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Insights, observations, and executive interviews that discuss data and evidence to guide value-based decisions in health care. For more, visit our blog: https://healtheconomics.com/theoretically-speaking/
65 Episodes
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This week’s tHEORetically Speaking News Roundup covers the sudden resignation of the FDA’s top drug chief amid controversy, Novo Nordisk’s sweeping restructuring and strategic reset in the obesity and diabetes markets, and a groundbreaking data partnership between ŌURA and Tidepool driving innovation in diabetes research. We also explore how rising healthcare costs threaten the future of clinical trial diversity. Tune in for this concise recap of these pivotal industry updates!
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 week’s tHEORetically Speaking News Roundup covers Astellas Pharma’s Phase 4 findings showing fezolinetant’s real-world benefits for menopausal symptom relief, improved sleep, and daily functioning. We also dive into Takeda’s $11 billion collaboration with Innovent Biologics to advance next-generation cancer therapies and expand its global oncology pipeline. Tune in for this concise recap of these pivotal industry updates!
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....
This week’s tHEORetically Speaking News Roundup covers the FDA’s new boxed warning for J&J’s CAR-T therapy Carvykti, a major study linking post-Dobbs abortion restrictions to rising intimate partner violence, and Pelage Pharmaceuticals’ $120M funding to advance a next-generation hair loss treatment. We also spotlight Ōura’s $900M investment to expand its AI-driven health tech platform. Tune in for this concise recap of these pivotal industry updates!
This week’s tHEORetically Speaking News Roundup covers nirsevimab’s real-world success in reducing RSV hospitalizations among infants, Boehringer Ingelheim’s FDA approval of Jascayd for idiopathic pulmonary fibrosis, and Arthrosi Therapeutics’ $153 million raise to advance a next-generation gout drug. We also highlight this year’s Nobel Prize in Medicine, honoring discoveries in immune tolerance that continue to shape today’s biggest breakthroughs. Tune in for this concise recap of these pivo...
In this episode of tHEORetically Speaking, Paige McGarry interviews Aaron Berger, SVP & Head of Evidence Development Solutions at UBC discussing the evolution of direct-to-patient (DTP) study designs and how they are reshaping the landscape of clinical research. Learn more here: https://healtheconomics.com/theoretically-speaking-rethinking-decentralization-in-direct-to-patient-studies/ Introducing Trial Insights—the essential tool for pharma researchers and biotech investors. Se...
This week’s tHEORetically Speaking News Roundup covers Pfizer’s new Medicaid pricing deal with the current administration, Cartography Biosciences’ $67M raise to advance its next-generation colorectal cancer therapy, and calls for a U.K. anticompetition probe into pharma investment freezes. Tune in for this concise recap of the key HEOR, RWE, and Market Access headlines shaping our industry.
This episode features Dr. Renée Arnold, the President & CEO of Arnold Consultancy & Technology, LLC (ACT), focusing on outcomes research and software for healthcare sectors. She specializes in evidence-based health and real-world data modeling for healthcare decisions. Dr. Arnold is a founding member of ISPOR and chairs a special interest group at the Society for Medical Decision Making, with numerous publications in her field. Learn more about some of Renée's work here: https://he...
This week’s tHEORetically Speaking News Roundup covers the ACIP’s heated vaccine policy debates, growing state-level divides in COVID-19 vaccine access, and pharma’s race to develop multi-specific antibodies. We also explore the looming $32 billion revenue loss tied to expiring ACA subsidies and the latest legal battles over IRA drug pricing. Tune in for this concise recap of these pivotal industry updates!
This week’s tHEORetically Speaking News Roundup covers the CDC’s ACIP meeting and its implications for U.S. vaccine policy, GHO Capital’s acquisition of AI-powered R&D platform Scientist.com, and GSK’s $30 billion investment in U.S. drug manufacturing. We also explore Eli Lilly’s promising pediatric trial results for Mounjaro in type 2 diabetes and several upcoming FDA decisions poised to reshape the pharmaceutical landscape. Tune in for this concise recap of these pivotal industry upda...
This week’s tHEORetically Speaking News Roundup covers new research on social-genetic influences in adolescent depression, Novartis’s $1.4B acquisition of Tourmaline Bio for a promising heart drug, and encouraging Phase 2 results for rezatapopt in solid tumors. We also explore the FDA’s draft guidance on non-opioid pain treatments and the AMA’s release of 2026 CPT codes amid growing scrutiny. Tune in for this concise recap of these pivotal industry updates!
This week’s tHEORetically Speaking News Roundup covers Novo’s Wegovy showing superior cardiovascular benefits over Lilly’s Zepbound, the FDA’s new Rare Disease Evidence Principles to accelerate ultra-rare drug development, and Florida’s move to abolish vaccine mandates. We also explore HHS’s expansion of catastrophic health plans amid looming ACA premium hikes. Tune in for this concise recap of these pivotal industry updates!
This week’s tHEORetically Speaking News Roundup covers DaVita’s massive ransomware attack impacting 2.7 million patients, the FDA’s updated COVID-19 booster approvals for high-risk groups, and Roche’s $700M investment in a new obesity drug facility in North Carolina. We also highlight Virginia’s success in attracting major pharma investments from AstraZeneca and Eli Lilly. Tune in for this concise recap of the week’s most important HEOR, RWE, and Market Access updates!
This week’s tHEORetically Speaking News Roundup covers semaglutide’s potential in Alzheimer’s treatment, Delcath’s new Phase II trial for colorectal cancer, and a court ruling overturning limits on Medicare Advantage broker payments. We also break down CVS’s $290 million penalty for Medicare drug overcharges and the Supreme Court’s decision upholding NIH grant cuts tied to DEI policies. Tune in for this concise recap of the week’s most impactful industry updates!
This week's tHEORetically Speaking News Roundup covers the impact of pharmacists prescribing minor ailments in Ontario, significant Medicaid payment cuts affecting US hospitals, and Kaiser Permanente's robust Q2 earnings amidst cost pressures. We also delve into the FDA's PreCheck program for boosting US pharma manufacturing and the approval of a groundbreaking immunotherapy for a rare respiratory disease. Tune in for this concise recap of these pivotal industry updates!
This week's tHEORetically Speaking News Roundup covers the U.S. Department of Health and Human Services' new 340B rebate model pilot, a lawsuit against Novo Nordisk over misleading sales projections for Ozempic and Wegovy, and the GAO's findings on illegal NIH grant cuts by the Trump administration. We also delve into Merck's $10 billion acquisition of Verona Pharma and AstraZeneca's precision strategy in lung cancer treatment. Tune in for a concise recap of these pivotal industry updat...
This week's tHEORetically Speaking News Roundup covers Moderna's strides toward COVID-19 vaccine approval in Europe, Eli Lilly's promising trial results for Jaypirca in leukemia treatment, and J&J's innovative CAR-T therapy ad campaign. We also explore the Trump administration's new health data sharing initiative and a groundbreaking platform predicting antibiotic resistance. Tune in for this concise recap of these pivotal industry updates!
In this episode of Theoretically Speaking, Paige McGarry interviews David W. Miller, CEO of Genesis Research Group, discussing the unique challenges faced by biotech companies in evidence generation, market access, and stakeholder engagement. David W. Miller discusses how Genesis Research Group addresses these challenges, including the importance of demonstrating value early in development, the role of real-world evidence in supporting biotechs, and how to navigate uncertainty in the biotech ...
This episode features Matt McLoughlin, Senior Vice President of Compliance and Categories at Scientist.com. With 25 years in pharma R&D and Procurement, Matt has enhanced outsourcing for biopharma companies, focusing on speed, efficiency, and compliance. His expertise in regulated industries extends to RWE, HEOR, and Market Access, transforming access to external services to boost innovation while cutting costs and project timelines. To stay connected with us, visit our LinkedIn page and...
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