FDA Vouchers, Orphan Cures & IP with Joshua Kresh

In this week’s episode, John breaks down the White House headlines, the FDA’s new wave of priority review vouchers, and September approvals, then celebrates National IP Month with guest Joshua Kresh. We dig into criteria for the new wave of CNPVs, domestic manufacturing pushes (Augmentin XR and ketamine), and why some approvals matter for patients who’ve run out of options. John also unpacks the Orphan Cures Act debate, the latest CBO chatter, and what it all means for long-term innovation. Finally, Joshua explains why IP is the backbone of biotech and flags fixes on eligibility, injunctions, and PTAB. Tell us what you think and we may feature your comment next week.What’s your take on the FDA’s new voucher selections - smart acceleration or risky subjectivity? Should Congress protect the Orphan Cures Act or revisit it in light of CBO’s estimates?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Disclaimers0:23 Welcome & episode setup0:46 Headlines: White House update & FDA Vouhcer program1:20 FDA criteria & first recipients (overview)3:00 Domestic manufacturing: Augmentin XR & ketamine3:55 Approvals Corner: September FDA approvals4:54 Orphan Cures Act: fix, CBO score & repeal talk6:49 Tracking investor sentiment: life science & rare disease8:05 National IP Month intro8:47 Guest Joshua Kresh & IPI’s mission12:36 The big IP issues: eligibility, injunctions (RESTORE), PTAB24:49 Outro & call to actionDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.