Podcasts about Amgen

Check out the video version of this episode on HCPLive!Finerenone's expansion into non-diabetic kidney disease is prompting a broader rethink of how chronic kidney disease is measured, mechanistically understood, and treated across its many causes.On an episode of Don't Miss a Beat recorded at the 10th Annual Heart in Diabetes Meeting, hosts Stephen Greene, MD, meeting co-chair and heart failure specialist at Duke University School of Medicine, and Muthiah Vaduganathan, MD, MPH, codirector of the Center for Cardiometabolic Implementation and cardiologist at Brigham and Women's Hospital, spoke with Katherine Tuttle, MD, professor of medicine at the University of Washington, about the phase 3 FIND-CKD trial and how it informs on the overall role of finerenone (Kerendia) in management of cardiovascular-kidney-metabolic syndrome.FIND-CKD showed finerenone slowed total estimated glomerular filtration rate (eGFR) slope by 0.7 mL/min/1.73 m² per year versus placebo, irrespective of diagnosis. Much of the discussion focused less on the number and more on why it counts as clinically meaningful.Drawing on CKD Prognosis Consortium data from hundreds of thousands of patients, Tuttle explained why eGFR slope reliably predicts kidney failure when a trial runs at least 2 years. CKD progresses rather than striking as a discrete event, so the field has moved toward endpoints measurable without waiting for organ failure or death.On safety, hyperkalemia occurred more often with finerenone than placebo, about 12% versus 3%, though fewer than 1% of patients discontinued. The framing was practical, with background SGLT2 inhibition expected to lower the risk.Mechanism anchors much of the conversation between Tuttle, Greene, and Vaduganathan.Tuttle highlighted how glomerular diseases, like IgA nephropathy, are immunologic disorders needing disease-specific therapy, yet all CKD converges on shared final common pathways of inflammation and fibrosis. Broad agents like finerenone target those pathways, making combination therapy the emerging model, pairing treatment of the inciting disease with control of progression.The group also discussed the field's trend toward precision nephrology. Protocol biopsies from the Kidney Precision Medicine Project showed only about half of patients labeled as diabetic CKD had classic diabetic nephropathy. A parallel to oncology followed, where deep phenotyping replaced uniform regimens, suggesting not every patient will need every drug.Tuttle positioned finerenone alongside renin-angiotensin system inhibitors and SGLT2 inhibitors as an emerging pillar for non-diabetic CKD, with GLP-1 receptor agonists and endothelin antagonists possibly to come. A pooled analysis of FIDELIO-DKD, FIGARO-DKD, and FIND-CKD showed roughly 30% reductions in kidney and cardiovascular outcomes and an 11% drop in all-cause mortality. The closing point held the cardiorenal patient often arrives through either specialty's door, making preservation of organ function and quality of life the shared aim.Relevant disclosures for Tuttle include Alnylam, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GSK, Novo Nordisk, Roche, and Travere Therapeutics. Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.References: Heerspink HJL, Neuen BL, Agarwal R, et al. Finerenone in Persons with Chronic Kidney Disease without Diabetes. N Engl J Med. Published online June 4, 2026. doi:10.1056/NEJMoa2604625 Bayer. Bayer to Present First Full FIND-CKD Results Investigating KERENDIA® (finerenone) in Non-Diabetic Chronic Kidney Disease at ERA 2026. Bayer.com. Published June 2, 2026. Accessed June 21, 2026. https://www.bayer.com/en/us/news-stories/kerendia-in-non-diabetic-chronic-kidney-disease

This week we talk about LDL, HDL, and cardiovascular issues.We also discuss one-time therapies, statins, and pharmaceutical economics.Recommended Book: Blood by Dr. Jen GunterTranscriptCholesterol is the most common type of what's called a sterol, which is a type of steroid, but also structurally technically an alcohol. But functionally, and classified by scientists, cholesterol is a lipid, which in this case is similar to a fat in all but how the body uses it. Cholesterol is the type of sterol most commonly found in animals—other types are found in plants and fungi—and its function, and this is where it varies from fats, which are used to store energy, is to basically help hold the cell membrane together, and it also serves as an intracellular messenger.Cholesterol is especially prevalent in the brain and spinal cord of animals, but it's found throughout their bodily tissues, as well, and again, it's vital for holding everything together and helping things communicate, in addition to being a precursor for vitamin D, steroid hormones, and bile.You want to have cholesterol, then, as without it you would be dead.Too much cholesterol in the blood, however, can also make you dead, especially when it's bound to what's called low-density lipoprotein, or LDL, as that contributes to cardiovascular disease like heart attacks and aneurysms, which can massively impact one's overall wellness and quality of life, and at extremes lead to the whole system shutting down as a consequence of heart attack, stroke, and the like.A lot of things can contribute to the development of cardiovascular disease, including habits like smoking, genetic predisposition, and the enthusiastic consumption of alcohol and unhealthy foods. But high blood cholesterol, of the LDL variety, is one of the top contributors, as these low-density clusters of lipoprotein can clog the pathways that blood takes throughout our bodies. Other, denser types of lipoproteins, HDLs, can clear it, like a heavier, denser substance pushing through clogs of less-dense materials that are gumming up a pipe, but LDL is at times accumulated as a result of consuming delicious but unhealthy foods, which are hard to avoid, and for some people the only consistently available and affordable foods; and for other people LDL accumulates as a result of their genetic predispositions—two things that are devilishly difficult to change.What I'd like to talk about today is a new type of therapy that may be very good news for people who struggle with the accumulation of LDL, and why this is being seen as very good news more broadly, at the scale of entire nations, as well.—Pharmaceutical company Eli Lilly is testing a new, experimental drug called VERVE-102 which is a one-time infusion that is currently administered over the course of about four hours, and once completed, it turns off a gene called PCSK9, which is responsible for making a protein that regulates cholesterol levels in humans.As I said, this drug is still being tested, so these are early results. But in a study of 35 people with high cholesterol levels, high levels of LDL or LDL-C, which is short for lipoprotein cholesterol, they found that this infusion, which again, is a one-time treatment, so get it once and then theoretically at least you never have to get anything done ever again, it reduced those LDL and LDL-C levels by as much as 62%, and that reduction was maintained a year and a half after the infusion; that's how far out they're retested so far, and the hope is that each retest will continue to show the same.On the strength of those very promising results, a Phase 2 study has been planned by the end of 2026, and the US Food and Drug Administration, the FDA, previously fast-tracked this existing study, because of the promise and potential this drug already demonstrated in early studies; all of which is considered to be very significant progress and possibility.To understand that significance, though, it's useful to know some health stats. And I'm going to focus on the US here, as that's where this drug is being developed, but many wealthy countries have similar stats, at least in terms of cardiovascular disease struggles.As of 2024, which is the last year we had good, cohesive data on this in the US, it was estimated that about 11-12% of the US adult population has high cholesterol levels. This typically doesn't come with any symptoms, but it can contribute a higher risk for all those cardiovascular diseases, including heart attack and stroke. A further 86 million US adults have borderline or elevated cholesterol levels, which can easily tip higher, but also, even in that existing, elevated state, contribute to negative cardiovascular outcomes.There are treatments for high cholesterol, the most common of category of which are called statins, which reduce the production of LDL by inhibiting an enzyme that produces cholesterol in the body.Unfortunately, these drugs do come with some usually minor side effects, which can cause patients to stop using them, and they have to be taken daily, ideally at the same time each day. That necessity for consistency leads to a lot of incorrect or incomplete usage, which reduces the effectiveness of these drugs. But it's also estimated that only about 54.5% of US adults who would benefit from statins are currently taking one—so that's people who could benefit and who have it prescribed, and then within that number are all the people who are taking this drug incorrectly or incompletely, reducing the effectiveness. So a relatively small number of people who should probably be on these things are getting the full benefit they offer because of the nature of the drug.And that's not great, because in the US alone, heart disease is the leading cause of death for pretty much every adult demographic; men, women, people of most racial and ethnic and economic groups, you name it, heart disease is the biggest threat to their lives.One US citizen dies every 34 seconds of some kind of cardiovascular condition, and as of 2023, 1 in every 3 deaths in the US was caused by the same, adding up to just over 919,000 people that year.Between 2021 and 2022, alone, the cost of services and medications related to heart disease added up to more than $168 billion; again, that's just in that period, and just in the US.And once more, these are ailments that are caused or heavily influenced by high levels of cholesterol, which are themselves amplified by common lifestyle choices, environmental factors that are hard for many people to avoid, and just by raw, dumb luck because of genetics.This treatment category, then, is being seen as a pretty big deal because a one-time infusion means those who receive it don't have to remember to take a pill every day at the same time, and won't experience those statin-based side-effects.It also means that people who are currently costing the medical system a bunch of money each year, because they need treatments for all the issues they suffer as a result of high cholesterol, will suddenly cost the system a lot less money, for treatments and medications. Not for nothing, their health and quality of life will likely improve as well. So in addition to having better, healthier outcomes personally, their cost to healthcare systems will drop.Eli Lilly's drug isn't the only one currently working its way through clinical trials, either.Amgen is working on a similar treatment, and Novartis and Ionis Pharmaceuticals have drugs that are even further along in the process, their medicines that cut heart attacks, strokes, and cardiovascular deaths could be approved by the FDA as soon as next year.There are a lot of caveats worth noting here, including that the science is still out as to whether this approach, silencing proteins that lead to the creation of more LDL and a similar substance called Lp(a)—which is more dangerous because it's stickier and thus more likely to get stuck in important blood pathways, and it's also more likely to be caused by genetics than lifestyle—the word is still out on whether reducing these things in the body actually reduces hearth attacks and stroke.Some people have had this particular risk variable dramatically reduced, but have still suffered from cardiovascular events, which raises the question of whether this path is the right one to take in trying to reduce this category of health issues; the correlation between LDL and heart attacks and strokes might not be a clear-cut as long assumed.There's also the issue of price. Drug-makers are economically incentivized to sell treatments over cures, because that means they can continue selling their product over time, potentially for the life of the patient, and a cure, in contrast, is a one-time hit that in theory should alleviate the need for future treatment.There's a chance, then, that the drug-makers will decide they need to make these one-hit treatments really, really expensive in order to make their R&D dollars back and to make the kinds of profits their investors expect from them. That could then reduce the potential audience for these treatments, even if they are effective, and could further slow their deployment and future research in this space.If these trials continue to go well, though, there's a good chance that this combination of similar but distinct treatment types will provide a more sustainable alternative to current options, and that, like the recent bogglingly rapid and widespread deployment of GLP-1 treatments for all sorts of issues, could lead to a new paradigm in this facet of the medical world.Show Noteshttps://en.wikipedia.org/wiki/Cholesterolhttps://en.wikipedia.org/wiki/Cardiovascular_diseasehttps://en.wikipedia.org/wiki/High_cholesterolhttps://pmc.ncbi.nlm.nih.gov/articles/PMC10982736/https://www.cdc.gov/heart-disease/data-research/facts-stats/index.htmlhttps://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1https://www.ama-assn.org/public-health/chronic-diseases/what-doctors-want-patients-know-about-high-cholesterolhttps://en.wikipedia.org/wiki/Statinhttps://pubmed.ncbi.nlm.nih.gov/42187087/https://abcnews.com/GMA/Wellness/new-drug-game-changer-people-high-cholesterol/story This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit letsknowthings.substack.com/subscribe

Take charge of your future. Our next group proram starts in September and is limited to 10 people. The Very Early Registration discount (45%) ends on June 21. Learn more here. — Dan Pontefract spent two decades building leadership, culture, and engagement inside high-tech and telecom organizations, and never once thought seriously about age. Then, in his early fifties, he had a wake-up call. It sent him to look under a rock he'd never lifted, where he found “an absolute cavern of issues.” The result is his sixth book, The Future is Grey: The Untapped Value of Age in the Workforce. Dan lays out the coming “bell to bulb” demographic inversion and the risks for organizations ignoring it. For individuals, he reframes the whole arc of a working life, from the language of generations (which he rejects as an ageist cognitive bias) to three universal career eras: Rivers, Rocks, and Rubies. That demographic inversion means experience will become more scarce and valuable. The through-line is don’t retire,  rewire instead. He shares stories of people who kept working or returned to work in a different way, which brings his concept of the “experience dividend” to life. ________________________ Bio Dan Pontefract is a renowned leadership and culture strategist, author, and keynote speaker with over two decades of experience in senior executive roles at companies such as SAP, TELUS, and Business Objects. Since then, he has worked with organizations globally, including Salesforce, Amgen, State of Tennessee, Nestlé, Canada Post, Autodesk, BMO, Government of Canada, Manulife, Nutrien, UBC, McGill University, Virgin Media O2, City of Toronto, among others. Dan has firsthand experience in turning leaders and corporate cultures into a competitive advantage. In addition to The Future of Work Is Grey, Dan has written five other books: WORK-LIFE BLOOM, LEAD. CARE. WIN., OPEN TO THINK, THE PURPOSE EFFECT, and FLAT ARMY garnering multiple awards including the Thinkers50 Top New Management Book and the Axiom Business Book Awards Gold Medal. Dan has also written for Forbes, Harvard Business Review, Leader to Leader, The Globe and Mail, Inc., among other outlets. Dan is a renowned keynote speaker who has presented at four TED events and delivered over 600 keynotes. He is an adjunct professor at the University of Victoria and has received over 25 personal awards. Dan’s career is interwoven with corporate and academic experience, coupled with an MBA, B.Ed, and multiple distinctions. Notably, Dan is listed on the Thinkers50 Radar, HR Weekly’s 100 Most Influential People in HR, PeopleHum’s Top 200 Thought Leaders to Follow, and Inc. Magazine’s Top 100 Leadership Speakers. ___________________________ The Future is Grey: The Untapped Value of Age in the Workforce Website ___________________________ Other Retirement Podcast Conversations You’ll Love The Second Curve of Life – Arthur C. Brooks Design a Phased Retirement – Anna Rappaport Rewirement – Helen Dennis ___________________________ Wise Quotes On Wisdom “Wisdom is to the experience dividend what oxygen is to fire.” On Retiring Retirement “Instead of using the word retire, I very much encourage people to use the word rewire.” On Demographic Shifts “We're shifting from a bell-shaped society to a bulb-shaped society, and it's going to change the talent makeup of your organization very, very soon.” ___________________________ About The Retirement Wisdom Podcast There are many podcasts on retirement, often hosted by financial advisors with their own financial motives, that cover the money side of the street. This podcast is different. You'll get smarter about the investment decisions you'll make about the most important asset you'll have in retirement: your time. About Retirement Wisdom I help people who are retiring, but aren't quite done yet, discover what's next and build their custom version of their next life. A meaningful retirement doesn't just happen by accident. Schedule a call today to discuss how the Designing Your Life process created by Bill Burnett & Dave Evans can help you make your life in retirement a great one — on your own terms. About Your Podcast Host Joe Casey is an executive coach who helps people design their next life after their primary career and create their version of The Multipurpose Retirement.™ He created his own next chapter after a 26-year career at Merrill Lynch, where he was Senior Vice President and Head of HR for Global Markets & Investment Banking. Joe has earned Master's degrees from the University of Southern California in Gerontology (at age 60), the University of Pennsylvania, and Middlesex University (UK), a BA in Psychology from the University of Massachusetts at Amherst, and his coaching certification from Columbia University. In addition to his work with clients, Joe hosts The Retirement Wisdom Podcast, ranked in the top 1% globally in popularity by Listen Notes, with over 2 million downloads. Business Insider recognized Joe as one of 23 innovative coaches who are making a difference. He's the author of Win the Retirement Game: How to Outsmart the 9 Forces Trying to Steal Your Joy.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll explore a series of pivotal advancements and challenges shaping the industry landscape—ranging from scientific breakthroughs to regulatory maneuvers, all underscoring the sector's dynamic evolution. Novartis has made headlines with its investigational drug, Delpacibart Braxlosiran, which successfully met primary endpoints in a Phase 1/2 trial for treating Facioscapulohumeral Muscular Dystrophy (FSHD). This RNA therapy utilizes an antibody-oligonucleotide conjugate to target the DUX4 gene, a significant cause of FSHD. The promising results not only mark a potential therapeutic breakthrough for this debilitating neuromuscular disease but also highlight Novartis' commitment to innovative treatments in rare diseases. In parallel, Enliven Therapeutics has reported positive outcomes from a Phase 1 trial of ELVN-001 for patients with Chronic Myeloid Leukemia (CML), who are heavily pretreated. This small molecule tyrosine kinase inhibitor shows improved efficacy, offering hope for those who have exhausted existing treatment options. As ELVN-001 progresses into later-stage trials, it may significantly enhance therapeutic options and outcomes for CML patients. Regulatory activities remain at the forefront, exemplified by Amgen's engagement with the Duke Clinical Research Institute to defend Tavneos amid an FDA push for market withdrawal. This illustrates the intricate complexity of regulatory processes and the importance of evidence-based advocacy in preserving access to critical therapies. In another regulatory development, Guardant Health's Guardant360 CDx has received FDA approval as a companion diagnostic for Boehringer Ingelheim's Hernexeos targeting HER2-mutant non-small cell lung cancer. The approval emphasizes the growing significance of liquid biopsy technologies in personalized oncology care, offering precise and less invasive diagnostic solutions. In business development news, strategic collaborations are gaining momentum. Simcere Pharmaceutical has partnered with Stanford Medicine to develop first-in-class therapies for Idiopathic Pulmonary Fibrosis. Meanwhile, Ildong Pharmaceutical and Welt are joining forces to create AI-driven digital therapeutics. These alliances reflect an increasing trend towards integrating cutting-edge technology and cross-disciplinary expertise to accelerate drug discovery and development. Funding dynamics within the sector are evolving, as seen with Neion Bio's successful Series A fundraising of $23 million aimed at enhancing its biologics manufacturing platform. Similarly, Human Continuum secured $5.13 million to advance its exosome-based regenerative medicine platform. These investments underscore a strong focus on innovative platform technologies promising to transform therapeutic modalities and manufacturing processes. Not all news is positive, however; Jazz Pharmaceuticals and PharmaMar faced setbacks as their Phase 3 trial for Zepzelca (Lurbinectedin) failed to meet its overall survival endpoint in metastatic small cell lung cancer. This highlights the inherent challenges in oncology drug development and underscores the need for continuous innovation. Regulatory hurdles persist as well, evidenced by Camurus receiving a second complete response letter from the FDA regarding Oclaiz (Octreotide) due to manufacturing concerns. The industry is also navigating cybersecurity challenges, as seen with Novo Nordisk's recent data breach incident. This breach underscores vulnerabilities within biopharma companies concerning intellectual property and patient data protection. It serves as a stark reminder of the necessity for robust cybersecurity measures to safeguard sensitive information critical to clinical trials and corporate integrity. Meanwhile, strategic planning remains essential as Astellas confronts a looming $6 billion patent cliff with Xtandi, its prostate cancer drug. The company's five-year strategy focuses on cost savings while sustaining innovation and competitiveness amidst impending revenue declines. The biotechnology sector continues to thrive amidst these challenges, evidenced by record levels of initial public offerings (IPOs). Despite broader economic uncertainties, investor confidence remains robust, highlighting biotech's potential for groundbreaking advancements and lucrative returns. Finally, artificial intelligence is making significant strides across health agencies, with a reported 148% increase at the FDA by 2025 alone. This surge in AI integration highlights its transformative potential in regulatory processes and healthcare delivery—offering opportunities to enhance efficiency and decision-making within the sector. In summary, today's developments encapsulate the vibrant pharmaceutical and biotech industries characterized by scientific innovation, regulatory intricacies, strategic collaborations, and financial maneuvers. These advancements offer new hope for patients while navigating complex landscapes that demand continuous innovation and compliance—a balance that defines success in this ever-evolving sector.Support the show

Welcome to IDEA Collider. In this episode, host Dr. Alex Gray, Chief Medical and Innovation Officer at IDEA Pharma, is joined by colleague Jacqueline Poot, President of Strategic Consulting and Analytics, to discuss the intricacies of pharmaceutical portfolio strategy.  This episode has accompanying slides that can be found on YouTube https://youtu.be/DKdy_MShWBA They tackle the growing view that the pharmaceutical industry doesn't just have a science problem; it has an execution problem. Alex breaks down how human biases, such as confirmation bias and champion bias, can derail clinical development and lead to poor portfolio choices. They emphasize that stopping a failing project early is just as critical to an organization's overall success as advancing a good one.  The episode explores successful decision-making frameworks from top-performing companies, analyzing how AstraZeneca's 5Rs framework reversed late-stage failures and examining structured matrices such as Roche's RAVE, Amgen's RAVE, and Pfizer's DICE. Alex also highlights Eli Lilly's highly successful Chorus unit and their use of AI to drive objective resource allocation. Tune in to hear why relying solely on standard Probability of Technical Success (PTS) models or Risk-Adjusted NPV is flawed, how operational issues drive numerous Phase 3 failures, and the incremental but powerful role machine learning will play in the next generation of drug development.

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.

In this episode sponsored by Amgen, Susan Britton, Director of Scientific Liaisons for Cencora's IntrinsiQ Specialty Solutions is joined by the American Oncology Network's Dr. Ralph Boccia and Vice President of Pharmacy Services at OneOncology Lisa Raff as they give an overview on the basics of bispecifics.If you have any other questions for our guests, or suggestions for future topics, email us at OnCall@cencora.com.Disclaimer: The OnCall podcast is for educational purposes only and not a substitute for any professional medical advice, legal advice, or clinical judgment. Views expressed are opinions only and not endorsed by Cencora or any of its affiliates. The opinions expressed are solely those of the author and may include certain marketing statements. The content of this presentation is owned or licensed by Cencora, and reproduction of the content is not permitted without Cencora's consent. Neither OnCall nor Cencora control the accuracy of any third-party information. Accessing any referenced site is subject to such site's terms of use.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're delving into a series of groundbreaking advancements and strategic movements reshaping the landscape of drug development and patient care. Eli Lilly's retatrutide has emerged as a significant breakthrough in obesity treatment, demonstrating a remarkable 30.3% weight reduction over two years in a Phase 3 trial. This drug, a triple agonist targeting glucagon-like peptide-1 receptors, regulates appetite and energy balance effectively. Such results not only highlight its potential as a transformative therapy for obesity but also position Eli Lilly prominently within metabolic disorder treatment landscapes. With global obesity rates on the rise, retatrutide's success could meaningfully impact public health strategies and pharmaceutical approaches to managing weight. In the oncology sector, Johnson & Johnson's acquisition of Firefly Bio for $1 billion is a strategic move aimed at enhancing their oncology pipeline with Firefly's Degrader Antibody Conjugate platform. This technology is designed to target KRAS-driven tumors, which are notoriously difficult to treat, prevalent in cancers such as pancreatic and colorectal cancer. By integrating Firefly's innovative platform, J&J aims to offer new hope for patients dealing with these challenging cancers. Turning to regulatory developments, the FDA has expanded Pfizer's Hympavzi label to include pediatric patients aged six and older with hemophilia A and B. This decision follows robust Phase 3 results that demonstrate Hympavzi's efficacy as a prophylactic treatment in this young population. The expanded label underscores efforts to address pediatric needs in areas traditionally focused on adults, thus broadening treatment options for young patients with bleeding disorders. In Europe, Chiesi's Loxujta (lomitapide) has gained EU pediatric label expansion for treating homozygous familial hypercholesterolemia, supported by strong Phase 3 data. This expansion aligns with a growing trend toward personalized medicine, tailoring treatments to specific genetic profiles even in younger populations. Collaborative efforts in biotechnology are also gaining momentum. GSK has partnered with Engitix to research liver fibrosis regression through extracellular matrix-targeted drug discovery. This collaboration highlights an industry shift towards leveraging biotechnology for innovative therapeutic solutions. Hikma Pharmaceuticals has shown confidence in the U.S. pharmaceutical manufacturing sector by committing $267 million to expand its facilities in Ohio. This expansion enhances Hikma's production capabilities while creating 350 jobs, positively impacting local economies and ensuring robust supply chain capabilities for essential medicines. The clinical trial landscape is vibrant with promising data across various therapeutic areas. Amgen's Repatha (evolocumab) has demonstrated cardiovascular risk reduction in high-risk diabetes patients without prior heart attacks or strokes, reinforcing its role not just in cholesterol management but also in broader cardiovascular risk mitigation strategies. Dexcom has made strides in metabolic diseases with its G7 continuous glucose monitor showing significant benefits for non-insulin-dependent type 2 diabetes patients. This development illustrates the increasing integration of digital health technologies into chronic disease management. Moreover, emerging treatments like Sciwind Biosciences' ecnoglutide have shown superior weight loss outcomes compared to existing therapies such as semaglutide. Such head-to-head comparisons are crucial for advancing competitive therapeutic landscapes and optimizing patient outcomes. In summary, the pharmaceutical and biotech sectors are experiencing transformative changes driven by scientific advancements and strategic collaborations. These developments not only expand treatment options across various therapeutic areas but also signify a shift toward more personalized and integrated healthcare solutions that could significantly impact patient care and drug development pathways globally. As these trends continue to evolve, they will likely drive further progressions in how pharmaceutical companies approach drug development and regulatory engagements, ultimately benefiting patients worldwide through more effective and personalized treatment modalities. Stay tuned for more updates from Pharma Daily as we continue to bring you the latest insights from the world of pharmaceuticals and biotechnology.Support the show

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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 evolving landscape of the pharmaceutical and biotechnology industries, where scientific advancements, regulatory updates, and strategic business decisions are reshaping the future. A significant development in this dynamic arena is the strategic withdrawal by Eli Lilly and Boehringer Ingelheim from planned investments in Germany. Both companies have decided to cut at least $1 billion each from their investments, a direct response to Germany's healthcare reforms targeting reduced branded drug prices. This decision highlights how governmental policy can significantly influence pharmaceutical investment strategies, prompting companies to be more cautious in markets with strict pricing controls. Another critical area of focus is clinical trials, where ADC Therapeutics has encountered a significant challenge. The company's antibody-drug conjugate, Zynlonta, which was granted accelerated FDA approval in 2021, recently reported three times as many deaths in its study arm compared to the control group. This raises important questions about the safety profile of antibody-drug conjugates, a class of drugs celebrated for their potential in targeted cancer therapy. The situation underscores the ongoing struggle to balance efficacy with safety in innovative cancer treatments. Regulatory oversight remains a pivotal aspect of the industry. The FDA recently issued a warning letter to Medline over recurring issues with toxic bacteria in finished products, emphasizing the critical need for compliance and safety within the medical device sector. Additionally, an untitled letter was sent to QOL Medical for potentially misleading promotional communications regarding Sucraid. Such actions demonstrate the FDA's vigilance in monitoring marketing practices that could mislead healthcare providers or patients. In drug approval news, AbbVie's Qulipta and Amgen's Imdelltra have secured approvals in Europe. These milestones are part of a broader strategy by pharmaceutical companies to expand geographically and enhance product portfolios through new indications. Meanwhile, Axsome Therapeutics successfully defended its narcolepsy medication Sunosi against generic competition until 2040 by settling patent litigation with a prospective generic manufacturer. This move reflects the intense patent battles common in the industry to extend product lifecycles and maintain market exclusivity. Turning to geopolitical influences, there is heightened scrutiny on China's biotech sector following calls from U.S. lawmakers for increased oversight. The potential application of the Comprehensive Outbound Investment National Security Act to Chinese biotech investments signals escalating tensions and could significantly impact international collaborations and investments. This reflects growing concerns over intellectual property protection and biotechnological advancements within international trade dynamics. In financial developments, Parabilis Medicines is preparing for an IPO with aims to raise $476 million to fund Phase 3 trials of its desmoid tumor drug candidate. This move illustrates continued investor interest in oncology innovations despite broader economic uncertainties. On the scientific front, Autobahn Therapeutics is making strides with its thyroid hormone receptor stimulator, showing efficacy in reducing depression symptoms in bipolar disorder during Phase 2 trials. This success paves the way for pivotal trials and highlights how hormone mimics can offer new therapeutic avenues for neuropsychiatric disorders. Meanwhile, Alnylam Pharmaceuticals has entered into a groundbreaking $2 billion agreement with Inceptive Nucleics to incorporate artificial intelligence into small interfering RNA design. By leveraging AI-driven methodologies, Alnylam aims to enhance precision and efficacy in siRNA therapies, potentially speeding up drug discovery processes. Operational challenges are also evident as companies navigate complex markets like Japan, underscoring the importance of integrating regulatory and strategic planning early on to mitigate risks and ensure market feasibility. These developments paint a vivid picture of a vibrant pharmaceutical and biotech landscape where scientific innovation is rapidly advancing alongside strategic partnerships and regulatory oversight. Breakthrough technologies such as AI-driven drug design hold promise for more targeted therapies while emphasizing personalized medicine approaches. However, these advancements come with challenges like safety concerns and regulatory compliance that demand constant vigilance and adaptability from industry stakeholders. The implications for patient care are significant as these scientific breakthroughs promise new treatment avenues for complex diseases while highlighting personalized medicine approaches. As these industries continue to evolve, staying informed about scientific innovations and regulatory landscapes will be crucial for stakeholders aiming to drive future growth and improve global health outcomes. Thank you for tuning into Pharma Daily. Stay informed and stay ahead with us as we continue to bring you the latest insights from around the pharmaceutical and biotech world.Support the show

US equity markets retreated, breaking a five session stretch of record closing highs for the three benchmark indices as oil prices and bond yields climbed. Dow was down 621 points or 1.2%. IBM down 7.2% to be the worst performer in the 30 stock index. Honeywell and Salesforce both fell 5.1%, while all of American Express, Boeing, Microsoft, and Nvidia fell over 3%. On the upside, Amgen and Walmart both gained over 3%. US Central Command, or CENTCOM, said that Iranian drones unsuccessfully attempted to attack American forces in Kuwait.

US equity markets retreated, breaking a five session stretch of record closing highs for the three benchmark indices as oil prices and bond yields climbed. Dow was down 621 points or 1.2%. IBM down 7.2% to be the worst performer in the 30 stock index. Honeywell and Salesforce both fell 5.1%, while all of American Express, Boeing, Microsoft, and Nvidia fell over 3%. On the upside, Amgen and Walmart both gained over 3%. US Central Command, or CENTCOM, said that Iranian drones unsuccessfully attempted to attack American forces in Kuwait.

Soon-to-arrive drugs promise to address elevated Lp(a); Best natural alternatives to repel mosquitoes and ticks; When cancer treatments cause osteoporosis; Organoids and computer simulations promise to reduce the toll of live animal experimentation; Land snails and pythons yield clues for new drug development; Shortfall in doctors accelerated by early retirement as physicians cite “hassle factor.”

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent updates offer a fascinating glimpse into an industry marked by dynamic shifts and groundbreaking advancements, each promising to reshape the future of healthcare. Let's delve into some of the most notable developments that are capturing attention across the globe. Starting with Eli Lilly's obesity medication, Zepbound, which has regained insurance coverage through CVS Caremark. This decision is emblematic of a broader recognition of obesity as a significant health issue that demands comprehensive treatment solutions. The reinstatement of coverage enables more patients to access Zepbound, potentially setting a benchmark for other insurers and leading to improved health outcomes. Shifting focus to oncology, AbbVie has secured FDA approval for a new therapy derived from its acquisition of ImmunoGen, adding to its portfolio of antibody-drug conjugates (ADCs) with Elahere. This development underscores the escalating value of ADCs in precision cancer therapies, offering innovative solutions for targeting cancer cells while preserving healthy tissues. Japan's pharmaceutical R&D stance is under examination as Prime Minister Sanae Takaichi meets with over 20 industry leaders to discuss maintaining the nation's competitive edge. This gathering highlights a global race among nations to enhance their R&D capabilities, ensuring leadership in pharmaceutical innovations. In neuroscience, Novartis's relentless pursuit to conquer the blood-brain barrier reflects ongoing efforts to revolutionize treatments for neurological disorders. Despite recent advancements, Novartis continues to explore new strategies for drug delivery to the brain, aiming to unlock therapies for conditions like Alzheimer's and Parkinson's disease. Viridian Therapeutics' collaboration with Wuxi Biologics marks a notable push in the eye drug market, positioning them against major players like Amgen. This partnership emphasizes manufacturing capability as a critical factor in ensuring resilient supply chains and competitive advantage. The hepatitis B treatment landscape has witnessed significant progress with GSK's phase 3 trial results for its drug Bepirovirsen. Achieving a functional cure in around one-fifth of patients signifies a major step forward in addressing this widespread disease. The potential to reduce lifelong antiviral therapy and lower liver cancer rates illustrates the transformative impact of nucleic acid-based therapies. Leadership dynamics also play a crucial role in pharma strategies. PharmaEssentia's appointment of Eric Vogel highlights the industry's reliance on seasoned talent to drive market expansion and broaden therapeutic indications, particularly for its rare blood cancer drug Besremi. In longevity research, Human Longevity's collaboration with Insilico Medicine introduces Human Life Foundation Models (HLFM), leveraging AI and genomics to extend human lifespan. This initiative is part of a broader trend integrating cutting-edge technologies into healthcare research, reflecting an evolving focus on longevity and genomic sciences. Regulatory landscapes are also evolving, as seen with CMS finalizing changes to the No Surprises Act dispute resolution process. By streamlining arbitration amidst rising disputes, these updates aim to refine healthcare policy frameworks for more efficient stakeholder service. Meanwhile, biosimilar approvals are gaining traction globally. ANVISA's approval of EMS's Ozivy in Brazil introduces a cost-effective alternative to Novo Nordisk's semaglutide (Ozempic) for type 2 diabetes. This step enhances access to affordable diabetes treatments, crucial for managing this prevalent metabolic disorder. In clinical trials innovation, D&D Pharmatech's Zabopegdutide has shown promising Phase 2 results for metabolic dysfunction-associated steatohepatitis (MASH), indicating fibrosis improvement and potential disease resolution. These findings underscore dual receptor agonists' therapeutic promise in tackling complex metabolic conditions. Additionally, Kailera Therapeutics' KAI-4729 demonstrates significant weight loss in Phase 1 obesity trials, potentially reshaping the obesity treatment landscape by offering superior weight management options compared to existing therapies. Funding rounds like Secretome Therapeutics' successful $30 million Series A highlight ongoing investments in regenerative medicine and cell-based therapies, propelling advancements in cardiovascular disease treatment pipelines. The acquisition landscape remains active with CordenPharma's purchase of AmbioPharm, expanding peptide manufacturing capabilities across U.S. and China markets. This move meets growing demand for peptide APIs vital in drug development processes. Technological innovation remains pivotal as Biohub releases an AI World Model for protein biology to expedite therapeutic discovery processes. This tool exemplifies computational biology's integration into drug discovery efforts, enhancing efficiency and innovation. Overall, these developments illustrate a vibrant pharmaceutical and biotech landscape characterized by scientific breakthroughs, strategic partnerships, regulatory achievements, and technological advancements—all aimed at advancing patient care and expanding therapeutic possibilities across diverse medical domains. As these trends continue unfolding, they promise not only improved treatment outcomes but also a more robust global healthcare ecosystem committed to innovation and excellence. Thank you for tuning into Pharma Daily; stay informed as we continue bringing you the latest from this rapidly evolving industry.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.

Ahead of their Irish, UK and European Tour, Irish band Keywest will perform at the Amgen Irish Open in Doonbeg, this September. Defending champion Rory McIlroy will headline the on-course action, while off the course, five-piece rock and pop band Keywest will take centre stage on Saturday, 12 September, in the Championship Village at Trump International Golf Links Ireland. To find out more, Daragh Dolan was joined by the lead singer, Andrew Kavanagh. Image (c) Keywest

Andrew, Ben, and Tom discuss the reported two-phase US-Iran deal to reopen the Strait of Hormuz and dispose of enriched uranium, market reactions with oil dropping to the low $90s and the 10-year falling to 4.50%, Kevin Warsh's first comments as Fed Chair signaling reform, the WSJ piece on the vanishing equity risk premium, and Eli Lilly's VERVE-102 one-shot gene editing therapy showing up to 62% LDL cholesterol reduction in early trials as a potential challenger to Amgen's Repatha.Join our live YouTube stream Monday through Friday at 8:30 AM EST:http://www.youtube.com/@TheMorningMarketBriefingPlease see disclosures:https://www.narwhal.com/disclosure

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 the pharmaceutical and biotech sectors, a domain experiencing profound changes marked by leadership transitions, regulatory challenges, and groundbreaking scientific advancements. Recent developments within the FDA highlight significant shifts as the agency finds itself at a critical juncture following the departure of Commissioner Marty Makary. This leadership vacuum presents an unprecedented challenge for the FDA, with analysts predicting a prolonged period of uncertainty. Such transitions hold considerable implications for the regulatory framework, potentially influencing drug approval processes and the strategic direction of the agency at large. Amidst this backdrop, industry insiders have proposed Richard Pazdur, a former cancer regulator renowned for his impactful tenure, as a potential successor. His appointment could introduce stability and renewed focus on regulatory frameworks that encourage innovation while upholding stringent safety standards. The recent spate of exits at the FDA, including Vinay Prasad's departure, underscores an urgent need for steady leadership capable of navigating the intricacies of modern drug regulation effectively. In response to these leadership changes, the stock market has shown some volatility, with shares of companies such as uniQure and Replimune experiencing a surge following Makary's exit. However, analysts caution against premature optimism, emphasizing that substantial regulatory relief is unlikely without broader systemic changes. The industry must advocate for policies that sustainably support innovation in light of these shifts. Turning to scientific developments, Lilly's next-generation obesity drug has emerged as a beacon of hope for metabolic disorder treatments. This triple agonist has demonstrated impressive weight loss results in clinical trials, comparable to those achieved through bariatric surgery. Such breakthroughs underscore the critical importance of investing in novel therapeutics that address significant health challenges with high unmet needs. Meanwhile, Amgen's rare disease drug Tavneos is witnessing regulatory progression in Japan after overcoming initial safety concerns. The decision to allow new patient access following a reversal reflects evolving attitudes toward risk-benefit analysis in rare disease treatments. This trend aligns with broader movements in personalized medicine where targeted therapies are gaining precedence despite complex regulatory landscapes. However, beneath these advancements lie economic pressures starkly illustrated by CEO compensation ratios in relation to median employee wages. These disparities raise pertinent questions about resource allocation and investment priorities within pharmaceutical organizations. Such financial dynamics could significantly influence both the pace and direction of future innovations. In oncology, efforts to tackle challenging indications continue with emerging treatments like Revolution's pancreatic cancer drug making headlines. Companies such as Immuneering and Actuate are at the forefront of striving to surpass existing breakthroughs, underscoring competitive innovation as a defining trait of today's biotech landscape. As we reflect on these transformative times within the pharmaceutical and biotech industries, it becomes evident that they are navigating a complex interplay between regulatory upheavals and scientific milestones. The potential appointment of leaders like Richard Pazdur at the FDA may well shape future regulatory directions. Simultaneously, pioneering drugs such as Lilly's obesity treatment exemplify therapeutic advancements poised to redefine patient care paradigms. Nevertheless, financial pressures coupled with market dynamics continue to present formidable obstacles requiring strategic foresight and collaboration among stakeholders to maintain innovation momentum. As these sectors evolve, striking a delicate balance between rigorous regulation and scientific progress will be paramount for advancing public health goals effectively. Thank you for tuning into Pharma Daily. Stay informed and stay ahead with us as we continue to explore these pivotal developments in the world of pharmaceuticals and biotechnology.Support the show

FDA Commissioner Marty Makary officially resigned last week following reports of his ouster. Then, the acting directors for the agency's two main review units also left their posts, as did the FDA chief of staff and chief AI officer. Domino effect aside, the reaction from the industry has been mostly positive, given Makary's tumultuous reign. But he might be hard to replace. If it were up to the biotech industry, former longtime oncology regulator and short-lived CDER director Richard Pazdur would take the role. For now, FDA Deputy Commissioner for Food Kyle Diamantas is in charge.Eli Lilly's David Ricks was the highest paid pharma CEO last year, but J&J's Joaquín Duato made the most relative to rank-and-file employees, with a median pay ratio of 358 to one. He was on the top of BioSpace's list last year, too, with a ratio of 293 to 1. Last month, Revolution Medicines' RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. This week, Truist Securities went so far as to nominate RevMed as “the next oncology titan,” a title currently held by Merck and its blockbuster cancer drug Keytruda. Safety continues to challenge the gene therapy space, especially in Duchenne muscular dystrophy. Late last week, REGENXBIO announced mixed results from a Phase 3 program—the gene therapy did lead to functional improvements, but two serious adverse events caused the stock to drop 37%.Finally, Amgen's rare disease drug Tavneos continues to face scrutiny. Last month, the FDA alleged that doctored data were filed to support Tavneos' initial approval. Now, it's been linked to 20 deaths in Japan.

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

Hear two post-fracture care specialists share their perspective on how to effectively transition patients' post-fracture osteoporosis care from the inpatient to outpatient setting. Dr. Aloiya Kremer will share her perspective on best practices for starting a post-fracture osteoporosis care program, while Jacqi Kernaghan will discuss what she has learned about the inpatient to outpatient integration from her work in a specialized osteoporosis clinic. Listeners will gain valuable insights into how to effectively manage patients after they leave the hospital to minimize the risk of subsequent fractures. Dr. Kremer and Ms. Kernaghan are paid consultants for Amgen.This episode is sponsored by Amgen.

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.

PODCAST LAS NOTICIAS CON CALLE DE 12 DE MAYO - Inspector Federal viene a PR a investigar muertos cobrando cupones - El Nuevo Día No hay personal del NIE y se van a retirar una tercera parte - El Vocero Rivera Schatz vuelve a disparar contra la gobernadora por nombramientos que él ha confirmado - Facebook Reactivación de zona industrial en el este por Onovexa, Millicent, expansiónnes de Amgen y Stryker - El Nuevo Día Demasiado genérico el dinero de Educación y usado para cosas que no explican según Sembrando Sentido - El Nuevo Día Alabama también va a lograr nuevo mapa electoral, hoy votan en South Carolina - Politico  Trump considera que Venezuela debe ser el próximo estado de USA Policía presenta presupuesto de 34 millones menos, pero pedirán más dinero para cosas específicas  - El Vocero Codo sueño empieza con uno.Un cliente.Una oportunidad.Un paso adelante.Y poco a poco… esos números empiezan a crecer.Más ventas.Más empleados.Más futuro.En One Park Financial Puerto Rico, convertimos esos números en el impulso que tunegocio necesita, con acceso a capital rápido, basado en tus ingresos reales.Porque cuando los números empiezan a cuadrar…los sueños dejan de ser sueños.One Park Financial Puerto Rico. Alimentamos tus sueños.Solicita hoy llamando al 787.558.5203 o accede a onepark.prBuscan dinero para hacer elección e representante del consumidor en la Junta AEE - El Vocero Pon tu cuenta de banco en SURI si quieres el incentivo rápido dice Hacienda Justicia reevalúa caso de Baby y Suzanne Roig - Wapa TV Corea del Sur considera un incentivo de dividendo tras Samsung romper récords por Inteligencia Artificial - Bloomberg No va FEI contra procuradora de la mujer - TelemundoPR Trump aterriza en China mañana (hoy) — Cumbre con Xi el jueves en Beijing. Lleva a Tim Cook, Musk, Ortberg de Boeing Trump dice que el cese al fuego está en respirador artificial - FTRepublicanos consideran eliminar la erudita federal de 18.4centavos por galón de gasolina y 24.4 centavos del galón de diesel Energía federal vuelve a dar permiso de emergencia para operar sistema eléctrico de PR - Noticel Se retiran policías y bomberos advierten en Seguridad Pública - Noticel Ética presenta querella contra directora escolar que alteró asistencia de su esposa y no pidió inhibición - Noticel OCIF dice que ya estaba contra Allied no cuando croqueta fee fue escrito en textos privados - Metro 21 asesinatos por encima de 2025: Arabia Saudita advierte de que escasez de gasolina y jet fuel va a empeorar y el estrecho tiene que abrir para junio de una u otra forma - Financial Times LOS DATOS DEL DÍA• Brent: $104.21/barril (+~3%)• WTI: $101.74/barril (+3.7%)• S&P 500: 7,398.93 (+0.84%)• Dow Jones: 49,609.16 (+0.02%)• Bono 10Y del Tesoro: 4.39%• Euro/USD: 1.1785• Gas natural (Henry Hub): $2.80/MMBtu• Tasa hipotecaria 30Y: 6.25%–6.33%• Gasolina promedio EE.UU.: $4.50/galón• Gasolina promedio PR: $1.14/litro (~$4.32/galón)#oneparkfinancial #incluyeauspicio

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

PODCAST LAS NOTICIAS CON CALLE DE 6 DE MAYO - Pakistán publica que Irán y USA están a punto de acuerdo con un documento de una página - Reuters Baja dramática el precio del petróleo - Oil PricePelea dentro del gabinete de JGo por proyecto de permisos - El Nuevo Día R3 le arregló casas a personas que no calificaban y a propiedad ejecutada por el banco - El Nuevo Día Sube el uso del tren urbano tras aumentar el costo de la gasolina, estiman en 15% de más usuarios - Primera Hora Gobernadora no sacará a jefa de Familia, Rivera Schatz dice que Justicia debió reabrir investigación - El Vocero No va proyecto para enmendar la orden 408 para ingreso involuntario - El Vocero Te lo digo desde ahora… el Día de las Madres es este domingo, así que no improvises. Empieza por el app de T-Life de T-Mobile. Ahí tienes opciones para todo tipo de mamá: la techie, la fitness o la que vive con su playlist encendío. Teléfonos, tablets, smartwatches, accesorios… todo en un mismo sitio y sin salir de tu casa. Lo pides desde el app o llamando al 1-800-TMOBILE. Y si quieres hacerlo bien de verdad, te cambias o activas una línea nueva y aprovechas las ofertas. Entra hoy a T-Life o llama y deja ese regalo cuadrado desde ya!Asesinatos y calcinados 4 en Morovis y 2 en Arecibo Murió Mr. Blup - Facebook Rivera Schatz Drogas por votos, el caso de los federales deteniendo investigación sobre PR - Pro Publica Carlos Mellado vuelve a federales a pedir investigación por traqueteo con fondos de Salud - Bárbara Figueroa Rosa para Jay Fonseca Premium Tribunal ordena que no se pueden cerrar portones de la UPRM - Metro Le ponen condición a Genera para poder gasificar Cambalache porque estaban cobrando muy caro - El Nuevo Día PR regala demasiado dinero para lo que recibe en incentivos y créditos - Espacios Abiertos Trump suspende "Project Freedom" y negocia con Irán - Bloomberg Gasolina  roza máximo histórico a $4.50/galón promedio - AAA Genera dejó casi 99,000 abonados sin luz el lunes por relevo de carga en Costa Sur 6. Carolina, Caguas y San Juan los más afectados.Trump cobró venganza en Indiana: 5 de 7 senadores estatales republicanos que votaron contra su redistribución electoral perdieron sus primarias. Mensaje directo a Tennessee, Carolina del Sur y Alabama.Amgen invierte $300 millones más en Juncos - News is my Business Trump dice que viene con 25% de arancel a autos europeos "pronto" si no hay acuerdo comercial - FTSEC propone eliminar reportes trimestralesBrent: $101.00/barril (–8% intradía tras anuncio de Trump)Gasolina EE.UU. promedio: $4.48–$4.50/galón (cerca de récord histórico)S&P 500: 7,259.22 (+0.81% al cierre del 5 de mayo)Dow Jones: 49,298.34 (+0.74%)Bono 10Y del Tesoro: 4.35% (–0.06 pts hoy)Gas natural (Henry Hub): $2.86/MMBtu (máximo de cuatro semanas)Tasa hipotecaria 30Y (Freddie Mac): 6.30%Bono 30Y EE.UU.: rondando el 5%Deuda federal EE.UU./PIB: camino al récord de 108% en 2030 (CBO)#tmobile#incluyeauspicio

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's episode dives into the ever-evolving landscape of the pharmaceutical and biotechnology industries, which are experiencing significant transformations driven by scientific advancements, strategic realignments, and regulatory changes. Sanofi is making a significant move by investing $294 million to expand its AI center of excellence in Toronto. This investment is part of a broader trend in the sector to optimize pharmaceutical operations and accelerate drug development through digital transformation. By enhancing its AI capabilities, Sanofi aims to streamline processes and reduce time-to-market for new drugs, positioning itself as a leader in this digital era. In clinical trials, Cytokinetics has reported a pivotal success with MyoKardia's drug Myqorzo in a Phase 3 trial aimed at treating non-obstructive hypertrophic cardiomyopathy. If approved, Myqorzo would be the first treatment available for this condition, highlighting ongoing efforts within the industry to address unmet medical needs with innovative therapies. However, not all ventures meet expectations. Pfizer's acquisition of Trillium Therapeutics for $2.3 billion did not materialize as hoped, leading to the discontinuation of its remaining clinical-stage candidates. This outcome underscores the risks inherent in pharmaceutical investments and the importance of thorough evaluation of potential therapeutic candidates. Similarly, Vertex Pharmaceuticals encountered challenges with its inhaled cystic fibrosis candidate developed with Moderna due to tolerability issues, highlighting patient safety's role in clinical trials. Strategic shifts are also taking place in workforce management. BioNTech plans to cut 1,860 jobs as it exits manufacturing sites in Germany and Singapore, reflecting broader industry trends toward operational optimization. Similarly, Novartis is closing its manufacturing site in Wehr, Germany, resulting in 220 job cuts as part of efforts to streamline operations. Regulatory developments continue to shape industry dynamics. Axsome Therapeutics received FDA approval for Auvelity as a treatment for agitation associated with Alzheimer's disease. This not only enhances Axsome's market potential but also underscores the critical role of regulatory agencies in facilitating access to treatments for complex conditions. Moreover, CAR-T therapies are expanding beyond oncology into autoimmune diseases. Kyverna Therapeutics is advancing toward a groundbreaking approval for CAR-T therapy in autoimmune disorders, marking an evolution in therapeutic applications. The recent developments underscore a dynamic phase characterized by technological innovation and strategic restructuring. AI technologies are revolutionizing drug discovery processes while successful clinical trials expand treatment options for previously unmet needs. Yet challenges remain with investment risks and organizational realignments reshaping operational strategies. Pfizer's discontinuation of its investment in Trillium Therapeutics due to inadequate clinical results emphasizes the necessity for robust data to support therapeutic viability. On a regulatory front, Strand Therapeutics stresses reforming the FDA's Investigational New Drug process to maintain U.S. leadership in biomedical innovation amid global competition. Passage Bio's strategic review following regulatory setbacks with its gene therapy program further exemplifies biotechnological unpredictability. Viridian Therapeutics' success with its anti-IGF-1R antibody bodes well for FDA approval and competition against established players like Amgen. The formation of the American Biotech Innovation Alliance signifies efforts to unify domestic biotech strategies amid global competition. Investments continue despite these challenSupport the show

First quarter earnings continue to roll in, with Pfizer, Eli Lilly, Amgen and more reporting in the past week. While Pfizer beat consensus estimates, it wasn't enough for analysts, who had greater expectations for the New York pharma. Analysts were more than satisfied with Lilly's 56% revenue increase, though the company itself appeared to want more—a feat executives believe it could have achieved had it not lowered prices on many of its medicines. Meanwhile, a host of small– to-medium biotechs are beginning to report, with analysts focused squarely on key near-term catalysts. On the regulatory beat, the FDA tapped Katherine Szarama as a temporary replacement for outgoing Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, whose controversial reign over the biologics division ended April 30. And the FDA held its first advisory committee meeting in nine months, for two AstraZeneca cancer drug applications, which former regulator Harpreet Singh said was missing the “Pazdur moment,” after stalwart oncology leader Richard Pazdur left the agency last November.Over in R&D, an optimistic story is unfolding in a treatment space that has endured much heartache over the past few years: ALS. In the past week, QurAlis and Corcept Therapeutics both reported positive mid-stage data for their respective candidates, with QurAlis' QRL-201 eliciting an up to 50% in decrease progression, and Corcept reporting a two-year survival advantage for patients talking its dazucorilant.Finally, in BioPharm Executive this week, senior BioSpace editor Annalee Armstrong sits down with biotech founders to discuss the challenges of being a founder today.

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 significant updates that highlight the dynamic nature of our industry, driven by cutting-edge science, regulatory evolution, and strategic business innovations. The pharmaceutical landscape is ever-shifting, with recent developments underscoring this fluidity. Pfizer and Arvinas have secured early FDA approval for their breast cancer drug, Veppanu. This move signals the FDA's growing inclination to fast-track promising therapies, particularly in areas with high unmet needs. Interestingly, Pfizer and Arvinas are opting not to commercialize Veppanu independently and are instead seeking a partner. This decision reflects a broader industry trend where biopharmaceutical companies leverage partnerships to maximize the reach and impact of their therapies. Such strategies are becoming increasingly common as companies navigate complex market dynamics. Legal and healthcare domains intersected dramatically when the U.S. Supreme Court temporarily restored online access to the abortion pill mifepristone. This decision underscores the profound influence of legal rulings on healthcare access and distribution channels within the pharmaceutical sphere in the United States. It's a poignant reminder of how regulatory decisions can ripple through healthcare systems, affecting both providers and patients. Meanwhile, Samsung Biologics faces significant financial repercussions—estimated at $102 million—due to an ongoing union strike. This situation reveals vulnerabilities within contract development and manufacturing organizations (CDMOs) regarding labor relations, emphasizing the need for robust operational strategies to maintain production continuity. In a move that underscores its commitment to biologics manufacturing, Amgen announced a $300 million investment in Puerto Rico. This expansion aligns with growing global demand for biologics and biosimilars and highlights Puerto Rico's strategic importance as a pharmaceutical manufacturing hub, thanks to its favorable business environment and skilled workforce. On a different front, Novartis is optimizing its workforce by implementing additional job cuts at its U.S. headquarters. These adjustments are part of a larger multiyear plan aimed at streamlining operations and reallocating resources towards areas with higher growth potential within its portfolio. The potential resurgence of psychedelics is gaining traction, partly fueled by political support from figures like Donald Trump. The regulatory landscape for psychedelics remains complex, with discussions focusing on their therapeutic potential versus societal acceptance and legitimacy concerns. In the competitive weight-loss drug market, Novo Nordisk's Wegovy pill is currently outperforming Eli Lilly's Foundayo in prescription trends. This rivalry highlights the dynamic nature of the GLP-1 receptor agonist segment—a market experiencing rapid growth due to increasing attention on obesity management as a critical public health issue. Deloitte's latest analysis reveals an intriguing shift: obesity drugs have now overtaken oncology as the leading contributor to late-stage pipeline value for the first time in 16 years. This transition underscores a growing recognition of obesity as an essential therapeutic area with significant market potential, driven by advances in drug efficacy and heightened patient demand. Celcuity has reached a pivotal milestone in breast cancer treatment development with its Phase 3 trial success of a pan-PI3K/mTOR inhibitor against Novartis' Piqray. Achieving primary endpoints positions Celcuity favorably for FDA review, further highlighting continuous innovation within oncology research. UCB's acquisition of Candid Therapeutics for $2 billion exemplifies intensified competition Support the show

CNBC Business News Update with Jessica Ettinger - market numbers and news featuring CNBC expert analysis and sound from top business names. Visit https://www.cnbc.com/ for more. Hosted by Simplecast, an AdsWizz company. See https://pcm.adswizz.com for information about our collection and use of personal data for advertising.

We discuss what's at stake from Apple's big report in Overtime with Alger's Dan Chung, Big Technology's Alex Kantrowitz and Wedbush's Dan Ives. Plus, one of the nation's top financial advisors – Chris Toomey of Morgan Stanley – tells us how he is advising his clients right now. And, we drill down on the massive move in Eli Lilly ahead of Amgen's numbers. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Join endocrinologist Elizabeth Bauer, MD, FACP, FACE, DABOM, as she speaks with Michelle about her experience living with obesity, including the challenges, stigma, and turning points that shaped her path. Together, they explore the AACE Journey for Patients With Obesity, as Michelle shares which parts she found most helpful for understanding obesity as a chronic disease and navigating next steps. Don't miss this inspiring discussion, brought to you with the support of Boehringer-Ingelheim, Lilly, Novo Nordisk, and Amgen.

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 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.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into an array of dynamic changes and strategic maneuvers within the industry, showcasing how these transformations are shaping the future of healthcare and patient treatment. Starting with regulatory innovation, the FDA's new initiative to facilitate real-time review of clinical trial data is a potential game-changer for drug development timelines. With AstraZeneca and Amgen participating in this pilot program, the industry anticipates a more efficient approval process that addresses issues during trials rather than post-completion. This could significantly reduce the time it takes for patients to access cutting-edge therapies, marking a pivotal shift towards more agile regulatory frameworks. Such initiatives reflect a broader move towards streamlining drug approvals without sacrificing safety and efficacy. Turning to strategic investments, AstraZeneca's renewed commitment to a £300 million investment in the UK, following earlier disputes over drug pricing, signals confidence in resolving these issues favorably. This decision underscores AstraZeneca's dedication to fostering innovation within the UK's life sciences sector. Similarly, Teva Pharmaceuticals' $700 million acquisition of Emalex Biosciences positions it to introduce a new therapy for Tourette syndrome, highlighting efforts to address conditions with limited treatment options. In oncology, GSK is aligning its strategy with industry trends by focusing on cancer therapies. Despite withdrawing from a partnership with Mersana Therapeutics and pausing its mRNA bird flu shot program, GSK aims to channel resources into more promising ventures. This reflects a broader industry focus on oncology due to its high unmet needs and market potential, which companies are eager to capitalize on through innovative treatments. Additionally, Kite Pharma is preparing for potential approval of its next-generation CAR-T therapy for multiple myeloma, representing ongoing progress in personalized medicine approaches aimed at complex diseases like cancer. Furthermore, Pfizer's Elrexfio has shown promising results in multiple myeloma trials, potentially expanding treatment options and reinforcing Pfizer's oncology market position. The competitive dynamics in Alzheimer's treatments are also noteworthy as Biogen and Eli Lilly vie for market share with Leqembi and Kisunla, respectively. This competition highlights complexities in chronic disease management where dosing differences may influence patient decisions. The biotech sector remains robust in fundraising activities despite challenges. Noteworthy is Vivacta's $50 million Series A round and Coultreon's $125 million fundraising effort, indicating strong investor confidence in biotech innovations. These financial injections are vital for advancing ambitious projects that promise transformative impacts on patient care. Strategic acquisitions continue to shape the industry landscape. Chiesi Group's $1.9 billion acquisition of KalVista Pharmaceuticals exemplifies this trend, focusing on expanding rare disease offerings—a niche market with significant unmet needs but fewer competitors. Meanwhile, AbbVie's acquisition option for Kestrel Therapeutics underscores its strategic expansion into targeted cancer therapies, particularly through Kestrel's promising oral pan-KRAS inhibitor. In regulatory scrutiny news, AstraZeneca's camizestrant faces intense evaluation ahead of advisory committee meetings. Such scrutiny ensures that only effective treatments reach the market while emphasizing the rigorous standards required during drug development processes. Lastly, technological integration within pharmaceutical operations is becoming increasingly crucial as companies leverage AI to enhance R&D efficiency and accelerate value crSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The industry continues to evolve rapidly with significant developments in drug approvals, regulatory changes, and innovative therapies. The latest updates highlight the tension between scientific advancement and regulatory scrutiny. A prime example is the FDA's proposal to rescind approval of Amgen's Tavneos due to alleged data manipulation and safety concerns. This action underscores the critical importance of rigorous data integrity and post-market surveillance in drug development. In a win for AstraZeneca, their Breztri Aerosphere has gained FDA approval for asthma treatment, strengthening its status as a blockbuster drug following its success in treating chronic obstructive pulmonary disease (COPD). This approval marks a significant milestone in AstraZeneca's ambition to achieve $80 billion in revenue by 2030. The inhaler's three-in-one formulation addresses a substantial unmet need in asthma management, offering enhanced convenience and efficacy for patients. Meanwhile, Novartis remains confident in its $5 billion peak sales projection for Pluvicto, even as it faces European regulatory setbacks and competitive pressures from bispecific antibodies. This scenario highlights the strategic resilience required by pharmaceutical companies to navigate regulatory landscapes and maintain market confidence amid challenges. Rocket Pharmaceuticals recently made headlines by selling a priority review voucher for $180 million following the approval of its gene therapy Kresladi. Such transactions are crucial for companies aiming to accelerate market entry for novel therapies, particularly in competitive fields like gene therapy. On the horizon for Kite Pharma, a subsidiary of Gilead Sciences, is the advancement of its next-generation CAR-T cell therapy for multiple myeloma. After refining its manufacturing processes, Kite is prepared to leverage its expertise in cell therapy to address the evolving landscape of hematologic malignancies. The potential approval of this therapy represents a significant step forward in personalized medicine and cancer treatment. GSK's ongoing legal dispute with AnaptysBio over Jemperli royalties emphasizes the complex interplay between strategic partnerships and intellectual property rights within the industry. As companies increasingly rely on collaborations for innovation, resolving such disputes amicably remains crucial for sustaining long-term alliances. Positive trial outcomes with Rezzayo from Mundipharma and CorMedix underscore an expanding focus on antifungal therapies, particularly for vulnerable populations like stem cell transplant recipients. This development could lead to broader prophylactic options against invasive fungal infections, improving patient outcomes in immunocompromised settings. Beyond therapeutic advancements, Medtronic's successful containment of a cyberattack highlights the growing importance of cybersecurity measures in safeguarding sensitive data and maintaining operational integrity. This incident reinforces the need for robust IT infrastructure within healthcare organizations to prevent disruptions and protect patient safety. Looking forward, Artificial Intelligence (AI) integration into pharma operations is reshaping traditional models from task execution to outcome ownership. AI-driven approaches are enabling life sciences organizations to scale impact, enhance decision-making processes, and accelerate value creation across drug discovery and development pipelines. Eli Lilly's collaboration with Profluent marks a significant move in the genetic medicine landscape. This $2.2 billion partnership focuses on developing AI-designed recombinases, a novel approach to gene editing that holds promise for addressing diseases with severe unmet needs. Recombinase-based Support the show

First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi welcoming Belén Garijo as CEO. Still to come this week are Eli Lilly, AstraZeneca, Regeneron and many more.Lilly will undoubtedly discuss its recent streak of dealmaking, including a $2.25 billion pact with AI biotech Profluent, plus buyouts of Ajax Therapeutics for up to $2.3 billion and Kelonia Therapeutics for up to $7 billion.Meanwhile, Regeneron earned FDA approval for the highly anticipated gene therapy that will now be known as Otarmeni. The same day the approval came down, Regeneron also struck a deal with the White House.Over at the FDA, the agency has requested—again—that Amgen remove the autoimmune therapy Tavneos from the market. Separately, the FDA has issued three Commissioner's National Priority Vouchers to unnamed psychedelic drug developers. Finally, who will replace Vinay Prasad, the head of the agency's Center for Biologics Evaluation and Research (CBER), who departs at the end of April after one year as the biologics chief?

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/CPE/IPCE information, and to apply for credit, please visit us at PeerView.com/KVU865. CME/CPE/IPCE credit will be available until April 25, 2027.The 3 P's of Pharmacist-Focused Care for DLL3-Targeting T-Cell Engagers in ES-SCLC: Plans, Protocols, and Patient Education 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 by educational funding provided by Amgen.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/CPE/IPCE information, and to apply for credit, please visit us at PeerView.com/KVU865. CME/CPE/IPCE credit will be available until April 25, 2027.The 3 P's of Pharmacist-Focused Care for DLL3-Targeting T-Cell Engagers in ES-SCLC: Plans, Protocols, and Patient Education 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 by educational funding provided by Amgen.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/CPE/IPCE information, and to apply for credit, please visit us at PeerView.com/KVU865. CME/CPE/IPCE credit will be available until April 25, 2027.The 3 P's of Pharmacist-Focused Care for DLL3-Targeting T-Cell Engagers in ES-SCLC: Plans, Protocols, and Patient Education 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 by educational funding provided by Amgen.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/CPE/IPCE information, and to apply for credit, please visit us at PeerView.com/KVU865. CME/CPE/IPCE credit will be available until April 25, 2027.The 3 P's of Pharmacist-Focused Care for DLL3-Targeting T-Cell Engagers in ES-SCLC: Plans, Protocols, and Patient Education 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 by educational funding provided by Amgen.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/CPE/IPCE information, and to apply for credit, please visit us at PeerView.com/KVU865. CME/CPE/IPCE credit will be available until April 25, 2027.The 3 P's of Pharmacist-Focused Care for DLL3-Targeting T-Cell Engagers in ES-SCLC: Plans, Protocols, and Patient Education 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 by educational funding provided by Amgen.Disclosure information is available at the beginning of the video presentation.

In Re Application of AMGEN

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 dive into a series of transformative updates that reflect the dynamic landscape of our industry. Johnson & Johnson is making strategic moves in the immunology space, with Tremfya and the newly launched Icotyde playing pivotal roles in their portfolio. This development indicates J&J's commitment to capturing a significant share of the immunology market, aiming for a staggering $100 billion in annual revenue. Their collaboration with Protagonist Therapeutics for Icotyde highlights the importance of partnerships in driving innovation and maintaining a competitive edge in this rapidly evolving sector. In regulatory news, Travere Therapeutics has achieved a milestone with Filspari becoming the first FDA-approved treatment for focal segmental glomerulosclerosis. This approval comes after overcoming initial setbacks and offers new hope for patients suffering from this rare kidney disease. It exemplifies the perseverance required to navigate the complex regulatory landscape and underscores the significance of providing novel therapies where none existed before. Novo Nordisk is taking a leap into digital transformation by integrating artificial intelligence through a partnership with OpenAI. By embedding AI into their R&D and manufacturing processes, Novo aims to streamline data analysis and accelerate drug discovery timelines. This move reflects broader industry trends towards leveraging advanced technologies to enhance efficiency and innovation, ultimately benefiting patient outcomes. This approach aligns with trends towards precision medicine and improved patient care outcomes. However, not all news is positive. Pfizer recently faced FDA scrutiny over misleading advertisements for its cancer drug Adcetris on Facebook. This incident serves as a reminder of the critical importance of transparency and compliance in advertising practices, essential for ensuring patient safety and maintaining regulatory standards. The FDA has also issued reminders to clinical trial sponsors to report study results, revealing that 30% of registered studies remain unreported. This call to action is crucial for fostering transparency and accountability in clinical research, which are vital for understanding drug efficacy and safety profiles comprehensively. On the restructuring front, Astellas is closing its stem cell therapy unit in Seattle as part of strategic realignment efforts. Similarly, Click Therapeutics is downsizing its workforce following a commercial deal restructuring. These changes highlight ongoing challenges in resource allocation within the biotech sector. Financially, Harbinger Health has secured $100 million for its blood-based cancer detection tests, signaling growing interest in non-invasive diagnostics. Meanwhile, Alamar Biosciences prepares for an IPO amidst a surge in life sciences public offerings, indicating robust investor confidence in biotech innovations. In other news, Boehringer Ingelheim and Amgen have discontinued early-stage immunology candidates due to insufficient clinical promise. Such decisions underscore the rigorous evaluation processes inherent in drug development pipelines, emphasizing strategic prioritization necessary for advancing viable therapeutic candidates. Eli Lilly's acquisition of Crossbridge Bio for $300 million highlights their interest in antibody-drug conjugates (ADCs), underscoring a growing trend towards targeted cancer therapies. ADCs offer enhanced efficacy by combining cancer-specific antibodies with potent cytotoxic agents, reducing systemic toxicity while improving therapeutic outcomes. These updates illustrate an industry at the intersection of scientific innovation and strategic realignment. As companies navigate complex regulatory landscapes and adapt to market dynamicSupport the show

Why are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis patients behind, and what it would take to change that.John discusses how FDA clarity on endpoints transformed the rare kidney disease investment landscape, why the dialysis bundle makes innovation functionally impossible for providers, and how the Kidney Care Access Protection Act could be the first meaningful step toward a sustainable path for new dialysis therapies.A few of John's key takeaways:Regulatory clarity is the single biggest driver of rare kidney disease investment — FDA's work with industry to define approvable endpoints changed the entire landscapeThe dialysis bundle is structurally hostile to innovation — at $280 per session for all services, supplies, and drugs, there's no room for new therapiesThe Corsuva story is a cautionary tale — a good product at a reasonable price failed because the payment mechanism didn't workK-CAPA could change the calculus by extending the TDAPA window to three years and shifting to pay-per-use reimbursementInvestors are willing to take clinical risk, but they need a clear path to both approval and paymentFDA and CMS are generally better when they don't try to coordinate — FDA should focus on science and benefit-risk, not system costThe science is moving upstream — SGLT-2s, GLP-1s, porcine kidney transplants, and wearable kidneys all point toward a future with fewer patients on dialysisAbout John ButlerJohn Butler is President and CEO of Akebia Therapeutics, where he has led the company for over 12 years. He has worked in kidney disease since 1991, with roles at Amgen and 13 years at Genzyme leading the renal and rare disease businesses. John chaired the American Kidney Fund and Kidney Care Partners, and recently testified before the House Ways & Means health subcommittee on dialysis innovation and reimbursement reform. He holds an MBA from Baruch College's Zicklin School of Business and a BA in Chemistry from Manhattan University.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 a series of dynamic changes and strategic shifts reshaping these industries, driven by scientific advancements and regulatory updates. Let's start with Biogen, which recently resolved an investor lawsuit concerning its Alzheimer's drug, Aduhelm. Approved under controversial circumstances by the FDA, Aduhelm faced scrutiny for its efficacy and costs. This settlement is a critical reminder of the importance of transparent communication with investors, especially when navigating high-stakes therapeutic areas like Alzheimer's. The broader implication for pharmaceutical companies is the need to balance innovation with accountability and transparency—a challenge that resonates across the industry. Meanwhile, Pfizer's decision to vacate office space in South San Francisco exemplifies a significant trend toward remote work, accelerated by the COVID-19 pandemic. This shift suggests that traditional workplace models are being reassessed in favor of flexibility and cost efficiency, a change likely to influence real estate investments and organizational structures across biotech firms. Amgen stands out with its notable financial growth highlighted by CEO Robert Bradway's $24.7 million compensation package in 2025. This success underscores Amgen's strategic prowess in maintaining robust performance amidst competitive pressures. Their approach could serve as a blueprint for other firms aiming to achieve sustained growth through innovation and strategic management. On the clinical trial front, Insmed's decision to halt development of Brinsupri after underwhelming mid-stage results illustrates the inherent risks in drug development. This highlights the need for rigorous trial designs and adaptive strategies within development pipelines to address potential setbacks efficiently. Turning to Gilead Sciences, there's a strategic pivot from mergers and acquisitions towards strengthening its internal research pipeline, now described as stronger than ever. This shift away from external acquisitions reflects an industry trend prioritizing internal R&D capabilities, potentially leading to breakthrough therapies that enhance patient care while ensuring sustained business growth. In regulatory developments, GSK's Exdensur received new approval in China, showcasing the ongoing globalization of pharmaceutical markets. Navigating diverse regulatory environments becomes crucial for maximizing drug accessibility worldwide. Another trend is seen through Invivyd's “Antibodies for Any Body” campaign featuring Olympic skier Lindsey Vonn. Leveraging public figures can significantly raise awareness about innovative treatments, playing a crucial role in educating the public about medical advancements. There's also significant financial movement within the sector as Jeito Capital announced a record $1.2 billion fundraising for an independent biopharma-focused European fund. This capital influx is poised to accelerate research and development activities across Europe, potentially leading to new therapeutic breakthroughs. Vivtex Therapeutics' $2.1 billion deal with Novo Nordisk illustrates the power of strategic collaborations in advancing therapeutic solutions and enhancing drug delivery systems—key components for improving patient outcomes. Sidewinder Therapeutics is making strides with a $137 million funding round to develop antibody-drug conjugates (ADCs), highlighting investor confidence in technologies that integrate precision medicine approaches to offer potent cancer treatments with reduced side effects. Astellas Pharma's collaboration with Dyno Therapeutics marks another milestone in gene therapy advancements. A $15 million agreement aims at utilizing engineered adeno-associated virus (AAV) capsids for muscle disorders, proSupport the show

Today's guest is Emma Vitalini, Head of Global Digital Health Technology Innovation at Amgen. Amgen is a global biotechnology company focused on discovering, developing, and delivering medicines for serious illnesses. Emma joins Emerj Editorial Director Matthew DeMello to examine how data and AI are reshaping patient recruitment, decentralized clinical trials, and compliance workflows in highly regulated healthcare environments. Emma also discusses practical ways AI can surface unstructured genomic and clinical data to improve patient identification, how API-based access supports hypothesis testing without large-scale data movement, and how modular consent and explainable AI frameworks help sponsors scale trial operations while maintaining regulatory trust and patient transparency. Learn how brands work with Emerj and other Emerj Media options at go.emerj.com/partner

Hear from two post-fracture care specialists at distinct practice locations on their approach to osteoporosis care. Dr. Greg Mines will share his perspective and best practices for working with osteoporosis patients in a sports medicine setting, while Christina Yazdani will discuss differences in the orthopedic surgery setting. Listeners will gain valuable insights into how to adapt post-fracture care across practice settings to maximize patient outcomes. Ms. Yazdani and Dr. Mines are paid consultants for Amgen.This episode is sponsored by Amgen.