'Disruption' In Action: Lilly Tries To Upend PD1 Pricing – But Instead Upsets US FDA
Lilly set out to “disrupt” US pricing models for checkpoint inhibitors by working with Innovent to seek US FDA approval of sintilimab. Did it end up disrupting its own relationship with the FDA?
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Advisory committee says additional trials needed to demonstrate applicability of ORIENT-11 results to US population; in opting to seek approval only with Chinese data, Innovent said it relied on 2019 comments by FDA’s Richard Pazdur, but the oncology center head said therapeutic and societal changes have caused an evolution in the agency’s thinking.
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?
The US Medicare Payment Advisory Commission is continuing its work on proposals to overhaul federal payment for physician administered drugs. That is an ominous message for the biopharma industry as it reels from passage of dramatic pricing legislation earlier this year.