Progen liver cancer program accelerates
This article was originally published in Pharmaceutical Approvals Monthly
Progen's recent discussions with FDA suggest that development time for its liver cancer agent PI-88 will be cut by up to three years, Progen announces May 16. In response to FDA's request that the firm submit a special protocol assessment for a Phase III trial, the company plans to advance its current Phase II trial directly to Phase III. The Brisbane, Australia firm notes that "FDA supports a registration approach based on a single pivotal trial" and "an accelerated approval based on meeting the secondary endpoint of disease-free survival." Progen describes PI-88 as a heparan sulfate mimetic; the agent exerts its anti-angiogenic activity by inhibiting VEGF, FGF-1 and FGF-2...
You may also be interested in...
Cognoa said it will submit its AI-powered digital app for early detection of autism for de novo clearance with the US FDA. See what the company’s senior medical director of clinical adoption said about it here.
Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.
In sign of how much has changed in four years, industry might be better off if Biden takes CAP’s advice and launches ‘march-in’ actions to address pricing of COVID products.