Biogen
1901 articles about Biogen
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2022's Top Clinical Advancements: See Pivotal Data in NASH, Alzheimer’s, Sickle Cell Disease
12/23/2022
2022 featured pivotal data that could change the landscape in non-alcoholic steatohepatitis, Alzheimer’s disease, sickle cell disease and many more indications. -
Eisai Initiates BLA Submission of Data for Lecanemab in China
12/22/2022
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated submission of data for Biologics License Application to the National Medical Products Administration of China for lecanemab, an investigational anti-amyloid beta protofibril antibody.
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Biogen Reaches Agreement with Genentech to Receive Royalties on the Potential Commercialization of a Late-Stage Bispecific Antibody as Part of Anti-CD20 Collaboration
12/19/2022
Biogen Inc. (Nasdaq: BIIB) announced that it has reached an agreement with Genentech, a member of the Roche Group, related to the commercialization and sharing of economics for glofitamab.
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FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)
12/9/2022
Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.
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Sage Therapeutics and Biogen Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
12/6/2022
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
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European Medicines Agency Accepts Tofersen Marketing Authorization Application to Treat Rare, Genetic Form of ALS
12/5/2022
Biogen Inc. (Nasdaq: BIIB) announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for review of tofersen, an investigational drug for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
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Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday.
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BioSpace sat down with Roche Global Head of Neurodegeneration Rachelle Doody, Ph.D. and Alzheimer’s Drug Discovery Foundation Co-founder Howard Fillit, M.D. to discuss the highlights.
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Eleven Experts From Leading Medical Institutions and Eight Experts From Eisai* Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity AD Study for Early Alzheimer's Disease in the New England Journal of Medicine
11/30/2022
Eisai Co., Ltd. and Biogen Inc. announced that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD with confirmed presence of amyloid pathology in the brain, were published in the New England Journal of Medicine, one of the world's most prestigious peer-reviewed medical journals.
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Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity AD Study for Early Alzheimer's Disease at Clinical Trials on Alzheimer's Disease (CTAD) Conference
11/30/2022
Eisai Co., Ltd. and Biogen Inc. announced that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer's Disease conference, in San Francisco, California and virtually.
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Full data from the Phase III Clarity AD trial show Eisai and Biogen's lecanemab has a favorable safety profile in patients with Alzheimer's disease.
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A second patient death has been linked to the Phase III clinical trial of Eisai and Biogen’s investigational Alzheimer's drug lecanemab, according to the journal Science.
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Sage Therapeutics and Biogen to Host Investor Webcast on December 6, 2022 to Discuss Potential Commercialization Plans for Zuranolone
11/22/2022
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced that the companies will host a joint investor webcast to discuss the planned commercialization approach and opportunity for their investigational product, zuranolone, on Tuesday, December 6 at 8:00 a.m. ET.
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When Roche announced that gantenerumab failed to meet the primary endpoint in two Phase III studies, several of its competitors saw their stocks rise - including Biogen and Eisai.
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GSK and Sanofi veteran Christopher A. Viehbacher will take over as chief executive officer for Biogen. He replaces Michel Vounatsos, whose departure was announced in May.
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Biogen Names Christopher Viehbacher President and Chief Executive Officer
11/10/2022
Biogen Inc. (NASDAQ: BIIB) today announced that its Board of Directors has appointed Christopher A. Viehbacher as President and Chief Executive Officer and a member of the Board of Directors, effective November 14.
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BioAge Labs, PTC Therapeutics, Biogen and others highlighted novel mechanisms targeting newer pathways in neurodegenerative diseases at the recent Discovery on Target meeting.
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An investigator in the Phase III trial for Biogen and Eisai’s experimental Alzhiemer’s drug, lecanemab, is attributing a patient’s death to the treatment.
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Merck, Bristol Myers Squibb, Biogen and others presented their latest data from MS programs at the 38th ECTRIMS conference.
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New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS
10/26/2022
Biogen Inc. announced new data from its industry-leading portfolio of multiple sclerosis therapies being presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis meeting October 26-28, 2022.