Selects former Schering legislative affairs director Dennis Jackman as the company's first director of government affairs. Previously, Jackman had served as legislative assistant to Sen. Specter (R-Penn.) and worked as a government and industry for Peat Marwick Main & Co. . . . Shering-Plough: Appoints Richard Kinney staff VP legislative affairs, effective July 1. Kinney, 49, who was Schering's director of state and community affairs, succeeds Diane Darneille. . . .
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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 concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.