In this episode, John Stanford breaks down the surge in U.S. biomanufacturing investments, including Virginia’s new $500B hub, and what it means for the nation’s workforce. He contrasts this expansion with the recent closure of Arena BioWorks, raising questions about the balance between onshoring and sustaining innovation. The discussion also dives into major rumors of a potential Medicare-GLP-1 deal with Eli Lilly and Novo Nordisk and explores the possible implications of new CMS demonstration projects that could impact Part B manufacturers. Finally, John reflects on the growing pressure of tax and pricing policies that could reshape the biotech landscape. Do you think the U.S. is striking the right balance between manufacturing and innovation? How might Medicare coverage of GLP-1 drugs change the healthcare system? What policy signals should Congress send to protect early-stage biotech?

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0:00 Disclaimer and introduction
0:23 Welcome to the Making Medicine Podcast
0:57 FDA leadership shakeup and industry uncertainty
2:06 Arena BioWorks closure and policy contrasts
2:32 FDA predictability and regulatory challenges
3:28 Medicare and GLP-1 coverage discussion
4:08 New FDA guidance on biosimilars and gene editing
5:00 FDA moves to reduce biosimilar development costs
5:49 Gene editing progress and regulatory flexibility
6:53 Impact of pricing and revenue policies on innovation
7:48 Arena BioWorks shutdown and biotech investment climate
10:40 Virginia’s new manufacturing hub and workforce initiative
13:14 White House drug pricing rumors and CMMI demonstration projects
17:39 Closing thoughts and call for engagement 

DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.