Marisa Wexler, MS, senior science writer —

Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union. A committee of the European Medicines Agency (EMA) recommended against approving Aduhelm late last year. Biogen had requested a re-examination of that decision, made by the Committee for Medicinal Products…

The Centers for Medicare and Medicaid Services (CMS), in a final national policy decision, is allowing Medicare to cover the cost of Aduhelm (aducanumab) and other medicines in its class given accelerated approval only for Alzheimer’s disease patients enrolled in qualifying clinical trials. Should Adulhelm or future amyloid-targeting monoclonal antibodies be…

Most adults in the U.S., as well as many doctors, have difficulty distinguishing between the early stages of Alzheimer’s disease and cognitive changes due to normal aging, according to the latest annual report from the Alzheimer’s Association. The report draws on responses to surveys, one of adult Americans…

Fosgonimeton, an experimental therapy Athira Pharma is developing to treat Alzheimer’s disease, was well-tolerated overall in a Phase 1 clinical trial that included Alzheimer’s patients as well as healthy volunteers. “These encouraging results showed a positive safety and tolerability profile of fosgonimeton across a wide dose range,” Hans Moebius,…

Although the vast majority of older Americans are concerned about Alzheimer’s disease, most are unaware of Aduhelm (aducanumab), the recently approved treatment for the disease, according to a survey study. “The contrast between older Americans who were very concerned about developing Alzheimer’s disease and those that actually knew…

ACI-35.030, an experimental anti-tau vaccine that AC Immune is developing for Alzheimer’s disease, was able to potently induce an immune response as intended and was generally well-tolerated, according to 10-week interim data from a Phase 1/2 clinical trial. “These latest interim results add to the robust clinical dataset…

Acadia Pharmaceuticals has resubmitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of Nuplazid (pimavanserin) for hallucinations and delusions associated with psychosis in Alzheimer’s disease. The announcement from Acadia comes less than a year after the FDA rejected the company’s original application…

A recent proposal to limit Medicare coverage for Aduhelm (aducanumab) and similar medicines to Alzheimer’s disease patients who are enrolled in clinical trials ignores current science and would drastically curtail access these therapies, UsAgainstAlzheimer’s argues. UsAgainstAlzheimer’s (UsA2), based in Washington, D.C., is founded by family members of people affecting by…

An optimized version of ACI-24, an experimental vaccine designed to induce an immune response against abnormal protein clumps that drive Alzheimer’s disease, was able to induce a powerful immune response — as intended — and generally was well-tolerated in animal studies. Scientists at AC Immune, which is developing ACI-24,…

A recent proposal that Medicare only cover Aduhelm (aducanumab) for patients with Alzheimer’s disease who are enrolled in clinical trials is needlessly restrictive, and will prevent many people from accessing a medication that may be able to help them. That’s the argument made by Jeffrey Cummings, MD, a…