FDA is continuing to review Takeda's febuxostat NDA past the Jan. 18 user fee deadline. Febuxostat is being considered for the treatment of hyperuricemia in patients with gout; an advisory committee recommended approval (12-0 with one abstention) at a Nov. 24 meeting (1"The Pink Sheet," Dec. 1, 2008, p. 5). The committee expressed concern with a potential cardiovascular signal and encouraged FDA to use its post-approval authorities to require further study. FDA also missed the Oct. 24 user fee date for Takeda's alogliptin; that review is now expected to extend until June 2009 (2"The Pink Sheet" DAILY, Dec. 29, 2008)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
