Endocyte CEO Ron Ellis shows no hard feelings that EC145 was turned down for accelerated approval, although he clearly thinks the PRECEDENT trial was well designed and that its median PFS results showed a sufficiently robust improvement over the control to warrant AA. Jason Kantor at RBC is not surprised. He says that, by FDA’s lights, robustness of data can mean different things: magnitude of variance, statistical rigor. “Endocyte showed benefit in a single trial – but that’s not as robust as when a larger Phase III trial confirms your findings.”
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.
In this exclusive article with Peter Crowley, Secretary and Scientific Director of the BP Commission, you’ll discover how the BP is preparing for its landmark 2026 edition while strengthening its influence as a global bridge between science, regulation, and industry.
