No Safety Shortcuts Under Breakthrough Designation, Synthetic Biologics Finds
Executive Summary
Synthetic Biologics emerged from meetings with US FDA without its breakthrough designation, but with hope that agency will allow decoupling of safety and efficacy endpoints in planned Phase III trial for prevention of C. difficile infection.
You may also be interested in...
War on C Difficile Is Being Fought On Multiple Fronts
Pivotal trials are underway for two microbiota restoration therapies, a narrow-spectrum antibiotic and a vaccine; funding from non-profits and new owners have revived stalled projects at Summit, Deinove and MGB Biopharma.
Breakthrough Designation Rescissions: Who Might US FDA Drop Next?
Our chart details the pipeline candidates who might lose the coveted status as treatment paradigms change and trial results come in.
Keeping Track: CDER Approves Its First Two Novel Agents Of 2019
The latest drug development news and highlights from our US FDA Performance Tracker.