Regeneron/Sanofi, Amgen PCSK9 Rivalry Continues, But Not In US Courts
Federal Circuit Affirms Invalidation Of Two Amgen Patents
The battle for PCSK9 inhibitor market share continues with Amgen’s Repatha outselling Praluent, but a now-ended patent dispute no longer threatens Regeneron’s ability to sell its product in the US.
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A resolution in a long-running patent dispute, expansion of coronavirus vaccine production, drug development trends over the past decade, hematological malignancies in a clinical trial, and the last instalment in the Scrip Asks series all feature in this week's podcast version of Scrip's Five Must-Know Things.
The timeline for a US resubmission of the closely watched PCSK9-targeting cholesterol treatment could be either Q2 or Q3 and approval will depend on whether the FDA needs to make a physical inspection of an Italian facility.
ODYSSEY Outcomes data added to US label for Praluent; update includes claim for reduced cardiovascular incident risk and trial data indicating an all-cause mortality benefit.