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The Billion Dollar REMS: Xenazine and the Value of Facing Regulatory Realities

This article was originally published in RPM Report

Executive Summary

Prestwick's Huntington's chorea therapy won FDA approval in August, triggering a flurry of deals valued at over $1 billion. Not bad for a 50-year-old drug expected to treat no more than 5,000 patients-and a powerful case study in how embracing the new regulatory realities can pay off.

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