25-May-2015 - The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.
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
PEOPLE ON THE MOVE
25-May-2015 - And more ups and downs for people on the move in pharma.
25-May-2015 - Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK Biosciences in Hyderabad, India.
22-May-2015 - Top science academics have launched an initiative to consider emerging human gene-editing tools such as CRISPR-Cas9.
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.