FDA's licensure of Serono's Rebif marks the first time the agency has overridden orphan drug exclusivity based on an efficacy endpoint, a March 7 1Office of Orphan Products Development memo outlining FDA's rationale for the approval states
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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.’
Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.
Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.
One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.
