Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?

Shire makes a bolt-on acquisition that will complement both its rare disease franchise and its regenerative medicines unit.

Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.