Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.
Eiger BioPharmaceuticals, Inc.’s peginterferon lambda, Gilead Sciences, Inc.’s magrolimab, Takeda Pharmaceutical Co. Ltd.’s TAK-994 and Bavarian Nordic A/S’s RSV vaccine are the latest entrants to the small group of products that received breakthrough therapy designations but went on to struggle with clinical failure, changing strategic priorities, and regulatory missteps.
The BTD program is a success by most any measure. The Pink Sheet US FDA Performance Tracker has identified close...
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.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
