Approved

Approved

Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology.
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Резюме на епизода

The wild story of how a Cold War bioweapon became Botox — and how Allergan turned a sleepy ophthalmology drug into an enduring aesthetic franchise. Every part of this story looks nothing like your normal blockbuster drug. Botox started its development storyas a Cold War bioweapon so lethal the CIA was thinking of using it on Castro. Decades later, an eye surgeon in San Francisco mortgaged his house and managed to bootstrap his way to a BLA– no venture capital needed! After a contentious sale to a sleepy eye-drop company called Allergan, it turned Botox into one of the most durable, recurring-revenue franchises in the history of medicine. That cash cow provoked all sorts of financial battles– a hostile takeover attempt involving Bill Ackman, a tax-inversion scheme with Pfizer that united Bernie Sanders and Donald Trump in opposition, and a far-fetched plan to rent a Native American tribe's sovereign immunity to protect a different drug's patents. In this episode, we trace Botox from a 19th-century German…

Епизоди

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Allergan: Botox, Rogue Scientists, and the Ultimate Beauty Franchise

The wild story of how a Cold War bioweapon became Botox — and how Allergan turned a sleepy ophthalmology drug into an enduring aesthetic franchise. Every part of this story looks nothing like your normal blockbuster drug. Botox started its development storyas a Cold War bioweapon so lethal the CIA was thinking of using it on Castro. Decades later, an eye surgeon in San Francisco mortgaged his house and managed to bootstrap his way to a BLA– no venture capital needed! After a contentious sale to a sleepy eye-drop company called Allergan, it turned Botox into one of the most durable, recurring-revenue franchises in the history of medicine. That cash cow provoked all sorts of financial battles– a hostile takeover attempt involving Bill Ackman, a tax-inversion scheme with Pfizer that united Bernie Sanders and Donald Trump in opposition, and a far-fetched plan to rent a Native American tribe's sovereign immunity to protect a different drug's patents. In this episode, we trace Botox from a 19th-century German…

18 сеп. 2026
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What is Approved?

Approved tells the definitive stories behind the world's most interesting biotech ventures. Most people learn about the industry in a fragmented, ad hoc way-- an industry article here, a clinical trial readout there, some science twitter. In contrast, The Approved podcast tells comprehensive, definitive stories of how drugs are discovered, developed and sold. Whether we're tracking a single blockbuster drug's remarkable rise, or following a single startup’s decade-long path to approval, every episode we put out is an unvarnished look at how the biotech industry works. We break down what worked, what failed, and distill insights that you can apply to your own life science business. Every episode is accessible and entertaining, but ultimately designed for the life science professional. Hosted by Matthew Pech, PhD (cancer biologist and drug hunter) and Alex Kesin (biotech writer), every episode draws on hundreds of hours of research -- including Nature papers, corporate decks, SEC filings, and legal records.…

14 сеп. 2026
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Blueprint Medicines: Chasing Gleevec to a $9B Allergy Drug

Blueprint Medicines was built to find the next Gleevec-style cancer drug. It ended up pivoting to allergic disease instead, and selling to Sanofi for $9B. This is the platform, the pivot, and who got paid. Blueprint Medicines set out to be the natural sequel to Gleevec: a company founded by two of the scientists behind that landmark cancer drug, built to order by Third Rock Ventures' "venture creation" model, with a proprietary kinase-inhibitor library designed to drug the 517 other broken molecular switches Gleevec couldn't touch. A decade later, Sanofi paid roughly $9 billion for the company... just not for a cancer drug. Blueprint's blockbuster asset, avapritinib (AYVAKIT), found its real market almost by accident: indolent systemic mastocytosis, a debilitating, often-undiagnosed mast-cell disease that took patients years to get diagnosed and had no approved treatment. In this episode, we trace two threads at once: the science of designing truly selective kinase inhibitors, and the venture capital…

04 авг. 2026
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Keytruda: How Merck's Pembrolizumab Became the Best-Selling Cancer Drug of All Time

Keytruda is Merck's $31 billion a year PD-1 inhibitor and the best-selling cancer drug of all time. In Episode 3 of Approved, Alex Kesin and Matthew Pech trace the development of pembrolizumab , featuring interviews the scientists who drove the program forward : co-inventors Gregory Carven and Michel Streuli, and former Merck oncology CMO Roy Baynes. Topics include preclinical PD1 / CTLA-4 checkpoint biology that brought industry attention to the target (Jim Allison's CTLA-4 work and Tasuku Honjo's PD-1 discovery); how pembro started as a failed rheumatoid arthritis antibody program at a Dutch subsidiary of a paint company; the two mega-mergers that nearly killed the program; the biomarker enrichment trial design behind KEYNOTE-024 that let Merck break BMS's lead in lung cancer; the 41-patient Johns Hopkins MSI-H trial behind the first tissue-agnostic FDA approval, and the Jimmy Carter melanoma case that brought pembrolizumab to the public conscious. The episode closes on what comes next for Merck: the 2028…

14 май 2026
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Episode #2: Geron

Listen on Spotify Listen on Apple Podcasts Listen on YouTube TABLE OF CONTENTS (00:00:00) - Introduction (00:01:19) - Hayflick Limit (00:08:30) - Michael West & Founding of Geron (00:15:16) - Early Science & IP Strategy (00:27:25) - Cloning the Telomerase Gene (00:29:30) - Embryonic Stem Cells & Political Context (00:44:21) - Okarma, West’s Departure & Corporate Turmoil (01:05:08) - Spinal Cord Injury Trial (01:30:45) - Pivot to Blood Cancer (01:43:08) - Clinical & Commercial Drama (02:01:45) - Legacy & Lessons CREDITS Co-hosted by Alex Kesin and Matthew Pech Written, edited, and produced by Alex Kesin Music: “Food” by nerowski * Special thanks to the team at NFX for the use of their recording studio. SOURCES Last updated: March 2026 I. BOOKS Hall, Stephen S. Merchants of Immortality: Chasing the Dream of Human Life Extension. Houghton Mifflin, 2003. Williams, Tory. Inevitable Collision: The Inspiring Story That Brought Stem Cell Research to Conservative America.Mary Ann Liebert, Inc., 2014. II. KEY…

13 мар. 2026