White House health and economic advisor Mark McClellan, MD/PhD, unanimously confirmed by Senate Oct. 17 after Health Committee member Jeff Bingaman (D-N.M.) lifted hold on nomination (1"The Tan Sheet" Oct. 14, 2002, p. 7). Confirmation comes 21 months after former Commissioner Jane Henney, MD, left office. Although no swearing-in date had been set as of Oct. 18, FDA's Science Board meeting in Rockville, Md. Oct. 25 could mark his first public appearance as commissioner. Meeting agenda lists introductory remarks to be given by McClellan "pending confirmation." Meeting will include discussion of CFSAN counterterrorism efforts, CDER's drug GMP initiative...
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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 gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
