Amylin is planning a six-week Symlin safety study to evaluate the increased incidence of hypoglycemia associated with the antidiabetic agent, the company said following a July 26 FDA advisory committee recommendation against approval of the drug.
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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.’
