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

Weighing the Risks: Vivus View of Regulatory Risks in Qnexa Reprise

This article was originally published in RPM Report

Executive Summary

A good-news press release from Vivus on the resubmission and acceptance of its application to FDA for the weight-loss drug Qnexa contains an unusually long and descriptive list of the risks involved in the application. This more than boiler-plate “forward-looking” statement adds new interest to the sport of footnote-analysis.

You may also be interested in...



Setting the Stage: Qnexa and the Power of REMS

Vivus’ second trip to an advisory panel was a much happier one, with the company’s weight loss therapy garnering an overwhelming “yes” vote on approvability. The key change? A Risk Evaluation & Mitigation Strategy that will be precedent setting if approved—and that demonstrates the power of REMS even if FDA moves in a different direction with this application.

The Real Obesity Drugs Hurdle: Paying for Them

Obesity drugs are readying for round two at FDA. But if ever approved, given the airing of safety issues at advisory committee meetings, who would pay for them?

FDA Rethinking Weight Loss Standards: A Test Case for Patient-Focused Drug Development

The Center for Drug Evaluation & Research is working with George Washington University as a “neutral convener” to rethink weight loss drug development standards. That may make for an unexpected legacy from the wave of failed weight loss candidates from 2010: a whole new approach to drug development guidance from FDA.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080924

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