Podcasts about Daiichi Sankyo

This episode covers: Cardiology This Week: A concise summary of recent studies Transcatheter treatment of tricuspid regurgitation Carcinoid heart disease Milestones: MADIT-II Trial Host: Wilfried Mullens Guests: Stephan Baldus, Heidi Connolly and Konstantinos Koskinas Want to watch that episode? Go to: https://esc365.escardio.org/event/2560 Want to watch that extended interview on transcatheter treatment of tricuspid regurgitation, go to: https://esc365.escardio.org/event/2560?resource=interview   Disclaimer  ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Heidi Connolly, Nicolle Kraenkel and Wilfried Mullens have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. Stephan Baldus has declared to have potential conflicts of interest to report: research grant from Abbott, lecture fees from Abbott and Edwards. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Wilfried Mullens Guest: Stephan Baldus Want to watch that extended interview, go to: https://esc365.escardio.org/event/2560?resource=interview Want to watch that entire episode? Go to: https://esc365.escardio.org/event/2560   Disclaimer ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Wilfried Mullens have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. Stephan Baldus has declared to have potential conflicts of interest to report: research grant from Abbott, lecture fees from Abbott and Edwards. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Pharma commercial teams are generating more data than ever, but field intelligence is still arriving too late to change rep behavior before the engagement window closes. In this episode, Damion Nero, Global Head of Statistics at Daiichi Sankyo, joins Emerj editor Yolandi de Weerdt to examine why fragmented data pipelines, not a shortage of data, are the structural root of the gap between commercial insight and field execution. The conversation covers what separates teams that successfully adopt AI from those stuck in the pilot phase, and why starting with routine, high-certainty use cases consistently produces more commercial lift than chasing ambitious automation. This episode is sponsored by ODAIA. Learn how leading organizations approach AI investment more like a venture portfolio, and why interdisciplinary collaboration is critical to defining the right data for AI success. Download our free PDF report, "Beginning with AI," at emerj.com/aik1

For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/courses/the-evolving-role-of-antibody-drug-conjugates-in-metastatic-triple-negative-breast-cancer-10800SummaryThis CME/CE-certified podcast will provide multidisciplinary clinicians with an evidence-based update on the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline treatment of metastatic triple-negative breast cancer. A medical and an ocular oncology specialist review the latest efficacy and safety data from pivotal clinical trials evaluating ADCs, their integration into contemporary treatment algorithms, and guideline recommendations based on PD-L1 status, BRCA mutation status, and immunotherapy eligibility. Learners will explore key factors influencing treatment selection, compare the benefits and limitations of more established therapeutic options, and examine practical strategies for preventing, recognizing, and managing ADC-associated toxicities. Special emphasis will be placed on multidisciplinary approaches to the management of ocular adverse events and other clinically significant toxicities to optimize patient outcomes and support safe implementation of these therapies in clinical practice.Learning ObjectivesEvaluate the current and emerging clinical evidence surrounding the use of trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates (ADCs) in the first-line treatment of metastatic triple-negative breast cancer (TNBC)Integrate TROP2-directed ADCs into frontline treatment regimens for metastatic TNBC based on the latest clinical evidence, guidelines, and patient- and tumor-specific factorsApply multidisciplinary and patient-centric strategies for the prevention, recognition, and management of toxicities associated with the use of TROP2-directed ADCs in patients with metastatic TNBCThis activity is accredited for CME/CE CreditThe National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.50 contact hours (which includes 0.50 hours of pharmacology). For additional information about the accreditation of this program, please contact NACE at info@naceonline.com.Faculty and Moderator Aditya Bardia, MDProgram Director, Breast Medical Oncology, UCLAProfessor of Medicine, UCLALos Angeles, CADr. Bardia has disclosed the following financial relationships:Consultant: Alyssum, AstraZeneca/Daiichi, BMS, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeAdvisor/Advisory Board: Alyssum, AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeContracted Research: AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, PfizerStock options: Vyome (immuno-inflammatory and rare diseases)All of his consultant, advisor/advisory board, and contracted research disclosures are related to cancer.Maura Di Nicola, MDAssistant Professor of OphthalmologyBascom Palmer Eye InstituteMedical Director of Imaging and EchographyBascom Palmer Eye InstituteMiami, FLDr. Di Nicola has disclosed the following financial relationships:Consultant: AbbVie (ophthalmology), SpringWorks Therapeutics (oncology)Advisor/Advisory Board: AbbVie (ophthalmology)Research Grant: Castle Biosciences (ocular oncology)Please review additional planner disclosures here.Disclosure of Commercial SupportThis educational activity is supported by a medical education grant from AstraZeneca Pharmaceuticals and a medical education grant from Daiichi Sankyo, Inc.Please visit  http://naceonline.com to engage in more live and on demand CME/CE content.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The landscape of these industries is one of constant evolution, characterized by scientific advancements, strategic mergers, and regulatory maneuvers that shape the future of healthcare. In a significant scientific breakthrough, Merck & Co. and Gilead Sciences have made strides in HIV treatment with the development of a weekly pill. This innovative regimen combines Merck's islatravir with Gilead's lenacapavir, showing promise in two phase 3 trials. If approved, this long-acting oral therapy could revolutionize HIV care by offering a more convenient dosing schedule, potentially improving patient adherence and outcomes substantially. This novel regimen signifies progress towards simplifying HIV treatments with once-weekly dosing. Meanwhile, in the oncology sector, Gilead's Trodelvy faced challenges when combined with Merck's Keytruda as a first-line treatment for PD-L1-high non-small cell lung cancer. The phase 3 EVOKE-03 trial was terminated, shifting attention to competitors like AstraZeneca and Daiichi Sankyo, who continue to advance their own therapies in this area. In a strategic move to bolster its position in lung cancer treatment, GlaxoSmithKline (GSK) is acquiring Nuvalent for $10.6 billion, aiming to secure near-approval cancer therapies capable of challenging market leaders like Roche and Pfizer. This acquisition underscores the focus on targeted cancer therapies that increase treatment efficacy by honing in on specific genetic markers. Nuvalent's innovative pipeline of small molecule inhibitors targets drug resistance and mutations in cancer treatment—a strategic addition to GSK's portfolio aimed at enhancing its position amidst rapid advancements and intense competition in oncology. In diabetes and obesity management, Eli Lilly is advancing with its new oral GLP-1 receptor agonist, Foundayo (orforglipron), which has shown competitive efficacy over oral semaglutide. Analysts see Lilly's progress as strengthening its leadership in the growing obesity drug market. Similarly, AstraZeneca is making progress with its own GLP-1 candidate, elecoglipron, as phase 2 data sets the stage for pivotal studies. Promising clinical trial data from Eli Lilly's retatrutide for obesity-related conditions and AstraZeneca's elecoglipron suggest a strengthening pipeline for GLP-1 receptor agonists known for their dual effects on weight management and glycemic control. On the diagnostics front, Roche reaffirms its €600 million investment in Germany amid industry retrenchments by companies like Eli Lilly and Boehringer Ingelheim. However, Roche remains cautious about future risks due to shifting economic conditions. The financial dynamics within biotech are also noteworthy. Parabilis Medicines is planning a potentially record-setting IPO following Kailera Therapeutics' successful public offering earlier this year. These trends indicate strong investor confidence and an influx of funding towards innovative cancer therapies. Meanwhile, CeQur's $100 million Series E funding round aims at accelerating insulin patch delivery systems' commercial growth—highlighting ongoing innovation in diabetes management solutions. Regulatory updates reveal AstraZeneca facing reprimands from the UK marketing watchdog due to repeated breaches related to LinkedIn activities—an ongoing challenge in pharmaceutical marketing compliance. The integration of digital health solutions continues apace as ixlayer partners with Vertex Pharmaceuticals to launch a digital acute pain management platform. This initiative aims at improving patient care by reducing reliance on opioid-based treatments. These developments paint a picture of an industry where scientific innovations, regulatory hurdles, and technological advancements intersect to shape future therapeutic landscapes. Precision oncology is another area witnessing substantial growth. The landscape also sees notable activity in rare disease therapeutics. Johnson & Johnson's Talvey has gained acceptance in Scotland for treating relapsed multiple myeloma using bispecific antibody technology—a trend toward leveraging immune system targeting technologies to enhance cancer treatment efficacy. Moreover, Zai Lab's Tivdak received approval from China's NMPA for cervical cancer treatment based on Phase 3 data, highlighting the rise of antibody-drug conjugates (ADCs) as potent oncology therapies due to their targeted delivery mechanisms. On the research collaboration front, AlzeCure Pharma's partnership with Eli Lilly focuses on Alzheimer's disease research through Alzstatin ACD680—a small molecule targeting neurodegenerative pathways—a testament to the collaborative efforts needed to tackle complex diseases like Alzheimer's. However, challenges persist as Bial discontinued its GCase activator program after failing Phase 2b trials for Parkinson's patients with GBA1 variants—a stark reminder of the high-risk nature inherent in drug development despite initial promise. These myriad developments underscore a vibrant period within pharmaceutical and biotech sectors where scientific advancements rapidly translate into actionable therapies promising substantial improvements in patient care by addressing unmet medical needs globally.Support the show

This episode covers: Cardiology This Week: A concise summary of recent studies The heart in high altitude Mitral annular disjunction Mythbusters: Weekend mortality Host: Rick Grobbee Guests: JP Carpenter, Kristina Haugaa, Silvia Ulrich Want to watch that episode? Go to: https://esc365.escardio.org/event/2563 Want to watch that extended interview on mitral annular disjonction, go to: https://esc365.escardio.org/event/2563?resource=interview   Disclaimer ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Kristina Haugaa, Nicolle Kraenkel and Silvia Ulrich have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Rick Grobbee Guest: Kristina Haugaa Want to watch that extended interview on https://esc365.escardio.org/event/2563?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2563   Disclaimer ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Kristina Haugaa and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The landscape of these industries continues to evolve with significant scientific advancements, regulatory breakthroughs, and strategic maneuvers that are reshaping drug development and patient care. One of the noteworthy developments is the U.S. FDA's recent approval of Gilead Sciences' Hepcludex (bulevirtide) for hepatitis D. This approval marks a comeback for Gilead after previous setbacks due to manufacturing and delivery issues, highlighting the critical importance of addressing regulatory feedback. It's a testament to persistence in overcoming manufacturing challenges to ensure vital therapies reach those in need. This approval signifies a milestone as it's the first FDA-approved therapy targeting chronic hepatitis D virus infection—a niche condition with limited treatment options. Similarly, Pfizer's Braftovi (encorafenib) is expanding its global reach beyond U.S. borders with regulatory approvals in the EU and Canada for colorectal cancer treatment. This broadening geographic footprint reflects a broader industry trend where companies aim to maximize the therapeutic impact of oncology drugs across diverse patient populations. Meanwhile, Astellas Pharma is navigating the looming patent cliff for its prostate cancer drug Xtandi by actively pursuing new licensing deals and implementing cost-cutting measures. This dual approach underscores a widespread industry strategy where companies balance acquisitions with operational efficiency to sustain growth. In the radiopharmaceutical sector, there's notable activity with Lantheus Holdings possibly being acquired by Curium for $7 billion. This potential deal underscores growing interest in radiopharmaceuticals due to their precision in targeting specific cancer types. Complementing this is Niowave's $75 million investment in a radiopharmaceutical isotope plant in Michigan, set to produce actinium-225 by 2028—an isotope crucial for targeted cancer therapies. Regulatory landscapes are also in flux with continued reforms at the FDA despite leadership changes. Initiatives like the Commissioner's National Priority Voucher program illustrate regulatory bodies' commitment to streamlining drug approvals and fostering innovation. On an international note, SK Bioscience is partnering with Colombia to locally produce the chickenpox vaccine Skyvaricella, enhancing vaccine accessibility through technology transfer. Similarly, Eli Lilly's acquisition spree in infectious disease research signals a robust push toward expanding its R&D pipeline for viral and bacterial pathogens. Eli Lilly has announced plans to acquire Curevo, Limmatech Biologics, and another vaccine company for up to $3.8 billion. This strategic acquisition underscores a commitment to enhancing capabilities in infectious diseases—a field that has gained focus post-COVID-19 pandemic. By integrating these companies, Eli Lilly aims to leverage their platforms and expertise for advanced therapeutic solutions against infectious diseases. In gene editing, Eli Lilly is preparing for a Phase 2 trial of a lipid-lowering gene editor from Verve Therapeutics, showing promising cholesterol reductions akin to PCSK9 inhibitors. This highlights gene editing's potential in addressing cardiovascular diseases. A significant development from Lilly's pipeline includes promising results from their base editor technology acquired through Verve Therapeutics—an exciting breakthrough suggesting substantial potential for gene-editing technologies addressing genetic disorders like high cholesterol. In oncology, AstraZeneca and Daiichi Sankyo's Datroway gained FDA approval for triple-negative breast cancer as a first-line treatment. This antibody-drug conjugate targets Trop2, demonstrating the potential of targeted therapy in difficult-to-treat cancers. Kura Oncology's combination therapy featuring darlifarnib and Krazati showed up to a 69% response rate in KRAS G12C-mutated solid tumors during Phase 1 trials, emphasizing precision medicine's potential in targeting specific genetic mutations driving cancer progression. In obesity management, Eli Lilly's retatrutide achieved Phase 3 success with bariatric surgery-like outcomes. The drug acts as a triple hormone receptor agonist, showcasing advancements in metabolic therapies targeting obesity—a condition linked with numerous comorbidities. Moderna's mFlusiva is poised for an FDA advisory committee review as an influenza preventative for older adults—an extension of Moderna's mRNA technology initially used against COVID-19. Collectively, these developments highlight an industry leveraging cutting-edge science and technology to tackle complex medical challenges. As pharmaceutical giants like Eli Lilly consolidate their positions through acquisitions and research collaborations, transformative advancements promise to reshape patient care across various therapeutic areas. These initiatives not only reflect the industry's dynamic nature but also its pivotal role in addressing unmet medical needs worldwide. Eli Lilly's recent strategic acquisitions underscore its commitment to advancing pharmaceutical innovations, particularly in vaccines and cholesterol management sectors. Acquiring three vaccine-focused biotech firms signifies substantial investment in expanding its vaccine portfolio—a move aligned with global immunization strategies. This follows hiring Peter Marks from the FDA, indicating a strategic focus on bolstering expertise within the vaccine domain. The company has been recognized by IDEA Pharma as a leader in pharmaceutical innovation—a testament to its robust pipeline and successful integration of scientific advancements into marketable therapies. Across oncology landscapes highlighted at ASCO conferences are exciting potentials like Summit Therapeutics and Akeso's potential Keytruda rivals that could reshape cancer treatment paradigms if proven effective. As pharmaceutical landscapes continue evolving rapidly through scientific strides tempered by regulatory hurdles—the current environment promises significant advancements offering new hope while demanding strategic agility within healthcare sectors globally.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of noteworthy advancements and challenges that are shifting the landscape of drug development and patient care. Starting with AstraZeneca and Daiichi Sankyo, their Trop2-directed antibody-drug conjugate, Datroway, has secured FDA approval for first-line treatment in triple-negative breast cancer. This form of cancer is notoriously aggressive and offers limited treatment options, making this approval a significant milestone. It positions Datroway as a key player in the ADC market targeting TNBC, highlighting the increasing role of antibody-drug conjugates in oncology. This advancement not only expands therapeutic options for patients but also emphasizes the growing importance of ADCs in effectively targeting cancer cells while sparing healthy tissues. In another exciting development, Merck and Kelun Biotech have reported on their SAC-TMT ADC, which when paired with Keytruda, shows a profound impact on PD-L1-positive non-small cell lung cancer patients. Their combination therapy demonstrated a remarkable 65% reduction in disease progression or death compared to Keytruda alone. Presented at the ASCO annual meeting, these findings could potentially revolutionize first-line treatments for NSCLC, further underscoring the promising therapeutic potential of combining ADCs with immunotherapies. However, AstraZeneca faced a setback with a novel breast cancer drug as an FDA advisory committee recommended against its approval. Interestingly, the European Medicines Agency provided a favorable opinion, illustrating the divergent regulatory landscapes across continents. Such discrepancies highlight the complex regulatory environment pharmaceutical companies must navigate and could influence strategic decisions regarding market focus. On the legal front, Eli Lilly is embroiled in controversy over an alleged $200 million rebate fraud scheme involving its diabetes drug, Trulicity. This situation sheds light on ongoing issues within pharmaceutical distribution channels and raises questions about compliance and oversight mechanisms necessary to prevent such financial misconduct. Meanwhile, industry dynamics continue to evolve as AbbVie announced workforce reductions in its Allergan Aesthetics unit. This move reflects broader trends where companies streamline operations to prioritize core competencies and promising therapeutic areas. From a regulatory perspective, Maat Pharma's decision to seek re-examination for its graft-versus-host disease medication underscores the iterative nature of drug approval processes. Persistence in addressing regulatory feedback remains crucial as companies strive for successful market entry. In obesity management, Novo Nordisk's oral GLP-1 receptor agonist, Wegovy, gains traction as a convenient treatment option. The shift towards oral medications could significantly improve patient adherence and outcomes by offering an easier alternative to injections. Biogen's decision to terminate its collaboration with Denali Therapeutics after unsuccessful phase 2 trials for a Parkinson's disease candidate highlights the inherent risks in neurological drug development. Rigorous clinical evaluation remains essential to ensure efficacy before advancing therapies further. Despite these advancements, challenges persist as Biogen and Denali's BIIB122 failed in phase 2b trials for idiopathic Parkinson's disease. This underscores the complexity of neurological disorders and emphasizes the need for continued innovation targeting LRRK2 kinase inhibitors. In the realm of CAR-T therapies, Novartis' T-Charge platform faces competition from emerging in vivo technologies. This competitive landscape demonstrates rapid evolution within cell therapy domains, aiming to enhance efficacy and accessibility for patients. Meanwhile, strategic mergers and acquisitions continue as Liminatus Pharma acquires CAR-T biotech Innocsai for $320 million, underscoring sustained interest in oncology cell therapies. Switching gears to Eli Lilly's recent Phase 3 TRIUMPH-1 trial results for retatrutide, they reveal promising weight loss outcomes comparable to bariatric surgery. As a triple hormone receptor agonist targeting GLP-1, retatrutide holds significant potential in addressing obesity—a condition with profound public health implications. Medtronic's acquisition of SPR Therapeutics to enhance its chronic pain portfolio reflects a focus on minimally invasive treatments. Financially, Research Alliance III raised $75 million through a SPAC IPO targeting mergers with China-based biotech firms, signaling increased global collaboration within the sector. Dandelion Health's $14 million Series A funding aims to advance clinical intelligence platforms that could transform drug development through data analytics. Finally, Moderna's mRNA-based flu vaccine is set for review by the FDA's vaccine advisory committee after overcoming initial regulatory hurdles. This scrutiny highlights ongoing challenges faced by novel vaccine technologies within rigorous regulatory environments. In summary, these developments illustrate an industry at the forefront of scientific innovation while grappling with regulatory complexities and operational challenges. From antibody-drug conjugates and immunotherapy combinations to gene editing and advanced cell therapies, there's a clear commitment to improving patient outcomes through novel scientific approaches. As these trends evolve, they promise to redefine treatment landscapes across various therapeutic areas—offering new opportunities for scientific advancements and enhanced patient care worldwide.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The industry is currently navigating a pivotal era marked by a blend of scientific innovation, regulatory shifts, and intriguing clinical trial results. A key regulatory upheaval unfolds as the FDA faces leadership changes. The recent departures of key figures from both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) underscore a period of uncertainty. With former commissioner Marty Makary stepping down, concerns arise about how these changes might affect drug approvals and regulatory guidance at such a crucial time in the industry. Turning to clinical trials, Regeneron has experienced a setback as its lag-3 inhibitor failed to surpass Merck's Keytruda in phase 3 melanoma studies. This marks Regeneron's second significant late-stage failure within a year, prompting analysts to reassess its strategic direction in oncology. In parallel, Regeneron has inked a $2.3 billion agreement with Parabilis Medicines to develop an advanced antibody-drug conjugate (ADC)-like therapy. The goal is to enhance targeting capabilities by improving binding to complex target sites, which could revolutionize ADC technology. Similarly, BioMarin's substantial investment in Inozyme's enzyme replacement therapy faced hurdles after falling short on one of two primary endpoints in a phase 3 trial for a rare genetic disorder. Such outcomes highlight the inherent risks and high stakes involved in late-stage drug development. Yet, innovation continues to drive progress. Vincentage Pharma's oral GLP-1 agonist has demonstrated a promising mean weight loss of 12.4% over a year, positioning it as a competitor to Eli Lilly's Orforglipron in the burgeoning Chinese market. This reflects the global pursuit to harness GLP-1 receptor agonists in tackling metabolic disorders and obesity. Ipsen has made strides with its long-acting neurotoxin for aesthetic applications, advancing into phase 3 trials following encouraging phase 2 results that showed significant improvements in frown lines lasting up to 24 weeks post-treatment. This progress suggests robust competition against established players like Botox. Meanwhile, Merck and Kelun-Biotech have successfully completed a phase 3 trial with their trop2-directed ADC sacituzumab tirumotecan (SAC-TMT) for endometrial cancer, achieving primary endpoints and paving the way for further regulatory submissions. Such advancements emphasize ADC technology's growing importance in oncology therapeutics. Broad industry trends reflect strategic investments, exemplified by Boston Scientific's $1.5 billion investment in Mirus and an option to acquire its transcatheter aortic valve replacement system—highlighting continued interest in high-growth medtech sectors. In another notable development, Daiichi Sankyo and AstraZeneca have reached a milestone with their ADC Enhertu, securing dual FDA approvals for early breast cancer treatment. These approvals underscore Enhertu's potential to expand treatment options for patients at an early disease stage, potentially altering standard treatment protocols. On the regulatory front, AstraZeneca has secured FDA approval for baxdrostat—an aldosterone synthase inhibitor developed through its acquisition of CinCor Pharma—demonstrating strategic investment in innovative cardiovascular therapies aligned with ambitious revenue goals. However, challenges persist as demonstrated by Amgen's Tavneos being linked to fatalities across Japan and the U.S., raising significant concerns about data integrity and pharmacovigilance. In contrast, Revolution Medicines' RAS inhibitor doubled survival rates in phase 3 pancreatic cancer trials. This breakthrough positions Revolution as an emerging leader in oncology therapeutics amidst fierce competition from companies aiming to improve drug tolerability and extend survival benefits. These narratives paint a picture of an industry poised for transformation—balancing scientific breakthroughs against regulatory challenges and financial pressures. As therapeutic modalities evolve—from oral biologics to advanced ADCs—the sector is set on course for substantial impacts on patient care and drug development pipelines. In summary, the pharmaceutical and biotech industries' focus on advancing therapeutic options through scientific innovation while navigating complex regulatory landscapes underscores an ongoing commitment to addressing unmet medical needs through new drug classes and targeted therapies. These efforts highlight trends toward personalized medicine and precision oncology that are likely to shape future trajectories in these dynamic fields.Support the show

Join Digital Education Committee member Jason T. Jacobson, MD, FHRS, and his guests John L. Sapp, Jr., MD, FHRS and Kyoko Soejima, MD for this conversation at Heart Rhythm 2026 in Chicago. This discussion reviews the late-breaking clinical trial Ventricular Intramyocardial Navigation and Tachycardia Ablation Guided by Electrograms (VINTAGE): First-in-Human Experience with a Novel Therapy for Refractory Ventricular Arrhythmia, presented at HRS 2026 in Chicago. Faculty discuss the novel VINTAGE technique, which enables catheter-based navigation and ablation within the myocardial wall to target deep intramural ventricular arrhythmia substrates that are often inaccessible with conventional endocardial or epicardial approaches. The conversation highlights the potential clinical impact of this first-in-human experience, including procedural feasibility, mechanistic innovation, and future implications for the treatment of patients with refractory ventricular tachycardia and complex ventricular arrhythmias.   Learning Objectives Describe the VINTAGE intramyocardial navigation approach and its proposed role in the treatment of refractory ventricular arrhythmias.  Evaluate the clinical challenges associated with mapping and ablating deep intramural ventricular tachycardia substrates using conventional techniques.  Assess the potential implications of first-in-human feasibility and safety findings for future ventricular arrhythmia ablation strategies.    Podcast Contributors Jason T. Jacobson, MD, FHRS John L. Sapp, Jr., MD, FHRS Kyoko Soejima, MD   Host and Contributor Disclosure(s): J. Jacobson • Honoraria/Speaking/Teaching/Consulting: Zoll Medical Corporation, Vektor Medical Inc. • Stocks, Privately Held: Atlas 5D • Research: CardioFocus, Inc. • Membership on Advisory Committees: Abbott Medical, Johnson and Johnson J. Sapp • Honoraria/Speaking/Teaching/Consulting: Medtronic, Varian Medical Systems, Biosense Webster • Research: Abbott Medical, Biosense Webster K. Soejima • Honoraria/Speaking/Consulting: Medtronic Japan, Boston Scientific Japan, Abbott Medical, Abbott Japan, Boehringer Ingelheim, Daiichi Sankyo 

This episode covers: Cardiology This Week: A concise summary of recent studies Biomarkers in heart failure Digoxin in HFrEF Scientific Highlights from Heart Failure 2026 Host: Wilfried Mullens Guests: Lynne Stevenson, Dirk van Veldhuisen, Theresa McDonagh Want to watch that episode? Go to: https://esc365.escardio.org/event/2565 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. A ny views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel, Dirk van Veldhuisen and Lynne Warner Stevenson have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report:Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi.  Theresa McDonagh has declared to have potential conflicts of interest to report: honoraria from Boeringer Ingelheim. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most compelling stories and trends shaping the industry. Daiichi Sankyo has unveiled a bold five-year business plan with an eye on rising to become a top-five global oncology leader by 2035. This ambition is driven by a $1.3 billion initiative focused on antibody-drug conjugates, or ADCs, which are targeted cancer therapies. These plans highlight a strategic emphasis on oncology and operational efficiencies designed to maintain competitive advantage in a rapidly evolving market. Meanwhile, CSL Limited faces a more challenging landscape, adjusting its revenue projections and facing a significant impairment related to its acquisition of Vifor Pharma. These financial challenges underline the risks inherent in large-scale acquisitions within the pharmaceutical sector, necessitating a reassessment of strategic priorities and investments in R&D. Regulatory developments continue to be pivotal, with Partner Therapeutics' bispecific antibody Bizengri gaining FDA national priority designation for rare bile duct cancer. This underscores the FDA's dedication to expediting critical therapies through its National Priority Pilot program, aiming to bring life-saving treatments to underserved populations quickly. However, regulatory uncertainty looms with President Donald Trump's reported plan to dismiss FDA Commissioner Marty Makary, which could impact the agency's leadership and agenda. Additionally, a Supreme Court ruling has temporarily reinstated telemedicine access to mifepristone, an abortion pill, spotlighting the ongoing debates about reproductive healthcare accessibility through telemedicine. In research news, Novo Nordisk's collaboration with an AI biotech firm marks a strategic shift aimed at rescuing its Parkinson's cell therapy program. This partnership highlights the increasing role of artificial intelligence in drug development, particularly for revitalizing stalled projects using advanced technological applications. On the clinical trial front, Inhibrx's midphase results are promising for their OX40 agonist combined with Merck's Keytruda, showing doubled response rates in cancer patients. Such advancements underscore the potential of combination therapies in oncology and are likely to draw more investment interest from major players like Merck. Amgen's investment in a quantum technology firm poised for an IPO represents another exciting frontier. The application of quantum computing in drug discovery could revolutionize computational biology by accelerating therapeutic discoveries and improving precision medicine approaches. The biotech sector is also seeing financial maneuvers with quantum tech firms planning IPOs following investments from companies like Amgen. This signals a growing interest in leveraging quantum technology for breakthroughs in drug discovery. In Alzheimer's research, a novel gene therapy study presents an innovative method for clearing amyloid plaques from mouse brains without crossing the blood-brain barrier. By sending a protective gene to the liver, researchers achieved systemic plaque clearance—an approach that could revolutionize treatment strategies if successful in human trials. A new development in diagnostics involves a blood test predicting patient responses to GLP-1 receptor agonists like Ozempic and Wegovy. As these drugs become popular for weight management, such diagnostics could optimize outcomes by identifying patients most likely to benefit. Omada Health reported a 42% revenue increase in Q1, reflecting the expanding digital health solutions market. Their collaboration with Eli Lilly's employer weight loss program indicates rising demand for comprehensive health strategies integrating pharmacotherapy and digital health platforms. Overall, thSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's episode delves into a range of significant industry updates, spotlighting scientific advancements, regulatory challenges, and strategic movements that are shaping the future of drug development and patient care. The pharmaceutical landscape is often marked by rapid changes, as evidenced by recent reports indicating President Donald Trump's plan to dismiss FDA Commissioner Marty Makary. This potential leadership change is set against a backdrop of controversies during Makary's tenure, including the rejection of Replimune's advanced melanoma therapy, RP1. This therapy was designed as an oncolytic immunotherapy using a genetically modified herpes simplex virus to target and destroy cancer cells. The FDA's rejection of RP1 ignited debate over the agency's decision-making processes, which some critics view as inconsistent and lacking transparency. Such decisions can have profound implications—delaying patient access to critical treatments and affecting company financials and market dynamics. Furthermore, internal discord at the FDA during Makary's leadership period underscores the importance of stable leadership in maintaining efficiency and fostering scientific rigor. Turning to corporate developments, Gilead Sciences has revised its first-year sales forecast for YezTugo, its long-acting PrEP injection for HIV prevention. The company now projects revenues to reach $1 billion, reflecting strong market uptake. This adjustment highlights the growing demand for innovative PrEP solutions as part of broader HIV prevention strategies. Meanwhile, Daiichi Sankyo is grappling with a $610 million profit setback due to an overextension in their manufacturing capabilities for antibody-drug conjugates (ADCs). This situation illustrates the financial risks inherent in scaling production within rapidly evolving therapeutic areas like ADCs, where balancing supply and demand remains critical. In legal news, Capricor Therapeutics has initiated a lawsuit against NS Pharma concerning a breach-of-contract over Deramiocel, a Duchenne muscular dystrophy treatment. With an FDA decision pending, this legal battle underscores the complexities of partnerships and contract compliance in advancing neuromuscular therapies. On the regulatory front, Biogen and Eisai are experiencing delays from the FDA regarding their Alzheimer's drug Leqembi. These regulatory hurdles highlight the complex processes that can impact drug rollout timelines significantly. Odyssey Therapeutics' successful $304 million IPO aims to bolster its autoimmune and inflammatory disease pipeline. This reflects robust investor interest in biotech firms with promising therapeutic candidates addressing high-need areas. In terms of market dynamics, the competition between Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo is reshaping the oral GLP-1 receptor agonist market. A newly launched weekly tracker will monitor prescription trends to provide insights into how these weight-loss solutions are impacting obesity management. Additionally, Johnson & Johnson's efforts to enhance awareness around depression treatment through public health campaigns illustrate how companies are addressing mental health challenges. Advancements in digital health continue with Tether's rollout of medical AI for mobile devices and MedAptus' operational 'command center,' highlighting ongoing innovations poised to transform healthcare delivery by enhancing efficiency and patient engagement. Strategic acquisitions remain a key theme as Angelini Pharma acquires Catalyst Pharmaceuticals for $4.1 billion—a move that expands Angelini's footprint into the U.S. rare neurological drug market. Similarly, Blackstone's $250 million investment in Anagram Therapeutics for cystic fibrosis enzyme replacement therapySupport the show

This episode covers: Cardiology This Week: A concise summary of recent studies Genetics and genetic testing in HCM Asymptomatic aortic valve stenosis Statistics Made Easy: Mediation analysis Host: Wilfried Mullens Guests: JP Carpenter, Caroline Coats, Marc Dweck Want to watch that episode? Go to: https://esc365.escardio.org/event/2564 Want to watch that extended interview on asymptomatic aortic valve stenosis, go to: https://esc365.escardio.org/event/2564?resource=interview   Disclaimer  ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails.  ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.    Declarations of interests Stephan Achenbach, Yasmina Bououdina, Antonio Greco and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Caroline Coats has declared to have potential conflicts of interest to report: in the last 5 years, consultant/advisor to Bayer, Bristol Myers Squibb, Cytokinetics, Sanofi, Roche Diagnostics. Marc Dweck has declared to have potential conflicts of interest to report: consultancy fees from Novartis, Silence, and AstraZeneca related to aortic stenosis and development of a medical therapy. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Wilfried Mullens Guest: Marc Dweck Want to watch that extended interview on https://esc365.escardio.org/event/2564?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2564   Disclaimer ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Antonio Greco and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Marc Dweck has declared to have potential conflicts of interest to report: consultancy fees from Novartis, Silence, and AstraZeneca related to aortic stenosis and development of a medical therapy. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology This Week: A concise summary of recent studies Time for physiological pacing in heart failure? Same-day discharge after EP procedures: from evidence to practice EHRA 2026 Scientific Highlights Host: Gerd Hindricks Guests: Haran Burri, Emma Svennberg, Julia Vogler Want to watch that episode? Go to: https://esc365.escardio.org/event/2555    Disclaimer ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video.  The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Haran Burri has declared to have potential conflicts of interest to report: institutional research and fellowship support or speaker honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, Microport. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honorary from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Gerd Hindricks has declared to have potential conflicts of interest to report: institutional research and fellowship support or speaker honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, Microport. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Helmut Puererfellner has declared to have potential conflicts of interest to report: speaker fees, honoraria, consultancy, advisory board fees, investigator, committee member, etc., including travel funding related to these activities for the following companies: Abbott, Biotronik, Biosense Webster, Boston Scientific, Daiichi Sankyo, Medtronic. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson. Julia Vogler has declared to have potential conflicts of interest to report: honoraria for talks: Abbott.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most intriguing advancements and strategic moves shaping the future of drug development and patient care. Regeneron has recently ventured into the radiopharmaceuticals market through a substantial $2.1 billion agreement with Australia's Telix Pharmaceuticals. This move marks a significant diversification from Regeneron's traditional focus, such as obesity treatments, to an area that combines radioactive isotopes with targeting molecules for diagnosing and treating diseases like cancer more effectively. The strategic alliance positions Regeneron as a formidable player in this emerging field, promising to expand its therapeutic portfolio and revenue streams. In oncology innovation, GSK is pushing forward with a bold initiative, conducting Phase 3 trials for antibody-drug conjugates (ADCs) in collaboration with Hansoh Pharmaceutical. This effort underscores GSK's commitment to expanding its oncology pipeline, particularly in targeting unmet medical needs through innovative therapies. Antibody-drug conjugates are designed to deliver cytotoxic agents directly to cancer cells, minimizing damage to healthy tissues and offering a precision approach to cancer treatment. Allogeneic CAR-T therapies are also making waves, with Allogene Therapeutics reporting promising early data from their off-the-shelf CAR-T therapy, cema-cel. This therapy effectively eradicated minimal residual disease in lymphoma patients, highlighting the potential of allogeneic approaches to provide accessible cancer treatments without the logistical complexities of autologous methods. In another significant milestone, Ideaya Biosciences, in collaboration with Servier, achieved success with their eye cancer drug candidate meeting its primary endpoint in a crucial Phase 2/3 trial. This success sets the stage for an accelerated FDA approval filing, offering new hope for patients dealing with this challenging condition. Revolution Medicines has made notable progress in oncology as well, with its highly anticipated RAS inhibitor demonstrating improved survival outcomes in a Phase 3 trial for pancreatic cancer. Extending survival by an average of six months compared to chemotherapy could redefine treatment paradigms for one of the most aggressive cancer types. Not every development has been favorable, however. Replimune faced its second FDA rejection for its melanoma candidate RP1, leading to workforce reductions—a testament to the rigorous nature of regulatory approvals and the challenges companies face when bringing novel therapies to market. Meanwhile, BioNTech and Synox Therapeutics are advancing towards FDA approval for their tumor-targeting therapies. These efforts could intensify competition within the oncology space, challenging established giants like AstraZeneca and Daiichi Sankyo. In pain management, AbbVie has expanded its portfolio through a $745 million deal with Haisco Pharmaceutical Group for two non-opioid pain treatment candidates. This move aligns with growing demand for non-opioid alternatives amid the opioid crisis, reflecting a strategic shift towards safer pain management solutions. Spyre Therapeutics has also reported positive Phase 2 results for its ulcerative colitis drug, setting it up as a potential competitor against Takeda's Entyvio. Success here could enhance therapeutic options for patients struggling with this chronic condition, highlighting continued innovation in gastrointestinal disorders. Eli Lilly's recent success with its BTK inhibitor Jaypirca marks a pivotal moment in chronic lymphocytic leukemia (CLL) treatment strategies. Having demonstrated substantial efficacy in a Phase 3 clinical trial—the fourth positive readout—Jaypirca establishes itself as an industry first. Its fixed-duratioSupport the show

This episode covers: Cardiology this Week: A concise summary of recent studies What's new in hypertension? Why I favour a critical approach in cardiology Snapshots Host: Sabiha Gati Guests: Konstantinos Koskinas, Gianfranco Parati, John Mandrola, Yasmina Bououdina Want to watch this episode? Go to: https://esc365.escardio.org/event/2561 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and John Mandrola have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: honorary from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi.  Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Gianfranco Parati has declared to have potential conflicts of interest to report: Merck Sharp and Dohme, Omron Healthcare, Viatris. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Sabiha Gati Guest: Gianfranco Parati Want to watch this extended interview? Go to: https://esc365.escardio.org/event/2561?resource=interview Want to watch the episode? Go to: https://esc365.escardio.org/event/2561 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: honorary from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi.  Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Gianfranco Parati has declared to have potential conflicts of interest to report: Merck Sharp and Dohme, Omron Healthcare, Viatris. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

In this podcast episode, Aditya Bardia, MD, MPH, FASCO, and Ruta Rao, MD, discuss ADCs for HER2-negative/ultralow/low metastatic breast cancer, including: Classifying HER2 expression in MBC today (HER2 negative/ultralow/low/positive) and why this is important ADCs for HER2-negative/ultralow/low MBC Patient communication: best practices in discussing treatment goals and potential AEs Presenters:  Aditya Bardia, MD, MPH, FASCO Professor of Medicine Geffen School of Medicine University of California Los Angeles, California Ruta Rao, MD​ Medical Director, Rush University Cancer Center Professor of Medicine Rush University Medical Center Chicago, Illinois ​ Content based on an online CME program supported by educational grants from AstraZeneca and Daiichi Sankyo, Inc. Link to full program: https://bit.ly/47JLtBt Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

This Special Episode on Atrial Fibrillation covers: Cardiology this Week: A concise summary of recent studies Atrial fibrillation burden: clinical relevance of a new outcome Pulsed field ablation: game changer? Drug treatment following atrial fibrillation ablation Spotlight: Holiday Heart Syndrome Host: Rick Grobbee Guests: Rick Grobbee, Konstantinos Koskinas, Jason Andrade, Arian Sultan, Michiel Rienstra Want to watch that special episode? Go to: https://esc365.escardio.org/event/2549 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Jason Andrade, Yasmina Bououdina, Rick Grobbee and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Michiel Rienstra has declared to have potential conflicts of interest to report: consultancy fees from Bayer (OCEANIC-AF national PI) , InCarda Therapeutics (RESTORE-SR national PI), Novartis to the institution. Speaker fee from Daiichi-Sankyo, Pfizer to the institution. Unrestricted research grant from the Dutch Heart Foundation and is conducted in collaboration with and supported by the Dutch CardioVascular Alliance, 01-002-2022-0118 EmbRACE. Unrestricted research grant from ZonMW and the Dutch Heart Foundation; DECISION project 848090001. Unrestricted research grants from the Netherlands Cardiovascular Research Initiative: an initiative with support of the Dutch Heart Foundation; RACE V (CVON 2014–9), RED-CVD (CVON2017-11). Unrestricted research grant from Top Sector Life Sciences & Health to the Dutch Heart Foundation (PPP Allowance; CVON-AI (2018B017). Unrestricted research grant from the European Union's Horizon 2020 research and innovation programme under grant agreement; EHRA-PATHS (945260). This research is funded by the Dutch Heart Foundation and is conducted in collaboration with and supported by the Dutch CardioVascular Alliance, 01 -002 -2022 -0118 EmbRACE.  Emma Svennberg has declared to have potential conflicts

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/CC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYK865. CME/CC/AAPA credit will be available until March 12, 2027.Pathway to Precision in Ovarian Cancer: A Pathology-Informed Guide to Translating Biomarker Testing Results Into Actionable Treatment With ADCs In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from AstraZeneca, Daiichi Sankyo, Inc. and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/CC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYK865. CME/CC/AAPA credit will be available until March 12, 2027.Pathway to Precision in Ovarian Cancer: A Pathology-Informed Guide to Translating Biomarker Testing Results Into Actionable Treatment With ADCs In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from AstraZeneca, Daiichi Sankyo, Inc. and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/CC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYK865. CME/CC/AAPA credit will be available until March 12, 2027.Pathway to Precision in Ovarian Cancer: A Pathology-Informed Guide to Translating Biomarker Testing Results Into Actionable Treatment With ADCs In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from AstraZeneca, Daiichi Sankyo, Inc. and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/CC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYK865. CME/CC/AAPA credit will be available until March 12, 2027.Pathway to Precision in Ovarian Cancer: A Pathology-Informed Guide to Translating Biomarker Testing Results Into Actionable Treatment With ADCs In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from AstraZeneca, Daiichi Sankyo, Inc. and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of developments that highlight the dynamism and complexity of our industry. The pharmaceutical and biotech sectors continue to evolve rapidly, driven by scientific innovations, regulatory shifts, and strategic initiatives.Eli Lilly's recent move to launch "Employer Connect," a platform aimed at improving access to its obesity medications, marks a significant step in addressing the growing public health issue of obesity. This initiative reflects the increasing influence of employer-driven healthcare solutions in managing chronic conditions. By directly involving employers, Eli Lilly seeks to enhance both the accessibility and affordability of its treatments, which could lead to better patient outcomes and reduced healthcare costs associated with obesity-related complications.In dermatology, Galderma has doubled its sales projections for Nemluvio (nemolizumab), an atopic dermatitis treatment, following a successful market debut. The revised projection to over $4 billion in peak annual sales underscores Nemluvio's strong market performance against competitors like Dupixent. This success not only highlights the drug's therapeutic efficacy but also indicates robust market demand for innovative dermatological therapies.Regulatory landscapes remain pivotal in shaping the industry. Vanda Pharmaceuticals' ongoing efforts to expand Hetlioz's label for jet lag treatment have been met with regulatory challenges since 2019. The FDA's response to Vanda's request for a public hearing underscores the complexities involved in navigating approval processes for label expansions. The outcome of such hearings could have broader implications for similar drugs seeking label amendments.Geopolitical dynamics also influence biopharma investments, with Ireland emerging as a stable manufacturing hub amidst global uncertainties. Despite geopolitical tensions, U.S. investments continue to flow into Ireland, highlighting its strategic importance as a location for biopharmaceutical manufacturing and innovation.In oncology, Pfizer is advancing its research and development strategy under Jeff Legos' leadership by leveraging its $43 billion acquisition of Seagen. The aim is to build an antibody-drug conjugate empire while advancing a PD-1xVEGF bispecific drug licensed from 3SBio. This approach underscores Pfizer's commitment to expanding its oncology pipeline through innovative therapies and combination regimens that could potentially transform cancer treatment paradigms.Meanwhile, Merck KGaA faces challenges with declining U.S. sales of Mavenclad due to anticipated generic competition. This situation reflects a broader industry trend where pharmaceutical companies must navigate patent expirations and generic market entries that threaten revenue streams of established products.Leo Pharma's launch of a direct-to-consumer campaign for Anzupgo, targeting hand eczema treatment, signifies the growing role of consumer engagement in pharmaceutical marketing strategies. Such approaches are becoming increasingly important in reaching patients directly.Collaborations remain a key driver of innovation within the industry. Daiichi Sankyo's partnership with German medtech Gaia to commercialize Lipodia—a digital therapeutic for high cholesterol management—illustrates the convergence between digital health technologies and traditional pharmaceuticals.In gene therapy news, uniQure finds itself in a contentious dialogue with the FDA over its Huntington's disease therapy. The debate centers around uniQure's claim that the FDA requested a "sham trial," which the agency denies. This situation underscores regulatory complexities surrounding gene therapies targeting rare diseases.Simultaneously, PepGen faces a partial clinical hold on its muscle wasSupport the show

Host: Sabiha Gati Guest: Thomas F. Luescher Want to watch that extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2556 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode.  The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology this Week: A concise summary of recent studies The future of guidelines in an era of big data and AI Exercise in hypertrophic cardiomyopathy Snapshots Host: Sabiha Gati Guests: Kostas Koskinas, Thomas F. Luescher, Michael Papadakis, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2556 Want to watch the extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode.  The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations.Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional interoperability, and AI reliability — and walks through the foundational steps companies should take, the organizational challenges they'll hit, and what measurable results look like when governance is done right.A few of Cary's key takeaways:Regulatory submissions are no longer just documents — they're structured data that demands consistent master data, controlled vocabularies, and traceable lineageStart with scope and pain points, not a boil-the-ocean exercise — pilot governance in one or two high-value use cases, then scaleData ownership belongs in the business, not IT — IT facilitates, but stewards and business owners should be accountable for their dataTools support governance but don't replace it — get the people and process foundation right before selecting platformsAI reliability depends on governed data — without standardized inputs and clear provenance, models produce unreliable or unexplainable outputsTie governance to business outcomes people are already measured on — submission cycle time, audit readiness, right-first-time metrics — or compliance won't stickAbout Cary SmithsonCary Smithson is Managing Partner and Owner of LeapAhead Solutions, Inc., where she leads a consulting practice focused on IT strategy, data governance, and business process consulting for life sciences. She leads the DIA RIM Working Group and the DIA RIM Intelligent Automation Team and co-authored the DIA RIM eBook. With experience spanning large consulting firms (Grant Thornton, PharmaLex), enterprise technology organizations (OpenText), and her own practice, Cary has served clients including Regeneron, Bristol-Myers Squibb, Johnson & Johnson, Daiichi Sankyo, Bayer, and BeiGene. She is a recognized thought leader who regularly presents at industry conferences on regulatory information management, intelligent automation, and AI adoption in life sciences.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the dynamic landscape of these industries, exploring significant regulatory shifts, scientific breakthroughs, and strategic corporate maneuvers that are shaping the future of healthcare.The pharmaceutical and biotech sectors are currently navigating a period of profound transition. Recent regulatory developments have captured attention, particularly the U.S. Supreme Court's decision to overturn emergency tariffs imposed by the previous administration. This ruling is pivotal as it alleviates financial pressures on the industry, allowing companies to redirect their resources towards innovation and development. It underscores the interconnectedness of global supply chains and highlights the importance of stable regulatory environments for fostering industry growth.In a notable advancement within oncology, AstraZeneca has achieved FDA approval for its combination therapy of Calquence and Venclexta as an all-oral regimen for first-line chronic lymphocytic leukemia (CLL). This approval not only positions AstraZeneca competitively in the BTK inhibitor market but also signifies a shift towards more patient-friendly treatment regimens. By simplifying therapy, this development promises to enhance patient compliance and improve outcomes, challenging existing standards in CLL care.Meanwhile, internal challenges at the Centers for Disease Control and Prevention have led to a postponement of a critical vaccine advisory panel meeting. This delay occurs amid evolving vaccine policies that have sparked debate within the public health community, potentially impacting immunization strategies and initiatives aimed at bolstering public health.Corporate governance within the industry is also experiencing shifts. Novo Nordisk has nominated two industry veterans to its board as part of an ongoing strategy to align leadership with evolving business objectives. Similarly, Roche is contemplating divesting its once-blockbuster antibiotic Rocephin in response to competitive pressures from generics in Europe. These moves reflect a broader industry trend where companies are re-evaluating their portfolios to better respond to market dynamics and patent expirations.Novartis is making strategic changes as well by selling its stake in Novartis India Limited while maintaining separate commercial and R&D interests in the region. This action highlights a growing trend among pharmaceutical giants towards streamlining operations and focusing on high-growth areas—a strategy aimed at maximizing resource allocation efficiency.Despite narrowly missing a $1 billion revenue target for 2025, Madrigal Pharmaceuticals remains optimistic about the growth prospects of its drug Rezdiifra within the metabolic dysfunction-associated steatohepatitis (MASH) market. The company anticipates further expansion driven by unmet medical needs, underscoring the competitive dynamics within this therapeutic area.In personnel movements that could influence strategic directions, Daiichi Sankyo has appointed former Novartis CMO John Tsai as head of its R&D division. His expertise is expected to bolster Daiichi's focus on oncology and other critical therapeutic areas, potentially accelerating innovation within their drug development pipeline.Meanwhile, Manus Bio has secured a $15 million contract with the U.S. government for domestic supply of shikimic acid, an essential component for producing Tamiflu. This contract highlights efforts to strengthen domestic pharmaceutical supply chains amid global uncertainties—a crucial consideration for ensuring medication availability during crises.In clinical research, a setback was observed with Grail's Galleri cancer blood test trial failing to meet its primary endpoint in collaboration with the NHS. The resulting decline in GrailSupport the show

This episode covers: Cardiology This Week: A concise summary of recent studies Atrial septal defects in adults Conservative and invasive management of chronic coronary syndromes Milestones: 4S trial   Host: Rick Grobbee Guests: JP Carpenter, Annemien van den Bosch, Rasha Al-Lamee, Roxana Mehran Want to watch the episode? Go to: https://esc365.escardio.org/event/2552 Want to watch the extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Roxana Mehran has declared to have potential conflicts of interest to report: institutional research payments from Abbott, Alleviant Medical, Chiesi, Concept Medical, Cordis, CPC Clinical Research, Daiichi Sankyo, Duke, Faraday Pharmaceuticals, Idorsia Pharmaceuticals, Janssen, MedAlliance, Medtronic, NewAmsterdam Pharma, Novartis, Novo Nordisk Inc., Population Health Research Institute (PHRI), Protembis GmbH, Radcliffe, RM Global Bioaccess Fund Management, Sanofi US Services, Inc. ; personal fees from: None ; Equity

Host: Rick Grobbee Guest: Annemien van den Bosch Want to watch that extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2552 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYC865. CME/MOC/AAPA credit will be available until January 29, 2027.The ADC Wave in SCLC: Emerging Evidence and Practical Considerations for New Options on the Horizon In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from Daiichi Sankyo, Inc., and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYC865. CME/MOC/AAPA credit will be available until January 29, 2027.The ADC Wave in SCLC: Emerging Evidence and Practical Considerations for New Options on the Horizon In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from Daiichi Sankyo, Inc., and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYC865. CME/MOC/AAPA credit will be available until January 29, 2027.The ADC Wave in SCLC: Emerging Evidence and Practical Considerations for New Options on the Horizon In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from Daiichi Sankyo, Inc., and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYC865. CME/MOC/AAPA credit will be available until January 29, 2027.The ADC Wave in SCLC: Emerging Evidence and Practical Considerations for New Options on the Horizon In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from Daiichi Sankyo, Inc., and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XYC865. CME/MOC/AAPA credit will be available until January 29, 2027.The ADC Wave in SCLC: Emerging Evidence and Practical Considerations for New Options on the Horizon In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through independent educational grants from Daiichi Sankyo, Inc., and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

Host: Emer Joyce Guest: Borge Nordestgaard Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2548 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology This Week: A concise summary of recent studies Lp(a) and aortic valve stenosis The truth about climate change and heart disease Snapshots Host: Emer Joyce Guests: JP Carpenter, Borge Nordestgaard, Hugh Montgomery, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2548 Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1.  Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Hugh Montgomery has declared to have potential conflicts of interest to report: funded and runs the charity-funded non-profit 'Real Zero'. Unpaid co-chair of the UK Health Alliance on Climate Change, Lancet Countdown on Health and Climate Change. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive into the latest happenings in this dynamic industry.Starting with a look at the projected launch of top drugs anticipated in 2026, it's fascinating to see how these developments are poised to influence the market. These drugs could collectively generate a substantial $45.9 billion in annual sales by 2032, underscoring their economic impact and potential to address unmet medical needs. This reflects a robust pipeline of innovative treatments, marking significant therapeutic advancements on the horizon.Regulatory actions continue to be a pivotal force in shaping market dynamics. The FDA's recent issuance of complete response letters to Aquestive Therapeutics and Pharming resulted in contrasting market reactions, with Aquestive's shares rising while Pharming's declined. This scenario highlights the critical role of regulatory decisions in shaping company fortunes and investor confidence. Additionally, the FDA has introduced a precheck manufacturing program aimed at streamlining domestic drug production processes. This initiative is part of a broader trend to bolster U.S. pharmaceutical manufacturing capabilities amid global supply chain concerns, reflecting an effort to reduce complexities associated with setting up manufacturing plants domestically.In the realm of policy debates, there's notable discord among Trump administration officials over the future of COVID-19 vaccines in the U.S. market. This internal division could have far-reaching implications for public health strategies and vaccine accessibility, emphasizing ongoing challenges in pandemic management and policy alignment.Turning to scientific innovation, Daiichi Sankyo's development of antibody-drug conjugates (ADCs) has faced some setbacks. The company has discontinued an internal next-wave candidate and is experiencing delays in pivotal phase 3 trial readouts for its AstraZeneca-partnered candidate, Datroway. Despite these challenges, ADCs remain a promising area of oncology research due to their targeted therapeutic potential.Positive regulatory feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has provided a boost for companies like Novo Nordisk and Amgen. Novo Nordisk received approval for semaglutide for non-alcoholic steatohepatitis (NASH), highlighting its potential to address this liver disease with limited treatment options. Conversely, Amgen's Tavneos faces a re-review due to data integrity concerns, illustrating the rigorous scrutiny that accompanies pharmaceutical approvals and the importance of maintaining data integrity throughout development.Sanofi's pipeline reflects mixed outcomes as its GCS inhibitor failed a phase 3 trial for Fabry disease but showed promise in Gaucher disease. This underscores the inherent uncertainties and challenges faced in drug development, where promising candidates may not always meet clinical expectations.In broader scientific research, AstraZeneca identified 22 genes potentially linked to chronic diseases following Epstein-Barr virus infection. This finding advances our understanding of viral pathogenesis and its long-term health impacts, potentially guiding future therapeutic interventions.These developments illustrate a dynamic landscape where scientific innovation, regulatory oversight, and market forces converge to shape the future of healthcare. Breakthrough technologies and new therapeutic approaches hold promise for improving patient care and advancing drug development. However, navigating complex regulatory environments and addressing data integrity concerns remain critical challenges that companies must overcome to bring these innovations to market successfully.On another front, Roche's substantial $1.7 billion deal with Sanegene marks its re-engageSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll delve into the multitude of changes and advancements sweeping across the industry, each with profound implications for drug development, patient care, and market dynamics.The pharmaceutical landscape continues to transform as companies like Daiichi Sankyo make significant progress with antibody-drug conjugates (ADCs). Their collaboration with AstraZeneca on products like Enhertu and Datroway represents a robust push into earlier lines of therapy. This strategic move aligns with a broader industry trend where ADCs are being positioned as front-line oncology treatments. These therapies are lauded for their targeted delivery mechanisms that maximize therapeutic efficacy while minimizing off-target effects. However, the competitive landscape is becoming increasingly fierce, necessitating robust clinical data to stand out in this rapidly evolving market segment.Elsewhere, Moderna's recent decision to pause new late-stage trials for infectious disease vaccines highlights the intricate interplay between public sentiment and corporate strategy. The rising anti-vaccine sentiment in the U.S., compounded by diminishing support infrastructure from previous administrations, has significantly influenced Moderna's strategic recalibration. This situation underscores a critical challenge for developers of mRNA platforms: how to navigate complex public perceptions and policy landscapes while pushing forward with vaccine innovations.From a regulatory perspective, Recipharm's commissioning of a new facility in Bengaluru, India for non-bacterial beta-lactam drugs aligns with evolving FDA standards. This investment is not just about compliance; it's a proactive adaptation to meet rising customer demand and represents a strategic partnership with a major biopharmaceutical player. Such collaborations are crucial as they help scale drug production capabilities effectively.The dissolution of the marketing partnership between Arcutis and Kowa over Zoryve reflects the ever-dynamic nature of commercial collaborations within the industry. Originally intended to broaden Zoryve's market beyond dermatologists to include primary care physicians, this shift may indicate strategic realignments or divergent priorities between partners. Such changes can significantly impact market penetration strategies and highlight the importance of aligned goals within partnerships.In Europe, regulatory expansion by GSK of its Arexvy vaccine for all adults marks a pivotal milestone in widening access to crucial vaccines. This development not only enhances GSK's market presence but also underscores the agility required in regulatory responses to public health needs.On the financial front, settlements under the False Claims Act reaching $6.8 billion in FY2025 demonstrate heightened scrutiny on compliance practices within the industry. This serves as a stark reminder of both financial and reputational risks tied to non-compliance and underscores an ongoing need for stringent oversight mechanisms.Amidst economic uncertainties, AstraZeneca's decision to pause its UK research site investment reflects broader industry challenges related to strategic reallocations of resources. Companies are increasingly re-evaluating their geographic footprints and investment priorities in response to evolving market conditions.In precision oncology, Guardant Health's FDA approval for its Guardant360 CDx test in conjunction with Pfizer's Braftovi highlights how companion diagnostics are becoming integral in enhancing therapeutic outcomes through tailoring treatments based on specific genetic profiles. These developments illustrate a multifaceted landscape where scientific innovation, regulatory changes, strategic partnerships, and compliance considerations converge.The recent landscapSupport the show

This episode covers: Cardiology This Week: A concise summary of recent studies What´s new in TAVI?  Digital solutions in arrhythmias Mythbusters - Gratitude is heart healthy Host: Emer Joyce Guests: JP Carpenter, Davide Capodanno, Fleur Tjong Want to watch that episode? Go to: https://esc365.escardio.org/event/2528 Want to watch that extended interview on Digital solutions in arrhythmias, go to: https://esc365.escardio.org/event/2528?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson. Fleur Tjong has declared to have potential conflicts of interest to report: Amsterdam UMC Innovation grant, Heath Holland TKI, Abbott, Dutch Research Council, Boston Scientific.

Host: Emer Joyce Guest: Fleur Tjong Want to watch that extended interview on https://esc365.escardio.org/event/2528?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2528 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson. Fleur Tjong has declared to have potential conflicts of interest to report: Amsterdam UMC Innovation grant, Heath Holland TKI, Abbott, Dutch Research Council, Boston Scientific.

Join podcast host Takanori Yamaguchi, MD, PhD, and his guests Masato Fukunaga, MD, PhD and Masateru Takigawa, MD, PhD, for this week's Lead episode. This episode was recorded LIVE at APHRS 2025 in Yokohama, Japan. This episode was recorded entirely in Japanese. The OCEAN randomized trial found that in patients who remained free of atrial arrhythmia at least one year after successful catheter ablation for atrial fibrillation, continuing anticoagulation with rivaroxaban did not significantly reduce the risk of stroke, systemic embolism, or covert cerebral infarcts compared with low-dose aspirin, with both groups experiencing very low event rates. Additionally, rivaroxaban was associated with a higher incidence of bleeding, suggesting that long-term anticoagulation may not be necessary for many post-ablation patients with low to moderate stroke risk.   Learning Objectives Evaluate the evidence regarding the risks and benefits of continuing oral anticoagulation after successful catheter ablation for atrial fibrillation. Interpret the clinical implications of low thromboembolic event rates and increased bleeding risk when comparing anticoagulation with antiplatelet therapy in post-ablation patients. Apply study findings to clinical decision-making by identifying which patient populations may safely discontinue long-term anticoagulation after atrial fibrillation ablation.   Article Authors Atul Verma, M.D., David H. Birnie, M.D., Chenyang Jiang, M.D., Ph.D., Hein Heidbüchel, M.D., Gerhard Hindricks, M.D., Paulus Kirchhof, M.D., D.Sc., Jeff S. Healey, M.D. , Yunhe Wang, M.D., Nikolaos Dagres, M.D., Marc W. Deyell, M.D., Prashanthan Sanders, M.B., B.S., Ph.D., Rajeev K. Pathak, M.B., B.S., Ph.D., Pieter Koopman, M.D., Dieter Nuyens, M.D., Paul Novak, M.D., Guy Amit, M.D., Charles Dussault, M.D., Bhavanesh Makanjee, M.D., F. Russell Quinn, M.D., Umjeet Jolly, M.D., Leon Iden, M.D., Malte Kuniss, M.D., Mukul Sharma, M.D., Andrew Ha, M.D., Vidal Essebag, M.D., Ph.D., Jean Champagne, M.D., Michael D. Hill, M.D., Eric E. Smith, M.D., M.P.H., and George A. Wells, Ph.D., for the OCEAN Investigators   Host and Contributor Disclosure(s): T. Yamaguchi •Honoraria/Speaking/Teaching/Consulting: Abbott Japan, Japan Medtronic, Inc., Daiichi Sankyo, Boehringer Ingelheim, Bayer Healthcare Pharmaceutical, Japan, Nihon Kohden, Japan Lifeline, Novartis M. Takigawa •Honoraria/Speaking/Teaching/Consulting: Biosense Webster, Inc., Medtronic Japan, Abbott Japan •Research: Abbott, Biosense Webster, Inc., Medtronic, Inc. M. Fukunaga   •Honoraria/Speaking/Teaching/Consulting: Boston Scientific Japan, Abbott Medical   Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner): S. Sailor: No relevant financial relationships with ineligible companies to disclose.

Join Digital Education Committee Member and podcast host Melissa E. Middeldorp, MPH, PhD, and her guests Helmut Pürerfellner, MD, FHRS, and Jonathan M. Kalman, MBBS, PhD, FHRS for this week's Lead episode. This episode was recorded LIVE at APHRS 2025 in Yokohama, Japan. The OCEAN randomized trial found that in patients who remained free of atrial arrhythmia at least one year after successful catheter ablation for atrial fibrillation, continuing anticoagulation with rivaroxaban did not significantly reduce the risk of stroke, systemic embolism, or covert cerebral infarcts compared with low-dose aspirin, with both groups experiencing very low event rates. Additionally, rivaroxaban was associated with a higher incidence of bleeding, suggesting that long-term anticoagulation may not be necessary for many post-ablation patients with low to moderate stroke risk.   Learning Objectives Evaluate the evidence regarding the risks and benefits of continuing oral anticoagulation after successful catheter ablation for atrial fibrillation. Interpret the clinical implications of low thromboembolic event rates and increased bleeding risk when comparing anticoagulation with antiplatelet therapy in post-ablation patients. Apply study findings to clinical decision-making by identifying which patient populations may safely discontinue long-term anticoagulation after atrial fibrillation ablation.   Article Authors Atul Verma, M.D., David H. Birnie, M.D., Chenyang Jiang, M.D., Ph.D., Hein Heidbüchel, M.D., Gerhard Hindricks, M.D., Paulus Kirchhof, M.D., D.Sc., Jeff S. Healey, M.D. , Yunhe Wang, M.D., Nikolaos Dagres, M.D., Marc W. Deyell, M.D., Prashanthan Sanders, M.B., B.S., Ph.D., Rajeev K. Pathak, M.B., B.S., Ph.D., Pieter Koopman, M.D., Dieter Nuyens, M.D., Paul Novak, M.D., Guy Amit, M.D., Charles Dussault, M.D., Bhavanesh Makanjee, M.D., F. Russell Quinn, M.D., Umjeet Jolly, M.D., Leon Iden, M.D., Malte Kuniss, M.D., Mukul Sharma, M.D., Andrew Ha, M.D., Vidal Essebag, M.D., Ph.D., Jean Champagne, M.D., Michael D. Hill, M.D., Eric E. Smith, M.D., M.P.H., and George A. Wells, Ph.D., for the OCEAN Investigators   Host and Contributor Disclosure(s):H. Purerfellner •Honoraria/Speaking/Teaching/Consulting: Biosense Webster, Inc., Abbott, Medtronic, Boehringer Ingelheim, Daiichi Sankyo, Bristol Meyers Squibb, Boston Scientific J.M. Kalman •Research: Zoll Medical Corporation, Abbott Medical, Boston Scientific •Fellowship Support: Biosense Webster, Inc., Medtronic M. Middeldorp   •Nothing to disclose. Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner): S. Sailor: No relevant financial relationships with ineligible companies to disclose.    

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, we're speaking with Kenneth Galbraith, CEO and Board Chair at Zymeworks, a biotech developing multispecific therapies internally and through partnerships with companies including Jazz Pharmaceuticals and BeOne Medicines (formerly BeiGene), J&J, Merck, Daiichi Sankyo, and GSK. Ken talks about Zymeworks' shift to a royalty model for development funding and value creation, lessons learned from platform deals and cross-border R&D, the benefits of strong royalty agreements and backloaded milestone payments over headline upfronts, and industry dynamics for the coming year. Ken also shares insights from his deep experiences as a biotech investor and corporate director, and explains why scientific primacy should always drive biotech business decisions.         Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Dr. Hope Rugo and Dr. Vivek Subbiah discuss innovative trial designs to enable robust studies for smaller patient populations, as well as the promise of precision medicine, novel therapeutic approaches, and global partnerships to advance rare cancer research and improve patient outcomes. TRANSCRIPT  Dr. Hope Rugo: Hello and welcome to By the Book, a podcast series from ASCO that features engaging conversations between editors and authors of the ASCO Educational Book. I am your host, Dr. Hope Rugo. I am the director of the Women's Cancers Program and division chief of breast medical oncology at the City of Hope Cancer Center [in Los Angeles]. The field of rare cancer research is rapidly transforming thanks to progress in clinical trials and treatment strategies, as well as improvements in precision medicine and next-generation sequencing that enable biomarker identification. According to the National Cancer Institute, rare cancers occur in fewer than 150 cases per million each year, but collectively, they represent a significant portion of all cancer diagnoses. And we struggle with the appropriate treatment for these rare cancers in clinical practice. Today, I am delighted to be joined by Dr. Vivek Subbiah, a medical oncologist and the chief of early-phase drug development at the Sarah Cannon Research Institute in Nashville, Tennessee. Dr. Subbiah is the lead author of a paper in the ASCO Educational Book titled "Designing Clinical Trials for Patients with Rare Cancers: Connecting the Zebras," a great title for this topic. He will be telling us about innovative trial designs to enable robust studies for small patient populations, the promise of precision medicine, and novel therapeutic approaches to improve outcomes, and how we can leverage AI now to enroll more patients with rare cancers in clinical trials. Our full disclosures are available in the transcript of this episode.  Dr. Subbiah, it is great to have you on the podcast today. Thanks so much for being here. Dr. Vivek Subbiah: Thank you so much, Dr. Rugo, and it is an honor and pleasure being here. And thank you for doing this podcast for rare cancers. Dr. Hope Rugo: Absolutely. We are excited to talk to you. And congratulations on this fantastic paper. It is such a great resource for our community to better understand what is new in the field of rare cancer research. Of course, rare cancers are complex and multifaceted diseases. And this is a huge challenge for clinical oncologists. You know, our clinics, of course, cannot be designed as we are being very uni-cancer focused to just be for one cancer that is very rare. So, oncologists have to be a jack of all trades in this area. Your paper notes that there are approximately 200 distinct types of rare and ultra-rare cancers. And, by definition, all pediatric cancers are rare cancers. Of course, clinical trials are essential for developing new treatment strategies and improving patient outcomes, and in your paper, you highlight some unique challenges in conducting trials in this rare cancer space. Can you tell us about the challenges and how really innovative trial designs, I think a key issue, are being tailored to the specific needs of patients with rare cancer and, importantly, for these trials? Dr. Vivek Subbiah: Rare cancers present a perfect storm of challenges. First, the patient populations are very small, which makes it really hard to recruit enough participants for traditional type trials. Second, these patients are often geographically dispersed across multiple cities, across multiple states, across multiple countries, across multiple zip codes. So, logistics become complicated. Third, there is often limited awareness among clinicians, which delays referrals and diagnosis. Add to that regulatory hurdles, funding constraints, and you can see why rare cancer trials are so tough to execute. To overcome these barriers, we are seeing some really creative novel trial designs. And there are four different types of trial designs that are helping with enrolling patients with rare cancers. The first one is the basket trial. So let us talk about what basket studies are. Basket studies group patients based on shared genetic biomarkers or shared genetic mutations rather than tumor type. So instead of running separate 20 to 30 to 40 trials, you can study one therapy across multiple cancers. The second type of trial is the umbrella trial. The umbrella trials flip that concept of basket studies. They focus on one cancer type but test multiple targeted therapies within it. The third category of innovative trials are the platform studies. Platform trials are another exciting innovation. They allow new treatment arms to be added or removed as the data matures and as the data evolves, making trials more adaptive and efficient. The final category are decentralized tools in traditional trials, which are helping patients participate closer to where they are so that they can sleep in their own bed, which is, I think, a game changer for accessibility.  These designs maximize efficiency and feasibility for rare cancer research and rare cancer clinical trials. Dr. Hope Rugo: I love the idea of the platform trials that are decentralized. And I know that there is a trial being worked on with ARPA-H (Advanced Research Projects Agency for Health) funding in triple-negative breast cancer as well as in lung cancer, I think, and others with this idea of a platform trial. But it is challenged, I think, by precision medicine and next-generation sequencing where some patients do not have targetable markers, or there isn't a drug to target the marker. I think those are almost the same thing. We have really seen that these precision medicine ideas and NGS have moved the needle in helping to identify genetic alterations. This helps us to be more personalized. It actually helps with platform studies to customize trial enrollment. And we hope that this will result in better outcomes. It also allows us, I think, to study drugs even in the early stage setting more effectively. How can these advances be best applied to the future of rare cancers, as well as the challenges of not finding a marker or not having a drug? Dr. Vivek Subbiah: Thank you so much for that question. I think precision medicine and next-gen sequencing, or NGS, are truly the backbone of modern precision oncology. They have transformed how we think about cancer treatment. Instead of treating based on where the tumor originated or where the tumor started, we now look at the genetic blueprint of cancer. The NGS or next-gen sequencing allows us to sequence millions of DNA fragments quickly. Twenty, 30 years ago, they said we cannot sequence a human genome. Then it took almost a decade to sequence the first human genome. Right now, we have academic centers and commercial sequencing companies that are really democratizing NGS across all sites, not just in academic centers, across all the community sites, so that NGS is now accessible. This means that we can identify these actionable alterations like picking needles in haystacks, like NTRK fusions, RET fusions, or BRAF V600E alterations, high tumor mutational burden. This might occur across not one tumor type, across several different tumor types. So for rare cancers, this is critical because some of these mutations often define the best treatment option. Here is why this matters. Personalized therapy, right? Instead of a one-size-fits-all approach, we can tailor treatment to the patient's unique molecular profile. For trial enrollment, this can definitely help because patients can join biomarker-driven trials even if their cancer type is rare or ultra-rare. NGS technology has also helped us in designing rational studies. Many times monotherapy does not work in these cancers. So we are thinking about rational combination strategies. So NGS technology is helping us. Looking ahead, I see NGS becoming routine in clinical practice, not just at major niche academic centers, but everywhere. We will see more tumor-agnostic approvals, more molecular tumor boards guiding treatment decisions in real time. And I think we are seeing an expanded biomarker setup. Previously, we used to have only a few drugs and a handful of mutations. Now with homologous recombination defects, BRCA1/2 mutation, and expanding the HRD and also immunohistochemistry, we are expanding the biomarker portfolio. So again, I personally believe that the future is precision. What I mean by precision is delivering the right drug to the right patient at the right time. And for rare cancers, this isn't just progress. It is survival. And it is maybe the only way that they can have access to these cutting-edge precision medicines. Dr. Hope Rugo: That is so important. You mentioned an important area we will get to in a moment, the tumor-agnostic therapies. But as part of talking about that, do you think that the trials should also include just standard therapies? You know, who do you give an ADC to and when with these rare cancers? Because some of them do not have biomarkers to target and it is so disappointing for patients and providers where you are trying to screen a patient for a trial or a platform trial where you have one arm with this mutation, one arm with that, and they do not qualify because they only have a p53 loss, you know? They just do not have the marker that helps them. But we see this in breast cancer all the time. And it is tough because we don't have good information on the sequencing. So I wonder, you know, just because for some of these rare cancers it is not even clear what to use when with standard treatments. And then that kind of gets into this idea of the tumor-agnostic therapies that you mentioned. There are a lot of new treatments that are being evaluated. We have seen approval of some treatments in the last few years that are tumor-agnostic and based on a biomarker. Is that the best approach as we go forward for rare cancers? And what new treatment options are most exciting to you right now? Dr. Vivek Subbiah: Tumor-agnostic therapies, really close to my heart, are real breakthrough therapies and represent a major paradigm shift in oncology. Traditionally, for the broad listeners here, we are used to thinking about designing clinical trials and therapy like where the cancer originated, breast cancer, kidney cancer, prostate cancer, lung cancer. A tumor-agnostic therapy flips that model. Instead of focusing on the organ, they target the specific genetic alteration or biomarker that drives cancer growth regardless of where the tumor started, regardless of the location of the tumor, regardless of the zip code of the tumor. So why is this so important for rare cancers? Because many rare cancers share molecular features with more common cancers. For instance, NTRK fusion might occur in pediatric sarcoma, a salivary gland tumor, or a thyroid cancer. Historically, each of these would require separate trials, which is nearly impossible, unfeasible to conduct in these ultra-rare cancers like salivary gland cancer or pediatric sarcomas. Tumor-agnostic therapies allow us to treat all those cancers with the same targeted drug if they share that biomarker. Again, we are in 2025. The first tissue-agnostic approval, the historic precedent, was in fact an immunotherapy. Pembrolizumab was approved in 2017, May 2017, as the first immunotherapy to be approved in a tumor-agnostic way for a genomic biomarker, for MSI-High and dMMR cancers. Then came the NTRK inhibitors. So today we have not one, not two, but three different NTRK inhibitors: larotrectinib, entrectinib, and repotrectinib, which show response rates of nearly more than 60 to 75% across a handful of dozens and dozens of cancer types. Then, of course, we have RET inhibitors like selpercatinib, which is approved tissue-agnostic, and pralsetinib, which also shows tissue-agnostic activity across multiple cancers. And more recently, combination therapy with a BRAF and MEK combination, dabrafenib and trametinib, received tumor-agnostic approval for all BRAF V600E tumors with the exception of colorectal cancer. And even recently, you mentioned about antibody drug conjugates. Again, I think we live in an era of antibody drug conjugates. And Enhertu, trastuzumab deruxtecan, which was used first in breast cancer, now it is approved in a histology-agnostic manner for all HER2-positive tumors defined by immunohistochemistry 3+. So again, beyond NGS, now immunohistochemistry for HER2 is also becoming a biomarker. So again, for the broad listeners here, in addition to comprehensive NGS that may allow patients to find treatment options for these rare cancers for NTRK, RET, and BRAF, immunohistochemistry for HER2 positivity is also emerging as a biomarker given that we have a new FDA approval for this. So I would say personally that these therapies are game changers because they open doors for patients who previously had no options. Instead of waiting for years for a trial in their specific cancer type, they can access a treatment based on their molecular profile. I think it is precision medicine at its finest and best. Looking ahead, the third question you asked me is what is exciting going on? I think we will see more of these approvals. My hope is that today, I think we have nine to ten approvals. My hope is that within the next 25 to 50 years, we will have at least 50 to 100 drugs approved in this space based on a biomarker, not based on a location of the tumor type. Drug targeting rare alterations like FGFR2 fusions, FGFR amplifications, ALK fusions, and even complex signatures like high tumor mutational burden. I think we will be seeing hopefully more and more drugs approved. And as sequencing becomes routine, we will identify more patients for these therapies. I think for rare cancers, this is not just innovative approach. This is essential for them to access these novel precision medicines. Dr. Hope Rugo: Yeah, that is such a good point. I do think it is critical. Interestingly in breast cancer, it hasn't been, you know, there is always like two patients in these tumor-agnostic trials, or if that. You know, I think I have seen one NTRK fusion ever. I think that highlights the importance for rare cancers. And you know, I am hoping that that will translate into some new directions for some of our rarer and impossible-to-treat subtypes of breast cancer. It is this kind of research that is really going to make a difference. But what about those people who do not have biomarkers? What if you do not fit into that? Do you think there is a possibility of trying to do treatments for rare cancers in some prospective way that would help with that? You know, it is really a huge challenge. Dr. Vivek Subbiah: Absolutely. I think, you know, you're right, usually many of these rare cancers are driven by specific biomarkers. And again, some of the pediatric salivary gland tumors or pediatric sarcomas like fibrosarcomas, they are pathognomonic with NTRK fusions. And again, given that we have a tumor-agnostic approval, now these patients have access to these therapies. And I do not think that we would have had a trial just for pediatric fibrosarcomas with NTRK fusions. So that is one way. Another way is SWOG, right? The SWOG DART [1609] had this combination dual checkpoint, it was called the DART study dual combination chemotherapy with ipi/nivo. Now here the rare cancer subtype itself becomes a biomarker and they showed activity across multiple rare cancer subtypes. They didn't require a biomarker. As long as it was a rare or ultra-rare cancer, these patients were enrolled into the SWOG DART trial and multiple arms have read out. Angiosarcoma, Kaposi sarcoma, even gestational trophoblastic disease. Again, they have shown responses in these ultra-rare, rare cancers. Sometimes they might be seeing one or two cases a whole year. And I think this SWOG effort, this cooperative group effort, really highlighted the need for such studies without biomarkers as well. Dr. Hope Rugo: That is such a fantastic example of how to try and treat patients in a collaborative way. And in the paper, you also emphasize the need for collaborative research efforts, you know, uniting resource expertise across different ways of doing research. So cooperative groups, advocacy organizations that can really help advance rare cancer research, improve access to new therapies, and I think importantly influence policy changes. I think this already happened with the agnostic approvals. Could you tell us more about that? How can we move forward with this most effectively? Dr. Vivek Subbiah: Personally, I believe that collaboration is absolutely critical and essential for rare cancer research. No single institution, no single individual, or no single state or entity can tackle these challenges alone. The patient populations are small and dispersed. So pooling resources is the only way to run these meaningful trials. Again, it is not like singing, it is like putting a huge, huge, I would say, an opera piece together. It is not a solo, vocal therapy, but rather putting a huge opera piece like Turandot. You know, you mentioned cooperative groups. Cooperative groups, as I mentioned earlier, the SWOG DART program, the ASCO [TAPUR study]. ASCO is doing a phenomenal work of the TAPUR study. Again, this ASCO TAPUR program has enrolled so many patients with rare cancers who otherwise would not have treatment options. NCI-MATCH, the global effort, right? NCI-MATCH and the ComboMATCH are great examples. They bring together hundreds of sites, thousands of clinicians to run large-scale trials that would be impossible for any individual center or institution. These trials have already changed practice. For instance, the DART demonstrated the power of immunotherapy in rare cancers and influenced NCCN guidelines. One of the arms of the NCI-MATCH study from the BRAF V600E arm contributed towards the BRAF V600E tissue-agnostic approval. So, the BRAF V600E tissue-agnostic approval was by a pooled analysis of several studies. The ROAR study, the Rare Oncology Agnostic Research study, the NCI-MATCH dataset of tumor-agnostic cohort, and another pediatric trial, and also evidence from literature and evidence of case reports. And all this pooled analysis contributed to the tissue-agnostic approval of BRAF V600E across multiple rare cancers. There are several patient advocacy organizations which are the real unsung heroes here. Groups like, for instance, we mentioned in the paper, Target Cancer Foundation, don't just raise awareness for rare cancer research, they actively connect patients to trials providing financial, emotional support, and even run their own studies like the TRACK trial. They also influence policy to make access easier. On a global scale, initiatives like DRUP in the Netherlands, the ROME study in Italy, the PCM4EU in Europe are expanding precision medicine across these borders. These collaborations accelerate research, improve trial enrollment, and ensure patients everywhere can have access to these cutting-edge therapies. Again, it is truly a team effort, right? It is a multi-stakeholder approach. Researchers, clinicians, investigators, industry, regulators, academia, patients, patient advocates, and their caregivers all working together. And it takes a village. Dr. Hope Rugo: Absolutely. I mean, what a nice response to that. And I think really exciting and it is great to see your passion about this as well. But it helps all of us, I think, getting discouraged in treating these cancers to understand what is happening moving forward. And I think it is also a fabulous opportunity for our junior colleagues as they rise up in academics to be involved in these international collaborative efforts which are further expanding. One of the things that comes up for clinical trials for patients, and I think it is highlighted with rare cancers because, as you mentioned, people are all over the place, you know, they are so rare. They are all far away. Our patients are always saying to us, "Should I go here for a phase 1 trial?" Can you talk a little bit about how we can overcome these financial and geographic burdens for the patients? You talked about having trials locally, but it is a big financial and just social burden for patients. Dr. Vivek Subbiah: Great point. Financial cost is a major barrier in rare cancer clinical trials. It is a major barrier not just in rare cancer clinical trials, but in clinical trials in general. The economics of rare cancer research are one of the toughest challenges we face. Developing a new drug is already expensive, often billions of dollars. On an average, it takes 2 billion dollars or 2.8 billion dollars according to some data from drug discovery to approval. For rare cancers, the market is tiny, which means the pharmaceutical companies have really little financial incentive to invest. That is why initiatives like the Orphan Drug Act were created to provide tax credits, grants, and market exclusivity to encourage development for rare diseases. Clinical trials themselves are expensive because the small patient populations mean longer recruitment times and higher per-patient costs. Geographic dispersion, as you mentioned, for the patients adds travel, coordination. That is why we need to think out of the box about decentralized trial infrastructure so that we can mitigate some of these expenses. Complex trial designs like basket or platform trials sometimes require sophisticated data systems and regulatory oversight. That is a challenge. And I think some of the pragmatic studies like ASCO TAPUR have overcome those challenges. Advanced technologies like next-gen sequencing and molecular profiling also add significant upfront cost to this. Funding is also limited because rare cancers receive less attention compared to common cancers. Public funding and cooperative group trials help a lot, but I think they cannot cover everything. Patient advocacy organizations sometimes step in to bridge these gaps, but sustainable financing remains a huge challenge. So, the bottom line is without financial incentives and collaborating funding models, many promising therapies for rare cancers would never make it to patients. That is why we need system-wide policy changes, global partnerships, and innovative, effective, seamless trial designs which are so critical so that they can help reduce the cost and make research feasible so that we can deliver the right drug to the right patient at the right time. Dr. Hope Rugo: There is a lot of excitement about the future integration of AI in screening. Just at the San Antonio Breast Cancer meetings, we have a number of different presentations about AI to find markers, even like HER2, and using AI where you would screen and then match patients to clinical trials. Do you have any guidance for the rare cancer community on how to leverage this technology in order to optimize patient enrollment and, I think, identification of the best treatment matches? Dr. Vivek Subbiah: I think artificial intelligence, AI, is a game-changer in the making. Right now, clinical trial is clunky. Matching patients to trial is often manual, time consuming, laborious. You need a lot of personnel to do that. AI can automate this process by analyzing genomic data, medical records, and trial eligibility criteria to find the best matches quickly, accurately, and effectively. For the community, the key is to invest in data standardization and interoperability because AI needs clean, structured data to work effectively. Dr. Hope Rugo: Thank you so much, Dr. Subbiah, for sharing these fantastic insights with us on the podcast today and for your excellent article. Dr. Vivek Subbiah: Thank you so much. Dr. Hope Rugo: We thank you, our listeners, for joining us today. You will find a link to Dr. Subbiah's Educational Book article in the transcript of this episode. And please join us again next month on By the Book for more insightful views on key issues and innovations that are shaping modern oncology.  Thank you. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:        Dr. Hope Rugo   @hoperugo   Dr. Vivek Subbiah @VivekSubbiah Follow ASCO on social media:        ASCO on X  ASCO on Bluesky       ASCO on Facebook        ASCO on LinkedIn        Disclosures:       Dr. Hope Rugo:    Honoraria: Mylan/Viatris, Chugai Pharma   Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer   Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx   Dr. Vivek Subbiah: Consulting/Advisory Role: Loxo/Lilly, Illumina, AADI, Foundation Medicine, Relay Therapeutics, Pfizer, Roche, Bayer, Incyte, Novartis, Pheon Therapeutics, Abbvie Research Funding (Inst.): Novartis, GlaxoSmithKline, NanoCarrier, Northwest Biotherapeutics, Genentech/Roche, Berg Pharma, Bayer, Incyte, Fujifilm, PharmaMar, D3 Oncology Solutions, Pfizer, Amgen, Abbvie, Mutlivir, Blueprint Medicines, Loxo, Vegenics, Takeda, Alfasigma, Agensys, Idera, Boston Biomedical, Inhibrx, Exelixis, Amgen, Turningpoint Therapeutics, Relay Therapeutics Other Relationship: Medscape, Clinical Care Options

Dr. Monty Pal and Dr. Hope Rugo discuss advances in antibody-drug conjugates for various breast cancer types as well as treatment strategies in the new era of oral SERDs for HR-positive breast cancer. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and vice chair of academic affairs here at the City of Hope Comprehensive Cancer Center, Los Angeles. Today, I'm thrilled to be joined by Dr. Hope Rugo, an internationally renowned breast medical oncologist and my colleague here at City of Hope, where she leads the Women's Cancers Program and serves as division chief of breast medical oncology. Dr. Rugo is going to share with us exciting advances in antibody-drug conjugates (ADCs) that are expanding treatment options in various breast cancer types. She'll also address some of the complex questions arising in the new era of oral SERDs (selective estrogen receptor degraders) that are revolutionizing treatment in the hormone receptor-positive breast cancer space. Our full disclosures are available in the transcript of this episode.  Dr. Rugo, welcome, and thanks so much for being on the podcast today. Dr. Hope Rugo: Thank you. Pleasure to be here. Dr. Monty Pal: So, I'm going to switch to first names if you don't mind.  The first topic is actually a really exciting one, Hope, and this is antibody-drug conjugates. I don't know if I've ever shared this with you, but I actually started my training at UCLA, I was a med student and resident there, and it was in Dennis Slamon's lab. I worked very closely with Mark Pegram and a handful of others. This is right around the time I think a lot of HER2-directed therapies were really evolving initially in the clinics. Now we've got antibody-drug conjugates. Our audience is well-familiar with the mechanism there but tell us about how ADCs have really started to reshape therapy for HER2-positive breast cancer. Dr. Hope Rugo: Yeah, I mean, this is a really great place to start. I mean, we have had such major advances in breast cancer just this year, I think really changing the paradigm of treating patients. But HER2-positive disease, we've been used to having sequenced success of new agents. And I think the two biggest areas where we've made advances in HER2-positive disease, which were remarkably advanced this year in 2025, have been in antibody-drug conjugates with trastuzumab deruxtecan and with new oral tyrosine kinase inhibitors (TKIs) that have less of a target on EGFR and more on HER2, so they have an overall more tolerable toxicity profile and therefore a potentially better efficacy in the clinic. At least that's what we're seeing with these new strategies that we couldn't really pursue in the past because of toxicities of the oral TKIs. So, although our topic is ADCs, I'm going to include the TKI because it's so important in our thinking about treating HER2-positive disease. In the metastatic setting, we've seen these remarkable improvements in progression-free and overall survival in the second-line setting with T-DXd, or trastuzumab deruxtecan, compared to T-DM1. And then sequencing ADCs with giving T-DXd after T-DM1 was better than an oral tyrosine kinase or a trastuzumab combination with standard chemotherapy. That was DESTINY-Breast03 and DESTINY-Breast02. So, then we've had other trials since then, and T-DXd has moved into the early-stage setting, which I'll talk about in just a moment. But the next big trial for T-DXd in HER2-positive disease was moving it to the first-line setting to supplant what has become an established treatment for now quite a long time: the so-called CLEOPATRA regimen, which used the combined antibodies trastuzumab, pertuzumab with a taxane as first-line therapy. And then we've proceeded on with maintenance with ongoing HP for patients with responding or stable disease. And we'd seen long-term data showing, you know, at 8 years there was a group of patients whose cancers had never progressed and continued improved overall survival. So, T-DXd was studied in DESTINY-Breast09, either alone or in combination with pertuzumab compared to THP. The patient population had received a little bit more prior treatment, but interestingly, not a lot compared to CLEOPATRA. And they designed the trial to be T-DXd continued until progression with or without pertuzumab versus THP, which would go for six cycles and then stop around six cycles, and then stop and continue HP. Patients who had hormone receptor-positive disease could use hormone therapy, and this is one of the issues with this dataset because, surprisingly in this dataset and one other I'll mention, very few patients took hormone therapy. And even in the maintenance trial, the HER2CLIMB-05, less than 50% took hormone therapy as maintenance. This is kind of shocking to me and highlights an area of really important education, that outcome is improved when you add endocrine therapy for hormone receptor-positive HER2-positive metastatic disease in the maintenance phase, and it's a really important part of treatment. But suffice it to say, you know, you're kind of studying continued chemo versus stopping chemo in maintenance. And T-DXd, as we all expected, in combination with pertuzumab was superior to THP in terms of progression-free survival, really remarkably improved. And you could stop the chemo with toxicity, but most people continued it with T-DXd. Again, not a lot of people got hormone therapy, which is an issue, and you stop the chemo in the control arm. So, this has brought up a lot of interest in trying to use T-DXd as an induction and then go to maintenance, much as we do with the CLEOPATRA regimen with hormone therapy. But it brings up another issue. So first, T-DXd is superior; it's a great treatment. Not everybody needs to have it because we don't know whether it's better to give T-DXd first or second with progression - that we need a little bit longer follow-up. But just earlier this week, interestingly, the third week of December, the U.S. FDA approved T-DXd in the DESTINY-Breast09 approach with pertuzumab. So as I mentioned earlier, there was a T-DXd-alone arm; that arm has not yet reported. So very interesting, we don't know if you need pertuzumab or not. So what about the maintenance? That's the other area where we've made a huge advance here. So, we all want to stop chemo and we want to stop T-DXd. You don't want somebody being nauseated for two years while they're on treatment, and also there's a small number of patients with mostly de novo metastatic HER2-positive disease who are cured of their disease. We'd like to expand that, and I think these new drugs give us the opportunity to improve the number of patients who might be cured from metastatic disease. So the first maintenance study we saw was adding palbociclib, the CDK4/6 inhibitor, to endocrine therapy and HP, essentially. There, we had a remarkable improvement in progression-free survival difference of 15.2 months: 29 to 44 months, really huge. At San Antonio this year, we saw data with this oral tyrosine kinase inhibitor tucatinib, already showed it was great in a triplet, but as maintenance in combination with HP, it showed also a remarkable improvement in progression-free survival. But the numbers were all shifted down. So in PATINA, the control arm was in the 24-month range; here it was the tucatinib-HP arm that was in the 25 months and 16 months for control. So there was a differential benefit in ER-negative and ER-positive disease. So I think we're all thinking that our ideal approach moving forward would be to give T-DXd to most patients, we see how they do, and treat to best response. And then, stop the T-DXd, start HP, trastuzumab, pertuzumab for ER-negative, with tucatinib for ER-positive with palbociclib. We also have early data that suggests that both approaches may reduce the development of brain metastases, an issue in HER2-positive disease, and delay time to progression of brain metastases as seen in HER2CLIMB-05 in very early data - small numbers, but still quite intriguing that you might delay progression of brain metastases with tucatinib that clearly has efficacy in the brain.  So, I think that this is a hugely exciting advance for our patients, and these approaches are quickly moving into the early stage setting. T-DXd compared to standard chemo, essentially followed by THP, so a sequenced approach resulted in more pathologic complete responses than a standard THP-AC-type neoadjuvant therapy. T-DXd alone for eight cycles wasn't better, and that's interesting. We still need the sequenced non-cross-resistant chemo. But I think even more importantly, the data from DESTINY-Breast05 looking at T-DXd versus T-DM1 in patients with residual disease after neoadjuvant HER2-targeted therapy showed a remarkable improvement in invasive disease-free survival with T-DXd versus T-DM1, and quite early. It was a high-risk population, higher risk than the T-DM1 trial with KATHERINE, but earlier readout with a remarkable improvement in outcome. We expect to be FDA approved sometime in the first half of 2026. So then we'll get patients who've already had T-DXd who get metastatic disease. But my hope is that with T-DXd, maybe with tucatinib in the right group of patients or even sequenced in very high-risk disease, that we could cure many more patients with early-stage HER2-positive breast cancer and cure a subset, a greater subset of patients with de novo metastatic disease. Dr. Monty Pal: That's brilliant. And you tackled so many questions that I was going to follow up with there: brain metastases, etc. That was sort of looming in my mind. I mean, general thoughts on an ADC versus a TKI in the context of brain mets? Dr. Hope Rugo: Yeah, it's an interesting question because T-DXd has shown quite good efficacy in this setting. And tucatinib, of course, had a trial where they took patients with new brain mets, so a larger population than we've seen yet for the T-DXd trials, and saw that not only did they delay progression of brain metastases and result in shrinkage of existing untreated brain mets, but that patients who develop a new brain met, they could stay on the same assigned treatment. They got stereotactic radiation, and then the patients who were on tucatinib with trastuzumab and capecitabine had a further delay in progression of brain mets compared to those on the placebo arm, even after treatment of a new one that developed on treatment. So, I think it's hard. I think most of us for a lot of brain mets might start with the tucatinib approach, but T-DXd is also a very important treatment. You know, you're kind of trading off a diarrhea, some liver enzyme elevations with tucatinib versus nausea, which you really have to work on managing because it can be long-delayed nausea, and this risk of ILD, interstitial lung disease, that's about 12%, with most but not all trials showing a mortality rate from interstitial lung disease of just under 1 percent. In the early-stage setting, it was really interesting to see that with T-DXd getting four cycles in the neoadjuvant setting, a lot less ILD noted than the patients who got up to 14 cycles, as I think they got a median of 10 cycles in the post-surgical setting, there was a little bit more ILD. But I think we're going to be better and better at finding this earlier and preventing mortality by just stopping drug and treating earlier with steroids. Dr. Monty Pal: And this ILD issue, it always seems to resurface. There are drugs that I use in my kidney cancer clinic, everolimus, common to perhaps the breast cancer clinic as well, pembrolizumab, where I think the pattern of pneumonitis is quite different, right? What is your strategy for recognizing pneumonitis early in this context? Dr. Hope Rugo: Well, it is, and you know, having done the very early studies in everolimus where we gave it in the neoadjuvant setting and we're like, "Hmm, the patient came in with a cough. What's going on?" You know, we didn't know. And you have mouth sores, you know, we were learning about the drug as we were giving it. What we don't do with everolimus and CDK4/6 inhibitors, for example, is grade 1 changes like radiation pneumonitis, we don't stop, we don't treat it. We only treat for symptoms. But because of the mortality associated with T-DXd, albeit small, we stop drug for grade 1 imaging-only asymptomatic pneumonitis, and some of us treat with a half dose of steroids just to try and hasten recovery. We've actually now published or presented a couple of datasets from trials, a pooled analysis and a real-world analysis, that have looked at patients who were retreated after grade 1 pneumonitis or ILD and tolerated drug very well and none of them died of interstitial lung disease, which was really great to see because you can retreat safely and some of these patients stayed on for almost a year benefiting from treatment. So, there's a differential toxicity profile with these drugs and there are risk factors which clearly have identified those at higher risk: prior ILD, for example. A French group said smoking; other people haven't found that, maybe because they smoked more in France, I don't know. And being of Japanese descent is quite interesting. The studies just captured that you were treated in Japan, but I think it's probably being of Japanese descent with many drugs that increases your risk of ILD. And, you know, older patients, people who have hypoxia, those are the patients. So, how do we do this? With everolimus, we don't have specific monitoring. But for T-DXd we do; we do every nine weeks to start with and then every 12 weeks CT scans because most of the events occur relatively early. Somebody who's older and at higher risk now get the first CT at six weeks. Dr. Monty Pal: This is super helpful. And I have to tell you, a lot of these drugs are permeating the bladder cancer space which, you know, is ultimately going to be a component of my practice, so thank you for all this. We could probably stay on this topic of HER2-positive disease forever. I'm super interested in that space still. But let me shift gears a little bit and talk about triple-negative breast cancer and this evolving space of HR-positive, HER2-low breast cancer. I mean, tell us about ADCs in that very sort of other broad area. Dr. Hope Rugo: So triple-negative disease is the absolute hardest subset of disease that we have to treat because if you don't have a great response in the early stage setting, the median survival is very short, you know, under two years for the majority of TNBCs, with the exception of the small percentage of low proliferative disease subsets. The co-question is what do we do for these patients and how do we improve outcome? And sacituzumab govitecan has been one strategy in the later line setting that was shown to improve progression-free and overall survival, the Trop-2 ADC. We had recently three trials presented with the two ADCs, sacituzumab govitecan and the other Trop-2 ADC that's approved for HR-positive disease, datopotamab deruxtecan. And they were studied in the first-line setting. Two trials with SG, sacituzumab govitecan, those trials, one was PD-L1 positive, ASCENT-04. That showed that SG with a checkpoint inhibitor was superior, so pembrolizumab was superior to the standard KEYNOTE-355 type of treatment with either a taxane or gemcitabine and carboplatin with pembrolizumab for patients who have a combined positive score for PD-L1, 10 or greater. So, these are patients who are eligible for a checkpoint inhibitor, and SG resulted in an improved progression-free survival.  The interesting thing about that dataset is that few patients had received adjuvant or neoadjuvant checkpoint inhibitor, which is fascinating because we give it to everybody now. But access is an issue and timing of the study enrollment was an issue. The other thing which I think we've all really applauded Gilead for is that there was automatic crossover. So, you could get from the company, to try and overcome some of the enormous disparities worldwide in access to these life-saving drugs, you could get SG through the company for free once you had blinded independent central review confirmation of disease progression. Now, a lot of the people who got the SG got it through their insurance, they didn't bill the company, but 80 percent of patients in the control arm received SG in the second-line setting. So that impacts your ability to look at overall survival, but it's an incredibly important component of these trials. So then at ESMO, we saw the data from SG and Dato-DXd in the first-line metastatic setting for patients who either had PD-L1-negative disease or weren't eligible for an immunotherapy. For the Dato study, TROPION-Breast02, that was 10 percent of the patients who had PD-L1-positive disease but didn't get a checkpoint inhibitor, and for the ASCENT-03 trial population it was only 1 percent. Importantly, the trials allowed patients who relapsed within a year of receiving their treatment with curative intent, and the Dato study, TB-02, allowed patients who relapsed while on treatment or within the first six months, and that was 15 percent of the 20 percent of early relapsers. The ASCENT trial, ASCENT-03, had 20 percent who relapsed between 6 and 12 months. The drugs were better than standard of care chemotherapy, the ADCs in both trials, which is very nice. Different toxicity profiles, different dosing intervals, but better than standard of care chemotherapy in the disease that's hardest for us to treat. And importantly, when you looked at the subset of early relapsers, those patients also did better with the ADC versus chemotherapy, which is incredibly important. And we were really interested in that 15 percent of patients who had early relapse. I actually think that six months thing was totally contrived, invented, you know, categorization and doesn't make any sense, and we should drop it. But the early relapsers were 15 percent of TB-02 and Dato was superior to standard of care chemo. We like survival, but the ASCENT trial again allowed the crossover to an approved ADC that improved survival and 80 percent of patients crossed over. In the Dato trial, they did not allow crossover, they didn't provide Dato, which isn't approved for TNBC but is for HR-positive disease, and they didn't allow, of course, pay for SG. So very few patients actually crossed over in their post-treatment data and in that study, they were able to show a survival benefit. So actually, I think in the U.S. where we can use approved drugs already before there's a fixed FDA approval, that people are already switching to use SG or Dato in the first-line setting for metastatic TNBC that's both PD-L1 positive for SG and PD-L1 negative for both drugs. And I think understanding the toxicity profiles of the two drugs is really important as well as the dosing interval to try and figure out which drug to use. Dr. Monty Pal: Brilliant. Brilliant. Well, I'm going to shift gears a little bit. ADCs are a topic, again, just like HER2-positive disease we could stay on forever. Dr. Hope Rugo: Huge. Yes. Dr. Monty Pal: But we're going to shift gears to another massive topic, which is oral SERDs. In broad strokes, right, this utilization of CDK4/6 inhibitors in the context of HR-positive breast cancer is obviously, you know, a paradigm that's been well established at this point. Where do we sequence in oral SERDs? Where do they fit into this paradigm? Dr. Hope Rugo: Ha! This is a rapidly changing area; we keep changing what we're saying every other minute. And I think that there are three areas of great interest. So one is patients who develop ESR1 mutations that allow constitutive signaling through the estrogen receptor, even when there's not estrogen around, and that is a really important mutation that is subclonal; it develops under the pressure of treatment in about 40 percent of patients. And it doesn't happen when you first walk in the door. And what we've seen is that oral SERDs as single agents are better than standard single-agent endocrine therapy in that setting. The problem that we've had with that approach is that we're now really interested in giving targeted agents with our endocrine therapies, not just in the first-line setting where CDK4/6 inhibitors are our standard of care with survival benefit for ribociclib and, you know, survival benefit in subsets with other CDK4/6 inhibitors, and abemaciclib with a numeric improvement. So we give it first line. The question is, what do you do in the second-line setting? Because of the recent data, we now believe that oral SERDs should be really given with a targeted agent. And some datasets which were recently presented, which I think have helped us with that, have been EMBER-3 and then the most recently evERA BC, or evERA Breast Cancer, that looked at the oral SERD giredestrant with everolimus compared to standard of care endocrine therapy with everolimus, where 100 percent of patients received prior CDK4/6 inhibitor and showed a marked improvement in progression-free survival, including in the subsets of patients with a short response, 6-12 months of prior response to CDK4/6 inhibitor and in those who had a PIK3CA pathway mutation. The thing is that the benefit looks like it's much bigger in the ESR1 mutant population, although response was better, PFS wasn't better in the wild type. So, we're still trying to figure that out. We also saw EMBER-3 with imlunestrant and abemaciclib as a second line. Not everybody had had a prior CDK4/6 inhibitor; they compared it to imlunestrant alone, but still the data was quite striking and seemed to cross the need for ESR1 mutations. And then lastly, we saw data from the single arms of the ELEVATE trial looking at elacestrant with everolimus and abemaciclib and showed these really marked progression-free survival data, even though single-arm, that crossed the mutation status. At least for the everolimus combination, abemaciclib analysis is still to come in the mutated subgroups. But really remarkable PFS, much longer.  Single-agent fulvestrant after CDK4/6 inhibitor AI has a PFS in like the three-month range and in some studies, maybe close to five months. These are all at 10-plus months and really looking very good. And so those questions are, is it ESR1 mutation alone? Is it all comers? We'd like all comers, right? We believe in the combination approach and we're learning more about combinations with drugs like capivasertib and other drugs as we move forward. Everybody now wants to combine their targeted agent with an oral SERD because they're clearly here to stay with quite remarkable data. The other issue, so the second issue in the metastatic setting is, does it make a difference if we change to an oral SERD before radiographic imaging evidence of progression? And that was the question asked in the SERENA-6 trial where patients had serial monitoring for the presence of ESR1 mutations in ctDNA. And those who had them without progression on imaging could be randomized to switch to camizestrant with the same CDK4/6 inhibitor or stay on their same AI CDK4/6 inhibitor. And they showed a difference in progression-free survival that markedly favored camizestrant. But interestingly, the people who were on the standard control arm had an ESR1 mutation, we think AIs don't work, they stayed on for nine more months. The patients who were on the camizestrant stayed on for more than 16 months. And they presented some additional subset data which showed the same thing: follow-up PFS data, PFS2, all beneficial in SERENA-6 at the San Antonio [Breast Cancer Symposium]. So, we're still a little bit unclear about that. They did quality of life, and pain was markedly improved. They had a marked delayed time to progression of pain in the camizestrant arm. So this is all a work in progress, trying to understand who should we switch without progression to an oral SERD based on this development of this mutation that correlates with resistance. And, you know, it's interesting because the median time to having a mutation was 18 months and the median time to switch was almost 24 months. And then there were like more than 3,000 patients who hadn't gotten a mutation, hadn't switched, and were still okay. So screening everybody is the big question, and when you would start and who you would change on and how this affects outcome. Patients didn't have access to camizestrant in the control arm, something we can't fix but we have experimental drugs. We're actually planning a trial, I hope in collaboration with the French group Unicancer, and looking at this exact question. You know, if you switch and you change the CDK4/6 inhibitor and then you also allow crossover, what will we see? Dr. Monty Pal: We're coming right to the tail end of our time here, and I could probably go on for another couple of hours with you here. But if you could just give us maybe one or two big highlights from San Antonio, any thoughts to leave our audience with here based on this recent meeting? Dr. Hope Rugo: Yeah, I mean, I talked about a lot of those new data already from San Antonio, and the one that I'd really like to mention which I think was, you know, there were a lot of great presentations including personalized screening presented from the WISDOM trial by my colleague Laura Esserman, fascinating and really a big advance. But lidERA was the big highlight, I think, outside of the HER2CLIMB-05 which I talked about earlier in HER2-positive disease. And this study looked at giredestrant, the oral SERD versus standard of care endocrine therapy as treatment for medium and high-risk early-stage breast cancer. And what they showed, which I think was really remarkable with just about a three-year median follow-up, was an improvement in invasive disease-free survival with a hazard ratio of 0.7. I mean, really quite remarkable and so early. It looked as though this was all driven by the high-risk group, which makes sense, not the medium risk, it's too early. And also that there was a bigger benefit in patients who were on tamoxifen compared to giredestrant versus AI, but for both groups, the confidence intervals didn't cross 1. There's even a trend towards overall survival, even though it's way too early. I think that, you know, really well-tolerated oral drug that could improve outcome in early-stage disease, this is the first advance we've seen in over two decades in the treatment of early-stage hormone receptor-positive disease with just endocrine therapy. I think we think that we don't want to give up CDK4/6 inhibitors because we saw a survival benefit with abemaciclib and a trend with giving ribociclib in the NATALEE trial. So we're thinking that maybe one approach would be to give CDK4/6 inhibitors and then switch to an oral SERD or to have enough data to be able to give oral SERDs with these CDK4/6 inhibitors for early-stage disease. And that's all in the works, you know, lots of studies going on. We're going to see a lot of data with both switching 8,000 patients with an imlunestrant switching trial, an elacestrant trial going on, and safety data with giredestrant with abemaciclib and soon to come ribociclib. So, this is going to change everything for the treatment of early-stage breast cancer, and I hope cure more patients of the most common subset of the most common cancer diagnosed in women worldwide. Dr. Monty Pal: Super exciting. It's just remarkable to hear how this has evolved since 25 years ago, which is really the last time I sort of dabbled in breast cancer.  Thank you so much, Hope, for joining us today. These were fantastic insights. Appreciate you being on the ASCO Daily News Podcast and really want to thank you personally for your remarkable contribution to the field of breast cancer. Dr. Hope Rugo: Thank you very much, and thanks for talking with me today. Dr. Monty Pal: You got it. And thanks a lot to our listeners today as well. You'll find links to all the studies we discussed today in the transcript of this episode. Finally, if you value the insights that you hear today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinion of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:   Dr. Monty Pal @montypal Dr. Hope Rugo   @hoperugo Follow ASCO on social media:        ASCO on X  ASCO on Bluesky       ASCO on Facebook        ASCO on LinkedIn        Disclosures:     Dr. Monty Pal:    Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview   Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical   Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Hope Rugo:    Honoraria: Mylan/Viatris, Chugai Pharma   Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer   Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx  

Join podcast host Takanori Yamaguchi, MD, PhD, and his guests Koichi Magashina, MD, PhD, and Michifumi Tokuda, MD, PhD for this week's Lead episode. This episode was recorded LIVE at APHRS 2025 in Yokohama, Japan. This episode is recorded entirely in Japanese. The DECAF trial investigated whether continuing regular caffeinated coffee consumption versus complete abstinence affected the recurrence of atrial fibrillation (AF) or atrial flutter in patients after successful cardioversion. Over six months in this randomized study of 200 adults, those who drank at least one cup of caffeinated coffee daily had a significantly lower rate of AF or flutter recurrence compared to those who abstained (47% vs. 64%), suggesting moderate coffee intake may be safe and potentially beneficial for rhythm stability in this setting.    Learning Objectives Evaluate the impact of caffeinated coffee consumption versus abstinence on atrial fibrillation recurrence following cardioversion. Interpret the design and key outcomes of the DECAF randomized clinical trial and their relevance to clinical practice. Apply the trial findings to patient counseling regarding caffeine intake and atrial fibrillation management.   Article Authors Christopher X. Wong, MBBS, MPH, PhD; Christopher C. Cheung, MD, MPH; Gabrielle Montenegro, BA, Hannah H. Oo, BS; Isabella J. Peña, BA; Janet J. Tang, MPH, PhD; Samuel J. Tu, MBBS; Grace Wall, BA1; Thomas A. Dewland, MD; Joshua D. Moss, MD; Edward P. Gerstenfeld, MD; Zian H. Tseng, MD, MAS; Henry H. Hsia, MD; Randall J. Lee, MD, PhD; Jeffrey E. Olgin, MD; Vasanth Vedantham, MD; Melvin M. Scheinman, MD; Catherine Lee, PhD; Prashanthan Sanders, MBBS, PhD; Gregory M. Marcus, MD, MAS Podcast Contributors Takanori Yamaguchi, MD, PhD Koichi Magashina, MD, PhD Michifumi Tokuda, MD, PhD   Link to article Host and Contributor Disclosure(s): T. Yamaguchi Honoraria/Speaking/Teaching/Consulting: Abbott Japan, Japan Medtronic, Inc., Daiichi Sankyo, Boehringer Ingelheim, Bayer Healthcare Pharmaceutical, Japan, Nihon Kohden, Japan Lifeline, Novartis K. Nagashina   Nothing to disclose M. Tokuda   Honoraria/Speaking/Consulting: Medtronic Japan   Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner): S. Sailor: No relevant financial relationships with ineligible companies to disclose.