Alzheimer’s disease
Even before the drug’s approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema, observed in the trials.
In a Bloomberg News survey of 25 large insurers, none described the drug as “medically necessary,” and said Aduhelm was still experimental.
The U.S. Securities and Exchange Commission has launched an investigation into Texas-based Cassava Sciences.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the company’s Marketing Authorization Application for Aduhelm.
Scientists from Brigham and Women’s Hospital are ready to start a clinical trial that will evaluate the use of an intranasal vaccine to prevent Alzheimer’s disease.
Thanks partly to Biogen’s pricey new Alzheimer’s drug, Medicare enrollees will be burdened with higher monthly premiums for their Part B coverage.
As the capabilities have been proven, AI is establishing a firm foothold in the key areas of R&D, drug development, clinical trials, and, to some extent, patient-facing products.
Eisai and Biogen announced positive updates on the Phase IIB 201 and open-label extension studies they are conducting on the use of lecanemab to treat early Alzheimer’s Disease.
AC Immune’s Phase II Lauriet study of investigational anti-Tau monoclonal antibody, semorinemab, in mild-to-moderate Alzheimer’s disease (AD), only met one endpoint.
The company is investigating the death of a 75-year-old woman who died of ARIA while receiving Aduhelm.
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