Teva Pharmaceutical Industries and Active Biotech have announced that both companies remain committed to the Nerventra(laquinimod)clinical development program for multiple sclerosis(MS)following the announcement of a negative opinion for ...
Tags: Medicine, clinical studies, Nerventra
Teva 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 ...
The 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, 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
The 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
Biogen Idec and Elan are seeking approvals from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for first-line use of Tysabri (natalizumab) in anti-JCV antibody negative patients with multiple sclerosis (MS). ...
XenoPort has received a US patent for, prodrugs of methyl hydrogen fumarate, pharmaceutical compositions thereof, and methods of use. The patent is directed to composition and formulations of the XP23829 compound and another patent ...
Tags: XenoPort, US patent, covering composition