Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Amevive gets cmte. okay

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biogen's Amevive (alefacept) is safe and effective for use in moderate to severe chronic plaque psoriasis, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee agrees in an eight to two vote (with one abstention) at its May 23 meeting. Based on concerns about serious infections (0.91% of Amevive patients vs. 0.24% of placebo patients) and malignancies (1.1% vs. 0.5%), the committee supports Biogen's proposal to develop a registry to track serious adverse events. Amevive use should not be limited to patients who have failed or had an inadequate response to phototherapy or systemic therapy, the committee say

You may also be interested in...



AbbVie/Allergan Merger Edges Closer To FTC Clearance

AstraZeneca will reacquire Allergan's investigational IL-23 inhibitor brazikumab, and Nestle is to buy its GI drug Zenpep, which had nine-month revenue of $208m.

Another Sterilization Plant Closes For Upgrades; FDA Monitoring Situation For Device Shortage

The US agency is engaged with an ethylene oxide (EtO) sterilizer in Illinois that has temporarily closed to determine if there are any potential risks to the medical device supply chain. While the plant shut down about a month ago, regulators have only recently been made aware of the decision, which resulted from a law passed last year by the state legislature.

Pfizer’s Biosimilar Strategy Might Be Working

Pfizer's biosimilar franchise  is well on its way to becoming a blockbuster business three years after the company launched its first US biosimilar.

Topics

UsernamePublicRestriction

Register

PS001910

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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