The latest news of submissions and expedited review designations from the Pink Sheet’s US FDA Performance Tracker
Earnings season brings information ranging from news tidbits, like a new brand name for BioMarin Pharmaceutical Inc.’s hemophilia gene therapy, to submissions including Sanofi’s novel biologic sutimlimab and new indications for Merck & Co. Inc.’s Keytruda and Novartis AG’s Entresto.
The ranks of breakthrough therapy designations rose by two, with BTDs announced by GlaxoSmithKline PLC (Benlysta for lupus nephritis)...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
