countries) are enrolled in WHO’s Global Antimicrobial Surveillance System. For the first report, 40 countries provided information about their national surveillance systems and 22 countries also provided data on levels of antibiotic resistance. Dr Carmem Pessoa-Silva, who coordinates the new surveillance system at WHO said, “The report is a vital first step towards improving our understanding of the extent of antimicrobial resistance. Surveillance is in its infancy, but it is vital to develop it if we are to anticipate and tackle one of the biggest threats to global public health.” Data presented in this first GLASS report vary widely in quality and completeness. Some countries face major challenges in building their national surveillance systems, including a lack of personnel, funds and infrastructure. WHO is supporting more countries to set up national antimicrobial resistance surveillance systems that can produce reliable, meaningful data. GLASS is helping to standardize the way that countries collect data and enable a more complete picture about antimicrobial resistance patterns and trends. Solid drug resistance surveillance programmes in TB, HIV and malaria have been functioning for many years and have helped estimate disease burden, plan diagnostic and treatment services, monitor the effectiveness of control interventions, and design effective treatment regimens to address and prevent future resistance. GLASS is expected to perform a similar function for common bacterial pathogens. ]]> https://biospectrumindia.com/news/57/10322/agilent-partners-with-usc-for-bioscience-research.html https://biospectrumindia.com/news/57/10322/agilent-partners-with-usc-for-bioscience-research.html Mon, 05 Feb 2018 15:10:00 +0530 Agilent Technologies is planning a collaboration with the University of Southern California (USC) Michelson Center for Convergent Bioscience to facilitate transformational research that combines biomedical science and engineering. The partners will establish the Agilent Center of Excellence (COE) in Biomolecular Characterization, which will specialize in convergent bioscience research. The COE will be housed at USC’s Michelson Hall, a $185 million building that opened in October 2017 as the largest building on the university’s campus. Michelson Hall is a research facility aimed at establishing a convergence of researchers with science and engineering backgrounds who collaborate on multidisciplinary approaches to developing new drugs, diagnostics, and medical devices.  The COE will also serve USC undergraduate and graduate students, as well as the company’s customers based in the area, by providing them with access to new Agilent instrumentation and broad exposure to the university’s researchers. The research will be anchored by the lab of Valery Fokin, Ph.D., a principal investigator at USC’s Michelson Center whose research has focused on chemical reactivity and biological interactions at the molecular level. ]]> https://biospectrumindia.com/news/57/10313/u-s-researchers-develop-an-online-tool-that-imparts-knowledge-of-breast-cancer-treatment-options.html https://biospectrumindia.com/news/57/10313/u-s-researchers-develop-an-online-tool-that-imparts-knowledge-of-breast-cancer-treatment-options.html Fri, 02 Feb 2018 17:55:00 +0530 Researchers from Cancer Surveillance and Outcomes Research Team at the University of Michigan Comprehensive Cancer Center have developed an interactive tool to help patients in the complex decision-making process about their treatment of breast cancer. According to a previous study published in the Journal of Clinical Oncology, patients using the interactive tool had higher knowledge and felt more prepared to make a treatment decision, as compared to static informational website users. Researchers enrolled 537 patients with newly diagnosed early-stage, breast cancer from multiple practices spread throughout four states. Patients were randomized to view a tailored, interactive decision tool called iCanDecide or to view similar information on a static website. They were then surveyed about five weeks later, after making their treatment decision. Of all participants, 496 completed the survey. Overall, 61% of patients who used the interactive tool had a higher knowledge of treatment options, compared to 42%, who viewed the static material. Patients who used the interactive tool were also more likely to say they felt prepared to make a treatment decision. The interactive site was designed to walk people systemically through key facts about breast cancer surgery, such as how often cancer recurs and the likelihood of needing additional surgery. A second module on the website helped patients understand options for systemic treatment, such as chemotherapy. The paper assesses only the surgery module. The tool also assessed patients’ values, taking them through a series of hypothetical scenarios. In the end, each patient had a customised bar graphic that showed how their preferences matched to treatments. For example, if they valued keeping their natural breast, the lumpectomy bar would be higher. Patients could interact with the figure to learn more. A similar number of patients from both groups reported making a choice in line with their values. The tool was funded by National Cancer Institute and developed by Michigan Medicine.     ]]> https://biospectrumindia.com/news/57/10311/big-6-countries-of-who-south-east-asia-region-meet-to-close-measles-immunity-gap.html https://biospectrumindia.com/news/57/10311/big-6-countries-of-who-south-east-asia-region-meet-to-close-measles-immunity-gap.html Fri, 02 Feb 2018 15:40:00 +0530 With nearly 4.8 million children in WHO South-East Asia Region missing measles vaccination every year, the ‘big six’ countries of the Region shared their immunization challenges and lessons learnt for accelerating efforts to eliminate measles and control rubella by the year 2020. Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia said, “Eliminating measles would avert half a million deaths, while controlling rubella and Congenital Rubella Syndrome would promote health of pregnant woman and the infants they give life to.” Two of the Region’s countries – Bhutan and Maldives – eliminated measles in 2017 while the others are carrying out largescale immunisation drives to achieve the same. “Nearly 500 million children in the Region are planned to be reached with measles and rubella containing vaccines through routine immunisation and supplementary immunisation campaigns in the next two years. Sharing challenges and lessons learnt from various recent achievements and initiatives will help member countries address their unique problems to close the immunity gap against measles, rubella and CRS”, she said. Last year India and Indonesia targeted 70 million and 35 million children respectively in supplementary measles immunization campaigns. Both have further strengthened routine immunization systems. Bangladesh has implemented an urban immunization strategy, with support of networks of volunteers to broaden immunisation coverage. Myanmar has protected around 14 million children against Japanese encephalitis. Nepal has pioneered an incentive scheme to recognize and celebrate villages and districts that are fully immunized. Thailand has demonstrated to the world the impact surveillance can have via its unique ‘data for action’ model. Further accelerated and focussed efforts are needed. Nearly 38 million children are born in the Region every year. Of them approximately 87% receive the first dose of measles-containing vaccine. Though this is a marked improvement from previous years, it still means around 4.8 million children are deprived of the most basic protection against measles each year. With majority of the missed children being accounted for by the ‘big six’ countries, immunisation programme managers of Bangladesh, India, Indonesia, Myanmar, Nepal and Thailand, along with partners WHO, UNICEF, GAVI, Bill and Melinda Gates Foundation and CDC, are deliberating challenges, experiences and lessons learnt in immunization in the Region that can be harnessed to eliminate measles and control rubella / CRS. “This dynamism and positive exchange is at the very core of south-south and triangular cooperation,” said Dr Khetrapal Since then all member countries in South-East Asia region have introduced two doses of measles-containing vaccines in their childhood immunisation programme. Five of them have achieved 95% coverage with both doses.  Measles elimination and rubella /CRS control strategies include ensuring over 95% coverage with two doses of measles and rubella containing vaccine in each district through routine and/or supplementary immunization activities, and developing and sustaining sensitive measles surveillance supported by an accredited measles laboratory network. Eliminating measles and controlling rubella would also mean extending the benefits of vaccine to all people everywhere, including communities in hard-to-reach or remote areas, the underserved or the neglected or marginalized; and advancing universal health coverage. ]]> https://biospectrumindia.com/news/57/10303/sanofi-dndi-ask-for-ema-review-to-treat-sleeping-sickness-.html https://biospectrumindia.com/news/57/10303/sanofi-dndi-ask-for-ema-review-to-treat-sleeping-sickness-.html Fri, 02 Feb 2018 11:10:00 +0530 Sanofi has asked the European Medicines Agency (EMA) to review an experimental medicine fexinidazole. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi) for the treatment of sleeping sickness, which is endemic in Africa.  Fexinidazole is a 10-day oral treatment under investigation for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), a fatal disease more commonly known as sleeping sickness.  The Paris, France-based drugmaker said it is hoped that the treatment will contribute to the elimination of the disease.  The European Medicines Agency has accepted the application under a special procedure called “Article 58”, which allows it to give a scientific opinion, in co-operation with the World Health Organisation (WHO), for medicinal products intended exclusively for markets outside of the European Union. Fexinidazole was previously granted accelerated assessment by the EMA. Following the evaluation of the dossier, the EMA will publish its scientific opinion of the benefit risk of the treatment and facilitate the registration of fexinidazole in HAT-endemic countries. ]]> https://biospectrumindia.com/news/57/10281/over-350000-children-to-get-additional-dose-of-diphtheria-vaccine-in-coxs-bazar-who.html https://biospectrumindia.com/news/57/10281/over-350000-children-to-get-additional-dose-of-diphtheria-vaccine-in-coxs-bazar-who.html Tue, 30 Jan 2018 14:40:00 +0530 WHO and UNICEF are working with Ministry of Health and Family Welfare to vaccinate over 350,000 children in the Rohingya camps and makeshift settlements with an additional dose of diphtheria vaccine in order to step up efforts to curtail the ongoing diphtheria outbreak in Cox’s Bazar Dr Bardan Jung Rana, World Health Organization’s Representative to Bangladesh said, “An additional dose of diphtheria vaccine is expected to further boost immunity of vulnerable children and help restrict diphtheria. These intense campaigns demonstrate the commendable efforts being made by Bangladesh to protect the health of a vulnerable population.” Each team comprises of two vaccinators and three community mobilisers, and is supported by five to 10 local community leaders. Children who are older than six weeks and under seven years are vaccinated with pentavalent vaccine that protects against diphtheria, tetanus, whooping cough, haemophilus influenzae type b, and hepatitis B. The older group of children, aged between seven and 15 years, will receive the tetanus and diphtheria (Td) vaccine. To ensure all children in the target age group are vaccinated, over 2,000 community volunteers, imams and teachers are involved in supporting community mobilization during the vaccination campaign. Volunteers and vaccinators have been trained to communicate the benefits of vaccination and to address parents’ queries and concerns relating to vaccination, should they arise. Edouard Beigbeder, Representative, UNICEF Bangladesh said, “We have procured more than 400,000 doses of diphtheria vaccines to cover the Rohingya children, health practitioners, volunteers and staff who are working in the camps. Currently, health workers strive to control the outbreak with antibiotics and vaccines, and to provide needed treatment to those who are infected. We expect to see reduced numbers of diphtheria cases when the effect of the mass immunization drives sets in.” Earlier, over half a million children were immunized in the first diphtheria vaccination campaign held in the Rohingya camps and makeshift settlements in December, and in host communities earlier this year. A third diphtheria vaccination campaign is planned to start four weeks after completion of the ongoing drive. Meanwhile, the Ministry of Health and Family Welfare, WHO, UNICEF and partners are working to establish routine childhood vaccination services against life-threatening disease in the Rohingya camps. So far, 4,800 suspected cases of diphtheria and 35 deaths have been reported in Cox’s Bazar. Thirty-seven of the suspected cases were in host communities. An estimated 688,000 Rohingyas have arrived in Cox’s Bazar from Myanmar since 25 August 2017, and are living in overcrowded makeshift camps and settlements. At least 58 per cent of them are children. Vaccinating vulnerable populations against diphtheria is one key component of the outbreak response, which also focuses on early detection of suspected cases, providing appropriate treatment, and tracing patients’ contacts and giving them preventive medication and vaccine. WHO is coordinating and supporting the overall diphtheria response with the Ministry of Health and Family Welfare. Antibiotics and over 2,500 doses of diphtheria antitoxin have been provided to treat patients.   ]]> https://biospectrumindia.com/news/57/10279/new-jersey-bariatric-center-performing-study-on-low-body-mass-index-bmi-weight-loss-surgery-.html https://biospectrumindia.com/news/57/10279/new-jersey-bariatric-center-performing-study-on-low-body-mass-index-bmi-weight-loss-surgery-.html Tue, 30 Jan 2018 12:15:00 +0530 New Jersey Bariatric Center is accepting new participants in a weight loss surgery study that makes bariatric surgery accessible to patients with a body mass index (BMI) of 30-35, lower than the current threshold to qualify for surgery. According to Ajay Goyal (New Jersey Bariatric Center surgical director and principal investigator),the study, which is the only of its kind in New Jersey, will add to the growing body of evidence that shows gastric bypass and sleeve gastrectomy are effective in reducing obesity related illnesses in patients suffering from moderate obesity.  Current bariatric surgical guidelines, which were established in 1991, restrict gastric bypass and sleeve gastrectomy procedures to patients with a BMI over 40 or a BMI over 35 with obesity-related illnesses. The study will provide an updated perspective on the health benefits of bariatric surgery and is vital to reaching more patients with the potential to alleviate obesity-related chronic conditions, Dr. Goyal explained.  Numerous studies have proven the safety and efficacy of bariatric surgery in patients with class 1 obesity, including the landmark 2012 STAMPEDE trial, which found the gastric bypass and sleeve gastrectomy in patients with a BMI of 27 to be effective in the treatment of type 2 diabetes. Based largely on this evidence in 2016, 45 international professional organizations, including the American Diabetes Association, issued guidelines urging that bariatric surgery be recommended or considered as a treatment option for some categories of people with diabetes, including those who are mildly obese and fail to respond to conventional treatment.  ]]> https://biospectrumindia.com/news/57/10258/the-powerful-nano-weapon-against-resistant-bacteria.html https://biospectrumindia.com/news/57/10258/the-powerful-nano-weapon-against-resistant-bacteria.html Thu, 25 Jan 2018 16:15:00 +0530 Scientists from the Palacký University (UP) in Olomouc have discovered a unique mechanism that enables bacteria to defend themselves against silver nanoparticles, which are widely used in antibacterial therapy. This mechanism does not require the bacteria to undergo genetic changes, and differs significantly from mechanisms of antibiotic resistance. The scientists have also found a way to suppress bacterial resistance to nanosilver, which could be crucial in addressing the global antibiotics crisis.  The long-standing overuse of antibiotics during the second half of the last century has caused increasing levels of bacterial antibiotic resistance. Therefore, in recent years, many chemists, microbiologists, and physicians have studied the antibacterial effects of silver nanoparticles, which have gradually become incorporated into dozens of commercial products as well as successful options for local antibiotic therapy and preventing the evolution of bacterial infections. In 2006, scientists from the Palacký University in Olomouc described in detail the effectiveness of silver nanoparticles against a wide range of bacteria including highly resistant strains. However, scientists and physicians have been unable to determine whether repeated exposure to nanoparticles can cause bacteria to develop resistance similar to that seen with antibiotics. After approximately five years of work, this question has been answered by researchers from the Regional Centre of Advanced Technologies and Materials (RCPTM), the Centre of the Region Haná for Biotechnological and Agricultural Research, and the Faculty of Medicine of the Palacký University in Olomouc. According to the scientists, silver nanoparticles have a lot more to contribute in the fight against bacterial infections. The team from Olomouc has developed a technology protected by European and American patents that involves using strong chemical bonds to anchor silver nanoparticles to materials such as plastics, metals, and textiles. The scientists also reported the high activity of silver nanoparticles against yeasts and the possibility of restoring antibiotics' activity against multi-resistant bacteria while simultaneously applying nanosilver at very low concentrations that are non-toxic to mammalian cells. ]]> https://biospectrumindia.com/news/57/10242/agilent-technologies-titled-company-of-the-year-by-ibo.html https://biospectrumindia.com/news/57/10242/agilent-technologies-titled-company-of-the-year-by-ibo.html Tue, 23 Jan 2018 16:15:00 +0530 Agilent Technologies Inc. is a global leader in life sciences, diagnostics and applied chemical markets. The company announced that it has been selected as 2017 Company of the Year by Instrument Business Outlook (IBO). IBO is the leading newsletter tracking trends and developments in the analytical and life science instrumentation, and laboratory products markets.  IBO monitors hundreds of life science and analytical instrument companies on a daily basis, continually tracking financial developments and new market entries.  The newsletter highlighted Agilent’s increased growth in revenues, operating profit, and net income, noting that the gains were the result of a sustained effort to position the company for future growth.  IBO is a twice-monthly publication of SDi, a division of BioInformatics LLC, which offers custom market research and consulting, and strategic advisory services. IBO will present the award to Agilent at the annual conference of the Society for Laboratory Automation and Screening (SLAS) in San Diego in early February. ]]> https://biospectrumindia.com/news/57/10237/fda-grants-fast-track-status-for-sobi003-to-treat-sanfilippo-a-syndrome.html https://biospectrumindia.com/news/57/10237/fda-grants-fast-track-status-for-sobi003-to-treat-sanfilippo-a-syndrome.html Tue, 23 Jan 2018 15:15:00 +0530 Swedish Orphan Biovitrum AB (publ) (Sobi™) is an international specialty healthcare company dedicated to rare diseases. The company declared that, FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. In addition, SOBI003 was granted Fast Track status by the FDA. SOBI003 is a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (MPS IIIA). MPS IIIA or Sanfilippo A syndrome is a progressive, life-threatening and rare inherited metabolic disorder affecting children already from a young age. SOBI003 was granted orphan designation by the European Commission for MPS IIIA in October 2016 and by the FDA in June 2017. The clinical study with SOBI003 is expected to start during 2018. ]]> https://biospectrumindia.com/news/57/10217/aeon-global-health-partners-with-sabal-therapeutics.html https://biospectrumindia.com/news/57/10217/aeon-global-health-partners-with-sabal-therapeutics.html Thu, 18 Jan 2018 13:20:00 +0530 Aeon Global Health, the operating arm of Authentidate Holding Corp., a growth-oriented provider of personalized, clinically actionable medical informatics and telemedicine. The company announced that it has agreed with Sabal Therapeutics, LLC to be the primary laboratory marketer of Naprosyn, the branded naproxen oral suspension USP. Under the agreement, Aeon will become the exclusive clinical laboratory marketing representative of Sabal and will market the drug alongside of its industry-leading drug monitoring service. Thus can providing physicians with an integrated, non-opiate solution for pain management.  Because Naprosyn is dispensed in a liquid form; healthcare professionals can more accurately prescribe and adjust the dosage based on individual patient needs. Specially for patients whose weight, medical condition or pain severities appropriately permit flexible dosing versus the fixed dosage of tablets. ]]> https://biospectrumindia.com/news/57/10194/nearly-half-a-million-children-being-vaccinated-against-diphtheria-in-coxs-bazar.html https://biospectrumindia.com/news/57/10194/nearly-half-a-million-children-being-vaccinated-against-diphtheria-in-coxs-bazar.html Mon, 15 Jan 2018 13:50:00 +0530 As part of an intensified response to the current diphtheria outbreak, WHO, UNICEF and health sector partners are working with the Bangladesh Ministry of Health and Family Welfare to vaccinate more than 475,000 children in Rohingya refugee camps, temporary settlements and surrounding areas. Nearly 150,000 children aged six weeks to seven years received pentavalent vaccine (that protects against diphtheria, tetanus, pertussis, haemophilus influenza type b and hepatitis B), and nearly 166,000 children aged 7 to 17 years were given tetanus and diphtheria (Td) vaccine, during a three-week vaccination campaign that ended on 31 December. Two more rounds of vaccination with a diphtheria-containing vaccine, at intervals of one month, are planned to fully protect the children in camps and surrounding areas. Dr Bardan Jung Rana, ai WHO Representative to Bangladesh said, “All efforts are being made to stop further spread of diphtheria. The vaccination of children in the Rohingya camps and nearby areas demonstrates the health sector’s commitment to protecting people, particularly children, against deadly diseases.” Edouard Beigbeder, UNICEF Country Representative said, “Children are particularly vulnerable to diphtheria. Volunteers are making door-to-door visits in the Rohingya settlements to ensure all children receive vaccination. The massive influx within a very short time has heavily affected basic services in the settlement areas. They have no choice but to live in a very congested environment, which is impacting their health and quality of life. We are making continued efforts to improve conditions of the camps. At the same time, diphtheria vaccination is vital to reducing the risk of further outbreak.” To limit the spread of diphtheria to communities living near the Rohingya camps and settlements, nearly 160,000 children in 499 schools of Teknaf and Ukhiya sub-districts are also being vaccinated. This initiative began on 1 January. Vaccination was initiated on a day when children attend school in large numbers to avail themselves of free books provided by the government at the start of the academic year. WHO, UNICEF and other health partners are working with the Ministry of Health and Family Welfare to establish fixed locations for immunization in the Rohingya camps to continue to provide life-saving vaccines to children, in line with Bangladesh’s childhood immunization programme. ]]> https://biospectrumindia.com/news/57/10189/upadacitinib-availed-breakthrough-therapy-designation-from-usfda.html https://biospectrumindia.com/news/57/10189/upadacitinib-availed-breakthrough-therapy-designation-from-usfda.html Fri, 12 Jan 2018 16:30:00 +0530 AbbVie is a global, research and development-based biopharmaceutical company. The company announced the U.S. FDA has granted Breakthrough Therapy Designation for the new, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis. This Breakthrough Therapy Designation is supported by positive Phase 2b results previously announced in September 2017 and marks 13 Breakthrough Therapy Designations granted to AbbVie's investigational treatments since the company's inception in 2013. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.  Atopic dermatitis, a chronic inflammatory skin disease, is characterized by skin erosion, oozing and crusting, redness, intense itching (pruritus) and dry skin. Symptoms can appear as a rash on the skin, or the skin may become thickened and leathery. The FDA's Breakthrough Therapy Designation program is intended to expedite the development and review of medicines. AbbVie will present additional data from the Phase 2b trial at upcoming scientific congresses. ]]> https://biospectrumindia.com/news/57/10186/systech-europe-declares-expansion-of-customer-base-and-pharmaceutical-serialization-partners-ready-to-meet-the-fmd-regulation.html https://biospectrumindia.com/news/57/10186/systech-europe-declares-expansion-of-customer-base-and-pharmaceutical-serialization-partners-ready-to-meet-the-fmd-regulation.html Fri, 12 Jan 2018 13:30:00 +0530 Systech International, the global technology leader in serialisation, track and trace, and brand protection grew its European presence in 2017 by 50% with new accounts in France, Germany, Greece, Turkey, and Finland.   The company also added new Authorized Solution Partners to its global network offering integrated turnkey solutions with Systech UniSeries, the industry standard for serialising products to meet the falsified Medicines Directive (FMD), as well as the Company's expanding track and trace and anti-counterfeiting technologies.  Systech arranged the world's first serialisation and aggregation project in Europe over a decade ago and has now implemented serialisation for 19 of the top 20 global pharmaceutical companies. With 30 years of industry experience, Systech utilizes award-winning configurable software technology, including vision, serialisation workflow, and number management. It ensures delivery of quick and cost-effective serialisation solutions to large and small pharmaceutical companies, including multinationals, regional manufacturers, and CMO/CPO's.    Servicepoint Oy, one of Systech's sales and integration partners, is implementing Systech's serialisation solution in Finland for Santen Pharmaceutical, the leading Northern European ophthalmic drug manufacturer. ]]> https://biospectrumindia.com/news/57/10181/u-s-fda-approves-boston-scientifics-spinal-cord-stimulator-system-.html https://biospectrumindia.com/news/57/10181/u-s-fda-approves-boston-scientifics-spinal-cord-stimulator-system-.html Thu, 11 Jan 2018 17:50:00 +0530 Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) have approved the Spectra WaveWriter™ Spinal Cord Stimulator (SCS) System. It is the first and only system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy. The system allows physicians and patients to combine therapeutic options, customize therapy and capture real-time feedback designed to treat chronic and devastating pain successfully. SCS works by sending low electrical pulses, which vary in frequency, pulse width and amplitude, to the spinal cord to interrupt pain signals. Paresthesia-based therapy provides pain relief with a light tingling sensation while sub-perception therapy works without that sensation. With the Spectra WaveWriter System, patients can choose to combine both of these therapies to target one specific area of pain or use each therapy as needed to best manage multiple areas of pain. Patients provide real-time feedback using the system's remote control. Together, these features benefit patients by addressing each individual's unique pain relief needs. The Spectra WaveWriter System was developed with more than a decade of clinical research focused on optimizing sub-perception and delivering multiple therapies intended for more effective, long-term pain relief. These studies include the WHISPER study and the PROCO study. The PROCO study was a multi-center, prospective, double-blind, randomized study in which patients acted as their own control. This study established in de novo patients that similar pain relief and improvement in quality of life measures are achieved independent of the type of frequency (from 1 kHz up to 10 kHz) used in sub-perception SCS therapy when the proper target and dose are identified.  The WHISPER study is a multi-center, prospective, cross-over, randomized, and controlled study evaluating the long-term safety and effectiveness of sub-perception SCS pain relief therapy. ]]> https://biospectrumindia.com/news/57/10165/perrigo-received-tentative-fda-for-prolensa-generic-.html https://biospectrumindia.com/news/57/10165/perrigo-received-tentative-fda-for-prolensa-generic-.html Mon, 08 Jan 2018 16:40:00 +0530 Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products. The company has received tentative approval from the U.S. Food and Drug Administration for the generic version of Prolensa® (bromfenac ophthalmic solution) 0.07%. Perrigo previously settled litigation with Bausch & Lomb Inc. for this product.  Prolensa® (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID). It is specified for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Branded market sales for the last twelve months were approximately $113 million. ]]> https://biospectrumindia.com/news/57/10163/evenitys-application-accepted-by-european-medicines-agency-.html https://biospectrumindia.com/news/57/10163/evenitys-application-accepted-by-european-medicines-agency-.html Mon, 08 Jan 2018 12:40:00 +0530 Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. Together, Amgen and UCB announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for EVENITY (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. If approved in Europe, EVENITY will be a novel osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.  The MAA for EVENITY is based on results from three pivotal Phase 3 studies: FRAME, including 7,180 postmenopausal women with osteoporosis; ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis. The agency will evaluate the clinical benefit: risk profile of EVENITY in these three pivotal studies, including the potential to increase BMD and reduce the risk of fractures in women with osteoporosis, as well as the cardiovascular safety signal seen in the ARCH study. ]]> https://biospectrumindia.com/news/57/10157/drug-to-cure-blindness-priced-at-rs-5-cr.html https://biospectrumindia.com/news/57/10157/drug-to-cure-blindness-priced-at-rs-5-cr.html Fri, 05 Jan 2018 17:35:00 +0530 A medication against hereditary degeneration of the retina that can lead to total blindness, will be sold for $850,000 (Rs 5,39,79,250) in the United States, making it one of the world's most expensive medical treatments. According to the manufacturer, Philadelphia-based Spark Therapeutics, the drug Luxturna is administered in a single dose. It is considered the first American medication to emerge from gene therapy, which consists of repairing a defective gene. The announcement comes amid a growing debate in the United States over the high cost of medicine, particularly for supposedly innovative treatments. Anticipating criticism, Spark promised to reimburse patients if the treatment proves to be ineffective. The company is following the lead of Novartis, which sells Kymriah, a treatment for a very aggressive form of leukemia in children and young adults. The Swiss drug maker has pledged to reimburse insurers and patients if the $475,000 drug doesn't work. ]]> https://biospectrumindia.com/news/57/10154/minoryx-therapeutics-initiated-the-treatment-of-amn-in-advance.html https://biospectrumindia.com/news/57/10154/minoryx-therapeutics-initiated-the-treatment-of-amn-in-advance.html Fri, 05 Jan 2018 11:55:00 +0530 Minoryx is a clinical stage biotech company leading the development of new therapies for X-ALD and other inborn errors of metabolism, a group of rare diseases of genetic origin with a high unmet medical need. The company announces the initiation of treatment of the first two patients in the ADVANCE trial, a pivotal phase 2/3 clinical trial of MIN-102 for the treatment of adrenomyeloneuropathy (AMN). The trial enrolls adult male patients affected by AMN, the most frequent phenotype of X-linked adrenoleukodystrophy (X-ALD).  The first patients were dosed at the Vall d'Hebron University Hospital (Barcelona, Spain) by Dr. Josep Gamez and at the Academic Medical Center (Amsterdam, The Netherlands) by Dr Marc Engelen. Recruitment was also initiated at the Institute of Genomic Medicine and Rare Disorders (Budapest, Hungary) by Dr. Maria Molnar. The ADVANCE trial will be initiated in several other European countries (United Kingdom, Germany, France, Italy and Poland) in the coming weeks and in the US by mid-2018. The ADVANCE trial is a randomized, double-blind, placebo-controlled study with an open-label extension to determine the efficacy and safety of MIN-102. Min 102 is a novel, orally bioavailable and selective PPAR gamma agonist with a superior profile for central nervous system-related diseases and promising in vivo efficacy. The primary outcome is to evaluate the efficacy of MIN-102 on the progression of AMN in male patients, as determined by a motor function test. The trial aims to enroll more than 100 patients and results are expected at the end of 2020.  The trial was designed based on input from Minoryx’s scientific advisory board, comprised of internationally renowned EU and US clinical experts in X-ALD.  Additional advice was also obtained from major patient advocacy groups. The design and endpoints were finalized following regulatory interactions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). ]]> https://biospectrumindia.com/news/57/10149/abzena-and-sartorius-stedim-work-conjointly.html https://biospectrumindia.com/news/57/10149/abzena-and-sartorius-stedim-work-conjointly.html Thu, 04 Jan 2018 14:40:00 +0530 Abzena provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products. The life sciences company Abzena has selected Sartorius Stedim Biotech as its preferred equipment supplier in the U.S. Abzena has selected Sartorius Stedim to equip its integrated CDMO facilities in Bristol, PA (development and GMP manufacture of antibody drug conjugates) and San Diego, CA (development and GMP manufacture of monoclonal antibodies and other recombinant proteins).  Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently Sartorius Stedim will provide both facilities with end-to-end process solutions in single-use (SU) format. It will equip Abzena’s San Diego process development lab with leading industry technologies such as Ambr250, enabling fast scale up to 500L initially and later to the 2000L scale single-use bioreactor for its centre of excellence in clinical manufacturing.   “We are pleased to have been selected by Abzena, a prominent global CDMO with a comprehensive industry portfolio across a wide range of modalities to supply single-use solutions that enable process development, tech transfer and GMP manufacturing. We look forward to working together to best serve the US and international markets.” Said by Reinhard Vogt,Executive VP Sartorius. ]]> https://biospectrumindia.com/news/57/10145/up-to-650-000-people-die-of-respiratory-diseases-linked-to-seasonal-flu-each-year-who.html https://biospectrumindia.com/news/57/10145/up-to-650-000-people-die-of-respiratory-diseases-linked-to-seasonal-flu-each-year-who.html Thu, 04 Jan 2018 13:05:00 +0530 According to new estimates by the United States Centers for Disease Control and Prevention (US-CDC) which is the World Health Organization and global health partners, up to 650 000 deaths annually are associated with respiratory diseases from seasonal influenza. This marks an increase on the previous global estimate of 250 000 – 500 000, which dates from over ten years ago and covered all influenza-related deaths, including cardiovascular disease or diabetes. The new figures of 290 000 – 650 000 deaths are based on more recent data from a larger, more diverse group of countries, including lower middle income countries, and exclude deaths from non-respiratory diseases. Dr Peter Salama, Executive Director of WHO’s Health Emergencies Programme said, “These figures indicate the high burden of influenza and its substantial social and economic cost to the world. They highlight the importance of influenza prevention for seasonal epidemics, as well as preparedness for pandemics.” The estimates take into account findings from recent influenza respiratory mortality studies, including a study conducted by the United States Centers for Disease Control and Prevention (US-CDC), published in The Lancet on Thursday (14 December). WHO’s Influenza Burden of Disease Working Group comprises experts from the All India Institute of Medical Science, the National University of Singapore, the South African National Institute of Communicable Diseases, US CDC, Universidad del Valle de Guatemala and the University of Edinburgh. According to US-CDC, most deaths occur among people aged over 75 years, and in the world’s poorest regions. Sub-Saharan Africa accounts for the world’s greatest flu mortality risk, followed closely by the Eastern Mediterranean and Southeast Asia. “All countries, rich and poor, large and small, must work together to control influenza outbreaks before the arrival of the next pandemic. This includes building capacity to detect and respond to outbreaks, and strengthening health systems to improve the health of the most vulnerable and those most at risk,” said Dr Salama. Nearly all deaths among children under five with influenza-related lower respiratory tract infections occur in developing countries, but the effects of seasonal influenza epidemics on the world’s poorest are not fully known. Seasonal influenza is an acute viral infection that spreads easily from person to person and circulates worldwide. Most people recover within a week without requiring medical attention. Common respiratory diseases related to seasonal influenza that can cause death include pneumonia and bronchitis. ]]> https://biospectrumindia.com/news/57/10142/ndf-collaborates-with-perkinelmer-for-rare-disease-research.html https://biospectrumindia.com/news/57/10142/ndf-collaborates-with-perkinelmer-for-rare-disease-research.html Thu, 04 Jan 2018 12:15:00 +0530 US based Neuromuscular Disease Foundation (NDF) is launching an alliance with PerkinElmer to use whole-genome sequencing to investigate the molecular pathways involved in GNE myopathy, a progressive muscle-wasting disease. It is a rare autosomal recessive condition in which a genetic mutation prevents the generation of sialic acid in cells, leading to muscle dysfunction and degeneration. In collaboration with PerkinElmer, NDF aims to use sequencing and metabolomics to study 100 patient samples. The partners will also collect their findings into a database to help with patient recruitment for clinical trials.  PerkinElmer has been working to expand its clinical genomic testing services in recent months, offering whole-exome and whole-genome sequencing for genetic disease diagnostics in newborns and partnering with advocacy groups and foundations focused on specific diseases. This is one of the first such known efforts made to understand the etiology of a rare disease at the molecular and biochemical level. ]]> https://biospectrumindia.com/news/57/10114/fda-clears-device-for-diabetic-foot-ulcer-treatment.html https://biospectrumindia.com/news/57/10114/fda-clears-device-for-diabetic-foot-ulcer-treatment.html Fri, 29 Dec 2017 11:00:00 +0530 The U.S. FDA permitted marketing of the Dermapace System to Sanuwave, Inc. Dermapace System is the first shock wave device intended to treat diabetic foot ulcers. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection. The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients, presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care. The FDA reviewed clinical data from two multi-centers, randomized, double-blind studies with a total of 336 diabetic patients. Who are receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.  The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period. The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA's 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device. ]]> https://biospectrumindia.com/news/57/10111/genscript-biotech-acquires-customarray.html https://biospectrumindia.com/news/57/10111/genscript-biotech-acquires-customarray.html Thu, 28 Dec 2017 12:00:00 +0530 GenScript is the world leader in gene synthesis, and a peptide, protein, and antibody research partner for fundamental life science research, translational biomedical research, early stage biopharmaceutical development and synthetic biology. The company announced that it will undergo acquisition agreement with it and GenScript USA Holding Inc., its wholly owned subsidiary, has entered into an agreement to acquire 100 percent of the issued shares of CustomArray Inc. CustomArray Inc.is a privately held DNA microarray company that provides customized oligonucleotide pools and microarrays to many of the world's leading academic and industrial organizations for applications in targeted sequencing, complex DNA libraries, synthetic biology, shRNA libraries, and CRISPR, from all of its shareholders. CustomArray uses semiconductor chip technology to electrochemically synthesize DNA right on the chip surface. The patented and proprietary technology allows the creation of large numbers of different oligonucleotides in a highly parallel, high-throughput, high-density, and cost-effective manner.  CustomArray, as a market leader in oligonucleotide pools, with one of the world's leading array-based synthesis technologies, strengthens GenScript's leadership in synthetic biology, such as gene synthesis, CRISPR library, shRNA library, enzyme and antibody engineering. According to Brooke Anderson,CEO of CustomArray, GenScript's innovation, entrepreneurial spirit, and aggressive growth, along with its depth of marketplace knowledge and reach will make a highly desirable partner for his company. ]]> https://biospectrumindia.com/news/57/10107/mallinckrodt-acquires-sucampo.html https://biospectrumindia.com/news/57/10107/mallinckrodt-acquires-sucampo.html Wed, 27 Dec 2017 17:30:00 +0530 Mallinckrodt, a leading global specialty pharmaceutical company has acquired Sucampo Pharmaceuticals, a global biopharmaceutical company. Sucampo's Commercial Assets includes AMITIZA® (lubiprostone), a leading global product in the branded constipation market. It is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic idiopathic constipation (CIC) in adults. The drug is promoted through commercial agreements in the U.S., the United Kingdom and Switzerland and in Japan. An Investigational New Drug Application for the product has been accepted in China. RESCULA® (unoprostone isopropyl ophthalmic solution) 0.15%, is indicated for ocular hypertension and open-angle glaucoma, and marketed in Japan. Mallinckrodt will acquire global rights to the product, with annual net sales of approximately $9 million. Mallinckrodt expects to build on the limited commercial infrastructure Sucampo has built for both VTS-270 and CPP-1X/sulindac with its sales organizations currently focused on rare diseases. At launch, patient access to these unique treatment options would also be supported and enhanced by Mallinckrodt's strong relationships with insurance companies and group purchasing organizations. Mallinckrodt's existing infrastructure of clinical and medical affairs experts will also support approval and launch of both products.  The acquisition is expected to be funded through borrowings under Mallinckrodt's existing revolving credit facility, a new secured term loan facility and/or cash on hand. Following the transaction, Mallinckrodt intends to utilize its significant cash generation to focus on reducing outstanding debt over time. Sucampo stockholders holding approximately 32% of the outstanding Sucampo shares have entered into a tender and support agreement for this transaction.  Mallinckrodt expects accretion from the acquisition to adjusted diluted earnings per share of at least $0.30 in 2018 and at least double that amount in 2019, assuming a first quarter 2018 close. ]]> https://biospectrumindia.com/news/57/10098/dsm-acquires-biocare-.html https://biospectrumindia.com/news/57/10098/dsm-acquires-biocare-.html Tue, 26 Dec 2017 13:45:00 +0530 Royal DSM is a global science-based company active in health, nutrition and materials. The company has publicized the acquisition of their company with BioCare Copenhagen. DSM along with biocare will expand its offering in gut health ingredients using probiotics. BioCare Copenhagen has multi-market distribution agreements with a number of leading dietary supplements and pharmaceutical companies and has launched products in over 40 countries worldwide.  DSM already has a strong position in gut health solutions with its Culturelle product range, the number-one-selling probiotic dietary supplement consumer brand globally, as well as with its ingredient brands Oatwell and Tolerase. The company sees further growth potential in gut health ingredients beyond the established indications for digestive health and immune health. Fields increasingly recognized as being impacted by the gut microbiome include the gut-brain axis, metabolic health and heart health. DSM's ambition in addressing the gut microbiome and its portfolio of nutritional ingredients are very synergetic with BioCare Copenhagen's approach and products, and the combination is well-catered to address the existing and emerging gut health areas. ]]> https://biospectrumindia.com/news/57/10113/airp-brings-affordable-biological-products-and-services-.html https://biospectrumindia.com/news/57/10113/airp-brings-affordable-biological-products-and-services-.html Thu, 21 Dec 2017 17:20:00 +0530 Abdi Ibrahim Remede Pharma (AIRP) is Biocon's partner in Algeria for the registration, marketing and pharmacovigilance monitoring of multiple Biotech Products.  Biocon Ltd., Asia's premier biopharmaceuticals company, obtained U.S. Food and Drug Administration (FDA) approval on 1st December 2017 for its biosimilar trastuzumab through its US Partner.  Biocon's trastuzumab has been approved in the US for all indications included in the label of the reference product including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).  Biocon's trastuzumab is the first FDA-approved biosimilar trastuzumab and the first biosimilar from Biocon´s portfolio to be approved in the U.S. It is only the second oncology biosimilar approved by US FDA. In addition, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for Biocon's proposed biosimilar trastuzumab for review.  Abdi Ibrahim Remede Pharma (AIRP) as Biocon's commercialization partner in Algeria launched the first biosimilar of trastuzumab named CANMAb® in 2016. Under its collaboration with Biocon in Algeria, AIRP also launched the first biosimilar of insulin glargine named BasalogOne® in 2017. Both these products are making a difference to patients by allowing them access to affordable biologics for diseases like diabetes and cancer. The global biologics drug market stands at an estimated US$ 231 billion. Under collaboration with Biocon, AIRP's biosimilars operate in the biologics market which is valued over one third of the US$1 billion total Algeria pharma market.  The introduction and strong adoption of biosimilars in Algeria is expected to facilitate access to safe and effective biological products as well as create substantial savings for the government.  In Europe, with over a decade of experience, biosimilar adoption rates have  significantly increased.  It is estimated that regulations on biosimilars adapted to the country's health and economic interests will enable Algeria to reduce its import bill by at least US$ 350 million in 2018 alone. ]]> https://biospectrumindia.com/news/57/10072/spark-therapeutics-luxturna-got-fda-approval-.html https://biospectrumindia.com/news/57/10072/spark-therapeutics-luxturna-got-fda-approval-.html Wed, 20 Dec 2017 12:50:00 +0530 The U.S. Food and Drug Administration approved Luxturna (voretigene neparvovec-rzyl); a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene. It is approved for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy that leads to vision loss and may cause complete blindness in certain patients.  Hereditary retinal dystrophies are a broad group of genetic retinal disorders that are associated with progressive visual dysfunction and are caused by mutations in any one of more than 220 different genes.  Luxturna works by delivering a normal copy of the RPE65 gene directly to retinal cells. These retinal cells then produce the normal protein that converts light to an electrical signal in the retina to restore patient's vision loss. Luxturna uses a naturally occurring adeno-associated virus, which has been modified using recombinant DNA techniques, as a vehicle to deliver the normal human RPE65 gene to the retinal cells to restore vision.  Luxturna should be given only to patients who have viable retinal cells as determined by the treating physician(s). Treatment with Luxturna must be done separately in each eye on separate days, with at least six days between surgical procedures. It is administered via subretinal injection by a surgeon experienced in performing intraocular surgery.  The safety and efficacy of Luxturna were established in a clinical development program with a total of 41 patients between the ages of 4 and 44 years. All participants had confirmed biallelic RPE65 mutations. The primary evidence of efficacy of Luxturna was based on a Phase 3 study with 31 participants by measuring the change from baseline to one year in a subject's ability to navigate an obstacle course at various light levels. The group of patients that received Luxturna demonstrated significant improvements in their ability to complete the obstacle course at low light levels as compared to the control group. The FDA granted this application Priority Review and Breakthrough Therapy designations. Luxturna also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. ]]> https://biospectrumindia.com/news/57/10070/prescient-surgical-got-fda-510k-clearance-for-its-novel-cleancision-system.html https://biospectrumindia.com/news/57/10070/prescient-surgical-got-fda-510k-clearance-for-its-novel-cleancision-system.html Wed, 20 Dec 2017 12:00:00 +0530 Prescient Surgical, Inc. located in San Carlos, Calif. is a medical device innovator that makes advanced tools and technologies to fight and defend against the sources of surgical site infection. The company announced that the U.S. Food and Drug Administration (FDA) have cleared the CleanCision Wound Retraction and Protection System (CleanCision System) for commercialization in the United States.  Developed by surgeons and infection control experts, CleanCision is the first in a new class of advanced technology. It is designed to fight and defend against the most pervasive sources of surgical infection. Utilizing active cleansing technology, CleanCision combines wound protection and irrigation in simple and effective retraction system that actively, consistently, and continuously clears harmful bacteria that may invade the incision during surgery.  When the threat of wound contamination is at its highest, CleanCision has been shown to reverse and reduce these pervasive sources of infection, clearing harmful bacteria throughout surgery. CleanCision can put more control over the root causes of infection into the hands of surgical teams where traditional methods fail to do so. Easily deployed to retract and protect the wound site, CleanCision provides access to the surgical site and uses a sterile irrigant solution, selected by the surgeon, to clear contamination invading the surgical incision. The wound edge is continuously and consistently irrigated while suction removes contaminants throughout the surgery. CleanCision is cleared for use in abdominal surgery and may aid in the prevention of wound edge contamination.  Hospitals can acquire CleanCision through the company's Early Access Program, developed to help surgical teams implement and measure the impact of the device as part of their infection reduction programs. ]]> https://biospectrumindia.com/news/57/10066/who-releases-us1-5-million-to-fight-diphtheria-in-coxs-bazar.html https://biospectrumindia.com/news/57/10066/who-releases-us1-5-million-to-fight-diphtheria-in-coxs-bazar.html Wed, 20 Dec 2017 10:45:00 +0530 The World Health Organization has deployed additional staff and resources to respond to a rapidly spreading outbreak of diphtheria among Rohingya refugees in Cox’s Bazar, Bangladesh. WHO has released US$1.5 million from its Contingency Fund for Emergencies to help finance scaling up of health operations in Cox’s Bazar over the next six months, in efforts to respond to an outbreak that has seen more than 1,500 probable cases, including 21 deaths. The Contingency Fund for Emergencies (CFE) allows WHO to respond rapidly to emergencies with health consequences before other donor funding can be triggered, minimizing injury, illness and the loss of life. Dr Roderico Ofrin, Regional Emergency Director, WHO South-East Asia Regional Office said, “The Rohingya refugees are an extremely vulnerable population, with low routine vaccination coverage. WHO is applying a ‘no regrets’ policy when allocating resources to help prevent and protect communities from the spread of diphtheria and ensure that those who are sick receive critical care and treatment. The funds released will be crucial to sustaining our efforts until we receive more support from donors for this response.” Over the next 6 months, the funds will be used to support immunization activities; improve laboratory capacity, support community engagement, contact tracing and case management in health facilities through critical guidance as well as the provision of essential medicines and supplies. For 2018, the health sector will request additional funding to help 1.2 million people living in refugee camps and temporary settlements.   ]]> https://biospectrumindia.com/news/57/10060/fda-approves-new-hiv-vitros-combo-test.html https://biospectrumindia.com/news/57/10060/fda-approves-new-hiv-vitros-combo-test.html Tue, 19 Dec 2017 16:20:00 +0530 Ortho Clinical Diagnostics is a global leader of in vitro diagnostics, serving the global clinical laboratory and immunohematology communities. Ortho announced its VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the U.S. Food and Drug Administration, for use on Ortho's VITROS 3600 Immunodiagnostic System.  The fourth-generation HIV Combo assay detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag), detecting an HIV-1 acute infection earlier than third-generation assays. The clinical and technical performance of the VITROS HIV Combo test on VITROS® Systems was evaluated during routine use at three external testing laboratories in the US and at Ortho's research and development laboratories. This assessment confirmed that the test provides competitive sensitivity and specificity when compared to a leading commercially available fourth-generation test.  In the comparison studies, assay sensitivity was evaluated on seroconversion panels. The VITROS HIV Combo test showed earlier detection of acute HIV infection in six of 32 seroconversion panels (agreement for 25 of 32 panels) when compared to a leading commercially available fourth-generation Ag/Ab test. Test findings indicate that the assay performance is competitive and shortens the diagnostic window. The results of the test, in conjunction with other serological evidence and clinical information, may be used to aid in the diagnosis of HIV-1 and/or HIV-2 infections. The test’s p24 sensitivity with uncompromised specificity is enhanced by various technologies: MicroWell technology combined with the Enhanced Chemiluminescence Detection Technology that improves signal detection with outstanding sensitivity, precision and a wide dynamic range; and the Intellicheck Technology which includes MicroSensor technology that detects endogenous interferences, and SMART Metering and VersaTIp technology that helps exclude carryover and cross-contamination through disposable tips. These provide laboratories the accuracy needed to have the utmost trust in their results.  Ortho plans to file Premarket Approval (PMA) supplements for the use of the VITROS HIV Combo test on the VITROS® ECi/ECiQ Immunodiagnostic Systems and the VITROS® 5600 Integrated System. ]]> https://biospectrumindia.com/news/57/10046/acquisition-of-factbio-by-scibite.html https://biospectrumindia.com/news/57/10046/acquisition-of-factbio-by-scibite.html Fri, 15 Dec 2017 17:35:00 +0530 SciBite is a leading provider of semantic solutions for the life sciences and pharmaceutical industries. Headquartered in the UK SciBite, a firm whose technology is revolutionising R&D for pharmaceutical companies across the globe. It has acquired Cambridge based FactBio. FactBio builds ontologies and tools for the curation and management of scientific data. The company's focus is on biomedical data, with the potential to apply its tools and techniques more widely. FactBio will become a wholly owned subsidiary of SciBite and all business will relocate to SciBite's offices at the Wellcome Trust Genome Campus, Cambridge, UK.     The era of data-driven R&D is motivating investment in technologies such as machine learning, artificial intelligence, data integration and natural language processing to provide deeper insights into new drug development strategies. Through its knowledge management platform, Kusp, FactBio provides the tools to streamline this process and generate the high quality data needed for meaningful analysis. "FactBio's platforms address a critical step in the data analysis pipeline, a growing issue for our customers. The technology shares SciBite's principles of using strong semantic data representation through high quality ontologies and together provide a holistic solution to today's big data challenges," said Rob Greenwood, CEO of SciBite.  "Being part of SciBite will mean FactBio and its technology can fulfil its potential to meet the data needs of its life science customers as part of a much broader platform strategy," said James Malone, CEO of FactBio. According to him it’s a great fit for both companies and they are very excited about the future. ]]> https://biospectrumindia.com/news/57/10043/who-advises-dengvaxia-to-be-used-only-in-people-previously-infected-with-dengue.html https://biospectrumindia.com/news/57/10043/who-advises-dengvaxia-to-be-used-only-in-people-previously-infected-with-dengue.html Fri, 15 Dec 2017 15:35:00 +0530 The World Health Organization (WHO) following a consultation of the Global Advisory Committee on Vaccine Safety finds that the dengue vaccine CYD-TDV, sold under the brand name Dengvaxia, prevents disease in the majority of vaccine recipients but it should not be administered to people who have not previously been infected with dengue virus. This recommendation is based on new evidence communicated by the vaccine’s manufacturer (Sanofi Pasteur), indicating an increase in incidence of hospitalization and severe illness in vaccinated children never infected with dengue. The WHO Global Advisory Committee on Vaccine Safety considered the company’s new results from clinical trial data analyses. Those studies indicate that increased risk of severe dengue disease in people who have never been infected affects about 15% of the vaccinated individuals. The magnitude of risk is in the order of about 4 out of every 1000 seronegative patients vaccinated who developed severe dengue disease during five years of observation. The risk of developing severe dengue disease in non-vaccinated individuals has been calculated as 1.7 per 1000 over the same period of observation. By contrast, for the 85% who have had dengue disease before immunization, there is a reduction of 4 cases of severe dengue per 1 000 who are vaccinated. The possibility of risk for seronegative people was raised by WHO and published in a position paper in July 2016: “vaccination may be ineffective or may theoretically even increase the future risk of hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination regardless of age." As this risk had at that time not been seen in the age groups for which the vaccine was licensed, WHO issued a conditional recommendation, emphasizing the use of the vaccine in populations having been previously infected with dengue virus. To minimize illness for seronegative vaccinated people, WHO recommends enhancing measures that reduce exposure to dengue infection among populations where the vaccine has already been administered. For vaccine recipients who present with clinical symptoms compatible with dengue virus infection, access to medical care should be expedited to allow for proper evaluation, identification, and management of severe forms of the disease. CYD-TDV is a live attenuated tetravalent vaccine made using recombinant DNA technology and is administered in three phases separated by six-month intervals. It became commercially available in 2016 and is currently licensed in 19 countries.     ]]> https://biospectrumindia.com/news/57/10040/fda-grants-fast-track-status-to-renova-therapeutics-heart-failure-drug.html https://biospectrumindia.com/news/57/10040/fda-grants-fast-track-status-to-renova-therapeutics-heart-failure-drug.html Fri, 15 Dec 2017 13:00:00 +0530 Renova Therapeutics is developing definitive, one-time gene therapies and peptide infusion treatments to restore the health of people suffering from cardiovascular and metabolic diseases. This biotechnology company  announced that the U.S. FDA has granted Fast Track designation for the company's lead product candidate, RT-100 AC6 gene transfer (Ad5.hAC6), to treat heart failure with reduced ejection fraction (HFrEF).  The FDA's Fast Track program is designed to expedite the development and review of drugs and biologics with the potential to treat serious or life-threatening conditions and address an unmet medical need. The designation allows for Rolling Review of a New Drug Application (NDA) or Biologic License Application (BLA). The designation also provides eligibility for Priority Review, if relevant criteria are met, potentially resulting in quicker access to patients. RT-100 AC6 gene transfer involves infusing an inactivated adenovirus vector encoding human adenylyl cyclase type 6 (Ad5.hAC6) into the arteries that feed the heart during cardiac catheterization, a commonly performed procedure. AC6 is a protein found in heart muscle cells that regulates heart function and appears to be down-regulated in heart failure patients.  Results of a Phase 2 clinical trial indicate that, through a one-time administration, RT-100 safely increased heart function beyond optimal heart failure therapy. The treatment also lowered the heart failure hospitalization rate at 12 months, which will be the primary endpoint in the program's upcoming Phase 3 trial.  Renova Therapeutics will conduct a randomized, placebo-controlled, double-blind multicenter Phase 3 trial of intracoronary delivery of RT-100 to evaluate safety and efficacy. This pivotal trial – known as FLOURISH (Heart Failure with Reduced Left Ventricular Ejection Fraction: One-time Gene Transfer Using RT-100 – Intracoronary Administration of Adenovirus 5 encoding Human AC6) – is expected to commence in Q1 2018 in the United States. ]]> https://biospectrumindia.com/news/57/10036/partership-between-biolife-solutions-and-iovance-biotherapeutics.html https://biospectrumindia.com/news/57/10036/partership-between-biolife-solutions-and-iovance-biotherapeutics.html Thu, 14 Dec 2017 16:15:00 +0530 BioLife Solutions, the leading developer, manufacturer and marketer of proprietary clinical grade biopreservation media announced that it has executed an agreement to supply its CryoStor cell freeze media and HypoThermosol cell storage and shipping media to Iovance Biotherapeutics. Lovance is currently conducting several clinical trials for tumor infiltrating lymphocyte (TIL) therapies targeting multiple solid tumor types including metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck and recurrent, metastatic or persistent cervical cancer.  Mike Rice, BioLife President & CEO, commented, "We are very pleased to support the team at Iovance in their mission to bring potentially lifesaving cancer therapies to the market.It's very rewarding to see our proprietary bio preservation media products being broadly adopted in the regenerative medicine market, due to the improved yield and extended shelf life our IP platform can offer our customers."  Maria Fardis, President and Chief Executive Officer of Iovance, Commented on the collaboration with BioLife Solutions, "As we advance into later stages of our clinical development, we continue building strong collaborative relationships with our suppliers and partners. We are pleased to have established this supply agreement with BioLife, assuring our access to biopreservation media for storage and shipment of our products using our Gen 2 manufacturing process, which includes cryopreservation of our final product."  BioLife management estimates that CryoStor and HypoThermosol have been incorporated into the manufacturing processes of at least 250 regenerative medicine applications, including numerous late-stage clinical trials. ]]> https://biospectrumindia.com/news/57/10032/half-the-world-lacks-access-to-essential-health-services-world-bank-and-who.html https://biospectrumindia.com/news/57/10032/half-the-world-lacks-access-to-essential-health-services-world-bank-and-who.html Thu, 14 Dec 2017 11:30:00 +0530 The findings, released recently in Tracking Universal Health Coverage: 2017 Global Monitoring Report says that at least half of the world’s population cannot obtain essential health services, according to a new report from the World Bank and WHO. And each year, large numbers of households are being pushed into poverty because they must pay for health care out of their own pockets. Currently, 800 million people spend at least 10 percent of their household budgets on health expenses for themselves, a sick child or other family member. For almost 100 million people these expenses are high enough to push them into extreme poverty, forcing them to survive on just $1.90 or less a day. The report is a key point of discussion at the global Universal Health Coverage Forum 2017, currently taking place in Tokyo, Japan. Convened by the Government of Japan, the Forum is co-sponsored by the Japan International Cooperation Agency (JICA), UHC2030 which is the leading global movement advocating for UHC, UNICEF, the World Bank, and WHO. Japanese Prime Minister Shinzo Abe, UN Secretary-General Antonio Guterres, World Bank President Kim, WHO Director-General Tedros and UNICEF Executive Director Anthony Lake will all be in attendance, in addition to heads of state and ministers from over 30 countries. Dr Tedros Adhanom Ghebreyesus, Director-General of WHO said, "It is completely unacceptable that half the world still lacks coverage for the most essential health services. And it is unnecessary. A solution exists: universal health coverage (UHC) allows everyone to obtain the health services they need, when and where they need them, without facing financial hardship." Dr. Jim Yong Kim, World Bank Group President said, “The report makes clear that if we are serious – not just about better health outcomes, but also about ending poverty – we must urgently scale up our efforts on universal health coverage. Investments in health, and more generally investments in people, are critical to build human capital and enable sustainable and inclusive economic growth. But the system is broken: we need a fundamental shift in the way we mobilize resources for health and human capital, especially at the country level. We are working on many fronts to help countries spend more and more effectively on people, and increase their progress towards universal health coverage." On a positive side, The report shows that the 21st century has seen an increase in the number of people able to obtain some key health services, such as immunization and family planning, as well as antiretroviral treatment for HIV and insecticide-treated bed nets to prevent malaria. In addition, fewer people are now being tipped into extreme poverty than at the turn of the century. “There are wide gaps in the availability of services in Sub-Saharan Africa and Southern Asia. In other regions, basic health care services such as family planning and infant immunization are becoming more available, but lack of financial protection means increasing financial distress for families as they pay for these services out of their own pockets”, according to report. This is even a challenge in more affluent regions such as Eastern Asia, Latin America and Europe, where a growing number of people are spending at least 10 percent of their household budgets on out-of-pocket health expenses. Inequalities in health services are seen not just between, but also within countries: national averages can mask low levels of health service coverage in disadvantaged population groups. For example, only 17 percent of mothers and children in the poorest fifth of households in low- and lower-middle income countries received at least six of seven basic maternal and child health interventions, compared to 74 percent for the wealthiest fifth of households. Katsunobu Kato, Minister of Health, Labour and Welfare, Japan said, “Past experiences taught us that designing a robust health financing mechanism that protects each individual vulnerable person from financial hardship, as well as developing health care facilities and a workforce including doctors to provide necessary health services wherever people live, are critically important in achieving 'Health for All. I firmly believe that these early-stage investments for UHC by the whole government were an important enabling factor in Japan’s rapid economic development later on." The Forum is the culmination of events in over 100 countries, which began on Dec. 12—Universal Health Coverage Day—to highlight the growing global momentum on UHC. It seeks to showcase the strong high-level political commitment to UHC at global and country levels, highlight the experiences of countries that have been pathfinders on UHC progress, and add to the knowledge base on how to strengthen health systems and effectively promote UHC. Anthony Lake, UNICEF Executive Director said, "Without health care, how can children reach their full potential? And without a healthy, productive population, how can societies realize their aspirations? Universal health coverage can help level the playing field for children today, in turn helping them break intergenerational cycles of poverty and poor health tomorrow."   ]]> https://biospectrumindia.com/news/57/10031/bangladesh-moves-to-protect-rohingya-children-from-diphtheria.html https://biospectrumindia.com/news/57/10031/bangladesh-moves-to-protect-rohingya-children-from-diphtheria.html Wed, 13 Dec 2017 18:05:00 +0530 The Government of Bangladesh has recently launched a vaccination campaign with the support of UNICEF, the World Health Organization and GAVI, the Vaccine Alliance against diphtheria and other preventable diseases for all Rohingya children aged 6 weeks to 6 years living in 12 camps and temporary settlements near the Myanmar border. Accelerated immunization will cover nearly 255 000 children in Ukhiya and Teknaf sub-districts in Cox’s Bazar, while the Government and health partners continue to increase support for diphtheria treatment and prevention. Edouard Beigbeder, UNICEF Representative to Bangladesh said, “Diphtheria usually appears among vulnerable populations that have not received routine vaccinations, such as the Rohingyas. The outbreak shows a steep rise in cases, an indicator of the extreme vulnerability of children in the Rohingya camps and settlements. This calls for immediate action to protect them from this killer disease. Vaccination provides effective prevention.” According to the recent data from the WHO Early Warning Alert and Response System (EWARS) and Médecins Sans Frontières (MSF), “722 probable diphtheria cases, including 9 deaths, in the camps and makeshift settlements hosting the refugees, between 12 November and 10 December.” Dr Abul Kalam Azad, Director General of Health Services, Ministry of Health and Family Welfare, Government of Bangladesh said, “The Government of Bangladesh will do everything necessary to contain this outbreak. We thank WHO, UNICEF and other health partners for their swift response to the request of the Government to combat this diphtheria outbreak, and for continuously supporting our efforts to provide essential health services for these vulnerable people.” The children are being administered pentavalent vaccines (which protects against diphtheria, pertussis, tetanus, Haemophilus Influenzae, and hepatitis B), pneumococcal conjugate vaccines (PCV) and bivalent oral polio vaccine. The Serum Institute of India has donated 300 000 doses of pentavalent vaccines for use in the response. WHO and UNICEF are working with communities to ensure that they are aware of the signs and symptoms of diphtheria, and that they can access treatment as quickly as possible. Dr Navaratnasamy Paranietharan, WHO Representative to Bangladesh said, “We are moving quickly to control this diphtheria outbreak before it spins out of control. The vaccines will help protect every Rohingya child in these temporary settlements from falling prey to the deadly disease. Beyond vaccinations, we are helping health workers to clinically manage suspected cases, trace their contacts, and ensure sufficient supplies of medicines.” WHO is procuring 2 000 doses of diphtheria anti-toxins to treat diphtheria patients. Nearly 345 doses were hand carried by WHO from Delhi to Cox’s Bazar.   ]]> https://biospectrumindia.com/news/57/10028/essa-pharma-announced-sudden-marketed-equity-offering.html https://biospectrumindia.com/news/57/10028/essa-pharma-announced-sudden-marketed-equity-offering.html Wed, 13 Dec 2017 16:55:00 +0530 ESSA Pharma Inc.is pleased to announce that today it has undertaken overnight marketed public offering of equity securities of the Company. The Offering will be conducted in each of the provinces of British Columbia, Alberta and Ontario by way of a prospectus supplement to ESSA's base shelf prospectus dated December 22, 2015 and elsewhere on a private placement basis. The Securities may also be offered for sale in the United States through H.C. Wainwright & Co., as exclusive U.S. placement agent. The number and type of Securities to be distributed under the Offering and the price of each Security will be determined in the context of the market.  The Company expects to close the Offering during the week of December 18, 2017. The closing conditions, including, but not limited to, the receipt of all necessary stock exchange approvals, such as the conditional approval of the TSX Venture Exchange (the "TSXV") and the NASDAQ Capital Market. The Company intends to use the net proceeds of the Offering primarily to continue the ongoing preclinical development of the Company's next-generation Aniten compounds. The net proceeds will also be used for the interest and principal payments on the Company's outstanding debt and for working capital and general corporate purposes.  The Securities have not been registered under the United States Securities Act of 1933, as amended,or any state securities laws, and accordingly, may not be offered or sold to. ]]> https://biospectrumindia.com/news/57/10027/stop-street-drug-alternative-fda-warns.html https://biospectrumindia.com/news/57/10027/stop-street-drug-alternative-fda-warns.html Wed, 13 Dec 2017 14:15:00 +0530 The U.S. Food and Drug Administration posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a "snortable" chocolate powder, for selling unapproved new drugs and misbranded drugs.  The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and marketed, may pose safety concerns. Drug abuse is a serious public health issue, and the FDA is concerned that products like Legal Lean Syrup and Coco Loko encourage drug abuse in individuals, including minors. Street drug alternatives are products that claim to mimic the effects of recreational drugs and are intended to be used for recreational purposes to affect psychological circumstances.  "As a physician and a parent, I'm deeply troubled by the unlawful marketing of these potentially dangerous products, especially since they are so easily accessible by minors.Encouraging the use of snortable chocolate as an alternative to illegal street drugs is not acceptable There are very real consequences to snorting any powder, not to mention the societal dangers of promoting drug abuse," said FDA Commissioner Scott Gottlieb, M.D. He added further"At a time where drug addiction is threatening the fabric of American society, we must take action when we see efforts that may further fuel illicit drug abuse. We'll continue to vigorously target bad actors that sell unapproved products, including products that contain undeclared drug ingredients."  Coco Loko is described as a "snuff" and promoted to be "snorted" (inhaled intranasally). Intranasal administration of a powder substance can trigger spasms of the vocal cords making it difficult to speak or breathe (laryngospasm) or tightening of the muscles that line the airways in the lungs (bronchospasm) and may also induce or exacerbate asthma. The ingredients listed on the product label for Coco Loko also include taurine and guarana, neither of which has been evaluated for intranasal administration.   An FDA laboratory analysis found that Legal Lean Syrup contained the active pharmaceutical ingredient doxylamine, which was not included in the product labeling. FDA-approved products that contain doxylamine warn against its use with alcoholic beverages and instruct people with certain medical conditions to consult a physician before use. Furthermore, the inclusion of undeclared doxylamine in Legal Lean Syrup poses a potentially serious risk to those who have already had adverse reactions to this ingredient and whose physicians have advised them to avoid it. In general, products that contain undeclared drug ingredients pose a serious health risk, because consumers with underlying medical issues may take the products without knowing of any potential side effects or interactions. The companies have 15 days to respond to the FDA and correct the issues noted, or they may face regulatory action. ]]> https://biospectrumindia.com/news/57/10026/gsk-receives-nod-for-nucala-mepolizumab-to-treat-egpa.html https://biospectrumindia.com/news/57/10026/gsk-receives-nod-for-nucala-mepolizumab-to-treat-egpa.html Wed, 13 Dec 2017 12:05:00 +0530 US Food and Drug Administration (FDA) have given approval to Nucala (mepolizumab) of GlaxoSmithKline. Nucala deliver the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.         GSK submitted a supplemental Biologics License Application (sBLA) for mepolizumab, an interleukin-5 (IL-5) antagonist, in June 2017.  Eric Dube, Senior Vice President & Head, GSK Global Respiratory Franchise, said: "Following physician and patient experience with Nucala in severe eosinophilic asthma, we are thrilled that the FDA has expanded the use of this medicine to patients with EGPA, another eosinophil-driven disease, enabling GSK to make it available to patients. This approval follows the positive results of the largest prospective treatment study conducted in EGPA to date, and now for the first time physicians have a targeted treatment option for this debilitating condition." He stated further  Mepolizumab is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.  The approval for EGPA is based on results from the pivotal, 52-week, Phase III MIRRA1 study, conducted as a collaboration between GSK and the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.  The MIRRA study evaluated the efficacy and safety of 300mg of mepolizumab administered subcutaneously every four weeks versus placebo as add-on therapy to standard of care in 136 patients with relapsing and/or refractory EGPA.  Both co-primary endpoints (accrued time in remission and proportion of patients achieving remission at both weeks 36 and 48) were statistically significant in favour of mepolizumab.  All six secondary endpoints (investigating relapse, remission, and corticosteroid use) were met in favour of mepolizumab. The percentage of patients experiencing on-treatment adverse events was comparable between the two treatment groups (97% mepolizumab versus 94% placebo). Injection site reactions (e.g., pain, erythema, and swelling) occurred at a rate of 15% in patients receiving mepolizumab compared with 13% in patients receiving placebo. Eighteen percent of patients receiving mepolizumab reported serious adverse events compared with 26% in the placebo group, with the most frequently reported being asthma worsening/exacerbation (3% versus 6%). Dr. Peter A. Merkel, Chief, and Division of Rheumatology at Perelman School of Medicine, University of Pennsylvania & MIRRA study site investigator said: "Patients suffering from EGPA too often face a frustrating journey from a delay in receiving a proper diagnosis to having few effective treatment options with an acceptable safety profile.” According to him, Rheumatologists, immunologists, and pulmonologists have an important role in properly diagnosing and treating patients with EGPA. Today's approval of mepolizumab provides specialists with the ability to offer a targeted treatment to appropriate patients with this complex disease.  Dr. Michael E. Wechsler, Professor of Medicine at National Jewish Health in Denver, Colorado, US & Principal Investigator of the MIRRA study, said: "Patients with EGPA often suffer from recurrent relapses that place them at greater risk of permanent tissue and organ damage. Clinical data demonstrated that mepolizumab increased accrued time in remission, reduced the frequency of relapse and flares, and enabled patients to have their dose of corticosteroid reduced compared to placebo in patients already receiving standard of care. These are key treatment goals and this approval is an important milestone both for treating physicians and for patients."  Nucala for treatment of EGPA in the US is available now.  In recognition of the fact that US consumers are increasingly being asked by their insurers to take on more cost sharing, making affordability a concern for some patients, GSK has various patient assistance programmes available for those who be suitable. ]]> https://biospectrumindia.com/news/57/10020/a-joint-venture-between-mundipharma-and-ntc.html https://biospectrumindia.com/news/57/10020/a-joint-venture-between-mundipharma-and-ntc.html Tue, 12 Dec 2017 16:10:00 +0530 Mundipharma is a network of independent associated companies, covering pharmaceutical markets in Asia-Pacific, Latin America, the Middle East and Africa.  Mundipharma has expanded its ophthalmology portfolio in the Middle East and Africa by agreeing a new commercial partnership with NTC. NTC is an Italian pharmaceutical company with deep experience in research and development.  NTC’s portfolio was developed to address unmet medical needs in the treatment of several ophthalmic diseases, including blepharitis, dry eye, allergies and glaucoma.  “The addition of the NTC medicines complements Mundipharma’s current ophthalmology porfolio in the Middle East and Africa,” said Mundipharma CEO, Raman Singh. “It’s another bold and important step in our efforts to establish market leadership in the region backed by a strong and diversified portfolio of medicines.” He added  As well as licensing and distribution rights, under the partnership Mundipharma will also benefit from NTC’s commitment to research and development in ophthalmology.  NTC operates an international ophthalmology research and development program called Italian Innovation.  Through the program, it engages with a large number of opinion leaders and clinical centres.  It will focus on developing novel therapeutic solutions, with rich clinical insights, to release better and more affordable therapeutic treatments for patients.  “As NTC’s strategic partner in Middle East and Africa, Mundipharma can now leverage its world class development and clinical programs to improve clinical outcomes in ophthalmology,” stated Mr Singh.  According to  him, this is a great result for patients, who will benefit from improved access to more medicines with higher therapeutic value.  “Partnering with a leading company like Mundipharma is of real value and importance to NTC as it confirms the importance of our development efforts in the ophthalmic area,” said Riccardo Carbucicchio, President and CEO, NTC.  “Mundipharma are an ideal strategic partner in the Middle East and Africa with the capability and expertise to extend the reach of these medicines to benefit more patients,” he added ]]> https://biospectrumindia.com/news/57/10019/discngine-build-up-1-1-million-1-3m-in-series-a-funding-round-.html https://biospectrumindia.com/news/57/10019/discngine-build-up-1-1-million-1-3m-in-series-a-funding-round-.html Tue, 12 Dec 2017 15:15:00 +0530 Discngine, a software company specializing in applications for life sciences research, announced a Series A financing round of €1.1 million ($1.3M), received from Extens Developpement e-Sante.  The funds raised will allow Discngine to move forward with its Software-as-a-Service (SaaS) solution offering for the life sciences industry, a model that is not, as yet, widely used in this sector.  Discngine already offers software for data management, visualization and decision-making processes in the life sciences industry, with leading pharmaceutical and cosmetics firms among its clients.  Besides speeding up the development and commercialization of its SaaS solution offering, the company will use the new funds to extend its international reach, as well as to hire ten new staff members by the end of 2018.  The company will also establish a supervisory board, comprising of representatives from Extens and Discngine as well as two experts from the life sciences research sector: Gordon Waldron, from Sequoia Business Solutions and Simon Valentine, from Illumina.  The Software-as-a-Service approach offers services to clients based on a subscription model. It is well established in several industries, with strong growth potential. In the life sciences sector however the model is not yet widespread. Discngine could be among the first companies to make it more accessible to clients, building on the company’s long-standing technical and scientific knowledge of 14 years.  "Thanks to this investment, our team will be able to industrialize our high value-added projects and commercialize them via a SaaS (Software-as-a-Service) offer available to researchers all over the world. Discngine now has the means to accelerate its international development." said Eric Le Roux, founder and CEO of Discngine.  "We are excited to invest in Discngine. The company has developed a state-of-the-art technology platform that increases the efficiency of drug discovery, helping to find ‘bankable’ molecules,” said Arnaud Houette, managing director of Extens.  “The challenge is not only financial, but above all medical. This is a good example of our strategy: identifying French e-health startups that develop promising technologies, helping them accelerate their development and contributing to an improvement in our health system." Arnaud Houette stated again.  Discngine is already collaborating with Dassault Systemes BIOVIA on the distribution of its first two SaaS solutions. It is also planning to launch new solutions dedicated to life sciences research in 2018. ]]> https://biospectrumindia.com/news/57/10018/merck-joined-hands-with-avanti-polar-lipids-.html https://biospectrumindia.com/news/57/10018/merck-joined-hands-with-avanti-polar-lipids-.html Tue, 12 Dec 2017 14:25:00 +0530 Merck is a leading science and technology company in healthcare, life science and performance materials. Company announced that it has entered into an agreement with Avanti® Polar Lipids. It will be exclusive multinational distributor of the USA-based company's research lipids portfolio outside of the United States.  Under the terms of the agreement, Merck will employ its sales, marketing and e-commerce expertise to distribute Avanti® Polar Lipids research lipid portfolio. The distribution agreement includes all regions worldwide, except for the United States, where Avanti® Polar Lipids will continue to reach customers via its own channels. Financial details were not disclosed.  "High-quality lipids are an essential component of precision in the laboratory. Avanti Polar Lipids' research lipids strengthen Merck's overall Life Science portfolio, giving our customers access to a broad portfolio of the highest purity lipids on the market." said Klaus Bischoff, Head of the Research Solutions business area, Life Science at Merck.  Merck offers a complete portfolio of products and solutions that enable scientific discovery, including life science reagents and kits, lab and specialty chemicals and lab separation and workflow tools.  Avanti® Polar Lipids is a leading manufacturer and supplier of the highest purity lipids for research and pharmaceutical product development. Through this agreement, customers outside of the United States will have enhanced on-demand access to the Avanti® research lipid portfolio. The access will make available through life science business of Merck's robust e-commerce platform, SigmaAldrich.com, regional inventory and company sales representatives. Products will be stocked globally for improved availability to customers.  Transition of approximately 2,000 products from the Avanti® research lipid portfolio to Merck is expected to be completed in early 2018. In the interim, these products will continue to be available through existing Avanti® Polar Lipids' channels. Avanti® lipidomics products included in this agreement provide a new approach to answer fundamental questions about lipid structure and function and meet the demands of lipid researchers. ]]> https://biospectrumindia.com/news/57/10015/milliporesigma-collaborates-with-avanti-polar-lipids.html https://biospectrumindia.com/news/57/10015/milliporesigma-collaborates-with-avanti-polar-lipids.html Tue, 12 Dec 2017 11:05:00 +0530 MilliporeSigma has entered into an agreement with Avanti Polar Lipids to be the exclusive multinational distributor of the Alabama-based company's research lipids portfolio outside of the United States. Avanti Polar Lipids is a leading manufacturer and supplier of the highest purity lipids for research and pharmaceutical product development. MilliporeSigma will employ its sales, marketing and e-commerce expertise to distribute Avanti Polar Lipid's research lipid portfolio. The distribution agreement includes all geographies worldwide except for the United States, where Avanti will continue to reach customers via its own channels. Financial details of this agreement were not disclosed. Through this agreement, customers outside of the US will have enhanced, on-demand access to the Avanti research lipid portfolio through MilliporeSigma's robust e-commerce platform, SigmaAldrich.com, regional inventory and MilliporeSigma sales representatives. Products will be stocked globally for improved availability to customers. Transition of approximately 2,000 products from the Avanti research lipid portfolio to MilliporeSigma is expected to be completed in early 2018. In the mean-time, these products will continue to be available through existing Avanti Polar Lipids channels. ]]> https://biospectrumindia.com/news/57/10012/fda-sanctioned-hologics-new-panther-fusion-system.html https://biospectrumindia.com/news/57/10012/fda-sanctioned-hologics-new-panther-fusion-system.html Mon, 11 Dec 2017 18:00:00 +0530 Hologic made an announcement about getting 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion AdV/hMPV/RV assay, a multiplexed assay that runs on the new Panther Fusion system.  The new assay detects Adenovirus, human Metapneumovirus, and Rhinovirus.  It is the third diagnostic assay available on the Panther Fusion system, complementing the Panther Fusion Flu A/B/RSV assay and the Panther Fusion Paraflu assay, which both received clearance in October 2017. "Clearance and launch of the new Fusion AdV/hMPV/RV assay completes our initial set of modular assays for respiratory viruses," said Tom West, president of the Diagnostic Solutions division at Hologic. He specified further "We now offer a suite of molecular assays that help labs maximize their efficiency when running respiratory tests, in addition to the benefits of doing so on the fully automated Panther Fusion system."  A number of respiratory panels currently on the market require testing for 20 or more targets even when a physician has only requested three or four, making testing time-consuming and expensive for laboratories. The Panther Fusion assays offer a modular approach to syndromic respiratory testing via the ability to run one, two or all three assays from a single patient specimen.  The Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities.  Specifically, the Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry that powers the Company's Aptima® brand. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities.  Adenoviruses cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, and also can cause illnesses such as gastroenteritis, conjunctivitis, cystitis, and neurological disease. Infants and people with weakened immune systems are at high risk for developing severe illnesses caused by Adenovirus infection. hMPV is a common respiratory pathogen, particularly in infants and young children. The virus is associated with both upper and lower respiratory tract infections and may be a trigger for asthma. Clinical symptoms of hMPV infection may progress to bronchiolitis or pneumonia. Rhinoviruses are the causative pathogens in more than half of viral respiratory infections, and they are associated with acute exacerbations of respiratory disease, including asthma, sinusitis, otitis media, and COPD. A number of studies have confirmed rhinoviruses as being the most common cause of the common cold. ]]> https://biospectrumindia.com/news/57/10007/sartorius-stedim-launched-new-data-analytics-software-.html https://biospectrumindia.com/news/57/10007/sartorius-stedim-launched-new-data-analytics-software-.html Mon, 11 Dec 2017 12:20:00 +0530 Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. The company has launched a new version of its SIMCA and SIMCA online data analytical solutions, which are offered by its subsidiary Sartorius Stedim Data Analytics, formerly known as Umetrics. Every day, businesses generate a vast array of data derived from a variety of different sources. This data holds the key to better performance. The challenge is to interpret this information in a meaningful way. However, with so many parameters and such vast system complexity to consider, it is hard to find a solution that is both powerful and smart enough. SIMCA, an established advanced data analytics and visualization program as part of the company’s proven Umetrics Suite. It makes possible to combine and analyze data from all sources to isolate, understand and act on the hidden gems that hold the secret to better decision-making and greater business success. SIMCA is multivariate data analysis engine enables companies to swiftly detect and analyze deviations from normal operating conditions by modeling an idealized process. Once this model is transferred into SIMCA online, it serves as a valuable reference for your current production. The newly enhanced software offers an intuitive graphical interface and the flexibility to handle complex data, such as reworking, splitting and merging, and more. SIMCA projects can be uploaded directly to an available SIMCA-online server for real-time visualization of the process from a data point of view.  The real-time monitoring and prediction system, SIMCA online, constantly monitors processes to provide a continuous snapshot of the users operations. It not only helps to identify when set parameters change, but also enables remedial action to be taken before production is affected, ensuring that product quality remains consistent. With this level of control, it is possible to maximize resource efficiency, minimize operational costs and benefit from increased confidence in end-product quality. SIMCA online has the self-service analytics capability, which allows anyone to create fundamental process models, regardless of their background. The new notification system, along with the new web client, gives the user peace of mind about the quality of production anywhere and anytime as this system provides an overview of the production processes on devices such as tablets or mobile phones. SIMCA and SIMCA online have been developed according to GAMP5 and have been extensively tested and validated. These programs are also used by the EMA and FDA for Real-Time Release testing.  As leading experts for analyzing data, Sartorius Stedim Data Analytics helps companies in any industry, which include the pharma, chemical and food sectors, find the growth opportunities they need using the comprehensive Umetrics Suite. These solutions enable them to harness the wealth of data within an organization, identifying vital elements to improve the results of research, product development and manufacturing processes. With improved process understanding and more consistent product quality, users will be able to reduce risk, speed up time to market and accelerate business growth. A complete solution encompasses software, training, support and project management. Sartorius Stedim Data Analytics also provides the backup of an international network. ]]> https://biospectrumindia.com/news/57/9996/mekong-countries-call-for-accelerated-action-to-eliminate-malaria-before-2030.html https://biospectrumindia.com/news/57/9996/mekong-countries-call-for-accelerated-action-to-eliminate-malaria-before-2030.html Fri, 08 Dec 2017 13:25:00 +0530 Representatives from Cambodia, China, the Lao People’s Democratic Republic, Myanmar, Thailand and Viet Nam today called for accelerated action to eliminate malaria in the Greater Mekong Subregion (GMS) by the year 2030. The call comes amid concern over resistance of malaria parasites to antimalarial drugs, including artemisinin—the core compound of the best available antimalarial medicines. To date, resistance has been detected in five of the six GMS countries. The best way to address the threat posed by drug resistance is to eliminate malaria altogether from the countries of the Mekong. At a high-level meeting convened by the Ministry of Health and Sports of Myanmar in collaboration with the World Health Organization (WHO) and the Asia Pacific Leaders Malaria Alliance (APLMA), representatives from the six GMS countries stressed that eliminating malaria in the Subregion requires urgent and coordinated action, with support from implementing agencies, funders and other partners. Ministers from the six countries pledged to ensure activities to eliminate malaria in the subregion are fully funded, including with more domestic funds; improve cross-border collaboration and establish an independent oversight body, for which WHO will act as the secretariat; strengthen systems for the identification and timely reporting of malaria infections, including drug-resistant forms; provide the best possible prevention, diagnosis and care for all people at risk of malaria, including free services for ethnic minorities and mobile and migrant populations, as part of universal health coverage; ensure available antimalarial medicines are safe and effective for use; bring all concerned sectors together to translate policies into time-bound and results-oriented actions; and engage communities in malaria elimination using innovative communication tools. Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia said, “Malaria is a disease that we can—and must—eliminate from the Greater Mekong Subregion. The drive to achieve this goal by 2030 demonstrates the joint commitment of health leaders from across the subregion to secure the health and well-being of vulnerable populations and ensure no one is left behind.” Dr Shin Young-soo, WHO Regional Director for the Western Pacific said, “The malaria parasite doesn't need a passport or a visa to cross borders. You must work more closely together as one region, with one strategy to drive elimination. Accelerating malaria elimination in the Greater Mekong will not only improve lives today. It will also free future generations from the plague of malaria, and set an example for the rest of the world.” WHO helps governments achieve malaria elimination by setting and disseminating guidance and policies on malaria control and elimination; supporting countries as they adapt, adopt and implement WHO global norms and standards for malaria control and elimination; assisting countries in the implementation of national malaria strategic plans; helping countries develop robust malaria surveillance systems; and responding to requests from countries to address threats, operational emergencies and bottleneck issues.     ]]> https://biospectrumindia.com/news/57/9993/fda-approves-paris-innovative-eflow-technology-to-treat-copd.html https://biospectrumindia.com/news/57/9993/fda-approves-paris-innovative-eflow-technology-to-treat-copd.html Thu, 07 Dec 2017 18:05:00 +0530 PARI Pharma announces the approval of its first innovative eFlow closed system nebulizer Magnair together with Sunovion's Lonhala (glycopyrrolate) Inhalation Solution. MAGNAIR, designed, optimized, and developed by PARI Pharma, is intended only for use with LONHALA (glycopyrrolate) Inhalation Solution vials in patients with COPD. The drug/device combination product received FDA approval on December 5th, 2017 under a New Drug Application (NDA). MAGNAIR is the first product to be commercialized using PARI Pharma's innovative eFlow closed system nebulizer technology which does not have a traditional open medication reservoir in which patients manually transfer the liquid drug product from a vial. MAGNAIR features a proprietary blow-fill-seal ampule which is inserted into the cap of MAGNAIR and pierced open once the cap of the MAGNAIR handset is closed, without the need for a manual filling step. This feature is designed to reduce risk of spilling of the medication when the vial is emptied. As with all eFlow Technology nebulizers, MAGNAIR allows the patient to breathe naturally without any special breathing technique. The patient inhales and exhales as they normally do at rest.  "With the approval of LONHALA MAGNAIR for COPD, we are bringing a new advancement in nebulizers that are designed to be efficient, silent and fast to people with COPD. It is great to see our technology addressing an unmet medical need for a nebulized LAMA," states Dr. Martin Knoch, President of PARI Pharma. "MAGNAIR is a great example of the flexibility of development and optimization using the eFlow Technology platform," added Geoff Hunziker, President of PARI Pharma's US sister company eFlow LLC.  "Sunovion is pleased that the FDA has approved LONHALA MAGNAIR as the first nebulized long-acting muscarinic antagonist treatment option for people in the U.S. living with COPD," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion. According to him, LONHALA MAGNAIR is an important advancement for patients who may prefer nebulized medications and a therapy that fits into their everyday lives. LONHALA MAGNAIR is approved for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ]]> https://biospectrumindia.com/news/57/9986/global-survey-illustrates-type-2-diabetes-people-undervalue-their-cardiovascular-risk.html https://biospectrumindia.com/news/57/9986/global-survey-illustrates-type-2-diabetes-people-undervalue-their-cardiovascular-risk.html Thu, 07 Dec 2017 11:30:00 +0530 The International Diabetes Federation (IDF) presented the interim results of the first ever multi-country online survey on CVD risk awareness and knowledge among people living with type2 diabetes. The result indicates low levels of awareness and limited dialogue between patients and healthcare professionals. The global survey ‘Taking Diabetes to Heart’ developed in partnership with Novo Nordisk, runs until March 2018 and is open to all people with type2 diabetes.  Diabetes currently affects 425 million adults worldwide, with most cases being type2 diabetes. Cardiovascular disease, which includes stroke, coronary heart disease and peripheral artery disease, is the leading cause of disability and death in people with type 2 diabetes.  The survey has been done in 32 countries and from these 943 responses received. Interim conclusions showed that, One third of the respondents living with type 2 diabetes consider their risk of CVD to be low.26% of respondents had either never learned about CVD or received information on CVD several years following their type 2 diabetes diagnosis.1 in 6 respondents had never discussed their type 2 diabetes and CVD risk with a healthcare professional.  "The interim results of Taking Diabetes to Heart reiterate the importance of raising awareness of the association between type 2 diabetes and cardiovascular disease to promote prevention, timely diagnosis and appropriate treatment to help reduce the current burden that the two conditions represent," said Dr Shaukat Sadikot, outgoing IDF President. He stated further, "With the world facing an increase in the prevalence of type 2 diabetes, better understanding the link between these conditions is needed more than ever." Survey is done to gather information on current gaps in education and CVD risk behaviour among people with type2 diabetes, and to put in place advocacy and patient support strategies and tactics to improve health and wellbeing among populations.  "Cardiovascular disease is the leading cause of disability and death among people living with type 2 diabetes. Too few individuals with diabetes are being informed by healthcare professionals of their cardiovascular risk and the impact that risk may have on their longevity and quality of life," said Alan Moses, senior vice president and chief medical officer of Novo Nordisk. "We encourage more people in the diabetes community to complete the Taking Diabetes to Heart survey to strengthen the global findings that will inform future efforts to help improve outcomes."  The results of Taking Diabetes to Heart will serve to define the actions that are required to improve the health outcomes of people with type 2 diabetes. The initiative will culminate in a comprehensive report with country-specific results and resources to help support knowledge and awareness of CVD among people with type 2 diabetes around the world. ]]> https://biospectrumindia.com/news/57/9980/robocath-boost-up-with-6-4-million-in-2017.html https://biospectrumindia.com/news/57/9980/robocath-boost-up-with-6-4-million-in-2017.html Wed, 06 Dec 2017 15:35:00 +0530 To treat the vascular diseases Robocath, designs and develops innovative robotic solutions. The company announced an increase in capital of €1.7 million ($2M).  In total capital, €1.25 million ($1.5M) contribution is from Credit Agricole Innovations ET Territoires (CAIT); a fund dedicated to technological innovation in France, managed by Supernova Invest. Co-owned by Amundi and the CEA, Supernova Invest is a key player in investment capital in Europe; particularly in France. Cardio Participation, a holding company bringing together several business angels, also invested €450,000 ($530K). This latest financial contribution supplements the €4.7 million ($5.6M) rose by Robocath in a previous round of fund raising in May. R-One TM is a unique technology that optimizes and increases the safety of robotic-assisted coronary angioplasty. This medical procedure consists of revascularizing the cardiac muscle by inserting one or more implants (stents) into the arteries that supply it with blood. This type of procedure is performed more than one million times each year. There are many benefits to R-OneTM, for both the patient and the doctor. The technology allows the surgeon to operate with extreme precision and in optimal conditions. Intuitive to use, the technology allows the surgeon to operate from a seated position and to use a portable protective screen to guard against X-rays. This first robotic platform will be marketed in Europe and the Middle East in 2018.  Due to this funding, Robocath will also begin researching and developing the next generation of robotic solutions. The new platform will be used to treat neurovascular diseases such as strokes; the second leading cause of death in the world after heart attacks. The new solution will also aim to improve care for these conditions. ]]> https://biospectrumindia.com/news/57/9978/merck-in-collaboration-with-genea-biomedx-got-fda-510k-permission-for-benchtop-embryo-incubator-geri-.html https://biospectrumindia.com/news/57/9978/merck-in-collaboration-with-genea-biomedx-got-fda-510k-permission-for-benchtop-embryo-incubator-geri-.html Wed, 06 Dec 2017 13:00:00 +0530 Leading healthcare science and technology company, Merck, announced the FDA 510(K) clearance of the benchtop embryo incubator Geri. This innovative technology, designed to improve processes in fertility laboratories, will be commercially available to IVF clinics in the U.S. in the first half of 2018. Merck will help to advance assisted reproductive treatment (ART) technologies by offering new, relevant solutions to patients and their healthcare professionals. "Geri is one of the flagship products of our fertility technologies portfolio and has been successfully used in clinics across Australia, Europe and Asia for the last two years," said Rehan Verjee, Chief Marketing and Strategy Officer at Merck's biopharma business. "Offering Geri in the U.S. will allow us to further our aspiration of becoming an integrated fertility treatment partner, continuously aiming to improve treatment outcomes." stated Rehan Verjee  An incubator is critical for embryo development while it is being cultured outside of the uterus. Getting as close as possible to in-vivo incubation conditions is essential to ensure the most favorable environment for embryonic development, given that exposure to non-optimal conditions outside of an incubator may affect the viability and quality of embryos. Geri was designed by embryologists who know the lab processes and what optimizes successful embryo growth. Geri has six individual chambers, each independently controlled, facilitating the care of the embryos of six patients at the same time. It is equipped with high-definition cameras to take a picture of the embryos every 5 minutes and provide continuous imaging. With the help of these images, supervising embryologist can observe embryos as they develop without removing them from their optimum environment. This minimizes lid openings and potential disruptions that can cause stress to embryos.  "Genea Biomedx is an IVF medical device company uniquely positioned within a clinical fertility business allowing it direct access to world leading IVF laboratories. This enabled us to develop Geri in collaboration with the embryologists that use it day in, day out," said Dr. Tammie Roy, General Manager at Genea Biomedx. "We are looking forward to working with EMD Serono to bring our innovative technology to clinics across the U.S."  With the exception of Australia, Geri is distributed by Merck through its Fertility Technologies unit, in accordance with a global distribution agreement executed with Genea Biomedx in May 2015.   ]]> https://biospectrumindia.com/news/57/9970/countries-in-who-south-east-asia-region-to-accelerate-road-safety-measures.html https://biospectrumindia.com/news/57/9970/countries-in-who-south-east-asia-region-to-accelerate-road-safety-measures.html Tue, 05 Dec 2017 18:10:00 +0530 Alarmed at the increasing incidence of deaths and injuries in road crashes, mostly involving motorcyclists and other vulnerable road users, countries in WHO South-East Asia Region has committed to accelerate action for road safety. Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia, said, “Countries across the Region need to drive and fast-track road safety initiatives with highest political commitment to effectively address road traffic injuries which continues to be a leading cause of death in the age group of 15 to 29 years, mostly motorcyclists and other vulnerable road users.” The Phuket Commitment calls for prioritization, high-level commitment, united efforts of all stakeholders, knowledge management, enforcement of regulations and time-bound deliveries. Prof Dr Piyasakol Sakolsataydorn, said, “Everyone needs to participate and share the responsibility – the government, the ministries, the private sector, civil society organizations, non-government organizations, communities and the general public.” The WHO South-East Asia Region accounts for more than one-quarter of the global road accident deaths. In 2013, as many as 316 000 people were killed in road crashes in the Region. Over 50% of these deaths were of vulnerable road users, primarily motorcyclists, and other two and three-wheeler riders. The vulnerable road users (VRUs)– comprising of pedestrians, cyclists and riders of powered two and three wheelers - are exposed to greater risks and are disproportionately vulnerable. In some countries nearly 80% of all road traffic deaths are motorcycle riders. Many countries in the Region have a large fleet of two-and three-wheelers, which is expanding further. Electricity powered bikes pose significant road safety risks as they are silent, fast and do not require registration in many countries. With the number of VRUs set to grow further across the Region, countries need to vigorously focus attention on this group to reduce the number of road crash deaths, the Regional Director said. Zahid Maleque, The State Minister of Bangladesh; Dunya Maumoon, State Minister of Health Maldives were present at the meeting that also sought accelerated implementation of UN Decade of Action for Road Safety 2011-2020 through ‘five road safety pillars’ – road safety management, safer road infrastructure, safer vehicles, safer road users and effective post-crash response. Over 150 representatives from various sectors such as transport, vehicle standard regulators, police and health, from countries within and outside the Region participated in the meeting. ]]> https://biospectrumindia.com/news/57/9968/tiny-robots-enhance-the-chances-of-surgical-interventions.html https://biospectrumindia.com/news/57/9968/tiny-robots-enhance-the-chances-of-surgical-interventions.html Tue, 05 Dec 2017 17:05:00 +0530 Maker of novel robotic solutions, Medical Microinstruments S.r.l. (MMI) discloses its robotic platform specifically designed for open microsurgery. The platform allows the surgeon to control two tiny articulated microinstruments that simplify reconstruction procedures after traumatic injuries as well as after tumor removal in soft tissue and bones, and offers the potential for improved surgical success rates and patient outcomes.  MMI's instruments are equipped with the smallest articulated wrist having a 3-millimeter outer diameter and tips just 150 micron in width. The wrist is the key to performing robotic microsurgery in real clinical settings and allows easy manipulation of small sutures, from 9-0 to 12-0 in size. "Thanks to the use of advanced materials and novel microfabrication processes, we have designed the smallest articulated wrist to provide microsurgeons unique instrument dexterity and robotic precision," said Massimiliano Simi, Co-founder and VP R&D.  The surgeon operates the microinstruments while sitting at the surgical bedside and looking through the operating microscope. MMI's robotic platform captures surgeon's hand movements and a scaled-down motion is imposed on the microinstruments.  "We have developed this groundbreaking technology together with microsurgeons from the product's conception and the positive feedback and response that we've received along the way has really been overwhelming and led us to believe that we are on the right track in developing a robot by and for microsurgeons," said Hannah Teichmann, Co-founder and VP Clinical.  Prof. Marco Innocenti, Chief of Plastic and Reconstructive Microsurgery at Careggi University Hospital in Florence and MMI's Clinical Advisor, who has presented preclinical work with MMI's robot at 9th Congress of World Society for Reconstructive Microsurgery in Seoul, including 0.35mm arterial robotic anastomosis. According to him, the MMI robotic platform will push the frontier of microsurgery forward and beyond the capabilities of the human hand, thus allowing more surgeons to perform more complex procedures but also enabling supermicrosurgery, such as lymph reconstruction, for the more expert ones. In a surgery conducted by surgical robots, the incision is small, the loss of blood is very minimal, and the patient has quick recovery, shorter hospital stays and a faster return to normal life. MMI's President and Co-founder, Giuseppe Maria Prisco, estimates the potential annual market opportunity to be in the order of $2.5 billion. ]]> https://biospectrumindia.com/news/57/9966/dr-gary-kobinger-received-award-for-ebola-virus-treatment-.html https://biospectrumindia.com/news/57/9966/dr-gary-kobinger-received-award-for-ebola-virus-treatment-.html Tue, 05 Dec 2017 16:35:00 +0530 Ebola virus disease, a severe and often fatal infection can be cured now. Microbiologist and researcher Gary Kobinger developed a treatment against this disease, trademarked ZMapp. In the appreciation of his research he received the Ernest C. Manning Innovation Awards' Principal Award in Toronto on November 29, 2017.  Dr. Kobinger is the director of the Québec City–University Laval Hospital Research Centre's CRI Infectious Disease Research Centre as well as a professor with University Laval's Faculty of Medicine and a world authority in vaccine research. He shares the award with his research partner Dr. Qui Xiangguo of Winnipeg.  The Ernest C. Manning Awards Foundation was established in 1980 to foster a culture of innovation and cement Canada's position as a global leader in that area. It recognizes and tells the stories of outstanding Canadian innovators whose work improves the lives of people in Canada and world-wide. Its evaluation and selection process is modelled on that of the Nobel Prizes.  "This kind of recognition shows how the Québec City–University Laval CHU Research Centre (CRCHU) acquired its reputation for excellence," said Centre director Serge Rivest. Dr. Kobinger was also named Scientist of the Year in 2015 by Radio-Canada for contributions to the fight against Ebola virus disease.  "This high-level Canadian recognition is further proof of the global leadership shown by University Laval and its Faculty of Medicine in such cutting-edge fields as microbiology and infectiology," said Eugénie Brouillet, Vice Rector of Research, Creation, and Innovation. "Professor Kobinger and his team are internationally recognized for their work on Ebola virus disease and are now turning their attention to the development of an HIV vaccine." informed Eugenie Brouillet The treatment developed by Dr. Kobinger's team, in collaboration with the Public Health Agency of Canada, is based on three specific antibodies, two of which came from CRI. It made headlines all over the world when first used on humans in 2014 where two American medical missionaries infected with the virus in Liberia. This was at the height of the Ebola epidemic the World Health Organization had declared a "public health emergency of international concern." The team from the National Microbiology Laboratory has earned international status as leaders in scientific research for the deadliest of infectious diseases. ]]> https://biospectrumindia.com/news/57/9964/mylan-and-aspen-launched-generic-busulfex-injection.html https://biospectrumindia.com/news/57/9964/mylan-and-aspen-launched-generic-busulfex-injection.html Tue, 05 Dec 2017 15:15:00 +0530 Mylan and its partner Aspen announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical's Busulfex Injection. Aspen received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. The drug is specified for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. As part of its partnership with Aspen, Mylan will commercialize Busulfan Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial in the U.S. Mylan has one of the largest injectable portfolios in the industry and is also one of the largest suppliers of cancer medicines by volume in the U.S. U.S. sales for Busulfan Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial were approximately $97 million for the 12 months ending Sept. 30, 2017, according to IQVIA. ]]> https://biospectrumindia.com/news/57/9959/eurofins-closes-acquisition-of-eag-labs.html https://biospectrumindia.com/news/57/9959/eurofins-closes-acquisition-of-eag-labs.html Tue, 05 Dec 2017 11:20:00 +0530 A global leader in bioanalytical testing, Eurofins Scientific, has successfully closed the acquisition of EAG Laboratories (EA), a leading global scientific services company providing analytical testing and consulting solutions to a diverse and demanding set of end markets. The agreed acquisition price is $780 million on a cash free debt free basis and the transaction should be immediately margin accretive for Eurofins after closing. EAG employs over 1,000 highly educated and talented scientists and support personnel, and expects to generate revenues in excess of $ 220 million in 2017. EAG provides Eurofins an entry into the dynamic and growing Materials and Engineering Sciences markets. EAG is a leading North American provider of advanced chemical testing services for pesticides, industrial and household chemicals. It provides end-to-end support for e-fate, metabolism, eco-toxicology and residue studies required for pesticide and chemical regulatory testing to support global registration requirements. EAG adds a highly desirable asset to the Eurofins BioPharma Product Testing group to strengthen Eurofins’ extensive range of small molecule and biologics testing and characterization services to a broad range of biopharmaceutical customers. ]]> https://biospectrumindia.com/news/57/9952/reduction-in-blood-sugar-and-body-weight-by-xultophy-in-type-2-diabetes.html https://biospectrumindia.com/news/57/9952/reduction-in-blood-sugar-and-body-weight-by-xultophy-in-type-2-diabetes.html Mon, 04 Dec 2017 15:10:00 +0530 The Comparison between Xultophy and IGlarLixi is done indirectly in people with type 2 diabetes who struggle to achieve desired blood sugar targets with basal insulin alone. The result illustrates that the treatment with Xultophy® (insulin degludec/liraglutide) provides statistically significant greater reductions in blood sugar levels and body weight compared with IGlarLixi (insulin glargine U100/lixisenatide). "In the absence of a head-to-head trial between Xultophy® and IGlarLixi, the solid methodology of this indirect comparison, where we adjusted for key differences between study designs and patient populations; allows us to conclude that Xultophy® can deliver greater reductions in the overall blood sugar levels and weight for people with type 2 diabetes who are uncontrolled on basal insulin, compared to IGlarLixi," said lead study author Professor Marc Evans of University Hospital, Llandough in Cardiff, UK. This analysis is based on published data from individual clinical trials which involved over 700 adults living with type 2 diabetes.  This indirect comparison provides evidence for estimating the relative efficacy and safety of Xultophy® versus IGlarLixi in people with type 2 diabetes uncontrolled on basal insulin. The outcomes came up with 0.44% greater reduction of their overall blood sugar levels (HbA1c), and a 1.42 kg greater weight loss when treated with Xultophy®, compared to those treated with IGlarLixi, at similar doses of insulin.  Additionally, the analysis found a higher likelihood of reaching target blood sugar levels (HbA1c <7%) with Xultophy®, compared to IGlarLixi. ]]> https://biospectrumindia.com/news/57/9951/bayer-and-the-broad-institute-of-mit-and-harvard-expand-partnership.html https://biospectrumindia.com/news/57/9951/bayer-and-the-broad-institute-of-mit-and-harvard-expand-partnership.html Mon, 04 Dec 2017 13:20:00 +0530 Bayer and the Broad Institute of MIT and Harvard announced that they have extended their multi-disciplinary research partnership by an additional five years, to advance the novel cancer treatments. The expanded agreement will focus on a defined goal to jointly identify three new additional investigational drugs (INDs) for novel oncology targets. "With Bayer's commitment to oncology, we are excited to build on our relationship with the Broad Institute to translate discoveries into real benefit for patients. We credit the Broad Institute as an entrepreneurial, forward-thinking collaboration partner that has helped us build a base of trust and close communication between our scientists," said Chandra Ramanathan, Vice President and Head of the Bayer East Coast Innovation Center. "Having built a robust portfolio in the first few years, including the identification of multiple drug candidates, we are thrilled to continue our work with the Broad scientists to bring novel cancer treatments to the clinic." He commented again  Established in 2013, the partnership brings together the Broad Institute's expertise in cancer research and chemical biology with Bayer's in-depth experience in small, chemically manufactured molecules and biologics drug discovery. In 2015, the collaboration was expanded to examine genomics and drug discovery in cardiovascular disease. With this recent extension, the Broad Institute will also bring their expertise in biomarker development and patient selection and clinical trial design.  Now extended to 2023, the Bayer-Broad collaboration is uniquely structured to encourage close coordination and ongoing, face-to-face interactions between researchers at both organizations. An association manager from Bayer is located at the Broad Institute to help and coordinate projects and ensure researchers have rapid access to information. The research is guided by joint project and governance teams. Institutions  will identify investigational drugs for novel oncology targets and make the associated intellectual property. The institutions will also continue to openly share the biological knowledge generated with the scientific community, including through publicly-available datasets and publications in academic journals. ]]> https://biospectrumindia.com/news/57/9941/ricoh-meg-measurement-system-has-received-510k-approval-from-usfda.html https://biospectrumindia.com/news/57/9941/ricoh-meg-measurement-system-has-received-510k-approval-from-usfda.html Fri, 01 Dec 2017 14:30:00 +0530 Ricoh, headquartered in Tokyo, made an announcement that the RICOH MEG Measurement System has received 510(k) clearance from the U.S. Food and Drug Administration RICOH MEG, Ricoh's magnetoencephalography system, is a noninvasive way to detect faint signals within the brain. It provides deeper measurement (hippocampus and hypothalamus), clearer signal using coaxial gradiometer sensors and greater patient comfort for better data acquisition. "Ricoh is committed to helping advance research and treatment for neurological disorders and MEG is another tool to help healthcare professionals and researchers measure brain activity," said Scott Abelson, Business Development Director, Medical Imaging, Ricoh USA, Inc. Ricoh entered the medical device industry when it acquired a portion of a Yokogawa Electric business in 2016. Ricoh is empowering digital workplaces using innovative technologies and services enabling individuals to work smarter. ]]> https://biospectrumindia.com/news/57/9929/dupont-nutrition-health-partners-with-apc-microbiome-institute.html https://biospectrumindia.com/news/57/9929/dupont-nutrition-health-partners-with-apc-microbiome-institute.html Thu, 30 Nov 2017 14:20:00 +0530 DuPont Nutrition & Health announces the development of a significant new initiative with the creation of a Microbiome Venture to spearhead development of new microbiome science-based solutions. The Microbiome Venture will play a key role in DuPont’s business growth strategy. “Microbiome science is developing extremely fast with tremendous opportunity for innovation,” said DuPont Nutrition & Health Global Technology and Innovation Leader Angela Naef. “With the Microbiome Venture, we intend to build on our probiotics leadership position to develop new microbiome science-based solutions for health and wellness.” For further development of product, the Microbiome Venture will involve in strategic partnerships with other microbiome science leaders in academia and industry The Microbiome Venture is a focused entrepreneurial team with a strong connection to the larger DuPont organization, tapping into global research, development and commercialization capabilities. The Microbiome Venture investment will complement DuPont’s existing product portfolio, especially in the areas of probiotics and prebiotics, including human milk oligosaccharides (HMOs.) As one of the pioneers in the field of the microbiome, the APC has knowledge in microbiome science capability including an impressive track record in the areas of mother-infant and gut-brain axis. This made them an ideal partner for DuPont Nutrition & Health’s new venture. ]]> https://biospectrumindia.com/news/57/9924/us-fda-approves-first-implanted-lens-.html https://biospectrumindia.com/news/57/9924/us-fda-approves-first-implanted-lens-.html Wed, 29 Nov 2017 17:35:00 +0530 The U.S. Food and Drug Administration has approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses. Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. Following cataract surgery, during which the natural lens of the eye that has become cloudy is removed and replaced with an artificial lens (intraocular lens, or IOL), many patients have some minor residual refractive error requiring use of glasses or contact lenses. Refractive error, which is caused when the artificial lens does not focus properly, causes blurred vision. “Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health. “This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.” The RxSight IOL is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device, 17-21 days after surgery. Patients receive three or four light treatments over a period of 1-2 weeks, each lasting about 40-150 seconds, depending upon the amount of adjustment needed. The patient must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment. A clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the RxSight Light Adjustable Lens and Light Delivery Device. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart, for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75 percent also had a reduction in astigmatism. The device is intended for patients who have astigmatism (in the cornea) before surgery and who do not have macular diseases. The device should not be used in patients taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen. Treatment in patients taking such medications may lead to irreversible eye damage. The device is also contraindicated in cases where patients have a history of ocular herpes simplex virus. The FDA approved the Vision Light Adjustable Lens and the Light Delivery Device to RxSight Inc. ]]> https://biospectrumindia.com/news/57/9920/merck-and-pfizer-updated-phase-iii-javelin-gastric-300-study-for-advanced-gastric-cancer.html https://biospectrumindia.com/news/57/9920/merck-and-pfizer-updated-phase-iii-javelin-gastric-300-study-for-advanced-gastric-cancer.html Wed, 29 Nov 2017 12:50:00 +0530 Merck and Pfizer Inc. announced that the Phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival (OS) with single-agent avelumab compared with physician's choice of chemotherapy. The trial investigated avelumab as a third-line treatment for unresectable adenocarcinoma patients whose disease progressed following two prior therapeutic regimens, regardless of programmed death ligand-1 (PD-L1) expression. The safety profile of avelumab was consistent with that observed in the overall JAVELIN clinical development program. "Gastric cancer in the third-line setting is a particularly hard-to-treat and heterogeneous disease, and importantly, this was the first trial conducted with a checkpoint inhibitor compared to an active chemotherapy comparator rather than placebo in a global patient population," said Luciano Rossetti, M.D., E. V. P., Global Head of Research & Development at the Biopharma business of Merck. "Data from this study will provide valuable information for physicians treating this late stage disease. We remain committed to our ongoing gastric cancer program with avelumab including the JAVELIN Gastric 100 study in the first-line switch maintenance setting." Luciano further commented. Chris Boshoff (M.D., Sr.V. P.and Head of Immuno-Oncology, Pfizer Global Product Development). said"Gastric cancer is a leading cause of cancer death globally with clear unmet needs, and the results provide important insights as we continue to investigate the role of avelumab for the treatment of gastric cancer," Chris continued "With approvals for two cancers in 2017, our companies have made tremendous progress with avelumab on behalf of patients this year, and we are confident that our broad clinical development program in both monotherapy and combinations across a range of cancers will continue to bring new potential treatment options to patients." The JAVELIN Gastric 300 data will be further examined in an effort to better understand the results and will also be submitted for presentation at an upcoming medical congress. The outcome of JAVELIN Gastric 300 does not have any impact on current avelumab approvals. JAVELIN Gastric 300 is a Phase III, clinical trial investigating avelumab versus physician's choice of protocol-specified chemotherapy plus best supportive care in patients with unresectable adenocarcinoma whose disease has progressed following two prior therapeutic regimens. The trial enrolled 371 patients from 147 sites in Asia, Australia, Europe, North America and South America. The primary endpoint was OS.  The avelumab gastric clinical development program also includes JAVELIN Gastric 100, a multicenter, randomized, open-label Phase III study. It evaluates avelumab as first-line maintenance therapy following induction chemotherapy in unresectablec gastric cancer. The trial will continue as planned.  Avelumab is under clinical investigation for treatment of gastric/GEJ cancer and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for gastric/GEJ cancer by any health authority worldwide. ]]> https://biospectrumindia.com/news/57/9919/1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified-who.html https://biospectrumindia.com/news/57/9919/1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified-who.html Wed, 29 Nov 2017 12:30:00 +0530 According to the new research conducted by WHO, An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified. This means that people are taking medicines that fail to treat or prevent disease. Not only is this a waste of money for individuals and health systems that purchase these products, but substandard or falsified medical products can cause serious illness or even death. Dr Tedros Adhanom Ghebreyesus, WHO Director-General says, “Substandard and falsified medicines particularly affect the most vulnerable communities. Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action.” Since 2013, WHO has received 1500 reports of cases of substandard or falsified products. Of these, anti-malarial and antibiotics are the most commonly reported. Most of the reports (42%) come from the WHO African Region, 21% from the WHO Region of the Americas, and 21% from the WHO European Region. This is likely just a small fraction of the total problem and many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region, and just 2% from the WHO South-East Asia Region. Dr Mariângela Simão, Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals at WHO said, “Many of these products, like antibiotics, are vital for people’s survival and wellbeing. Substandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat.” Prior to 2013, there was no global reporting of this information. Since WHO established the Global Surveillance and Monitoring System for substandard and falsified products, many countries are now active in reporting suspicious medicines, vaccines and medical devices. WHO has trained 550 regulators from 141 countries to detect and respond to this issue. As more people are trained, more cases are reported to WHO. WHO has received reports of substandard or falsified medical products ranging from cancer treatment to contraception. They are not confined to high-value medicines or well-known brand names and are split almost evenly between generic and patented products. This study was based on more than 100 published research papers on medicine quality surveys done in 88 low- and middle-income countries involving 48 000 samples of medicines. More research is needed to more accurately estimate the threat posed by substandard and falsified medical products. Based on 10% estimates of substandard and falsified medicines, a modelling exercise developed by the University of Edinburgh estimates that 72 000 to 169 000 children may be dying each year from pneumonia due to substandard and falsified antibiotics. A second model done by the London School of Hygiene and Tropical Medicine estimates that 116 000 (64 000 – 158 000) additional deaths from malaria could be caused every year by substandard and falsified antimalarial in sub-Saharan Africa, with a cost of US$ 38.5 million (21.4 million – 52.4 million) to patients and health providers for further care due to failure of treatment. Substandard medical products reach patients when the tools and technical capacity to enforce quality standards in manufacturing, supply and distribution are limited. Falsified products, on the other hand, tend to circulate where inadequate regulation and governance are compounded by unethical practice by wholesalers, distributors, retailers and health care workers. A high proportion of cases reported to WHO occur in countries with constrained access to medical products. Modern purchasing models such as online pharmacies can easily circumvent regulatory oversight. These are especially popular in high-income countries, but more research is needed to determine the proportion and impact of sales of substandard or falsified medical products. Globalization is making it harder to regulate medical products. Many falsifiers manufacture and print packaging in different countries, shipping components to a final destination where they are assembled and distributed. Sometimes, offshore companies and bank accounts have been used to facilitate the sale of falsified medicines. “The bottom line is that this is a global problem. Countries need to assess the extent of the problem at home and cooperate regionally and globally to prevent the traffic of these products and improve detection and response”, says Dr Simão ]]> https://biospectrumindia.com/news/57/9918/global-response-to-malaria-at-crossroads-world-malaria-report-2017.html https://biospectrumindia.com/news/57/9918/global-response-to-malaria-at-crossroads-world-malaria-report-2017.html Wed, 29 Nov 2017 12:20:00 +0530 World Malaria Report 2017 by World Health Organisation says that after unprecedented global success in malaria control, progress has stalled. There were an estimated 5 million more malaria cases in 2016 than in 2015. Malaria deaths stood at around 445,000 which is a similar number to the previous year. Dr Tedros Adhanom Ghebreyesus, Director-General of WHO said, “In recent years, we have made major gains in the fight against malaria. We are now at a turning point. Without urgent action, we risk going backwards, and missing the global malaria targets for 2020 and beyond.” The WHO Global Technical Strategy for Malaria calls for reductions of at least 40% in malaria case incidence and mortality rates by the year 2020. The report says that the world is not on track to reach these critical milestones. A major problem is insufficient funding at both domestic and international levels, resulting in major gaps in coverage of insecticide-treated nets, medicines, and other life-saving tools. The report also says that, “An estimated US$ 2.7 billion was invested in malaria control and elimination efforts globally in 2016. That is well below the US $6.5 billion annual investment required by 2020 to meet the 2030 targets of the WHO global malaria strategy.” In 2016, governments of endemic countries provided US$ 800 million, representing 31% of total funding. The United States of America was the largest international funder of malaria control programmes in 2016, providing US$1 billion (38% of all malaria funding), followed by other major donors, including the United Kingdom of Great Britain and Northern Ireland, France, Germany and Japan. The report shows that, in 2016, there were an estimated 216 million cases of malaria in 91 countries, up from 211 million cases in 2015. The estimated global tally of malaria deaths reached 445 000 in 2016 compared to 446 000 the previous year. While the rate of new cases of malaria had fallen overall, since 2014 the trend has levelled off and even reversed in some regions. Malaria mortality rates followed a similar pattern. The African Region continues to bear an estimated 90% of all malaria cases and deaths worldwide. Fifteen countries – all but one in sub-Saharan Africa – carry 80% of the global malaria burden. “Clearly, if we are to get the global malaria response back on track, supporting the most heavily affected countries in the African Region must be the primary focus,” said Dr Tedros. In most malaria-affected countries, sleeping under an insecticide-treated bednet (ITN) is the most common and most effective way to prevent infection. In 2016, an estimated 54% of people at risk of malaria in sub-Saharan Africa slept under an ITN compared to 30% in 2010. However, the rate of increase in ITN coverage has slowed since 2014, the report finds. The African Region has seen a major increase in diagnostic testing in the public health sector: from 36% of suspected cases in 2010 to 87% in 2016. A majority of patients (70%) who sought treatment for malaria in the public health sector received artemisinin-based combination therapies (ACTs) – the most effective antimalarial medicines. However, in many areas, access to the public health system remains low. National-level surveys in the African Region show that only about one third (34%) of children with a fever are taken to a medical provider in the public health sector. The report also outlines additional challenges in the global malaria response, including the risks posed by conflict and crises in malaria endemic zones. Commenting on the findings of this year’s report, Dr Pedro Alonso, Director of the Global Malaria Programme said, “We are at a crossroads in the response to malaria. We hope this report serves as a wake-up call for the global health community. Meeting the global malaria targets will only be possible through greater investment and expanded coverage of core tools that prevent, diagnose and treat malaria. Robust financing for the research and development of new tools is equally critical.”   ]]> https://biospectrumindia.com/news/57/9914/dante-labs-launches-cheap-dna-test-kits.html https://biospectrumindia.com/news/57/9914/dante-labs-launches-cheap-dna-test-kits.html Wed, 29 Nov 2017 10:55:00 +0530 Italian biotech company, Dante Labs has developed the first DNA tests available in Europe, which will allow the public to test their health and wellbeing from the comfort of their own homes. The test is non-invasive, requiring a saliva sample, which can be collected using the kit at home and shipped back to Dante Labs for free. Customers can expect their test results within 3 weeks and can make sense of them using personalized online reports, which provide more information about topics including the risk of heart attacks, muscle fatigue, digestion, blood and the side effects of different drugs. The company uses Next Generation Sequencing (NGS) technology, which is a very powerful genetic testing tool. It allows an individual’s genome to be quickly and cheaply interpreted, and it has revolutionized healthcare, enabling personalized medicine. This sort of technology is already available in the US but can be very expensive, particularly due to high shipping costs. Dante Labs looks to overcome this by bringing high-quality technology to the European market, without the frightening costs. The biotech company wants to develop accessible genomic testing, giving people the knowledge and information they need to live long, healthy lives. ]]> https://biospectrumindia.com/news/57/9912/ge-healthcare-acquires-puridify.html https://biospectrumindia.com/news/57/9912/ge-healthcare-acquires-puridify.html Tue, 28 Nov 2017 16:50:00 +0530 GE Healthcare has completed the acquisition of Puridify, a bioprocessing start-up that is developing a nanofiber-based platform purification technology for biopharmaceutical production. GE will acquire Puridify with its all 17 employees, who will join GE Healthcare Life Sciences’ BioProcess business. The Puridify team will remain at their current location in Stevenage, UK, which will serve as a small research hub for BioProcess. FibroSelect is the technology of Puridify which harmonizing to the bead resins and chromatography membranes. This technology is used in downstream bioprocessing, promising faster mass transfer, scalability and ease of use. “The technology that Puridify has been developing gives GE, access to exciting technology that could give considerable improvements for some customers in their purification step. The early feedback from collaborators has been positive. Today’s investment in this new technology is further evidence of GE’s strong commitment to innovation in the production of biopharmaceuticals to the benefit of our customers and of patients world-wide,” said Jan Makela, General Manager, BioProcess -GE Healthcare Life Sciences. “Puridify has spent the last three years developing the industrial FibroSelect technology in close collaboration with leading biomanufacturers with promising results.We are excited to take this next step as part of GE Healthcare, with the full support and experience associated with one of the industry leaders in this field. Our goal is to introduce significant improvements to bioprocessing and being part of GE helps us to maximize this opportunity. This deal gives full recognition to Puridify’s development team and to the strong potential of the FibroSelect technology platform,” said Oliver Hardick, Chief Executive Officer, Puridify. ]]> https://biospectrumindia.com/news/57/9911/indian-doctors-successfully-perform-first-ever-kidney-transplant-in-tanzania.html https://biospectrumindia.com/news/57/9911/indian-doctors-successfully-perform-first-ever-kidney-transplant-in-tanzania.html Tue, 28 Nov 2017 16:25:00 +0530 In a major step forward in the field of medical science, the first ever kidney transplant was successfully performed in Tanzania by doctors from city-based BLK Super Specialty Hospital in partnership with Muhimbili National Hospital in Dar es Salaam. "It is a matter of great honour that the first ever kidney transplant in Tanzania was performed by a team of Indian doctors," Naresh Kapoor, Executive Director, BLK Super Specialty Hospital, said in a statement. "Such surgeries are enormously complicated with significant risks. Hence, the success of this first ever kidney transplant enlivens hope for the people of Tanzania. I congratulate our team on the success," Kapoor said. The surgery was carried out on a 30-year-old Tanzanian woman who was suffering from end-stage kidney disease and was on haemodialysis for over a year. "The kidney donor was her 27-year-old brother," said HS Bhatyal, Head of Urology and Kidney Transplantation at the hospital. The doctors also acknowledged the support of a team of doctors at Muhimbili National Hospital in conducting the surgery. "Both donor and recipient are recuperating well and should return to normal activities soon. They are under our care and supervision," Sunil Prakash, Director & Head of Nephrology at BLK hospital said.  With a broader aim to promote cooperation and mutual understanding between the two countries, the New Delhi-based hospital established partnerships with Muhimbili National Hospital as well as other healthcare institutes in the region such as the JakayaKikwete Cardiac Institute (JKCI) and Muhimbili Orthopaedic Institute. "We have established credible linkage with countries in Africa through a number of collaborative programmes with an objective to build healthcare capacities locally in the countries such as Tanzania," Kapoor said. "This surgery will certainly boost Indo-Tanzanian relationship in the field of healthcare," he added. ]]> https://biospectrumindia.com/news/57/9907/global-vaccination-coverage-has-stalled-at-86-with-no-significant-changes-during-the-past-year-who.html https://biospectrumindia.com/news/57/9907/global-vaccination-coverage-has-stalled-at-86-with-no-significant-changes-during-the-past-year-who.html Tue, 28 Nov 2017 12:05:00 +0530 According to the fact sheet on immunization by World Health Organisation, “An estimated 19.5 million infants worldwide are still missing out on basic vaccines.” Immunization averts an estimated 2 to 3 million deaths every year from diphtheria, tetanus, pertussis (whooping cough), and measles; however, an additional 1.5 million deaths could be avoided if global vaccination coverage improves. Global vaccination coverage – the proportion of the world’s children who receive recommended vaccines – has stalled over the past few years. During 2016, about 86% of infants worldwide (116.5 million infants) received 3 doses of diphtheria-tetanus-pertussis (DTP3) vaccine, protecting them against infectious diseases that can cause serious illness and disability or be fatal. By 2016, 130 countries had reached at least 90% coverage of DTP3 vaccine. A summary of global vaccination coverage in 2016 follows: Haemophilus influenzae type b (Hib) causes meningitis and pneumonia. Hib vaccine had been introduced in 191 countries by the end of 2016. Global coverage with 3 doses of Hib vaccine is estimated at 70%. There is great variation between regions. In the WHO Region of the Americas, coverage is estimated at 90%, while it is only 28% in the WHO Western Pacific Region. The WHO South-East Asia Region raised coverage from 56% in 2015 to 80% in 2016. Hepatitis B is a viral infection that attacks the liver. Hepatitis B vaccine for infants had been introduced nationwide in 186 countries by the end of 2016. Global coverage with 3 doses of hepatitis B vaccine is estimated at 84% and is as high as 92% in the Western Pacific. In addition, 101 countries introduced one dose of hepatitis B vaccine to newborns within the first 24 hours of life, and the global coverage is 39%. Human papillomavirus is the most common viral infection of the reproductive tract, and can cause cervical cancer, other types of cancer, and genital warts in both men and women. Human papillomavirus vaccine was introduced in 74 countries by the end of 2016, including four countries with introduction in some parts of the country. Measles is a highly contagious disease caused by a virus, which usually results in a high fever and rash, and can lead to blindness, encephalitis or death. By the end of 2016, 85% of children had received one dose of measles vaccine by their second birthday, and 164 countries had included a second dose as part of routine immunization and 64% of children received two doses of measles vaccine according to national immunization schedules. Meningitis A is an infection that can cause severe brain damage and is often deadly. By the end of 2016 – 6 years after its introduction – more than 260 million people in African countries affected by the disease had been vaccinated with MenAfriVac, a vaccine developed by WHO and PATH. Ghana and Sudan were the first two countries to include the MenAfriVac in their routine immunization schedule in 2016. Mumps is a highly contagious virus that causes painful swelling at the side of the face under the ears (the parotid glands), fever, headache and muscle aches. It can lead to viral meningitis. Mumps vaccine had been introduced nationwide in 121 countries by the end of 2016. Pneumococcal diseases include pneumonia, meningitis and febrile bacteraemia, as well as otitis media, sinusitis and bronchitis. Pneumococcal vaccine had been introduced in 134 countries by the end of 2016, including three in some parts of the country, and global coverage was estimated at 42%. Polio is a highly infectious viral disease that can cause irreversible paralysis. In 2016, 85% of infants around the world received three doses of polio vaccine. Targeted for global eradication, polio has been stopped in all countries except for Afghanistan, Pakistan and Nigeria. Polio-free countries have been infected by imported virus, and all countries – especially those experiencing conflict and instability – remain at risk until polio is fully eradicated. Rotaviruses are the most common cause of severe diarrhoeal disease in young children throughout the world. Rotavirus vaccine was introduced in 90 countries by the end of 2016, including six in some parts of the country, and global coverage was estimated at 25%. Rubella is a viral disease which is usually mild in children, but infection during early pregnancy may cause fetal death or congenital rubella syndrome, which can lead to defects of the brain, heart, eyes, and ears. Rubella vaccine was introduced nationwide in 152 countries by the end of 2016, and global coverage was estimated at 47%. Tetanus is caused by a bacterium which grows in the absence of oxygen, for example in dirty wounds or in the umbilical cord if it is not kept clean. The spores of C. tetani are present in the environment irrespective of geographical location. It produces a toxin which can cause serious complications or death. The vaccine to prevent maternal and neonatal tetanus had been introduced in 106 countries by the end of 2016. An estimated 84% of newborns were protected through immunization. Maternal and neonatal tetanus persist as public health problems in 18 countries, mainly in Africa and Asia. Yellow fever is an acute viral haemorrhagic disease transmitted by infected mosquitoes. As of 2016, yellow fever vaccine had been introduced in routine infant immunization programmes in 35 of the 42 countries and territories at risk for yellow fever in Africa and the Americas. In these 42 countries and territories, coverage is estimated at 45%. Also, In 2016, an estimated 19.5 million infants worldwide were not reached with routine immunization services such as DTP3 vaccine. Around 60% of these children live in 10 countries: Angola, Brazil, the Democratic Republic of the Congo, Ethiopia, India, Indonesia, Iraq, Nigeria, Pakistan and South Africa. Monitoring data at subnational levels is critical to helping countries prioritize and tailor vaccination strategies and operational plans to address immunization gaps and reach every person with lifesaving vaccines.   ]]> https://biospectrumindia.com/news/57/9908/commercial-conflict-between-beckman-coulter-and-quidel-to-sell-bnp-directly.html https://biospectrumindia.com/news/57/9908/commercial-conflict-between-beckman-coulter-and-quidel-to-sell-bnp-directly.html Tue, 28 Nov 2017 11:45:00 +0530 Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information whenever they need. To further these goals, Beckman Coulter plans in the future to sell directly to its customers a natriuretic peptide assay for its Access Family of Immunoassay Systems. Currently, Beckman Coulter customers have access to a BNP assay which, although developed and manufactured by Beckman Coulter, is sold exclusively by Quidel and its designated distributors. Quidel took over this commercial role as a result of its recent transaction with Alere. Now, Beckman Coulter requested to San Diego courts in California about, clarify and enforce Beckman Coulter's rights to sell a natriuretic peptide assay directly to its customers. While this legal matter is being resolved, Beckman Coulter's production and supply of the TRIAGE® BNP assay to Quidel and Quidel's customer relationships are expected to continue. Therefore, customers can rely on Beckman Coulter for continued and ongoing supply of high-quality BNP. Beckman Coulter believes that when efficiency and clinical outcomes are improved then patients benefit also improves. With that strong confidence they take healthcare forward for every person. ]]> https://biospectrumindia.com/news/57/9905/merck-to-set-up-research-facility-in-london.html https://biospectrumindia.com/news/57/9905/merck-to-set-up-research-facility-in-london.html Tue, 28 Nov 2017 10:45:00 +0530 Merck is planning to focus on early bioscience discovery and entrepreneurial innovation by establishing a state of the art life sciences discovery research facility in London. The new UK Discovery Centre is anticipated to create 150 new research roles with the aim of attracting the brightest and best research scientists to work in London. The company is currently evaluating several potential locations in the London region with a target date of 2020 for operational readiness. Till then, the firm plans to establish a small temporary research facility in the area and is actively recruiting for suitably qualified scientific talent. The new site will accommodate approximately 800 existing additional staff for the UK domestic market and other European clinical functions currently based in its UK’s Hoddesdon headquarters. It is intended that the UK Discovery Centre will become the location for Merck’s UK HQ, making the central London site a unique location within the UK pharmaceutical sector. The proposed investment is in line with its Research Laboratories arm’s continued pursuit of new innovative scientific discovery and collaboration, and follows similar investments in new biomedical centres in the San Francisco Bay Area and Cambridge Massachusetts. ]]> https://biospectrumindia.com/news/57/9901/the-uk-government-announces-major-life-sciences-venture-as-it-unveils-its-industrial-strategy.html https://biospectrumindia.com/news/57/9901/the-uk-government-announces-major-life-sciences-venture-as-it-unveils-its-industrial-strategy.html Mon, 27 Nov 2017 18:25:00 +0530 The UK Government is going to unveil its flagship industrial strategy White Paper which is aimed at improving productivity and bolstering investment. The UK’s business department has secured a major multi-million pound investment with a leading Life Sciences firm, MSD, known as Merck and co. in North America. It has also said that this deal is a huge vote of confidence in the Government’s industrial strategy for the future. While details of MSD’s plans are expected to be unveiled later, the investment by the global healthcare company will involve creating a new world class hub in the UK, which will help ensure innovative research into future treatments for patients and pioneering medicines are completed in Britain. According to the news reported by The Herald, The new venture, at an as yet undisclosed location, will create a new world-leading life sciences discovery research facility in the UK, supporting a total of 950 jobs in high-skilled and high-value research roles. The investment has been secured through the upcoming Life Sciences Sector Deal, one of four such deals the Government is set to confirm later today and announce details in the weeks ahead. Alongside the Life Sciences Sector Deal, Whitehall will confirm it has agreed deals with the construction, artificial intelligence and automotive industries. Each deal, said the Department, represented a new strategic and long-term partnership with Government, backed by private sector co-investment. Business Secretary Greg Clark said: “Powered by new technology, new industries are being created, existing ones changing and the way we live our lives – as workers, citizens and consumers – transformed.” He insisted the UK was an open, flexible economy, built on trade and engagement with the world with a competitive business environment, renowned for innovation and discovery and with commercial and industrial sectors, that were competitive with the best in the world. Admitting Britain’s productivity performance had not been good enough and was holding back our earning power as a country, Mr Clark added: “This Industrial Strategy deliberately strengthens the five foundations of productivity: ideas; people; infrastructure; business environment and places. “By acting together as a nation, and in a sustained way, to improve the underperforming conditions for productivity we can drive up our earning power,” he added. The White Paper follows extensive engagement by Government with industry, academia and business bodies, which submitted almost 2,000 responses to the Green Paper consultation earlier in 2017. In the Strategy, the Government identifies four “grand challenges,” global trends that will shape the country’s rapidly changing future and which it made clear the UK must embrace and lead to ensure it harnessed all the economic and social opportunities they brought. The first four are - *Artificial Intelligence. The Department said the rise of AI was changing the world and the UK had to be at the forefront of this data-driven revolution and grasp the opportunities it presented through the AI Sector Deal. *Clean growth. The global shift to clean growth presented huge opportunities for innovation that Government and industry must take advantage of by backing the development, manufacture and use of low carbon technologies. *An ageing society. To effectively meet the needs of an ageing population, the Department said the UK must harness innovations in medical care, technology and services. *Future mobility. From driverless cars to drone-delivered goods, the way people, goods and services were transported was evolving rapidly and the UK needed to be a world leader in shaping what the future of mobility looked like. The Department said that the investment is built on the announcement made by the Government last week that its ambition was to deliver a step-change in the level of investment in research and development, rising from 1.7 per cent to 2.4 per cent of GDP by 2027. This, it added, could mean around £80bn of additional investment in advanced technology in the next decade, helping to transform whole sectors, create new industries, and support innovation across the country. ]]> https://biospectrumindia.com/news/57/9896/extension-of-orchards-collaboration-with-manchester-university-to-include-sanfilippo-syndrome-type-b.html https://biospectrumindia.com/news/57/9896/extension-of-orchards-collaboration-with-manchester-university-to-include-sanfilippo-syndrome-type-b.html Mon, 27 Nov 2017 15:45:00 +0530 Orchard Therapeutics Limited (“Orchard) announced that, it has acquired an exclusive license to develop lentivirus-based autologous ex-vivo gene therapy for Sanfilippo syndrome type B (or MPS-IIIB) from The University of Manchester, UK.  The technology developed in Professor Brian Bigger’s laboratory and recently published in the journal Brain. It involves the use of a high-titre lentiviral vector to drive the expression of a codon-optimized α-N-acetylglucosaminidase (NAGLU) gene under the control of the myeloid-specific CD11b promoter (LV.CD11b.NAGLU). MPS-IIIB is a rare neurodegenerative inherited lysosomal storage disease. It is caused by mutations in the NAGLU gene. The disease, which affects children as early as 2 years of age, results in severe and rapidly progressive brain disease and neurological symptoms. Currently effective treatment option for MPS-IIIB is not available. This programme in MPS-IIIB complements the existing collaboration program between Orchard, The University of Manchester and Manchester University NHS Foundation Trust in MPS-IIIA. Autologous ex-vivo lentiviral haematopoietic stem cell gene therapy is expected to correct neurological manifestations. It happens through the engraftment of subpopulations of haematopoietic stem cells in the central nervous system.Thus it provides the supranormal and widespread enzyme expression throughout the brain.  In both MPS-IIIA and MPS-IIIB, preclinical studies have produced encouraging results, showing a normalization of heparan sulphate levels in the brain and peripheral organs, as well as neurological disease correction. Dr Jesus Garcia-Segovia, Orchard’s VP Clinical Development, CNS and Metabolic Disorders stated: “The incorporation of MPS-IIIB into our development pipeline is a significant milestone in the consolidation of our neurometabolic franchise, which is currently focused on the development of autologous ex-vivo haematopoietic stem-cell gene therapy for children suffering from MPS-IIIA. We are very excited at the possibility of bringing effective treatments capable of addressing the high unmet medical need in children suffering from these devastating conditions”. Prof Brian Bigger, Professor of Cell and Gene Therapy in the Faculty of Biology, Medicine and Health, The University of Manchester commented: “It’s incredibly exciting for us to work with our trusted partner Orchard Therapeutics to translate another autologous ex-vivo gene therapy that has demonstrated efficacy in a preclinical mouse model of MPS-IIIB into clinical development and scale-up”.  Dr. Andrea Spezzi, Orchard’s Chief Medical Officer added: “MPS-IIIA and MPS-IIIB are devastating diseases. Orchard and its collaborators are highly motivated to develop gene therapies to address the root cause of these disorders and will work tirelessly to make treatments available to patients as soon as possible.  We are now focussing all our efforts on completing the preclinical activities required, to start the clinical studies in MPS-IIIA till the end of 2018 and thereafter in MPS-IIIB”.  Orchard’s development pipeline of autologous ex-vivo gene therapies includes novel treatments for primary immune deficiencies, and inherited metabolic disorders including other undisclosed early and late-stage programmes. ]]> https://biospectrumindia.com/news/57/9862/shanghai-pharma-buys-drug-distribution-unit-of-us-based-cardinal-health.html https://biospectrumindia.com/news/57/9862/shanghai-pharma-buys-drug-distribution-unit-of-us-based-cardinal-health.html Tue, 21 Nov 2017 18:05:00 +0530 Shanghai Pharma has announced that it has agreed to purchase Cardinal Health’s pharmaceutical and medical products distribution business in China. With the deal, Shanghai Pharma will become one of the largest importers of foreign drugs in China, as demand for medicines surges with an aging population where chronic diseases such as cancer and diabetes are commonplace.  According to media reports, David Liu, head of mergers and acquisitions at Shanghai said that the company is interested in acquiring specialty drugs as well as branded generics. Liu noted that the drugmaker will pursue deals in the US and some EU countries such as Germany and Sweden. Shanghai Pharma has said that it expects its final cash outlay for the Cardinal China deal, excluding any debt assumption, will be about $557 million, reports Bloomberg. That price values the target at about 28 times its net income for the year ended June, according to a Hong Kong exchange filing. Shanghai Pharma also plans to create a new direct-to-pharmacy chain, combining its own outlets with Cardinal China’s, to distribute imported drugs.  In addition, Shanghai Pharma and Cardinal Health have reached a strategic cooperation agreement to explore business development in the U.S., as well as collaborate in developing the global market for medical equipment and service innovation, according to the statement. Shanghai Pharma beat out private equity firms FountainVest Partners Co., Warburg Pincus and PAG Asia Capital for the target. Cardinal’s China business is the 8th largest pharmaceutical distributor in China, with a network covering 322 cities and 11,000 medical institutions, the filing shows. Cardinal China also controls 14 direct sale companies, 17 distribution and operation centers and 30 direct-to-pharmacy outlets. The sale does not include Cardinal Health’s remaining businesses in China, such as its medical sourcing team and Cordis business, according to a separate Cardinal Health statement.     ]]> https://biospectrumindia.com/news/57/9827/who-welcomes-appointment-of-new-executive-director-of-the-global-fund.html https://biospectrumindia.com/news/57/9827/who-welcomes-appointment-of-new-executive-director-of-the-global-fund.html Thu, 16 Nov 2017 12:25:00 +0530 WHO welcomes the appointment of Peter Sands as the new Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. WHO works closely with the Global Fund, providing countries with evidence-based guidance and technical assistance to reduce the burden of infectious diseases, to address health inequities, and to strengthen health systems. Peter Sands will bring a wealth of experience and expertise to the Global Fund and help the organization to enhance its critical role in the global fight against HIV, TB and malaria, which together kill over 2.7 million people each year. Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, "WHO looks forward to working with Peter Sands to continue saving lives and to help countries move towards universal health coverage. We wish him the very best." "This is a critical time in the global fight against HIV, TB and malaria. We need to accelerate progress and pay special attention to regions that have fallen behind. Slowing down is not an option," said Dr Tedros. A strong strategic partnership between WHO and the Global Fund will be central to future efforts to strengthen basic health services around the world, and build political and financial support for universal health coverage.   ]]> https://biospectrumindia.com/news/57/9819/department-of-science-technology-conducts-india-and-canada-technology-summit.html https://biospectrumindia.com/news/57/9819/department-of-science-technology-conducts-india-and-canada-technology-summit.html Wed, 15 Nov 2017 12:55:00 +0530 With an aim of opening a new chapter in the bilateral relationships of India and Canada, Department of Science & Technology has organised a two day India-Canada Technology Summit in New Delhi. The Summit was inaugurated by Dr. Harsh Vardhan, Union Minister for Science & Technology and Earth Sciences, Environment, Forests & Climate Change and Navdeep Singh Bains, Canada’s Minister of Innovation, Science and Economic Development. In his inaugural address, Dr. Harsh Vardhan said that “As partners in the 21st century knowledge economy, this Technology Summit reinforces our common belief in the power of science and technology in contributing to the present and future strategic Indo-Canadian partnership.”  A new call for joint projects under the Indo-Canadian Industrial R&D programme was also announced on this occasion. Industry led joint R&D projects that have significant potential for commercialisation leading to product or process development in the areas of advanced manufacturing, clean technologies, smart cities and food and agro technologies will be supported by DST from India and the National Research Council of Canada. In order to foster research and industrial linkages by promoting cross-border cooperation under support of the Science and Engineering Research Board (SERB) of DST and MITACS of Canada, a new mobility based student internship was also announced. The new phase of India Canada - IMPACTS program between DST and NSERC, Canada, was announced to promote multidisciplinary research partnerships aimed to deliver practical solutions through application of science and technology. MoU to facilitate continued innovative partnerships between Canadian and Indian researchers was also signed by Professor Ashutosh Sharma, Secretary, Department of Science and Technology and Dr. B. Mario Pinto, President of the Natural Sciences and Engineering Research Council of Canada (NSERC).  The themes for the Technology Summit highlight a broad range of research and innovations areas where India and Canada have common interests. A particular focus of the Summit is highlighting the role of women in science and business as well as promoting the start-up and incubator communities in India and Canada. The Canadian and Indian companies for the Tech Summit include world class innovators and technologies that have potential to forge new knowledge-market-economy connect at bilateral level. Sixty smart technologies were also showcased as a part of the exhibition.   ]]> https://biospectrumindia.com/news/57/9808/us-researchers-develop-a-gene-therapy-to-cure-lca.html https://biospectrumindia.com/news/57/9808/us-researchers-develop-a-gene-therapy-to-cure-lca.html Tue, 14 Nov 2017 18:05:00 +0530 Leber congenital amaurosis (LCA) is a rare condition that begins in infancy and progresses slowly, eventually causing complete blindness. It affects about one in 80,000 individuals. US researchers have developed a gene therapy that may help patients, who have lost their sight to an inherited retinal disease, to see well enough to navigate a maze. While the treatment does not restore normal vision, it does, however, allow patients to see shapes and light, allowing them to get around without a cane or a guide dog, said the researchers led by Stephen R. Russell, Ophthalmologist at the University of Iowa. The new genetic treatment, called voretigene neparvovec (Luxturna, Spark Therapeutics), involves a genetically modified version of a harmless virus. The virus is modified to carry a healthy version of the gene into the retina. Doctors inject billions of modified viruses into both of a patient’s eyes. The findings showed that after the treatment 93 per cent of patients experienced meaningful improvements in their vision, enough that they could navigate a maze in low to moderate light. These patients also showed improvement in light sensitivity and peripheral vision, which are two visual deficits these patients experience. However, it is unclear how long the treatment will last, but so far, most patients have maintained their vision for two years, the researcher said while presenting the results at the 121st Annual Meeting of the American Academy of Ophthalmology 2017 in New Orleans. While, there are currently no treatments available for inherited retinal diseases, the new gene therapy is under review by the US Food and Drug Administration. The FDA is expected to make its decision no later than January 2018, the researchers said. An approval could open the door for other gene therapies that could eventually treat more than 225 genetic mutations known to cause blindness, the study noted.     ]]> https://biospectrumindia.com/news/57/9794/us-launches-clinical-trial-for-uterine-transplant.html https://biospectrumindia.com/news/57/9794/us-launches-clinical-trial-for-uterine-transplant.html Fri, 10 Nov 2017 15:00:00 +0530 University of Pennsylvania School of Medicine will conduct the Northeast's first clinical trial of uterine transplants, to provide women with Uterine Factor Infertility (UFI) - an irreversible form of female infertility that affects as many as 5 percent of women worldwide and 50,000 women in the United States - with a new path to parenthood. The Uterine Transplantation for Uterine Factor Infertility (UNTIL) trial is the third of its kind in the United States. More than 30 uterine transplants have been completed across the world including in Brazil, China, the Czech Republic, Germany, Sweden, India, Saudi Arabia, Turkey, and at two clinics in the United States. Though the procedure is still experimental, a team in Sweden who completed the world's first uterine transplant has successfully delivered eight babies from women who received a uterus from a friend or family member. Following an extensive evaluation, participants in the UNTIL trial will be followed for several years by a multidisciplinary team of specialists with expertise in transplant, obstetrics & gynecology, clinical trials, bioethics, nursing, social work, psychology, pathology, and infectious diseases. More than 35 providers will be involved in each participant's care over the course of a five- to 10-year period. The UNTIL trial is a joint effort between Penn Medicine's department of Obstetrics & Gynecology and the Penn Transplant Institute. The procedure is part of the highly specialized vascularized composite allotransplantation (VCA) field, which in recent years has allowed for the development of advanced procedures that require the transplantation of multiple tissues such as muscle, bone, nerve, and skin, as a functional unit, such as hands and the face. ]]> https://biospectrumindia.com/news/57/9779/stop-using-antibiotics-on-healthy-farm-animals-who.html https://biospectrumindia.com/news/57/9779/stop-using-antibiotics-on-healthy-farm-animals-who.html Wed, 08 Nov 2017 12:05:00 +0530 WHO has recommended the farmers and the food industry to stop using antibiotics routinely in order to promote growth and prevent disease in healthy animals. WHO is recommending that farmers and the food industry stop using antibiotics routinely to promote growth and prevent disease in healthy animals. The new recommendations aim to help preserve the effectiveness of antibiotics that are important for human medicine by reducing their unnecessary use in animals. Over-use and misuse of antibiotics in animals and humans is contributing to the rising threat of antibiotic resistance. Some types of bacteria that cause serious infections in humans have already developed resistance to most or all of the available treatments, and there are very few promising options in the research pipeline. Dr Tedros Adhanom Ghebreyesus, Director-General of WHO said, “A lack of effective antibiotics is as serious a security threat as a sudden and deadly disease outbreak. Strong, sustained action across all sectors is vital if we are to turn back the tide of antimicrobial resistance and keep the world safe." WHO strongly recommends an overall reduction in the use of all classes of medically important antibiotics in food-producing animals, including complete restriction of these antibiotics for growth promotion and disease prevention without diagnosis. Healthy animals should only receive antibiotics to prevent disease if it has been diagnosed in other animals in the same flock, herd, or fish population. Where possible, sick animals should be tested to determine the most effective and prudent antibiotic to treat their specific infection. Antibiotics used in animals should be selected from those WHO has listed as being “least important” to human health, and not from those classified as “highest priority critically important”. These antibiotics are often the last line, or one of limited treatments, available to treat serious bacterial infections in humans. Dr Kazuaki Miyagishima, Director of the Department of Food Safety and Zoonoses at WHO said, "Scientific evidence demonstrates that overuse of antibiotics in animals can contribute to the emergence of antibiotic resistance. The volume of antibiotics used in animals is continuing to increase worldwide, driven by a growing demand for foods of animal origin, often produced through intensive animal husbandry.” Many countries have already taken action to reduce the use of antibiotics in food-producing animals. For example, since 2006, the European Union has banned the use of antibiotics for growth promotion. Consumers are also driving the demand for meat raised without routine use of antibiotics, with some major food chains adopting “antibiotic-free” policies for their meat supplies. Alternative options to using antibiotics for disease prevention in animals include improving hygiene, better use of vaccination, and changes in animal housing and husbandry practices.   ]]> https://biospectrumindia.com/news/57/9774/who-global-leadership-meeting-concludes-with-new-commitment-.html https://biospectrumindia.com/news/57/9774/who-global-leadership-meeting-concludes-with-new-commitment-.html Mon, 06 Nov 2017 15:45:00 +0530 More than 260 of WHO’s leaders from headquarters, regional and country offices gathered in Geneva to discuss how to transform WHO into an organization that is better able to deliver meaningful improvements in health to the world’s people. It was first time that WHO’s new Director-General, Dr Tedros Adhanom Ghebreyesus, had the opportunity to meet face-to-face with all senior leadership in the same room. Ninth bi-annual Global Meeting of heads of WHO country offices drove an agenda to return WHO’s focus to strengthen its work at country level. Shambhu Acharya, WHO’s Director of Country Cooperation and Coordination with the United Nations System said, “This was an unprecedented opportunity to have leadership from all levels, including the most recent senior leaders to join the WHO team, together at one time to chart the future course of our work in countries throughout the world. There was a real spirit of energy and appetite for change, you could feel it in in the discussions and working groups throughout the three days.” The meeting also included contributions from key partners, including the United Nations Development Programme, the International Committee of the Red Cross, GAVI and the Global Fund to Fight AIDS, Tuberculosis and Malaria, who all expressed their renewed commitment to working with WHO to tackle global health challenges. Throughout the meeting leaders from headquarters, regional and country offices discussed the specific challenges and solutions to WHOs work at country level. They debated what it will take to deliver on the proposed priorities and direction of the Organization’s work for the next five years. Dr Piedad Huerta, WHO Representative in Honduras said, “I know one thing that impacted and impressed Heads of Country was that Dr Tedros was there throughout the entire meeting. He didn’t just drop in and out at the beginning and end. We had a variety of positions and opinions, regardless of what they were, he was listening.” “I am proud of everything we have accomplished together in the past four months. And I am excited about everything we can achieve together in the months and years ahead. One thing that is clear to me is that you are all proud to work for WHO. So am I. We have a unique mission. I am more determined than ever to work with you all to harness the extraordinary potential of this organization to make meaningful change in our world. Please join me on that mission”, Dr Tedros added.   ]]> https://biospectrumindia.com/news/57/9755/world-hepatitis-summit-2017-calls-for-accelerated-action-to-eliminate-viral-hepatitis.html https://biospectrumindia.com/news/57/9755/world-hepatitis-summit-2017-calls-for-accelerated-action-to-eliminate-viral-hepatitis.html Wed, 01 Nov 2017 11:55:00 +0530 WHO reports increasing global momentum in the response to viral hepatitis. A record 3 million people were able to obtain treatment for hepatitis C over the past two years, and 2.8 million more people embarked on lifelong treatment for hepatitis B in 2016. The World Hepatitis Summit 2017 will be attended by over 900 delegates from more than 100 countries, including Ministers of Health, national programme managers, and representatives from organizations of people affected by viral hepatitis. The Summit will review progress and renew commitments by global partners to achieve the elimination of viral hepatitis by 2030 – a target reflected in WHO's elimination strategy and the UN Sustainable Development Goals. Dr Gottfried Hirnschall, Director of WHO's Department of HIV and Global Hepatitis Programme said, "We have seen a nearly 5-fold increase in the number of countries developing national plans to eliminate life-threatening viral hepatitis over the last 5 years. These results bring hope that the elimination of hepatitis can and will become a reality." Hosted by the Government of Brazil, the World Hepatitis Summit 2017 is being co-organized by WHO and the World Hepatitis Alliance. The Summit aims to encourage more countries to take decisive action to tackle hepatitis, which still causes more than 1.3 million deaths every year and affects more than 325 million people. Charles Gore, President of World Hepatitis Alliance said, "We cannot lose sight of the fact that last year 194 governments committed to eliminating viral hepatitis by 2030. For sure we are still a long way from this goal but that doesn’t mean it’s some unattainable dream. It’s eminently achievable. It just requires immediate action. The World Hepatitis Summit 2017 is all about how to turn WHO’s global strategy into concrete actions and inspire people to leave with a ‘can do’ attitude." Dr Adele Schwartz Benzaken, Director of the Brazilian Ministry of Health’s Department of Surveillance, Prevention and Control of STIs, HIV/AIDS and Viral Hepatitis said, "Brazil is honored to host the World Hepatitis Summit 2017 – and welcomes this extraordinary team of experts, researchers, managers and civil society representatives to discuss the global health problem posed by viral hepatitis. Brazil is committed to taking recent advances in its response to hepatitis forward – on the road to elimination." Many countries are demonstrating strong political leadership, facilitating dramatic price reductions in hepatitis medicines, including through the use of generic medicines—which allow better access for more people within a short time. In 2016, 1.76 million people were newly treated for hepatitis C which is a significant increase on the 1.1 million people who were treated in 2015. The 2.8 million additional people starting lifelong treatment for hepatitis B in 2016 was a marked increase from the 1.7 million people starting it in 2015. But these milestones represent only initial steps – access to treatment must be increased globally if the 80% treatment target is to be reached by 2030. However, funding remains a major constraint: most countries lack adequate financial resources to fund key hepatitis services. To achieve rapid scale-up of treatment, countries need urgently to increase uptake of testing and diagnosis for hepatitis B and C. As of 2015, an estimated 1 in 10 people living with hepatitis B, and 1 in 5 people living with hepatitis C, were aware of their infection. Countries need to improve policies, and programmes to increase awareness and subsequent diagnosis. Countries need to provide a full range of hepatitis prevention services that are accessible to different population groups, particularly those at greater risk. Largely due to increases in the uptake of hepatitis B vaccine, hepatitis B infection rates in children under 5 fell to 1.3% in 2015, from 4.7% in the pre-vaccine era. However, the delivery of other prevention services, such as birth-dose vaccination for hepatitis B, harm reduction services for people who inject drugs, and infection control in many health services, remains low. This has led to continuing rates of new infections, including 1.75 million new hepatitis C cases every year. Innovation in many aspects of the hepatitis response must continue. New tools required include a functional cure for hepatitis B infection and the development of more effective point-of-care diagnostic tools for both hepatitis B and C. Dr Ren Minghui Assistant Director-General for Communicable Diseases, WHO said, "We cannot meet the ambitious hepatitis elimination targets without innovation in prevention interventions and approaches, and implementing them to scale. The great successes of hepatitis B vaccination programmes in many countries need to be replicated and sustained globally in the context of moving forward to universal health coverage."   ]]> https://biospectrumindia.com/news/57/9747/urgent-need-for-greater-political-commitment-to-end-tuberculosis-who-global-tb-report-2017.html https://biospectrumindia.com/news/57/9747/urgent-need-for-greater-political-commitment-to-end-tuberculosis-who-global-tb-report-2017.html Tue, 31 Oct 2017 12:15:00 +0530 According to the Global TB report 2017 recently released by WHO, Global efforts to combat tuberculosis (TB) have saved an estimated 53 million lives since 2000 and reduced the TB mortality rate by 37%. Despite of this, TB remains the top infectious killer in 2016 and it is also the main cause of deaths related to antimicrobial resistance and the leading killer of people with HIV. Progress in most countries is stalling and is not fast enough to reach global targets or close persistent gaps in TB care and prevention. Dr Tedros Adhanom Ghebreyesus, Director-General of WHO said, "While the world has committed to ending the TB epidemic by 2030, actions and investments don’t match the political rhetoric. We need a dynamic, global, multisectoral approach. The good news is that we finally have two great opportunities to move forward: the first WHO Global Ministerial Conference to End TB in Moscow in 2017, followed by the first UN General Assembly High-Level Meeting on TB in 2018. These will build momentum, get different sectors engaged, and accelerate our efforts to make TB history." WHO estimates that in 2016, there were an estimated 10.4 million new TB cases worldwide, 10% of which were people living with HIV. Seven countries accounted for 64% of the total burden, with India bearing the brunt, followed by Indonesia, China, Philippines, Pakistan, Nigeria and South Africa. An estimated 1.7 million people died from TB, including nearly 400 000 people who were co-infected with HIV. This is a drop by 4% compared to 2015. Multidrug-resistant TB (MDR-TB) remains a public health crisis and a health security threat. WHO also estimates that there were 600 000 new cases with resistance to rifampicin – the most effective first-line drug, of which 490 000 had MDR-TB. Almost half of these cases were in India, China and the Russian Federation. Dr Mario Raviglione, Director of the WHO Global TB Programme said, "The sheer numbers of deaths and suffering speak for themselves – we are not accelerating fast enough. Prompt action towards universal health coverage and social protection, as well as breakthroughs in research and innovations – will be critical to enable access to patient-centered care of the highest standards for all, especially the poorest, most disadvantaged people everywhere." Underreporting and underdiagnosis of TB cases continues to be a challenge, especially in countries with large unregulated private sectors and weak health systems. Of the estimated 10.4 million new cases, only 6.3 million were detected and officially notified in 2016, leaving a gap of 4.1 million. India, Indonesia and Nigeria accounted for almost half of this global gap. Only one in five MDR-TB cases were started on treatment. India and China accounted for 39% of the global gap. Treatment success remains low, at 54% globally. Of the almost half a million reported cases of HIV-associated TB, 15% were not on antiretroviral therapy (ART) as recommended by WHO. Most of the gaps related to HIV-associated TB were in the WHO African Region. TB preventive treatment is expanding in two priority risk groups - people living with HIV and children under 5 years. However, most people eligible for TB preventive treatment are not accessing it. For TB care and prevention, investments in low- and middle-income countries fall almost US$ 2.3 billion short of the US$ 9.2 billion needed in 2017. In addition, at least an extra US$ 1.2 billion per year is required to accelerate the development of new vaccines, diagnostics, and medicines. said Dr Katherine Floyd, Coordinator of WHO’s Monitoring and Evaluation Unit at the Global TB Programme said, “Shortfalls in TB funding are one of the main reasons why progress is not fast enough to be on track to reach the end TB targets. We have a double challenge. More domestic funding is needed in middle-income countries, and more international donor support is needed to support low-income countries.” For the first time the Global TB Report presents results from a new multisectoral monitoring framework that identifies linkages with the TB epidemic across seven Sustainable Development Goals (SDGs). Analysis of the latest status of the indicators for the 30 high TB burden countries show that most will be challenged to reach SDG targets. ]]> https://biospectrumindia.com/news/57/9712/india-all-set-to-conduct-11th-world-congress-on-adolescent-health-.html https://biospectrumindia.com/news/57/9712/india-all-set-to-conduct-11th-world-congress-on-adolescent-health-.html Wed, 25 Oct 2017 11:55:00 +0530 The World Congress on Adolescent Health is coming to India. Held only once every 4 years, the International Association for Adolescent Health’s 11th World Congress on Adolescent Health, ‘Investing in Adolescent Health – the Future is Now’ will be held in New Delhi, India from 27-29 October 2017. During the press Briefing in New Delhi on 24 October 2017, Professor Susan Sawyer, President, International Association for Adolescent Health, Dr. Sunil Mehra, Executive Director, MAMTA Health Institute for Mother and Child, Sushma Dureja, Deputy Commissioner (Adolescent Health), Ministry of Health and Family Welfare and Dr. V. Chandra-Mouli, Scientist, Department of Reproductive Health & Research, WHO were present. Professor Susan Sawyer said: “India has been chosen as the venue for the conference as it has the largest number of adolescents in the world. Policies in India are changing in favor of adolescents. When we started the IAAH in Australia 30 years ago as a resource to help build capacities in the field of adolescent health, we had people only from high income countries but now there is participation from across the world since 90 per cent of the adolescents are in middle and low income countries.’’ Dr. Sunil Mehra, said: ``It is an appropriate time to choose India as the venue for the conference since the country is faced with challenges such as early marriage, early pregnancies, malnutrition and obesity and violence.’’ The world is home to 1.2 billion adolescents, and India has the largest population of adolescents in the world i.e. 253 million. This demographic makes India a potent host for a global conference on this theme. The agenda for Sustainable Development Goals 2030 and the new Global Strategy on Women’s Children’s and Adolescents’ Health have brought adolescence to the centre-stage. These agendas recognize the opportunities and contribution of adolescence to achieving a wide array of global health priorities including improvements in communicable diseases (e.g. HIV) and non-communicable diseases, women’s health, mental health, nutrition, and more.  For example, over half of new HIV cases occur in adolescents, and more than 2 million adolescents are living with HIV. Addressing the global HIV epidemic – and other key global health agendas, will not be achieved without attending better to adolescent health and wellbeing. David Ross said, “It is indeed heartening to know that the world has started appreciating the issues of the adolescents such as education, behaviour change, smoking, drinking, and mental health which have roots in adolescence but impact the later life. The morality rates among neonates and child mortality has come down but adolescent mortality rates are showing an increasing though most of these are preventable causes such as self-harm and injuries.’’ Sushma Dureja said, “We (government) has a responsibility towards the adolescents and we cannot achieve the Sustainable Development Goals (SDGs) without focusing on adolescent health for a life-cycle approach to health.” Dr. V. Chandra-Mouli said: ``The world is looking up to India’s National Adolescent Health Programme (Rashtriya Kishore Swasthya Karyakram) after its win over polio.’’ The World Congress will cover topical themes through discussions in sessions such as ‘Global adolescent health: Opportunities and challenges’, ‘Programming for adolescent health in India: RKSK and beyond’, ‘Toward a gendered approach to adolescent health’, ‘Mental health and adolescents’, and more. The conference which is the first-of-its kind to be held in India will see the participation of prominent global public health experts as well as policy makers. The World Congress is being organized under the supportive leadership of the Ministry of Health & Family Welfare, Government of India. MAMTA Health Institute for Mother and Child (MAMTA) is the lead organisation that is hosting the World Congress with a consortium of partners including Pathfinder International, Population Foundation of India (PFI), Population Services International (PSI), and The YP Foundation. The World Congress also has scientific support from Indian Academy of Pediatrics (IAP), Federation of Obstetric and Gynecological Societies of India (FOGSI), Public Health Foundation of India (PHFI) and Trained Nurses Association of India (TNAI).   ]]> https://biospectrumindia.com/news/57/9704/amazon-plans-to-open-ai-centre-in-germany.html https://biospectrumindia.com/news/57/9704/amazon-plans-to-open-ai-centre-in-germany.html Tue, 24 Oct 2017 11:50:00 +0530 Amazon is planning to open a research centre in Germany focusing on Artificial Intelligence (AI). This development is a part of an effort led by Germany’s Max Planck Society to create the world’s leading hub for AI around Stuttgart and Tübingen. Cyber Valley was launched last December when the Max Planck Society, two technical universities and the State of Baden-Württemberg joined forces with six leading companies including to combine academic and industry research to advance artificial intelligence.  Amazon recently purchased the AI human modelling start-up Body Labs. Amazon aims to open a research centre in Tübingen and create 100 jobs dedicated to expanding applied research with AI.  The Max Planck Society comprises 84 institutes around the world dedicated to specific areas from microbiology to astronomy. Its Institute for Intelligent Systems, established in 2011 at two locations in Stuttgart and Tübingen, aims to do for artificial intelligence what Stanford University did for digital technology, resulting in Silicon Valley.          The aim of the hub Cyber Valley is to combine the two cities’ strengths to develop artificial intelligence in the fields of human cell research, mobility and any other area involving enormous amounts of data.    ]]> https://biospectrumindia.com/news/57/9700/global-access-to-affordable-medicines-should-not-be-restricted.html https://biospectrumindia.com/news/57/9700/global-access-to-affordable-medicines-should-not-be-restricted.html Mon, 23 Oct 2017 14:55:00 +0530 As 16 countries negotiating the Regional Comprehensive Economic Partnership (RCEP) agreement meet this week in Incheon, Korea, the international medical humanitarian organization Médecins Sans Frontières (MSF) is appealing to Korea and Japan to withdraw proposals that could hinder global access to affordable generic medicines and life-saving vaccines. Negotiators from the 10 member countries of the Association of Southeast Asian Nations (ASEAN) and its free trading partners – Korea, Japan, China, India, Australia, and New Zealand–are meeting in Incheon for the 20th round of negotiations on RCEP, a multilateral trade deal that covers nearly half of the world’s population. The governments of Korea and Japan are pushing for measures in the RCEP deal that would extend pharmaceutical corporation power through broader intellectual property (IP) protection that hinders competition and trade in life-saving generic medicines and vaccines. The measures go beyond what is required by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), and are called ‘TRIPS-plus’ provisions. This would mean extending drug and vaccine patent terms and entrenching new monopolies in the national drug regulatory system (‘data exclusivity’) in countries like India, which is known as the ‘pharmacy of the developing world.’ This, in turn, would delay market entry of other manufacturers, blocking price-lowering competition in drugs and vaccines that would benefit people across the world.  MSF has witnessed the negative impact of monopoly pricing on life-saving medicines and vaccines in its medical projects all over the world, including for medicines used to treat HIV, drug-resistant tuberculosis (DR-TB) and hepatitis C, as well as with pneumonia vaccines.  “The balance between public health and the intellectual property regime seems to be broken,” said Thierry Coppens, General Director of MSF Korea. “Protection of unmerited intellectual property is blocking development and introduction of new and affordable quality drugs and vaccines. This impacts humanitarian actors like MSF globally, but also hinders Korean patients from accessing more affordable health products in a timely manner. A large number of patents and other intellectual property rights held by global pharmaceutical corporations stand in the way of Korean manufacturers – who are pioneers in the development of more affordable biological medical products such as life-saving vaccines – from making them available to people and governments. The burden of the broken balance falls not only on our patients, but also on health systems that are struggling to provide health care in the midst of spiraling monopoly prices for medicines.” Weak and ‘evergreening’ patents granted in South Korea and India already block the early launch of more affordable pneumococcal conjugate vaccines (PCV) needed to tackle the increasing burden of infectious pneumococcal disease. Pneumococcal bacteria are one of the leading causes of pneumonia in children, and nearly a million children lose their lives to the disease every year.  Pfizer has been building so-called ‘patent thickets,’ restricting development and competition in the area of PCV. Pfizer (previously Wyeth) filed and obtained patents in South Korea and India to create barriers to the development of less-expensive versions of PCV. One such evergreening patent involves the mere addition of serotypes to the already established 7-valent pneumococcal vaccine - a tactic to preserve Pfizer’s monopoly - for many more years. MSF and vaccine manufacturers are challenging Pfizer, and trying to get the patent revoked.  “It is ironic that the RCEP agreement will not address the issue of evergreening practices that lead to patent offices erroneously granting monopolies on inventions for obvious modifications of existing medical products, but instead aims to extend the terms of such unmerited and spurious patents. As a result, Korea and India will have to rely on imported pneumonia vaccines, despite their own manufacturers having the capacity to develop and market more affordable versions,” said Leena Menghaney, MSF Access Campaign representative who is in Incheon to follow the RCEP IP negotiations, which start October 21. Today, high medicine prices charged by pharmaceutical corporations with monopolies are already straining the budgets of governments around the world, and leaving treatment providers like MSF, and patients, without access, including in high-income countries. In MSF’s experience, competition among generic producers has proven an effective way to bring medicine prices down and increase access to treatment for people in need. For example, in 2000, when MSF began providing antiretroviral (ARV) treatment for HIV/AIDS, the cost of treatment was more than $10,000 per year for one patient. Today, thanks to affordable generic drugs, the cost of treatment has dropped by more than 99% to less than $100 per year per patient.  But for other diseases today, prices can exceed $100,000 per person for new cancer therapies, and $1,000 per pill in some countries for hepatitis C drugs, because of pharmaceutical corporation market monopolies. These medicines mean life or death for patients the world over, including those in high-income countries like South Korea.  “Extending the intellectual property regime is not a solution to the lack of innovation and access to medicines for patients across the globe,” said Brian Davies, East Asia Head for MSF’s Access Campaign. “It is time for the governments to rethink the right balance between public health and corporate gains and stop pushing for ever-higher levels of monopoly control of medicines through free trade agreements.”  ]]> https://biospectrumindia.com/news/57/9697/30-million-newborns-could-die-by-2030-unicef-report.html https://biospectrumindia.com/news/57/9697/30-million-newborns-could-die-by-2030-unicef-report.html Mon, 23 Oct 2017 11:50:00 +0530 According to the report ‘Levels and Trends in Child Mortality 2017’ released by UNICEF, the World Health Organization, the World Bank and the Population Division of UNDESA which make up the Inter-agency Group for Child Mortality Estimation (IGME). The report reveals that that although the number of children dying before the age of five is at a new low– 5.6 million in 2016, compared with nearly 9.9 million in 2000 – the proportion of under-five deaths in the newborn period has increased from 41% to 46% during the same period. Stefan Swartling Peterson, UNICEF Chief of Health said, “The lives of 50 million children under-five have been saved since 2000, a testament to the serious commitment by governments and development partners to tackle preventable child deaths.” “But unless we do more to stop babies from dying the day they are born, or days after their birth, this progress will remain incomplete. We have the knowledge and technologies that are required – we just need to take them where they are most needed”, he also added. Most newborn deaths occurred in two regions: Southern Asia (39%) and sub-Saharan Africa (38%). Five countries accounted for half of all new-born deaths: India (24%), Pakistan (10%), Nigeria (9%), the Democratic Republic of the Congo (4%) and Ethiopia (3%). Dr Flavia Bustreo, Assistant Director-General for Family, Women’s and Children’s Health at WHO said, “To achieve universal health coverage and ensure more newborns survive and thrive, we must serve marginalized families.” “To prevent illness, families require financial power, their voices to be heard and access to quality care. Improving quality of services and timely care during and after childbirth must be prioritized.” The report notes that many lives can be saved if global inequities are reduced. If all countries achieved the average mortality of high-income countries, 87% of under-five deaths could have been averted and almost 5 million lives could have been saved in 2016. Tim Evans, Senior Director of Health Nutrition and Population at the World Bank Group said, “It is unconscionable that in 2017, pregnancy and child birth are still life-threatening conditions for women, and that 7 000 newborns die daily.” Tim also said, “The best measure of success for Universal Health Coverage is that every mother should not only be able to access health care easily, but that it should be quality, affordable care that will ensure a healthy and productive life for her children and family. We are committed to scaling up our financing to support country demand in this area, including through innovative mechanisms like the Global Financing Facility (GFF).” Pneumonia and diarrhea top the list of infectious diseases which claim the lives of millions of children under-five globally, accounting for 16% and 8% of deaths, respectively. Preterm birth complications and complications during labour or child birth were the causes of 30% of newborn deaths in 2016. In addition to the 5.6 million under-5 deaths, 2.6 million babies are stillborn each year, the majority of which could be prevented. Ending preventable child deaths can be achieved by improving access to skilled health-professionals during pregnancy and at the time of birth; lifesaving interventions, such as immunization, breastfeeding and inexpensive medicines; and increasing access to water and sanitation, that are currently beyond the reach of the world’s poorest communities. For the first time, mortality data for older children age 5 to 14 was included in the report, capturing other causes of death such as accidents and injuries. Approximately 1 million children aged 5 to 14 died in 2016. LIU Zhenmin, UN Under-Secretary-General for Economic and Social Affairs said, “This new report highlights the remarkable progress since 2000 in reducing mortality among children under age 5. Despite this progress, large disparities in child survival still exist across regions and countries, especially in sub-Saharan Africa. Yet many deaths at these ages are easily preventable through simple, cost-effective interventions administered before, during and immediately after birth. Reducing inequities and reaching the most vulnerable newborns, children and mothers are essential for achieving the SDG target on ending preventable childhood deaths and for ensuring that no one will be left behind.”   ]]> https://biospectrumindia.com/news/57/9689/india-joins-hands-with-uk-to-fight-microbial-resistance.html https://biospectrumindia.com/news/57/9689/india-joins-hands-with-uk-to-fight-microbial-resistance.html Thu, 19 Oct 2017 15:15:00 +0530 The Academy of Medical Sciences recently announced the pledge from The Yusuf and Farida Hamied Foundation for a scheme to build stronger research links between the UK and India to jointly address the challenge of antimicrobial resistance (AMR). The new five-year Academy of Medical Sciences programme will include a UK-India visiting professor scheme and two major scientific meetings, supported by The Yusuf and Farida Hamied Foundation. The Yusuf Hamied-Academy of Medical Sciences UK India Exchange Programme on AMR provides a timely opportunity to bring together leading researchers and to develop new capacity for international collaboration. It will focus on all aspects of AMR, including prevention and control of infection, environmental and veterinary science. Over five years the scheme will support 25 visiting professorships between India and the UK and two major international scientific meetings on AMR, one in the UK and one in India. This will strengthen UK-India links to share knowledge, foster research collaborations, and increase awareness, which will deliver the ultimate goal of developing robust interventions to tackle AMR across the world. ]]> https://biospectrumindia.com/news/57/9683/gsk-collaborates-with-plasticell-for-stem-cell-technology.html https://biospectrumindia.com/news/57/9683/gsk-collaborates-with-plasticell-for-stem-cell-technology.html Tue, 17 Oct 2017 15:40:00 +0530 Plasticell, the biotechnology company specialising in stem cell screening and cell therapy development, has entered into a collaboration with GSK to use its combinatorial stem cell screening technology, CombiCult, to optimise the directed differentiation of induced pluripotent stem cells (iPSCs) to specific blood cell lineages for use by GSK in its therapeutic research. In the collaboration, Plasticell will use its CombiCult technology to screen combinations of molecules provided by GSK to identify and optimise iPSC differentiation protocols. Plasticell’s proprietary technology will allow the simultaneous screening of multiple iPSC lines, facilitating the development of a robust protocol that is applicable across lines. Commenting on the collaboration, Plasticell’s founder and Executive Chairman, Dr Yen Choo, said: “During the course of developing its therapeutic programmes, Plasticell has acquired considerable expertise in pluripotent and hematopoietic stem cells, the derivation of specific hematopoietic cell types and the use of small molecules to drive stem cell differentiation. Moreover, Plasticell’s combinatorial and multiplexing technologies are an ideal solution for iPSC differentiation where high developmental potency and variability between different patient-derived cell lines often frustrates the search for robust and efficient differentiation protocols.” Plasticell’s hematopoietic cell therapy portfolio includes the expansion of hematopoietic stem cells, currently in late pre-clinical development for cell and gene therapy applications. In addition, the company is working on the manufacture of red blood cells, platelets and immune cells from iPSC. Plasticell and GSK have worked together on various stem cell research projects for more than a decade. Plasticell is co-located at the Stevenage Bioscience Catalyst, an emerging cell therapy hub on the site of GSK’s Medicines Research Centre. ]]> https://biospectrumindia.com/news/57/9674/antabio-raises-funds-for-developing-antibacterial-treatment.html https://biospectrumindia.com/news/57/9674/antabio-raises-funds-for-developing-antibacterial-treatment.html Mon, 16 Oct 2017 15:45:00 +0530 Antabio, a biopharmaceutical company developing novel antibacterial treatments in areas of highest unmet needs, announced the completion of a €7.3 milliom series A financing with subscriptions from investment funds iXO Private Equity, IRDI SORIDEC Gestion, Galia Gestion and from the company’s historical investors including former President of OM Pharma Christophe Ricard. The funding will be used to accelerate the development, up to completion of Phase 1 clinical trials, of Antabio’s novel inhibitor of bacterial metallo ß-lactamases (“MBLIs”) which will be combined with a carbapenem to fill an important gap in the treatment of drug-resistant infections. This financing complements the recent CARB-X grant of up to $8,9 million awarded to Antabio in July 2017 to support the company’s  Elastase Inhibitor program (PEI) for the treatment of chronic Pseudomonas infections in Cystic Fibrosis patients. “We are delighted to welcome iXO Private Equity, Irdi Soridec and Galia Gestion to Antabio, and we are honored by the continued solid support of our historical investors” said Marc Lemonnier, CEO of Antabio. “This new financing, coupled with the non-dilutive funding recently received from CARB-X, will advance Antabio’s innovative programs into clinical studies, thereby accelerating the development of our novel approaches to treat infections caused by WHO’s priority pathogens”. "We initiate this collaboration with the Antabio team with a lot of enthusiasm" said Jean-Michel Petit, Investment Director at IRDI Soridec Gestion. "Beyond the compelling medical need, we have been impressed with the professionalism of the team and the quality of the programs developed at Antabio, which have already earned the support of global organizations such as the Wellcome Trust and CARB-X". ]]> https://biospectrumindia.com/news/57/9652/high-level-commission-on-non-communicable-diseases-to-be-established-by-who.html https://biospectrumindia.com/news/57/9652/high-level-commission-on-non-communicable-diseases-to-be-established-by-who.html Thu, 12 Oct 2017 13:15:00 +0530 World Health Organisation (WHO) is planning to establish a new high level commission on Non-Communicable Diseases (NCDs). This was announced by Dr Tedros Adhanom Ghebreyesus, Director-General of WHO at the 64th Session of WHO’s Regional Committee for the Eastern Mediterranean in Islamabad. The commission will identify innovative ways to curb the world’s biggest causes of death and extend life expectancy for millions of people. Ongoing political efforts to accelerate action on cardiovascular disease, cancers, diabetes and respiratory disease, as well as reducing suffering from mental health issues and the impacts of violence and injuries will also be supported by the commission. This high level commission will be chaired by Dr Sania Nishtar, a prominent global advocate for action against NCDs, former Federal Minister of the government of Pakistan and civil society leader. She has also previously served as co-chair of the WHO Commission on Ending Childhood Obesity. According to WHO data, “NCDs kill approximately 40 million people globally each year, accounting for 70% of all deaths. About 15 million of those deaths are in people between the ages of 30 and 69. Low- and middle-income countries are particularly affected by NCDs with more than 80% of all deaths from NCDs occurring in these countries. Violence and injuries take an overwhelming toll on young people, particularly boys.” In 2015, world leaders committed to reduce premature deaths from NCDs by one third by 2030 as part of the Sustainable Development Goals. Recent WHO reports indicate that the world will struggle to meet that target. Dr Tedros said, “We urgently need new approaches and action on a dramatically different scale if we are to stop people dying unnecessarily from Non-Communicable diseases.” “I am committed to engaging the very best people in the world to address our health challenges. So, I am especially pleased that Dr Nishtar has agreed to lead this commission. I know she will bring impressive knowledge, credibility, and commitment to this effort”, he added. Progress of the same will be reviewed by ministers and other health leaders from around the world progress in Montevideo, Uruguay at the WHO Global Conference on Non-Communicable Diseases, which will be co-hosted by WHO and the President of Uruguay.   ]]> https://biospectrumindia.com/news/57/9649/tb-alliance-declares-potential-of-two-novel-tb-drugs.html https://biospectrumindia.com/news/57/9649/tb-alliance-declares-potential-of-two-novel-tb-drugs.html Thu, 12 Oct 2017 12:30:00 +0530 TB Alliance recently announced that TBA-7371 and sutezolid entered phase 1 clinical trials. Both compounds have proceeded through early preclinical development and were granted "Investigative New Drug" status by the U.S. Food and Drug Administration. The phase 1 clinical trials are presently ongoing. TBA-7371 is an antimicrobial compound developed by TB Alliance in collaboration with AstraZeneca. Sutezolid on the other hand belongs to a class of drugs that has already shown evidence of clinical activity against TB but the associated toxicity can be problematic. In March 2017, TB Alliance and the Medicines Patent Pool announced a sublicensing agreement for the development and commercialization of sutezolid for the treatment of TB. We still have a way to go before we arrive at a universal cure for this disease, but we have building blocks coming through the research pipeline that show us we can get there. ]]> https://biospectrumindia.com/news/57/9631/who-delivers-million-antibiotics-for-fighting-madagascar-plague.html https://biospectrumindia.com/news/57/9631/who-delivers-million-antibiotics-for-fighting-madagascar-plague.html Mon, 09 Oct 2017 15:00:00 +0530 WHO has delivered nearly 1.2 million doses of antibiotics and released $1.5 million dollars in emergency funds to fight plague in Madagascar. WHO has delivered 11,90,000 doses of antibiotics to the Ministry of Health and partners this week, and a further supply of 244,000 doses is expected in the days ahead. The different types of drugs will be used for both curative and prophylactic care. These are enough to treat up to 5000 patients and protect up to 100,000 people who may be exposed to the disease. The medicines are being distributed to health facilities and mobile health clinics across the country with the support of the Ministry of Health and partners. WHO is also filling critical shortages in disinfection materials and personal protective equipment for health professionals and safe burials. WHO and the Ministry of Health are training local health workers on how to identify and care for patients, and how to trace people who have had close contact with symptomatic patients so that they may be given protective treatment. Most of the 231 infections and 33 deaths that the Ministry of Health has reported since August are associated with pneumonic plague – a more dangerous form of the disease that affects the lungs and is transmitted through coughing at close range. Both bubonic and pneumonic plague can be cured using common antibiotics if delivered early. Antibiotics can also help prevent infection among people who have been exposed to plague. WHO has rapidly released $1.5 million from it emergency funds to allow for immediate support to the country until more substantial funds are received. WHO is appealing for $5.5 million to effectively respond to the outbreak and save lives. ]]> https://biospectrumindia.com/news/57/9629/india-south-africa-celebrates-20-years-of-strategic-partnership-in-science-technology.html https://biospectrumindia.com/news/57/9629/india-south-africa-celebrates-20-years-of-strategic-partnership-in-science-technology.html Mon, 09 Oct 2017 11:20:00 +0530 Dr. Harsh Vardhan, Union Minister for Science & Technology and Earth Sciences, Environment, Forests & Climate Change recently attended the celebrations of the collaboration in science and technology in Durban. The event was co-hosted by the departments of Science and Technology of South Africa and India. Naledi Pandor, South African Minister for S&T along with Dr. Vardhan released a booklet highlighting the two decades of fruitful cooperation in science and technology spanning across the knowledge chain which has resulted into a robust networking of the best researchers and academic institutions. Inter-governmental agreement on cooperation in the field of Science & Technology was concluded in 1995. Since then the S&T cooperation has progressively evolved as an important pillar in the India-South Africa strategic partnership based on mutual trust, warmth and friendship.  Areas like Astronomy & Astrophysics, Agriculture Sciences, Green Chemistry, Indigenous Knowledge System and Health Sciences has been the focus so far. A multi-institutional project on HIV Vaccine Research Collaboration has been also initiated this year which is aimed to develop preventive HIV vaccine and will also lead to the identification of biomarkers and development of novel techniques for diagnosis and management of tuberculosis. Dr. Harshvardhan remarked that this is a unique project, where two countries will use science for addressing the health care needs of people of both countries, in the area of HIV and TB.  Another hallmark of the vibrant collaboration was the launch of a new program on ‘Grass Root Innovation’ aimed towards sharing of open source technologies and IPR protection of traditional knowledge systems. This program is designed for co-development of products through value addition, validation through product deployment and market ready technology transfer with a focus on affordability. “Both India and S. Africa have a rich pool of traditional knowledge which can be leveraged by providing the scientific knowledge base required for technology development for societal benefit. This cooperation on grass root innovation will provide scientific and technological solutions for addressing the unmet needs of the common man. The novel initiative has been aptly named as ‘Gandhi-Mandela Program on Grass Root Innovation’. National Innovation Foundation, Ahmedabad will implement this program on the Indian side”, Harshvardhan added. ]]> https://biospectrumindia.com/news/57/9620/breast-cancer-death-rate-drops-by-almost-40-percent-in-u-s-.html https://biospectrumindia.com/news/57/9620/breast-cancer-death-rate-drops-by-almost-40-percent-in-u-s-.html Thu, 05 Oct 2017 12:20:00 +0530 Breast cancer death rates declined almost 40 percent between 1989 and 2015, averting 322,600 deaths, reports the American Cancer Society. Breast cancer death rates increased by 0.4 percent per year from 1975 to 1989, according to the study. After that, mortality rates decreased rapidly, for a 39 percent drop overall through 2015. The report, the latest to document a long-term reduction in breast-cancer mortality, attributed the declines to both improvements in treatments and to early detection by mammography. Deanna Attai, a breast cancer surgeon at the University of California, Los Angeles who was not involved in the study, said the advances in treatment included much better chemotherapy regimens — developed in the 1980s and refined ever since — that are administered post-surgery to reduce the risk of recurrence. Other improvements have included tamoxifen, an anti-estrogen agent that was approved in the late 1970s; Herceptin, a drug used to treat tumors with a higher-than-normal level of a protein called HER2 and drugs called aromatase inhibitors. More recently, more sophisticated targeted treatments are being used to treat cancer that has spread beyond the breast. Even with the gains, however, the toll of the disease remains high. Breast cancer is the most common cancer diagnosed in U.S. women and the second-leading cause of death after lung cancer. About 252,000 new cases of breast cancer are expected to be diagnosed in the United States this year, and more than 40,600 women are expected to die of the disease. A woman in the U.S. has a 12.4 percent, or 1 in 8, lifetime risk of being diagnosed with breast cancer. Eighty-one percent of breast cancers are diagnosed among women age 50 years and older, the study found, and 89 percent of breast-cancer deaths occur in that age group. The median age at diagnosis for women overall is 62 years. ]]> https://biospectrumindia.com/news/57/9619/three-scientists-awarded-nobel-prize-in-chemistry-for-work-to-visualize-biomolecules.html https://biospectrumindia.com/news/57/9619/three-scientists-awarded-nobel-prize-in-chemistry-for-work-to-visualize-biomolecules.html Thu, 05 Oct 2017 09:30:00 +0530 The Nobel Prize in Chemistry 2017 is awarded to Jacques Dubochet, Joachim Frank and Richard Henderson for the development of cryo-electron microscopy, which both simplifies and improves the imaging of biomolecules. This method has moved biochemistry into a new era. A picture is a key to understanding. Scientific breakthroughs often build upon the successful visualisation of objects invisible to the human eye. However, biochemical maps have long been filled with blank spaces because the available technology has had difficulty generating images of much of life’s molecular machinery. Cryo-electron microscopy changes all of this. Researchers can now freeze biomolecules mid-movement and visualise processes they have never previously seen, which is decisive for both the basic understanding of life’s chemistry and for the development of pharmaceuticals. Electron microscopes were long believed to only be suitable for imaging dead matter, because the powerful electron beam destroys biological material. But in 1990, Richard Henderson succeeded in using an electron microscope to generate a three-dimensional image of a protein at atomic resolution. This breakthrough proved the technology’s potential. Joachim Frank made the technology generally applicable. Between 1975 and 1986 he developed an image processing method in which the electron microscope’s fuzzy twodimensional images are analysed and merged to reveal a sharp three-dimensional structure. Jacques Dubochet added water to electron microscopy. Liquid water evaporates in the electron microscope’s vacuum, which makes the biomolecules collapse. In the early 1980s, Dubochet succeeded in vitrifying water – he cooled water so rapidly that it solidified in its liquid form around a biological sample, allowing the biomolecules to retain their natural shape even in a vacuum. Following these discoveries, the electron microscope’s every nut and bolt have been optimised. The desired atomic resolution was reached in 2013, and researchers can now routinely produce three-dimensional structures of biomolecules. In the past few years, scientific literature has been filled with images of everything from proteins that cause antibiotic resistance, to the surface of the Zika virus. Biochemistry is now facing an explosive development and is all set for an exciting future. ]]> https://biospectrumindia.com/news/57/9615/merck-invests-in-its-new-biotech-manufacturing-site.html https://biospectrumindia.com/news/57/9615/merck-invests-in-its-new-biotech-manufacturing-site.html Wed, 04 Oct 2017 14:40:00 +0530 Merck, a leading science and technology company, will invest EUR35 million in a new production line for the aseptic filling of biotech medicines under isolator at its manufacturing site of Bari, Italy. The announcement was made as part of an event celebrating the 25th anniversary of the site and its leading role on the science and technology scene in the South Italian region of Apulia. The new production line is expected to be fully operational in 2022. It will be equipped with an isolator designed with the latest technologies available and with a high level of automation. The isolator technology represents best practice in aseptic filling which is a prerequisite to ensure the safety of injectable medicines. The new production line is intended to be used for the aseptic filling of Merck's biotech medicines in the areas of multiple sclerosis, fertility and endocrinology with a capacity of 14 million units per year. The Bari site is part of a network of 15 manufacturing sites dedicated to the production of Merck's biotech and pharmaceutical medicines serving 60 million patients across the globe each and every day. ]]> https://biospectrumindia.com/news/57/9610/three-americans-take-away-nobel-prize-in-medicine.html https://biospectrumindia.com/news/57/9610/three-americans-take-away-nobel-prize-in-medicine.html Tue, 03 Oct 2017 11:20:00 +0530 Three Americans have won the Nobel Prize in Physiology or Medicine for their discoveries about the body's daily rhythms, opening up whole new fields of research and raising awareness about the importance of getting proper sleep. Jeffrey C. Hall, Michael Rosbash and Michael W. Young won the 9-million-kronor ($1.1 million) prize for isolating a gene that controls the body’s normal daily biological rhythm. Circadian rhythms adapt the workings of the body to different phases of the day, influencing sleep, behavior, hormone levels, body temperature and metabolism. Mr. Rosbash is on the faculty at Brandeis University, Mr. Young is at Rockefeller University and Mr. Hall has been associated with the University of Maine. The awardees’ work stems back to 1984, when Mr. Rosbash and Mr. Hall, who was then also at Brandeis, along with Mr. Young isolated the period gene in fruit flies. Mr. Hall and Mr. Rosbash found that a protein encoded by the gene accumulated during the night and degraded during daytime. A decade later, Mr. Young discovered another clock gene. The paradigm-shifting discoveries by the laureates established key mechanisms for the biological clock.   ]]> https://biospectrumindia.com/news/57/9592/kenya-launches-oral-healthcare-campaign.html https://biospectrumindia.com/news/57/9592/kenya-launches-oral-healthcare-campaign.html Wed, 27 Sep 2017 17:40:00 +0530 Kenya's ministry of health in conjunction with industry partners has launched a month long campaign to combat oral diseases that have worsened against a backdrop of healthcare personnel deficit and changing dietary habits. The nationwide campaign will sensitize the public on proper hygiene and regular checkups to curb spread of bacterial diseases that affects the mouth. The Kenya Oral Health Survey that was conducted recently indicated Kenya has one dentist per 42,000 patients, which falls short of the recommended ratio of one dentist per 7,000 patients by the World Health Organization (WHO). Most health facilities in the country lack modern infrastructure to deal with oral diseases. The majority of dental laboratories are poorly equipped and facilities lack sufficient commodities. The government has prioritized training of dentists to help deal with personnel gaps in public health facilities where poor citizens affected by oral diseases seek treatment. The common dental ailments in the country are tooth decay, gum diseases, dental caries, dental fluorosis and maxillofacial trauma (interpersonal violence that cause injuries to head, mouth and neck). ]]> https://biospectrumindia.com/news/57/9562/the-world-is-running-out-of-antibiotics-who-confirms.html https://biospectrumindia.com/news/57/9562/the-world-is-running-out-of-antibiotics-who-confirms.html Wed, 20 Sep 2017 17:55:00 +0530 A report, Antibacterial agents in clinical development which is an analysis of the antibacterial clinical development pipeline, including tuberculosis, launched today by WHO shows a serious lack of new antibiotics under development to combat the growing threat of antimicrobial resistance. Most of the drugs currently in the clinical pipeline are modifications of existing classes of antibiotics and are only short-term solutions. The report found very few potential treatment options for those antibiotic-resistant infections identified by WHO as posing the greatest threat to health, including drug-resistant tuberculosis which kills around 250 000 people each year. Dr Tedros Adhanom Ghebreyesus, Director-General of WHO said, "Antimicrobial resistance is a global health emergency that will seriously jeopardize progress in modern medicine. There is an urgent need for more investment in research and development for antibiotic-resistant infections including TB, otherwise we will be forced back to a time when people feared common infections and risked their lives from minor surgery." In addition to multidrug-resistant tuberculosis, WHO has identified 12 classes of priority pathogens – some of them causing common infections such as pneumonia or urinary tract infections – that are increasingly resistant to existing antibiotics and urgently in need of new treatments. The report identifies 51 new antibiotics and biologicals in clinical development to treat priority antibiotic-resistant pathogens, as well as tuberculosis and the sometimes deadly diarrhoeal infection Clostridium difficile. Among all these candidate medicines, however, only 8 are classed by WHO as innovative treatments that will add value to the current antibiotic treatment arsenal. There is a serious lack of treatment options for multidrug- and extensively drug-resistant M. tuberculosis and gram-negative pathogens, including Acinetobacter and Enterobacteriaceae (such as Klebsiella and E.coli) which can cause severe and often deadly infections that pose a particular threat in hospitals and nursing homes. There are also very few oral antibiotics in the pipeline, yet these are essential formulations for treating infections outside hospitals or in resource-limited settings. Dr Suzanne Hill, Director of the Department of Essential Medicines at WHO said, "Pharmaceutical companies and researchers must urgently focus on new antibiotics against certain types of extremely serious infections that can kill patients in a matter of days because we have no line of defence.” To counter this threat, WHO and the Drugs for Neglected Diseases Initiative (DNDi) set up the Global Antibiotic Research and Development Partnership (known as GARDP). On 4 September 2017, Germany, Luxembourg, the Netherlands, South Africa, Switzerland and the United Kingdom of Great Britain and Northern Ireland and the Wellcome Trust pledged more than €56 million for this work. Dr Mario Raviglione, Director of the WHO Global Tuberculosis Programme said, "Research for tuberculosis is seriously underfunded, with only two new antibiotics for treatment of drug-resistant tuberculosis having reached the market in over 70 years. If we are to end tuberculosis, more than US$ 800 million per year is urgently needed to fund research for new anti-tuberculosis medicines.”   ]]> https://biospectrumindia.com/news/57/9561/iaah-11th-world-congress-on-adolescent-health-coming-to-india.html https://biospectrumindia.com/news/57/9561/iaah-11th-world-congress-on-adolescent-health-coming-to-india.html Wed, 20 Sep 2017 17:30:00 +0530 The biggest global event in adolescent health – The World Congress on Adolescent Health - is coming to India. Held once in every 4 years, the International Association for Adolescent Health’s 11th World Congress on Adolescent Health, ‘Investing in Adolescent Health – the Future is Now’ will be held in New Delhi, India from 27-29 October 2017. The world is home to 1.2 billion adolescents, and India has the largest population of adolescents in the world – 253 million1. This demographic makes India a potent host for a global conference on this theme. The mortality of adolescents globally stands at staggering 1.3 million deaths per year. Unintended injuries such as road traffic accidents and drowning are the leading causes of death among adolescents, together with self-harm, interpersonal violence, communicable diseases and teenage pregnancy. Tobacco, alcohol and other substance use contribute to health concerns among adolescents (e.g. injuries) and are associated with unemployment, accidents, depression and suicide during adolescence. Yet rather than a passing phase, these behaviours and states risk reverberating across the life-course, contributing to the future burden of disease in adults and to that of the next generation. The agenda for Sustainable Development Goals 2030 and the new Global Strategy on Women’s Children’s and Adolescents’ Health have brought adolescence to the centre-stage. These agendas recognize the opportunities and contribution of adolescence to achieving a wide array of global health priorities including improvements in communicable diseases (e.g. HIV) and non-communicable diseases, women’s health, mental health, nutrition, and more. The World Congress seeks to cover topical themes through discussions in sessions such as ‘Global adolescent health: Opportunities and challenges’, ‘Programming for adolescent health in India: RKSK and beyond’, ‘Toward a gendered approach to adolescent health’, ‘Mental health and adolescents’, and more. The World Congress is organized under the supportive leadership of the Ministry of Health & Family Welfare (MoHFW), Government of India. MAMTA Health Institute for Mother and Child (MAMTA) is the lead organisation that is hosting the World Congress with a consortium of partners including Pathfinder International, Population Foundation of India (PFI), Population Services International (PSI), and The YP Foundation. The World Congress also has scientific support from Indian Academy of Pediatrics (IAP), Federation of Obstetric and Gynaecological Societies of India (FOGSI), Public Health Foundation of India (PHFI) and Trained Nurses Association of India (TNAI). Dr. Sunil Mehra, Executive Director, MAMTA Health Institute for Mother and Child said, “Adolescents need to be at the centre of future investment in health and education for sustainable development.” Professor Susan Sawyer, President, International Association for Adolescent Health, says, “This meeting couldn’t be better timed, as never has there been such global recognition of the importance of advancing the health and wellbeing of adolescents, including in India. IAAH is delighted that the 11th World Congress on Adolescent Health is in the country with the largest number of adolescents in the world. A groundswell of professionals, global partners and young people are coming to Delhi from all over the world to share ideas, evidence and actions to advance adolescent health. The world is looking towards India and we are confident this World Congress will deliver.” The World Congress is anticipating around 800 international and national delegates including adolescent health experts from across the globe, academia, representatives from MoHFW - Government of India, national and global representatives of UN organizations, youth leaders from several countries including India who have made a difference in their communities, national and international NGOs, donor organizations, policy makers and corporates.   ]]> https://biospectrumindia.com/news/57/9517/align-national-tb-strategies-with-commitment-to-end-tb-by-2030-who.html https://biospectrumindia.com/news/57/9517/align-national-tb-strategies-with-commitment-to-end-tb-by-2030-who.html Mon, 11 Sep 2017 14:45:00 +0530 ‘Bending the curve’ and ending TB was a key agenda item at the Seventieth session of the Regional Committee which concluded yesterday in Maldives. The Regional Committee is the highest decision-making body for public health in the South-East Asia Region, and includes health ministers and senior health ministry officials of the Region’s 11 Member countries – Bangladesh, Bhutan, Democratic People’s Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. World Health Organization has called on countries in South-East Asia Region to build on recent momentum aimed at ending TB by 2030, commending their resolve to take action and urging all countries to review and align national plans with the Delhi Call to Action. Dr Khetrapal Singh, Regional Director, WHO South-East Asia, said, “The Region-wide momentum established to ‘bend the curve’ and end TB by 2030 is laudable. The Delhi Call for Action, issued by health ministers in March, demonstrates high-level awareness that business as usual is not enough, and that intensified efforts are needed. We have reached a critical consensus; the pressing need now is to translate commitment into action.” Dr Singh also emphasised that, “As a critical first step in implementing recent commitments, emphasized the need for countries to align national plans with the 2030 target. “By reviewing and amending national TB plans countries will enhance their ability to mobilize and utilize resources efficiently. Good planning is key to establishing the foundations for success.” The Regional Director likewise highlighted the need for countries to identify the package of interventions best suited to their challenges, whether that means focusing on strengthening TB services, accelerating case detection or investing in research and development. “All countries face unique challenges, meaning they should each adapt the regional and global strategies to their context. We must avoid taking one-size-fits-all approach, and must instead seek-out and embrace tailored solutions that meet specific needs and challenges. The Regional Director affirmed WHO South-East Asia Region’s ongoing commitment to supporting countries implement the Delhi Call for Action, including by implementing mandatory case notification and working with regulatory authorities to introduce newer drugs for the treatment of drug-resistant TB. The Regional Director also reiterated WHO’s continued support for the provision of universal Drug susceptibility testing (DST)-guided treatment, for addressing MDR-TB and TB in immunocompromised patients, and for increased focus on the social aspects of TB. "By planning effectively and making smart, high-impact interventions, countries across the South-East Asia Region can lift TB’s significant burden and end the disease as a public health threat once and for all,” Dr Khetrapal Singh said.   ]]> https://biospectrumindia.com/news/57/9508/maldives-host-seventieth-regional-committee-session-of-who-south-east-asia-.html https://biospectrumindia.com/news/57/9508/maldives-host-seventieth-regional-committee-session-of-who-south-east-asia-.html Fri, 08 Sep 2017 11:30:00 +0530 The Seventieth Regional Committee session of WHO South-East Asia Region, the annual governing body meeting of WHO in the Region, is being hosted by Maldives this year from 6 – 10 September and includes health ministers and senior health ministry officials of the Region’s 11 Member countries – Bangladesh, Bhutan, Democratic People’s Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. First day of the meeting emphasized the need to make health for all a top priority in WHO South-East Asia Region as health ministers, leaders and officials. At the inauguration of the Seventieth Regional Committee session of WHO South-East Asia, the governing body meeting of WHO in the Region Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia Region said, “The challenges we all face are real and complex. We are committed to the achievement of universal health coverage. Every single country is making headway and we have powerful means to measure progress.” Universal health coverage (UHC) is the best and most powerful means we have at our disposal for changing peoples’ lives through better health, she said, emphasizing how sustained investment in health will ensure hard-won economic progress continues.  WHO Director General, Dr Tedros Adhanom, said “there is nothing better you can do for the people of your countries than to invest in strengthening your health systems. This includes ensuring the right number of health workers with the right skills, in the right places, to give the right care, at the right time. It means ensuring that essential medicines are available, and that people do not have to choose between buying medicine and buying food.” Abdulla Nazim Ibrahim, Health Minister of Maldives, and Dr Mohamed Shainee, the special envoy of the President of Maldives and the Minister of Fisheries and Agriculture, addressed the inaugural session of the annual meeting being hosted by Maldives this year. Second day of the meeting recognised the immense and increasing public health risks caused by climate change, Member countries of WHO South-East Asia Region unanimously endorsed the Malé Declaration, committing to build health systems able to anticipate, respond to, cope with, recover from and adapt to climate-related shocks and stress. “Climate change is happening, and is a risk to public health. Whether from greater severity and intensity of extreme weather events, changes in the spread and abundance of disease-carrying vectors such as mosquitoes, or changes to the physical environment that cause displacement or threaten livelihoods, climate change is already having an impact across our Region. Today’s Declaration demonstrates the commitment of the South-East Asia Region’s Member countries to take effective and immediate action,” Dr Khetrapal said The Declaration being adopted at the Seventieth Regional Committee session of the WHO South-East Asia Region – the Region’s highest decision-making body – builds on recent initiatives at country, regional and global levels to tackle the public health risks caused by climate change.  The Declaration is accompanied by a Framework for Action to be implemented between 2017 and 2022, and calls on UN agencies and other international organizations, development partners, philanthropic agencies, academic and civil society organizations to mobilize human, financial and technical resources for this purpose. ]]> https://biospectrumindia.com/news/57/9487/thermo-fisher-forms-consortium-for-cancer-research.html https://biospectrumindia.com/news/57/9487/thermo-fisher-forms-consortium-for-cancer-research.html Tue, 05 Sep 2017 12:00:00 +0530 Thermo Fisher Scientific has formed the Immuno-Oncology Consortium to drive adoption of highly sensitive, next-generation sequencing (NGS) clinical research panels designed to help identify predictive and prognostic biomarkers associated with cancer immunotherapy. Recognizing this shift towards a multi-targeted approach to detect a broad set of gene variants with a single panel, the company has also launched the Ion AmpliSeq Immune Repertoire Assay Plus, TCR beta and expanded its portfolio of liquid biopsy assays for analysis of cell-free nucleic acid (cfNA) in lung and breast cancer. Led in collaboration with Dr. Sabine Merkelbach-Bruse from the Institute of Pathology of the University of Cologne, the Immuno-Oncology Consortium brings together a prestigious group of clinical researchers from renowned institutions in Europe. The consortium will initially spearhead efforts to validate Thermo Fisher's previously launched Oncomine Immune Response Research Assay with the expectation to extend studies with the new immune repertoire assay and an application to interrogate tumor mutational burden currently under development by Thermo Fisher. ]]> https://biospectrumindia.com/news/57/9482/australian-digital-health-and-life-sciences-delegation-explores-partnerships-in-india.html https://biospectrumindia.com/news/57/9482/australian-digital-health-and-life-sciences-delegation-explores-partnerships-in-india.html Mon, 04 Sep 2017 15:50:00 +0530 As part of the Australian digital health and life sciences delegation’s visit to India a session on Australia-India Digital Health Dialogue was organised in New Delhi recently by The Australian Trade & Investment Commission (Austrade), Australian Government. The Australia Business Week in India features more than 50 business events and activities spread across 6 cities. The ABWI Australian business delegation would visit New Delhi, Mumbai, Kolkata, Bhopal, Bengaluru and Hyderabad. ABWI will feature seminars, roundtables and site visits with Indian businesses, industry and government. The week-long series of activities is designed to enhance Australia’s trade, education and investment relationships with India. The session focused on the digital health sector in India and some of the key issues discussed at this session included developing a road map for a technology-enabled healthcare ecosystem; defining the future of health through use of technology; transforming India through technology enabled care and innovations in digital health & medical devices. Australia’s experience delivering healthcare in remote areas and using data analytics to predict future demand is synergistic with India’s need for remote health in rural parts of the country. Senior representatives from Indian healthcare companies, IT companies, hospitals & telemedicine experts, med-tech and medical devices companies, digital health start-ups & investors participated in this session. Speaking about the delegation, John Madew, Senior Trade & Investment Commissioner, Australian Trade & Investment Commission, Australian Government said, “Australian Government and businesses are investing in digital health solutions to build a sustainable healthcare system and respond to challenges including increased cost and demand pressures, greater demand for personalised care and an ageing population. In particular, Australia’s ability to deliver healthcare in remote areas and use data analytics to predict future demand can help India meet its need for remote health in rural parts of the country.” “Australia has a diverse health industry, with capabilities spread across a wide range of niche and complex health areas. The country has a strong reputation in medicine including cardiology, neuroscience, oncology and sports science, and can demonstrate these capabilities in the delivery of policy, research, equipment, technology, skills and services”, he added.         ]]> https://biospectrumindia.com/news/57/9438/qiagen-partners-with-clinical-genomics-for-cancer-diagnosis.html https://biospectrumindia.com/news/57/9438/qiagen-partners-with-clinical-genomics-for-cancer-diagnosis.html Thu, 24 Aug 2017 11:40:00 +0530 Qiagen and Clinical Genomics, a private company developing evidence-based diagnostic tools for colorectal cancer, have implemented the PAXgene Blood ccfDNA Tube sample collection in Clinical Genomics’ Colvera colorectal cancer (CRC) recurrence assay. Colvera, an integrated liquid biopsy solution, is designed to enable easy and accurate monitoring for recurrence of colorectal cancer with a simple blood test. Clinical Genomics and Qiagen have demonstrated that PAXgene ccfDNA yield and Colvera assay performance is equivalent to the performance from blood samples collected in EDTA tubes, spun down to plasma and frozen within eight hours of collection, whereby the PAXgene process demonstrated a significantly superior ease of use and robustness. Clinical Genomics is the sole U.S. provider of Colvera, a PCR-based assay that detects hypermethylated BCAT1 and IKZF1 DNA in the blood of patients. Colvera has been demonstrated to detect more than twice the number of CRC recurrence cases compared to the current guidelines-recommended blood test. PAXgene technology offers highly integrated and automated solutions for the collection, stabilization and purification of circulating cell-free DNA from blood samples. It allows whole blood to be drawn and stored at cooled and ambient temperatures for up to seven days before samples are processed and tested for the presence of circulating cell-free DNA. ]]> https://biospectrumindia.com/news/57/9432/pe-firm-enhances-life-science-portfolio.html https://biospectrumindia.com/news/57/9432/pe-firm-enhances-life-science-portfolio.html Wed, 23 Aug 2017 11:15:00 +0530 Private equity firm Calculus Capital, a leading EIS and VCT investor, has further expanded its life science portfolio, by investing £2.5 million in Cambridge-based Axol Bioscience (Axol), a provider of stem cells produced from reprogrammed human blood and tissue cells. Axol supplies the world’s top pharma companies, biotechs and research institutions with sustainable, physiologically relevant human derived cell culture models for pioneering research and drug discovery applications. By harnessing advances in stem cell biology, Axol is able to generate self-renewing cell-lines specific to any part of the human body from healthy and unhealthy tissue. Importantly, Axol’s unique and innovative approach to this process ensures that each cell line is identical to its previous production batch, maintaining the high quality and the consistency required for the development of novel therapeutics. Once a new cell line is developed from a healthy or unhealthy tissue source, it is added to Axol’s suite of ‘off the shelf’ products available via their website. The combination of these properties means that the reprogrammed stem cells developed by Axol are an essential research tool for the development of new treatments for serious illnesses and diseases, including Alzheimer’s and Huntington’s. “Axol Bioscience is doing very important work; its products and services – stem cells and the culture systems required to maintain them – are essential to gene-based medical research,” said Alexandra Lindsay of Calculus Capital. “Our investment will enable Axol to grow and develop more product lines that are able to make a real and effective contribution to medical research efforts to combat killer diseases.” “The market for our products is growing rapidly from all around the world,” said Dr Yichen Shi, CEO of Axol. “The funding from Calculus will help us make the most of that opportunity through new product development and increasing our sales and marketing capabilities.” ]]> https://biospectrumindia.com/news/57/9423/astrazeneca-ties-up-with-german-biotech-ethris.html https://biospectrumindia.com/news/57/9423/astrazeneca-ties-up-with-german-biotech-ethris.html Tue, 22 Aug 2017 11:35:00 +0530 AstraZeneca has invested €25million into gene messenger drug development, through a research tie-up with German biotech Ethris. The drugmaker has agreed to pay Munich-based Ethris the sum upfront, with further payments and royalties possible depending on development progress. Ethris, which was founded by two German scientists in 2009, specialises in RNA drugs, which instruct human cells to produce therapeutic proteins. The alliance with AstraZeneca and its biotech division MedImmune will focus on asthma and other respiratory diseases. Scientists believe the RNA approach holds potential to treat a range of conditions, including cancer and heart disease. It is not AstraZeneca’s first investment in the field. Last year the company invested a further $140 million in RNA specialist Moderna Therapeutics, upping its stake to 9pc. AstraZeneca is looking to bounce back after a negative readout from its lung cancer drugs trial Mystic last month led to its biggest single day share price fall, wiping £10 billionn from the company’s market value. ]]> https://biospectrumindia.com/news/57/9416/amgen-collaborates-with-humana-to-improve-health-outcomes.html https://biospectrumindia.com/news/57/9416/amgen-collaborates-with-humana-to-improve-health-outcomes.html Mon, 21 Aug 2017 11:05:00 +0530 Biotechnology company, Amgen and leading health organization, Humana have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana's 13 million members. In the collaboration agreement between Amgen and Humana, six projects are currently underway or planned, with more expected over the term of the agreement. Both organizations are committed to expanding the work into further therapeutic areas where the partnership can bring value to both Amgen and Humana. The goal is the same across all projects: deliver increased value to patients and the health care system by focusing on working to improve quality and outcomes in the context of total health care costs. The collaboration will initially target multiple serious conditions, including cardiovascular disease, osteoporosis, neurologic disorders, inflammatory diseases and cancer. Researchers will combine available sources of real world evidence (RWE) with data from wearable technology, digital apps and Bluetooth-enabled drug delivery devices. Prospective observational studies are also planned. Planned research will identify patients whose serious medical conditions are likely to result in an adverse patient outcome, which may lead to development of algorithms that can predict risk and drive to early intervention. The partnership will also dive deeply into specific therapeutic areas, from defining the burden of osteoporotic fractures to understanding the impact of wearable technology on medication adherence for inflammatory diseases. ]]> https://biospectrumindia.com/news/57/9378/tissue-regenix-acquires-cellright-technologies.html https://biospectrumindia.com/news/57/9378/tissue-regenix-acquires-cellright-technologies.html Fri, 11 Aug 2017 11:10:00 +0530 Tissue Regenix Group plc, a UK-based leading medical devices company in the field of regenerative medicine announced the completion of the acquisition of CellRight Technologies LLC, a US-based specialist in regenerative osteoinductive bone scaffolds. The acquisition, expands the Group’s presence within the US healthcare market and increases US sales by more than double, bringing together two highly complementary technology and product platforms focused on soft-tissue regeneration and regenerative bone matrices, respectively. TRX has built a portfolio of soft tissue products for use in wound care, orthopaedics and cardiac applications, based on its patented dCELL Technology with DermaPure, a decellularised dermal allograft for chronic and acute wound care, currently commercialised.   CellRight, brings a complementary regenerative technology which is used to turn allograft bone into various malleable applications including, DBM Putty, strips, blocks and fibres, primarily for use in spine, orthopaedics and dental surgeries.      Leveraging the capabilities of CellRight Technologies’ existing tissue bank in San Antonio, TX, Tissue Regenix is set to launch its OrthoPure HT, decellularised human tendon, into the U.S. orthopaedics market in early 2018, which will initially address anterior cruciate ligament repair. This facility also provides the Group with a purpose built U.S. base to self-manufacture products utilising its patented dCELL process. ]]> https://biospectrumindia.com/news/57/9374/nih-promotes-the-use-of-genomics-in-clinical-care.html https://biospectrumindia.com/news/57/9374/nih-promotes-the-use-of-genomics-in-clinical-care.html Thu, 10 Aug 2017 12:30:00 +0530 The National Institutes of Health (NIH) is awarding $18.9 million towards research that aims to accelerate the use of genome sequencing in clinical care. The new awards will generate innovative approaches and best practices to ensure that the effectiveness of genomic medicine can be applied to all individuals and groups, including diverse and underserved populations, and in healthcare settings that extend beyond academic medical centers. The research is being funded as part of the Clinical Sequencing Evidence-Generating Research (CSER2) Consortium. CSER2 builds upon the Clinical Sequencing Exploratory Research (CSER) Consortium, initiated in 2010 and funded by the National Human Genome Research Institute (NHGRI) and the National Cancer Institute (NCI), both part of NIH. The new grants will support the development of methods needed to integrate genome sequencing into the practice of medicine, improve the discovery and interpretation of genomic variants, and investigate the impact of genome sequencing on healthcare outcomes. With this new round of funding, CSER2 investigators will continue the effort to generate evidence for the usefulness of genome sequencing in clinical care, but with a particular focus on diverse and underserved individuals. To that end, NHGRI and NCI have partnered with the National Institute on Minority Health and Health Disparities (NIMHD) to improve processes for recruiting and retaining patients to participate in research from diverse racial and ethnic groups, as well as from currently understudied clinical healthcare settings where genomic medicine could potentially be put into practice. ]]> https://biospectrumindia.com/news/57/9333/eurofins-signs-agreement-to-acquire-discoverx.html https://biospectrumindia.com/news/57/9333/eurofins-signs-agreement-to-acquire-discoverx.html Tue, 01 Aug 2017 12:45:00 +0530 Eurofins Scientific, a world leader in providing analytical support to the global pharmaceutical industry, has signed an agreement to acquire DiscoverX, a leader in drug discovery products and services across all stages of discovery from target identification and lead discovery to preclinical and beyond. The transaction is expected to close in the coming weeks, upon fulfillment of customary closing conditions. DiscoverX is an innovative company that develops, manufactures, and commercializes reagents, complete cell-based assay kits, profiling and screening services as well as other disruptive solutions for the drug discovery, screening, and life science markets. The company has over 15 years’ experience in drug discovery and development leveraging on the Enzyme Fragment Complementation (EFC) technology and has become a reputable market leader in GPCR screening applications. EFC technology is a proven, established screening platform in most major pharmaceutical companies. The combination of Eurofins Pharma Discovery Services and DiscoverX provides the pharmaceutical and biotech industries with a partner of choice for end-to-end drug discovery services, enabling customers to improve research productivity and effectiveness of their screening, lead optimization and structure-activity relationships (SAR) campaigns, thus accelerating the discovery and development of new drugs. In addition, DiscoverX’s KINOMEscan platform and epigenetics services, combined with Eurofins Pharma Discovery’s kinase profiling services would result in the largest available portfolio of kinase products and services in the market. Furthermore, it provides researchers with a comprehensive technology platform for assessment of drugs to kinases, the most widely evaluated drug target. DiscoverX’s expertise complements Eurofins discovery pharmacology capabilities following the previous acquisitions of Panlabs, Cerep, EMD Millipore Discovery and Development Solutions and Villapharma. The company is well-positioned to capitalize on the growing R&D outsourcing market in the USA and provides a gateway to the Asia-Pacific region. ]]> https://biospectrumindia.com/news/57/9305/siemens-to-purchase-aleres-blood-diagnostics-unit.html https://biospectrumindia.com/news/57/9305/siemens-to-purchase-aleres-blood-diagnostics-unit.html Tue, 25 Jul 2017 14:30:00 +0530 Siemens Healthineers has signed a definitive agreement to buy point-of-care diagnostics firm Alere's blood diagnostic systems unit, Epocal. The financial details of the acquisition have not been revealed. The agreement covers Epocal’s handheld, wireless testing solution called epoc Blood Analysis System and will bolster Siemens Healthineers’ blood gas portfolio. epoc Blood Analysis System is designed to deliver blood gas, electrolyte and metabolite results in around 30 seconds following introduction of the sample. The system comes with epoc room-temperature stable BGEM test card, reader and host2 mobile computer. The epoc range is expected to integrate into the firm’s digital systems network to offer a broad solution to its customers. With an aim to improve customers’ workflows, Siemens Healthineers portfolio of blood gas diagnostics includes a variety of devices such as low-volume, single-use handheld device and high-volume, multi-use benchtop solution. Blood gas test systems are used in critical care settings, including hospitals, clinics, emergency departments and pulmonary laboratories. The Epocal deal is subject to completion of Abbott's acquisition of Alere, antitrust approvals, and other customary closing conditions. ]]> https://biospectrumindia.com/news/57/9300/incyte-launches-phase-iii-trial-for-assessing-gvhd-candidate-itacinib.html https://biospectrumindia.com/news/57/9300/incyte-launches-phase-iii-trial-for-assessing-gvhd-candidate-itacinib.html Mon, 24 Jul 2017 18:30:00 +0530 Incyte Corporation announced that the first patient treated has been treated in Incyte’s Phase III clinical trial, GRAVITAS-301, assessing itacitinib, its Janus Kinase Inhibitor (JAK1) as a potential treatment for acute graft-versus-host disease (GVHD) in combination with corticosteroids. “Today, there are no approved treatment options for acute GVHD, a severe and life-threatening condition that can lead to tissue damage, organ failure, and death in certain transplant recipients,” said Steven Stein, M.D., Incyte’s Chief Medical Officer in a release. “The initiation of the GRAVITAS-301 trial represents an important milestone for Incyte as we continue to progress our clinical development portfolio, and we look forward to further evaluating the potential of itacinitib to address the unmet needs of patients with this potentially devastating condition.” GVHD is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar stem cells or tissue), whereby the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body. GVHD can be acute or chronic, and is a significant cause of morbidity and mortality in transplant recipients. The skin, gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with acute GVHD.   ]]> https://biospectrumindia.com/news/57/9291/heartbeat-labs-plans-to-launch-digital-health-startups.html https://biospectrumindia.com/news/57/9291/heartbeat-labs-plans-to-launch-digital-health-startups.html Fri, 21 Jul 2017 16:20:00 +0530 Heartbeat Labs is a new company builder by HitFox Group, which will launch up to five digital startups a year. It will back three to five startups working on health tech solutions with seed funding between €500,000 and €5 million. It will launch its first company by the end of August. Heartbeat Labs was founded by Jan Beckers, Hendrik Krawinkel, and Eckhardt Weber, who previously founded the fintech company builder FinLeap, which raised €39 million earlier this week. Heartbeat Labs will assist startups on a business and product development level and help them prepare for entering what is a heavily regulated market. The program is supported by a board of medical experts. Eckhardt Weber stated that the European digital health sector is starting to catch up with the US. Heartbeat Labs believes that this is the right time to invest in healthcare. Changing regulations in Europe is opening up the markets and technological capabilities are developing quickly. ]]> https://biospectrumindia.com/news/57/9272/bayer-awards-research-grants-for-hemophilia-.html https://biospectrumindia.com/news/57/9272/bayer-awards-research-grants-for-hemophilia-.html Tue, 18 Jul 2017 14:55:00 +0530 16 winners from 8 countries were awarded research grants of more than $ 2 million under the global Bayer Hemophilia Awards Program (BHAP). The grants will support research into a broad range of projects, including anxiety among female carriers of Hemophilia, Factor VIII splicing-switching molecules for tailored Hemophilia A therapies, and the assessment of therapeutic relationships in Hemophilia care.   Two Indian researchers were among the BHAP award winners, announced at the ISTH (International Society on Thrombosis and Hemostasis) Congress held recently in Berlin, Germany.  B.Sulochana from the Manipal College of Nursing was awarded for her research focusing on anxiety, stress and coping strategies and lived experiences among women carriers of Hemophilia. The second awardee from India, Cilla Joseph from the Hemophilia Treatment Centre, Kochi was awarded for her research which focused on Effectiveness of Hydrotherapy along with Ai Chi techniques for arthritic knee joint in Hemophilia patients. “Since its inception in 2002, the Bayer Hemophilia Awards Program (BHAP) aims to support research that has the potential to have a significant impact on our understanding of hemophilia and bleeding disorders,” said Manoj Saxena, Managing Director – Bayer Zydus Pharma, India. “BHAP continues to be a tangible reflection of Bayer’s ongoing commitment to research and advancing scientific knowledge that improves patient care. We are proud to recognize and award these individuals for their talent, expertise and commitment in their fields.”   The largest program of its kind in Hemophilia, BHAP provides valuable funds to support basic, clinical and outcome research, encourage recently qualified physicians to undertake further training in hemostasis and support projects undertaken by allied healthcare professionals such as nurses and physical therapists. Till date, BHAP has awarded more than 280 grants, totaling more than USD 33 million, to researchers and caregivers from 32 countries around the world.  “Winning the Bayer Hemophilia Caregiver Award 2017 from applicants across the world is a huge motivation for me and my organization. I am honored that the Grants Review and Awards Committee of BHAP considered the project as important and relevant. This project gives an in-depth information and understanding of physical symptoms, psycho-social aspects of life and lived experience among mothers who are carriers of hemophilia and will guide us in designing targeted interventions” said B. Sulochana. Speaking about her win, Cilla Joseph, said, “I am privileged and honored to be selected for the BHAP award from multiple entrants across the world. This award reflects the research interest in my chosen area. The focus of my study would be the effectiveness of aquatic therapy with AI CHI techniques for arthritic knee joint in Hemophilia A patients. If I am successful in proving the effectiveness of this therapy, this will greatly impact the rehabilitation of Hemophilia as most patients suffer from arthritic pain in the early decades of their life.”  This year, awards were presented in five categories: Special Projects: provides support for a wide range of scientific research in the field of hemophilia Early Career Investigator: provides salary support and research funds for junior faculty members to undertake mentored and/or basic research projects Fellowship Project: facilitates the development of specific clinical expertise for applicants who have completed medical training Caregiver: recognizes the essential role of caregivers and allied health professionals Outcomes Research: encourages the development of relevant tools for outcome assessment, or their validation and applications in different health care situations Both the winners from India, B. Sulochana and Cilla Joseph were recognized in the Caregiver category. The BHAP award recipients are selected by a global panel of distinguished hemophilia clinicians, researchers and caregivers. Till date, BHAP support has contributed to more than 400 publications, poster presentations and other scientific communications by awardees. ]]> https://biospectrumindia.com/news/57/9263/university-of-birmingham-launches-global-research-project.html https://biospectrumindia.com/news/57/9263/university-of-birmingham-launches-global-research-project.html Mon, 17 Jul 2017 13:25:00 +0530 The University of Birmingham has secured £2 million from the National Institute for Health Research (NIHR) to launch a research group aimed at improving healthcare for patients with lung diseases around the world. The NIHR Global Health Research Group on Global COPD in Primary Care will be based at the University of Birmingham and will be co-directed by Dr Rachel Jordan and Professor Peymané Adab at the University's Institute of Applied Health Research, who will work with leading primary care experts in China, Brazil, Georgia and FYR Macedonia. Together they will embark on several research projects over the next two years to find better ways of early detection and improving the management of Chronic Obstructive Pulmonary Disease (COPD) in primary care and the community in each of the four global regions, with transferrable lessons to other settings and countries. There is no cure for COPD, but treatment can help ease symptoms, lower the chance of complications and hospitalisations, and generally improve quality of life. Over half of those with the condition do not know they have it, and so earlier diagnosis could improve the outcome for patients. ]]> https://biospectrumindia.com/news/57/9256/pitt-medicine-collaborates-with-french-research-institutes.html https://biospectrumindia.com/news/57/9256/pitt-medicine-collaborates-with-french-research-institutes.html Fri, 14 Jul 2017 12:50:00 +0530 The University of Pittsburgh School of Medicine has entered into an agreement with three world-renowned French research institutions, the University Pierre et Marie Curie of the Sorbonne Universités in Paris, the Institut National de la Santé et de la Recherche Médicale (Inserm); and the Centre National de la Recherche Scientifique (CNRS), to focus on collaborative research and education in the fields of medicine and biomedical sciences. The agreement will enable researchers of all four institutions to cooperate on fundamental research, development of novel therapeutics, and clinical trials, with an initial focus on ophthalmology, vision and neuroscience. Along with joint research, the agreement also emphasizes exchange of academic personnel, joint academic conferences, and exchange of scientific, educational and scholarly materials. Inserm, the French National Institute of Health and Medical Research, is the only public research institution solely focused on human health and medical research in France and a leading medical research agency worldwide; and CNRS, the French National Center for Scientific Research is the largest governmental research organization in France and the largest fundamental science agency in Europe. ]]> https://biospectrumindia.com/news/57/9249/elite-pharma-collaborates-with-sungen.html https://biospectrumindia.com/news/57/9249/elite-pharma-collaborates-with-sungen.html Thu, 13 Jul 2017 11:55:00 +0530 Elite Pharmaceuticals, Inc., a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, has entered into a new Development and License Agreement with SunGen Pharma, LLC. This collaboration is intended to develop and commercialize generic pharmaceutical products based upon a unique drug delivery platform used for extended release products. The parties intend to begin with the development of five generic extended release products and to develop additional such products after that. More than a dozen products utilize this type of technology. This new co-development agreement will build upon the success of the first development agreement signed by Elite and SunGen in 2016. Under the terms of the Agreement, Elite and SunGen will share the responsibilities and costs of the development and marketing of the products. Upon FDA approval, the products will be owned jointly by Elite and SunGen. Elite will manufacture and package all the products on a cost plus basis. The product classes include CNS stimulants, anticonvulsives, antipsychotics and antihypertensives. For the twelve months ending March 31, 2017, the five products and their generic equivalents had total U.S. sales of more than $2.5 billion according to IMS Health Data. ]]> https://biospectrumindia.com/news/57/9242/nestle-health-science-joins-hands-with-enterome.html https://biospectrumindia.com/news/57/9242/nestle-health-science-joins-hands-with-enterome.html Wed, 12 Jul 2017 13:05:00 +0530 Nestlé Health Science and Enterome are jointly creating Microbiome Diagnostics Partners (MDP), which aims to lead the development and commercialization of innovative microbiome-based diagnostics. It holds the potential to transform therapeutic approaches across a broad spectrum of challenging health conditions, including inflammatory bowel diseases (IBD) and liver diseases. The partnership follows Nestlé Health Science’s initial investment announced in April 2016. MDP’s initial focus will be accelerating Enterome’s diagnostic programs, which include IBD 110 for the assessment and management of mucosal healing and MET210 for NASH (non-alcoholic steatohepatitis). Current standard of care for these conditions include invasive procedures such as endoscopy and biopsies, rather than a non-invasive stool/serum combined Dx tests that will be developed by MDP. Future innovation efforts will leverage advanced microbial and serum-based metabolic technologies developed respectively at Enterome and Nestlé Health Science’s diagnostics arm Prometheus Laboratories. Microbiome Diagnostics Partners (MDP) will be a 50:50 joint venture between Enterome and Nestlé Health Science. Prometheus will contribute its Diagnostics (Dx) development and commercialization expertise. Enterome will contribute its current microbiome diagnostic programs and intellectual property (IP) derived from its unique microbiome-based platform for the development of Dx in all therapeutic areas except immuno-oncology. ]]> https://biospectrumindia.com/news/57/9212/j-p-nadda-addresses-brics-health-ministers-meeting-at-china.html https://biospectrumindia.com/news/57/9212/j-p-nadda-addresses-brics-health-ministers-meeting-at-china.html Fri, 07 Jul 2017 11:45:00 +0530 J P Nadda, Union Minister of Health and Family Welfare spoke on the theme ‘Strengthen Health System and Achieve Health-Related SDGs’ at the ‘BRICS Health Ministers’ Meeting at Tianjin, China He stated, “Strengthening of health systems is critical to achieving the Sustainable Development Goals (SDGs). India has prioritized strengthening health systems as a non-negotiable strategy towards achieving SDGs” In his address, he stressed on the importance of building strong and resilient health systems and said that the case for strengthening health systems stems from the basic realization that even the most well-crafted or well-designed health interventions cannot succeed without a strengthened health system that encompasses improvements in healthcare service provision, utilization, quality and efficiency of healthcare services delivered including adoption of healthy behaviours and practices. The Health Minister further stated that the health sector adds direct economic value by expanding the number of jobs, investing in infrastructure projects and purchasing supplies needed for health-care delivery. He also informed the participants that the National Health Policy, 2017 adopted by India is well aligned with the SDG-3 targets. “The new policy enunciates health in all policies, comprehensive primary healthcare, organisation of public healthcare delivery, improving vaccines and drug security and progressive movement towards universal health coverage. The National Health Mission (NHM), one of the largest health programmes in the world, represents the prime vehicle to achieve the SDG-3, and in its next phase is aligning its goals with the National Health Policy 2017 and the SDG-3”, he added Highlighting the achievements of India in the health sector, he stated that India has expanded the number of vaccines under Universal Immunisation Programme (UIP) and launched Mission Indradhanush aimed at expanding coverage by reaching the unreached. India has taken various measures to augment number, quality and skill mix and geographical distribution to address shortage of critical health human resource such as increasing medical seats, upgradation of District Hospitals to Medical colleges in underserved areas, establishing new AIIMS. The Health Minister further informed that free dialysis services are provided free of cost to the poor under the recently launched Pradhan Mantri National Dialysis Programme which is on Public Private Partnership mode. The proposed National Health Protection Scheme (NHPS) envisages inclusion of preventive care, robust IT platform, strong grievance redressal mechanism in addition to expanding both population and benefit coverage and providing an additional coverage to senior citizens. Nadda also stated that to address the growing burden of Non-Communicable Diseases (NCDs) on account of premature mortality and morbidity, India has launched a universal population-based free screening, control and management programme for five common NCDs that is envisaged to translate into one of the largest population based screening and management programmes in the world in next few years. India stands unwavering in its commitment towards synergizing collaboration with BRICS countries especially through the ‘BRICS Framework for Collaboration on Strategic Projects in Health’. ]]> https://biospectrumindia.com/news/57/9205/scientists-consortium-gets-funding-for-developing-antibiotics.html https://biospectrumindia.com/news/57/9205/scientists-consortium-gets-funding-for-developing-antibiotics.html Wed, 05 Jul 2017 17:15:00 +0530 A consortium of scientists from Ingenza Ltd (Edinburgh), the National Physical Laboratory (NPL, London) and the University of Plymouth has received funding of £933k from Innovate UK to develop a design and manufacturing platform for the production of a new family of antibiotics. The funding will be for three years. Ingenza is the UK's premier industrial biotechnology company and will engineer systems for production of the new antibiotics. NPL (the UK's National Measurement Institute) will apply its expertise in the design and measurement of antibiotics that selectively attack microbial cells, and contribute artificial intelligence approaches for antimicrobial discovery developed in collaboration with IBM and the Science and Technology Facilities Council's (STFC) Hartree Centre. Staff at the University of Plymouth are internationally recognised for the discovery and development of novel antibiotics. No such combined capability currently exists in the development of new antibiotics and antimicrobials. The consortium will develop new antibiotics/antimicrobials, which have similar capabilities. The team will work with bacteriocins, potent toxins produced by bacteria to kill other, closely-related strains. Bacteriocins are naturally active in the human body but have not evolved to function as effective drugs in the clinic. The aim is to generate derivatives which show drug-like properties without compromising the bacteriocin's original potent bacteria-killing abilities. The manufacture of the derivatives will then be scaled-up into commercially attractive production systems. ]]> https://biospectrumindia.com/news/57/9182/csi-receives-us-patent-for-health-management-system.html https://biospectrumindia.com/news/57/9182/csi-receives-us-patent-for-health-management-system.html Mon, 03 Jul 2017 12:35:00 +0530 Computerized Screening, Inc. (CSI) has been granted a patent by the US Patent and Trademark Office directed to community based managed health kiosks and prescription drug dispensing systems. It is meant more particularly to facilitating automated drug dispensement by a kiosk system following authorization by a remotely located health care professional monitoring a patient via the CSI Managed Health Kiosk System. Publicly available self-directed health care stations have been available at varying levels of complexity and sophistication for many years, and blood pressure monitoring systems are often available in retail pharmacies, doctors' offices, corporate facilities, and retail centers. As health care costs have increased, the need for convenient, efficient, low cost, and professionally accurate screening has become extremely important, and CSI's patent makes it possible to measure, record, analyze, and communicate data from non-invasive and invasive testing from a variety of input devices so a patient can receive a diagnosis through a telemedicine visit with a physician and thereafter receive a non-narcotic prescription, if needed, directly dispensed at the CSI Managed Health Kiosk. This patent will change the way individuals receive care; particularly in remote locations, while traveling, at worksites, and when seeing a doctor is not possible in a timely manner. Computerized Screening, Inc. is a privately held health care technology, medical device and information company manufacturing medical kiosks in the US since 1978 that dramatically decrease health care costs by providing ease-of-use access to self-administered health and fitness testing with convenient access through telehealth to health monitoring, assessment tools, early symptom detection, and information for disease prevention. ]]> https://biospectrumindia.com/news/57/9169/glooko-raises-35-m-for-diabetes-management.html https://biospectrumindia.com/news/57/9169/glooko-raises-35-m-for-diabetes-management.html Thu, 29 Jun 2017 12:15:00 +0530 Glooko, a startup selling data management healthcare service on top of a device-agnostic platform to make it easier for doctors to remotely monitor patients, has pulled in $35 million Series C funding. It had previously raised $36 million in various rounds, bringing the total up to $71 million. Glooko was founded in 2010 with the mission of making diabetes management easier.  Used by millions worldwide, the company provides relevant insights to the users to help make data-driven treatment decisions. The company will need to continue to rapidly expand to compete with some of the larger players in the space, like Dexcom and Medtronic. Glooko plans to use the funding to help it get there by expanding its sales, marketing and development teams, as well as increasing commercialization efforts in France, Germany, the U.K., Asia and the Middle East. Toronto-based Georgian Partners led the round, along with other new investors Insulet Corporation and Mayo Clinic. They join existing investors Canaan Partners, Social Capital, Medtronic and Samsung Next. With this capital, Glooko will accelerate the investments in clinical solutions that aim to increase medication adherence, provide personalized insights and prompts that drive behavior change for people with diabetes, and deliver clinical decision support to thousands of clinicians and coaches so they can better support people with diabetes in between office visits. ]]> https://biospectrumindia.com/news/57/9161/philips-agrees-to-buy-us-firm-electrical-geodesics.html https://biospectrumindia.com/news/57/9161/philips-agrees-to-buy-us-firm-electrical-geodesics.html Wed, 28 Jun 2017 11:40:00 +0530 Netherlands-based Royal Philips has entered an agreement to purchase US-based Electrical Geodesics (EGI) for €32.9m. Philips is a Dutch technology company headquartered in Amsterdam with primary divisions focused in the areas of electronics, healthcare and lighting. EGI designs, develops and commercialises various non-invasive technologies to monitor and interpret brain activity and, with the acquisition, Philips intends to establish a portfolio of neurological imaging, mapping and therapy guidance. Philips’ current range of neurological imaging technologies and advanced informatics are expected to be complemented by EGI’s EEG hardware, software and acquisition sensors line. This acquisition will enable Philips to provide an integrated neurology solution comprising diagnostic imaging and clinical informatics to assess brain anatomy and physiological processes, and EEG mapping tools from EGI to measure electrical brain activity. Philips will leverage the combined portfolios for neurological disorders such as Parkinson’s disease, stroke, epilepsy and traumatic brain injury. The firm plans to use the integrated tools to create a comprehensive map of the brain and unlock new computational algorithms to aid in shortening the steps required for definitive diagnosis and treatment strategies. ]]> https://biospectrumindia.com/news/57/9152/eli-lilly-expands-biotechnology-center.html https://biospectrumindia.com/news/57/9152/eli-lilly-expands-biotechnology-center.html Fri, 23 Jun 2017 17:00:00 +0530 Eli Lilly and Company has announced completion of a $90 million expansion of its Biotechnology Center in San Diego, California. Lilly's new space will help foster and accelerate the discovery of medicines within the company's core therapeutic areas of immunology, diabetes, oncology and neurodegeneration, as well as the emerging area of pain. The center features a new technologically-advanced laboratory and an additional 180,000 square feet of working space, which is an increase of 145 per cent compared to the former facility. In addition to the center's established presence in preclinical and clinical immunology research, the new space allows for closer partnership between Lilly experts in biotechnology, discovery chemistry and research technologies while also fostering external collaborations. As a pioneer in automated organic synthesis, Lilly is creating the Lilly Life Science Studio in San Diego. Building upon Lilly's Automated Synthesis Laboratory in Indianapolis, the new facility will allow researchers across the globe to remotely design, synthesize and screen investigational molecules in an unprecedented manner. Using the power of automation, the Lilly Life Sciences Studio will shape the next generation of drug discovery and expand the reach of individual scientists to test new ideas, while reducing the cost and minimizing the environmental impact of our research activities. San Diego has long been an important location for Lilly. In 2004 Lilly acquired Applied Molecular Evolution, Inc. before establishing the Lilly San Diego Biotechnology Center in 2009, located near the University of California, San Diego, among other prominent biomedical research institutes. Since its establishment, the center has created more than 100 jobs with more than 200 scientists currently working in various research activities. ]]> https://biospectrumindia.com/news/57/9139/300m-invested-in-biotech-by-alphabet.html https://biospectrumindia.com/news/57/9139/300m-invested-in-biotech-by-alphabet.html Thu, 22 Jun 2017 14:30:00 +0530 Google’s parent company Alphabet has invested $300 million in a new fund that will buy stakes in European biotech companies. Alphabet’s division Verily Life Sciences will be one of the main investors managed by Medicxi, a venture capital group. The fund will focus on biotech companies that need financial resources to pay for clinical trials of experimental drugs. With this new late-stage fund, Medicxi will help fill a clear gap in Europe, where talented life sciences entrepreneurs do not have access to as much local financial support as their US-based counterparts to expand exciting opportunities into more mature companies. Novartis will also be a strategic investor, and together with Verily, it will appoint two members to the fund’s scientific advisory board. Medicxi, which was spun out of tech-focused Index Ventures last year, has become one of the major forces in European biotech, launching funds with the backing of large pharmaceutical groups such as GlaxoSmithKline, Johnson & Johnson, and now Novartis. ]]> https://biospectrumindia.com/news/57/9125/intellia-to-win-china-patent-for-crispr.html https://biospectrumindia.com/news/57/9125/intellia-to-win-china-patent-for-crispr.html Tue, 20 Jun 2017 16:10:00 +0530 Intellia Therapeutics has received notice from China’s State Intellectual Property Office (SIPO) that it will grant the company a broad patent covering CRISPR/Cas9 single-guide gene-editing methods and compositions. The CRISPR patent to be issued by SIPO includes claims covering methods for editing DNA in noncellular and cellular settings, including in eukaryotic cells such as human and mammalian cells. Also included in the patent are CRISPR/Cas9 composition of matter and system claims for use in any setting, including claims covering the use of CRISPR/Cas9 in producing medicines for treating disease. Intellia holds rights to CRISPR intellectual property developed by the Regents of the University of California (UC), the University of Vienna, and Emmanuelle Charpentier, Ph.D., a director at the Max-Planck Institute in Berlin, through a 2014 license agreement with Caribou Biosciences, the exclusive licensee of the UC and University of Vienna. Those rights include human therapeutic, prophylactic, and palliative uses (including companion diagnostics), excluding antifungal and antimicrobial applications. China’s plans to grant a patent for CRISPR come less than a year after the nation has seen two clinical trials involving the technology. In October 2016, You Lu, M.D., and colleagues at Sichuan University’s West China Hospital in Chengdu launched the world’s first CRISPR trial in humans by using the technology to knock out a gene encoding the programmed cell death protein 1 (PD-1) in patients with non-small-cell lung cancer (NSCLC). The second trial was initiated in April 2017 in patients with late-stage nasopharyngeal carcinoma, by researchers led by Jia Wei, M.D., Ph.D., vice director of the Clinical Cancer Institute of Nanjing University. The first U.S. trial is expected to be started later this year by a team led by Carl June, M.D. of the University of Pennsylvania. ]]> https://biospectrumindia.com/news/57/9107/promising-results-for-ebola-vaccine-developed-in-canada.html https://biospectrumindia.com/news/57/9107/promising-results-for-ebola-vaccine-developed-in-canada.html Mon, 19 Jun 2017 11:30:00 +0530 A phase 1 randomized controlled trial has found an Ebola virus disease (EVD) vaccine, developed in Canada, was well-tolerated with no safety concerns, and high antibodies were present in participants 6 months after immunization. The research team conducted the clinical trial as part of a coordinated, international effort to expeditiously evaluate candidate EVD vaccines and make them available to control the epidemic. The trial involved 40 healthy people aged 18 to 65 years and looked at safety of the vaccine and the lowest dose required for an immune response after injection with one of 3 doses. At a ratio of 3:1, thirty participants received the vaccine and 10 received placebo injections. The researchers found that adverse events were mild to moderate, with only 3 severe reactions, including headache, diarrhea and fatigue, which completely resolved. The results of this trial were positive and very promising with all 3 dose levels of the VSV (vesicular stomatitis virus) Ebola vaccine being well-tolerated by participants, and no safety concerns were identified. An upcoming study at 2 sites in Africa, as well as in Montréal and Ottawa in Canada, will test the safety and protection levels of the VSV-Ebola vaccine in HIV-infected adults and adolescents. A completed phase 3 trial showed that the vaccine is effective in preventing EVD in contacts of recently confirmed cases. ]]> https://biospectrumindia.com/news/57/9096/novartis-and-verily-promote-biotech-growth.html https://biospectrumindia.com/news/57/9096/novartis-and-verily-promote-biotech-growth.html Fri, 16 Jun 2017 10:00:00 +0530 Novartis and Verily have helped Medicxi raise $300 million (€268 million) to invest in late-stage drug developers. The fund sees Medicxi move beyond its original focus on early-stage biotechs to give European companies with drugs in phase 2 and beyond an alternative to selling up or partnering. Medicxi, in its current iteration and as part of Index Ventures, made its name with an asset-centric investment strategy designed to hustle drugs to midphase data on a budget. But it has found that the partnering and M&A exit options available to companies at this stage of R&D are premature and generally suboptimal, prompting it to consider how it can provide biotechs with a better way to get drugs through late-phase trials. The result is a $300 million growth fund that will invest $10 million to $30 million in each of its portfolio companies. The scope of the new fund starts where that of Medicxi’s first fund ends. Whereas the first fund helps biotechs get into and through early-phase trials, the new vehicle will back companies that have one or more drugs in phase 2 and beyond.
 Novartis, Alphabet’s Verily (formerly known as Google Life Sciences) and the European Investment Fund (EIF) are the cornerstone investors in the fund. The presence of EIF, the European Union’s investment bank, ensures that Medicxi will spend most of the money in Europe. Medicxi also pulled in cash from most of the institutional investors that backed its first fund. The Anglo-Swiss VC shop raised €210 million from GlaxoSmithKline, Johnson & Johnson and others for that first fund last year. ]]> https://biospectrumindia.com/news/57/9079/new-management-for-type-2-diabetes.html https://biospectrumindia.com/news/57/9079/new-management-for-type-2-diabetes.html Wed, 14 Jun 2017 12:10:00 +0530 Switzerland-based Ascensia Diabetes Care has entered a global technology partnership with French firm Voluntis to optimise insulin management for patients suffering from type 2 diabetes. Voluntis’ Insulia Diabetes Management Companion, a basal insulin management solution for type 2 diabetes, will be integrated with Ascensia’s Contour Next One and Contour Plus One blood glucose monitoring systems (BGMS). Based on diabetes-related data such as blood glucose values, Insulia provides insulin dose recommendations and educational coaching messages via a smartphone app. The Contour systems feature a blood glucose smart metre that is connected to a mobile app called Contour Diabetes. Through Bluetooth, the app collects, stores and analyses patient blood glucose measurements that are delivered by the metres. Basal insulin dosing for the patients will be calculated using the blood glucose readings obtained from the devices. The primary objective of the integration is to enable self-management and insulin management optimisation for patients. The connected solutions are expected to be available for diabetes patients and healthcare professionals in the fourth quarter of this year. ]]> https://biospectrumindia.com/news/57/9069/oncosec-enters-in-a-preclinical-agreement.html https://biospectrumindia.com/news/57/9069/oncosec-enters-in-a-preclinical-agreement.html Tue, 13 Jun 2017 11:40:00 +0530 OncoSec Medical Incorporated, a company developing DNA-based intra-tumoral cancer immunotherapies, has engaged in a preclinical agreement through the OncoSec Technology Access Program (TAP) with Jounce Therapeutics, Inc., Cambridge, MA, a company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment. Established in 2011, OncoSec Medical Incorporated is a San Diego-based biotechnology company pioneering new technologies to stimulate the body’s immune system to target and attack cancer. Under the agreement, Jounce can utilize OncoSec's gene delivery technology to evaluate in vivo efficacy in murine models of intratumorally-delivered therapeutic candidates. The agreement includes the GENESIS research generator and proprietary applicators developed for research use. Through the establishment of these programs, OncoSec benefits from extensive, multi-party characterization and validation of their proprietary, state-of-the art electroporation technologies. OncoSec has developed a unique delivery technology that will enable Jounce to rapidly assess potential candidates in preclinical models. ]]> https://biospectrumindia.com/news/57/9064/nih-funding-for-aids-research.html https://biospectrumindia.com/news/57/9064/nih-funding-for-aids-research.html Mon, 12 Jun 2017 14:40:00 +0530 The National Institutes of Health has awarded researchers at Albert Einstein College of Medicine, The Rockefeller University, The City University of New York Graduate School of Public Health and Health Policy (CUNY), a $7.5 million grant for the Center for AIDS Research focused on preventing HIV transmission and ending the AIDS epidemic. The Einstein-Rockefeller-CUNY Center for AIDS Research (ERC-CFAR) is driving a "bench-to-bedside-to-community and back-to-the-bench" research agenda, with resources devoted to behavioral science, clinical translation of research findings into novel treatments, the discovery of biomarkers, applying advanced technologies for improving clinical outcomes and developing an HIV vaccine. Experts in implementation science will determine and apply the most effective ways to provide patient care, therapies, testing, and pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) medications to prevent HIV acquisition. A major focus of the ERC-CFAR's mission is to translate research into sustainable implementation of population level interventions and strategies that have the potential to improve HIV-related outcomes and reduce health disparities on a large scale. The leadership team of the center includes two additional associate directors- Sarah Schlesinger, M.D., of Rockefeller, who is an expert on designing and implementing immune-based clinical trials to prevent HIV-1 infection and Betsy Herold, M.D., of Einstein, who is a leader in developing safe and effective topical microbicides for preventing HIV, genital herpes and other sexually transmitted infections. ]]> https://biospectrumindia.com/news/57/9053/eli-lilly-collaborates-with-key-bioscience.html https://biospectrumindia.com/news/57/9053/eli-lilly-collaborates-with-key-bioscience.html Fri, 09 Jun 2017 12:35:00 +0530 Eli Lilly will acquire worldwide rights from KeyBioscience to develop and commercialize its pipeline of dual amylin calcitonin receptor agonists (DACRAs) for type 2 diabetes and other metabolic disorders. The companies have agreed to collaborate on developing new treatments based on KeyBioscience’s DACRA platform. That pipeline includes KBP-042, now in Phase II development as well as KBP-089, KBP-056, and other candidates in phases ranging from preclinical to Phase I. The dual activation of calcitonin and amylin receptors can successfully improve insulin sensitivity, suppress food intake, reduce fat deposition, improve blood glucose levels, and cause weight reduction. Lilly agreed to pay KeyBioscience an initial $55 million, plus additional undisclosed payments tied to achieving development, regulatory, and commercialization milestones, as well as tiered royalties on future sales. KeyBioscience is a fully owned subsidiary of Nordic Bioscience, a global drug development organization specializing in clinical research and innovative biomarker research focused on connective tissue diseases. ]]> https://biospectrumindia.com/news/57/9052/sciclone-acquired-for-605m.html https://biospectrumindia.com/news/57/9052/sciclone-acquired-for-605m.html Fri, 09 Jun 2017 11:55:00 +0530 SciClone Pharmaceuticals has agreed to be acquired for approximately $605 million by a consortium of Chinese investors, asserting that the deal would not only benefit shareholders but offered the best option for the company to continue operating in China. The buyer consortium consists of entities affiliated with GL Capital Management, Bank of China Group Investment, CDH Investments, Ascendent Capital Partners, and Boying Investments. Headquartered in Foster City, California, SciClone is a specialty pharma focused on developing and marketing drugs in China. Its product portfolio includes treatments in oncology, infectious diseases, and cardiovascular disorders. The company’s lead product Zadaxin, marketed since 1996, is approved in more than 30 countries for indications that include hepatitis B, hepatitis C, and some types of cancers, as well as an immune system enhancer. The company finished last year with net income of $30.729 million, up 4.3 per cent from 2015, on revenues that rose 1.8 per cent over the previous year, to $160.096 million. ]]> https://biospectrumindia.com/news/57/9051/a-translational-research-collaboration.html https://biospectrumindia.com/news/57/9051/a-translational-research-collaboration.html Fri, 09 Jun 2017 11:35:00 +0530 The Scripps Research Institute (TSRI) and ShangPharma Innovation, Inc. (SPII) announced a strategic collaboration to accelerate the development of innovative drug candidates through a services relationship with Shanghai ChemPartner Co. Ltd. (ChemPartner), sponsored research at TSRI and its drug discovery affiliate, California Institute for Biomedical Research (Calibr). The parties aim to leverage the drug discovery pipeline, expertise, and momentum emerging from the TSRI and Calibr affiliation announced late last year. SPII facilitates and accelerates drug discovery by offering funding, incubator space, and other essential support to its collaborators. The partnership with TSRI marks a major new initiative for SPII to enable its mission to support therapeutic research at the earliest stages with the ultimate goal of getting innovative new treatments to patients. Under the terms of the collaboration, institute scientists will put forth translational research projects to a joint committee comprising drug discovery experts across TSRI, Calibr, and SPII.  In turn, SPII will contribute cash and in-kind services totaling up to $15 million over an initial term of three years. TSRI and Calibr will retain control over assets resulting from the collaboration, with SPII receiving a significant share of future value. ]]> https://biospectrumindia.com/news/57/9040/jackson-lab-associates-with-chinese-groups.html https://biospectrumindia.com/news/57/9040/jackson-lab-associates-with-chinese-groups.html Thu, 08 Jun 2017 12:45:00 +0530 The Jackson Laboratory has signed a collaborative clinical genomics research agreement with three groups in China. Specifically, the Jackson Lab has partnered with the Wenzhou Municipal People's Government, Ouhai District People's Government (WZ), and Wenzhou Medical University and its affiliated hospitals (WMU) to research genomic propensities for disease. Under the terms of the agreement, WZ and WMU will form the Wenzhou Institute for Genomic Medicine (WIGM), which will conduct research under the scientific direction and management of the Jackson Lab. Jackson Lab scientists will also form medical genomics research collaborations with WMU investigators in the US and China. There are already some collaborations underway examining the structure of DNA, the development of cardiomyopathies, and pediatric brain tumors. The Jackson Lab will initially establish a clinical research presence on the WMU campus and in the Life & Health Town of Ouhai District, where approximately 50 to 70 new staff in six research groups will conduct research and clinical genomics. Later, a standalone facility for the WIGM will be built in the Life & Health Town, where an additional 200 faculty and staff will be employed in 15 planned research groups. ]]> https://biospectrumindia.com/news/57/9039/veloxis-signs-agreement-with-italys-chiesi.html https://biospectrumindia.com/news/57/9039/veloxis-signs-agreement-with-italys-chiesi.html Thu, 08 Jun 2017 12:40:00 +0530 Veloxis Pharmaceuticals announced that its U.S. subsidiary, Veloxis Pharmaceuticals, Inc., has entered into an exclusive license, supply and distribution agreement with Chiesi Farmaceutici S.p.A. to register, commercialize and distribute Envarsus XR in the territories of China and Taiwan. Envarsus XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. This agreement greatly expands Chiesi’s investment and interests in Envarsus XR, which already includes the territories of Europe, Turkey and ex-CIS countries licensed through a previous agreement between Veloxis and Chiesi in October, 2012.  Chiesi has launched Envarsus XR in 18 countries to date, resulting in over 5,000 patients on Envarsus XR as immunosuppressive therapy following organ transplantation. Under the terms of this agreement, Veloxis will receive an up-front payment in the amount of USD 6 million and a milestone payment upon approval.  Veloxis will supply Envarsus XR to Chiesi for sale in China at a pre-specified transfer price.  The initial term of the agreement shall be for a period of 15 years from the effective date of the agreement.  Chiesi is an international company based in Parma, Italy, with over 80 years of experience and a strong focus on research, development, production and the commercialization of innovative medicines in the Respiratory, Neonatology, Rare Disease and Special Care Therapeutic Areas.  With a turnover of more than EUR 1.5 billion sales, Chiesi is among the top 50 pharmaceutical companies in the world. ]]> https://biospectrumindia.com/news/57/9029/immuno-oncology-collaboration-between-f-star-and-merck-kgaa.html https://biospectrumindia.com/news/57/9029/immuno-oncology-collaboration-between-f-star-and-merck-kgaa.html Tue, 06 Jun 2017 17:55:00 +0530 Merck KGaA, Darmstadt, Germany, a leading science and technology company which operates its biopharmaceutical business as EMD Serono in the US and Canada, has announced a new strategic collaboration with biopharmaceutical company F-star, Cambridge, UK, for the development and commercialization of five bispecific immuno-oncology antibodies. These bispecific antibodies target specific pathways to augment the anti-tumor immune response. Beyond these five bispecific antibodies, Merck KGaA will have further rights to replace, as well as to add to these antibodies using F-star's bispecific antibody platform. This collaboration will further strengthen Merck KGaA’s immuno-oncology pipeline and underscores the commitment to discovering and developing breakthrough cancer therapies that make a meaningful difference to patients' lives. Under the agreement and upon delivery of pre-defined data packages, Merck KGaA has the option to acquire five of F-star's bispecific programs. Merck KGaA will pay up to €115 million in upfront, R&D funding and milestone payments in the first 2 years, and may make further payments upon exercising its option and based on milestones. Merck KGaA already has a bifunctional antibody in its pipeline, M7824. Currently in Phase I, M7824 is believed to combine two mechanisms in one molecule to fight cancer. The addition of assets from F-star's bispecific antibody platform enrich and complement Merck KGaA's existing in-house technologies investigating molecules that offer the potential advantage of taking a dual approach to tackling cancer. ]]> https://biospectrumindia.com/news/57/9015/novartis-teams-up-with-ibm-watson-health.html https://biospectrumindia.com/news/57/9015/novartis-teams-up-with-ibm-watson-health.html Mon, 05 Jun 2017 17:55:00 +0530 The swiss drugmaker Novartis has agreed to work with IBM Watson Health to explore ways to use patient data and advanced analysis to glean insights on the likely outcomes of breast cancer treatments, Through this collaboration with IBM Watson Health, Novartis will use real-world breast cancer data and cognitive computing to identify solutions that may help physicians better understand which therapy may be best for which patients or advise clinical practice guidelines. Watson is the first commercially available cognitive computing capability representing a new era in computing. The system, delivered through the cloud, analyzes high volumes of data, understands complex questions posed in natural language and proposes evidence-based answers. Watson continuously learns, gaining in value and knowledge over time, from previous interactions. Novartis is hopeful that this collaboration also uncovers care efficiencies that can be applied beyond breast cancer. With one of the broadest portfolios and largest number of advanced breast cancer compounds in development, breast cancer is a priority oncology focus area for Novartis. Scientific understanding of advanced breast cancer is improving and the treatment landscape is expanding, but new therapies and real-world evidence can raise more questions around the optimal treatment plan for individual patients. Novartis has four marketed products in breast cancer: Kisqali, Afinitor, Tykerb and Femara. ]]> https://biospectrumindia.com/news/57/9009/cirina-merges-with-grail-for-cancer-diagnostics.html https://biospectrumindia.com/news/57/9009/cirina-merges-with-grail-for-cancer-diagnostics.html Mon, 05 Jun 2017 16:05:00 +0530 GRAIL, Inc., a life sciences company whose mission is to detect cancer early when it can be cured has entered into a definitive agreement to combine with Cirina Ltd., a privately held company that is also focused on the early detection of cancer. Cirina was co-founded by world renowned scientist in non-invasive molecular diagnostics, Dennis Lo, his colleagues Rossa Chiu and Allen Chan at the Chinese University of Hong Kong (CUHK), and lead investor, Decheng Capital. The company is headquartered in Hong Kong with research and development teams in Hong Kong and South San Francisco. Dr. Lo was the first scientist to discover the presence of circulating fetal DNA in a pregnant mother’s blood. Drs. Lo, Chiu and Chan have also been key contributors to the growing body of scientific evidence that cancer patients may be distinguished from healthy individuals using analyses of the plasma nucleic acid components of the bloodstream. Min Cui, founding partner and managing director of Decheng Capital, will join GRAIL’s Board of Directors as an observer. Maneesh Jain, chief executive officer of Cirina, will join the GRAIL team as well. With this business combination, GRAIL will also expand its ability to make an impact globally by developing and commercializing products in Asian as well as Western markets. As an operating GRAIL subsidiary, Cirina has ongoing research collaborations with CUHK and looks forward to further consolidating this relationship. ]]> https://biospectrumindia.com/news/57/8999/cure-one-partners-with-guardant-health.html https://biospectrumindia.com/news/57/8999/cure-one-partners-with-guardant-health.html Mon, 05 Jun 2017 13:15:00 +0530 Cure-One, a non-profit organization dedicated to advancing precision medicine, announced the participation of Guardant Health, the leader in comprehensive liquid biopsy testing, as a cornerstone laboratory in Cure-One's N1 Registry. The N1 Registry seeks to better understand the genetic basis of malignancy as it relates to physician decisions and patient outcomes. It also intends to collect granular genomic data to allow a more comprehensive understanding of the complexity, intricacy, and application of advanced genomic sequencing analyses as it relates to clinical outcomes. N1 registry plans to align with the direction and efforts of other national and international groups seeking to advance precision medicine. Dane J. Dickson, M.D., Chief Executive Officer and Founder of Cure-One pointed out that Guardant Health is the world leader in liquid biopsies, and its participation with N1 Registry is a testament to its commitment to advance the field of precision medicine, and to increase the availability of non-invasive comprehensive sequencing to advanced cancer patients. Guardant Health has raised more than $500 million from leading venture capital firms. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc. ]]> https://biospectrumindia.com/news/57/8990/new-research-and-development-collaboration-launched.html https://biospectrumindia.com/news/57/8990/new-research-and-development-collaboration-launched.html Fri, 02 Jun 2017 11:50:00 +0530 Mayo Clinic and Baxter International Inc. announced a new research and development collaboration to advance innovation across a spectrum of therapeutic areas where there are high unmet patient needs. The collaboration agreement will bring together the clinical and development expertise at Baxter and Mayo Clinic, where clinicians and researchers will work together to advance new technologies and therapies that transform patient care. The primary emphasis of the collaboration will be in areas where breakthrough treatment options can be introduced and innovation can drive access to high-quality care. The first project will focus on kidney disease, with additional projects planned in other areas. The collaborators are confident that this initiative will help accelerate discoveries, development and application of life-changing therapies for patients. Baxter's global footprint and the critical nature of its products and services play a key role in expanding access to health care in emerging and developed countries. On the other side, Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. The combined power of the two organizations will help advance new solutions to the most pressing health care challenges, further delivering on Baxter's mission to save and sustain lives. ]]> https://biospectrumindia.com/news/57/8989/new-resource-launched-for-cancer.html https://biospectrumindia.com/news/57/8989/new-resource-launched-for-cancer.html Fri, 02 Jun 2017 11:40:00 +0530 The University of Liverpool and Radboud University, Nijmegen have launched a new website for promoting safer prescription and improving quality of care for cancer patients called http://www.cancer-druginteractions.org. The new website will host an easy-to-use, interaction checker, enabling rapid screening for drug-drug interactions (DDIs) with anti-cancer agents. The anti-cancer agents will be organized by generic name, trade name and indication and a comprehensive list of commonly prescribed co-medication will be available on the website. The rationale and quality of evidence behind each recommendation will also be clearly displayed. The team plans to produce a comprehensive resource hosting up to 200 anti-cancer agents used for treating both solid and haematological cancers which will be rolled out over the next three to five years. Cancer patients are at significant risk of DDIs since they can often be prescribed multiple drugs as part of their anti-cancer therapy regimen, in order to manage the side effects of therapy and, increasingly, in order to manage additional comorbidities. They may also use complementary and alternative medicines. This new resource will address this challenge by improving DDI education and empowering Health Care Professionals to manage DDIs more effectively. ]]> https://biospectrumindia.com/news/57/8986/syria-opens-its-first-solar-powered-hospital.html https://biospectrumindia.com/news/57/8986/syria-opens-its-first-solar-powered-hospital.html Thu, 01 Jun 2017 18:05:00 +0530 After months of testing, a hospital in Syria will have uninterrupted power from this week, charged by solar power in a project designer shop will save lives and can be repeated across the country. Syria's electrical grid has taken a big hit after six years of a volatile civil war with most the electrical infrastructure bombed, dismantled or destroyed, leaving hospitals relying on diesel generators but at the mercy of fuel shortages. So the Union of Medical Care and Relief Organizations (UOSSM), an international coalition of international medical organisations and NGOs, said it hoped creating the country's first solar-power hospital would save lives. The France-based UOSSM launched the initiative, "Syria Solar", with the aim of getting hospitals less dependent on diesel which the organisation says is expensive and not reliable. The first solar hospital - the name and location of which the UOSSM would not release for safety reasons - runs on mixture of a diesel generator and 480 solar panels built near the hospital that link to an energy storage system. If there is a complete fuel outage the solar system can fully power the intensive care unit, operating rooms and emergency departments for up to 24 hours without diesel, which is 20 to 30 percent of the hospital's energy cost. ]]> https://biospectrumindia.com/news/57/8981/vetter-and-microdermics-enter-into-a-strategic-cooperation.html https://biospectrumindia.com/news/57/8981/vetter-and-microdermics-enter-into-a-strategic-cooperation.html Thu, 01 Jun 2017 17:00:00 +0530 Vetter , a leading and innovative provider of aseptic prefilled drug delivery systems and Microdermics Inc ., a Vancouver-based medical device company developing a novel hollow, metal microneedle drug and vaccine delivery system, have entered into a strategic cooperation agreement. The market in novel alternatives to needle injections is forecasted to grow rapidly, reaching in excess of 480 million units by 2030 (Roots Analysis report). Microneedles are a novel technology that can offer promising advantages as an alternative to classical needle injections and other routes of administration, mainly in reducing the injectable dose needed to trigger an immune response and accelerating drug absorption by the body. The roadblocks to commercialization are mainly due to limited investment in scalable aseptic manufacture at the later phases of development. To overcome this hurdle the two companies have joined forces to lever the expertise of both firms and enable late stage process development and device manufacture on a commercial scale. Microdermics microneedle technology is commercially scalable and capable of pain-free injections into the pharmacokinetically beneficial intradermal space, providing improved comfort and treatment to patients. Microdermics has successfully demonstrated the initial safety of its microneedle system, and is planning Phase 1 human clinical trials for vaccine and therapeutic delivery, to be initiated in 2017.  As a leading contract development and manufacturing organization (CDMO), Vetter offers its customers a beneficial service through a combination of device development and associated drug product manufacturing and packaging services . Vetter tries to integrate its customers in technological advancements as early as possible. By continuously participating in market development in innovative and proactive ways, the company is committed to acting with the goal of increasing patient convenience and compliance in mind.  Microdermics has developed a novel commercially scalable, low-cost, customizable, metal, hollow, microneedle platform that provides efficient delivery of vaccines and biologics -- addressing the global reliance on the 160-year old hypodermic needle and the economic and health implications associated with widespread needle phobia. The company's Phase 1 clinical trials to validate the effectiveness and reliability of intradermal delivery are expected to initiate in 2017. Microdermics will focus product development and clinical activities on new delivery methods for existing commercial products, providing innovative methods for partners to differentiate via a novel intradermal delivery system, as well as pursue product life cycle extensions.  "We are very happy to enter into this agreement with Microdermics, and we are excited by the initial experience of cooperation and entrepreneurial spirit we have established with key individuals at this company," said Dr. Claus Feussner, Vetter's Senior Vice President Development Service. "We believe that microneedles are a particularly innovative technology and may prove to be a promising future alternative for selected areas of drug delivery."  "Microdermics is extremely excited to work with a world-class partner like Vetter, since our strategic interests align and their decades of experience and innovation in the fill and finish segment will enable us to accelerate our commercialization strategy. Vetter's vast experience with a wide variety of drug substances provides us with an invaluable opportunity for a successful development path for our microneedle drug delivery technology," said Grant Campany, President & CEO of Microdermics. "While our individual companies differ in size, experience and structure, we are fully aligned in our vision to achieve the best possible patient convenience with our product offerings," said Prof. Boris Stoeber, Microdermics' Co-founder and Chief Technology Officer. ]]> https://biospectrumindia.com/news/57/8976/certara-partners-with-pumc-to-support-drug-development.html https://biospectrumindia.com/news/57/8976/certara-partners-with-pumc-to-support-drug-development.html Thu, 01 Jun 2017 11:05:00 +0530 Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, announced that it is partnering with Phase I Unit, Peking Union Medical College (PUMC) Hospital’s Clinical Pharmacology Research Center (PUMCH-CPRC) in Beijing to help Chinese pharmaceutical companies enhance their drug development processes.  Phase I Unit at PUMCH-CPRC will employ Certara’s Simcyp Population-based Simulator to develop physiologically-based pharmacokinetic (PBPK) models in support of Chinese new and generic drug applications to the Chinese Food and Drug Administration (CFDA).  “We are proud to support China’s efforts to foster healthcare innovation. By increasing its adoption of PBPK modeling and simulation, it will expedite its pharmaceutical companies’ drug development processes and regulatory submissions, whilst also helping to bring safer therapies to market,” said Simcyp President and Managing Director Dr. Stephen Toon.  “An increasing number of Chinese pharmaceutical companies want to use PBPK modeling and simulation as part of their drug development plans. We felt that the best way to maintain Certara’s high scientific standards for these Chinese customers and help circumvent some of the language-related commercial impediments was to partner with Phase I Unit at PUMCH-CPRC, which is one of the most prestigious academic pharmaceutical research institutions in China,” added Dr. Toon.  “We are delighted to expand our partnership with Certara and be able to provide Chinese pharmaceutical companies with modeling and simulation consulting support to strengthen their regulatory submissions,” said Professor Pei Hu, MD, professor and director of Phase I Unit at PUMCH-CPRC. Certara and Phase I Unit at PUMCH-CPRC already have a great partnership track record. The two organizations have been working together for several years to increase PBPK modeling and simulation education and training in China and have co-hosted several national workshops. Phase I Unit at PUMCH-CPRC uses Certara’s modeling and simulation technology for first-in-human, point-of-care, and late-phase clinical trials. It has many years’ experience using both Certara’s Simcyp Simulator and Phoenix® software and has published numerous peer-reviewed papers based on research conducted using those platforms. Phase I Unit at PUMCH-CPRC is a Phoenix Center of Excellence.  CFDA also employs Certara’s Phoenix software and is a regulatory affiliate member of the Simcyp Consortium.  PUMC Hospital, which was founded by the Rockefeller Foundation in 1921, conducts clinical research into severe, rare and complicated diseases. It has 4,000 employees and is affiliated with both PUMC and the Chinese Academy of Medical Sciences.  Certara’s Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations, and predicting drug-drug interactions and PK outcomes in clinical populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function.  Phoenix is the most advanced, intuitive, and widely-used software for PK, pharmacodynamic, and toxicokinetic modeling and simulation.  Through this new partnership with PUMC Hospital, Certara is providing Chinese customers with access to its modeling and simulation technology and helping accelerate safer and more effective drug development in China. ]]> https://biospectrumindia.com/news/57/8974/a-new-collaboration-for-malaria-vaccine-development.html https://biospectrumindia.com/news/57/8974/a-new-collaboration-for-malaria-vaccine-development.html Wed, 31 May 2017 17:35:00 +0530 The Radboud University Medical Center (Radboudumc) in the Netherlands, the Instituto de Medicina Molecular Lisboa (iMM Lisboa) in Portugal, and PATH in Seattle, Washington announced that they will collaborate to test a new approach to malaria vaccine development in humans for the first time. In this clinical trial, based on data from earlier animal studies conducted by iMM Lisboa, the researchers will use a rodent version of the malaria-causing parasite (known as Plasmodium berghei) to determine if it can induce protection against infection by Plasmodium falciparum, the deadliest version of the parasite that infects humans. The trial will be conducted in two phases at Radboudumc in the Netherlands. In the first phase, 18 healthy adult volunteers will be recruited into three groups and exposed to varying, but carefully controlled number of bites from mosquitoes infected with the genetically modified P. berghei parasite. The researchers will closely monitor volunteers for signs of infection to make sure they are treated if they become ill. If all goes well in the Phase 1 study, volunteers from the highest dose group will enter the second phase of the study which is designed to assess protective efficacy of the approach. iMM Lisboa, a nonprofit research institute devoted to biomedical research, will collaborate with Radboudumc on the conduct of the clinical trial and will provide the vaccine candidate, Pb(PfCS@UIS4), for use. ]]> https://biospectrumindia.com/news/57/8973/online-program-for-palliative-care-launched.html https://biospectrumindia.com/news/57/8973/online-program-for-palliative-care-launched.html Wed, 31 May 2017 17:20:00 +0530 Researchers at Flinders University in Australia have developed palliAGED, an online program which connects health professionals and family members with evidence-based support for palliative. The program is being managed by Flinders’ CareSearch palliative care knowledge network, which has searched the world’s research literature to find the best evidence to support care. alliAGED comprises two different apps — palliAGEDgp and palliAGEDnurse — as well as a website which will support nurses, care workers, GPs, general practice nurses, allied health professionals and support staff with evidence, tools, guidance and practice resources about palliative care for older Australians, plus information and resources for older people and their families. The program seeks to ensure that evidence-based palliative-care guidance reaches the people who need it most. Although palliAGED was designed for the Australian public, the information is being made available to the rest of the world, with a focus on reaching rural and remote areas. The apps are free to use and can be accessed via www.palliaged.com.au, iTunes and Google Play. ]]> https://biospectrumindia.com/news/57/8934/international-day-of-yoga-2017-to-be-organised-in-lucknow.html https://biospectrumindia.com/news/57/8934/international-day-of-yoga-2017-to-be-organised-in-lucknow.html Mon, 29 May 2017 11:50:00 +0530 The capital of Uttar Pradesh, Lucknow, will host the main mega event of this year’s International Day of Yoga on 21st June and the event will be led by the Prime Minister, Narendra Modi. This was formally announced by the Shripad Yesso Naik , Minister of State (Independent Charge) for AYUSH   Shripad said, Ministers of the Government of India, Chief Minister of Uttar Pradesh and several Yoga Gurus are also expected to take part in the event at Lucknow. The venue for IDY-2017 is Ramabhai Ambedkar Sabha Sthal in Lucknow and nearly 51,000 people are expected to demonstrate common yoga protocol along with the dignitaries in this event. “Besides the main event in Lucknow, Delhi will also hold events in seven places. These events are being planned in association with NDMC, DDA and different Yoga Organisations. The leading Yoga Organisations are planning several other programmes on the occasion of IDY – 2017 in Delhi as well as other parts of the country and also outside the country.”, he added The AYUSH Minister also said that the Central Council for Research in Yoga & Naturopathy (CCRYN) is conducting One Month free Yoga camp in almost all the districts of the country through Govt. and Private Organisations. He said that the training programme has already started from 21st May, 2017. Giving further details,  Naik said that Ministry of AYUSH is planning to have a few Yoga Parks across the country, specially meant for Yoga activities throughout the year, which will be managed voluntarily by the Yoga or other organisations. He said that it is expected that nearly 100 such Yoga parks will come up within this year, which will be further expanded subsequently. In his welcome address C.K Mishra, Secretary, Health and Family Welfare and AYUSH said, “A sustainable Yoga atmosphere should be created throughout the year by organising Yoga activities even after the International Day of Yoga is over. The Yoga institutions/organisations in and around Lucknow will be actively involved in the main event this year”   ]]> https://biospectrumindia.com/news/57/8918/who-to-begin-pilot-prequalification-of-biosimilars-for-cancer-treatment.html https://biospectrumindia.com/news/57/8918/who-to-begin-pilot-prequalification-of-biosimilars-for-cancer-treatment.html Thu, 25 May 2017 17:55:00 +0530 This year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. In September, WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO Essential Medicines List: rituximab (used principally to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia), and trastuzumab (used to treat breast cancer). The decision comes after a two-day meeting in Geneva between WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers and policymakers to discuss ways to increase access to biotherapeutic medicines. WHO also plans to explore options for prequalifying insulin. Biotherapeutic medicines, which are produced from biological sources such as cells rather than synthesised chemicals, are important treatments for some cancers and other non-communicable diseases. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics. They are usually manufactured by other companies once the patent on the original product has expired. Dr Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation said, “Innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support countries to regulate and use these medicines.” Dr Suzanne Hill, WHO’s Director of Essential Medicines and Health Products said, “Biosimilars could be game-changers for access to medicines for certain complex conditions. But they need to be regulated appropriately to ensure therapeutic value and patient safety.” If WHO finds that the biosimilars submitted for prequalification are comparable to originator products in terms of quality, safety and efficacy, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies. Many low- and middle-income countries also rely on WHO prequalification before buying medicines. In addition, WHO will advocate for fairer prices for all biotherapeutics to ensure that these treatments can truly benefit public health. This will include support to countries to develop price-setting strategies that foster sustainable markets to deliver treatments to patients, savings to payers and incentives to producers to keep manufacturing the medicines needed. ]]> https://biospectrumindia.com/news/57/8906/elsevier-adds-clinicalkey-to-its-global-resources.html https://biospectrumindia.com/news/57/8906/elsevier-adds-clinicalkey-to-its-global-resources.html Thu, 25 May 2017 11:30:00 +0530 Elsevier, the information analytics company specializing in science and health, will add ClinicalKey to its global research and health resources available through Research4Life starting in June 2017. The expansion of the Research4Life access program with ClinicalKey benefits healthcare professionals in under-resourced, low- and middle-income communities around the globe. ClinicalKey is Elsevier's premier clinical search engine, providing access to the most current scientific and medical information, and it will help Research4Life meet the 2012 World Health Organization (WHO) declaration that health policies and practices globally should be informed by the best research evidence. As a founding partner of Research4Life, Elsevier contributes more than a quarter of the 77,000 peer-reviewed journals, books and scholarly databases that are available through the program. Access to ClinicalKey adds to an existing collection of research resources offered by Elsevier, including ScienceDirect and Scopus. Elsevier also provides technical, strategic and communications expertise to help advance and promote Research4Life. ]]> https://biospectrumindia.com/news/57/8888/astrazeneca-and-francis-crick-institute-sign-research-agreement.html https://biospectrumindia.com/news/57/8888/astrazeneca-and-francis-crick-institute-sign-research-agreement.html Wed, 24 May 2017 11:15:00 +0530 The Francis Crick Institute has signed a new research agreement with global biopharmaceutical company AstraZeneca. The five-year initiative will see researchers from AstraZeneca and the Crick collaborate on early-stage research that could translate into new treatments and health innovations in the future. The combination of AstraZeneca's expertise in developing new medicines and the Crick's strength in discovery science will maximize the potential to make breakthroughs neither partner could alone. The joint goal is to stimulate and accelerate basic research into the understanding of human health across a range of cancers, cardiovascular and respiratory diseases. The new partnership will also offer Crick researchers access to AstraZeneca compounds and a range of technology platforms. Crick projects that receive funding through the partnership could see scientists from AstraZeneca join the team at the Crick and vice versa. Knowledge exchange between participants will be at the heart of the collaboration, and it will create opportunities for postdoctoral researchers in both industry and academia to learn from each other. Accelerating translation for health and wealth is one of the Crick's strategic priorities and this new agreement with AstraZeneca reflects that goal. ]]> https://biospectrumindia.com/news/57/8871/biofabrication-institute-opening-in-queensland.html https://biospectrumindia.com/news/57/8871/biofabrication-institute-opening-in-queensland.html Mon, 22 May 2017 16:00:00 +0530 An Australian-first research institute that will ultimately manufacture human organs, bones and tissue using advanced technology including 3D printing and robotics will be established in Brisbane this year. Metro North Hospital and Health Service and Queensland University of Technology (QUT) have partnered to create the new Biofabrication Institute on the world-class Herston Health Precinct. Biofabrication offers the opportunity to print or manufacture implantable or graftable human tissue, bone and solid organs on demand, making future healthcare more personalised. The Biofabrication Institute will be located at the junction of the precinct’s clinical and research zones, sitting alongside the Royal Brisbane and Women’s Hospital, Queensland Institute of Medical Research Berghofer and Herston Imaging Research Facility. The location also provides immediate opportunities for scientists and clinicians to be employed in cutting-edge research, which will attract significant private sector and philanthropic investment. Metro North and QUT received funding last year from MTP Connect to investigate setting up the Biofabrication Institute. Negotiations with major industry and philanthropic funding sources to support the fit-out and research are also underway. It’s expected that within five years, the Herston Biofabrication Institute will be attracting several million dollars per year in research grants, and philanthropic and industry support. ]]> https://biospectrumindia.com/news/57/8832/sofie-biosciences-to-acquire-zevacor-pharma.html https://biospectrumindia.com/news/57/8832/sofie-biosciences-to-acquire-zevacor-pharma.html Fri, 12 May 2017 15:40:00 +0530 Sofie Biosciences, Inc. has entered into a definitive agreement under which it will purchase Zevacor Pharma (previously IBA Molecular North America) and its high-performance manufacturing and distribution network of PET imaging diagnostics and radio-therapeutics. Sofie Biosciences, Inc., (SOFIE) is a developer of molecular imaging diagnostics and technologies to empower widespread access to Positron Emission Tomography (PET). Zevacor Pharma, currently owned by Illinois Health and Science (IHS), is a highly valuable asset, full of talented employees who ensure patients have access to advanced imaging and treatment. The combined capabilities will provide customers with an ecosystem of PET products from imaging diagnostics to chemistry technologies for manufacturing of new compounds, to PET imaging systems. Customers and partners will greatly benefit from SOFIE taking commercial leadership in the PET radio-pharmacy industry to not only grow FDG PET/CT service, which is still vastly underutilized, but expand the use of newly FDA-approved PET diagnostics, support Phase I/II/III clinical trials, and enable the preclinical sciences with expanding access to PET, in concert with the pipeline of imaging diagnostics. ]]> https://biospectrumindia.com/news/57/8815/sensely-collaborates-with-mayo-clinic.html https://biospectrumindia.com/news/57/8815/sensely-collaborates-with-mayo-clinic.html Wed, 10 May 2017 18:10:00 +0530 Sensely, the breakthrough virtual medical assistant application for patient engagement and chronic disease monitoring, announced an agreement with Mayo Clinic to leverage technology in support of optimal health outcomes for individuals. Supporting more than 20 conditions and protocols, Sensely offers therapeutic help with expertise and empathy. Sensely's healthcare solutions have achieved remarkable results regarding patient compliance, reduction of readmissions, and lowering of costs. Mayo Clinic's health guidance expertise will help Sensely enhance its innovative avatar to assess patients and triage them to the most appropriate care resources such as self- care, clinical advice, scheduling an appointment, nurse line and ER direction. This new digital solution can help reduce the burden on the healthcare's most expensive services, such as emergency rooms and clinical office visits. With research showing that 65 percent of ER visits are avoidable, it's crucial for digital healthcare to continue to evolve at a rapid pace. ]]> https://biospectrumindia.com/news/57/8791/diplomat-acquires-wrb-communications.html https://biospectrumindia.com/news/57/8791/diplomat-acquires-wrb-communications.html Tue, 09 May 2017 11:30:00 +0530 Diplomat Pharmacy, Inc. has completed its acquisition of WRB Communications, Inc., a health care service center company based in Virginia. WRB specializes in relationship management programs for leading pharmaceutical manufacturers and health care service organizations. WRB will join Envoy Health Management, LLC, as part of Diplomat's commercialization support services for manufacturers, biotech firms, and other service companies. Together, WRB and EnvoyHealth will offer extensive solutions to meet growing demand for patient access; medical information; customer care; reimbursement; inside sales and tele-detailing; and unique distribution. WRB is a leading provider of multichannel service center solutions for pharmaceutical manufacturers, biotech, medical device organizations, and other health care industries. WRB's management team has more than 100 years of combined experience in health information offerings and customer service programs. Under the terms of the agreement, Diplomat is paying WRB $24.5 million cash and $4.5 million of Diplomat common stock. Under the terms of a two-year contingent earnout, WRB can earn an additional payout of up to $1 million based upon achievement of EBITDA-based targets in the 12-month periods ending May 31, 2018, and May 31, 2019. In 2016, WRB generated $15 million in revenue and $2.2 million in adjusted EBITDA. ]]> https://biospectrumindia.com/news/57/8717/brains-can-be-transplanted-in-the-near-future.html https://biospectrumindia.com/news/57/8717/brains-can-be-transplanted-in-the-near-future.html Fri, 28 Apr 2017 16:18:56 +0530 Professor Sergio Canavero, Director of the Turin Advanced Neuromodulation Group, is aiming to carry out the first human head transplant within 10 months and then wants to begin trials on brain transplants. If the procedures are successful, he believes that frozen brains could be thawed and inserted into a donor body. Hundreds of people who are dying or paralysed have had their bodies or brains cryogenically preserved in the hope that medical science will be able to bring them back to life and cure their conditions. Although many experts are sceptical that huge organs like the brain can be thawed without damage, Prof Canavero said he believes the first frozen head could soon be resurrected. Prof Canavero is working with a Chinese team of doctors led by Dr Xiaoping Ren, of Harbin Medical Centre who helped perform the first successful hand transplantation in the US. The technology to carry out the world's first head transplant is expected to be in place by the end of the year, and then the team will then need to find a suitable donor body. Although Russian computer scientist Valery Spiridonov, who suffers spinal muscular atrophy, had volunteered to become the first head transplant patient, the team have since said the first trial is likely to be carried out on someone who is Chinese, because the chance of a Chinese donor body will be higher. Prof Canavero said a 'high number' of people had volunteered for the transplant. ]]> https://biospectrumindia.com/news/57/8681/asembia-partners-with-goodrx-to-expand-services-for-specialty-patients.html https://biospectrumindia.com/news/57/8681/asembia-partners-with-goodrx-to-expand-services-for-specialty-patients.html Thu, 27 Apr 2017 15:26:10 +0530 Asembia, the nation's leading provider of solutions to the specialty pharmacy industry, partners with GoodRx, America's top source for prescription prices and savings, to support the unique needs of specialty pharmacy patients. With a database of prices for virtually every brand and generic prescription drug, the GoodRx website and free IOS and Android mobile apps allow consumers to compare drug prices and find discounts, free coupons and savings tips. Patients requiring complex specialty medications often require additional information and support. Utilizing the vast dispensing capabilities of Asembia's national network of pharmacies, ASPN OneSource offers one-stop, white-glove specialty prescription services to help patients' fill prescriptions for the best price, with on-time, door-to-door delivery. Consumers searching cost information for specialty medications using GoodRx will be connected to Asembia's ASPN OneSource for additional support. The professional and compassionate patient care coordinators at ASPN OneSource offer key services to specialty patients. As Asembia continues to expand the company's high-touch patient service model, this new partnership reinforces the company's ongoing commitment to collaborating with multiple industry partners to enable the highest quality care. ]]> https://biospectrumindia.com/news/57/8676/national-jewish-health-to-establish-respiratory-institute-in-philadelphia.html https://biospectrumindia.com/news/57/8676/national-jewish-health-to-establish-respiratory-institute-in-philadelphia.html Thu, 27 Apr 2017 14:44:18 +0530 Jefferson Health is teaming up with National Jewish Health, a 118-year-old specialty hospital in Denver that focuses on respiratory care, to create the Jane and Leonard Korman Respiratory Institute in Philadelphia. The collaboration leverages the strengths of each organization and will define best practices for treatment and research of pulmonary and related diseases. These include COPD, asthma, interstitial lung disease, sarcoidosis, infectious respiratory diseases and lung cancer in coordination with specialists at the Sidney Kimmel Cancer Center. The Respiratory Institute is expected to open this summer, with additional locations anticipated across Jefferson Health’s regional campuses. The Respiratory Institute will provide a unique and deep patient care experience tailored for Jefferson Health. The Respiratory Institute also will focus on a research network, bringing together investigators to advance care for complex respiratory diseases. In addition, the Jane and Leonard Korman Respiratory Institute will be integrated with the Respiratory Institute that National Jewish Health and Mount Sinai in New York established in 2014. Together, these three entities will collaborate on research, clinical trials and other programs that will serve patients throughout the Northeast in an unparalleled respiratory network. ]]>