Novartis Gambles Priority Review Voucher On Ilaris Gout Indication
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Priority Review Vouchers: Does Novartis Have User's Regret?
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.
J&J’s Bedaquiline Advisory Cmte. Could Test Strength Of Phase II Argument For Tuberulosis Drugs
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.
R&D For Diseases Of Developing Countries Could Be Driven By Pooled Funds
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.
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