Pennsylvania U.S. Attorney is seeking documents related to the formulary status of proton pump inhibitors Prilosec and Nexium at a regional health maintenance organization and a national pharmacy benefits manager, AstraZeneca announces in recent third-quarter earnings report. The firm says it "intends to cooperate fully" with the document requests. AstraZeneca's Nexium marketing is the target of a consumer suit filed in U.S. Superior Court last month (1"The Tan Sheet" Oct. 24, 2004, p. 11)...
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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.’
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
