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Clinical / R&D

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Latest From Research & Development

French Industry Welcomes Moves To Speed Up Access To Innovative Drugs

A French government/industry discussion forum has come up with concrete plans for accelerating access to innovative medicines by streamlining clinical trial approval and price negotiations.

France Innovation

Ex-US FDA Director John Jenkins Sketches Regulatory Path For Esperion's Bempedoic Acid

Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.

Clinical Trials FDA

Breakthrough, Priority Review Designations Could Set High-Water Marks In 2018

Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018. 
Drug Review Review Pathway

Real-World Evidence Could Help Relax Clinical Trial Enrollment Criteria

FOCR study suggests overall survival for PD-1s seen in real-world datasets is similar to results from clinical trials.

Cancer Drug Approval Standards

Bharat Biotech Justifies Trial Site Shifts For Tetravalent Vaccine

Trial-related challenges in India appear to have pushed vaccine maker Bharat Biotech towards opting for alternative sites for studies on its tetravalent vaccine. The firm says it has justified its position to the regulator, though some experts advise diligence in site selection.

India Regulation

Global Blood Makes Case For Accelerated Approval Of Sickle Cell Drug Voxelotor

Plan to pursue accelerated approval carries risk that US FDA will ask for more data, which could significantly delay the launch, some analysts warn.

FDA Blood & Coagulation Disorders
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