Drop Two, Add One: Vertex Adjusts Adaptive Trial Seeking An All-Oral HCV Regimen
• By The Pink Sheet Daily
The ongoing Phase II study trying combinations backboned by telaprevir and experimental polymerase inhibitor VX-222 continues with two quad-treatment arms and a plan to drop interferon again in the first quarter.
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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 US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.