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.’
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
