Collective top-line data from the Phase III program testing Vertex Pharmaceuticals' protease inhibitor telaprevir in treatment-naïve and treatment-experienced hepatitis C patients set a high bar for competitors, particularly for Merck & Co.'s boceprevir, with which telaprevir is dueling to be the first approved specifically targeted antiviral therapy for hepatitis C (STAT-C).
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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 new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
