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

Don't Cry Too Hard for Avandia

This article was originally published in RPM Report

Executive Summary

GSK suffered a major commercial loss after news of Avandia's cardiovascular safety exploded onto the market in 2007. But there is a sliver of a silver lining for GSK: FDA's post-Avandia safety rules may make it tougher for new competing products to reach the market.

You may also be interested in...



FDA’s First “Program” Reviews: Fast Approvals, But Still Some Surprises

The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.

Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor

It's a buyer's market for type 2 diabetes drugs, and you can thank FDA for that. At least, that is the sentiment of business development executives from Big Pharma. Transaction data in 2008 back up that view.

Avandia's Black Box: FDA's Office of New Drugs Wins

The decision by FDA to add another "black box" warning to GalxoSmithKline's diabetes drug shows where the drug safety group stands on the agency's totem pole.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS080491

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