Since the mid-2000s, GlaxoSmithKline has been working to rejuvenate its R&D organization, which it believed wasn't sufficiently productive. Industry watchers are gauging progress closely, particularly as the cornerstone of its new approach, the division of GSK's drug discovery operations into nearly 40 specialized and idiosyncratic Drug Performance Units, or DPUs, approaches milestone deadlines in 2011, and as the rest of the industry also struggles with R&D productivity.
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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.’
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
