Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline
Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.
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Pricing of $31,000 annually for GSK/J&J's single-tablet, two-drug HIV regimen Juluca (dolutegravir/rilpivirine) is on par with marketed fixed-dose combinations that include integrase inhibitors.
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