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‘Project Facilitate’: US FDA Plans May Meeting On Expanded Access Call Center

Oncology Center of Excellence pilot program is intended to make the single patient IND process easier to navigate and more efficient; regulatory project managers will help walk providers through the process and provide contact information for drug companies and institutional review boards.

Clinical Trials Review Pathway

J&J’s Esketamine: A Model “Breakthrough” Program For US FDA

J&J’s treatment-resistant depression drug esketamine had an easy time at an FDA advisory committee despite raising some tough regulatory questions. If you are looking for a showcase of how “Breakthrough” drug development collaboration can help a new therapy get to patients faster, this might be it.

Review Pathway Approvals

Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot

Genentech/AbbVie drug becomes the seventh product known to be pilot-testing US FDA's new pathway; our infographic details the program's goals and how it has been used so far for more efficient reviews of supplemental oncology indications.
Drug Review Review Pathway

Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

Our chart details the pipeline candidates who might lose the coveted status as treatment paradigms change and trial results come in.
Review Pathway Drug Review

Breaking Up With Breakthrough: Trevena And Tonix Lose Designation, But Continue With Pivotal Plans

US FDA rescinds breakthrough designations for Tonix’ PTSD therapy Tonyma and Trevena’s novel pain drug Olinvo after clinical trial disappointments – and after identifying other regulatory pathways to market.
Review Pathway Neurology

MHRA Reinforces Brexit Road-Map, Indian Firms Expect Tough Transition

The MHRA highlighted at a recent conference in India the key changes that await pharma in the event of a no-deal Brexit, and the agency’s general readiness in that scenario, including putting in place its own IT systems such as a UK national replacement for the EudraGMDP.
Regulation Review Pathway

EU Accelerated Assessment Tracker

Accelerated assessment requests at the European Medicines Agency.

Review Pathway Europe

EU ‘Repurposing’ Project Plans Pilot Phase

A dedicated working group is taking forward a drug repurposing proposal originally devised by European industry bodies, with a view to determining the procedures to be used and running a pilot project with individual drug candidates.
Research and Development Strategies Regulation

EU Accelerated Assessment Tracker 2018: Rejection Rates Remain High

The European Medicines Agency will fast-track Shionogi’s new antibiotic, cefiderocol, through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, entrectinib. More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.

Europe BioPharmaceutical
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