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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 Centers for Medicare & Medicaid Services elaborated Thursday on plans for coverage of Eisai and Biogen's Leqembi should the anti-amyloid drug receive full FDA approval.
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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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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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Alzheon to Present Baseline Imaging Characteristics from Ongoing APOLLOE4 Phase 3 Trial of Oral Tablet ALZ-801 (Valiltramiprosate) and Results of Phase 2 Biomarker Study at American Academy of Neurology Conference in Boston
4/18/2023
Alzheon, Inc. announced that it will be presenting baseline imaging characteristics from ongoing APOLLOE4 Phase 3 clinical trial and 12-month results from the Phase 2 biomarker study evaluating ALZ-801 oral tablet at the upcoming American Academy of Neurology Conference to be held from April 22 – April 27, 2023 in Boston, Massachusetts.
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MHRA Grants ADvantage Therapeutics Innovative Licensing and Access Pathway (ILAP) Designation for Novel Lead Product AD04™ for Phase 2b Trial in Alzheimer’s DiseaseILAP Designation accelerates patient access and commercialization
4/5/2023
ADvantage Therapeutics, Inc. (“ADvantage” or “the Company”) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom National Competent Authority, has granted the Company’s lead compound AD04™ an Innovation Passport for the treatment of AD under the Innovative Licensing and Access Pathway (ILAP).
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EISAI PUBLISHES LONG-TERM HEALTH OUTCOMES USING SIMULATION MODEL OF LECANEMAB USING PHASE 3 CLARITY AD DATA IN PEER-REVIEWED NEUROLOGY AND THERAPY JOURNAL
4/3/2023
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced an article about long-term health outcomes of anti-amyloid-beta (Aβ) protofibril* antibody lecanemab in people living with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) using simulation modeling was published in the peer-reviewed journal Neurology and Therapy.
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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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Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting
3/30/2023
Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented new analyses on amyloid-related imaging abnormalities with the use of antiplatelet and anticoagulant medications, isolated ARIA-H, and caregiver burden and health-related quality of life, from the results of Eisai’s Phase 3 Clarity AD study of lecanemab, an anti-amyloid-β protofibril* antibody, at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases annual meeting AD/PD™.
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Lead Therapeutic Candidate, PMN310, Demonstrates Enhanced Selectivity for Toxic Oligomers Compared to Other Amyloid-Beta-Directed Antibodies in Poster Presentation at AD/PD 2023
3/29/2023
ProMIS Neurosciences Inc. presented new in vitro preclinical data supporting the differentiation of PMN310 from other amyloid-beta -directed antibodies at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders.
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Renowned Public Health Advisor Jim O’Neill Joins Board of Directors of ADvantage TherapeuticsAppointment announced today at inaugural Entrepreneurship, Longevity and Biotech Conference Held in Boca Raton
3/24/2023
ADvantage Therapeutics, Inc. announced the election of James O’Neill — a recognized leader in health, aging, and longevity — to its Board of Directors.
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Eisai to Present New Lecanemab Data, Including Research Evaluating Safety Profile, Clinical Outcomes and Quality of Life Measures, as Well as Other Important Alzheimer's Disease Research, at the AD/PD™ 2023 Annual Meeting
3/22/2023
Eisai Co., Ltd. announced the company will present the latest findings on lecanemab, Eisai's anti-amyloid beta protofibril* antibody for the treatment of Alzheimer's disease, at the 2023 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders from March 28-April 1 in Gothenburg, Sweden and virtually.
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Alzheon to Present Biomarker, Brain Preservation and Clinical Effects of Oral Tablet ALZ-801 (Valiltramiprosate) at Upcoming AD/PD 2023 Conference in Gothenburg, Sweden
3/22/2023
Alzheon, Inc. announced that it will be presenting interim findings from an ongoing Phase 2 study evaluating ALZ-801 tablet at the upcoming AD/PD 2023 Conference to be held from March 28 – April 1, 2023 in Gothenburg, Sweden.
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Eisai Publishes Societal Value of Lecanemab Using Phase 3 Clarity Ad Data in Peer-reviewed Neurology and Therapy Journal
3/19/2023
Eisai Co., Ltd. announced the publication of updated results from an evaluation estimating the societal value of anti-amyloid-beta protofibril* antibody lecanemab in people living with mild cognitive impairment due to Alzheimer's disease and mild AD using data from the Phase 3 clinical study, Clarity AD by applying a validated disease simulation model.
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ADvantage Therapeutics Developing Therapies to Treat Neurodegenerative Conditions with Focus on Alzheimer’s Disease
3/15/2023
ADvantage Therapeutics, Inc. (“ADvantage” or “the Company”) today announces it is working on the development of its lead candidate, the AD04™ compound for the treatment of early Alzheimer’s disease (AD).
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FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
3/5/2023
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has accepted Eisai’s supplemental Biologics License Application for LEQEMBI™ 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval.
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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.