Novartis Transderm Scop: Scopolamine patch will be available later this year following resolution of manufacturing issues with Alza regarding consistency of drug delivery. The patch, previously approved for motion sickness, received "approvable" status April 22 for prevention of peri-operative nausea ("The Pink Sheet" May 12, In Brief). The duration of therapy for the new indication will depend on the operative procedure and on the physician's discretion. The product can be used up to 72 hours prior to surgery...
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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.
