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Vertex seeks broader use of CF drug Kalydeco

This article was originally published in Scrip

Executive Summary

Perhaps it was the distraction on the eve of a pending US government shutdown, which had Wall Street jittery on 30 September – with the Dow Jones, S&P 500 and Nasdaq all tumbling – but investors appeared to have mixed emotions over Vertex Pharmaceuticals' news it had submitted a supplemental new drug application (sNDA) to the US FDA to expand the labeling of Kalydeco (ivacaftor) as a monotherapy for cystic fibrosis (CF) patients 6 years or older who have at least one non-G551D gating mutation in the CF transmembrane conductance regulator (CFTR) gene.



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