Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings
Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.
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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.