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

Hepatic Safety Of Biogen Idec’s Zinbryta Under Close Scrutiny In EU

Executive Summary

The EU review of Biogen Idec’s MS drug Zinbryta is continuing as a special group at the European Medicines Agency prepares to discuss a list of questions regarding the product’s hepatic safety profile. The EMA has until the end of November to give its views on the product’s future.

You may also be interested in...



The Zinbryta Withdrawal And The Limits Of US FDA’s Proactive Communication

FDA is getting justifiably high marks for its efforts to accelerate drug development, and the proactive communication approach of Commissioner Gottlieb is a big part of that dynamic. But a drug safety withdrawal could be a sign of trouble ahead, if the perception takes hold that Europe is more proactive when it comes to patient safety.

Zinbryta Global Withdrawal Driven In Part By Difficulty Of Safety Assessment

EMA safety investigation pushes decision as AbbVie, Biogen acknowledge 'characterizing the evolving benefit/risk profile … will not be possible going forward given the limited number of patients being treated.'

Biogen, AbbVie Withdraw Struggling MS Drug Zinbryta Due To Safety Issues

Antibody was approved in the US with a liver safety warning while EU regulators recently limited the drug's use. Now, EMA has begun an urgent review of reports of inflammatory brain disorders related to Zinbryta.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121519

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