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Amgen’s Evolocumab At FDA: Dawn Of PCSK9 Era Still Cloudy

This article was originally published in The Pink Sheet Daily

Executive Summary

Firm files BLA for eagerly-awaited PCSK9 inhibitor for high cholesterol, amid continued uncertainty on surrogate markers in cardiovascular trials; Amgen’s heart failure drug ivabradine now has priority review status from FDA and drug could help pave the way for evolocumab.

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