INsights & OUTcomes with Mark Larkin

Weekly News Roundup — Wegovy Pill’s Historic Debut, Lilly’s Manufacturing Expansion, and Robotic GI Breakthroughs

This week’s tHEORetically Speaking News Roundup covers Novo Nordisk’s oral Wegovy pill shattering market expectations with $355 million in first-quarter sales, [https://healtheconomics.com/novos-wegovy-pill-shatters-expectations-with-1-million-patients-and-355m-in-sales/] and Eli Lilly’s massive $4.5 billion investment to expand its manufacturing footprint in Indiana [https://healtheconomics.com/eli-lilly-expands-indiana-manufacturing-footprint-with-4-5-billion-investment/]. We also explore Neptune Medical’s Triton GI robot reaching major clinical milestones in its first-in-human trials [https://healtheconomics.com/neptune-medicals-gi-robot-hits-major-milestones-in-clinical-debut/].  Tune in for this concise recap of these pivotal industry updates!

Weekly News Roundup — Real-Time Clinical Trials, Canadian Breast Cancer Standards, and FDA Data Integrity Concerns

This week’s tHEORetically Speaking News Roundup covers the FDA’s new real-time clinical trial initiative utilizing AI for faster drug development [https://healtheconomics.com/fda-launches-real-time-clinical-trial-initiative-to-accelerate-drug-development/], and Breast Cancer Canada’s new unified national recommendations to eliminate regional disparities in care [https://healtheconomics.com/breast-cancer-canada-real-canadian-breast-cancer-alliance-establish-national-recommendations-for-breast-cancer/]. We also break down the FDA’s proposal to withdraw Amgen’s Tavneos over data integrity issues and safety concerns. [https://healtheconomics.com/fda-proposes-withdrawal-of-amgens-tavneos-over-clinical-trial-data-integrity-issues/] Register for the WODC USA here: https://www.terrapinn.com/WODC/US/2026/HealthEconomics [https://www.terrapinn.com/WODC/US/2026/HealthEconomics] Use code HE25 for an extra 25% off your registration fee!

INsights & OUTcomes with Mark Larkin

On this episode of INsights & OUTcomes, we sit down with Mark Larkin, real-world evidence expert at Vitaccess, to explore why the "gold standard" of clinical trials often falls short the moment a treatment hits the real world. We dive deep into the shift toward patient-centered science, discussing the critical difference between a study that is truly patient-centric versus one that is merely "patient-advised." Mark explains how longitudinal data is filling the gaps left by RCTs, from capturing the granular daily impacts of rare diseases to understanding the ripple effect of treatments on caregivers. Watch the full conversation here: https://youtu.be/ApKzubFy4Ao

Weekly News Roundup — PhRMA Leadership Transition, The ICHRA Shift, and MDUFA VI Preliminary Deal

This week’s tHEORetically Speaking News Roundup covers Steve Ubl’s planned departure from PhRMA after a decade of navigating the industry through landmark legislative shifts [https://healtheconomics.com/steve-ubl-to-step-down-as-longest-serving-ceo-of-phrma/], and the growing momentum of ICHRAs as employers move toward "defined contribution" healthcare models [https://healtheconomics.com/the-ichra-shift-insurance-growth-meets-market-volatility/]. We also break down the preliminary MDUFA VI agreement [https://healtheconomics.com/fda-and-medtech-industry-reach-preliminary-mdufa-vi-agreement/], which signals a major hiring push at the FDA and a new "America-First" fee structure for medtech.  Tune in for this concise recap of these pivotal industry updates!

Weekly News Roundup — Medtech Mega Deals, EU Regulatory Delays, and Global Supply Chain Shock

This week’s tHEORetically Speaking News Roundup covers Abbott’s $21 billion acquisition of Exact Sciences, signaling a major expansion in cancer diagnostics [https://healtheconomics.com/abbott-finalizing-21-billion-acquisition-of-exact-sciences/], and Boehringer Ingelheim’s concerns over Europe’s slowing regulatory timelines compared to the U.S. [https://healtheconomics.com/boehringer-ingelheim-flags-europes-regulatory-delays-as-u-s-drug-launches-accelerate/]We also break down a global supply chain shock triggered by the Strait of Hormuz closure.  [https://healtheconomics.com/boehringer-ingelheim-flags-europes-regulatory-delays-as-u-s-drug-launches-accelerate/] Tune in for this concise recap of these pivotal industry updates!