BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

FDA Asks Genzyme Corporation (GENZ) to Redo Lemtrada Marketing Application


8/27/2012 7:51:07 AM

French pharmaceutical group Sanofi SA Monday said the U.S. Food & Drug Administration has asked the group to refile its application for approval of its Lemtrada drug, which aims to treat relapsing forms of multiple sclerosis. The FDA asked Sanofi's unit Genzyme to modify the presentation of the data sets "to enable the agency to better navigate the application" for Lemtrada, also known as alemtuzumab, Sanofi said in a statement. The French group said it would work with the FDA in the coming weeks to resubmit the application "as soon as possible".

Read at Market Watch
Read at News Release
Read at Reuters
Read at RTT News

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES