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,...
Biogen Names Priya Singhal as Executive Vice President, Head of Development
January 05, 2023 07:30 ET
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Biogen Inc.
CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that Priya Singhal, M.D., M.P.H., currently Head of Global Safety and Regulatory Sciences and Interim Head of...
Biogen and Alcyone Therapeutics Announce License and Collaboration Agreement to Evaluate a Novel Device to Improve Patient Experience and Access to Neurological ASO Therapies
January 04, 2023 07:30 ET
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Biogen Inc.
Alcyone’s ThecaFlex DRx™ System is an implantable medical device in development for intrathecal drug delivery CAMBRIDGE, Mass. and LOWELL, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Biogen Inc....
Biogen Reaches Agreement with Genentech to Receive Royalties on the Potential Commercialization of a Late-Stage Bispecific Antibody as Part of Anti-CD20 Collaboration
December 19, 2022 07:30 ET
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Biogen Inc.
Glofitamab is an investigational T-cell engaging bispecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other blood cancers CAMBRIDGE, Mass., Dec. 19, 2022...
FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)
December 09, 2022 07:30 ET
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Biogen Inc.
CAMBRIDGE, Mass., Dec. 09, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License...
European Medicines Agency Accepts Tofersen Marketing Authorization Application to Treat Rare, Genetic Form of ALS
December 05, 2022 07:30 ET
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Biogen Inc.
SOD1-ALS is a rare, genetic form of ALS,1 comprising approximately 2% of people with ALS2If approved, tofersen would be the first treatment to target a genetic cause of ALS CAMBRIDGE, Mass., Dec. ...