France Suspends Bayer Diane 35: Post-Mediator Strictness Or Prelude To Broad Withdrawal?
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Fluad's Italian Problem Could Reduce Confidence In Vaccines Across Europe
The EMA has given Novartis’ flu vaccine Fluad the all-clear after serious safety concerns were raised in Italy, but the publicity around the drug could pressure an already burdened vaccines industry.
EMA Warning For Ariad’s Iclusig, While CHCs Get The Benefit Of The Doubt
EMA doesn’t suspend, but warns on Ariad’s leukemia drug Iclusig for potential blood clots, while saying combined hormonal contraceptives’ benefit outweighs their risk.
European Notebook: Sanofi, AstraZeneca Seek New Uses For Old R&D Sites
VCs address the need for new capital at the U.K’s BioTrinity partnering and investor meeting; France and Germany move to work together on translational drug research; and France’s suspension of Bayer’s Diane 35 shows its tougher regulatory line.