FDA Breakthrough Designation Generates Big Meetings, Big Results, Scioderm Says
This article was originally published in Pharmaceutical Approvals Monthly
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.
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.