Latest News in the pharma Industry

Policy & Regulation

EU Moves Closer to Approving First Gene Therapy

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

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

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

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

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

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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Pharma Firms Seek EU Concessions to Protect Drug Supply to Troubled Nations

Pharma Firms Seek EU Concessions to Protect Drug Supply to Troubled Nations

29 Jun 2012

The head of the EFPIA has urged EU leaders to grant concessions to prevent problems with the supply and demand of medicines in the region.

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EMA Finalises Guidance on Medicines Containing Monoclonal Antibodies

EMA Finalises Guidance on Medicines Containing Monoclonal Antibodies

19 Jun 2012

The EMA has finalised two documents providing pharmaceutical companies with guidance on how to develop medicines containing monoclonal antibodies.

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China Revises Patent Law in Fight for Cheaper Drugs

China Revises Patent Law in Fight for Cheaper Drugs

14 Jun 2012

The amended law allows the country to issue compulsory licences to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

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Mylan Settles Provigil Litigation with Teva

Mylan Settles Provigil Litigation with Teva

11 Jun 2012

Mylan is permitted to launch its Modafinil Tablets, 100 mg and 200 mg, on August 10, 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva.

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US Legislation Will Ensure Tighter Checks on Foreign Drug Factories

US Legislation Will Ensure Tighter Checks on Foreign Drug Factories

28 May 2012

US lawmakers are taking steps to increase the safety of drugs manufactured on foreign soil.

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FDA Approves Generic Versions of Blood Thinner Plavix

FDA Approves Generic Versions of Blood Thinner Plavix

22 May 2012

Clopidogrel is FDA-approved to treat patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery.

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