Category: Alzheimer’s

Alzheimer’s experts call for changes in FDA drug approval standards

Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer’s Disease," urging the Food and Drug Administration (FDA) to clarify and modernize its current approach for approving new treatments for Alzheimer’s disease. http://www.worldpharmanews.com/development/3931-alzheimer-s-experts-call-for-changes-in-fda-drug-approval-standards

FDA authorizes first direct-to-consumer genetic test panel for predisposition to Alzheimer’s disease and other serious disorders

The FDA has announced its decision to grant a de novo application submitted by 23andMe for the company’s direct-to-consumer (DTC) Personal Genome Service Genetic Health Risk (“GHR") tests. The GHR test panel currently includes genetic variants…By: DLA Piper http://www.jdsupra.com/legalnews/fda-authorizes-first-direct-to-consumer-40610/

Genentech plans second Phase 3 Alzheimer’s trial following endpoint failures

Genentech, Roche’s biotech group, has announced its plans to conduct a second Phase 3 study for crenezumab, its anti-Abeta antibody for the treatment of early Alzheimer’s disease.
The trial is designed to further elucidate earlier traces data on the drug’s efficacy in treating Alzheimer’s; crenezumab failed to meet its primary endpoint of slowing cognitive degeneration in mild-to-moderate forms of the disease in two 2014 Phase 2 studies, but did show promise as a treatment in the earliest stages.
read more http://www.pharmafile.com/news/513609/genentech-plans-second-phase-3-alzheimers-trial-following-endpoint-failures