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by Alex Kesin and Matthew Pech
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- 5 days ago2h 7m
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 patent cliff, the Keytruda QLEX subcutaneous launch, and efforts to find the next blockbuster checkpoint inhibitor, including Summit/Akeso's PD-1 / VEGF bispecific ivonescimab.This episode is presented by JLL. Featuring Grant Dettmer on biotech real estate strategy.CHAPTERS 00:00:00 — Introduction: The Best-Selling Cancer Drug of All Time 00:02:15 — Part One — A Century of Failed Cancer Immunotherapy 00:04:17 — T Cells, CD28, and the Two-Signal Model of Immune Activation 00:06:25 — Jim Allison's CTLA-4 Discovery and the Path to Yervoy 00:12:03 — Tasuku Honjo Discovers PD-1: A Better Brake on T Cells 00:14:26 — Lieping Chen and the PD-L1 Tumor Evasion Hypothesis 00:16:26 — Part Two — Organon: The Dutch Paint-Company Subsidiary Behind Keytruda 00:19:48 — How Michel Streuli Caught the Solid-Phase Screening Artifact 00:22:09 — The Accidental Antagonist: From Rheumatoid Arthritis Drug to Cancer Drug 00:26:34 — Sponsor: Grant Detmer (JLL) on Biotech Real Estate Strategy 00:30:01 — Russian Nesting-Doll M&A: Schering-Plough Acquires Organon (2007) 00:31:43 — The $41 Billion Merck–Schering-Plough Mega-Merger of 2009 00:34:58 — Corporate Guerrilla Warfare: Four Scrappy Stunts That Saved Pembrolizumab 00:39:32 — BioNovion's Spite-Company Bid to Buy Pembro Back 00:42:10 — BMS at ASCO 2010: The Data Print That Revived Merck's PD-1 Program 00:45:55 — Part Three — Roger Perlmutter Joins a Bleeding Merck (April 2013) 00:50:48 — "Let Me Manage the Tigers": Ken Frazier Backs the All-In Bet on Pembrolizumab 00:55:22 — Breakthrough Therapy Designation and Eric Rubin's Adaptive Trial Design 00:58:25 — Keytruda's 2014 FDA Approval Erases BMS's Four-Year Lead 01:00:24 — The Lung Cancer Battlefield and the PD-L1 Biomarker Bet 01:02:19 — BMS vs. Merck: All-Comers vs. Biomarker-Enriched Trial Strategy 01:08:18 — KEYNOTE-024 vs. CheckMate-026: The Trial That Decided the Category 01:12:03 — Luis Diaz, MSI-H, and the Failed BMS Trial That Made Keytruda Tissue-Agnostic 01:17:18 — KEYNOTE-189: Perlmutter's Bet on Combining Keytruda with Chemotherapy 01:19:21 — Merck's Clinical Development Playbook: Basket Trials, Backwards March, External Collabs 01:25:29 — Part Four — The IO Graveyard: TIGIT, CD47, IDO1, LAG-3 and Tens of Billions Incinerated 01:30:23 — Why PD-1 Was the Only Checkpoint That Worked (Lieping Chen Revisited) 01:33:32 — Part Five — Inside the Best-Selling Drug of All Time 01:37:03 — "Build a Wall, High and Wide": Merck’s Commercial Strategy for Keytruda 01:43:44 — Part Six — The Patent Cliff and Loss of Exclusivity in Pharma 01:45:35 — Keytruda QLEX (Subcutaneous) and the Lifecycle Management Playbook 01:50:23 — PD-1/VEGF Bispecifics: Ivonescimab, Summit Therapeutics, and the Next Threat 01:55:31 — The Scorecard: Patient, Academic, and Financial Impact 02:01:19 — Who Actually Profited: Merck vs. Organon vs. the Scientists Who Built the Drug 02:05:54 — Epilogue: The Jimmy Carter DrugSourcesLast updated: May 2026Essential readingShaywitz, David. "The
- Mar 13, 20262h 22m
Episode #2: Geron
Listen on SpotifyListen on Apple PodcastsListen on YouTubeTABLE OF CONTENTS - Introduction - Hayflick Limit - Michael West & Founding of Geron - Early Science & IP Strategy - Cloning the Telomerase Gene - Embryonic Stem Cells & Political Context - Okarma, West’s Departure & Corporate Turmoil - Spinal Cord Injury Trial - Pivot to Blood Cancer - Clinical & Commercial Drama - Legacy & LessonsCREDITSCo-hosted by Alex Kesin and Matthew PechWritten, edited, and produced by Alex KesinMusic: “Food” by nerowski* Special thanks to the team at NFX for the use of their recording studio.SOURCESLast updated: March 2026I. BOOKSHall, 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 SCIENTIFIC PUBLICATIONSHayflick, L. & Moorhead, P.S. “The serial cultivation of human diploid cell strains.” Experimental Cell Research 25 (1961): 585–621.Kim, N.W. et al. “Specific association of human telomerase activity with immortal cells and cancer.” Science 266, no. 5193 (1994): 2011–2015.Feng, J. et al. “The RNA component of human telomerase.” Science 269, no. 5228 (1995): 1236–1241.Nakamura, T.M. et al. “Telomerase catalytic subunit homologs from fission yeast and human.” Science 277, no. 5328 (1997): 955–959.Meyerson, M. et al. “hEST2, the putative human telomerase catalytic subunit gene, is up-regulated in tumor cells and during immortalization.” Cell 90, no. 4 (1997): 785–795.Bodnar, A.G. et al. “Extension of life-span by introduction of telomerase into normal human cells.” Science 279, no. 5349 (1998): 349–352.Thomson, J.A. et al. “Embryonic stem cell lines derived from human blastocysts.” Science 282, no. 5391 (1998): 1145–1147.Asai, A. et al. “A novel telomerase template antagonist (GRN163) as a potential anticancer agent.” Cancer Research 63, no. 14 (2003): 3931–3939. Herbert, B-S et al. “Effect of the lipid modification of GRN163.” Nature: Oncogene 24 (2005): 5765–5772. Baerlochr, G. et al. “A pilot study of the telomerase inhibitor imetelstat for myelofibrosis.” New England Journal of Medicine 373 (2015): 908–919. Platzbecker, U. et al. “Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge).” The Lancet (2024).Lennox, A.L et al. “Imetelstat, a novel, first-in-class telomerase inhibitor: Mechanism of action, clinical, and translational science.” Clinical and Translational Science 17, no. 11 (2024).Scott, C. & Magnus, D. “Wrongful Termination: Lessons From the Geron Clinical Trial” Stem Cell Reports 3, no. 5 (2014): 721–723. III. REGULATORY & CLINICALPrescribing Information (Label) U.S. Food and Drug Administration. “RYTELO (imetelstat) for injection: Highlights of Prescribing Information.
- Jan 30, 20261h 46m
Episode #1: Amylin Pharmaceuticals
Listen on SpotifyListen on Apple PodcastsListen on YouTubeTABLE OF CONTENTS - Introduction - $50 of Dried Lizard Venom - Fax of Death - Sleeping Beauty Awakens - Carl Icahn Sends a Letter - Endgame - Postmortem & PlaybookCREDITSCo-hosted by Alex Kesin and Matthew Pech Written, edited, and produced by Alex KesinMusic: “Food” by nerowski* Special thanks to the team at NFX for the use of their recording studio.SOURCESLast updated: January 2026I. PRIMARY DOCUMENTSFDA Regulatory DocumentsSymlin (pramlintide acetate) - NDA 21-332* Approval Letter & Package (March 16, 2005)* Medical Review* Statistical Review* Clinical Pharmacology & Biopharmaceutics Review* Administrative Documents & CorrespondenceByetta (exenatide) - NDA 21-773* Approval Letter & Package (April 28, 2005)* Medical Review* Statistical Review* Clinical Pharmacology & Biopharmaceutics Review* Administrative Documents & CorrespondenceBydureon (exenatide ER) - NDA 22-200* Approval Letter (January 27, 2012)* Other Action Letters (Complete Response)* Summary Review* REMS* Administrative CorrespondenceSEC Filings & Financial Documents* Amylin 2005 Results Press Release (Ex-99.1, 8-K)* Amylin 2007 Results Press Release (Ex-99.1)* Amylin 2011 Form 10-K (Net Product Sales)* Carl Icahn SEC Filing (Schedule 13D)Proxy Fight & Legal Documents* Carl Icahn Letter to Amylin (April 15, 2009)* Amylin Response to Icahn (April 20, 2009)* Police Fund v. Bradbury (Amylin) Trial (May 4, 2009)* Lilly Litigation Ruling (May 25, 2011)II. ORAL HISTORY & INTERVIEWS* Howard Greene Oral History (UCSD Library, October 8, 2008) - Primary source for Hybritech founding, Ted Greene’s background, a
About Approved
Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology. www.approved.fm
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