One To Watch: Ruling On AZ’s First-In-Class Anemia Drug Roxadustat Expected Shortly
Label Warning Will Be Key
AstraZeneca is in pole position to open up the HIF-PH inhibitor market – but GSK has a rival in the wings.
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Roxadustat CKD Doubts Fanned By FibroGen Data Blunder
AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.
AstraZeneca’s COVID-19 Vaccine PR Nightmare Won’t Faze Investors
Comment: While the travails around the COVID-19 vaccine continue, AstraZeneca has plenty in its pipeline to cheer investors.
AstraZeneca/FibroGen’s Roxadustat Comparison To ESAs In Anemia May By Clarified At FDA Advisory Cmte.
Payers would welcome any additional clarity provided by advisory panel review, given the perception, expressed in a recent ICER report, that the evidence is insufficient to determine whether the new drug is safer or more effective than erythropoiesis-stimulating agents.