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Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia
February 12, 2024 16:06 ET | Biogen Inc.
Friedreich’s ataxia is a rare, genetic, life-shortening, debilitating, and neurodegenerative disorderTreatment with SKYCLARYS improved patient function compared to placeboBiogen is leveraging its...
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Biogen to Realign Resources for Alzheimer's Disease Franchise
January 31, 2024 07:30 ET | Biogen Inc.
Company to reprioritize resources allocated to ADUHELM® (aducanumab-avwa) to advance LEQEMBI® (lecanemab-irmb) and to develop new treatment modalitiesBiogen committed to building a leading Alzheimer’s...
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Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission
December 19, 2023 07:30 ET | Biogen Inc.
CAMBRIDGE, Mass., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions...
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CHMP Issues Positive Opinion for Biogen’s SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease
December 15, 2023 09:05 ET | Biogen Inc.
Friedreich’s ataxia is a genetic, debilitating and life-shortening neuromuscular disease1Milestone highlights Biogen’s growing portfolio in rare diseases and focus on addressing unmet needs of...
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ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.
December 14, 2023 06:30 ET | Biogen Inc.
ZURZUVAE, the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD Patient...
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Biogen Appoints Monish Patolawala to its Board of Directors
November 06, 2023 07:30 ET | Biogen Inc.
Biogen Appoints Monish Patolawala to its Board of Directors
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Eisai Presents New LEQEMBI® (lecanemab-irmb) Investigational Subcutaneous Formulation Interim Study Results and Clinical Improvement Data in Earlier Stages of Early Alzheimer’s Disease From Additional Analyses of Clarity AD at The Clinical Trials On Alzheimer’s Disease (CTAD) Conference
October 25, 2023 17:26 ET | Biogen Inc.
Investigational Subcutaneous Formulation Clears 14% More Plaque Than IV, Pharmacokinetics (AUC) 11% Higher, And Similar ARIA Rates To IV 76% Of Patients Showed No Decline And 60% Showed Clinical...
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New Data from Biogen’s Investigational Antisense Oligonucleotide (ASO) Targeting Tau Shows Promise for Potential New Generation of Treatments in Early Alzheimer’s Disease
October 25, 2023 10:51 ET | Biogen Inc.
In the Phase 1b study, favorable trends were reported for the high-dose groups on multiple measures of cognition and function.First study of a tau targeting drug that shows reduction of aggregated tau...
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Biogen to Present New Data at the Clinical Trials on Alzheimer’s Disease (CTAD) 2023 Meeting
October 19, 2023 07:30 ET | Biogen Inc.
Late-breaking Phase 1b data assesses the clinical outcomes of reducing tau in patients with early-stage Alzheimer’s diseaseAdditional late-breaking presentations from the CLARITY AD study explore...
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FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®
September 29, 2023 16:06 ET | Biogen Inc.
TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United StatesFDA approval is based on a robust analytical, non-clinical and clinical data package comparing...