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Synaptogenix Abstract Highlighting Bryostatin-1 Benefits in Severe Alzheimer's Disease Accepted for Presentation at 11th International Brain Research Organization World Congress of Neuroscience
7/13/2023
Synaptogenix, Inc. today announced that an abstract featuring secondary endpoint data of its National Institutes of Health (NIH) sponsored Phase 2 Bryostatin-1 trial was accepted for presentation at the 11th International Brain Research Organization (IBRO) World Congress of Neuroscience to be held in September 2023 in Spain.
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CMS has stated that it will cover new Alzheimer’s drugs if the therapies are fully approved. But significant financial questions remain.
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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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Researchers elucidate the component structure of Alzheimer’s-associated plaques, shedding light on anti-amyloid antibodies’ mechanism of action.
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Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.
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Alzheimer's Association Statement on Donanemab Phase 3 Topline Data Release
5/3/2023
On behalf of the millions of Americans impacted by the devastation of Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes the robustly positive topline data reported by Eli Lilly on the TRAILBLAZER-ALZ2 Phase 3 clinical trial of donanemab for the treatment of early symptomatic Alzheimer's disease.
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During its Q1 earnings call Tuesday, Biogen announced a handful of program pauses and cuts and touted the potential of anticipated approvals.
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The Boston Business Journal reported the layoffs would affect the multiple sclerosis team, but Biogen declined to confirm the details.
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After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
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BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
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Caroline Dorsa to Succeed Stelios Papadopoulos as Chair of Biogen Board of Directors
3/8/2023
Biogen Inc . (NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective immediately following the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”), scheduled to take place on June 14, 2023.
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AB Science announced the publication of the masitinib pivotal phase 3 clinical trial in Alzheimer’s Disease in the journal Alzheimer's Research & Therapy
2/28/2023
AB Science SA announced publication of results from its positive pivotal phase 3 trial of masitinib in mild-to-moderate Alzheimer’s disease in the renowned international peer-reviewed journal Alzheimer's Research & Therapy.
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Billy Dunn, director of the FDA's Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.
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If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
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Biogen's 2022 fourth-quarter and full-year report comes the day after an additional warning on the company's first Alzheimer's drug came to light.
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Phase I/II data showed AC Immune’s anti-amyloid-beta vaccine candidate could safely elicit an antibody response in patients with Alzheimer’s disease. Now, it will expand to Down Syndrome patients.
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Cognetivity Neurosciences’ CognICA™ Platform Successfully Monitors Cognitive Performance in Alzheimer’s Patients Receiving Disease-Modifying Therapy
1/24/2023
Cognetivity Neurosciences Ltd. (the "Company" or "Cognetivity") (CSE: CGN) (OTCQB: CGNSF) (FWB: 1UB), a technology company that has created a unique brain health screening platform for use in medical, commercial and consumer
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The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
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The FDA approved Eisai and Biogen's lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer's disease in two years.
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Two documents recently came to light: first, the results of a congressional investigation into the approval of Aduhelm; second, a revised clinical trial consent form for lecanemab.