FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®
September 29, 2023 16:06 ET
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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...
Biogen Completes Acquisition of Reata Pharmaceuticals
September 26, 2023 08:59 ET
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Biogen Inc.
Reata acquisition bolsters Biogen’s rare disease portfolio with the addition of SKYCLARYS® (omaveloxolone), the first and only FDA approved treatment for Friedreich’s ataxia in the U.S. CAMBRIDGE,...
LEQEMBI® Intravenous Infusion (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan
September 25, 2023 01:02 ET
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Biogen Inc.
TOKYO and CAMBRIDGE, Mass., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...
Biogen Appoints Jane Grogan as Head of Research
September 06, 2023 07:30 ET
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Biogen Inc.
CAMBRIDGE, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the appointment of Jane Grogan, Ph.D., as Executive Vice President, Head of Research effective 2 October...
FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder
August 04, 2023 22:41 ET
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Biogen Inc.
Postpartum depression (PPD) approval based on results from two Phase 3 clinical trials; in the SKYLARK Study treatment with ZURZUVAE rapidly improved symptoms of PPD at Day 15 and as early as Day 3...
Biogen to Acquire Reata Pharmaceuticals
July 28, 2023 07:05 ET
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Biogen Inc.
SKYCLARYS® recently approved in US as the only treatment indicated for patients with Friedreich’s ataxia Proposed acquisition represents meaningful step forward in Biogen’s strategy for...
Eisai Presents Latest Analysis of Lecanemab’s Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer’s Association International Conference (AAIC) 2023
July 19, 2023 19:30 ET
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Biogen Inc.
Further Phase 3 analysis shows benefits of lecanemab on both amyloid-beta and tau, two underlying pathological hallmarks of Alzheimer’s disease New data on subcutaneous formulation shows...
FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
July 06, 2023 20:00 ET
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Biogen Inc.
The first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease The Centers for Medicare &...
New Data at Cure SMA Highlight Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs After Gene Therapy
June 30, 2023 16:06 ET
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Biogen Inc.
Interim results from the RESPOND study show improved motor function in most participants treated with SPINRAZA after Zolgensma® (onasemnogene abeparvovec)Biogen also reported new real-world evidence...
Biogen Announces Changes to Its Board of Directors
June 12, 2023 17:14 ET
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Biogen Inc.
Biogen Will Adjourn Its Annual Meeting of Stockholders Until June 26, 2023, to Give All Stockholders Sufficient Time to Review and Vote on Proposed Slate CAMBRIDGE, Mass., June 12, 2023 (GLOBE...