Alzheimer's Disease

Found 821 articles

• Alzamend Neuro to Present at Sequire Biotechnology Conference

  1/26/2023

  Alzamend Neuro, Inc. today announced that it will be presenting virtually at the upcoming Sequire Biotechnology Conference on Thursday, February 2, 2023.

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  Cassava's Mixed Alzheimer's Data Underwhelms Investors (Updated)

  1/24/2023

  Cassava Sciences reported Phase II data from its Alzheimer's candidate simufilam Tuesday. The company’s stock dropped 17% following the reveal.
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  FDA Made the Right Call on Lilly's Donanemab, Some Experts Say

  1/24/2023

  Research hasn't shown that removing amyloid plaques alone improves function in Alzheimer's patients, said Sharon L. Rogers, CEO of AmyriAD.
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  Innovative Trial Design may have Cost Lilly’s Donanemab Accelerated Approval

  1/20/2023

  The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
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  Despite Regulatory Progress, Delivery Hurdles Persist for Neurodegenerative Space

  1/19/2023

  The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.

• AC Immune Partner Life Molecular Imaging Initiates Phase 3 Study of Tau PET Diagnostic PI-2620 for Alzheimer’s Disease

  1/18/2023

  AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that its collaboration partner, Life Molecular Imaging (LMI), has imaged the first patient in ADvance, the pivotal Phase 3 trial of PI-2620, a Tau PET (positron emission tomography) imaging agent for AD (Alzheimer’s disease).

• APRINOIA Therapeutics and ROSS Acquisition Corp II Announce Business Combination Agreement to Create Publicly Listed Company Focused on Neurodegenerative Diseases

  1/18/2023

  APRINOIA Therapeutics Inc. and Progressive Supranuclear Palsy ("PSP"), and Ross Acquisition Corp II today announced that they have entered into a definitive agreement (the "Business Combination Agreement") for a business combination (the "Business Combination"). 

• Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan

  1/16/2023

  Eisai Co., Ltd. and Biogen Inc. announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril1 antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency.

• BioArctic's partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer's disease in Japan

  1/16/2023

  BioArctic AB's partner Eisai announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril[1] antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency.

• BioArctic's partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer's disease in the EU

  1/11/2023

  BioArctic AB's partner Eisai announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer's disease and mild AD dementia) to the European Medicines Agency.

• AlzeCure Selects CD and Enters Next Development Phase with Alzstatin ACD680 Against Alzheimer's

  1/11/2023

  AlzeCure Pharma AB announced that the company has chosen a candidate drug and started the preclinical development phase with the company's preventive and disease-modifying candidate drug Alzstatin® ACD680.

• Early, Accurate Diagnosis of Alzheimer’s Disease with DISCERN™ Test is Critical for Identifying Appropriate Patients for Prescribing and Coverage of LEQEMBI™

  1/10/2023

  SYNAPS Dx, a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease, emphasizes that FDA approval of LEQEMBI™ as a new drug for AD signals a turning point for clinicians, payers and all stakeholders in the benefits community.

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  FDA Approves Second Alzheimer’s Treatment in Two Years (Updated)

  1/9/2023

  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.

• Diadem Reports New Data Showing Its AlzoSure® Predict Blood Test Can Accurately Identify "Rapid Progressors" Who Will Develop Alzheimer's Disease Within Two Years

  1/9/2023

  Diadem SpA, a company developing the first blood-based test for the early prediction of progression to Alzheimer's disease, announced that its researchers have developed computational methods that enable its AlzoSure® Predict prognostic technology to accurately identify individuals who will rapidly progress to AD within two years' time.

• BioArctic's partner Eisai submits supplemental Biologics License Application to FDA for traditional approval of LEQEMBI™ (lecanemab-irmb) for the treatment of Alzheimer's disease

  1/9/2023

  BioArctic AB's partner Eisai announced they have submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the conversion of the Accelerated Approval of LEQEMBI™ 100 mg/mL injection for intravenous use to a traditional approval.

• Cyclo Therapeutics Announces First Patient Dosed in Phase 2b Study of Trappsol® Cyclo™ for the Treatment of Early Alzheimer’s Disease

  1/9/2023

  Cyclo Therapeutics Announces First Patient Dosed in Phase 2b Study of Trappsol ® Cyclo™ for the Treatment of Early Alzheimer’s Disease.

• Vaccinex Announces First Patient Dosed with Anti-CCR8 Antibody Licensed to Surface Oncology

  1/9/2023

  Vaccinex, Inc. today announced that its licensee, Surface Oncology (NASDAQ: SURF, “Surface”) dosed the first patient in its Phase 1/2 clinical study investigating SRF114, an antibody discovered using Vaccinex’s ActivMAb.

• Otsuka and Lundbeck Announce FDA Acceptance and Priority Review of sNDA for Brexpiprazole for the Treatment of Agitation Associated With Alzheimer’s Dementia

  1/7/2023

  Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration has determined that the supplementary New Drug Application for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia is sufficiently complete to permit a substantive review.

• Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer's Disease

  1/7/2023

  Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the conversion of the Accelerated Approval of LEQEMBI™ 100 mg/mL injection for intravenous use to a traditional approval.

• Eisai's Commitment to Scientific Evidence and Patient Safety

  1/6/2023

  LEQEMBI™ has the potential to make a difference for people living with early Alzheimer's disease, their loved ones and healthcare professionals, and was recently approved by the U.S. Food and Drug Administration for the treatment of AD.