PD-1 Fatigue: Cross-Labeling May Help Pare Checkpoint Inhibitor Pipeline
US FDA encouraging developers to embrace cross-labeling rather than continue separate development of proprietary PD-1 agents, but agency sounds eager for any other good ideas to pare back the number of checkpoint inhibitors in development.
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Shared Control: Novel Trial Design Works In COVID, But Will Sponsors Buy In?
COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.
Combination Therapies: Incentives Needed To Encourage Labeling Across Products
If sponsors will not work together to ensure that labeling for all drugs used as part of a combination regimen are in sync, then US FDA should take measures to streamline process and Congress may need to step in with carrot or stick incentives, a multi-stakeholder group suggests.
Medicare Proposes Earlier Deadline For Rx Add-On Payment Candidates
Starting in fiscal year 2025, products would need to meet an earlier, May deadline for FDA approval in order to be eligible for enhanced payments in the Hospital Inpatient Prospective Payment System (IPPS). The change would give CMS more to handle the surge in NTAP applications.