FDA will essentially play the part of a sponsor during the Aug. 4 pharmaceutical science panel meeting, arguing for favorable approval standards, while the brand sponsor, ViroPharma, will play the role of skeptic.
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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.’
