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Ilaris Complete Response Letter Raises Questions About The Validity of Priority Review Vouchers

Executive Summary

What’s a Priority Review Voucher worth? That’s a complicated question now that the first voucher used on an application, from drug maker Novartis AG for Ilaris (canakinumab), has received a complete response letter from US regulators.

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FDA’s innovative priority review voucher, intended to incentivize the development of new drugs for neglected diseases, may actually have created a hurdle in some cases.

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