Pharma has come a long way in the last three years in developing tactics to respond to large, government-funded comparative clinical trials. Aggressive and well-prepared responses by the antipsychotic manufacturers to the CATIE comparison of four atypical brands to perphenazine changed what could have been a threatening study into an event for publicizing the strengths of individual brands.
By Cole Werble
The media grabbed its message quickly.
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The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
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.
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.
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.
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.
