CHMP backs Lecanemab again for early Alzheimer’s as EC reviews approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion on lecanemab, a monoclonal antibody therapy developed by ... Read More
Roche’s Gazyva shows superior efficacy in lupus nephritis treatment, Phase III trial data reveals
Roche has announced promising new data from its phase III REGENCY clinical trial, published in the New England Journal of Medicine, highlighting the superior efficacy ... Read More
FDA approves Leqembi maintenance dosing for early Alzheimer’s treatment
The U.S. Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi (lecanemab-irmb), an innovative treatment for early Alzheimer’s disease developed ... Read More
Biogen’s SKYCLARYS becomes first approved treatment for Friedreich’s Ataxia in EU
In a landmark decision, the European Commission (EC) has authorized Biogen Inc.'s SKYCLARYS (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents ... Read More
Biogen reprioritizes Alzheimer’s disease resources, discontinues ADUHELM development
Biogen Inc. (Nasdaq: BIIB), a leading pharmaceutical company, today announced a strategic reprioritization of its resources in Alzheimer’s disease (AD), a key therapeutic area expected ... Read More
Sage Therapeutics, Biogen get ZURZUVAE FDA approval for postpartum depression treatment
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAE (zuranolone) 50 mg for adults ... Read More
Biogen to expand portfolio with $7.3bn acquisition of Reata Pharmaceuticals
Biogen Inc. (Nasdaq: BIIB) is set to acquire Reata Pharmaceuticals, Inc. (Nasdaq: RETA) for $172.5 per share in cash, amounting to an enterprise value of ... Read More
Eisai, Biogen secure Leqembi FDA accelerated approval for Alzheimer’s disease
Eisai and Biogen have secured the approval of the US Food and Drug Administration (FDA) for their jointly developed Leqembi (lecanemab-irmb) under the accelerated approval ... Read More
Sage Therapeutics strikes $3.1bn licensing deal with biogen for depression and neurological disorder treatments
Sage Therapeutics has entered into a high-stakes global collaboration and licensing agreement with Biogen, valued at up to $3.1 billion, aimed at advancing two promising ... Read More
FDA accepts SB11 BLA for review: A step towards affordable treatment for retinal vascular disorders
The United States Food and Drug Administration (FDA) has recently accepted the biologics license application (BLA) for SB11, a proposed biosimilar referencing Genentech's Lucentis (ranibizumab). ... Read More