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.’
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
