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.
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.
And more ups and downs for people on the move in pharma.
Access to yeast strains modified to produce opiates must be controlled say researchers who warn that stopping criminals using such API manufacturing routes to make narcotics is vital.
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.