Biogen
1924 articles about Biogen
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Acorda Therapeutics to Regain Global Commercialization Rights to FAMPYRA® by January 2025
1/11/2024
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced it will regain global commercialization rights to FAMPYRA ® (fampridine) following a decision by Biogen to terminate the license and collaboration agreement between the companies, effective January 1, 2025.
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Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
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The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.
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Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission
12/19/2023
Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s product TECFIDERA® (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and Teva.
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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
12/15/2023
Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in people aged 16 years and older.
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ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.
12/14/2023
Biogen Inc. and Sage Therapeutics, Inc. announced ZURZUVAE™ 50 mg CIV is now available by prescription for the treatment of postpartum depression for adults in the United States, with product already at specialty pharmacies and delivered to patients.
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While the biotech’s third-quarter revenue beat Wall Street expectations, its $7.3 billion acquisition of Reata Pharmaceuticals—which closed in September—negatively impacted 2023 per-share earnings.
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Biogen Appoints Monish Patolawala to its Board of Directors
11/6/2023
Biogen Inc. announced the appointment of Monish Patolawala, currently President and Chief Financial Officer of 3M Company, to the Company’s Board of Directors, effective January 1, 2024.
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Subcutaneous injections of Eisai and Biogen’s Leqembi led to numerically greater amyloid removal than the intravenous version of the Alzheimer’s disease therapy, though risks of brain swelling and bleeding remained.
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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
10/25/2023
Biogen Inc. (Nasdaq: BIIB) reported new Phase 1b clinical data from the study of BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, in mild Alzheimer’s disease (AD).
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Eisai Presents New LEQEMBI® (lecanemab-irmb) Investigational Subcutaneous Formulation Interim Study Results & Clinical Improvement Data in Earlier Stages of Early Alzheimer’s Disease From Additional Analyses of Clarity AD at The CTAD Conference
10/25/2023
Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented new data for LEQEMBI® 100 mg/mL injection for intravenous use, in the Late Breaking Symposium 4 "Lecanemab for Early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration" at the 16th annual Clinical Trials on Alzheimer’s Disease conference held in Boston, Massachusetts, United States and virtually October 24-27, 2023.
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LEQEMBI® (lecanemab-irmb) Named One of Time's Best Inventions of 2023
10/24/2023
Eisai Inc. and Biogen Inc. are honored to announce that TIME has selected LEQEMBI® as one of the Best Inventions of 2023 in the Medical Care category.
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Biogen to Present New Data at the Clinical Trials on Alzheimer’s Disease (CTAD) 2023 Meeting
10/19/2023
Biogen Inc. (Nasdaq: BIIB) will present new data from its Alzheimer’s disease portfolio at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) meeting taking place October 24-27 in Boston, Mass.
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The layoffs, set to take effect in late November, will impact about a third of Reata’s headcount. The workforce reduction comes just weeks after Biogen completed its $7.3 billion Reata buy.
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Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible.
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Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here's a closer look.
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FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®
9/29/2023
Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.
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Biogen Completes Acquisition of Reata Pharmaceuticals
9/26/2023
Biogen Inc. (Nasdaq: BIIB) – has completed the acquisition of Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a company focused on developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases.
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Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.
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Reata Pharmaceuticals Stockholders Approve Merger Transaction With Biogen Inc.
9/21/2023
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”) announced that at a special meeting held today, preliminary results indicate that the stockholders of the Company voted to approve the Company’s previously announced acquisition (the “Merger”) by Biogen Inc., a Delaware corporation (“Biogen”).