Merck and Schering-Plough are talking up the future - the commercial, pipeline and cost savings advantages of a proposed $41.1 billion merger - like newlyweds who have already tied the knot, danced the first dance and cut the cake. But there's an uninvited guest at the affair, Johnson & Johnson, a third-party with bargaining power that could step in to thwart Merck and Schering's happily ever after
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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.’
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
