Ellis Unger’s US FDA Farewell Address?
The US FDA advisory committee review of AstraZeneca/FibroGen’s roxadustat for anemia was the last in the long tenure of Office of Cardiology Director Ellis Unger. His opening remarks struck a valedictory tone.
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FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy
But advisory committee members see a potential opportunity for the oral anemia drug in small percentage of dialysis-dependent patients not responsive to erythropoiesis-stimulating agents; FibroGen’s revised dosing algorithm, aimed at slowing hemoglobin rate of increase and reducing risk of thrombosis, needs to be clinically tested before marketing approval, panelists said.
Moderna And The All-American Drug Pricing Hearing
Moderna’s time in the hot seat of the US drug pricing debate went about as well as it could for the company. The firm astutely set a tone of an All-American success story – but the hearing also showcased other ‘only in America’ themes.
Xtandi Still Faces Likely US Price Cut Even As It Avoids ‘March In’ Proceeding
The Biden administration decision not to pursue ‘march in’ proceedings for Pfizer/Astellas’ Xtandi sounds like good news. The reality is that the prostate cancer therapy is likely to face a more certain federal pricing intervention in the first year of the new Medicare ‘negotiation’ process.