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

Obesity Drugs Go Back To The Drawing Board; FDA To Hold Advisory Cmte On CV Risk

This article was originally published in The Pink Sheet Daily

Executive Summary

Orexigen halts Contrave development for U.S., but the firm will appeal the division's "unprecedented" trial request through FDA's dispute resolution process.

You may also be interested in...



Potential Cardiovascular Benefit Colors CV Safety Expectations For Obesity Drugs

Only a superiority trial could give certainty of CV safety for weight-loss medications prior to approval, FDA’s Robert Temple tells the Endocrinologic and Metabolic Drugs Advisory Committee.

Diabetes Drug Development: Seeing Light In The Dark Ages?

Tougher regulatory hurdles introduced three years ago extended the timelines for successful diabetes drug development, discouragiing investment and partnering activity. An ever-increasing incidence of diabetes, metabolic disorders, and obesity continues to drive innovation and the development of new medicines – but with less emphasis on novel mechanisms.

Advisory Committee Set To Review Cardiovascular Risk Assessment For Obesity Drugs

Recent guidance on Orexigen’s Contrave could provide clues about how the agency is leaning on drugs in the highly safety conscious obesity category. New analysis of SCOUT data for Abbott’s withdrawn Meridia (sibutramine) could crop up in the discussion, former panelist says.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS072449

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