Biogen and Alkermes have announced that the FDA has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis. Biogen holds the exclusive, worldwide license to commercialize Vumerity and intends to make it available in the U.S. in the near future. The FDA approval was based on a New Drug Application (NDA) […]

Dicerna Pharmaceuticals has announced a research collaboration and licensing agreement with Roche to develop novel therapies for the treatment of chronic hepatitis B virus (HBV) infection using Dicerna’s proprietary GalXC RNAi platform technology. The collaboration will focus on worldwide development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase 1 clinical development. The collaboration also […]

After consulting with the FDA, Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer’s disease (AD). The Phase 3 EMERGE Study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in the Phase 3 ENGAGE Study who received […]

CRISPR Therapeutics and Bayer today announced proposed plans whereby Casebia Therapeutics, a joint venture between CRISPR and Bayer, would operate under the direct management of CRISPR. Upon closing of the transaction, Casebia would focus on the development of its lead programs in hemophilia, ophthalmology and autoimmune diseases, with Bayer having opt-in rights for two products at […]

The FDA has approved Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have the most common CF-causing mutation. With this approval, for the first time, approximately 6,000 people with CF ages 12 years and older who have one F508del mutation and one minimal function mutation […]