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Behind The Approval Letter: Drug Review Profiles

Executive Summary

A listing of the Drug Review Profile series articles published in the Pink Sheet.

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Will Fortune Favor The Brave? Biosimilar Sponsors Need High Tolerance For Uncertainty

Regulatory framework for biosimilars is still a work in progress, especially on the analytical and labeling issues that featured in the Pink Sheet's Drug Review Profile of Zarxio.

Repatha Was Almost Derailed By Formulation Bridging Concerns

FDA's worries about sufficiency of long-term safety data were exacerbated by 'weak' bridging data between two formulations; agency decided against refuse-to-file action but directed Amgen to immediately begin new PK/PD study.

Praluent Sponsors Set Tone For PCSK9 Labeling, Post-Marketing Negotiations

Sanofi and Regeneron's 'extended negotiations' with FDA on requirements would later apply to Amgen's Repatha.

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