Improved EU Pharmacovigilance May Not Prevent Another Mediator
This article was originally published in The Pink Sheet Daily
The affair surrounding Servier's withdrawn Mediator drug highlights serious loopholes in the new EU pharmacovigilance system.
You may also be interested in...
France Suspends Bayer Diane 35: Post-Mediator Strictness Or Prelude To Broad Withdrawal?
France has announced the suspension of Bayer’s acne drug, which is widely used as a contraceptive, after confirming its role in the death of four patients; a subsequent referral to the EMA could herald a Europe-wide suspension.
European Pharmacovigilance Update Still Causing Concern
The European pharma industry understands the need to tighten EU pharmacovigilance rules, but increased powers for a new advisory and assessment body could signal trouble ahead.
Biosimilars: Nearly The End Already, Or Is The Best Yet To Come?
Sales of Europe's first round of biosimilars have been poor, prompting some to suggest they're dead before they really got started. Others claim biosimilars' true value will come with the next wave: biosimilar antibodies.