PD-1 Fatigue: Cross-Labeling May Help Pare Checkpoint Inhibitor Pipeline
Executive Summary
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.
You may also be interested in...
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.
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan
US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.