Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Improved EU Pharmacovigilance May Not Prevent Another Mediator

This article was originally published in The Pink Sheet Daily

Executive Summary

The affair surrounding Servier's withdrawn Mediator drug highlights serious loopholes in the new EU pharmacovigilance system.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.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS071737

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel