22-May-2015 - Top science academics have launched an initiative to consider emerging human gene-editing tools such as CRISPR-Cas9.
News in brief
- US FDA investigates AZ, J&J and B-I's type 2 diabetes drugs after adverse events
- US CDC backs Tamiflu after this season’s flu vaccines found to be less effective
- 30 months for smuggler of Roche cancer drugs which lacked API
- Human hair in heparin vial prompts Hospira recall
- Impax hit with another US FDA Form 483
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.
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.
20-May-2015 - The EMA has released guidelines on developing combination drugs with more than one active pharmaceutical ingredient (API).
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
19-May-2015 - And more appointments in big and small pharma in our weekly round-up.
News in brief
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.
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)