BowTiedBiotech
BowTiedBiotech Podcast
The FDA Shreds The Rulebook | Ep. 940
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The FDA Shreds The Rulebook | Ep. 940

FDA rewrites the rules as biotech bets billions.

Hello Avatar! Welcome to the BowtiedBiotech podcast, where science meets business! If you're fascinated by breakthrough biotech, bold innovations, and the business behind the science, you're in the right place. Each week, we dive into the world of biotech with fresh insights, sharp analysis, and the stories that are shaping the future of health. Whether you’re an industry insider, an investor, or just biotech-curious, we’ve got something for you.

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This week we break down the FDA’s move to make one pivotal trial the new default for drug approvals and what that really means for risk, cost, and evidentiary standards. We unpack Moderna’s regulatory whiplash on its flu vaccine and its mounting legal pressure in the Arbutus patent fight, dig into Compass pushing psilocybin toward the FDA and the infrastructure reality behind the hype, examine a freshly funded Alzheimer’s antibody entrant trying to outdo modest incumbents, and close with J&J and Novartis placing billion-dollar bets on cell therapy manufacturing and next-gen peptide platforms. Policy shifts, legal overhangs, capital allocation, and where the downside hides.

📣🎙️ TODAY’S PODCAST:

[ 2:49 ] The one trial revolution begins
[ 4:42 ] $150 million Phase 3 gamble
[ 5:44 ] The type I error trap
[ 7:22 ] Moderna flu vaccine whiplash
[ 10:32 ] Psychedelics move from fringe
[ 11:17 ] Six to eight hour bottleneck
[ 13:56 ] $175 million Alzheimer’s bet
[ 15:27 ] $1 billion cell therapy buildout
[ 16:32 ] $1.7 billion sci-fi peptides
[ 18:07 ] Moderna Arbutus patent showdown

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CONCLUSION

We hope you are enjoying our first leap into the podcast world! Instead of waiting until everything is perfect, we’re diving in and will continue improving as we go. Feel free to send us your suggestions, feedback, or constructive criticism—we’d love to hear from you!

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ABOUT BOWTIEDBIOTECH

As a reminder, the purpose of the BowTiedBiotech substack is two-fold. Primarily, we aim to provide our scientist audience the tools to build a biotech company and ultimately translate their ideas into medicines for patients. Secondarily, biotech investors may find this substack useful as we will be providing weekly market updates of the public AND private markets as well as heavily leveraging current financing events as teaching examples.

DISCLAIMER

None of this is to be deemed legal or financial advice of any kind. All updates are sourced from publicly available disclosures. Insights are *opinions* written by an anonymous cartoon/scientist/investor.

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