Biogen Inc. develops and commercializes biopharmaceutical therapies focused on neurodegenerative diseases, rare diseases and adjacent specialty areas. Company news commonly covers Alzheimer’s disease therapy LEQEMBI with Eisai, spinal muscular atrophy treatment SPINRAZA, Friedreich’s ataxia therapy SKYCLARYS, postpartum depression therapy ZURZUVAE, ALS therapy QALSODY, multiple sclerosis products and CD20 collaboration revenue tied to Roche-partnered medicines.
Recurring updates include FDA review activity, supplemental biologics license applications, global regulatory status, clinical development programs, collaboration and licensing economics, asset-rights transactions and product demand trends. Biogen news also includes financial results, acquired in-process research and development expense, governance changes and corporate-status disclosures typical of a Nasdaq-listed biotechnology issuer.
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The FDA has granted accelerated approval for QALSODY (tofersen), a treatment for amyotrophic lateral sclerosis (ALS) in adults with a mutation in the SOD1 gene. This approval is based on a reduction of neurofilament, a biomarker for neurodegeneration, in patients. There are approximately 330 individuals in the U.S. living with this rare genetic form of ALS. The ongoing Phase 3 ATLAS study will serve as a confirmatory trial to assess clinical benefits. While the treatment is groundbreaking, there are warnings about serious neurological events associated with its use. Common adverse reactions include pain, fatigue, and muscle pain. QALSODY represents a significant advancement in ALS therapy, being the first approved treatment targeting a genetic cause.
Biogen has announced the appointment of Adam Keeney, Ph.D., as Executive Vice President and Head of Corporate Development, effective April 17, 2023. Dr. Keeney is set to join the Executive Committee and will report to Christopher A. Viehbacher, the company's President and CEO. With over 20 years in biopharmaceutical strategy and business development, Dr. Keeney previously served as CEO of NodThera and held significant roles at Sanofi and Johnson & Johnson. His appointment comes as Biogen aims for sustainable growth and strategic external collaborations.