New Data Presented at AD/PD™ 2023 Show Biogen’s BIIB080 (MAPT ASO) Substantially Reduced Tau Protein Levels in Patients with Early-stage Alzheimer’s Disease
March 29, 2023 08:45 ET
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Biogen Inc.
The BIIB080 Phase 1b clinical study is the first to show a reduction of this magnitude in tau PET across brain regionsPhase 1b Study of BIIB080 showed dose-dependent and sustained reduction of tau...
Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS
March 22, 2023 20:31 ET
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Biogen Inc.
CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System...
Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
March 16, 2023 06:30 ET
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Biogen Inc.
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines...
Biogen Appoints Chuck Triano as Head of Investor Relations
March 14, 2023 07:30 ET
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Biogen Inc.
CAMBRIDGE, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced the appointment of Chuck Triano as Senior Vice President, Head of Investor Relations effective 10...
Caroline Dorsa to Succeed Stelios Papadopoulos as Chair of Biogen Board of Directors
March 08, 2023 07:30 ET
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Biogen Inc.
CAMBRIDGE, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective...
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
March 05, 2023 18:30 ET
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Biogen Inc.
Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review...
Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration
February 27, 2023 18:30 ET
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Biogen Inc.
TOKYO and CAMBRIDGE, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...
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
February 06, 2023 06:30 ET
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Biogen Inc.
Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder (MDD) and postpartum depression (PPD)Depression is a public health...
Lecanemab Receives Priority Review Status in Japan
January 29, 2023 18:30 ET
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Biogen Inc.
TOKYO and CAMBRIDGE, Mass., Jan. 29, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...
Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency
January 26, 2023 18:30 ET
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Biogen Inc.
TOKYO and CAMBRIDGE, Mass., Jan. 26, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...