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To realize the vision of
making India an innovation hotspot, Mr Kapil Sibal, Minister for
Science & Technology, Government of India, has announced plans to
encourage multidisciplinary collaboration among business, government,
academia and R&D to create an environment that supports
technological development; recognizes contribution of young
researchers; and introduces more programs to support young researchers.
The agenda for innovation also includes the long-term academia-industry
collaborative relationships with open access to entanglement-free
intellectual property (IP) resources; and better integration of
corporate companies with higher educational and research institutions.
According to the minister, the National Innovation Council (NIC) which
will prepare a road map for the Decade of Innovation will include
approaches and methodologies to create an inclusive and sustainable
innovative ecosystem in India.
DBT to use RNAi for health, agri
needs
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In order to address
issues related to healthcare, agriculture and environment, the
Department of Biotechnology (DBT), under the Ministry of Science and
Technology, Government of India, plans to utilize RNAi technology
approaches for developing tools for research, early translation or
product development.
In this regard, the DBT will initiate projects focusing on miRNA
biomarkers for known diseases. That would include developing
genome-wide shRNA libraries, target-specific delivery, translational
research using RNAi-based approaches, and developing transgenics with
economic traits using RNAi approaches.
The DBT has invited the concept notes from researchers across academia
and industry. These concepts will be in the areas related to
identification of genome wide RNAi factors in various organisms to
manipulate the RNAi potential. In an approach towards finding cure for
the diseases, the target areas include the identification of total
cellular factors responsible for disease susceptibility, unraveling the
underlying molecular process for various diseases, metabolic/
physiological processes in animal or plant model using RNAi approach,
and profiling and prediction of miRNAs responsible for organism
development.
FDA to improve review mechanism
The US Food and Drug Administration (FDA) has announced its plan to
improve the most common path to market medical devices. The action plan
is intended to get implemented by the end of 2011. Before marketing
most low-risk medical products such as certain catheters or diagnostic
imaging devices, manufacturers must provide the FDA with a premarket
notification submission.
These submissions are known as 510(k)s for the section of the Federal
Food, Drug, and Cosmetic Act that describes this notification
requirement. Generally, 510(k)s must demonstrate that a proposed
product is substantially equivalent to another legally marketed medical
device. In September 2009, Center for Devices and Radiological Health
(CDRH) set-up two internal working groups to address concerns relating
to the premarket notification process, industry argued that the 510(k)
process was unpredictable, inconsistent and opaque, while consumers and
health care professionals argued that the review process was not robust
enough.
Cambrex Zenara gets GMP approval
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US-based life sciences
company, Cambrex Corporation has announced that the Danish Medicines
Agency (DKMA) has issued a Certificate of Good Manufacturing Practice
(GMP) compliance for its manufacturing site in Hyderabad, following an
audit conducted in October 2010. The DKMA Certificate is accepted by
all EU health authorities and by authorities of several other countries
that accept EU certification.
The DKMA certification allows Cambrex to expedite the European launch
of Nicotine Replacement Therapy (NRT) products, in addition to offering
finished dosage forms of other pharmaceutical products to our European
customers through an integrated value chain.