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Regulatory & Safety: Top Headlines

News in brief

US Senator dubs Sovaldi price ‘abuse of power’ and calls to defy patent

21-May-2015 - US Senator Bernie Sanders has called on the Secretary of Veteran Affairs to invoke a law which would break Gilead’s patent on Hepatitis C drug Sovaldi and allow cheaper generics.

Industry calls for global alignment of qualification and validation guidelines

21-May-2015 - EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.

EMA: show clinical justification for combination drugs

20-May-2015 - The EMA has released guidelines on developing combination drugs with more than one active pharmaceutical ingredient (API).

Two sterile compounders hit by FDA warning letters for violating cGMP

20-May-2015 - The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.

PEOPLE ON THE MOVE

Top lawyer moves to Amgen

19-May-2015 - And more appointments in big and small pharma in our weekly round-up. 

News in brief

US FDA investigates AZ, J&J and B-I's type 2 diabetes drugs after adverse events

18-May-2015 - Diabetes drugs made by J&J, AstraZeneca and Boehringer-Ingelheim are being investigated by the US FDA after 20 cases of acidosis resulting in hospitalisation were recorded.

EMA drug reviews must be independent of pharma influence as an example to others, says AMF

18-May-2015 - EMA assessment of new drugs must be independent of pharmaceutical industry influence as an example to others, according to the Access to Medicines Foundation (AMF)

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