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.
Low influenza activity in the face of COVID-19 mitigation measures has made it more difficult to predict which strains may become predominant, but US FDA advisory committee unanimously endorses WHO recommendations for influenza A and B strains to be included in US trivalent and quadrivalent vaccines.
Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.