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Latest From Astellas Pharma Inc.

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.

Advisory Committees Cardiovascular

Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan

Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.

Europe Drug Review

Astellas To Pay $3bn For Gene Therapy Company Audentes

Japanese company joins the ranks of big pharma buying up gene therapy pioneers

Asia Pacific Gene Therapy

A Year Of Reconsiderations For US FDA Advisory Committees

Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.

Advisory Committees Drug Review
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