NutraGenics: Phoenix-based biopharmaceuticals company forms joint venture with Chicago-based InCon Technologies to manufacture, market and sell specialty products for the dietary supplement, food ingredient, H&BA and animal feed markets. The companies expect to introduce 12 new products in the next year...
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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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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.