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

Valeant’s Brodalumab Delayed By FDA As REMS Is Negotiated

Executive Summary

FDA notified the company the US review goal date for the psoriasis pill has been extended three months from Nov. 16 to Feb. 16.

You may also be interested in...



Where’s The Suffix? Valeant’s Siliq Approved Without Four-Letter Identifier

Psoriasis treatment brodalumab is first novel biologic approved since US FDA released its final guidance on nonproprietary naming for new biologics and biosimilars; agency says it didn't want to delay the approval by taking more time to develop a suffix.

Siliq US Approval Expected To Make Little Dent In Valeant Debt Mountain

A Black Box warning on suicidal ideation and behavior, a REM program and a Medication Guide may hold back the sales growth of Valeant’s new psoriasis therapy in the US, Siliq, following its Feb. 15 approval, although the drug has been associated with high levels of total skin clearance, a finding that could differentiate it from competing products.

Keeping Track: Mylan Submits Biosimilar Herceptin; FDA Clears Opdivo For Head And Neck Cancer

The latest drug development news and highlights from our FDA Performance Tracker.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119478

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