Pink Sheet Podcast: Election Fallout, IRA Impacting Product Development, Updated US FDA Expanded Access Policy
Pink Sheet reporters and editor discuss the impact of the midterm elections, the Inflation Reduction Act’s effects on drug development, and adjustments to FDA expanded access guidance.
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US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.
Moderna CEO Reminds People About Value Of Government Negotiations At Senate Hearing
Stéphane Bancel also gave conflicting answers for how the company set the cost of its mRNA COVID-19 vaccine as Democratic lawmakers tried to berate Moderna for its coming price hikes. Republicans lawmakers argue against retroactive shaming, saying that if the government wanted to set the eventual commercial price, it should have done that early in negotiations.
Moderna CEO Hearing Highlights Dissatisfaction With Patient Assistance Programs
There was bipartisan agreement that Moderna needs to ensure that its patient assistance program will be easily accessible for under- and uninsured patients once the US switches to a commercial market for COVID vaccines – a sign of broader frustration with industry copay support initiatives.