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.
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.