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PCSK9 Sponsors Looked For Regulatory Advantages In Race To Market

Executive Summary

Both Sanofi/Regeneron and Amgen coveted priority review for their LDL-cholesterol-lowering agents, but the Praluent sponsors' purchase of a voucher gave them the definitive edge. Amgen found no help in the breakthrough program, with FDA twice denying designation requests for Repatha, review documents show.

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Gilead Buys Its Third Priority Review Voucher, But Is The Mania Over?
How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say

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