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Clinical / R&D

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Latest From Research & Development

Clinical Outcome Assessments To Be Developed Under US FDA Grants

The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.

Clinical Trials Drug Review

Pain/Addiction Products Need Regulatory Streamlining To Incentivize Development, Sponsors Say

Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.

Review Pathway Research & Development

Evolution In Clinical Outcome Assessments Reflected In US FDA’s Revised Gastroparesis Guidance

Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.

Drug Approval Standards Clinical Trials

Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients

US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.

Drug Approval Standards Cardiovascular

Cures 2.0: Can Congress Recapture The Legislative Magic?

Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?

Legislation Review Pathway

NHS England Tackles Barriers To Use Of Cannabis-Based Medicines

A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns. 

United Kingdom Neurology
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