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EU Transparency Directive Revisions May Accelerate Access To New Medicines, But IP Issues Set To Cause A Storm

 
• By Faraz Kermani

Proposed revisions to the EU Transparency Directive could drive faster access to medicines. But innovative product sponsors say IP rules will damage their business.

Proposed revisions to the European Commission’s Transparency Directive, which aims to speed access to medicines in Europe by shortening the often lengthy national pricing and reimbursement procedures, could slash time to access by a third.

But additional time granted for health technology assessment processes – more or less the norm these days – may render...

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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.