tHEORetically Speaking

This week’s tHEORetically Speaking News Roundup covers Novo Nordisk’s oral Wegovy pill shattering market expectations with $355 million in first-quarter sales, and Eli Lilly’s massive $4.5 billion investment to expand its manufacturing footprint in Indiana. We also explore Neptune Medical’s Triton GI robot reaching major clinical milestones in its first-in-human trials. Tune in for this concise recap of these pivotal industry updates!

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 cap...

This week’s tHEORetically Speaking News Roundup covers Abbott’s $21 billion acquisition of Exact Sciences, signaling a major expansion in cancer diagnostics, and Boehringer Ingelheim’s concerns over Europe’s slowing regulatory timelines compared to the U.S. We also break down a global supply chain shock triggered by the Strait of Hormuz closure. Tune in for this concise recap of these pivotal industry updates!

This week’s tHEORetically Speaking News Roundup covers the FDA’s new guidance aimed at streamlining biosimilar development and reducing drug costs, leadership changes at BioNTech as its founders step down to launch a new mRNA venture, and projections that the global rare disease drug market could surpass $400 billion by 2032. We also explore the FDA’s launch of a new unified adverse event monitoring platform designed to modernize safety surveillance and improve transparency. Tune in for...

This episode features Radek Wasiak, an expert in real world data generation, and real-world evidence. He has provided research services to the life sciences for more than two decades and is currently the director of Adigens Health. This chat wasn't just a technical deep dive; it was a journey through the past, present, and future of how we prove medicine actually works, and highlights the high-stakes world of Real-World Evidence (RWE). To watch the full interview, click here! Learn more abo...

This week’s tHEORetically Speaking News Roundup covers new real-world data showing Sanofi’s Beyfortus delivering multi-season protection against RSV hospitalizations, Compass Pathways’ positive Phase 3 results for its psilocybin therapy in treatment-resistant depression, and the FDA’s move toward a single-trial approval standard. We also explore stabilizing telehealth utilization trends and new FDA scrutiny of SSRI and RSV antibody safety. Tune in for this concise recap of these pivotal...

This week's tHEORetically Speaking News Roundup covers Humana’s rollout of a Google Cloud–powered AI tool to streamline 80 million annual member calls, Amgen’s pushback against the FDA to keep Tavneos on the market using real-world evidence, and AstraZeneca’s NYSE debut to fuel its global growth strategy. We also explore the new TrumpRx portal aimed at expanding discounted cash-pay prescriptions. Tune in for this concise recap of these pivotal industry updates! Register for World ...

This week’s tHEORetically Speaking News Roundup covers the looming funding crisis for rare disease biotechs as FDA priority review vouchers expire, CMS’s proposed crackdown on Medicare Advantage upcoding, and Cellares’ $257 million raise to scale automated cell therapy manufacturing. We also explore Sanofi’s defense of vaccines amid shifting U.S. policy and a landmark EU–India free trade agreement set to reshape global pharma access. Tune in for a concise recap of these pivotal industry...

This week’s tHEORetically Speaking News Roundup covers Novartis’ $1.5B Alzheimer’s licensing deal, the FDA’s push to accelerate drug development through Bayesian trial methods, and Bayer’s move to scale generative AI in antibody discovery. We also break down Oxford Biomedica’s takeover talks and a newly unveiled US healthcare cost plan. Tune in for a concise recap of these pivotal industry updates!

This week’s tHEORetically Speaking News Roundup breaks down four major developments shaping policy and biopharma. We cover the new US–UK trade deal exempting pharma from tariffs and resetting NHS pricing, the FDA’s push to curb non-human primate testing for monoclonal antibodies, and Capricor’s breakthrough Phase 3 results in Duchenne muscular dystrophy. We also highlight new HEOR research using copula modeling to better understand drivers of low birth weight and preterm birth. Tune in ...

This week on tHEORetically Speaking, we’re covering four major stories shaping the landscape across medtech, neurotech, drug development, and global pharma: Laborie buys Organon’s Jada system, NextSense raises a new round to launch EEG Smartbuds, Evotec and BMS hit an IND milestone, and Merck goes big with a $9.2B antiviral acquisition. A fast, focused roundup of the headlines you need to know. Subscribe for weekly drops!

This week’s tHEORetically Speaking News Roundup covers Evotec and Bristol Myers Squibb’s progress in developing next-generation therapies for neurodegenerative diseases, the FDA’s game-changing move to streamline biosimilar approvals and lower drug costs, and Novo Nordisk’s bold $6.5B counteroffer to outbid Pfizer for Metsera in the obesity treatment race. Tune in for this concise recap of the top stories shaping HEOR, RWE, and Market Access this week.

This episode features Dalfoni Banerjee, an award-winning entrepreneur and consultant with over 30 years of hands-on experience and her expertise spans the full drug development cycle. In 2011, Dalfoni founded and continues to operate 3Sixty Pharma Solutions, which has a mission to support startup and established pharmaceutical, biotechnology, and medical device companies with subject matter experts who help teams accelerate development, overcome challenges, and avoid preventable delays....