Author Archives: Marisa Wexler MS

Biogen Scraps Infrastructure for Aduhelm Sales in US

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…

Biogen Withdraws Application Seeking Approval of Aduhelm in EU

Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union.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

Medicare Coverage of Aduhelm Will Be Limited to Patients in Trials

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…

Fosgonimeton Shows Safety in Early Trial, Phase 3 Study Enrolling in US

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,…

Older Adults Aware of Alzheimer’s, But Know Little About Aduhelm

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…

Nuplazid Resubmitted for FDA Approval for Psychosis in Alzheimer’s

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…