Marketing a portfolio of high-risk drugs is a precarious proposition but Celgene Corp.has turned it into a profitable business model. Extreme risk management is not for everyone: it works best for high-price specialty products. Celgene has two products under risk management programs: thalidomide (Thalomid) and lenalidomide (Revlimid). Amylin Pharmaceuticals Inc. and Intarcia Therapeutics Inc. are also interested in risk management programs.
By Kate Rawson
The best thing that ever happened to Celgene Corp. was commercializing the most notorious human drug ever marketed.
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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.
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
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.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
