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.

Menu

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
My View
Tags:

FDA panel to review Wyeth’s Viviant

  • News

Executive Summary

FDA will convene an advisory committee in July to review Wyeth's Viviant (bazedoxifene) for both the treatment and prevention of osteoporosis, the company announces Jan. 31. Wyeth will meet with FDA in February to discuss issues raised in a December "approvable" letter for the prevention indication. During fourth quarter earnings call, Wyeth President-Pharmaceuticals Joe Mahady says agency concerns involve incidents of stroke and thrombotic events as well as data collection at one of the study sites. Firm expects a May FDA action date on the drug to change given the timing of the panel review...

Table

View full table

Tags:
Latest Headlines

Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

See All
UsernamePublicRestriction

Register

PS049258

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

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