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 Drug Approval Needs A New Paradigm, Stakeholder Group Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Group convened by George Washington University School of Public Health and Health Services recommends a “patient-centered” approach to reviewing obesity drugs that includes assessing the therapies for their risks and benefits for obese individuals who are healthy, have risk factors for co-morbidities or impairments to daily feeling or functioning, or are already sick.

You may also be interested in...



“The Pink Sheet” DAILY’s Most Popular Stories Last Week

Obesity and diabetes drug development and market issues drew the most attention from readers.

Orexigen On Quicker-Than-Expected Pace To Obtain Data Needed To Re-File NDA For Contrave

During its second quarter earnings call, the biotech said it sees recent FDA approvals of two other obesity drugs as a positive for its own prospects, but it is re-engaging with the agency on why it must perform a cardiovascular-outcomes trial prior to approval.

REMS For Qsymia Limits Distribution, But Vivus To Explore Expanding Access

Qsymia will launch through certified mail-order pharmacies, but FDA has asked the sponsor to look for ways to expand into the retail space with pharmacies that can meet requirements for distributing patient risk information and keeping track of prescribers.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS074510

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