Pink Sheet is part of the Business Intelligence Division 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

Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials

This article was originally published in The Pink Sheet Daily

Executive Summary

Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.

Advertisement

Related Content

Genzyme Nabs Elusive Lemtrada Approval, But As Third-Line MS Therapy
On The Offense: Sanofi Suits Up For A Game Change
NICE's Unrestricted MS Indication For Lemtrada Could Boost It Ahead Of Rivals
Sanofi Says Vaccines Getting Back On Track, Rejects M&A
Regulatory Briefs: Pradaxa’s New Indication, Lemtrada Resubmitted, New Hep C Drugs Under Review
Advisory Semantics: When Words Get In The Way Of Science At FDA Panels
Sanofi Fires Up Late-Stage R&D After Growth Rekindled in Fourth Quarter
Genzyme’s Lemtrada Experience Offers Lessons for “Breakthrough” Sponsors
Sanofi Claims Genzyme With $20.1 Billion Upfront And CVRs

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS075212

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