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FDA raises cognitive concerns with PCSK9s; Amgen, Sanofi, Regeneron hit

This article was originally published in Scrip

Executive Summary

Perhaps it was the massive snowstorm that walloped the Northeast on 13 February – one among many striking the US this winter – that had everyone so preoccupied that no one noticed tucked inside Regeneron Pharmaceuticals' annual report was a disclosure the FDA was probing adverse neurocognitive events in PCSK9 inhibitors, a new class of investigational agents aimed at reducing low-density lipoprotein (LDL) cholesterol.

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