The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The US Food and Drug Administration’s’s breakthrough therapy designation program provided fireworks in what was otherwise a quiet week at the FDA, thanks to not one but two designations in Alzheimer’s disease on the heels of one of one of the agency’s most controversial approvals ever, Biogen, Inc./Eisai Co., Ltd.’s Aduhelm (aducanumab), in the same space.
Lilly plans to follow the precedent set by the FDA’s accelerated approval of Aduhelm for AD based on a surrogate...
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.
