Enzyvant’s Path From Complete Response Letter To FDA Approval For Rethymic Included CMC Revamp
Two-year journey after CRL did not start with a meeting with US FDA, but rather a ‘pause’ to better understand agency’s perspective, execs say. Firm would later develop a roadmap with FDA to overcome manufacturing issues for the the first tissue-based therapeutic approved by the agency.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.
At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma
Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.