Safety of Dynavax's hepatitis B vaccine gets thumbs up from US FDA advisory committee, but panel remained concern that postmarketing proposal doesn't address questions about potential link to cardiovascular events.
Dynavax Technologies Corp. looks poised to finally get its hepatitis B vaccine Heplisav (rHBsAg-1018 ISS) to market, but it could require a more robust postmarketing plan than it has initially proposed to the US FDA.
During its July 28 review, the agency's Vaccines and Related Biological Products Committee voted 12 to 1 – with three...
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.
