Merck-Schering Merger Requires Divestiture of Phase II Antiemetic Due To Emend's Strength
FTC says Schering must divest its NK-1 receptor antagonist relapitant. Merck must also sell its interest in a $2.6 billion animal health joint venture.
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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.’
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Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.
Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.
Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.