Novartis Gambles Priority Review Voucher On Ilaris Gout Indication
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Stakeholders are sympathetic to FDA's concerns that voucher program requires diversion of precious resources, but some believe it provides substantial drug development incentive, particularly for small companies.
FDA’s Anti-Infective Drugs Advisory Committee will review J&J’s product, a diarylquinolone, for the treatment of multi-drug resistant pulmonary tuberculosis on Nov. 28.
WHO committee backs use of pooled funds to finance R&D, nixes priority review vouchers and finds no need for data exclusivity. Novartis’ Paul Herrling, a committee member, notes that governments would be responsible for R&D costs.