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Friday, 26 April 2019

CRO News

  • Supreme Court satisfied with new clinical trials approval process

    CRO |  News | By Rahul Koul Koul | 0 Comment | 22 Oct, 2013

    The supreme court has expressed satisfaction with the process of approvals that were set in place for the trials approved since January 2013 and has asked that all trials approved before De...Read more

  • Rules set for 'Ethnicity' as criteria to new drug approvals

    CRO |  News | By Rahul Koul Koul | 0 Comment | 09 Jul, 2014

    Ethnicity surely has more to it than being a part of a culture and nation. It might save your life in case the drugs that undergo trials are tested on your ethinic traits and their reaction...Read more

  • PPD earns awards for digital communications

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 22 Sep, 2015

    Pharmaceutical Product Development (PPD) has announced the company earned recognition for excellence in multimedia and digital communications that promote the people and technology vital to...Read more

  • GVK Bio acquires Vanta Bioscience

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 07 Nov, 2014

    Hyderabad-based GVK BIO said that it has signed a definitive agreement to acquire Chennai-based Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment contract re...Read more

  • GVK's drug studies suspended by 4 EU countries

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 09 Dec, 2014

    The EMA is currently reviewing findings of non-compliance with good clinical practice at this site and determining their impact on medicines authorized on the basis of studies performed at ...Read more

  • Drug approval process to go online

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 04 Aug, 2014

    The Drug Controller General of India (DCGI) is planning to shift the process of approving clinical trial applications online. Every trial would be given a unique identity number and pharmac...Read more

  • Cognizant to develop a clinical trial collaboration platform

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 01 Aug, 2014

    Cognizant has announced that it had been selected by TransCelerate BioPharma, a non-profit organization, with membership representation from 19 major pharmaceutical companies, to develop a ...Read more

  • Supreme court defers hearing on clinical trials

    CRO |  News | By Rahul Koul Koul | 0 Comment | 25 Aug, 2014

    Ongoing hearing of public interest litigation (PIL) filed by an NGO, Swasthya Adhikar Manch, that was supposed to come up for hearing today on August 25, 2014, has now been postponed for fu...Read more

  • Syngene Q3 profit up 31%; revenue up 23%

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 22 Jan, 2016

    Biocon's contract research arm Syngene recorded Rs 281 crore revenue for the third quarter ended December 31, 2015 with a year on year growth of 23 percent. For the same period, company rec...Read more

  • GVK Bio launches Clinogent

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 18 Jul, 2014

    In a bid to race ahead to be among the top three Asian clinical research organizations in the next five years, India's Hyderabad-based contract research company GVK Biosciences (GVK BIO) ha...Read more

  • GVK extends biomarker database license with FDA

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 04 Feb, 2013

    GVK Biosciences (GVK BIO) is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (USFDA). The GOBIOM datab...Read more

  • GVK Bio refutes data manipulation in drug studies

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 11 Dec, 2014

    Recently, European Medicines Agency (EMA) in a statement said that four EU Member States have decided to suspend marketing authorizations of medicines authorized on the basis of studies con...Read more

  • Silver Leaf Oak acquires 10% stake in Syngene

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 18 Sep, 2014

    Silver Leaf Oak (Mauritius) Limited, an investment vehicle advised by India Value Fund Advisors (IVFA) has agreed to acquire a minority 10% stake in Syngene International, Biocon's Research...Read more

  • PPD creates a Pediatric Investigator Network

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 06 Jul, 2015

    Pharmaceutical Product Development (PPD) has formalized relationships with eight investigator sites as part of a Pediatric Investigator Network (PIN). The company has been established to fu...Read more

  • Research support 'BYOD' approach in Clinical Trials

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 20 Jun, 2016

    ICON has announced research showing many pharmaceutical and clinical research organisations (CROs) support the use of a 'Bring Your Own Device' (BYOD) approach in clinical studies, enabling...Read more

  • Advaxis, Medimmune collaborate over immune-oncology trial

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 25 Jul, 2014

    MedImmune enters into a partnership with Advaxis for a immuno-oncology combination clinical trial. The immunotherapy study will evaluate the safety and efficacy of MedImmune's investigation...Read more

  • Syngene files DRHP, seeks approval for IPO

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 29 Apr, 2015

    This is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. Biocon along with its subsidiary Biocon Research Limited (BRL) currently holds an 84.5 percent equity sta...Read more

  • Dr Reddy's on Union Finance Budget 2016

    CRO |  News | By BioSpectrum Bureau  | 0 Comment | 30 Nov, -0001

    "On the healthcare front," says Mr Satish Reddy, Chairman, Dr Reddy's Laboratories, "the budgetary emphasis on the sector was fairly muted. While certain initiatives such as the new health ...Read more