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 aged 16 years and older. This approval heralds SKYCLARYS as the first medication sanctioned within the European Union for this rare, genetic, and progressively debilitating neurodegenerative disease, promising a new […]
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 to drive growth in both the near and long term. The company is set to continue advancing LEQEMBI (lecanemab-irmb), the first anti-amyloid beta treatment with FDA traditional approval in the […]
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 with postpartum depression (PPD). The treatment is the first of its kind, offering an oral, once-daily, 14-day course that can provide rapid improvements in depressive symptoms for women with postpartum […]
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 approximately $7.3 billion. This significant step forward was announced by both companies, showcasing Biogen’s dedication to expand its presence in the treatment of serious neurologic diseases. Reata Pharmaceuticals, recognized for […]
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 pathway for the treatment of Alzheimer’s disease. Leqembi is a 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and […]
Sage Therapeutics has secured a global collaboration and licensing deal worth up to $3.1 billion with Biogen for two of its drug candidates intended for the treatment of depression and movement disorders. Under the terms of the deal, the two US pharma companies will jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), […]
Samsung Bioepis and Biogen said that the US Food and Drug Administration (FDA) has accepted for review the biologics license application for SB11, a proposed ophthalmology biosimilar referencing Genentech’s Lucentis (ranibizumab). Ranibizumab is an anti vascular endothelial growth factor (VEGF) therapy for retinal vascular disorders, which are a major cause of blindness in the US. […]
Dutch generic drugmaker Mylan said that the US District Court for the Northern District of West Virginia has invalidated Biogen’s Tecfidera patent U.S. Patent No. 8,399,514 for lack of written description. According to the company, the 8,399,514 patent claimed methods for the treatment of multiple sclerosis (MS) with a dose of 480 mg/day of dimethyl […]
In a significant move within the biotech sector, Biogen, the US-based biotechnology giant, has announced its agreement to acquire Nightstar Therapeutics, a UK-based clinical-stage gene therapy company, in a deal valued at $800 million. The acquisition underscores Biogen’s commitment to expanding its pipeline, particularly in the ophthalmology space, where it aims to address rare and […]
Biogen, a leading US biotechnology firm, has reached a significant agreement to acquire Pfizer’s neurology drug candidate, PF-04958242, which is being developed to address cognitive impairment associated with schizophrenia (CIAS). The deal, potentially worth almost $600 million, includes an upfront payment of $75 million, with additional milestone payments and royalties that could total up to […]