The U.S. Food and Drug Administration (FDA) has accepted and given priority review designation to Biogen‘s application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. While the Prescription Drug User Fee Act (PDUFA) action date is set for…
Testing of a second and higher dose of ACI-35.030, a potential Alzheimer’s vaccine, is now beginning in a Phase 1b/2a clinical trial, AC Immune announced. Positive interim safety, tolerability, and specificity results from an initial dosing group of patients allowed the trial to advance to its medium…
Vaccines against the flu and pneumonia are associated with a lower risk of developing Alzheimer’s disease, while infections are generally linked to increased mortality among people with dementia, according to three research studies presented at this year’s Alzheimer’s Association International Conference, which is being held virtually this…
The U.S. Food and Drug Administration (FDA) has accepted a request by Acadia Pharmaceuticals‘ that  Nuplazid (pimavanserin) be approved for a new indication: the treatment of delusions and hallucinations associated with dementia-related psychosis. The company’s supplemental new drug application, which was submitted in June, was granted…
BAN2401, an experimental treatment for Alzheimer’s disease (AD), will be tested in the new global AHEAD 3-45 clinical trial, its developers have announced. The Phase 3 study — to be conducted in the U.S., Canada, Japan,…
The Alzheimer’s Foundation of America (AFA) is expanding the availability of its National Toll-Free Helpline — adding weekend hours as well as chat and message features in dozens of languages — to provide greater support to patients and family members. The resource’s hours now are 9 a.m. to…
Biogen and Eisai have submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. The submission, which was asking for priority review, had been pushed…
To promote brain health, the Alzheimer’s Foundation of America (AFA) is offering free online memory screenings that people can participate in from home. The confidential screenings — part of the AFA’s National Memory Screening Program — are provided Mondays and Wednesdays from 10…
AlzeCure Pharma announced positive results from its first clinical study of ACD856 for the potential treatment of Alzheimer’s disease. According to the company, ACD856 showed a good pharmacokinetic profile — namely a significantly shorter human half-life than its predecessor, ACD855 — and suitability for further clinical development as…
Amylyx Pharmaceuticals announced it has completed enrollment for the Phase 2 clinical trial of AMX0035 for treating Alzheimer’s disease. The placebo-controlled trial, PEGASUS (NCT03533257), will evaluate the compound’s safety and tolerability among patients with late mild cognitive impairment or early dementia due to Alzheimer’s disease. Other study…
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