News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, an update on the Reagan-Udall RWE Accelerator project and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.
Emerging biopharma companies – those that are at clinical or commercial stage with less than $1bn in revenues – are driving more new drug approvals in 2021 than in the past, according to analysis by BIO.
"We potentially have the highest number of small companies driving the approvals this year," BIO VP-industry research David Thomas said...
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.
