Pfizer Inc.'s decision to withdraw celecoxib's indication for familial adenomatous polyposis (FAP) in the U.S. and Europe illustrates the challenges of working with accelerated approvals of orphan indications - and the difficulties of handling the expectations of different regulatory bodies.
The European Parliament slammed the European Medicines Agency's handling of the Mediator (benfluorex) affair, questioning why the agency did not withdraw the diabetes drug from the EU market until 10 years after the first safety signals were detected.
NICE will continue to play a key role in determining the cost-effectiveness of treatments even after the U.K. moves to a new system of value-based pricing for drugs in 2014. To underscore that, the agency is to be placed on a firmer statutory footing that would prevent future politicians from abolishing it without passing new legislation.
Merck & Co. Inc.'s cholesterol agent ezetimibe will likely see reimbursement cuts in Germany unless persuasive public arguments are offered against them by May 31.
Europe's regulators at the European Medicines Agency are seeking assurances that medicines imported from Japan are not radioactive.
Following the radiation leaks from the Fukushima Daiichi nuclear power plant in east Japan in March, EMA said May 3 that it was to take a precautionary approach to whether medicines manufactured close by the plant were contaminated.
The B-word is back, and it rhymes with "trouble." With 21 U.S. initial public offerings in April alone, no wonder the barbarians are lined up at the gates, clamoring to get a piece.
