News

FDA Places Gene Therapy LX1001 on Fast Track

LX1001, a gene therapy for Alzheimer’s disease being developed by Lexeo Therapeutics, has been granted fast track designation by the U.S. Food and Drug Administration (FDA). The therapy is designed to deliver a version of the APOE gene, called APOE2, to cells in the central nervous system (the…

#AANAM – EMBARK Trial to Again Test Safety, Efficacy of Aducanumab

A new Phase 3 clinical trial, called EMBARK, will evaluate the long-term safety and efficacy of aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease in patients who took part in its previous clinical studies. The trial’s design was described by Carmen Castrillo-Viguera, a medical director at Biogen, in the poster “…

FDA Rejects Nuplazid to Treat Dementia-related Psychosis

The U.S. Food and Drug Administration (FDA) has rejected Acadia Pharmaceuticals’ request that Nuplazid (pimavanserin) be the first approved treatment of hallucinations and delusions associated with dementia-related psychosis. The decision comes less than nine months since the agency agreed to review the company’s supplemental new drug application, and a month…