Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Biotech Stocks and Advisory Committees: No News Is Good News?

This article was originally published in RPM Report

Executive Summary

FDA has approved six new molecules already in 2012--and five were approved without going to an advisory committee. Meanwhile, FDA has held four advisory committees to review new drug applications, and all four ended in overwhelming "no" votes.

You may also be interested in...



Chelsea’s Northera: The Perils of Drawing Conclusions in Real Time

Despite a “yes” vote from an advisory committee, FDA sent Chelsea’s Northera back to the development phase with a complete response letter asking for data from another trial. There may have been nothing Chelsea could have done to get a better result—but the company could have held off on a post-panel victory lap.

Shire’s Replagal Withdrawn: A “Non-Traditional” Review Ends Badly

Shire’s decision to take its Fabry Disease therapy and go home sets up two possible narratives. One accentuates FDA’s apparent inflexibility and is sure to reinforce calls for legislative changes to the approval standard. The other highlights a recalcitrant or even petulant-sounding sponsor. Neither is likely to sound good to Fabry’s patients.

What’s Going On With Eliquis and Xarelto at FDA?

A key date was removed from FDA’s tentative advisory committee calendar. But a panel is still expected to review BMS’s anti-clotting agent Eliquis and a new indication for J&J’s Xarelto in ACS.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS080972

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