Exelixis Building A Pipeline Out Of A Product, Unveils Cabozantinib Activity Across Tumor Types At ASCO
• By Shirley Haley
Exelixis Inc. is set to file the first NDA for its dual MET/VEGF2 inhibitor cabozantinib by the end of the year, but as that project winds down, plans for a suite of new indications are in the works as the company tries to leverage its asset as fully as possible.
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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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The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.