Latest News in the pharma Industry

Policy & Regulation

EMA Approves Isis Manufacturing Facility

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.

Read more 
EMA Sees Benefits of Interaction with Japanese Regulators

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.

Read more 
Pharmaceutical Approvals Set to Fall This Year

Pharmaceutical Approvals Set to Fall This Year

31 Jul 2012

Fitch Ratings predicts a fall in the number of new drug approvals in 2012.

Read more 
EMA Publishes Policy on Changing Scope of PIPs

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.

Read more 
FDA Clears Roche's Vitamin D Laboratory Test

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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more