Biogen
1924 articles about Biogen
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With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab.
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In addition to massive revenues predicted for their developers, Leqembi—and possibly donanemab, if approved—should bring in substantial dollars to the healthcare industry.
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Biogen Appoints Jane Grogan as Head of Research
9/6/2023
Biogen Inc. (Nasdaq: BIIB) announced the appointment of Jane Grogan, Ph.D., as Executive Vice President, Head of Research effective 2 October 2023.
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As the FDA’s recent rejection of Biogen and Sage’s zuranolone for major depressive disorder highlights, biopharma companies will need to tackle emerging challenges to bring more of these drugs to patients.
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A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.
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With a potential $509 billion up for grabs by 2028, companies including Biogen, Sage, Karuna Therapeutics and Cerevel Therapeutics are vying to bring their drugs across the regulatory finish line.
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The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.
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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
8/5/2023
Biogen Inc. and Sage Therapeutics, Inc. announced the U.S. Food and Drug Administration approved ZURZUVAE™ 50 mg for adults with postpartum depression.
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Partners Biogen and Sage Therapeutics had sought approval for the therapy in both postpartum depression and major depressive disorder, but the FDA rejected the application for the latter.
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Week in Review: Breakthrough Depression Drug, RSV and GLP-1 Lawsuits, and Earnings Season Shows C...
8/4/2023
A transformational moment in the treatment of depression, GSK takes first shot in a vaccine patent war with Pfizer, a Louisiana woman sues Novo Nordisk and Lilly, and companies face a steep COVID-19 cliff. -
Week in Review: Biogen M&A and Layoffs, Earnings Season Heats Up, and 12 Neuro Companies to Watch
7/28/2023
Biogen’s $7.3 billion Reata acquisition and layoffs dominated this week’s news, while BMS and Roche reported second-quarter earnings and BioSpace looked at 12 late-stage neuro companies. -
Biogen to Acquire Reata Pharmaceuticals
7/28/2023
Biogen Inc. (Nasdaq: BIIB) and Reata Pharmaceuticals, Inc. (Nasdaq: RETA) today announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire Reata for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3 billion.
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Following a sweeping cost-cutting plan announced earlier this week, including an 11% workforce reduction, Biogen is acquiring Reata Pharmaceuticals to bolster its neurological and rare disease pipeline.
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With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.
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The biotech’s “Fit for Growth” program, which includes the headcount reduction, is expected to generate a net savings of $700 million on operating expenses by 2025.
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With Eisai and Biogen’s Leqembi now fully approved, researchers are exploring combinations—including with therapies targeting tau and microglial function—that could increase its effectiveness.
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Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
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Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer's drug development.
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In its latest legal challenge to the Inflation Reduction Act, the U.S. Chamber of Commerce has appealed to a federal court to stop drug price negotiations until ongoing litigation plays out.
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FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
7/7/2023
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application supporting the traditional approval of LEQEMBI® 100 mg/mL injection for intravenous use, making LEQEMBI 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.