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

Chantix, Zyban Need Safety Studies In Patients With Mental Illness

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's mandate, part of a response to neuropsychiatric adverse events that also includes boxed warnings for the smoking-cessation drugs, follows a trend of requesting sicker patients in trials.

You may also be interested in...



Chantix Faces FDA Safety Gauntlet After Pfizer Settles Product Liability Suits

FDA advisory committees will discuss risk of serious neuropsychiatric adverse events with the smoking cessation drug at October meeting.

Arena Looking To Puff Up Belviq Sales With Smoking Indication

Arena’s Belviq has failed to gain much traction in the obesity market, but the biotech is hoping a smoking-cessation indication could help bolster sales.

Charting The Course Of Product Liability: From Yasmin/Yaz To Actos

Bayer’s birth control pills Yasmin and Yaz face the most pharmaceutical product liability actions in federal court followed by Pfizer’s Prempro and GlaxoSmithKline’s Avandia. While GSK has settled the bulk of cases before a single trial, Merck and Novartis are winning Fosamax and Aredia jury verdicts.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS069671

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