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October 26, 2022 06:02 ET | Source: Biogen Inc.

New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS

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...
October 17, 2022 07:30 ET | Source: Biogen Inc.

Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen

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...
September 30, 2022 07:00 ET | Source: Biogen Inc.

Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar Candidate Referencing RoACTEMRA® (tocilizumab)

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...
September 21, 2022 17:15 ET | Source: Biogen Inc.

The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS

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...
September 07, 2022 17:45 ET | Source: Biogen Inc.

The New England Journal of Medicine Publishes Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus

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...
July 28, 2022 07:30 ET | Source: Biogen Inc.

The New England Journal of Medicine Publishes Positive Phase 2 Data on Litifilimab (BIIB059) in Cutaneous Lupus Erythematosus

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...
July 26, 2022 07:30 ET | Source: Biogen Inc.

FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS

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...
June 21, 2022 06:37 ET | Source: Biogen Inc.

European Patent Office Grants Patent Related to TECFIDERA® (Dimethyl Fumarate)

Patent covers approved dosing regimen for TECFIDERA and expires in 2028 CAMBRIDGE, Mass., June 21, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Patent...
June 15, 2022 07:30 ET | Source: Biogen Inc.

New Data Presented at Cure SMA Reveal Residual Unmet Needs in Young SMA Patients Treated With Gene Therapy and Suggest Further Potential of Using SPINRAZA® (nusinersen)

RESPOND study is actively enrolling, with baseline characteristics reporting infants and toddlers have residual unmet medical needs in multiple areas after gene therapy; SPINRAZA treatment following...
June 14, 2022 07:30 ET | Source: Biogen Inc.

The Biogen Foundation and Community Lab Celebrates 20 Years of Serving our Communities

The Biogen Foundation has granted $70 million to help underserved communities in advancing science education, health equity, and food securityMore than 61,000 students have benefitted from Biogen’s...