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Novartis scores 5th FDA 'breakthrough' designation

This article was originally published in Scrip

Executive Summary

Novartis appears to be out front of its competitors when it comes to gaining breakthrough therapy designations from the FDA, with the fifth one rolling in for the company, this time for its personalized cell therapy CTL019, an experimental chimeric antigen receptor (CAR) therapy under investigation to treat pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL).

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