Podcasts about Sanofi

Earnings calls are a chance to catch up with the latest developments across Big Pharma and beyond, and last quarter was no different. From the rollout of AI to the oral GLP-1 battle between Novo Nordisk and Eli Lilly and new leadership at Sarepta and Sanofi, it feels like the opportunities and challenges for biopharma have never been greater. In this week’s episode of "The Top Line," Fierce Pharma Senior Editor Fraiser Kansteiner and Fierce Biotech Senior Editor James Waldron share their takeaways from another whirlwind season of earnings calls. Alongside a Q2 scorecard breakdown, the Fierce editors discuss how several new CEOs are finding their footing, which drugs appear poised to cross the $1 billion sales threshold in 2026 and more. To learn more about the topics in this episode: Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow Sarepta’s new CEO Michael Severino faces critical milestones to prove growth See omnystudio.com/listener for privacy information.

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 compelling stories that underscore the dynamic shifts and groundbreaking progress within the industry. Recently, Akeso's ivonescimab received a landmark approval for first-line treatment of non-small cell lung cancer (NSCLC) in China. This marks a significant shift in China's regulatory environment, which is increasingly fostering innovative treatment options. Ivonescimab's approval not only enhances Akeso's standing in oncology but also provides new hope for NSCLC patients, a cancer type notoriously difficult to treat. In the arena of mergers and acquisitions, Alfasigma has strategically expanded its reach by acquiring key assets from Nordic Pharma. This acquisition opens doors to new therapeutic areas like arthritis, women's health, and critical care—an astute move to diversify offerings and enhance global market presence. Such strategic expansions are essential for companies aiming to maintain competitive edge and explore untapped markets. Eli Lilly has taken legal action against six U.S. companies involved in unauthorized sales of its experimental weight-loss drug, retatrutide. This highlights ongoing challenges in intellectual property protection, emphasizing the balance between innovation safeguarding and market expansion. The legal actions are part of broader efforts to preserve public safety and ensure proper distribution channels for groundbreaking therapies. On the quality control front, Fresenius faced a setback with the recall of a batch of Actemra biosimilars due to glass particle contamination concerns. This incident serves as a stark reminder of the critical role rigorous quality assurance plays in pharmaceutical manufacturing, especially as biosimilars gain traction for their cost-effectiveness and accessibility. In an intriguing blend of technology and healthcare, Samsung Electronics has secured FDA clearance for its Galaxy Buds earphones to function as over-the-counter hearing aids. This development illustrates the increasing convergence of consumer electronics with medical devices, offering innovative solutions to enhance accessibility in hearing health. Turning to psychedelic therapies, Definium Therapeutics reported significant success in its Phase 3 trials for an LSD-based formulation targeting generalized anxiety disorder. Building on earlier successes in depression studies, Definium is paving the way for psychedelic compounds in mainstream medicine. The results not only bolster confidence in such therapies but also signal a potential paradigm shift in treating mental health disorders. Moreover, Oracle Health has introduced an upgraded patient portal featuring an AI assistant designed to simplify medical records management and appointment scheduling. This advancement is part of a larger trend towards integrating artificial intelligence into healthcare systems to improve patient engagement and streamline processes, ultimately enhancing healthcare delivery efficiency. BridgeBio's ATTR stabilizer Attruby achieved impressive quarterly sales of $222 million, nearing blockbuster status as it captures significant market share in treating transthyretin amyloidosis (ATTR). This success underscores the growing importance of small molecule therapies in addressing complex cardiovascular conditions and reflects an industry trend towards stabilizer-first markets. InduPro has successfully raised $77 million in Series B funding supported by industry leaders like Sanofi and Lilly. The investment is set to propel their cancer pipeline forward with a focus on induced proximity and bispecific antibody platforms—innovations poised to revolutionize oncology treatment by enhancing drug specificity and efficacy. On the regulatory front, Chiesi UK's delayed-release mercaptamine received NHS endorsement for cystinosis treatment—an advancement that expands therapeutic options for patients requiring cystine-depleting therapy. Such regulatory support is crucial for facilitating access to innovative treatments for rare diseases. Amidst these developments, Gilead Sciences licensed MacroGenics' bispecific antibody program—a strategic move to bolster its oncology portfolio through milestone payments and royalties. This reflects a broader industry pattern where larger pharmaceutical companies seek pipeline diversification through strategic partnerships and acquisitions of innovative technologies. In vaccine development news, StablePharma's SPVX02 tetanus-diphtheria vaccine achieved promising Phase 1 results without refrigeration requirements—an innovation that could significantly enhance global vaccination efforts by overcoming cold chain distribution challenges. Finally, Insilico Medicine stands at the forefront of AI integration into drug discovery processes under CEO Alex Zhavoronkov's leadership. By promoting a 'fail-fast' approach at the Bio International Convention, Insilico aims to accelerate drug development timelines while reducing costs—a strategy indicative of biopharma's evolution towards more data-driven decision-making processes. These stories collectively highlight an era marked by rapid innovation within pharmaceuticals and biotech sectors. As companies navigate these complexities through scientific advancements and strategic maneuvers alike—there lies immense potential not only for enhancing patient care but also driving economic growth across global healthcare landscapes.Support the show

Cuando nace un bebé, llegan muchas primeras veces… y una de las más importantes es comenzar su esquema de vacunación.En este episodio de El Desmadre platicamos con un especialista sobre por qué las vacunas son una de las herramientas más importantes para proteger la salud de nuestros hijos, especialmente durante sus primeros dos años de vida, una etapa clave para fortalecer sus defensas y ayudarlos a prevenir enfermedades potencialmente graves.Hablamos de las dudas más comunes de mamás y papás, los mitos que siguen existiendo alrededor de la vacunación, qué pasa si una vacuna se retrasa y por qué es tan importante completar el esquema en cada etapa.También conversamos sobre las citas clave de los 2, 4, 6 y 18 meses, y sobre enfermedades que siguen circulando entre los niños, como la tos ferina, además de otras que pueden prevenirse gracias a la vacunación.Porque cuando se trata de cuidar a nuestros hijos, la información confiable también forma parte de la prevención.Dale play a este episodio en Spotify y YouTube y acompáñanos en esta conversación realizada con el apoyo de Sanofi. Hosted on Acast. See acast.com/privacy for more information.

Technology is opening new possibilities for how multiple sclerosis is monitored, treated and managed. In this episode of the ECTRIMS Podcast, host Brett Drummond speaks with Prof. Ellen Mowry of Johns Hopkins University and Prof. Letizia Leocani of Vita-Salute San Raffaele University about how innovative medical technologies could transform MS research and clinical care. Together, they explore: How artifical intelligence, wearable devices and digital biomarkers could help monitor MS progression The potential to capture fatigue, cognition, pain, mood, sleep and other symptoms between clinical visits How passive monitoring could provide a more complete picture of everyday life with MS The growing role of virtual rehabilitation, digital therapies and other technologies in bringing care into people's homes Why digital biomarkers require rigorous research and validation before being used in clinical trials From earlier detection of disability progression to more accessible rehabilitation and personalised symptom management, this episode examines both the opportunities and challenges of using technology to improve MS care. --- This podcast episode is supported by an educational grant from Alexion, AstraZeneca Rare Diseases, Bristol Myers Squibb, Novartis, Roche, Sanofi, and UCB. Educational grant providers have no input into the podcast series content.

Guest Full Name: Dr. David-Alexandre (“DA”) C. Gros, MD CEODA's Bio:Dr. Gros has served as Chief Executive Officer and a member of the Board of Directors of Eledon Pharmaceuticals, Inc. since September 2020. He joined Eledon Pharmaceuticals from Imbria Pharmaceuticals Inc., where he served as Co-Founder, Chief Executive Officer and Chairman of the Board of Directors. Prior to Imbria, Dr. Gros was President and Chief Operating Officer of Neurocrine Biosciences, Inc., Chief Business and Principal Financial Officer of Alnylam Pharmaceuticals, Inc., and Chief Strategy Officer of Sanofi, S.A. Before joining Sanofi, Dr. Gros held leadership positions in healthcare investment banking at Centerview Partners, LLC, and Merrill Lynch, Pierce, Fenner & Smith Inc., and in healthcare consulting at McKinsey & Company. He previously served on the Board of Directors of Eliem Therapeutics, Inc., a biotechnology company which he co-founded, and is currently the Executive Chairman of Saint Jean Groupe, S.A., a leading French manufacturer of pasta products since 1935.Dr. Gros earned his Doctor of Medicine from The Johns Hopkins University School of Medicine, a Master of Business Administration from Harvard Business School, and a Bachelor of Arts from Dartmouth College.Company: Eledon Pharmaceuticals, Inc.Ticker: ELDNWebsite: https://eledon.com/About the Company:Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company's lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California.

Caroline Nogueras va vous raconter une affaire encore non élucidée à ce jour. En octobre 2005, quand Eric Boisseranc rentre chez lui à Chazay d'Azergue tout près de Lyon, il découvre sa fille Marine allongée derrière le canapé, morte de plusieurs coups de couteau… Dans le dernier épisode de cette saison, Caroline Nogueras reçoit Eric, le père de la victime, qui se bat toujours pour retrouver le meurtrier et faire justice à sa fille. Le sans-abri ou l'amoureux éconduit ? Octobre 2006. Cela fait un an que Marine a été tuée. Des agents de police lyonnais viennent de contrôler un sans-abri qui a un mandat de recherche sur le dos… ça peut les intéresser... Les gendarmes de la cellule d'enquête se précipitent au 3 rue du Père Chevrier, un centre pour SDF. Dans le casier du gars, ils trouvent : des vêtements de femme, un pantalon tâché de sang… et une sacoche du laboratoire Sanofi — le laboratoire pour lequel travaille Éric Boisseranc. Il n'y a pas l'ombre d'un doute : cette fois, nous tenons notre coupable ! Un podcast Bababam Originals Voix : Caroline Nogueras Ecriture : Tiphaine Pioger Learn more about your ad choices. Visit megaphone.fm/adchoices

A gripe afeta cerca de 1 bilhão de pessoas por ano em todo o mundo. Mas seus efeitos podem ir além dos sintomas imediatos, como febre, dor no corpo, cansaço, tosse, nariz entupido e calafrios.A doença também pode provocar consequências menos conhecidas, como risco aumentado de ataque cardíaco e AVC.Neste episódio do DrauzioCast, Drauzio Varella conversa com o cardiologista Múcio Tavares sobre a relação entre gripe e saúde cardiovascular e a importância da vacinação no longo prazo.Conteúdo produzido em parceria com Sanofi.MMAT-BR-2602634Veja também: Por que o Brasil ainda luta para atingir a meta de vacinação contra a gripe?

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 pivotal advancements that underscore the dynamic nature of our industry. Starting with Moderna, which has recently secured FDA approval for its mRNA-based influenza vaccine, MFLUSIVA. This marks a monumental leap in leveraging mRNA technology beyond its initial role in COVID-19 vaccine development. The approval not only highlights the technology's adaptability and efficiency but also hints at a transformative future for seasonal vaccines, potentially allowing for rapid responses to influenza virus mutations. In tandem with this development, Takeda has achieved FDA approval for Orzeyful (Oveporexton), an innovative therapy targeting narcolepsy type 1. This represents a significant breakthrough as it targets the root cause of the disorder through orexin receptor modulation. The implication here is profound—offering new hope for patients who have long been underserved by existing treatments and potentially setting a new standard in managing sleep disorders. On the leadership front, Sarepta Therapeutics welcomes new CEO Michael Severino during a critical growth phase. Known for its focus on rare diseases, Sarepta faces the challenge of maintaining its competitive edge and meeting stakeholder expectations in a rapidly evolving market landscape. Meanwhile, AstraZeneca and CSPC Pharmaceutical are enhancing their manufacturing capabilities through a joint venture aimed at bolstering biologics production in China—a strategic move that positions them well within one of the fastest-growing markets for such treatments. This partnership is expected to accelerate the availability of biologic therapies across Asia. In another significant leadership change, Fujifilm Biotechnologies appoints Maja Pedersen as president, signaling a strategic shift towards strengthening its contract development and manufacturing organization operations. This move is reflective of broader industry trends emphasizing operational efficiency and strategic restructuring amid changing market demands. Elsewhere, Emergent BioSolutions has eliminated its top R&D role as part of sweeping restructuring efforts. This decision underscores ongoing challenges companies face in balancing innovation with operational efficiency amidst market pressures. In legal arenas, Galderma Laboratories emerged victorious over Sanofi regarding claims made about its blockbuster drug Dupixent. This victory highlights the importance of substantiating promotional claims in an increasingly competitive pharmaceutical marketing landscape. Turning to clinical trials, Biovie's recent study on Parkinson's disease has sparked debate due to its emphasis on composite endpoints rather than primary ones. While offering insights into specific patient subgroups, this approach raises questions about trial design and result interpretation—a critical factor for drug development success. Investment activities are also shaping industry trends significantly. Notably, Lifemine Therapeutics has secured substantial funding from high-profile investors like Bill Gates and Jeff Bezos. This investment reflects burgeoning interest in innovative biotech platforms capable of addressing complex diseases through unique mechanisms. Moreover, Icon's collaboration with Anthropics aims to integrate AI into clinical trials—an exciting development poised to streamline these processes significantly. By leveraging artificial intelligence capabilities, this partnership could accelerate drug development timelines and improve trial outcomes. Overall, these developments highlight transformative changes within the pharmaceutical and biotech sectors. Innovative therapeutics, strategic partnerships, leadership transitions, regulatory milestones, and technological advancements collectively drive significant progress in patient care and drug development. As we navigate these changes, it's crucial for industry stakeholders to capitalize on emerging opportunities while addressing associated challenges such as regulatory compliance, market competition, and operational efficiencies. Thank you for tuning into Pharma Daily—stay informed and stay ahead!Support the show

This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits. The speakers were compensated by Sanofi and Regeneron in connection with this program.   COPD trial outcomes are not all equal, yet conventional endpoints can make it difficult to weigh severe events, exacerbations, lung function, and symptom burden within a single clinical picture.   In this AMJ podcast, Sanjay Ramakrishnan and Simon Couillard discuss how win ratio methodology may help capture a broader, more clinically meaningful view of treatment benefit by comparing outcomes across a prespecified hierarchy.   Listen to the full episode to learn:   Why standard COPD endpoints may not tell the full story How win ratio analysis prioritizes outcomes by clinical importance What the pooled BOREAS and NOTUS analysis showed How this approach could shape future respiratory trial design Speakers: Sanjay Ramakrishnan, Clinical Senior Lecturer, UWA Medical School, Centre for Respiratory Health, The University of Western Australia, Perth, Australia Simon Couillard, Professor, Faculty of Medicine and Health, Université de Sherbrooke, Quebec, Canada

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 latest scientific advancements, regulatory milestones, and strategic business maneuvers shaping the industry. One of the standout developments comes from Otsuka with their drug Voyxact, which has shown promising results in stabilizing kidney function decline in patients with immunoglobulin A nephropathy (IgAN). In a Phase 3 trial, patients exhibited kidney function comparable to that of healthy adults. IgAN is a challenging autoimmune condition often leading to end-stage renal disease. This advancement, leveraging a monoclonal antibody to target specific pathways, could mark a new era in managing this chronic kidney disease. In oncology, Jiangsu Alphamab Biopharmaceuticals has been making waves through strategic collaborations, securing deals worth $125 million upfront and potential milestone payments reaching over $2 billion. Their focus on developing antibody-drug conjugates (ADCs) using AI and machine learning underscores the promise of precision oncology. ADCs marry the targeting precision of antibodies with potent anti-cancer drugs, highlighting robust investment and confidence in these cutting-edge therapies. Merck & Co. continues to expand its financial outlook, driven by the success of its flagship drugs like Keytruda. This monoclonal antibody remains pivotal in cancer immunotherapy, while drugs like Winrevair and Lipfendra are broadening Merck's reach into cardiovascular health. This growth trajectory reflects a strategic push toward diversifying product lines and leveraging breakthrough therapies to maintain strong financial performance. Additionally, Merck's $10.8 billion acquisition of Prometheus Biosciences aims to expand their therapeutic portfolio with targeted biologics. Although mid-stage trials showed mixed results for their anti-TL1A antibody therapy, such acquisitions are pivotal in addressing unmet medical needs. On the regulatory side, Sanofi's MenQuadfi vaccine has achieved EU approval for use in infants as young as six weeks. This approval enhances preventive measures against invasive meningococcal disease in vulnerable populations, representing a significant public health advancement. In research methodologies, Sethera Therapeutics' collaboration with Receptor.AI is notable. By integrating AI-driven platforms for polymacrocyclic peptide discovery aimed at hard-to-drug targets, they're paving the way for overcoming traditional drug discovery challenges through computational tools. However, not all news is about progress. Jazz Pharmaceuticals faced a setback by withdrawing its label indication for Zepzelca after failing Phase 3 trials for small-cell lung cancer. This underscores the inherent risks in clinical development pathways. From a financial standpoint, BioNTech has adjusted its 2025 sales forecast downward due to waning global demand for COVID-19 vaccines—a reflection of the volatile vaccine markets post-pandemic peaks. Meanwhile, Pfizer's discontinuation of its Phase 2 GIPR antagonist for obesity illustrates strategic pivots within R&D pipelines as companies reassess priorities based on trial outcomes and market potential. Recent corporate strategies include Pfizer's ambitious cost-saving plan totaling $9.7 billion through 2029. Amid economic pressures and patent expirations looming on key products like Eliquis, Pfizer is optimizing operations to stay competitive. Speculation around a possible merger between Bristol Myers Squibb (BMS) and AstraZeneca has stirred interest. With both facing patent cliffs, this merger could rejuvenate portfolios—though the strategic benefits for AstraZeneca are still debated. On the technological front, advancements in cellular therapies promise to revolutionize medicine production at the cellular level, potentially enhancing patient outcomes through more personalized treatments. The regulatory landscape is also evolving. There's a growing call for streamlining Investigational New Drug applications under the FDA's Trialblazer initiative—crucial for accelerating clinical trials and bringing innovative therapies to market swiftly. Finally, initiatives such as Boston Scientific's restructuring efforts highlight challenges within the medical device sector as companies adapt to shifting market dynamics. Overall, these developments underscore an industry in motion where innovation and adaptation are key to navigating complex landscapes and advancing patient care globally. As we look ahead, these trends will likely continue shaping the future of pharmaceuticals and biotech in profound ways.Support the show

On this episode of Diabetes Connections In the news… Sanofi acknowledges an insulin shortage, a new oral therapy for type 1 moves along in research, could there be an actual, accurate, non-invasive CGM in the works, ADA conflict continues and a new documentary about Girl Scout cookies shines a spotlight on T1D. Don't miss our upcoming events! Moms' Night Out in Detroit and Seattle, Club 1921 in Charlotte and Phoenix: https://diabetes-connections.com/events/   Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom  All about VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com   Transcript:  (Stacey Track) On this episode of Diabetes Connections In the news… Sanofi acknowledges an insulin shortage, a new oral therapy for type 1 moves along in research, could there be an actual, accurate, non-invasive CGM in the works, ADA conflict continues and I can't wait to tell you about Cookie Queens.. that's coming up right after this. (AD BREAK) Welcome! I'm your host Stacey Simms and this is an In The News episode.. where we bring you the top diabetes stories and headlines happening now. A reminder that you can find the sources and links and a transcript and more info for every story mentioned here in the show notes. We are still looking for your community commercials. These are 30–60 second audio spots created by members of the diabetes community to share: Events you're organizing: a fundraiser, walk, or local meetup Products you've created: maybe you've written a book, have a Substack, designed a T1D-friendly gadget, or launched a small business Helpful projects or resources: things you think others in our community should know about It's your chance to share what you're doing and help others get connected! Full instructions are on the website. While you're there please check out our events. We're turning toward fall and we have a lot going on – MNO and Club 1921.   Okay.. our top story this week: XX I want to talk about Cookie Queens! It might not sound like a hard news story.. but It's my show and I can't wait to watch this. This move follows four Girl Scouts ages 5-12 during cookie season. One of the girls has type 1 – they don't mention it in the trailer, but you can see her omnipod. Here's a clip:   Start the very beginning and stop after "I want to be a supreme court justice." (stop after the "oh..laughter" https://www.youtube.com/watch?v=nnSQS43Eil8   Viewers meet Ara from San Diego, CA (5), Shannon Elizabeth from El Paso, TX (8), Nikki from Chino, CA (9), and Olive from Charlotte, NC (12). Ara has Type 1 diabetes and is shown taking insulin, refilling her pump before bed, and determining with her dad how to sample the cookies she's selling while keeping her blood sugar levels safe. Thumbs down to the Hollywood reporter dot com. In their review they say.. "if this film were itself a baked good, Ara would need to be careful because one bite could cause hyperglycemia or even diabetic ketoacidosis. It's just that sweet." Cookie Queens comes out this month. https://www.hollywoodreporter.com/movies/movie-reviews/cookie-queens-review-prince-harry-meghan-markle-girl-scouts-1236484555/ trailer:   XX Supply issues for Lantus SoloStar pens being acknowledged by Sanofi. The company says it's experiencing "a period of intermittent supply due to increased demand. The company said the increase in demand is being driven by "broader market dynamics," but did not provide additional details. Sanofi said the situation is temporary and is expected to improve over the coming weeks. The company said Lantus U-100 vials and Toujeo U-300, which contain the same active ingredient, remain available. https://www.wral.com/news/local/common-insulin-pen-faces-supply-issues-amid-rising-demand-july-23-2026/ XX The University of Alabama at Birmingham startup TIXiMED Inc. has launched the next phase of clinical testing for a novel oral therapy for Type 1. For now called TIX100, a small-molecule drug designed to inhibit a protein linked to pancreatic beta-cell loss and diabetes progression. The new double-blind, randomized, placebo-controlled study will evaluate the drug's safety, tolerability and pharmacokinetics. Researchers will enroll 18 healthy participants across three dose cohorts at a single United States study site. Participants will receive either TIX100 or a placebo twice daily for 28 days, followed by a seven-day follow-up period. Six participants making up the first cohort have been successfully enrolled thus far. In addition to its potential use in Type 1 diabetes, TIX100 may have applications in Type 2 diabetes and obesity. A recent study found that the drug prevented weight regain and preserved lean muscle mass after discontinuation of GLP-1 therapies in preclinical models. https://www.uab.edu/news/research-innovation/startup-advances-novel-oral-type-1-diabetes-therapy-to-next-phase-of-human-testing XX Researchers at the University of California San Diego say they have developed and validated a Continuous Health Analyzing Ring Module (CHARM), a compact, fully integrated wearable smart ring capable of continuous real-time monitoring of multiple biomarkers in sweat. The wearable device can simultaneously measure up to four biomarkers, including glucose, ketone, uric acid, lactate, ascorbic acid, and alcohol, to provide real-time insights into metabolic health. The study is published in Nature Communications. They say CHARM device contains all necessary biomarker sensors, low-power electronics, and a flexible battery. The left compartment of the device is designed to draw sweat passively using an osmotic hydrogel, a soft polymer that creates a pressure gradient to pull fluid from the skin painlessly. The sweat is then analyzed by multiplexed electrochemical sensor arrays within the same compartment, leading to simultaneous and real-time tracking of four biomarkers at a time.   The right compartment of the device contains a flexible zinc-silver oxide rechargeable battery that supplies power for up to 12 hours of operation between charges. Biomarker information generated through sensors is wirelessly transferred to a connected Bluetooth-enabled device for real-time display The findings indicated that the device performed well in initial temperature, cytotoxicity, and on-body compatibility tests. It also demonstrated high analytical accuracy in preliminary studies involving healthy participants and individuals with type 1 diabetes, highlighting its potential for non-invasive metabolic monitoring. The calculated estimated sweat-based blood glucose concentration showed a mean absolute relative difference of approximately 13.7% against its corresponding blood concentration values.   The device needs further validation in diverse clinical settings and across large diabetic cohorts.   https://www.news-medical.net/news/20260727/Prototype-smart-ring-tracks-multiple-sweat-biomarkers.aspx   XX Hotter weather and rising temps appear to increase the short term risk for low blood sugar in adults with type 1. An analysis of more than 32 million continuous glucose monitor (CGM) readings from nearly 700 adults with T1D in the UK showed a 26% greater risk for hypoglycemia at a temperature of 25 °C (77 °F) than at 13 °C (55.4 °F). Hypoglycemia was defined as a glucose level < 3.9 mmol/L (70 mg/dL). The study included 679 individuals with T1D and 32,966,282 CGM readings collected between February 23, 2017, and August 8, 2024. Participants had a mean age of 46.4 years and a mean T1D duration of 23.7 years. The researchers observed strong seasonal patterns, with lower odds of hypoglycemia in late winter and early spring, followed by a peak during the summer. The lowest risk occurred on Mondays. The odds then increased over the course of the week and peaked toward the weekend, with a significant odds ratio of 1.14 on Saturdays compared with Mondays. Increases in hypoglycemia were observed during both hot and cold weather, but the association was stronger for heat. The net odds ratio was 1.26 at 25 °C compared with 13 °C.   https://www.medscape.com/viewarticle/when-temperatures-climb-hypoglycemia-risk-rises-type-1-2026a1000q4r XX Seven weeks after the expulsion of five diabetes experts from the American Diabetes Association conference, controversy continues. More than 200 members now calling for two ADA leaders to resign. In response, the ADA delivered its own message Tuesday, expressing appreciation for members' patience while a report is prepared.   The resignation demand, sent last week in an open letter to the ADA board of directors, calls for the removal of CEO Charles Henderson and chief scientific and medical officer Rita Kalyani. It also urges "an independent investigation into the events of the 2026 Scientific Sessions in New Orleans, a full apology to the five colleagues removed from the meeting, and the restoration of editorial independence at Diabetes Care," an ADA scientific journal.   https://www.statnews.com/2026/07/28/american-diabetes-association-fallout-researchers-expulsion/ XX XX Still to come, , a new link between diabetes and dementia, device updates, and why you might want to start rooting for the Red Sox..   XX New study says that people diagnosed with type 1 diabetes (T1D) before the age of 10 years had a 37% higher risk of developing all-cause dementia later in life than those diagnosed between ages of 18 and 30 years. These researchers used a Swedish national register of 43,440 individuals with T1D (mean age at cohort entry, 33 years; 44% women) Worth noting a couple of things.. the mean age in this study was 33 – so the people who were diagnosed under the age of ten would not have had access to current technology – no CGMs or AID systems. And while the study says it's 37% higher for the younger group, the actual rate was still very low. As always, I'll link to the study so you can learn more. My obvious bias here to look for a silver lining because I have a son who diagnosed with T1D at age 2.   https://www.medscape.com/viewarticle/type-1-diabetes-onset-before-age-10-tied-higher-risk-2026a1000pir XX Researchers have developed a machine learning model that uses routine clinical information to detect diabetes and distinguish between type 1, type 2, prediabetes, and diabetes caused by pancreatic disease. The model performed well in early testing, but researchers say it still needs to be validated in independent patient groups before it could be considered for use in diabetes screening or clinical care. It did not assess clinical utility, patient outcomes, or quality of life. https://www.news-medical.net/news/20260729/Researchers-train-AI-to-detect-diabetes-and-assign-four-diagnostic-labels.aspx XX Trinity Biotech and Latch Medical are teaming up to explore combining CGM with precision drug delivery technology for diabetes, obesity, and other metabolic conditions. The companies hope real-time glucose data from Trinity's CGM+ sensor could eventually help guide more personalized treatment decisions and medication delivery. Trinity's CGM+ is still in development, with a pivotal clinical trial planned for later this year. https://www.drugdeliverybusiness.com/trinity-biotech-collab-cgm-drug-delivery/ XX The FDA selects Dexcom as the first participant in a new digital health pilot that will exempt certain digital health devices from FDA premarket authorization requirements while collecting real world data through a complementary Medicare program. Dexcom, plans to implement an artificial intelligence-enabled glucose health program through the pilot. The program is intended to help screen for prediabetes and Type 2 diabetes. The company plans to integrate data from its sensors, including its prescription G7 CGM and its over-the-counter Stelo device, along with contextual health information such as nutrition, physical activity, sleep and stress. The FDA announced plans for the Technology-Enabled Meaningful Patient Outcomes, or TEMPO, pilot last year amid a broader push for adoption of digital health and wearables. It coincides with a new program by the CMS to fund the use of digital technologies for managing chronic conditions. https://www.healthcaredive.com/news/fda-names-dexcom-as-first-participant-in-digital-health-pilot/826215/ XX Medicare and Medicare Advantage beneficiaries now have access to the new MiniMed Flex insulin pump. Beneficiaries can now access the MiniMed Flex and its latest sensor portfolio, which currently includes the Simplera Sync sensor, a disposable, all-in-one sensor with easy two-step insertion. The company plans to roll it out with the Instinct sensor, made by Abbott, later this summer. It also added Abbott's dual glucose-ketone sensor (still investigational in the U.S.) to its portfolio this year. Flex picked up FDA clearance in March and the company announced the initial commercial rollout of the pump last month. https://www.drugdeliverybusiness.com/minimed-flex-pump-now-available-medicare/ XX Eli Lilly expands it's partnership with Resilience – the makers of the KwikPen device. Through the investment, Resilience will significantly increase U.S. production of Lilly's KwikPen injectable device for diabetes and obesity medicines. In February, Lilly won FDA approval for Zepbound in a multidose KwikPen device. The product includes four doses of the GLP-1/GIP receptor agonist, providing a month of treatment for obesity or overweight in one device. Resilience expects the KwikPen capacity expansion to create at least 400 jobs in the Cincinnati area. https://www.biospace.com/deals/lilly-and-resilience-invest-750m-in-diabetes-and-obesity-drug-device-supply XX Alex Cooper – the host of the top podcast Call her Daddy – announced she's been diagnosed with gestational diabetes.   "When I got this diagnosis, the first couple days, I was really hard on myself," the 31-year-old admitted. "It felt very isolating, like, as much as my family and my husband and everyone was there for me I just felt like, it's me on an island." She says she found an online community that's been helping. In sharing her experience, she hoped it would alleviate the stress. https://www.eonline.com/news/1434556/pregnant-alex-cooper-shares-isolating-gestational-diabetes-diagnosis XX Several amazing diabetes non profits are vying for big charity dollars from the Boston Red Sox. The IMPACT Awards provide Red Sox fans with the chance to nominate their favorite, most impactful nonprofit organization serving New England for their opportunity to win a grant from the Red Sox Foundation. In 2026, the IMPACT Awards will focus on organizations that are supporting research and providing awareness, advocacy, and services to people with diabetes. Check out all the charities and vote for your favorites – you've heard of so many of these I promise – at the link in the episode show notes, . https://www.mlb.com/redsox/community/red-sox-foundation/impact-awards?partnerId=redirect-bos-impact

¿Qué pueden tener en común el eczema de un bebé, el asma de un niño en edad escolar y la dificultad para tragar de un adolescente? Aunque parecen enfermedades completamente diferentes, pueden compartir un mismo motor inflamatorio: la inflamación tipo 2. Lo que vemos en la piel, los pulmones o el esófago puede ser solamente la punta del iceberg. Hoy abordamos lo que ocurre debajo de la superficie y de cómo esta inflamación puede afectar no solo la salud del niño, sino también su sueño, crecimiento, aprendizaje, bienestar emocional y vida familiar. Con este episodio iniciamos la sexta temporada y comenzamos una serie especial de cinco episodios, patrocinada por Sanofi, en la que vamos a conversar sobre la inflamación tipo 2 y su relación con diferentes enfermedades inflamatorias. Nuestra productora Vanessa Bernal, entrevista a la anfitriona del podcast Pediatras en Línea, la doctora Carla Torres-Zegarra, quien nos ayudará a entender estos temas de manera práctica, clara y basada en evidencia. La Dra. Carla Torres-Zegarra es dermatóloga pediatra, pediatra y dermatóloga, con triple certificación de especialidad. Se graduó de Medicina en la Universidad Peruana Cayetano Heredia en Lima-Perú, realizó su residencia de Pediatría y jefatura de residentes en Cleveland Clinic en Ohio-USA, y completó su formación en Dermatología y la subespecialidad en Dermatología Pediátrica en la Universidad de Colorado y Children's Hospital Colorado en Colorado-USA. Actualmente es profesora asociada en la Universidad de Colorado, dermatóloga pediatra en Children's Hospital Colorado y directora del programa de subespecialidad en Dermatología Pediátrica. Además, es creadora y conductora de Pediatras en Línea y se dedica a compartir información médica en español, clara y basada en evidencia. Este episodio cuenta con el patrocinio educativo de Sanofi. La información que compartiremos tiene fines educativos y no reemplaza la evaluación médica individualizada. Instagram: @dra.carlatorresz ¿Tienes algún comentario sobre este episodio o sugerencias de temas para un futuro podcast? Escríbenos a pediatrasenlinea@childrenscolorado.org.

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 events that underscore the dynamic nature of these industries, characterized by scientific advancements, strategic partnerships, and regulatory milestones. Johnson & Johnson has made headlines with its substantial $785 million upfront payment to Sail BioMed for an in vivo CAR-T cell therapy deal. This agreement includes an option for Johnson & Johnson to acquire Sail BioMed for $2.58 billion, underscoring the sustained interest in cell therapies, particularly for autoimmune diseases. In vivo CAR-T therapies represent a significant leap forward by modifying T cells directly within the patient's body. This method offers potential advantages over traditional ex vivo techniques by simplifying the manufacturing process and potentially reducing both costs and time to treatment. Such transactions highlight Johnson & Johnson's commitment to expanding its cell therapy portfolio, which could significantly enhance patient care by making advanced treatments more accessible. Eli Lilly and Resilience have announced a significant $750 million investment aimed at boosting the production of diabetes and obesity medications in the United States. This move comes as a response to the global rise in these conditions, necessitating increased production capacities to meet growing demand. The focus on injectable drug devices emphasizes efforts to improve drug delivery systems, ultimately enhancing patient compliance and therapeutic outcomes. Sanofi's financial outlook for 2026 is promising, driven by robust sales of Dupixent, which exceeded €5 billion in quarterly sales. Dupixent, a monoclonal antibody used for treating atopic dermatitis and other autoimmune conditions, has been a significant revenue driver for Sanofi. The success of Dupixent reflects its effectiveness and strong market adoption, highlighting the potential of monoclonal antibodies as cornerstones of modern pharmacotherapy, particularly for chronic inflammatory diseases. Regeneron and Sanofi's Dupixent continues performing strongly with $6 billion in sales during Q2 2026—marking its largest quarterly revenue since the pandemic began—illustrating robust demand across various indications within both companies' portfolios. On the regulatory front, Alfasigma's Linerixibat (Lynavoy) has received a positive opinion from the CHMP for treating cholestatic pruritus in primary biliary cholangitis following successful Phase 3 trials. As an IBAT inhibitor targeting bile acid metabolism pathways, Lynavoy introduces a novel therapeutic approach for managing symptoms associated with this autoimmune liver disease. Meanwhile, ImmunityBio's Anktiva has gained marketing authorization in the UAE for non-muscle invasive bladder cancer and metastatic non-small cell lung cancer. Anktiva, an IL-15 cytokine-based protein therapy, exemplifies the growing interest in harnessing immune system modulators for cancer treatment. Takeda's recent decision to discontinue its nanoparticle therapy (TAK-101) for celiac disease highlights the inherent challenges in developing new therapies for autoimmune disorders. The disappointing Phase 2 results suggest that achieving immune tolerance to dietary gluten remains a significant scientific hurdle. From a strategic perspective, Sanofi's CEO has emphasized stricter go/no-go decisions during Phase 3 clinical trials amid pipeline cuts and significant impairment losses. This approach could lead to more efficient resource allocation and potentially higher success rates for late-stage drug candidates. The industry is witnessing significant transformations through strategic shifts driven by executives like Sanofi's new CEO Belen Garijo. Her vision includes reversing recent challenges faced by Sanofi by capitalizing on its strengths while addressing setbacks such as discontinuing certain late-stage clinical programs like the joint venture with Regeneron on the IL-33 candidate itepekimab. This strategic pivot mirrors broader industry trends toward optimizing late-stage pipelines to enhance competitive positioning and drive future growth. Advancements in AI-powered drug discovery continue gaining momentum through collaborations like those between GSK and Relation Therapeutics, alongside Causaly and Sage. These partnerships aim to leverage AI and machine learning technologies to accelerate drug discovery processes by integrating vast amounts of scientific literature into data analytics platforms. GlaxoSmithKline's $110 million deal with an AI biotech firm further signals increased integration between artificial intelligence technologies and pharmaceutical research efforts aimed at enhancing dataset quality thereby accelerating innovation throughout drug discovery processes. Bristol Myers Squibb faces further delays regarding its Alzheimer's psychosis treatment Cobenfy—a postponement reflecting ongoing complexities related to neurological drug development which requires overcoming high scientific hurdles alongside regulatory scrutiny. Alnylam Pharmaceuticals recently experienced a 29% drop in stock value following disappointing sales of Amvuttra and a downward revision of its ATTR franchise outlook for 2026. Such fluctuations highlight volatility within biotech investments when market expectations are not met. These collective developments reveal significant trends shaping today's pharmaceutical landscape: strategic pipeline optimization efforts alongside robust investment initiatives targeting high-demand therapeutic areas—all while leveraging technological advancements like AI integration aimed at improving R&D efficiency ultimately impacting patient care worldwide through innovative therapies addressing unmet medical needs globally.Support the show

Fed maintained rates, though with 3 dissenters who favoured a 25bps hike. Chair Warsh said that if inflation remains elevated, rates could be part of fixing that.DXY came under pressure as the Fed failed to match hawkish expectations, though Warsh's press conference triggered pronounced UST curve steepening.US CENTCOM announced its forces successfully completed a heavy wave of strikes against Iran; Jordan intercepted five missiles launched by Iran.US after-market earnings saw results from ARM Holdings (-5.7%), Microsoft (+8.9%), Meta Platforms (-7.5%) and QUALCOMM (-4.7%).APAC stocks were mostly lower; European equity futures indicate a flat cash market open. Looking ahead, highlights include French GDP Prelim (Q2), Spanish GDP Flash (Q2), Inflation Prelim (Jul), German GDP Flash (Q2), State/Nationwide Inflation Flash (Jul), Italian GDP (Q2), EU GDP Flash (Q2), Consumer Confidence Final (Jul), US GDP Advance (Q2), PCE (Jun), Initial Jobless Claims (Jul/25), Personal Spending (Jun), Chicago Fed Labor Market Indicators (Jul), BoE Policy Announcement & MPR (Jul). Speakers include BoE Governor Bailey, Earnings from Bristol Myers Squibb, Mastercard, Apple, Amazon, Adidas, BMW, Leonardo, Renault, Sanofi, Schneider Electric, SocGen, BAE Systems, British American Tobacco, Shell & Rolls-Royce.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

In this episode, Dr. Steve Edelman and Dr. Jeremy Pettus are joined by Dr. Shara Bialo, Senior Medical Director of Type 1 Diabetes Immunology at Sanofi, pediatric endocrinologist, and person living with type 1 diabetes, for an in-depth discussion about what happens before type 1 diabetes is diagnosed. Together, they explore the autoimmune process that begins months or even years before symptoms appear, why early detection matters, and how screening is changing the future of type 1 diabetes care. Dr. Bialo shares her personal diagnosis story, discusses common misconceptions about what causes type 1 diabetes, and explains the three stages of the disease. The conversation also covers who should be screened, how diabetes autoantibody testing works, the benefits of preserving beta cell function, and why identifying people before they develop symptoms can lead to better long-term outcomes and fewer cases of diabetic ketoacidosis (DKA). Whether you have type 1 diabetes, have a family member at risk, or simply want to better understand the latest advances in prevention and early detection, this episode provides valuable insights into one of the fastest-moving areas of diabetes research.Key Topics:Dr. Shara Bialo's personal journey living with type 1 diabetesWhy type 1 diabetes is an autoimmune disease, not simply a blood sugar problemThe role of genetics, viral infections, and the immune systemUnderstanding the three stages of type 1 diabetesWhy most people diagnosed with type 1 diabetes have no family historyAdult-onset type 1 diabetes and why it is often mistaken for type 2 diabetesWhat diabetes autoantibodies are and how screening worksWho should consider screening for type 1 diabetesAvailable screening options, including blood tests and home screening kitsThe emotional challenges families face when considering screeningThe importance of preventing diabetic ketoacidosis through early detectionWhy preserving beta cell function can improve long-term outcomesItaly's national screening program and the future of population-wide screeningResources available through screenfortype1.comThis content was produced with support from Sanofi and screenfortype1.com.✨ Subscribe for practical diabetes management tips, technology updates, and treatment breakthroughs that help people with diabetes live healthier, more flexible lives.More diabetes resources:Website: tcoyd.orgBlog: tcoyd.org/blogPodcast: tcoydthepodcast.transistor.fmInstagram:   / tcoydFacebook:   / tcoydStay connected! Sign up for our monthly newsletter here!Support TCOYD's educational programs: tcoyd.org/donate ★ Support this podcast ★

Join Dr. Kal Patel, CEO and Co-Founder of BrightInsight, for an illuminating masterclass on navigating product-market fit (PMF) inside one of the most complex, highly regulated sectors in global business: healthcare. Every year, life science giants invest billions of dollars developing breakthrough biopharmaceutical therapies, yet nearly 50% of patients with chronic diseases drop off their prescribed medication regimes within the first twelve months. Drawing from his rare vantage point as a physician, former BCG strategist, former head of Amgen's Digital Health unit, and leader of BrightInsight, Dr. Patel breaks down why traditional "direct-to-consumer" wellness apps repeatedly fail, how to build enterprise software that biopharma giants trust to touch regulated therapies.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NDK865. CME/MOC/AAPA credit will be available until July 16, 2027.Innovations in Bullous Pemphigoid Management: Targeted Solutions for a Blistering Challenge 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 an educational grant from Sanofi and Regeneron Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into the latest groundbreaking advancements, strategic corporate maneuvers, and pivotal regulatory updates shaping this dynamic industry landscape. Starting with some exciting news, Scribe Therapeutics has successfully closed its initial public offering, raising a significant $129 million. This substantial funding will drive forward their pioneering work in gene editing technologies, particularly focusing on therapies for cardiovascular diseases and atherosclerotic cardiovascular disease (ASCVD). By leveraging CRISPR technology, Scribe Therapeutics is positioned at the forefront of developing transformative treatments for both rare and common diseases. This advancement could potentially revolutionize how these conditions are managed, offering new hope for patients worldwide. On the regulatory front, Amgen is actively working to maintain its competitive edge in the U.S. market by submitting a comprehensive data package to the FDA for its drug Tavneos. This strategic move highlights the competitive nature of the pharmaceutical landscape where maintaining market access and drug positioning is crucial. Additionally, an FDA panel has recently endorsed lifting restrictions on four peptides, a decision that could significantly enhance therapeutic options in wound healing and autoimmune diseases through compounding pharmacies. This shift indicates a broader acceptance of peptides' therapeutic potential, which are increasingly being explored for their targeted therapy applications. In clinical trial news, Meiji Seika Pharma has reached a significant milestone with its combination therapy involving HBI-8000 and nivolumab. The therapy has successfully met the progression-free survival endpoint in a Phase 3 trial for advanced melanoma. This approach combines an epigenetic immunomodulator with a PD-1 inhibitor, representing a strategic method to harness immune system modulation for cancer treatment. Such advancements highlight ongoing innovations within oncology therapeutics and emphasize opportunities for improved patient outcomes through novel treatment combinations. However, not all clinical trials meet success. Sanofi's recent decision to halt Phase 3 development of amlitelimab for atopic dermatitis due to insufficient data serves as a reminder of the inherent challenges in drug development. Similarly, Ipsen's Bylvay did not meet its primary endpoint in a pivotal trial for biliary atresia patients post-Kasai surgery. These setbacks highlight the complexities involved in translating scientific discoveries into viable therapeutic options and underscore the unpredictable nature of drug development. Shifting to corporate strategies, Roche has decided to discontinue its development of an obesity asset, acmopatide, while placing support behind another candidate, enicepatide. This decision reflects dynamic prioritization within pipelines as companies navigate scientific data alongside market demands. Meanwhile, Fresenius has launched a €200 million corporate venture capital fund targeting innovations across biopharma, medtech, and digital care sectors. This move aligns with an increasing trend towards supporting early-stage innovations addressing unmet medical needs. In mergers and acquisitions news, Scancell's acquisition of Neophoria Therapeutics via reverse merger showcases strategic maneuvers within the sector aimed at securing financial stability and market presence through listings such as on NASDAQ. These activities illustrate broader industry trends where companies seek growth through strategic partnerships and acquisitions to enhance technological capabilities and market reach. In oncology developments, GSK has achieved a landmark FDA approval for Jideytro following its acquisition of Nuvalent. This milestone underscores the strategic importance of mergers and acquisitions in achieving rapid growth and diversification in oncology pipelines. The quick payoff from this deal highlights how targeted acquisitions can accelerate therapeutic advancements. Turning our attention to HIV prevention strategies, Merck is expanding access to its investigational PrEP pill Alimatravir through voluntary licensing agreements even before regulatory approval. This proactive strategy mirrors Gilead's successful model and emphasizes the industry's shift towards accessibility and patient-centric approaches. Finally, technological advancements continue reshaping industry practices with AI integration into incentive compensation models being explored by companies like Novartis in collaboration with consulting firms such as ZS Associates. These efforts are part of a larger digital transformation within the industry aimed at enhancing operational efficiency and decision-making processes. As we wrap up today's insights, it's clear that these developments highlight an era where scientific innovation intersects with strategic business decisions and regulatory frameworks. The implications for patient care are profound as these efforts translate into more effective therapies with potential impacts on treatment accessibility, efficacy, and personalization. As the industry continues to evolve rapidly amidst scientific breakthroughs and regulatory changes, maintaining a balance between innovation, regulation, and market dynamics will be crucial for sustaining growth and improving health outcomes globally.Support the show

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NDK865. CME/MOC/AAPA credit will be available until July 16, 2027.Innovations in Bullous Pemphigoid Management: Targeted Solutions for a Blistering Challenge 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 an educational grant from Sanofi and Regeneron Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

In this episode, hosts Sameer Berry, MD, and William Chey, MD, speak with Sarah Enslin, PA-C, Vivek Kaul, MD, and Amy Stewart, CRNP, about the benefits of introducing advanced practice providers in practice and how to help them succeed. ·       How can advanced practice providers, or APPs, help overcome access barriers in gastroenterology? 6:54 ·       How can we effectively onboard APPs? 10:24 ·       Is ACG's APP Academy for Clinical Excellence accounting for the fact that different specialties and practices have different requirements? 18:21 ·       What models have worked well for deploying APPs into GI practices? 24:32 ·       What strategies are most effective for APP retention? 29:07 ·       How can we improve professional development for APPs? 42:14 We'd love to hear from you! Send your comments/questions to guttalkpodcast@healio.com. Follow us on X @HealioGastro, @sameerkberry and @umfoodoc.  Berry and Chey report no financial disclosures. Stewart reports financial relationships with AbbVie, Ardelyx, Celltrion, Cristcot, Eli Lilly & Co, Exact Sciences, Genentech, Johnson & Johnson, Merck, Mindset Health (Nerva), Nestle Health Science, Pfizer, Phathom Pharmaceuticals, Prometheus Laboratories, Regeneron, Salix Pharmaceuticals, Sanofi and Takeda Pharmaceuticals. Healio could not confirm relevant financial disclosures for Enslin and Kaul at the time of publication.

This episode covers: Cardiology This Week: A concise summary of recent studies Risk factors and longevity in women and in men  Mythbusters: Smartphone interference with pacemakers, ICDs Host: Rasha Al-Lamee Guests: JP Carpenter, Christina Magnussen Want to watch that episode? Go to: https://esc365.escardio.org/event/2559 Want to watch that extended interview on risk factors and longevity in women and in men, go to: https://esc365.escardio.org/event/2559?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 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. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. 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. Christina Magnussen has declared to have potential conflicts of interest to report: speaker fees from Novartiq, Novo Nordisk, Bayer, Boehringer Ingelheim and Edwards. 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: Rasha Al-Lamee Guests: Christina Magnussen Want to watch that extended interview on risk factors and longevity in women and in men, go to: https://esc365.escardio.org/event/2559?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/2559   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 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. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. 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. Christina Magnussen has declared to have potential conflicts of interest to report: speaker fees from Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim and Edwards. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're delving into a series of significant breakthroughs and strategic moves reshaping the industry landscape. Repligen Corporation's recent decision to acquire BioLife Solutions for $1.5 billion marks a pivotal moment in the cell therapy sector. BioLife Solutions' expertise in cryopreservation media is integral to maintaining cell viability during storage and transport—an essential factor for the success of cell therapies in oncology and regenerative medicine. This acquisition ensures Repligen a stable supply chain to support the burgeoning demand for advanced therapeutic options, potentially enhancing patient outcomes through more reliable treatments. Meanwhile, Novartis is expanding its reach in South Korea with a $95 million investment aimed at enhancing its radioligand therapy supply chain. Radioligand therapy represents a groundbreaking approach in oncology, utilizing targeted radioactive particles to specifically attack cancer cells while sparing healthy tissue. This strategic investment underscores Novartis's commitment to ensuring a robust infrastructure for delivering innovative cancer treatments. On the clinical front, Crystalys Therapeutics has made waves by securing $130 million in Series B funding, propelling their gout treatment, Dotinurad, into Phase 3 trials. This drug targets uric acid levels, addressing a significant unmet need in gout management. The progression into late-stage trials reflects confidence in Dotinurad's potential to provide effective relief for patients suffering from this painful condition. Regulatory advancements are also making headlines with the UK's MHRA granting approval to Chiesi's Clenil Modulite with a low-carbon propellant for asthma maintenance treatment. This move signifies a crucial step towards more sustainable pharmaceutical practices without compromising efficacy—setting a potential benchmark for future respiratory treatments that incorporate eco-friendly technologies. In business development news, Ashlins Pharmaceuticals and Lee's Pharmaceutical have struck a $31 million licensing deal for interferon alpha-2b outside China, focusing on rare diseases. Similarly, Jupiter Neurosciences' acquisition of MDMA asset ALA-002 from Pharmala Biotech illustrates ongoing interest in small molecule therapeutics for neurological conditions. Royalty Pharma's significant $425 million payment to Neurimmune highlights strategic investments in cardiovascular therapies through royalty financing, underscoring confidence in advancing novel treatments. Concurrently, Dimension has raised an impressive $800 million for an AI-driven biotech drug discovery fund. The integration of AI promises accelerated drug development timelines and enhanced precision in identifying viable candidates. However, not every development is favorable. Celldex Therapeutics faced a setback with their Phase 2 trial failure for barzolvolimab in prurigo nodularis patients. Such challenges highlight the inherent risks associated with innovative drug development. Turning our attention to another scientific milestone, Arrowhead Pharmaceuticals has reported promising Phase 3 data on its triglyceride-lowering drug, Plozasiran. With analysts praising its "best-in-class profile," Arrowhead aims for FDA approval by year-end, setting up potential competition with Ionis Pharmaceuticals' Tryngolza. These advancements underscore significant progress in targeting specific lipid disorders and the promise of novel therapies to improve cardiovascular health. Corporate strategies are also evolving as seen with Sanofi undergoing executive restructuring under new leadership by CEO Belen Garijo. This reflects broader industry trends where leadership shifts align corporate strategies with market demands and scientific opportunities. Legal developments have not gone unnoticed either. Amgen's $74 million settlement over allegations of concealing a substantial tax bill highlights ongoing scrutiny over corporate governance within the sector. Meanwhile, industry giants are rallying around regulatory defenses, as evidenced by biopharma companies supporting the FDA amidst legal challenges concerning mifepristone—a move emphasizing the industry's vested interest in maintaining access to drugs based on scientific merit. From a technological perspective, companies are increasingly adopting connected trial technologies to streamline processes such as consent and reporting—advancements crucial for reducing patient burden and accelerating drug development timelines. In conclusion, these developments portray an industry at the forefront of scientific innovation while navigating complex regulatory environments and ethical considerations. As firms continue exploring novel treatment avenues and leveraging technological advancements like AI, they position themselves for transformative impacts on patient care and global health outcomes. We look forward to keeping you updated on these exciting trends shaping the future of pharma and biotech industries.Support the show

Co-hosts Ryan Piansky, a patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Science Advisory Council, interview Dr. Claire Beveridge about EoE and dysphagia. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, research on eosinophilic esophagitis (EoE) and dysphagia.   [1:24] Holly introduces and welcomes today's guest, Dr. Claire Beveridge, a gastroenterologist at the Cleveland Clinic. Dr. Beveridge heads the EoE Adult Clinic and the Transition from Pediatric to Adult EoE Clinic.   [1:36] Holly, a speech pathologist, says she is very excited to dive into the research Dr. Beveridge did with EoE and dysphagia. Holly asks Dr. Beveridge to share some of her background.   [1:48] Dr. Beveridge was recruited to the Cleveland Clinic about five years ago to head the EoE Center. She loves the work they have done there.   [1:57] Dr. Beveridge says it's been nice to center everything on their EoE patients and have multidisciplinary care with speech-language pathologists, allergists, dietitians, pulmonologists, and more. It's been a great experience.   [2:15] Dr. Beveridge says the other thing they are really proud of is having a Transition Clinic. It can be tough for patients to transition from pediatric to adult care.   [2:23] Dr. Beveridge says this is something she was inspired to do when she was finishing her training at the University of Pennsylvania, where they had been doing some of that. It was really important to her when she joined Cleveland Clinic.   [2:34] Dr. Beveridge, with her Co-director, Dr. Sophia Patel, helps patients transition from pediatric to adult care.   [2:41] Holly speaks of the challenge of transitioning from pediatric care at a multidisciplinary clinic to adult care.   [3:08] Dr. Beveridge says you can't do any training at Northwestern without loving the esophagus. She did her residency there, got exposed to esophagology, and got to know Dr. Gonsalves and Dr. Hirano really well.   [3:33] Drs. Gonsalves and Hirano are really big names in EoE. Dr. Beveridge was fascinated by the disease. She loved the patients and wanted to help them and make them feel better. It's a burgeoning field.   [3:48] Dr. Beveridge says that it's only in the last few years that we have had FDA-approved medications for it, and that we have been jerry-rigging asthma medications to treat our patients.   [4:03] Dr. Beveridge says it's really exciting to see the treatment options we can offer.   [4:10] Ryan says it's exciting to see how EoE management has changed.   [4:16] Ryan says we see so many patients who are untreated or poorly treated for years, who have restructuring of their esophagus and present with dysphagia, or have strictures and rings leading to food impactions; the long-term effects of untreated EoE.   [4:34] Ryan says it's exciting that now we do have better treatment options for people, right off the bat.   [4:43] Dr. Beveridge conducted some research on EoE and dysphagia and presented a poster at the 2024 Digestive Diseases Week.   [4:51] The poster was titled, "Esophageal Luminal Diameter is Associated with Dysphagia and Eosinophilic Esophagitis: Implications for Endoscopic Dilation Therapy."   [5:11] Dr. Beveridge says dysphagia means issues with swallowing. It's a feeling of something getting stuck or something slowly moving down. There are also subtle symptoms that can happen.   [5:31] Dr. Beveridge says patients who have had EoE for a long time become accustomed to how they swallow. Things a patient may think are normal, like needing water and taking a sip after each bite, are learned accommodating behaviors.   [5:58] Dr. Beveridge says accommodating behaviors are that you're needing to imbibe extra water, you're modifying how you're eating, extra chewing, avoiding pills, avoiding other certain foods, and things like that that can be modifying factors.   [6:19] So, difficulty with swallowing, things getting stuck, slowly moving down, but also keeping in mind some of those modifying behaviors that we may end up using.   [7:23] Dr. Beveridge says her motivation was seeing patients in her clinic who were having persistent symptoms, and getting them into histological remission. The goal of treating your EoE is to get the eosinophils less than 15; close to zero is great.   [7:45] Dr. Beveridge says we have patients who, despite doing their endoscopies and taking biopsies, things look fine; they're still having issues with swallowing. Why is that the case?   [7:58] Dr. Beveridge says in a different research paper she had done, looking at some of the predictors for that, one of them was fibrostenosis. There are also other things that can contribute, like esophageal hypervigilance and a fear of swallowing.   [8:21] If a patient has had a food impaction, it's going to be scary to try to swallow again. Some of it is behavioral, but some of it is structural. At what luminal diameter (the size of the esophagus) is that causing a clinical problem for patients?   [8:45] A normal esophagus is 20 to 24 mm in diameter. Traditionally, around 14 to 16 mm in diameter has been when we say that patients get symptoms or they're feeling the issues with swallowing.   [9:03] Dr. Beveridge says a lot of those studies have never been done specifically for EoE patients.   [9:08] Dr. Beveridge wanted to know, if we exclude cancer, if we exclude acid reflux, and all of these other things, and just look at our EoE patients, what size of the esophagus are we looking at?   [9:20] Dr. Beveridge explained they specifically looked at patients whose histology was under control and then compared those who continued to experience symptoms with those who did not. The goal was to determine the histologic threshold at which patients begin to experience dysphagia.    [9:54] Dr. Beveridge says they saw this threshold at 16 mm (1.6 cm). That's still quite the difference from a normal esophagus of 20 to 24.   [10:08] Dr. Beveridge says our esophagus can definitely handle being smaller, but then, once you get to that 16 mm, for a lot of patients, it really does cause that feeling of things getting stuck or slowly moving down.   [10:20] Holly says what's cool about the retrospective data Dr. Beveridge looked at, and the parameters she placed in the research, is that when a patient goes in for an endoscopy, the doctor can measure and say maybe this is why dysphagia is going on.   [10:48] Holly finds that adult patients with food impactions are scared to eat the same food again. She loves having this data to share with patients and say, let's look at what your esophagus measures at. Let's do a smaller bite. Let's add a dip and liquid.   [11:12] Holly says data can push so much progress. Holly, having multiple chronic illnesses, loves when doctors can say, this is going to be safe. This is the mode that we're going to go with.   [11:30] Dr. Beveridge says in the retrospective study, they were looking at stuff that had already been done. We decided from here to assess patients more prospectively. All of this was based on chart review from when the note said symptoms or no symptoms.   [11:53] Dr. Beveridge says when she started this EoE clinic at the Cleveland Clinic, part of it was to standardize better how we were collecting data from patients to understand their symptoms.   [12:07] Dr. Beveridge has a standardized questionnaire for patients to understand if they are having heartburn and difficulty with swallowing, so she can know that at each point of their endoscopy.   [12:18] Dr. Beveridge says it will be nice, hopefully in the future, when she can give a little more detail and depth in terms of assessing this more prospectively and seeing if that same number holds up or if she needs to tweak it a little bit.   [12:34] Holly thinks it's fascinating. Numbers give us so much information, to know if my mm is this versus this, the next time, or during allergy season or not.   [12:53] Ryan says it's cool that you're able to look back at existing patient records and identify this information. Now we have that 16 mm number in mind to say maybe this is where we'll start to see increased risk of dysphagia in these patients.   [13:28] Dr. Beveridge says, how we had to do it retrospectively was based on the endoscopist estimating what the size is. Gastroenterologists recognize they're not always the best at estimating the size of the esophagus.   [13:50] Dr. Beveridge says, if your endoscope could not pass through, or it was snugly passing through, you know the diameter of the endoscope. If a dilation was done, at what size dilation do we start to see a disruption?   [14:19] Dr. Beveridge says, the goal of a dilation is to get a disruption because there's scar tissue we want to break open. A patient might think disruption means a perforation or something more scary, but that is the goal. We want to break open that scar tissue.   [14:42] Dr. Beveridge says, once we see that scar tissue break open a little bit, then we can estimate what the diameter is, based on the size dilator we used.   [15:10] Dr. Beveridge says for adults, we use a standard adult upper endoscope, and that's about 13 mm. The ones we use for kids are about 6 mm.   [15:35] Dr. Beveridge says the adult endoscope is around 13 mm, and it's around 14 to 16 mm when we start to see the symptoms.   [16:07] Dr. Beveridge says there are two main types of dilation that we do. One is the Savary dilator or wire-guided dilator, a long dilator that stretches the entire esophagus, from the mouth down to the stomach.   [17:20] Dr. Beveridge says another way of doing it is while you have the endoscope in, you thread a catheter. At the end of the endoscope, there's a balloon. You fill the balloon with saline up to different sizes. Typically, they go up by 3 mm, so 12 to 15 mm.   [18:01] Dr. Beveridge says the catheter balloon dilator is good for discrete strictures because the balloon isn't going to do the entire esophagus; it's just going to do one area of the esophagus, and you're watching it the whole time.   [18:19] For the wire dilator, you remove the scope. You're not able to see, so it's important to assess ahead of time how narrow things are, so you start at a safe dilation. You go in each time to see if there's starting to be disruption, and then you can do more.   [18:44] Holly asks if a gastroenterologist doing an upper endoscopy with sedation sees that it's tight, would the gastroenterologist automatically do a dilation? Or, can a patient with dysphagia symptoms request to have a dilation?   [19:28] Dr. Beveridge says, right before an endoscopy, she discusses it with the patient and gets consent. She asks, even if their symptoms are good, but in the endoscopy she sees a narrowing where she would recommend a dilation, if they're OK with that.   [20:05] Dr. Beveridge says, if they're having issues with swallowing, often she will ask if they're OK with her doing a dilation. If she sees a narrowing, she can focus on that area and dilate it.   [20:19] Dr. Beveridge says not everywhere in the esophagus can we see as well. The very beginning of the esophagus is challenging to see and challenging to evaluate on imaging.   [20:32] Dr. Beveridge talks about empiric dilation. You don't see a narrowing, but you want to rule it out, so you do a dilation at a safe size, like 16 or 18 mm, to make sure you're not missing something up high.   [20:58] Dr. Beveridge says she always talks about that with her patients. Most say, go ahead. Some patients definitely want dilation; other patients say no, they really don't.   [21:12] Dr. Beveridge then asks the patient if there's real narrowing that may cause a food impaction, would they want dilation then, or hold off for another day?   [21:30] Dr. Beveridge never wants to do something the patient is not comfortable with. She also doesn't want them to need another endoscopy unnecessarily, if she can avoid that for them in the moment.   [21:46] Dr. Beveridge mentions the BougieCap used in Europe. It's a cap you put at the end of the endoscope. You use your endoscope as the dilator. You watch the whole time. It is hard plastic that causes a nice dilation. We may see it come to the U.S.   [22:37] Dr. Beveridge speaks of the FLIP catheter, which is a catheter with a balloon that doesn't cause dilation but distends and helps measure the diameter.   [23:33] Holly asks if Dr. Beveridge gives tips to patients on how to prepare for dilation and the recovery process.   [23:49] Dr. Beveridge had an upper endoscopy. She says there's nothing like experience to understand it better. She didn't have a dilation, but the biopsies caused discomfort.    [24:21] Dr. Beveridge says a lot of her patients have been through upper endoscopies, so they know how it feels. She warns them that the biopsies and dilation can cause discomfort.   [24:33] What's challenging is that everyone is different. Some patients are going to be more hypersensitive to it, and other patients are going to say they felt nothing and they were fine.   [24:46] Dr. Beveridge says some patients need to modify their diet for a few days to avoid significant chest pain. You never want someone to have to go to the ER for significant chest pain when it will just heal over time, and there's no perforation.   [25:12] Dr. Beveridge says other patients will be like her, eating chips and pretzels and saying they're fine. Dr. Beveridge typically has them start with liquids, nothing too hot or too cold, and advance as tolerated.   [25:28] Dr. Beveridge says patients can always use TylenolⓇ and over-the-counter numbing agents. You'll still have patients who will get significant discomfort. For the most part, starting with liquids has worked for Dr. Beveridge's patients.   [25:44] Holly recommends over-the-counter when her patients call, after she talks to their GI. Holly says after she has an endoscopy, she starts on liquids and shakes. On day three, she's fine. Holly says individualized care is amazing. We all are different.   [26:14] In the pediatric setting, the parents get the counseling, and they have not had sedation, but on the adult side, you're talking with the patient, who had sedation. Sometimes they don't remember.   [26:40] Dr. Beveridge says when possible, she waits for family members to come back and tells them they're going to have to "be the memory" because the patient probably won't remember this conversation.   [26:55] If a patient says no, they don't want them to come back and hear about it, always respect that. But Dr. Beveridge always tells them, you may not remember what we say.   [27:30] Ryan asks about data on how many times someone may need dilations. Dr. Beveridge says it comes down to the patient, but the biggest issue can be uncontrolled inflammation.   [27:44] Dr. Beveridge says if a patient's EoE is not controlled, inflammation leads to continued scarring down. That's why we talk about dilation as being an adjunctive measure, but not a treatment for EoE. It doesn't do anything for the inflammation.   [28:03] Dr. Beveridge says she has patients who ask why she can't just do a dilation every now and then. Dr. Beveridge considers dilation to be safe when needed, but if you can avoid it, that would be nicer for everyone.   [28:21] Dr. Beveridge says there's no great data on whether you only need one, or whether you're going to need 10, but one big theme is just: have we gotten your inflammation under control? That's also true for other conditions, such as acid reflux.   [28:45] Holly wasn't diagnosed until she was in her mid-twenties, and she had several upper endoscopies as a teenager and college student to dilate her, to help the situation.   [29:17] Holly says she had to get more endoscopies to figure out her weird food triggers that are not typical for everybody, so even if she's treated, she still has inflammation. That's why she had so many upper endoscopies.   [29:30] Ryan talks about underlying issues causing inflammation. Dilation is not treating those underlying causes. It's just helping with one symptom of this dysphagia, by expanding the esophagus.   [29:50] Ryan asks, What changes in symptoms should patients expect after the dilation? Dr. Beveridge says, ideally, if there's been a stricture, you're going to start to feel like your swallowing is better. You can get pills and food down better.   [30:07] Dr. Beveridge says, immediately post-dilation, sometimes people feel a little bit worse. Everything you swallow may be uncomfortable for you. But if it's been a successful dilation, hopefully, you're going to feel that things are going down better.   [30:40] Holly says she is so grateful that Dr. Beveridge looked into this, and hopefully, there will be a new protocol in the future. Holly asks what other key takeaways from this research may interest Dr. Beveridge in researching something further.   [31:02] Dr. Beveridge says, making sure that we're not missing scar tissue is big and important. One thing that we're trying to look at with our Pediatric GI colleagues is what threshold we should be looking at for the pediatric patient population.   [31:19] Dr. Beveridge says a pediatric patient's esophagus is a different size than an adult patient's. Understandably, we are more cautious when doing a dilation in the pediatric patient population than we are with adults.   [31:34] Dr. Beveridge may recommend empiric dilation for an adult but will feel more cautious about that with pediatric patients than with adult patients. Understanding what that threshold should be for the pediatrics is going to be really interesting.   [31:57] Dr. Beveridge says the diameter threshold we discussed is going to be important to know about, but everyone is different. You may have a diameter of 14 mm, you feel fine, and you don't want a dilation; you can accommodate OK. That's reasonable.   [32:15] Dr. Beveridge says she has had patients who get up to 18 mm, and that helps them, but they need a little bit more. If someone needs more of a dilation, we do that. Yes, have a threshold to assess, but always assess for what's personal for your patient.   [33:04] Dr. Beveridge says not just to assess the luminal diameter, but a thing that is helpful for gastroenterologists to know will be if there are other factors at play. As in her study of dysphagia predictors, anxiety, depression, and hypervigilance can play roles.   [33:37] Dr. Beveridge has patients who have to have a critical narrowing for them to finally feel an issue. Other patients, if they have the slightest of narrowing, are feeling something. Some patients are just more vigilant of what's happening in their esophagus.   [34:07] Dr. Beveridge says there's definitely a role for asking if your anxiety is under control. If there's feedback in the nerves, should we ask your GI Psychologist to be involved in terms of CBT for your esophagus? Take a look at everything.   [34:27] Dr. Beveridge says another part of the study they looked at was: are there different thresholds of eosinophils that we should be looking at? Is it just less than 15, or do some patients need it to be lower? Less than six? Less than 10?   [34:43] Dr. Beveridge says look at it as a whole for your patient.   [34:53] Dr. Beveridge says next, she will be working on a very long-term project: Can we identify a non-invasive method of screening a patient, diagnosing a patient for EoE, or monitoring a response to therapy?   [35:13] Dr. Beveridge has looked at transnasal endoscopy, which is put into this category of minimally invasive. It's still invasive; you're putting a scope through someone's nose, but it doesn't require sedation, which is a nice thing for some patients.   [35:29] There's the EnteroTrack, which started in Colorado. A patient swallows a string, and it stays in their esophagus for an hour, and we look at the proteins to see if things are active or not active.   [35:45] Dr. Beveridge is also looking at the breath metabolome. If we breathe into a bag and take a look at all the volatile organic compounds that are in our breath, can we find a signature related to EoE?   [36:01] It's assessing about 100 different compounds, not looking at one in particular, but how the whole thing looks. What signature is there, based on looking at all the compounds?   [36:15] Dr. Beveridge presented some of that data at DDW and has a grant from the ACG to look at this and assess patients with and without EoE.   [36:33] Dr. Beveridge says further, doing longitudinal data of looking at patients once they've gotten into remission on treatment and seeing, do we then see a signature change?   [36:47] Dr. Beveridge says no one is under any illusion that endoscopies are going away. They will always be part of what we do in gastroenterology, but there are limitations: sedation, a full day away from work, nothing by mouth, and a driver, etc.   [37:04] If there are alternatives to help supplement that, it would be nice. One of the barriers for patients doing diet elimination is the number of endoscopies that are required. If there's a way to assess by breath if a food is a trigger, that would be good.   [37:32] Dr. Beveridge says that's the big thing she's looking at, but it will take years. It's not going to be a quick, easy one, but it's very interesting to take a look at.   [37:45] Holly speaks of how much treatment has changed since she was diagnosed. She has done all the scopes. She says this sounds amazing. She loves that people like Dr. Beveridge are thinking of how to make testing less invasive and more comfortable.   [38:12] Dr. Beveridge says another thing she is excited about is the transition of care. She recently did a survey and is analyzing the data to assess what the barrier is from the physician perspective in terms of helping our patients transition.   [38:40] Dr. Beveridge is also looking at doing a nice multi-center consensus to help this as well, led by Dr. Sophia Patel and Dr. Emily McGowan, who are fantastic in the EoE world, looking to see how we can make this better for our patients.   [38:58] Ryan says, with so much interesting work coming up, we'll have to have you back to chat about some of these additional projects. Everyone is super interested in less invasive stuff and better treatment pathways. Transition of care is an important part of that.   [39:11] Ryan appreciates Dr. Beveridge for joining the conversation and hopes to have her back on another episode so we can learn more about EoE and these different future research endeavors.   [39:20] For our listeners who would like to learn more about EoE today, you can visit apfed.org/EoE and check out the links in the show notes below. [39:27] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder, available at apfed.org/specialist.   [39:36] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [39:46] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experience, please check out apfed.org/shareyourstory.   [39:55] Ryan thanks Dr. Beveridge for joining us. This was a fun conversation and really insightful. Holly thanks APFED's Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.orgapfed.org/specialist apfed.org/connections Claire Beveridge, MD Cleveland Clinic Education Partners: This episode of APFED's podcast is brought to you thanks to the support of AstraZeneca, GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I have loved the work that we've done [at the Cleveland Clinic]. It's been really nice to center everything on our EoE patients and have nice multidisciplinary care with speech-language pathologists, allergists, dietitians, pulmonologists, and everyone." — Claire Beveridge, MD   "It's a little crazy to think that it's only in the last few years that we have had FDA-approved medications for [EoE], and that we have been jerry-rigging asthma medications to treat our patients." — Claire Beveridge, MD   "On the whole, dysphagia means issues with swallowing. … It's a feeling of something getting stuck or something slowly moving down. There are also subtle symptoms that can happen." — Claire Beveridge, MD   "The goal of a dilation is to get a disruption because there's scar tissue we want to break open." — Claire Beveridge, MD   "I am looking at the breath metabolome. If we breathe into a bag and take a look at all the volatile organic compounds that are in our breath, can we find a signature related to EoE?" — Claire Beveridge, MD   Guest Bio: Claire Beveridge, MD, is a Staff Member in the Department of Gastroenterology and Hepatology and heads the Eosinophilic Esophagitis (EoE) adult clinic as well as the transition pediatric to adult EoE clinic. Dr. Beveridge's specialty interests include: EoE, Achalasia, Barrett's esophagus, GERD, esophageal swallowing disorders, and esophageal motility disorders.

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 industry-shaping events, reflecting the ever-evolving landscape of drug development, regulatory challenges, and strategic maneuvers. In a significant move within the sector, Jasper Therapeutics has merged with Kira Pharmaceuticals, a strategic decision aimed at expanding its footprint in autoimmune therapeutics. This merger brings to Jasper a valuable asset in KP-104, a dual-inhibitor with the potential to address rare diseases—an area of considerable unmet need. Such consolidations highlight an industry trend where companies seek to bolster their portfolios with promising candidates that can tackle complex medical conditions. The merger exemplifies how strategic expansions are becoming increasingly integral to maintaining competitive edges in the biotech arena. Turning to clinical trials, Takeda's Zasocitinib has demonstrated promising results for patients suffering from moderate-to-severe plaque psoriasis. In Phase 3 trials, a significant 75% of patients achieved clearance of scalp psoriasis. Zasocitinib operates as a TYK2 inhibitor, targeting the IL-23 pathway—a crucial mechanism in autoimmune diseases like psoriasis. This breakthrough promises to enhance patient care by providing a more effective treatment option for those struggling with difficult-to-treat psoriasis. On the regulatory front, Novartis' Fabhalta (Iptacopan) has gained FDA approval for its role in slowing kidney function decline in patients with primary immunoglobulin A nephropathy. As a small molecule complement inhibitor, Iptacopan introduces a novel treatment class for this autoimmune kidney disorder. This approval underscores ongoing innovation within nephrology and offers renewed hope for improved patient outcomes. Recent regulatory updates also saw Novartis securing full FDA approval for Fabhalta—an affirmation of progress in addressing immunoglobulin A nephropathy through innovative therapeutic options. Business development remains a driving force in shaping industry landscapes. The acquisition of Mission Therapeutics' AKI candidate MTX652 by Dimerix is a prime example. This $5 million deal, with potential milestones up to $292 million, reflects high stakes and ambitions to advance treatments for acute kidney injuries—a field with significant unmet medical needs. The integration of artificial intelligence continues to revolutionize drug discovery processes. Aqemia's collaboration with Sanofi highlights this trend, showcasing AI's crucial role in expediting drug development and uncovering novel therapeutic targets. Their partnership potentially worth $140 million underscores AI's transformative potential within pharmaceutical research. Notably, Nobel laureate Jennifer Doudna's foray into AI-powered protein design signifies an exciting intersection between gene-editing technology and artificial intelligence. Her involvement signals potential revolutions in drug discovery through enhanced precision in protein engineering. However, regulatory challenges persistently loom over the industry. Novo Nordisk and Alvotech have faced FDA scrutiny concerning manufacturing deficiencies—an issue that accentuates the importance of stringent quality control and operational excellence in biologics manufacturing. The American Society of Health-System Pharmacists (ASHP) report on U.S. drug shortages during Q2 2026 reveals vulnerabilities within supply chains, notably impacting oncology drugs. These shortages emphasize the critical need for robust strategies to ensure consistent drug availability for essential therapies. Furthermore, geopolitical dynamics are influencing pharmaceutical supply chains. A U.S. Senate bill aimed at increasing transparency highlights concerns over China's dominance in drug ingredient supplies—an issue necessitating strategic adjustments by globally operating companies. Elsewhere within the sector, GSK made headlines by discontinuing the development of its chronic cough treatment camlipixant following mixed Phase 3 trial results—a setback illustrating the critical nature of trial outcomes in determining drug viability and market potential. In market trends, biotech IPOs have surged during the first half of 2026—a sign of robust investor interest fueled by innovations and favorable funding environments despite associated market volatility risks. Strategic adjustments continue across companies with mergers and acquisitions leading to workforce reductions—projected layoffs exceeding 14,000 within biopharma during H1 2026—as organizations streamline operations or pivot towards more promising research domains. Lastly, Merck's FDA approval for an oral PCSK9 inhibitor marks a significant achievement in cardiovascular care—representing another stride forward in therapeutic innovation. In summary, these developments encapsulate a landscape defined by scientific pursuits yielding mixed results amidst evolving regulatory interactions and strategic realignments—all contributing towards innovative healthcare solutions while navigating complex industry dynamics.Support the show

Agentic AI is only as useful as the data it can access, and getting that foundation right is proving to be the harder half of the work. Years of mergers, acquisitions, and local decision-making have left many talent operations running on data and processes that were never meant to work together, and no amount of AI on top will fix what lies beneath. Some organizations are now rethinking their technology strategy in light of that problem. So what does getting AI-ready actually involve, and what does it change about the decisions you make? My guest this week is Lia Manafova, Talent Technology Strategy Lead at Sanofi, a global pharmaceutical company hiring at scale across more than 70 countries. In our conversation, Lia explains why the data foundation must come first, what an anchor product strategy looks like in practice, and what she has learned about making technology stick. In the interview, we discuss: Why AI readiness starts with data, not AI Building a bridge between the business and the digital team The challenge of constant transformation and change fatigue What is an anchor product strategy? How the Workday, Paradox and HiredScore acquisitions changed the options Best-of-breed or a single source of truth? Keeping recruiters in one system rather than three Piloting with the people who will use it every day The case for keeping the semi-automated option Building an ROI story the business understands What does the future look like?

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The industry continues to forge ahead, making significant strides in scientific advancements, regulatory approvals, and strategic business developments. These moves are reshaping the landscape of drug development and patient care. Starting with Merck & Co.'s recent FDA approval for Lipfendra, the world's first oral PCSK9 inhibitor, this marks a pivotal shift in managing hypercholesterolemia. Traditionally, PCSK9 inhibitors have been administered via injection, but Lipfendra offers a more convenient oral alternative. This could significantly improve patient adherence and outcomes by easing the administration process for those managing cholesterol levels. The drug's approval highlights a crucial advancement in cardiovascular treatment, with expectations of reaching peak annual sales of $5 billion, underscoring its market potential. In another significant development, Eli Lilly has entered the burgeoning field of psychedelic therapeutics with its acquisition of Ataibeckley for up to $3.8 billion. This move reflects a growing trend toward exploring novel therapeutic avenues for psychiatric disorders. Psychedelic compounds promise new hope for patients with depression and other mental health conditions where conventional therapies have shown limited efficacy. Eli Lilly's investment signals confidence in the transformative potential of psychedelics, which could revolutionize treatment paradigms for conditions like depression and PTSD. Turning to obesity treatment, Novo Nordisk's Wegovy pill has received European Commission approval for obesity and overweight adults. As a small molecule GLP-1 receptor agonist, semaglutide enhances satiety and reduces caloric intake. This development underscores the increasing focus on metabolic disorders and highlights the competitive landscape as companies race to dominate the weight management sector with innovative oral formulations. In oncology news, Merck & Co.'s Keytruda has achieved a milestone in becoming the first PD-1 inhibitor to demonstrate phase 3 benefits as a single agent in frontline mismatch repair-deficient endometrial cancer. This success not only reinforces Keytruda's role in oncology but also emphasizes the importance of precision medicine approaches targeting specific genetic mutations in cancer therapy. The industry is also seeing substantial financial maneuvers aimed at bolstering research capabilities and market reach. Johnson & Johnson has raised its 2026 financial guidance following Tremfya's impressive $2 billion revenue milestone with its IL-23 inhibitor for autoimmune diseases. Additionally, their strategic supply chain restructuring reflects efforts to enhance operational efficiency amid a broader U.S. manufacturing push. On the regulatory front, Johnson & Johnson received UK MHRA approval for Akeega in BRCA1/2-mutated metastatic prostate cancer, highlighting ongoing focus on precision medicine and targeted therapies in oncology. Meanwhile, Medtronic's recall of Harmony Catheter Delivery Systems due to safety concerns serves as a reminder of ongoing vigilance in medical device safety regulations. In clinical trial advancements, InnoCare Pharma's TYK2 inhibitor demonstrated efficacy in a Phase 2 trial for nonsegmental vitiligo, achieving its primary endpoint and paving the way for Phase 3 studies. This highlights TYK2 inhibition as a promising strategy for autoimmune diseases like vitiligo. Moreover, we witness movements towards public offerings with companies like Vogenx and Braveheart Bio aiming for IPOs to fund their respective drug development projects. These efforts underscore the continuous drive for capital to propel innovative therapies through clinical trials and towards commercialization. Finally, turning to regulatory updates, Sanofi has entered new chapters in mRNA patent litigation against Pfizer and Moderna, reflecting ongoing tensions over intellectual property rights within the high-stakes realm of COVID-19 vaccines and mRNA technology. The outcomes here could have far-reaching implications for mRNA-based therapeutics and vaccine development. As we look at these developments collectively, they illustrate a vibrant period for pharmaceutical and biotech companies innovating new treatments while navigating complex regulatory terrains. The implications for patient care are profound, with potential improvements in therapeutic options driven by new scientific breakthroughs and strategic industry shifts. These dynamics promise to reshape the future landscape of global healthcare delivery and pharmaceutical innovation as these trends continue to unfold.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore the latest advancements shaping the future of drug discovery and patient care. Veradermics is making significant strides with its oral minoxidil formulation aimed at addressing female pattern hair loss. The mid-stage clinical trial results have analysts optimistic about Veradermics' potential to capture a significant portion of this underserved market. The oral form of minoxidil, traditionally used in topical Rogaine products, offers a novel delivery method that could enhance patient adherence and improve outcomes, marking an innovative leap in dermatological treatments. Johnson & Johnson is navigating the expiration of Stelara's patent protection with resilience, as Tremfya steps up to fill the revenue gap. With quarterly sales exceeding $2 billion, Tremfya underscores the critical role of strategic lifecycle management and robust product pipelines in weathering patent cliffs. This success highlights the necessity for pharmaceutical companies to sustain growth through a well-rounded portfolio that can absorb such impacts. In oncology, Celcuity has achieved a pivotal milestone with FDA approval for its small molecule inhibitor targeting breast cancer. This therapy promises blockbuster potential and could become a new standard-of-care, expanding treatment options for patients. The approval reflects ongoing innovation in oncology, where small molecules continue to play an essential role alongside biologics in advancing cancer therapies. AI-driven drug discovery is gaining traction as Insilico Medicine partners with CDMO Bora in a potentially $2.5 billion deal. This collaboration underscores AI's transformative potential in accelerating drug discovery and development processes. By leveraging artificial intelligence, Insilico aims to identify new drug candidates more efficiently, expediting their journey from bench to bedside. Kelun-Biotech is marking significant progress with its SAC-TMT program targeting non-small cell lung cancer (NSCLC), filling gaps left by Merck's phase 3 efforts. This development is crucial for providing more tailored therapeutic options in oncology, illustrating how advancements in drug development are driving forward personalized medicine. Roche continues its exploration of Alzheimer's disease treatments with a multifaceted approach that includes both amyloid and tau proteins as targets. While its phase 3 amyloid program is prominent, Roche's interest in tau protein highlights the complexity of tackling neurological disorders and the need for diverse therapeutic strategies. Meanwhile, Biogen remains steadfast in defending its anti-tau Alzheimer's candidate following mixed phase 2 results that showed slowed cognitive decline. Despite stock volatility, this endeavor illustrates the high-stakes nature of Alzheimer's research as companies pursue novel approaches to this challenging disease. Regulatory landscapes are also shifting as Johnson & Johnson halts development of an eye disease gene therapy after disappointing phase 2b results. This move reflects the inherent risks involved in gene therapy and underscores the necessity for thorough evaluation at each clinical stage. Medtronic's recall of its Harmony delivery catheter system due to potential detachment risks serves as a reminder of the paramount importance of safety and quality control in medical device manufacturing. Such recalls impact patient safety and emphasize regulatory vigilance over device reliability. In summary, these innovations demonstrate the dynamic nature of the pharma and biotech industries where cutting-edge science drives progress. Integrating AI into drug discovery, managing product lifecycles post-patent expiry, advancing personalized medicine, and maintaining regulatory diligence collectively shape a landscape focused on improving patient outcomes worldwide. Turning to recent scientific developments: Eli Lilly's presentation at AAIC 2026 on their anti-amyloid Alzheimer's drug Kisunla explores maintenance therapy possibilities once amyloid levels fall below a threshold. This potential shift could signify a paradigm change by extending therapeutic benefits and possibly improving long-term outcomes for patients with Alzheimer's. Biogen's advances with its anti-tau Alzheimer's therapy partnered with Ionis Pharmaceuticals further validate the tau hypothesis. The promising mid-stage data on their antisense drug Diranersen opens opportunities for other companies like Denali Therapeutics to explore similar avenues for treating neurodegenerative diseases. The industry is also witnessing a resurgence in biotech IPOs during 2026's first half, recovering from a sluggish 2025. This surge signals investor confidence in biotechnological innovation while providing capital for advancing research pipelines. Financial activities within the sector are robust as Attovia Therapeutics files for an IPO to fund its competitive pipeline against Sanofi's Dupixent. Meanwhile, Advancell's $315 million Series D funding supports advancing prostate cancer candidates into Phase 3 trials, backed by big pharma confidence in radiotherapy's potential. Lastly, regulatory transparency improves as the FDA resumes releasing drug rejection letters after a temporary pause—a move likely to influence future submissions significantly by offering clearer guidance on regulatory expectations. These developments collectively highlight how scientific innovation and strategic maneuvers transform pharmaceutical landscapes, promising profound impacts on patient care through advanced therapies and novel treatments worldwide. As these trends unfold, they reflect an industry increasingly reliant on technological integration and collaborations to drive future growth and innovation.Support the show

Whether you call it soccer or football, people all around the world love the “beautiful game” – including health brands.  When the 2026 FIFA World Cup kicked off about a month ago across 16 locations in North America, there were 48 teams competing for the gold trophy.  But more importantly for our sake, there were also several major health brands marketing and advertising throughout the five week tournament, including provider organizations and drugmakers.  Bristol Myers Squibb launched its We Won't Lose media campaign in mid-June and has served as an official supporter of New York New Jersey as a host city.  Similarly, its Big Pharma rival Sanofi served as an official supporter of Boston as a host city, while consumer health company Haleon served as the official consumer healthcare product partner of U.S. Soccer. The World Cup has been the main attraction for weeks now, so as it comes to a dramatic close in the coming days, our summer intern Lola Offenback brings us a jumbo World Cup episode with back-to-back interviews.  First up is Opeyemi Oluwole-Sowore, chief marketing officer at Hackensack Meridian Health, who details how the New Jersey-based health system has served as an official supporter of New York New Jersey as a host city. Then, you'll hear from Cologuard's marketing director Tara Cunningham about how the Exact Sciences brand produced its Halftime ad featuring U.S. women's soccer stars Abby Wambach and Julie Foudy. Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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 transformative updates and strategic shifts within the industry, reflecting both remarkable progress and inherent challenges. Sanofi's recent achievement marks a significant milestone in oncology with the FDA approval of Sarclisa Escena (isatuximab) as the first on-body injector for multiple myeloma treatment. This monoclonal antibody, targeting CD38, offers a novel subcutaneous delivery method, simplifying administration and potentially enhancing patient compliance by reducing the need for frequent clinic visits. This aligns with the industry's ongoing shift towards patient-friendly drug delivery systems, emphasizing convenience without compromising efficacy. In another promising development, GSK and Hansoh Pharmaceutical have reported positive results from their Phase 3 trial evaluating risvutatug rezetecan for small cell lung cancer. This antibody-drug conjugate, targeting B7-H3, has shown potential when combined with chemotherapy to extend patient survival. Given the aggressive nature of small cell lung cancer and limited treatment options, these findings underscore the potential of targeted therapies to improve clinical outcomes significantly. Forte Biosciences' FB102 also takes a spotlight in clinical advancements. In its Phase 1b trial for vitiligo, FB102 demonstrated a 45.8% placebo-adjusted benefit. This monoclonal antibody works by modulating immune responses through the IL-15 pathway via CD122, offering new hope for patients with this challenging autoimmune condition. On the regulatory front, ARPA-H's commitment of up to $160 million towards developing personalized genetic medicines for rare diseases is noteworthy. This investment is set to accelerate innovations in gene therapy and personalized medicine platforms. Such advancements promise to revolutionize pediatric care and extend beyond by tailoring treatments to individual genetic profiles, enhancing efficacy while minimizing adverse effects. Strategic collaborations continue to reshape the industry landscape. Rani Therapeutics' partnership with PegBio aims at advancing oral delivery systems for obesity and metabolic diseases. Similarly, Simcere Pharmaceutical's collaboration with Schrödinger leverages AI-driven drug discovery efforts. These alliances highlight an increased reliance on computational platforms to streamline therapeutic development processes. From a financial perspective, Mesoblast Limited reports substantial revenue from its cell therapy product Ryoncil, signaling strong commercial viability for cell-based treatments targeting rare diseases. Additionally, Cue Biopharma's successful $50 million fundraising underscores investor confidence in advancing therapies for immunological disorders. However, not all news is positive. Roche has decided to halt two programs targeting Huntington's disease due to inadequate efficacy and safety concerns. This decision reflects the complexities involved in developing effective treatments for neurological disorders—a field fraught with scientific challenges yet rich with potential rewards. In market dynamics, McKinsey's report advocates for a structural redesign of biopharmaceutical R&D to fully leverage AI's capabilities. This recommendation resonates with current industry trends focusing on strategic innovation to maximize efficiency and discovery potential. The FDA's third rejection of Hengrui Pharma and Elevar Therapeutics' combination therapy for liver cancer underscores the rigorous scrutiny such treatments face despite their promise in addressing complex cancers. In contrast, BioNTech's preparation to launch its HER2 antibody-drug conjugate (ADC) signifies its strategic pivot back towards oncology after mRNA vaccine successes. Bayer's decision to sell a minority stake in its contraceptives business demonstrates how companies are strategically realigning portfolios to focus on core areas while securing funding for innovation. This move reflects broader trends within pharma as companies navigate financial landscapes to support long-term research goals. Amid these developments, regulatory environments continue evolving. NICE's stance against future Lumakras reimbursement in the UK highlights ongoing challenges in balancing cost-effectiveness with access to innovative therapies. Meanwhile, ARPA-H's significant funding allocation signals robust governmental support for advancing precision medicine within genetic therapies. In conclusion, today's updates reveal an industry characterized by a relentless pursuit of innovation amidst complex regulatory landscapes. As companies navigate these dynamics through strategic collaborations and scientific breakthroughs, their efforts hold promise for enhancing patient care across diverse therapeutic areas globally. Stay tuned as we continue to track these exciting developments shaping the future of pharmaceuticals and biotechnology. Thank you for tuning into Pharma Daily—your go-to source for up-to-date insights from the world of pharmaceuticals and biotechnology.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements and challenges shaping the landscape of these dynamic sectors. Starting with Ipsen's Dysport, which has made notable strides in its Phase 3 trials for migraine prevention. The trials covered both episodic and chronic conditions, marking a first in the neurotoxin market. Dysport's success positions it as a formidable competitor to AbbVie's Botox, expanding therapeutic options for individuals battling migraine disorders. This achievement showcases the potential efficacy of botulinum toxin-based therapies in neurology and pain management, offering promising new avenues for patient care. In regulatory news, Boehringer Ingelheim has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for Jascayd, a small molecule PDE4B inhibitor with antifibrotic properties. This approval marks a significant milestone in the treatment of idiopathic and progressive pulmonary fibrosis. Jascayd's addition to the therapeutic arsenal offers new hope for managing this debilitating condition, emphasizing the ongoing efforts to improve patient outcomes through innovative treatments. The arena of business development sees HanChorBio partnering with InxMed to advance oncology research. By combining HCB101 with FAK inhibitors and FAP-targeted ADCs, this collaboration aims to leverage antibody and small molecule drug discovery techniques. The goal is to develop innovative cancer treatments that could redefine therapeutic approaches in oncology. Keenova Therapeutics has also reported success with Xiaflex for plantar fibromatosis. This enzyme injection therapy offers a novel approach by targeting collagen, thus providing an innovative solution for musculoskeletal conditions. Similarly, Fate Therapeutics' FT819, an off-the-shelf CAR-T therapy, has shown early promise in tackling treatment-resistant systemic sclerosis, underscoring the potential of cell therapies beyond oncology. Meanwhile, MindRank's successful Series B funding round of $52 million highlights the growing role of AI platforms in drug discovery. The funding will propel its AI-discovered oral GLP-1 obesity pill into Phase III trials, exemplifying how technology-driven solutions are gaining traction in addressing metabolic diseases like obesity. On the regulatory front, Saol Therapeutics has resubmitted SL1009 (DCA) to the FDA for pyruvate dehydrogenase complex deficiency. This submission underscores ongoing efforts to address rare metabolic disorders using small molecule therapies. Additionally, Sanofi's concessions to the EU regarding flu vaccine marketing illustrate the complexities of competitive dynamics and regulatory scrutiny within the vaccine market. However, not all developments are favorable. AstraZeneca and Ionis Pharmaceuticals faced a setback as their drug Wainua failed its Phase 3 trial for transthyretin-mediated amyloid cardiomyopathy. This outcome highlights the challenges inherent in developing effective treatments for complex cardiovascular conditions. Meanwhile, regulatory processes remain contentious as the FDA pauses its release of complete response letters amid debates over proprietary information disclosures. In another noteworthy development, GSK has terminated its $2.2 billion collaboration with Alector after underwhelming results from Alzheimer's drug trials. This decision highlights both financial implications and strategic shifts as companies reassess risk tolerance in neurodegenerative disease research. Conversely, Roche's success with its KRAS G12C inhibitor divarasib in Phase 3 lung cancer trials underscores the promise of precision medicine. Divarasib outperformed competitors Amgen's Lumakras and Bristol Myers Squibb's Krazati, positioning Roche to potentially redefine standards of care based on genetic profiles. In a move reflecting industry trends towards collaboration and innovation risk-sharing models, AstraZeneca has partnered with Sino Biopharmaceutical on respiratory disease research. This strategic alliance represents a substantial investment aimed at expanding AstraZeneca's pipeline in respiratory therapeutics. Lastly, amidst these developments, psychedelic drugs are experiencing a renaissance in psychiatric care. Companies like Compass Pathways are pioneering clinical validation for their use in treating depression, signaling a potential paradigm shift from traditional SSRIs to newer therapeutic classes pending safety and efficacy data. Overall, these stories illustrate a dynamic interplay of scientific progress and regulatory navigation within the pharmaceutical and biotech sectors. While challenges persist—particularly in neurodegenerative disease treatment—the breakthroughs in oncology and metabolic disorder therapeutics offer hopeful prospects for improving patient care. As these industries continue evolving, integrating advanced technologies such as AI will likely play a pivotal role in shaping future therapeutic landscapes.Support the show

This episode covers: Cardiology This Week: A concise summary of recent studies AI & digital solutions in emergency medicine Management of heart failure in cardiac amyloidosis Spotlight: Orthodexia-Platypnoea Syndrome Host: Emer Joyce Guests: Marianna Fontana, Wolf Hautz, Konstantinos Koskinas Want to watch that episode? Go to: https://esc365.escardio.org/event/2551 Want to watch that extended interview on the management of heart failure in cardiac amyloidosis, go to: https://esc365.escardio.org/event/2551?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, Wolf Hautz 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. Marianna Fontana has declared to have potential conflicts of interest to report: consultancy for Alnylam, Alexion/Caelum Biosciences, Astra Zeneca, Bridgbio/Eidos, Prothena, Attralus, Intellia Therapeutics, Ionis Pharmaceuticals, Cardior, Lexeo Therapeutics, Janssen Pharmaceuticals, Pfizer, Novo Nordisk, Bayer, Mycardium. Research grants from: Alnylam, Bridgbio, Astra Zeneca, Pfizer. Share options in LexeoTherapeutics and shares in Mycardium. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. 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: Emer Joyce Guests: Marianna Fontana Want to watch that extended interview on the management of heart failure in cardiac amyloidosis, go to: https://esc365.escardio.org/event/2551?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/2551   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 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. Marianna Fontana has declared to have potential conflicts of interest to report: consultancy for Alnylam, Alexion/Caelum Biosciences, Astra Zeneca, Bridgbio/Eidos, Prothena, Attralus, Intellia Therapeutics, Ionis Pharmaceuticals, Cardior, Lexeo Therapeutics, Janssen Pharmaceuticals, Pfizer, Novo Nordisk, Bayer, Mycardium. Research grants from: Alnylam, Bridgbio, Astra Zeneca, Pfizer. Share options in LexeoTherapeutics and shares in Mycardium. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. 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 of the Vital Health Podcast, host Duane Schulthess speaks with Michael Penn, US Head of Reimbursement and Public Policy at Sanofi, to discuss how pricing policy, the Inflation Reduction Act (IRA), small-molecule incentives, orphan drug provisions, and Most Favored Nation (MFN) proposals could shape oncology innovation, patient access, and U.S. biopharmaceutical competitiveness. Key Topics: IRA and Oncology: Late-stage research shifts, follow-on studies, lead asset selection. Small-Molecule Incentives: Pill penalty concerns, portfolio reassessment, biologic comparisons. Orphan Drug Policy: Orphan Cures Act provisions, rare disease investment, post-market indication development. Patient Access Risks: Fewer treatment options, affordability questions, unmet needs in oncology. U.S. Competitiveness: MFN proposals, global R&D incentives, comparisons with China and Europe. Our new preprint on the IRA’s impact on late-stage R&D is available on our website and examines declines in small-molecule oncology research and orphan oncology studies. Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 5/31/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.See omnystudio.com/listener for privacy information.

Drs. Donna Culton and Russell Hall explore the Burden of Disease and Diagnosis of BP.Dermalorian™ special edition sponsored by Sanofi and Regneron.Like what you're hearing? Want to learn more about the Dermatology Education Foundation? Explore assets and resources on our website.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The first quarter of 2026 has brought a wave of significant changes and advancements in the industry, marked by crucial regulatory updates, strategic acquisitions, and shifts in the competitive landscape. A pressing issue for many companies is the looming patent cliff for several branded biologics. This situation presents both challenges and opportunities for biosimilars in the U.S. market. The introduction of biosimilars for major products like AbbVie's Humira, Johnson & Johnson's Stelara, and Regeneron/Bayer's Eylea is shifting the narrative from slow adoption to a more competitive biosimilar market landscape. Vertex Pharmaceuticals has achieved a milestone with the FDA expanding the label for its gene therapy Casgevy, now approved for treating children as young as two with sickle cell disease or transfusion-dependent beta thalassemia. This expansion emphasizes the potential of gene therapies to revolutionize treatment options for younger patients suffering from these conditions. In a pivotal development, Novartis announced a significant acquisition of UK biotech Myricx. With an upfront payment of $1.1 billion and potential total value up to $1.5 billion, this acquisition is set to enhance Novartis' antibody-drug conjugate (ADC) pipeline by incorporating Myricx's novel payload technology and NMT inhibitor payloads. This move reflects Novartis' focus on precision oncology by improving ADC efficacy through targeting critical enzymatic pathways involved in tumorigenesis. Amgen faced a setback with a voluntary recall of approximately one million bottles of its heart medication Corlanor due to potential contamination, highlighting the critical importance of maintaining rigorous manufacturing quality control to ensure drug safety. The regulatory landscape continues to evolve, illustrated by Robert F. Kennedy Jr.'s Department of Health and Human Services revoking lingering COVID-19 emergency authorizations. This signals a transition towards post-pandemic normalcy and an evolving focus on pandemic preparedness frameworks. Sanofi's Genzyme unit in Ireland faced criticism after an FDA inspection linked to Altuviiio resulted in a Form 483 notice. This incident underscores ongoing challenges in maintaining compliance with stringent regulatory standards and emphasizes the importance of robust quality assurance mechanisms. Lonza is expanding its capacity for producing ADCs and enhancing its partnership with a large U.S. drugmaker, aligning with industry trends toward outsourcing complex biologics manufacturing amid growing demand for ADCs. Genentech is undergoing restructuring, resulting in 103 layoffs as part of a strategic rethink of its early development group. Despite these changes, Genentech entered a $490 million collaboration focused on breast cancer, demonstrating its commitment to innovation amid organizational shifts. AstraZeneca continued its collaborative efforts by signing a $1.7 billion kidney drug discovery pact with Chinese biotech CSPC Pharmaceutical. This partnership emphasizes AstraZeneca's strategy to leverage global collaborations to accelerate drug discovery and development efforts. Scribe Therapeutics filed for an Initial Public Offering (IPO) to advance its CRISPR-based gene editing technologies targeting cardiovascular diseases at a genetic level, highlighting an ongoing shift toward personalized medicine. Celea Therapeutics raised $180 million in venture funding to advance Deupirfenidone into late-stage clinical trials for Idiopathic Pulmonary Fibrosis (IPF), signaling confidence in its therapeutic potential amid ongoing investment trends targeting rare diseases. The Medicines and Healthcare products Regulatory Agency expanded approval for Novo Nordisk's Wegovy for Metabolic-Associated Steatohepatitis with moderate-to-advanced liver fibrosis. This expansion represents significant progress given MASH's rising prevalence and progression risks. BridgeBio's ATTRibute-CM study yielded promising results with Acoramidis offering kidney-protective benefits in transthyretin amyloidosis cardiomyopathy patients—a potential new approach managing this rare disease. Revolution Medicines reported encouraging data for its KRAS inhibitor Zoldonrasib in combination therapies targeting metastatic pancreatic ductal adenocarcinoma—offering new strategies against aggressive cancer types. Brii Bio's phase 2b trial results show promise for a combination therapy aimed at achieving a functional cure for chronic Hepatitis B Virus infection—offering hope for millions affected by this condition. Robust fundraising activities continue within biotech sectors as Monash University and Atisama Therapeutics secure funding from MRFF grants developing therapies targeting chronic lung diseases. Overall, these developments highlight dynamic transformations reshaping therapeutic landscapes through precision medicine approaches leveraging cutting-edge technologies promising improved patient care across various domains within pharmaceutical industries globally.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of remarkable advancements and strategic maneuvers that are shaping the future of drug development and patient care. Starting with Roche's breakthrough in oncology, their small molecule inhibitor, Divarasib, has shown promising results in a Phase 3 trial for patients with KRAS G12C-mutated non-small cell lung cancer. This trial demonstrated superior efficacy over competitors like Amgen's Lumakras and Bristol-Myers Squibb's Krazati. Historically, KRAS mutations have been difficult to target, but Divarasib's success underscores the potential of precision medicine in oncology. These findings could lead to more effective treatment options for NSCLC patients, showcasing how targeted therapies are revolutionizing cancer treatment by focusing on specific genetic mutations. In regulatory news, Vertex Pharmaceuticals has made significant strides with Casgevy (exagamglogene autotemcel), a gene therapy that now includes pediatric patients with sickle cell disease and transfusion-dependent beta thalassemia in its FDA-approved label. This marks a pivotal moment for gene therapy applications in blood disorders. Utilizing CRISPR technology, Vertex offers potentially curative solutions for debilitating conditions, signaling a new era where genetic disorders can be addressed at their root cause. Similarly, Novartis has gained European Commission approval for Itvisma to treat 5q spinal muscular atrophy in patients aged two years and older, further cementing gene therapies' role in mainstream medical practice. Strategic partnerships remain essential in driving innovation. Takeda's collaboration with Insilico Medicine on AI-driven drug discovery is a case in point. The $600 million partnership highlights the growing reliance on AI and machine learning to expedite therapeutic development processes. Platforms like Pharma.AI are being leveraged to identify novel drug candidates more efficiently. Additionally, AstraZeneca's alliance with CSPC Pharmaceutical Group to develop siRNA-based therapies for kidney diseases reflects the burgeoning interest in RNA therapeutics as these technologies open new avenues to address complex diseases. On the financial front, BridgeBio's ability to attract $1 billion in convertible preferred equity from Sixth Street and Healthcare Royalty underscores investor confidence in rare disease therapeutics. This funding will bolster its pipeline targeting cardiovascular and rare conditions, emphasizing the profitable potential found within niche markets of the pharmaceutical landscape. Manufacturing is also seeing expansion as Lonza deepens its partnership with an unnamed U.S. drugmaker to enhance biologics programs. Anticipated investments reaching into multi-billion Swiss Francs underscore the critical importance of robust manufacturing infrastructure to meet growing demands for biologics and antibody-drug conjugates. Clinical trials continue to yield promising results. Can-Fite Biopharma's Phase 2a trial for Namodenoson in treating advanced pancreatic ductal adenocarcinoma has shown promising survival data when combined with therapies targeting Wnt/β-catenin signaling pathways. At the same time, Otsuka's Phase 3 data for Voyxact (sibeprenlimab-szsi) demonstrated improved kidney function in patients with immunoglobulin A nephropathy, bolstering traditional FDA approval pathways. On the acquisitions front, GNI Group's acquisition of Ayumi Pharmaceutical for approximately JPY 44.8 billion highlights strategic moves to enhance global biopharma operations focusing on pain management solutions. Yet not all news is positive; Sanofi's Genzyme Ireland unit received an FDA warning letter regarding manufacturing violations related to Altuviiio production, pointing to ongoing regulatory challenges within production practices. Moving on to geopolitical considerations, recent congressional letters to major pharmaceutical CEOs have raised concerns about clinical trials conducted within China due to national security concerns. This tension illustrates the delicate balance between leveraging China's economic potential and safeguarding US interests—a critical issue as international collaborations continue to expand. Meanwhile, AstraZeneca's ongoing collaborations with CSPC Pharmaceutical Group further signify strategic bets on China's capabilities despite geopolitical tensions. Their joint efforts focus on kidney disease treatments while adding to existing agreements addressing obesity and chronic diseases. The FDA remains pivotal as key decisions anticipated this quarter could significantly influence investment strategies and research priorities. This includes revisiting applications previously delayed or rejected—decisions that could reshape industry dynamics. In conclusion, this dynamic landscape is marked by significant scientific breakthroughs and complex global interactions guiding pharmaceutical and biotech sectors toward a transformative era. Gene therapy advancements underscore progress in personalized medicine while geopolitical factors continue influencing strategic industry decisions. As regulatory bodies evolve their approaches alongside increasingly international partnerships, these developments collectively herald profound implications for drug development and patient care globally.Support the show

For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/learn/course/recent-research-into-biologics-in-asthma-10830Program DescriptionThis podcast activity provides an in-depth review of several recent trials in severe asthma management, highlighting the ongoing shift in asthma precision medicine towards identifying the right patients for the right treatments. Clinicians will examine clinical data from the NIMBLE trial (depemokimab), alongside the WAYFINDER trial (tezepelumab), as well ZEPHYR 5 (benralizumab), REMOMEPO (mepolizumab), VESTIGE (dupilumab) and VALLIANT (verekitug). This activity will grant clinicians critical insights to move beyond simple exacerbation reduction and precisely align advanced biologic therapies with the underlying cellular biology driving each patient's symptoms.Educational ObjectiveAt the conclusion of this activity, participants should be better able to:Review recent updates in the asthma literature, including recent guideline revisions and evolving clinical trial data for newer biologic therapies.Accredited ProvidersThe National Association for Continuing Education in partnership with the Association for Pulmonary Advanced Practice Providers (APAPP).The National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.25 Physicians should claim only the credit commensurate with the extent of their participation in the activity. The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.25 contact hours (which includes 0.25 hours of pharmacology).FacultyCedric Rutland, BS, MD, FCCPVolunteer FacultyUniversity of CaliforniaPulmonary Critical Care Internal Medicine, ProducerRutland Medical GroupNewport Critical Care PhysiciansLake Forest, CADr. Rutland has disclosed the following financial relationships:Consultant: Sanofi (asthma, diabetes, NP, RSV, AD), Boehringer Ingelheim (IPF, PPF), Regeneron (asthma, diabetes, NP, RSV, AD), Chiesi (asthma), Baxter (bronchiectasis), Insmed (bronchiectasis), AstraZeneca (asthma, cough)Advisor/Advisory Board: Sanofi (asthma, AD, NP), Regeneron (asthma, AD), Chiesi (asthma), Boehringer Ingelheim (IPF, PPF), AstraZeneca (asthma, cough)Speaker: Sanofi (asthma, NP, AD, AFRS, urticaria, EoE), Regeneron (asthma, NP, AD, AFRS, urticaria, EoE), Boehringer Ingelheim (IPF, PPF), AstraZeneca (asthma, cough), Chiesi (asthma), Baxter (bronchiectasis)These relationships have ended within last 24 months:Consultant: GSK (asthma, cough, RSV)Advisor/Advisory Board: GSK (asthma, cough, RSV)Speaker: GSK (asthma, cough, RSV)Diego J. Maselli, MD, FCCP, ATSFProfessor and ChiefDivision of Pulmonary Diseases & Critical CareUT Health at San AntonioDirector, Respiratory Care, University Health SystemDirector, Severe Asthma Program, University Health SystemSan Antonio, TXDr. Maselli has disclosed the following financial relationships:Consultant: AstraZeneca (asthma, COPD), Sanofi/Regeneron (asthma, COPD), GSK ( asthma, COPD), Amgen (asthma, COPD), Insmed (bronchiectasis)Speaker: GSK (asthma, COPD), AstraZeneca (asthma, COPD), Amgen (asthma, COPD), Sanofi/Regeneron (asthma, COPD)All of the relevant financial relationships listed for these individuals have been mitigated.Nurse Planner and Peer ReviewerMarjorie Crabtree, DNP, FNP, ANPHaymarket Medical EducationSteering CommitteeNurse Practitioner Healthcare FoundationAccredited Provider Program DirectorBellevue, WADr. Crabtree has no relevant conflicts of interest with any ACCME-defined ineligible company.Accredited Provider DisclosureNACE staff has no relevant financial relationships to disclose.Intended AudiencePulmonology, allergy/immunology, and critical care clinicians (physicians, nurse practitioners, and physician associates), as well as primary care and geriatric medicine clinicians caring for patients with asthma.Commercial SupportersThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.Please visit  http://naceonline.com to engage in more live and on demand CME/CE content.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant advancements and strategic shifts reshaping the industry landscape. To begin, the U.S. Food and Drug Administration has taken a noteworthy step by selecting key industry players, including Eli Lilly, Regeneron, Fujifilm, and Kriya Therapeutics, for its PreCheck pilot program. This initiative is designed to enhance U.S. drug manufacturing capabilities, emphasizing the importance of robust domestic production. By reducing dependency on international supply chains, the program aims to expedite the delivery of critical therapies, highlighting a strategic move towards self-reliance in pharmaceutical manufacturing. In oncology news, Beone's Brukinsa (zanubrutinib), a small molecule BTK inhibitor, has demonstrated a remarkable 43% reduction in risk of progression for patients with first-line mantle cell lymphoma in its Phase 3 trial. This breakthrough offers a promising chemotherapy-free option for non-Hodgkin lymphoma treatment, marking significant progress in targeted cancer therapies that could improve patient outcomes in previously underserved areas. Meanwhile, Boulevard Bio and Metis TechBio have sealed a substantial licensing agreement valued at $1.6 billion for MTS-128, a trispecific T-cell engager aimed at autoimmune diseases. This collaboration reflects a broader industry trend towards leveraging advanced AI and machine learning technologies to enhance the development of precision medicine and personalized therapies. Such partnerships indicate a shift towards more innovative approaches to tackling complex disease mechanisms and illustrate burgeoning interest in multispecific biologics within immunotherapy domains—offering new avenues for targeting multiple disease pathways simultaneously. On the regulatory front, Sanofi is advancing efforts to expand the U.S. label for Nexviazyme (avalglucosidase alfa) following successful Phase 3 trials for infantile-onset Pompe disease. As an enzyme replacement therapy targeting GAA enzyme deficiency, Nexviazyme could address a critical gap in treatment options for this debilitating genetic disorder, underlining the importance of regulatory pathways in facilitating access to life-saving therapies. Financially, Beeline Medicines has garnered $126.3 million in Series A extension funding to propel its autoimmune programs originally sourced from Bristol Myers Squibb. Similarly, SmartBax has raised €6.3 million to advance its lead antibiotic program targeting multi-drug resistant infections. These investments underscore an unwavering focus on addressing unmet medical needs through innovative therapeutic solutions. Regulatory challenges persist as well; Unicycive Therapeutics faced FDA rejection due to third-party manufacturing deficiencies surrounding oxylanthanum carbonate. This setback emphasizes the critical importance of maintaining rigorous quality standards throughout drug production processes to secure regulatory approvals and ensure patient safety. Globally, China has achieved a milestone with the approval of the world's first CAR-T therapy for solid tumors—a significant leap forward given the historical challenges of applying CAR-T technology beyond hematological malignancies. This approval could transform cancer treatment paradigms globally and prompt similar regulatory advancements in other regions. In other developments, Abbvie and Genmab's combination therapy involving Epkinly has shown promise in diffuse large B-cell lymphoma (DLBCL) trials following prior challenges with monotherapy approaches. This success story highlights the potential of combination therapies in enhancing outcomes for patients battling complex cancers like DLBCL. From a corporate perspective, Klick Health's acquisition of Oxford Pharmagenesis marks its third purchase in 18 months, expanding its global footprint and scientific capabilities—a testament to ongoing consolidation trends aimed at augmenting expertise and strategic growth within the sector. These developments collectively paint a picture of an industry dynamically evolving amidst scientific breakthroughs and regulatory recalibrations. As companies navigate this transformative landscape, their ability to adapt and innovate remains paramount for sustaining growth and addressing global healthcare challenges effectively. Stakeholders must remain agile to seize opportunities while mitigating inherent risks in this high-stakes environment that increasingly prioritizes patient-centric innovations.Support the show

It's In the News - a look at the top diabetes headlines and stories happening now. Our top stories: More information about type 1 and COVID, including the vaccine, why is the latest GLP-1 medication, not yet FDA approved, showing up all over the place, what table sugar and vinegar could mean for drug costs, a new inhaled insulin study and much more  I'll see you at Friends for Life next week. Come find me at Table T18 Learn more about our in-person events here: https://diabetes-connections.com/events/ Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom  All about VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Transcript & links:    Okay.. our top story this week: XX A large Swedish study found that the increased risk of being diagnosed with type 1 diabetes after COVID-19 infection is mostly limited to the first 30 days after infection and does not continue long term. Researchers followed nearly the entire Swedish population under age 80 from 2020 through 2023 and found that while SARS-CoV-2 infection was linked to a temporary rise in new type 1 diabetes diagnoses, the risk declined over time. The study also found no evidence that COVID-19 vaccination increases the long-term risk of developing type 1 diabetes. Vaccination did not significantly change the relationship between COVID-19 infection and diabetes risk, and any small increase in diagnoses seen among adults shortly after a first vaccine dose was not seen after later doses or during longer follow-up. The researchers concluded that their findings do not support changing current COVID-19 vaccination recommendations because of concerns about type 1 diabetes risk. https://www.infectiousdiseaseadvisor.com/news/covid19-infection-may-increase-short-term-type-1-diabetes-risk/ XX Two new studies are challenging the traditional view that type 1 diabetes develops solely because the immune system attacks insulin-producing beta cells. Researchers from Indiana University found evidence that beta cells themselves may play an active role in determining whether they survive or succumb to the stresses that lead to type 1 diabetes. In the first study, scientists discovered that some healthy human beta cells can quickly activate an antiviral defense system when exposed to interferon-alpha, an immune signal often produced during viral infections. This response relies on molecules called reactive oxygen species (ROS), which are usually associated with cell damage but, in this case, appeared to help switch on protective antiviral genes. Researchers found this defense program in healthy cells and in people at risk for type 1 diabetes, but not in beta cells from people who already had the disease. The findings suggest that losing this built-in defense mechanism may make beta cells more vulnerable during the development of type 1 diabetes. The second study focused on autophagy, the process cells use to recycle damaged or worn-out components. Using a new imaging technique, researchers observed that beta cells in a mouse model of type 1 diabetes showed defects in autophagy before blood sugar levels began to rise and even before a full immune attack was underway. This suggests that problems inside the beta cells may occur early in the disease process rather than being caused entirely by the immune system. Together, the studies point to a more complex picture of type 1 diabetes. While they do not show that beta-cell defects cause the disease, they suggest that differences in how beta cells respond to stress, viral signals, and cellular damage may influence who develops type 1 diabetes and how the disease progresses. https://medicalxpress.com/news/2026-06-beta-cells-players-diabetes.html XX Researchers have created the most detailed map yet of how the human pancreas develops during childhood, offering new clues about why children are especially vulnerable to developing diabetes. The study, published in Nature Communications, examined pancreatic tissue from 123 children without diabetes, ranging from newborns through age 10. Using advanced imaging techniques, scientists tracked how insulin-producing islet cells grow and mature during the first decade of life. The researchers found that pancreas size varies dramatically at birth, with some infants having pancreases nearly four times larger than others. They also discovered that insulin-producing beta cells grow more slowly after birth than previously thought, suggesting that much of a person's lifelong beta cell capacity may be established before birth and during early childhood. Other findings showed that insulin-producing cells mature earlier than glucagon-producing cells and that new hormone-producing cells may continue to form after birth. The researchers hope this new understanding of pancreas development will help scientists identify diabetes risk earlier and develop better strategies for prevention and treatment in children. https://news.vumc.org/2026/06/29/unlocking-diabetes-secrets-pediatric-organ-donors-help-map-a-path-to-a-cure-and-prevention/   XX At the American Diabetes Association annual meeting, 2-year results from the SUPPRESS-EARLY trial showed that initiating tirzepatide (Mounjaro, Zepbound) early in the course of type 2 diabetes led to substantially higher rates of near-normal glycemic control and also led to broader metabolic improvements compared with intensive conventional therapy.   In this MedPage Today video, investigator Stefano Del Prato, MD, of the University of Pisa in Italy, discusses the findings.     Following is a transcript of his remarks:   What happened is that in the tirzepatide-treated arm, 85% of the population at the end of the second year was on the maximum dose of tirzepatide 15 mg. And then the remaining 15 with the different doses.   Interestingly, in the population that had been treated with the intensive conventional approach, 85% of them ended up to have, on top of metformin, a GLP-1 receptor agonist, mainly represented by subcutaneous semaglutide [Ozempic, Wegovy], 60+%, another 15% on oral semaglutide [Rybelsus], and the remaining on dulaglutide [Trulicity].   And I have to say that maybe the recommendation to really push along the line to try to achieve and to strive to achieve [glycemic] control was successful in these individuals. Because the population that had been recruited in the study started off with a baseline A1C of 7.8% and it went down to 6.3% in the conventionally intensive treatment, which is not bad at all, on average is below the target of 6.5%.     However, when we look at the effect of tirzepatide, the final level of A1C at the end of the second year was 5.6%, which is on average below the upper limit of the normal range for A1C, 5.7%. This also translates into more people not only achieving normal glycemia, if we can define normal glycemia as A1C below 5.7%, greater than what we observed in conventionally treated individuals. So it was around three times more people achieving an A1C of 5.7%, in the range of around 65%, as compared to 28% with people on a conventional optimized treatment.   Now, this is not surprising knowing the potency of tirzepatide. But again, going back to the rationale of the design, can we change what is the natural history of the disease? This seems to be at least of interest and it's possibly changing the trajectory of the disease for glycemic control, as I mentioned, but also in terms of the body weight and waist circumference because both body weight and waist circumference went much lower with tirzepatide compared to the conventional treatment.   Tirzepatide also was associated with an improvement in the lipid profile, in particular with the LDL, triglycerides, and the triglyceride concentration and non-HDL cholesterol, and also with a statistically significantly lower systolic blood pressure with a numerical reduction in the diastolic blood pressure.   And also the other thing that probably will ... become more apparent with the study continuing is that the investigators were allowed to add on any other treatment ... needed to achieve their target. So tirzepatide was just metformin and tirzepatide. In the control group, there was already 10% of people who were receiving two drugs on top of the metformin.   So another potential result of the trial is that it's possible to achieve and maintain better glycemic or better metabolic control over the time without really needing to increase the number of medications in order to achieve that goal. And we know that type 2 diabetes is a progressive condition often requiring intensification of the treatment.   So these initial results really stand for a great opportunity with tirzepatide. Of course, we need to wait for the 4 years just to confirm that this is indeed the case, but the initial result seems to point along that line. https://www.medpagetoday.com/meetingcoverage/adavideopearls/121967 XX A study from the University of Virginia found that high blood pressure is extremely common among people with diabetes, even among those who believe their blood pressure is under control. Researchers measured blood pressure in 172 adults with type 1 or type 2 diabetes during routine eye clinic visits and found that only 8% had normal readings. About half had stage 2 hypertension, and more than 10% had blood pressure levels high enough to be considered a medical emergency. The study also revealed that many patients were unaware of how serious their blood pressure problems were. Among those who thought their hypertension was well controlled, more than half still had stage 2 hypertension. Nearly 60% of participants were advised to contact their primary care provider, and one patient required an emergency department referral. Most patients supported blood pressure screening during eye exams, leading researchers to suggest that routine blood pressure checks in ophthalmology clinics could help identify undiagnosed or poorly controlled hypertension before it leads to serious complications such as heart attack, stroke, or worsening diabetic eye disease. https://medicalxpress.com/news/2026-06-routine-eye-exams-reveal-stage.html XX What is going on with retatrutide? This is the next generation GLP-1 but it's not authorized outside of clinical trials. Big investigation by CBS shows retatrutide is for sale all over the internet, a phenomenon they say has no modern precedent. CBS News identified more than 120 websites selling or promoting retatrutide, including more than 50 clinics staffed by licensed medical professionals. After being contacted by CBS News, at least 21 clinics abruptly removed retatrutide from their websites or changed the language to state they don't offer it. Others defended prescribing it, saying they're confident enough in results from clinical trials sponsored by drugmaker Eli Lilly that they didn't need to wait for the FDA's independent, rigorous review. An FDA spokesperson said retatrutide "has not been found safe or effective for any condition," adding that it "cannot be manufactured or distributed except for investigational use." The Justice Department is prosecuting two cases – in Utah and Florida – involving the sale and prescription of retatrutide. But the first line of enforcement is often at the state level. Ohio's Board of Pharmacy has taken action against several pharmacies and clinics providing retatrutide, and just last month, Alabama's Medical Board warned physicians against prescribing research-grade medications. The FDA has sent 14 warning letters to companies that have advertised retatrutide since 2024. Of these, at least six have continued to offer it online, including a business called Pink Pony Peptides. A TikTok account associated with the firm responded to the warning in April by taunting the FDA, boasting that the business "just had the best 24 hours ever." In May, Eli Lilly announced that participants in a large clinical trial taking the highest dose of retatrutide lost an average of 28% of their body weight over 80 weeks. Side effects – including nausea, diarrhea, constipation and vomiting – were comparable to similar therapies, the company said. "Anyone purporting to sell retatrutide to consumers is breaking the law," an Eli Lilly spokesperson said https://www.cbsnews.com/projects/2026/experimental-weight-loss-drug/ XX Pioneering research has developed a new way of creating carbohydrate-based medicines, which could ultimately replace costly drugs for common health conditions, using two cheap basic ingredients – table sugar and vinegar. These medications include SGLT2 inhibitors, widely prescribed drugs used to treat type 2 diabetes, heart failure and chronic kidney disease. Co-lead author Professor Phil Baran, Dr. Richard A. Lerner Endowed Chair at Scripps Research, in San Diego, California, said: "The point of this is to show that anyone in a garage can make an SGLT2 inhibitor with reagents that are widely available. We have not patented this method, so we welcome any generic drug company – or anyone else – who wants to use it to help bring costs down for patients." https://www.newswise.com/articles/new-study-shows-table-sugar-could-hold-a-cheaper-quicker-key-to-making-vital-drugs-for-diabetes-heart-failure-and-chronic-kidney-disease XX England and Wales approve teplizumab to slow progression of T1D. At the moment, the Scottish Medicines Consortium does not have an appraisal of Tzield on the go, so, there is likely to be a disparity in access within the UK for the time being. In Northern Ireland, access will depend on a review and adoption of NICE guidance.  Sanofi is expecting to see an uptick in momentum thanks to two subsequent FDA approvals, one in children as young as one with stage 2 T1D, and a second to delay the decline in endogenous insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. btw you might here more people referring to stage 4 diabetes. They've added that to include people diagnosed with type 1 who've been on insulin for a longer period of time – basically long enough to not be eligible for the current guidelines for Tzield. https://www.bbc.com/news/articles/ce8mzd94r76oXX XX Obesity Association, a division of the American Diabetes Association® (the association), announced the next section in the Standards of Care in Overweight and Obesity, "Screening, Diagnosis, Evaluation, and Staging of Obesity in Adults," published in Diabetes, Obesity, and CardioMetabolic CARE® and BMJ Open Diabetes Research & Care.  Key highlights of the guidance: Early screening: Annual BMI screening with emphasis on tracking weight trends to identify risk earlier, including a longitudinal life-event weight graph tool for standardized assessment. Enhanced diagnosis: Combines BMI with waist measurements and population-specific thresholds to improve accuracy. Notably, the guidelines recommend that BMI in the overweight range together with central adiposity measurements warrant a formal obesity diagnosis. Comprehensive evaluation: Holistic assessment including medical, behavioral, and social factors. Offers a fully integrated obesity diagnostic algorithm. Risk stratification: Use of tools like the Edmonton Obesity Staging System to guide care. Chronic care approach: Ongoing monitoring and follow-up to support long-term management. Reducing bias: Promotes person-centered, non-stigmatizing care and system-level improvements at the clinical workflow level and encourages screening for prior weight bias/stigma experiences. https://www.prnewswire.com/news-releases/new-standards-of-care-in-overweight-and-obesity-section-screening-diagnosis-evaluation-and-staging-of-obesity-in-adults-302809670.html XX Dexcom (Nadsaq:DXCM) today announced the launch of its fully reimagined Stelo over-the-counter (OTC) sensor app experience. San Diego-based Dexcom plans to formally begin the new app rollout in July for Apple iPhone and Android users in the U.S. Dexcom said its reimagined app aims to make glucose insights easier to understand and act on. It hopes to help build awareness of how food, activity, sleep and stress influence overall wellbeing.   The company also reiterated plans to launch Stelo internationally. It expects to bring the sensor to the UK, Australia, New Zealand and South Korea later this year, continuing into 2027. https://www.drugdeliverybusiness.com/dexcom-launches-enhanced-stelo-app/ XX MannKind Corporation recently announced it received a grant from Breakthrough T1D to support the INHALE-1 clinical study of Afrezza, its ultra rapid-acting inhaled insulin, in newly diagnosed pediatric type 1 diabetes patients aged 10 to under 18 years. This external funding for a trial focused on early use of Afrezza in children highlights growing third-party support for inhaled insulin in pediatric diabetes care. https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-mnkd/mannkind/news/afrezza-pediatric-trial-grant-might-change-the-case-for-inve XX Alexander Zverev heads into Wimbledon with plenty of momentum. The French Open champion returns to the All England Club looking to build on his first Grand Slam title and gain ground on Carlos Alcaraz in the race for the No. 2 spot in the ATP rankings. Zverev has an opportunity to make up points quickly after a first-round exit at Wimbledon last year. But his final tune-up before Wimbledon came with an unexpected challenge. During his semifinal loss to Taylor Fritz at the Halle Open, Zverev said a malfunctioning glucose sensor led to serious diabetes management issues on court. The sensor incorrectly showed his blood sugar was high when it was actually low, causing him to take more insulin than needed. "I had huge problems with the sugar because the sensor I use gave me a completely incorrect reading," Zverev said after the match. "During the match, or rather during the first 45 minutes, I had to consume about 350 grams of sugar. I felt absolutely terrible." Despite feeling unwell, Zverev pushed the match to three sets before falling 6-7(4), 6-4, 7-5 to Fritz. He credited his opponent with playing the better match and said the diabetes-related issue was not an excuse for the result. Zverev, who was diagnosed with type 1 diabetes at age 4, uses Medtronic diabetes technology to help manage his glucose levels while competing on the ATP Tour. He said the sensor error was the first major problem he has experienced after nearly a decade of using the technology. The German said the incident should not affect his Wimbledon preparations. With the sensor issue behind him, Zverev will begin his Wimbledon campaign focused on adding another strong result to what has already been a breakthrough season.   https://www.reuters.com/sports/tennis/zverev-says-glucose-sensor-malfunction-affected-halle-semi-final-loss-fritz-2026-06-21/

Highlights from the PER® CME activity "Medical Crossfire®: Turning Therapeutic Innovation Into Practice—Personalizing Care in Multiple Myeloma" — this podcast is not certified for credit. To participate in the full accredited activity and earn CME credit, use the link below.In this podcast, experts Philippe Moreau, MD; Suzanne Lentzsch, MD, PhD; and Shaji Kumar, MD, discuss therapeutic innovations in the treatment of multiple myeloma, including frontline quadruplet therapy, administration considerations for therapy, and optimal sequencing of CAR T-cell therapy, bispecific antibodies, and antibody-drug conjugates.Earn CME credit by completing the full accredited activity (available through June 5, 2027):https://www.gotoper.com/courses/medical-crossfire-turning-therapeutic-innovation-into-practicepersonalizing-care-in-multiple-myeloma-p2f5This podcast, including the narration, was developed by PER® (Physicians' Education Resource®, LLC) editorial staff from the full online CME activity developed with these faculty. The narration was voiced by a PER staff member or by an AI tool. The podcast contains no product advertising. The full activity is supported by an educational grant from Sanofi.This content is for educational purposes only and is not a substitute for the independent clinical judgment of a health care professional. Faculty may discuss investigational or off-label uses; consult prescribing information for any products discussed.

Episode summary: In this episode of Insights Unlocked, Nathan Isaacs sits down with Robyn Bolton, founder of Mile Zero and author of Unlocking Innovation: A Leader's Guide to Turning Bold Ideas into Tangible Results, to explore why innovation fails so often inside successful companies—and what leaders can do about it. Drawing on her experience at P&G, BCG, and Innosight (Clayton Christensen's firm), Robyn shares the frameworks, mindset shifts, and leadership behaviors that separate real innovation from the illusion of it. Robyn makes the case that innovation isn't an idea problem—it's a leadership problem. She dives into how to set the right conditions before any brainstorming begins, why "innovation theater" breeds cynicism rather than creativity, and how customer insights are the most underutilized asset in most organizations. She also weighs in on AI: what separates the companies genuinely benefiting from it versus those just chasing the next shiny object. You'll learn: Why innovation is a leadership problem, not an idea problem How to define a "growth gap" before you ever go to the whiteboard What "innovation theater" looks like and why it backfires Why customer insights are everyone's job—not just the research team's How to build a culture of innovation (and why it takes years, not events) What separates companies getting real value from AI from those just experimenting A practical "George Costanza" leadership habit you can try this week Innovation starts with leadership, not ideas Robyn Bolton has spent her career helping large, successful companies do something that doesn't come naturally to them: innovate. From launching Swiffer at P&G to working with companies like Medtronic, Nike, and Sanofi, she's seen firsthand what makes innovation work—and what kills it. Her core argument is simple but counterintuitive: innovation doesn't fail because companies run out of ideas. It fails because leaders don't create the conditions for those ideas to survive. Culture, she says, is "the perception of what matters, as evidenced by the actions of executives." If you want a culture of innovation, you have to invest in it consistently for years—not just run an annual hackathon and hope for the best. Customer insights are everyone's job Few topics generate more conviction from Robyn than customer insights. She believes deeply that understanding customers—not just gathering data about them—is a responsibility that belongs to everyone in an organization, including executives. Her prescription is simple: get out of the office, be present with customers in their actual environment, and have the humility to listen rather than explain. Too many "insight sessions" turn into selling sessions, she notes. Real discovery means asking open-ended questions and resisting the urge to justify why the product works the way it does. She shared a vivid example: while working with a medical device company, she and the president of the business unit watched video footage of patients using their products. Within ten minutes, R&D team members were shouting at the screen—convinced the patients were doing it wrong. "They're not wrong," Robyn said. "They're teaching us." Resources & links Robyn's website, Mile Zero (https://www.milezero.io/) Robyn's book, Unlocking Innovation (https://www.amazon.com/Unlocking-Innovation-Leaders-Turning-Tangible/dp/1774585618) Robyn's personal website (https://robynmbolton.com/) Robyn on LinkedIn (https://www.linkedin.com/in/robynmbolton/) Nathan Isaacs on LinkedIn (https://www.linkedin.com/in/nathanisaacs/) Learn more about Insights Unlocked: https://www.usertesting.com/podcast

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 transformative events reshaping the landscape of this dynamic industry. Replimune has made headlines with the resubmission of its oncolytic virus-based immunotherapy, RP1, to the U.S. Food and Drug Administration for treating advanced melanoma. The FDA's acceptance after two prior rejections is significant, suggesting a shifting regulatory landscape that could favor innovative cancer therapies like oncolytic viruses. These therapies represent a novel approach to engage the immune system in targeting tumors, and if RP1 gains approval, it may open doors for similar treatments, potentially offering new hope for melanoma patients. On the regulatory side, Amgen has encountered challenges with Tavneos after losing European Union endorsement due to data integrity issues. This serves as a stark reminder of the critical importance of maintaining stringent data management throughout drug development. With an FDA hearing on the horizon, the implications are far-reaching, emphasizing increased scrutiny from regulatory bodies worldwide. This scenario could lead to more rigorous guidelines governing data practices in the future. The European Commission's approval of Henlius' Hetronifly as a first-line treatment for squamous non-small cell lung cancer marks a milestone in cancer immunotherapy. This approval highlights the ongoing efforts to improve patient outcomes through innovative PD-1 inhibitor-based combination therapies, showcasing progress in the fight against one of the most challenging forms of cancer. Epicrispr Biotechnologies brings promising news from its phase 1/2 trial of EPI-321, a gene therapy for facioscapulohumeral muscular dystrophy. The trial's success in enhancing muscle function through epigenetic silencing underscores significant advancements in gene therapy applications for neurological disorders. Similarly, Abbisko Therapeutics' phase 2 trial reports a 90% objective response rate using FGFR2/3 and PD-L1 inhibitors for gastric cancer, demonstrating the potential of targeted small molecule therapies in oncology. In financial developments, Definium Therapeutics and Ligachem Biosciences have made substantial funding strides to bolster their drug development pipelines. Definium's $805 million raise aims to advance psychiatric and neurological treatments, while Ligachem's funding will enhance its antibody-drug conjugate platforms. These investments reflect strong investor confidence in next-generation therapeutic platforms and underscore innovative financing strategies crucial for sustaining research and development efforts. Bayer's recent legal victory at the Supreme Court overturning a $1.25 million verdict related to its Roundup product is another focal point. This ruling not only positively impacts Bayer's financial standing but also highlights the complexities surrounding product liability cases within pharmaceuticals and agrochemicals. Strategically, Moderna has unveiled an ambitious R&D roadmap aiming for break-even by 2028 with over seven new products on the horizon. By focusing on mRNA vaccines for oncology and rare diseases, Moderna continues to leverage its technology beyond COVID-19 applications, potentially transforming treatment paradigms across various therapeutic areas. Shifting focus to industry trends, Sanofi finds itself under investigation by the European Commission for antitrust violations linked to its flu vaccine marketing practices. This situation underscores growing scrutiny over competitive practices within the pharmaceutical sector and could influence regulatory compliance strategies across global markets. In technological advancements, Eli Lilly is employing artificial intelligence to raise awareness about Alzheimer's disease through creative engagements like a European radio show road trip. These initiatives reflect an industry-wide shift towards technology-driven marketing strategies aimed at personalizing patient interactions. Lastly, Merck KGaA's $11 billion acquisition of Bio-Techne exemplifies a strategic move to enhance capabilities in immune cell therapy production. This deal underscores the growing importance of manufacturing innovations in bringing advanced therapies to market and highlights strategic collaborations increasingly seen across the sector. The landscape is further defined by significant scientific breakthroughs such as Revolution Medicines' development of a second RAS blocker, showing improved chemotherapy responses in pancreatic cancer patients. These advancements underscore the need for continued investment in targeted therapeutics research as they promise better patient outcomes and highlight ongoing innovation within oncology. As these developments unfold, they reflect an industry poised for transformation amid evolving scientific, regulatory, and market dynamics aimed at improving patient care globally. With these insights into current trends and future directions, it's clear that the pharmaceutical and biotech sectors are navigating a period rich with potential for groundbreaking advancements that will shape healthcare outcomes worldwide.Support the show

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Rachel Sha, CEO at Terrestrial Bio.   Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology ecosystem with Rachel, covering: Navigating the Genzyme Sanofi acquisition and building a leadership career on the other side of the transaction Being in the right place at the right time to pursue entrepreneurship, and the steep learning curve of stepping into a biotech CEO role The decision to adopt a dual strategy, partnering with biopharma on a platform technology while also advancing internal programs Leading a $50M Series C raise in a challenging funding environment and evolving the company's identity The real world trade offs between building manufacturing capabilities in house versus outsourcing to CDMOs Rachel Sha is the CEO at Terrestrial, a company focused on transforming the delivery of next generation therapies with its microarray skin patch that provides a patient friendly experience that is injection free and without the hassle of cold chain.  Prior to Terrestrial, she was an Operating Partner at Engine Ventures, a venture fund spun-out of MIT that invests in Tough Tech companies primarily in the Boston area.  She advised companies and worked with the investment team in exploring investment themes, opportunities, and programming.  Before her time in venture, she spent seventeen years at Genzyme and Sanofi where she held leadership positions in business development, strategy, and commercial.  Her last role at the firm was the Global Vice President of Digital Strategy, Partnering and Governance at Sanofi where she led global strategy, business development, and governance of digital programs to transform Sanofi and healthcare.   She has long been a supporter of developing women entrepreneurs and has supported organizations like Mass Next Gen and Springboard Enterprises.  She was recognized by the Boston Business Journal in the 2025 class of Women Who Lead in Life Sciences.  Rachel holds a BS from Massachusetts Institute of Technology in Chemistry and an MBA from Harvard Business School.   Please note: Vaxess Technologies is now Terrestrial (Terrestrial Bio, Inc.). This change reflects a brand evolution and is not part of a merger or acquisition. There has been no change in control or operations. All contracts, relationships and business activities continue uninterrupted under our new name.   Molecule to Market is also sponsored by Bora Pharmaceuticals, and supported by Lead Candidate. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!

Alarme é um quadro do canal Não Inviabilize. Aqui você ouve as suas histórias misturadas às minhas!Use a hashtag #DificilDeEngolir e comente a história no nosso grupo do telegram: https://t.me/naoinviabilizePUBLICIDADE SANOFI E ESOFAGITE EOSINOFÍLICAComo parte da campanha “Difícil de engolir é não tratar a EoE”, da Sanofi, esse episódio conta a jornada de uma paciente de Esofagite Eosinofílica, com depoimentos de Dr. Gabriel Benevides, CRM 152074, e Dra. Mariele Morandin, CRM 162098. O relato é baseado na experiência real da paciente e não constitui evidência de estudos clínicos, utilizado apenas para fins de conscientização. Para ter as referências e saber mais, acesse: www.dificildeengolir.com.br / MAT-BR-2602010QUER OUVIR MAIS HISTÓRIAS? BAIXE NOSSO APLICATIVO EM SUA LOJA APPLE/GOOGLE, CONHEÇA NOSSOS QUADROS EXCLUSIVOS E RECEBA EPISÓDIOS INÉDITOS DE SEGUNDA A SÁBADO: https://naoinviabilize.com.br/assineEnvie a sua história bem detalhada para naoinviabilize@gmail.com, seu anonimato será mantido, todos os nomes, profissões e locais são trocados para preservar a sua identidade.Site: https://naoinviabilize.com.brTranscrição dos episódios: https://naoinviabilize.com.br/episodiosYoutube: https://youtube.com/naoinviabilizeInstagram: https://www.instagram.com/naoinviabilizeTikTok: https://www.tiktok.com/@naoinviabilizeX: https://x.com/naoinviabilizeFacebook: https://facebook.com/naoinviabilizeEdição de áudios: Depois O Leo Corta MultimídiaVinhetas: Pipoca SoundVoz da vinheta: Priscila Armani

This episode covers: Cardiology This Week: A concise summary of recent studies Host: Emer Joyce Guests: Yasmina Bououdina, JP Carpenter, Milton Packer, Lorenz Raeber Want to watch that episode? Go to: https://esc365.escardio.org/event/2558 Want to watch that extended interview on PCI guidance by intracoronary imaging, go to: https://esc365.escardio.org/event/2558?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 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. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Milton Packer has declared to have potential conflicts of interest to report: 89bio, Abbvie, Actavis, Altimmune, Alnylam, Amarin, Amgen, Ardelyx, ARMGO, AstraZeneca, Attralus, Biopeutics, Boehringer Ingelheim, Caladrius, Casana, CSL Behring, Cytokinetics, Daiichi Sankyo, Imara, Lilly, Medtronic, Moderna, Novartis, NovoNordisk, Pharmacocosmos, Regeneron, Roche, Salamandra. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Lorenz Raeber has declared to have potential conflicts of interest to report: consultation/speaker fees from Abbott, Boston Scientific, Occlutech, and research grants to the institution by Abbott, Heartflow, Novo Nordisk and Heartflow. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Emer Joyce Guest: Lorenz Raeber Want to watch that extended interview on https://esc365.escardio.org/event/2558?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2558   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 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. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Lorenz Raeber has declared to have potential conflicts of interest to report: consultation/speaker fees from Abbott, Boston Scientific, Occlutech, and research grants to the institution by Abbott, Heartflow, Novo Nordisk and Heartflow. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

At the World Federation of Hemophilia World Congress in Kuala Lumpur, thousands gathered to discuss the future of bleeding disorders care. Gene therapies. Rebalancing agents. Artificial intelligence. New possibilities seemed to be everywhere. But beneath the excitement, one question echoed throughout the meeting: who still gets left behind? In this episode of the Global Hemophilia Report, Patrick Lynch sits down with Believe Limited's Amy Board, WFH Humanitarian Aid Director Assad Haffar, and Sanofi's Bonnie Anderson to explore the promises of innovation, the realities of global inequity, and the humanitarian efforts working to close the gap. From breakthrough science to life-changing access programs, this conversation examines what "Treatment for All" really means in 2026. Guests: Amy Board – Director, Engagement and Programs, Believe Limited Assad Haffar – WFH Humanitarian Aid Director Bonnie Anderson –  Head of Humanitarian Aid, Rare Diseases at Sanofi   Senior Advisor: Donna DiMichele, MD   Hosted by: Patrick James Lynch   Featured Advertiser: Sanofi   Subscribe to the Global Hemophilia Report Show Notes:   Connect with the Global Hemophilia Report Global Hemophilia Report on LinkedIn Global Hemophilia Report on X/Twitter Global Hemophilia Report on Facebook   Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on X/Twitter   

In this episode of The Lead, host Christopher Kowalewski, MD, is joined by John M. Mandrola, MD, and Nassir F. Marrouche, MD, FHRS, to discuss the journal article, The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial. Together, they explore the relationship between atrial fibrillation burden and quality of life, reviewing findings from this substudy of the SHAM-PVI Trial and discussing their relevance to patient-centered outcomes. Learning Objectives Review the key findings from the SHAM-PVI Trial substudy examining the association between atrial fibrillation burden and quality of life. Discuss the relationship between atrial fibrillation burden and patient-reported quality-of-life outcomes. Explore the implications of assessing both arrhythmia burden and quality of life when evaluating treatment outcomes in atrial fibrillation.   Host: Christopher Kowalewski, MD Guests: John M. Mandrola, MD and Nassir F. Marrouche, MD, FHRS   Disclosures: Christopher Kowalewski, MD No relevant disclosures   John M. Mandrola, MD No relevant disclosures   Nassir F. Marrouche, MD, FHRS •       Honoraria/Speaking/Consulting Fee/Speaker's Bureau: Biosense Webster, Inc., Boston Scientific, AtriCure, Inc., Abbott, Sanofi •       Research: Abbott, Biosense Webster, Inc., Medtronic, Siemens, General Electric, Boston Scientific, Sanofi, Samsung