Novartis Prexige NDA Re-Submission Expected In 2006; TARGET Data Are Clean, Firm Says
Novartis had earlier predicted a lumiracoxib launch in 2005, should FDA accept existing data to satisfy a request for a hip osteoarthritis study. The long-term TARGET study data have been unblinded, and Novartis sees no “surprises” with regard to Prexige’s liver or cardiovascular safety.
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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.’
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The African Medicines Agency is to appoint a director general and become operational at the end of this month.
After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.
Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.