Biogen
1924 articles about Biogen
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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.
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Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan
1/16/2023
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril1 antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency.
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EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER'S DISEASE IN EUROPE
1/10/2023
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 Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™).
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The FDA approved Eisai and Biogen's lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer's disease in two years.
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Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer's Disease
1/7/2023
Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the conversion of the Accelerated Approval of LEQEMBI™ 100 mg/mL injection for intravenous use to a traditional approval.
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FDA Approves LEQEMBI™ (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
1/6/2023
Eisai Co., Ltd. and Biogen Inc. announced today that under the Accelerated Approval Pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb (Brand Name in the U.S.: LEQEMBI™).