Astellas/Cardiome’s Vernakalant Wins Advisory Committee Approval In 6-2 Vote

Antiarrhythmic’s well-characterized safety profile is a “clear differentiator from other pharmacological therapies,” Astellas exec tells “The Pink Sheet” DAILY.

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EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.