Biogen
1924 articles about Biogen
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Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry.
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Thursday, Eisai and Biogen’s Leqembi also became the first disease-modifying treatment for Alzheimer’s to win traditional approval. CMS coverage is expected to begin immediately.
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Biosimilar BYOOVI now reimbursed in Quebec to treat serious retinal disorders
7/6/2023
Biogen Canada Inc. is pleased to announce that Quebec has become the first province to reimburse Pr BYOOVIZ™ (ranibizumab injection), an anti-vascular endothelial growth factor (anti-VEGF) biosimilar therapy for certain eye conditions affecting the retina.
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New data highlight potential benefit of SPINRAZA® (nusinersen) in infants and toddlers with unmet medical needs after gene therapy
6/30/2023
Ionis Pharmaceuticals announced that its partner Biogen presented new data highlighting the potential benefit of SPINRAZA® in infants and toddlers living with spinal muscular atrophy.
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New Data at Cure SMA Highlight Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs After Gene Therapy
6/30/2023
Biogen Inc. announced new SPINRAZA® data aimed at answering critical questions for the spinal muscular atrophy community.
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After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
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Recent changes in the board of directors at Biogen has garnered attention due to potential conflicts of interest. Such conflicts vary widely, but one thing is clear: perception matters.
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The company announced Monday its shareholders elected Susan Langer, current president of Souffle Therapeutics, to its board of directors, replacing her reputed romantic partner Alex Denner.
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The Centers for Medicare and Medicaid Services released details about the patient registry it will require physicians to use to prescribe Leqembi, should it be approved by the FDA.
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After an FDA advisory committee unanimously recommended Leqembi’s full approval, questions linger around amyloid-related imaging abnormalities and a potentially cumbersome patient registry.
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The biotech company is collaborating with Israel’s NeuroSense to study how the latter’s amyotrophic lateral sclerosis candidate affects plasma neurofilament levels in patients.
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Biogen Announces Changes to Its Board of Directors
6/12/2023
Biogen Inc. announced several changes to its Board of Directors. The changes will refresh the composition of the Board and follow the Board’s continual interaction with company stockholders to solicit their perspective on a range of issues around the company’s performance and strategy.
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In a 6-0 vote, the FDA’s advisory committee Friday affirmed that trial data confirmed the clinical benefit of Eisai and Biogen’s Leqembi (lecanemab) for the treatment of Alzheimer’s disease.
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Neurologist David Weisman, with financial ties to the companies, was removed from the FDA’s upcoming advisory committee meeting slated to consider Leqembi’s traditional approval.
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Biogen, and partner Denali, are discontinuing the Phase III LIGHTHOUSE study of BIIB122 in Parkinson’s disease due to the trial’s long timeline and complexity.
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The recent approval of Biogen’s Qalsody in SOD1–ALS highlighted the potential of ASOs in CNS diseases, while recent failures make it clear there is still work to be done.
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The FDA has three high-profile events this week, including one target action date and two advisory committee meetings—one to discuss potential traditional approval for Alzheimer’s drug Leqembi.
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Researchers elucidate the component structure of Alzheimer’s-associated plaques, shedding light on anti-amyloid antibodies’ mechanism of action.
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Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease
5/15/2023
Eisai Co., Ltd. and Biogen Inc. announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.
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The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas.