INTERNEURON DEXFENFLURAMINE ADVISORY COMMITTEE REDUX NOV. 16: FDA's Endocrinologic & Metabolic Drugs Advisory Committee will meet in November to resume discussion of the first long-term obesity therapy, oral dexfenfluramine, Lexington, Mass.-based Interneuron announced Oct. 3. Dexfenfluramine, tradenamed Redux, will be marketed by American Home Products if approved.
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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.’
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
