A U.S. Food and Drug Administration (FDA) advisory committee will meet June 10 to review clinical trial data related to donanemab, Eli Lilly‘s experimental anti-amyloid therapy, according to a company press release. The FDA is reviewing Lilly’s application seeking approval of donanemab to treat early Alzheimer’s…
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Elecsys Phospho-Tau 217 (pTau217), a blood-based biomarker test that can help distinguish Alzheimer’s disease from other neurodegenerative disorders. The test, developed by Roche in collaboration with Eli Lilly, is intended to support a more accurate…
BioXcel Therapeutics plans to launch a pivotal Phase 3 in-care trial — one involving patients in nursing or assisted living facilities — to continue to evaluate BXCL501 (dexmedetomidine sublingual film) for the acute treatment of agitation in patients with Alzheimer’s disease dementia. BXCL501 is an experimental orally dissolving…
Treatment with SNK01, a natural killer (NK) cell therapy being developed by NKGen Biotech, appears safe and well tolerated and may offer a cognitive benefit to people with Alzheimer’s disease, according to data from a small Phase 1 clinical trial. Given directly into the bloodstream, SNK01 was able…
Eisai is seeking approval in the U.S. of Leqembi (lecanemab)’s monthly maintenance dosing for people with early Alzheimer’s disease. The supplemental biologics license application with the U.S. Food and Drug Administration (FDA), recently announced by the company, is backed by modeling of observed data from the…
VY-TAU01, Voyager Therapeutics’s investigational therapy designed to prevent the formation of harmful tau tangles in the brains of people with Alzheimer’s disease, was well tolerated and showed promising pharmacological properties in preclinical studies. Based on these findings, the company expects to submit an application to the U.S. Food…
A U.S. Food and Drug Administration (FDA) advisory committee is expected to meet to discuss data from a Phase 3 trial of the anti-amyloid therapy donanemab in people with early Alzheimer’s disease. Developer Eli Lilly asked the FDA last year to approve donanemab, based on the…
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Quanterix’s experimental blood test measuring p-Tau 217, the protein that builds up as toxic tangles in the brains of people with Alzheimer’s disease. The test, Simoa p-Tau 217, has the potential to help doctors diagnose…
AriBio will soon start recruiting participants in the U.K. for the Phase 3 trial of AR1001 (mirodenafil), an investigational oral therapy for early Alzheimer’s disease. This follows a positive opinion of the U.K. Medicines and Healthcare Products Regulatory Agency. The Polaris-AD trial (NCT05531526), which is enrolling patients…
A Phase 3 clinical trial of AVP-786 failed to meet its main goal of easing agitation in adults with dementia due to Alzheimer’s disease, said sponsor Otsuka Pharmaceutical. The clinical trial (NCT03393520), also dubbed 17-AVP-786-305, tested AVP-786’s safety in addition to evaluating its effectiveness compared with a…
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