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Eisai to Present New Data From LEQEMBI® (lecanemab-irmb) Phase 3 Clarity AD Study and Other Alzheimer's Disease Pipeline Research at the Clinical Trials on Alzheimer's Disease (CTAD) Conference
10/16/2023
Eisai Co. Ltd announced that the company will present new data from the phase 3 Clarity AD study for its Alzheimer's disease treatment LEQEMBI® 100 mg/mL injection for intravenous use and new data on the subcutaneous formulation in development at the 16th annual Clinical Trials on Alzheimer's Disease conference.
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Alzheon To Present Pivotal Program of Oral ALZ-801/Valiltramiprosate at Singularity Conference, Goldman Sachs Alzheimer’s Disease Day, and BIO Investor Forum
9/26/2023
Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and related neurodegenerative disorders, announced that the company will be presenting at upcoming industry and investor conferences.
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Alzheon Reports Industry-Leading Biomarker, Brain Preservation and Clinical Benefits Following 24 Months of Treatment in Phase 2 Trial of Oral ALZ-801 (Valiltramiprosate) in Patients with Early Alzheimer’s Disease
9/13/2023
Alzheon, Inc. announced statistically significant and clinically relevant reduction in plasma biomarkers of neurodegeneration, preservation of brain volume, and positive cognitive effects in Early AD patients who are carriers of apolipoprotein ε4 allele following 24 months of treatment with investigational agent ALZ-801 in the Phase 2 biomarker trial.
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Biotechnology Market is Expanding USD 3,995.22 Billion By 2032
9/1/2023
According to Precedence Research, the global biotechnology market was valued at USD 1,224.31 billion in 2022
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Eisai to Present the Latest Alzheimer's Disease Pipeline and Research, Including Lecanemab and Anti-MTBR Tau Antibody E2814, at the Alzheimer's Association International Conference (AAIC) 2023
7/12/2023
Eisai Co. Ltd announced that the company will present the latest findings on its Alzheimer's disease pipeline and research, including Eisai's anti-amyloid beta protofibril* antibody for the treatment of Alzheimer's disease, lecanemab, and the company's investigational anti-MTBR** tau antibody, E2814, at the Alzheimer's Association International Conference.
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Alzheon to Present Baseline Imaging Characteristics from Ongoing APOLLOE4 Phase 3 Trial of Oral Tablet ALZ-801 (Valiltramiprosate) and Positive Biomarker/Clinical Correlations from Phase 2 Biomarker Study at AAIC in Amsterdam
7/11/2023
Alzheon, Inc. announced that it will be presenting baseline imaging characteristics from its ongoing APOLLOE4 Phase 3 clinical trial and new correlation analyses from the Phase 2 biomarker study evaluating ALZ-801 oral tablet at the upcoming Alzheimer's Association International Conference, to be held from July 16 – 20, 2023 in Amsterdam, Netherlands.
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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.
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Oral Simufilam Slowed Cognitive Decline in a Randomized Withdrawal Trial of Mild-to-Moderate Alzheimer’s Disease
7/5/2023
Simufilam Slowed Cognitive Decline by 38% Versus Placebo Over 6 months in Patients with Mild-to-Moderate Alzheimer’s Disease.
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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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ADvantage Therapeutics Secures Approvals for Clinical Trial of AD04™ in Alzheimer’s Disease Treatment in Poland, Bulgaria, and Slovakia
6/20/2023
ADvantage Therapeutics, Inc. today announced that regulatory authorities in Poland, Bulgaria, and Slovakia have approved its Clinical Trial Application (CTA) to conduct a clinical trial on its lead candidate, AD04™ for the treatment of mild Alzheimer’s disease (AD) in each respective country.
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FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
6/9/2023
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI® 100 mg/mL injection for intravenous use for the treatment of Alzheimer’s disease.
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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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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.