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. ...
Biogen Names Christopher Viehbacher President and Chief Executive Officer
November 10, 2022 07:30 ET
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Biogen Inc.
CAMBRIDGE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced that its Board of Directors has appointed Christopher A. Viehbacher as President and Chief Executive...
Biogen Data at ECTRIMS 2022 Highlight Innovation in Digital Health Focused on Advancing Treatment and Personalized Care of People Living with MS
October 26, 2022 06:05 ET
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Biogen Inc.
Data demonstrate potential of Manual Dexterity Test and Konectom™ smartphone-based technology in measuring MS disease progressionRetrospective analysis applying machine learning, artificial...
New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS
October 26, 2022 06:02 ET
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Biogen Inc.
Final safety and efficacy results from the Phase 3 EVOLVE-MS-1 trial demonstrate decreases in disease activity and favorable tolerability for VUMERITY® (diroximel fumarate) consistent with previous...
Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen
October 17, 2022 07:30 ET
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Biogen Inc.
The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023 CAMBRIDGE, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the...
Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar Candidate Referencing RoACTEMRA® (tocilizumab)
September 30, 2022 07:00 ET
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Biogen Inc.
CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for...
The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS
September 21, 2022 17:15 ET
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Biogen Inc.
Publication includes the Phase 3 VALOR SOD1-ALS trial and its open-label-extension study, underscoring the importance of these longer-term data12-month data show earlier initiation of tofersen slowed...
The New England Journal of Medicine Publishes Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus
September 07, 2022 17:45 ET
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Biogen Inc.
Part A results from the two-part Phase 2 LILAC study show litifilimab significantly reduced disease activity based on active joint count in people with systemic lupus erythematosus (SLE) compared to...
The New England Journal of Medicine Publishes Positive Phase 2 Data on Litifilimab (BIIB059) in Cutaneous Lupus Erythematosus
July 28, 2022 07:30 ET
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Biogen Inc.
Results from Phase 2 LILAC study showed litifilimab significantly reduced skin disease activity in people with cutaneous lupus erythematosus (CLE) compared to placebo as measured by the primary...
FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS
July 26, 2022 07:30 ET
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Biogen Inc.
SOD1-ALS is a rare genetic form of ALS that affects approximately 330 people in the U.S.,1 it is progressive, leads to the loss of everyday functions and is uniformly fatalIf approved, tofersen would...