Biogen
About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
Company Ownership: Public
Stock Symbol: BIIB
Stock Exchange: NASDAQ
At Biogen we are connected by a greater purpose to help improve the lives of patients, work fearlessly, and grow together. Hear from the best and brightest at Biogen on what inspires them every day and why you should join our team.
1830 articles with Biogen
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Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
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Sangamo Therapeutics lost two powerhouse partners Friday after it reported that both Novartis and Biogen discontinued focusing on gene regulation therapies in the neurology space.
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An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
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Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
3/16/2023
Biogen Inc. announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency, and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® because of TECFIDERA’s regulatory data and marketing protection.
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The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.
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Sage Therapeutics and Biogen Share Update on FDA Advisory Committee for Zuranolone
3/8/2023
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) notified the companies that the agency does not currently plan to convene an advisory committee meeting to discuss the New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
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Caroline Dorsa to Succeed Stelios Papadopoulos as Chair of Biogen Board of Directors
3/8/2023
Biogen Inc . (NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective immediately following the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”), scheduled to take place on June 14, 2023.
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The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.
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FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
3/5/2023
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has accepted Eisai’s supplemental Biologics License Application for LEQEMBI™ 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval.
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PrBYOOVIZ™, first PrLUCENTIS® biosimilar, now available in Canada to treat debilitating retinal disorders
3/1/2023
Biogen Canada Inc. is pleased to announce that PrBYOOVIZ™, the first biosimilar referencing PrLUCENTIS® is now available in Canada to treat serious eye disorders including neovascular age-related macular degeneration, which can lead to rapid vision loss.
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Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration
2/27/2023
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
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If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
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Biogen's 2022 fourth-quarter and full-year report comes the day after an additional warning on the company's first Alzheimer's drug came to light.
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Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
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Sage Therapeutics and Biogen Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
2/6/2023
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
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Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
2/6/2023
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
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Lecanemab Receives Priority Review Status in Japan
1/29/2023
Eisai Co., Ltd. and Biogen Inc. announced that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare.
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Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency
1/26/2023
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™).
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The FDA's approval of Biogen and Eisai's Leqembi and subsequent decision not to approve Eli Lilly's donanemab have sparked debate anew about the anti-amyloid theory in Alzheimer's.
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The FDA's Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis's ALS candidate tofersen on March 22nd.