- Location
Alemtuzumab
"-
Health Care Reform Survives a Lawsuit
Jan 21, 2014The New York Times: Health Care Reform Survives A Lawsuit A long-shot lawsuit that could have damaged the effectiveness of health care reform got a well-deserved brushoff from a federal district judge on Wednesday. The suit was brought ...
Tags: New York Times, Alemtuzumab, Maternity Leave, FDA
-
The FDA Has Rejected The New Multiple Sclerosis Drug Lemtrada
Jan 6, 2014The FDA has rejected the new multiple sclerosis drug Lemtrada, saying the drugmaker didn't show the drug's benefits outweigh some serious risks. The agency asked the maker, Genzyme, to test the drug in more clinical trials. The drug was ...
Tags: FDA, Lemtrada, Genzyme, relapsing-remitting MS, rejection
-
Genzyme Has Received a Complete Response Letter From The U.S
Jan 2, 2014Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of ...
Tags: Genzyme, Biologics License Application, Lemtrada, multiple sclerosis
-
Genzyme Has Obtained an Approval From Health Canada for Its Lemtrada
Dec 17, 2013Genzyme, a Sanofi company, has obtained an approval from Health Canada for its Lemtrada (alemtuzumab) for the treatment of relapsing remitting multiple sclerosis (RRMS). Health Canada has approved Lemtrada for the management of adult ...
-
Danish Biotechnology Firm Genmab Has Unveiled Positive Results From a Phase II Study
Oct 12, 2013Danish biotechnology firm Genmab has unveiled positive results from a Phase II study of its sclerosis drug candidate ofatumumab in relapsing-remitting multiple sclerosis (RRMS). In a randomized study of 232 patients with RRMS, treatment ...
Tags: Genmab, Sclerosis Drug
-
A Multiple-sclerosis Drug Was Approved for Sale in Europe on Tuesday
Sep 22, 2013A multiple-sclerosis drug that was at the center of Sanofi SA's SAN.FR +1.12% $20 billion takeover battle for Genzyme Corp. three years ago was approved for sale in Europe on Tuesday, the drug's first regulatory approval world-wide. The ...
-
FDA Has Accepted Genzyme Lemtrada (Alemtuzumab) Biologics License Application for RMS
Jan 30, 2013The US FDA has accepted Genzyme Lemtrada (alemtuzumab) biologics license application (sBLA) for review for relapsing multiple sclerosis (RMS). Genzyme also reported encouraging early US launch indicators for Aubagio (teriflunomide) such ...
Tags: FDA, biologics license application, relapsing multiple sclerosis
-
Genzyme Submitted a Supplemental Biologics License Application
Dec 5, 2012Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS
-
AbD Serotec to Introduce HuCAL Anti-Drug Antibodies Supporting Development of Therapeutics
Nov 28, 2012AbD Serotec, MorphoSys' division for research and diagnostic antibodies, is set to introduce a series of the human combinatorial antibody library (HuCAL) anti-drug antibodies supporting the development of novel antibody therapeutics. The ...
Tags: AbD Serotec, HuCAL Anti-Drug Antibodies, antibody therapeutics, MorphoSys
-
Genzyme Received a Refuse to File Letter From The US Food and Drug Administration
Aug 27, 2012Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment ...
Tags: Genzyme, Lemtrada marketing, FDA
