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Second CHMP knock back for Novartis's serelaxin

This article was originally published in Scrip

Executive Summary

The EU's CHMP has again refused to recommend approval of Novartis's acute heart failure therapy RLX030 (serelaxin), just weeks after the FDA rejected the BLA in the US (scripintelligence.com, 16 May 2014). The EU committee originally said no in January and has now confirmed its stance after Novartis requested a re-examination the following month.

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