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By: Alex Kesin and Matthew Pech
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 Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology.Alex Kesin
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  • Episode #2: Geron

    Episode #2: Geron
    Mar 13 2026
    Listen on SpotifyListen on Apple PodcastsListen on YouTubeTABLE 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 & 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.” NDA 217779. June 2024. NDA Approval Letter U.S. Food and Drug Administration. “NDA Approval Letter: RYTELO (imetelstat) for injection.” NDA 217779. June 6, 2024. Multi-Discipline Review & Evaluation U.S. Food and Drug Administration. “NDA Multi-Disciplinary Review and Evaluation: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. ODAC Briefing Document U.S. Food and Drug Administration. “FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, NDA 217779, Imetelstat.” March 14, 2024. REMS/Risk Assessment Review U.S. Food and Drug Administration. “Risk Assessment and Risk Mitigation Review: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. Kim, N. et al. “US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia.” The Oncologist (2025). PMID: 41135032.FDA. “FDA Approves Imetelstat for Low- to Intermediate-1-Risk Myelodysplastic Syndromes with Transfusion-Dependent Anemia.” June 2024.ICER. “Evidence Report: Treatment for Anemia in Myelodysplastic Syndrome.” August 2024. ICER. Press Release on Imetelstat Evidence Assessment. ClinicalTrials.gov. GRNOPC1 Phase I Trial. NCT01217008. Myelodysplastic Syndrome Epidemiology. PMC4553145.MDS Risk and AML Progression. Blood (2023). IV. CORPORATE FILINGS & PRESENTATIONS
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    2 hrs and 22 mins
  • Episode #1: Amylin Pharmaceuticals

    Episode #1: Amylin Pharmaceuticals
    Jan 30 2026
    Listen on SpotifyListen on Apple PodcastsListen on YouTubeTABLE OF CONTENTS(00:00:00) - Introduction(00:04:40) - $50 of Dried Lizard Venom(00:29:17) - Fax of Death(00:43:04) - Sleeping Beauty Awakens(00:52:07) - Carl Icahn Sends a Letter(01:09:19) - Endgame(01:13:40) - 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, and early Amylin historyIII. NEWS & TRADE PRESS2000* “The Rumsfeld Resume” - CBS News (December 28, 2000) - Donald Rumsfeld’s board tenure at Amylin (1991-1996)* “Roller Coasting” - Forbes (July 24, 2000) - Joe Cook narrative, J&J partnership collapse2005* “Investing for a Profit and a Daughter’s Health” - NYT (March 19, 2005) - Allen Andersson investment story, “tablecloth deal”2006* “Diabetics see hope (and weight loss) in new drug” - NYT (March 2, 2006) - “Lizzie” nickname, patient testimonials* “4 Diabetes Drugs Are Seen Raising Hope and Profit” - NYT (June 22, 2006) - Manufacturing shortage, 400,000+ patients* “Don’t kill off life-saving drugs” - Heritage Foundation (August 15, 2006) - Policy perspective on Byetta’s potential impact* “Byetta Craze Is First Salvo in Promising New Line of Drugs” - diaTribe - ADA conference chaos, “one man cried”2007* Dr. John Eng Profile - Diabetes In Control (September 18, 2007) - Eng’s discovery story, patent struggles, Amylin vs. Lilly negotiations2008* Xenome/Amylin Partnership - BioSpace (February 5, 2008) - Venom peptide library partnership2009* Eastbourne Capital Sells Stake - San Diego Union-Tribune (October 10, 2009) - End of Eastbourne activist campaign* Survey: Additional Diabetes Dru...
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    1 hr and 46 mins
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