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EMA re-confirms drug suspensions due to faulty trial data from GVK Biosciences

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. 

Draft guidance stresses need for quality in development of gene therapies

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.


Pfizer research veteran moves to UK biotech

And more ups and downs for people on the move in pharma. 

Home-brew morphine: Is opiate production about to get way too easy?

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.

Industry calls for global alignment of qualification and validation guidelines

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.

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