- Location
COPAXONE
"-
Teva Pharmaceuticals Received Approval for sNDA for Three-Times-a-Week COPAXONE 40mg/mL
Feb 7, 2014Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE. COPAXONE (glatiramer acetate ...
-
Teva Pharmaceutical Has Licensed Rights to Commercialize Glatiramer Acetate
Dec 9, 2013Teva Pharmaceutical has licensed rights to commercialize glatiramer acetate to Takeda Pharmaceutical in Japan as part of their agreement signed earlier in 2013. Currently both the firms are working on additional agreements for ...
Tags: Teva Licenses, Medicine
-
The USFDA Has Accepted Teva Pharmaceutical Industries' sNDA
May 31, 2013The USFDA has accepted Teva Pharmaceutical Industries' supplemental new drug application (sNDA) for reviewing Copaxone (glatiramer acetate injection) 40mg/1mL. Indicated for patients with relapsing-remitting multiple sclerosis (RRMS), the ...
Tags: Drug Application, Medicine
-
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
-
The US District Court Ruled in Favor of Teva Pharmaceutical Industries
Dec 6, 2012The US District Court for the Southern District of New York has ruled in favor of Teva Pharmaceutical Industries in Copaxone patent infringement litigation. Teva filed lawsuit against Momenta/Sandoz and Mylan/Natco for infringement of ...
Tags: patent, Teva Pharmaceutical Industries, FDA
-
Teva Has Reported The GALA Study Evaluating a New Dose of GA Met Its Primary Endpoint
Jun 15, 2012Teva Pharmaceutical Industries has reported that the Glatiramer Acetate Low-Frequency Administration (GALA) study evaluating a new dose of glatiramer acetate injection (GA) met its primary endpoint. The Phase III trial evaluated the ...
Tags: Teva Pharmaceutical Industries, Medicine, glatiramer acetate injection
