Latest News in the pharma Industry
Policy & Regulation
GSK Announces Submissions in the EU and US for Dabrafenib and Trametinib
6 Aug 2012
GSK has announced regulatory submissions in the EU and US related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib.
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EMA Approves Isis Manufacturing Facility
6 Aug 2012
The EMA's approval of the Isis manufacturing facility in California allows Isis to supply Genzyme with KYNAMRO? drug substance to support commercial launch in Europe.
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EMA Sees Benefits of Interaction with Japanese Regulators
1 Aug 2012
The Agency has increased its level of interaction and cooperation with medicines regulatory authorities in Japan over the past three years.
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Pharmaceutical Approvals Set to Fall This Year
31 Jul 2012
Fitch Ratings predicts a fall in the number of new drug approvals in 2012.
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EMA Publishes Policy on Changing Scope of PIPs
30 Jul 2012
The new policy allows the scope of a previously agreed PIP to be extended or merged if the company wishes to apply for marketing authorisation for more than one condition at the same time.
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FDA Clears Roche's Vitamin D Laboratory Test
26 Jul 2012
Roche has received clearance from the FDA for a fully automated vitamin D test for use on cobas? modular platforms.
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EU Moves Closer to Approving First Gene Therapy
25 Jul 2012
The CHMP has issued a positive opinion on Glybera, which could soon become the first approved gene therapy in Europe.
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EU Commission Proposes Simpler Rules for Clinical Trials
23 Jul 2012
The EU Commission has issued a proposed regulation to make it easier for pharmaceutical companies to carry out cross-border clinical trials.
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EMA Recommends Approval of Glybera
23 Jul 2012
The Agency has recommended approval of Glybera, the world’s first gene therapy drug.
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China's Healthcare Reforms Offer Opportunities for Global Pharma
10 Jul 2012
China's massive investment in healthcare presents significant opportunities for pharmaceutical companies around the world.
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Lupin Receives FDA Approval for Generic LYRICA
6 Jul 2012
Lupin's Pregabalin Capsules are the AB-rated generic equivalent of LYRICA capsules which had annual U.S sales of approximately $1.8 billion for the twelve months ending March 2012.
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GSK to Pay $3Bn to Settle US Drug Fraud Charges
4 Jul 2012
GSK will pay $3 billion in fines after reaching an agreement with the US government, several states and the district of Columbia.
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