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

Tysabri Return To Market With Expanded Indication Backed By Committee

Executive Summary

Biogen Idec's Tysabri could return to market as early as April with an expanded indication following review by FDA's Peripheral & Central Nervous System Drugs Advisory Committee on March 7-8

You may also be interested in...



FDA Approving More Novel Drugs Without Advisory Committee Review

The Center for Drug Evaluation and Research is becoming more comfortable approving new molecular entities and novel biologics without first seeking the views of its outside experts. In 2011, 13 of the 30 novel therapeutics cleared did not undergo advisory committee scrutiny beforehand.

Tysabri Out Of Remission; Returns With Updated Indication, Risk Management

The indication for Biogen Idec/Elan's re-approved multiple sclerosis therapy Tysabri (natalizumab) stops short of limiting it to use as a second-line therapy

Tysabri Out Of Remission; Returns With Updated Indication, Risk Management

The indication for Biogen Idec/Elan's re-approved multiple sclerosis therapy Tysabri (natalizumab) stops short of limiting it to use as a second-line therapy

Related Content

Latest News
UsernamePublicRestriction

Register

PS046969

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