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

Genzyme Revises Fabrazyme Phase IV Proposal In Bid For April Approval

Executive Summary

Genzyme's proposal for completing its Phase IV Fabrazyme study is the kind of innovative drug development proposal that FDA Commissioner McClellan is encouraging, Genzyme CEO Henri Termeer suggested during a March 5 conference call

You may also be interested in...



The Mark Of McClellan? Commissioner Downplays Role In Drug Approvals

FDA Commissioner McClellan's direct contribution to product reviews is limited to drawing on a network of outside experts to assist in decisions, the commissioner suggested during a May 16 Manhattan Institute-sponsored roundtable with buy-side analysts

The Mark Of McClellan? Commissioner Downplays Role In Drug Approvals

FDA Commissioner McClellan's direct contribution to product reviews is limited to drawing on a network of outside experts to assist in decisions, the commissioner suggested during a May 16 Manhattan Institute-sponsored roundtable with buy-side analysts

Fabrazyme Approved; FDA Weighing What Confirmatory Data Will Be Needed

FDA has set a deadline of Jan. 31, 2004 for Genzyme's Fabrazyme confirmatory placebo-controlled trial following its April 24 approval

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS041394

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