Author Archives: Marisa Wexler MS

The U.S. Food and Drug Administration (FDA) has granted marketing permission to a new test that checks for amyloid plaques in people being checked for Alzheimer’s disease. The Lumipulse G β [beta]-Amyloid Ratio (1-42/1-40) test, which will be sold by Fujirebio Diagnostics, is now approved for adults ages…

Biogen is eliminating corporate infrastructure that had been put in place to support sales of Aduhelm (aducanumab) in the U.S., the company announced. The decision is being made in response to a policy announced last month that Medicare would only cover the cost of Aduhelm for people…

A standardized MRI protocol to screen for brain imaging abnormalities in people with Alzheimer’s who are being treated with Aduhelm in a large observational study was described in a presentation at the 2022 American Academy of Neurology (AAN) annual meeting. “Consistency in MRI acquisition is important for efficient and…

Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union.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…