Genentech Pulls Plug on Two Alzheimer’s Trials

February 4, 2019

Genentech has closed two large Phase III trials for its once-hyped anti-Alzheimer’s drug crenezumab after an independent data monitoring committee warned the company that crenezumab wasn’t likely to hit its primary endpoint.

FDA to Accelerate Gene, Cell Therapy Approvals

January 21, 2019

The FDA expects to receive some 200 new gene and cell therapy INDs in the next two years and plans to expedite their processing by hiring up to 50 extra staffers to handle review and other tasks. The agency also is considering new guidances focusing on regenerative therapies.

Gov’t Shutdown Puts INDs, Trials in Limbo

January 7, 2019

Gov’t Shutdown Puts INDs, Trials in Limbo Clinical trials executives are scrambling to understand the effects of the now two-week-old federal shutdown on their studies and applications, with the only FDA advice coming via Twitter.