FDA Breakthrough Designation Generates Big Meetings, Big Results, Scioderm Says
This article was originally published in The Pink Sheet Daily
Biotech start-up met with 22 agency officials to discuss development of its compound for treatment of epidermolysis bullosa, a rare, genetic connective tissue disorder.
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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.
Senators ask the agency to address the “regulatory loophole” permitting telehealth companies to promote prescription drugs without disclosing side effects and question if FDA has enforcement authority over third-party social media influencer promotions.