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The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday. -
FDA accepts sBLA for traditional approval of LEQEMBI™ (lecanemab-irmb) for the treatment of Alzheimer's disease and grants Priority Review: BioArctic
3/6/2023
BioArctic AB's partner Eisai 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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Athira Pharma to Present Data Supporting Therapeutic Potential of Enhancing HGF/MET Neurotrophic System at Upcoming Scientific Conferences
3/6/2023
Athira Pharma, Inc. today announced that it will participate in two upcoming scientific conferences: American Society for Experimental Neurotherapeutics (ASENT) 2023 Annual Meeting, which will be held virtually from Mar. 13-15, 2023.
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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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Wednesday, the FDA’s VRBPAC agreed that GSK's respiratory syncytial virus vaccine candidate is safe and effective in older adults. -
BioVie Announces Completion of Patient Enrollment in Phase 3 Trial Assessing NE3107 in Alzheimer’s Disease
3/2/2023
BioVie Inc. today announced that its NM101 trial evaluating NE3107 in the treatment of patients with Alzheimer’s Disease, has achieved its revised enrollment target of 400 patients.
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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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ALS is the 5,000-piece jigsaw puzzle of the therapeutic world. As the regulatory edges come together, new research pieces are also connecting. -
Cognition Therapeutics and ACTC Receive FDA Clearance for Phase 2 START Study of Oral CT1812 in Early Alzheimer’s Disease
2/22/2023
Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that it has cleared the U.S. Food and Drug Administration comment period and may now proceed with the 540-patient Phase 2 START study of CT1812 in adults with mild cognitive impairment or early Alzheimer’s disease.
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Advocating for Alzheimer's Patients: Dr. Christopher Hancock Wins Leadership Award for Outstanding Contributions
2/22/2023
HALO Precision Diagnostics™ announced Christopher Hancock, MD, HALO's neuroscience innovation officer, will receive the Edie Keller Leadership Award for his outstanding contributions to Alzheimer's disease patient advocacy and clinical education from Alzheimers Coachella Valley at its annual Endless Possibilities event.
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Cognito Therapeutics Announces First Patient Enrollment in US Pivotal Study HOPE
2/21/2023
Cognito Therapeutics , a clinical-stage neurotechnology company, announced today the first patient enrollment in its US pivotal study (HOPE), designed to demonstrate the safety and efficacy of its proprietary non-invasive stimulation device CogTx-001 in patients with Alzheimer’s Disease.
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Cognition Therapeutics Announces New Episode of “Conversations” Podcast: What if it’s not Alzheimer’s? The Caregiver’s Perspective on Lewy Body Dementia
2/21/2023
Cognition Therapeutics, Inc. , (Nasdaq: CGTX), (the “Company” or “Cognition”) has released its third “Conversations” video podcast, featuring a discussion with two Lewy body dementia caregivers, who are also passionate advocates for the second most common and devastating form of dementia.
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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. -
C2N Diagnostics Announces Follow-on Investment from GHR Foundation as It Builds on Success in Novel Diagnostics to Aid in Alzheimer’s Disease Fight
2/16/2023
C2N Diagnostics, LLC, a leader in advanced brain health diagnostics, announced it has received a $15 million program-related investment from GHR Foundation.
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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. -
Cure Alzheimer's Fund Appoints Drs. John S. Lazo and Patrick C. May to Research Strategy Council
2/14/2023
Cure Alzheimer's Fund, a nonprofit dedicated to funding the most promising research to prevent, slow or reverse Alzheimer's disease, is pleased to announce the appointment of Drs. John S. Lazo and Patrick C. May to its Research Strategy Council.
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Hoth Therapeutics Announces Increased Positive Results of its Alzheimer's Therapeutic HT-ALZ
2/8/2023
Hoth Therapeutics, Inc. today announced proof-of-concept data generated using cognitive and behavioral assessments in an Alzheimer's disease mouse model (aged APP/PS1+/- mice), supporting the therapeutic cognitive potential of HT-ALZ after chronic oral dosing of 20mg/kg and 40mg/kg of HT-ALZ.
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The discovery of novel Alzheimer's biomarkers is enabling better trial selection, earlier pipeline decision making and new targets for therapeutics. -
Oligomerix Announces First-in-Human Dosing of Tau Self-Association Inhibitor OLX-07010
2/2/2023
Oligomerix, Inc. today announced the dosing of its first subjects in the company’s Phase 1a clinical trial evaluating lead candidate OLX-07010.