After implementing a workforce reduction of 1,900 U.S. employees in January, Abbott Laboratories Inc. in recent months had re-organized its diversified company into three units – proprietary pharmaceuticals, durable growth products and innovation-driven devices. Its latest announcement cements that change: Abbott will divide into a diversified medical products company, to retain the Abbott name, and a research-based pharmaceuticals company, which will take a new, to-be-determined name.
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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.
