FDA Priority Review Voucher Scheme Under Fire

The Drugs for Neglected Diseases initiative and Medecins Sans Frontieres are calling into question the validity of the US Food and Drug Administration’s present priority review voucher system, citing the case of the $125 million Knight Therapeutics has recently received from Gilead Sciences.

In particular, DNDi and Medecins Sans Frontieres are turning up the heat on Knight, which got the PRV in March in connection with approval for its leishmaniasis drug Impavido (miltefosine) and the firm’s ex-US distribution and manufacturing partner Endo.

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