There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted.
A further two investigational therapies have been granted accelerated assessment status in the EU. This brings to 11 the number of known successful applicants for this fast-track review mechanism at the European Medicines Agency this year to date.
The two products are uniQure N.V./CSL Behring’s hemophilia B gene therapy candidate etranacogene dezaparvovec (CSL222/AMT-061 and also referred to...
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
