Roche's Copegus Meets Generic Competition
This article was originally published in The Pink Sheet Daily
FDA approves ANDAs filed by Three Rivers, Teva and Zydus, with Three Rivers offering a higher-dose tablet than currently available from the brand company.
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Three Rivers/Par launch Ribasphere at a 10% discount to Schering-Plough’s Rebetol. The generics are approved for use in combination with interferon alfa-2b for the treatment of hepatitis C.
Benefits of independence from exogenous insulin outweighed the risks from long-term immunosuppression necessary with the allogeneic pancreatic islet cellular therapy, majority of panelists said, but they urged the FDA to limit the indication to a very small subpopulation of patients.
Agency wants to use pandemic-interrupted clinical trials to gauge how decentralized approaches impacted study integrity and to inform prospective use of such designs post-COVID.