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Latest From Research & Development

Adverse Event Assessment In India Gets Harvard-Built Tool; Will Increased Trial Activity Follow?

Against backdrop of subdued trial activity in the country and concerns about injury compensation, Indian Society for Clinical Research and Harvard's MRCT Centre offer a portal to facilitate a more objective assessment of causality of serious adverse events.

Drug Safety Clinical Trials

Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Regulation Clinical Trials

Intercept's Revised NASH Trial Improves Prospects

The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.

Clinical Trials Research & Development

Catabasis Refutes MRI T2 Biomarker In Duchenne Study

Catabasis says biomarker MRI T2 doesn't work after all in boys with Duchenne's, plans to stick with four-step climb test or 10-meter walk/run test from now on.

Clinical Trials Research & Development

Small Biopharmas Should Be Wary Of Early Results – US FDA Official

Two former Genzyme execs, one of whom now works at CDER, warn small companies to avoid over-emphasizing results from early, uncontrolled trials in their planning and business decision-making.

Research & Development Clinical Trials

NIH Director Collins Stays On: Continuity For ‘Moonshot’ – And Barrier To ‘March In’

For industry, the sole health agency head held over from the Obama Administration means the ‘Moonshot’ priorities will move forward – and one possible threat to pricing is cut off.

Research & Development Pricing Debate
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