Podcasts about fda approval

Welcome to OncLive On Air®! OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions. In today's episode, we had the pleasure of speaking with Harry P. Erba, MD, PhD, about the FDA approval of ziftomenib (Komzifti) for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Dr Erba is a professor of medicine in the Division of Hematologic Malignancies and Cellular Therapy in the Department of Medicine at the Duke University School of Medicine, as well as director of the Leukemia Program and director of Phase I Development in Hematologic Malignancies. He is also a member of the Duke Cancer Institute in Durham, North Carolina. In our exclusive interview, Dr Erba discussed the significance of this approval, key efficacy and safety findings from the pivotal phase 1/2 KOMET-001 trial (NCT04067336), and the role ziftomenib may play throughout the evolution of the AML treatment paradigm. _____ That's all we have for today! Thank you for listening to this episode of OncLive On Air. Check back throughout the week for exclusive interviews with leading experts in the oncology field. For more updates in oncology, be sure to visit www.OncLive.com and sign up for our e-newsletters. OncLive is also on social media. On X and BlueSky, follow us at @OncLive. On Facebook, like us at OncLive, and follow our OncLive page on LinkedIn. If you liked today's episode of OncLive On Air, please consider subscribing to our podcast on Apple Podcasts, Spotify, and many of your other favorite podcast platforms,* so you get a notification every time a new episode is posted. While you are there, please take a moment to rate us! Thanks again for listening to OncLive On Air. *OncLive On Air is available on: Apple Podcasts, Spotify, CastBox, Podcast Addict, Podchaser, RadioPublic, and TuneIn. This content is a production of OncLive; this OncLive On Air podcast is supported by funding, however, content is produced and independently developed by OncLive.

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a landscape marked by significant scientific advancements, regulatory approvals, and strategic shifts that are reshaping the industry.Starting with Regeneron, the company's ophthalmic drug Eylea HD has recently secured two FDA approvals. These endorsements not only grant a new indication but also introduce a more flexible dosing regimen. This positions Eylea HD competitively against Roche's Vabysmo, highlighting the importance of regulatory navigation and strategic positioning in the pharmaceutical sector. These approvals come after extensive negotiations with both the FDA and third-party manufacturers, emphasizing the intricate processes involved in bringing a drug to market.In oncology, Bayer has achieved an accelerated FDA approval for Hyrnuo, a treatment targeting HER2-mutated non-small cell lung cancer. This move allows Bayer to challenge Boehringer Ingelheim's Hernexeos, underscoring the fiercely competitive nature of the oncology market. Such advancements are driven by innovative treatments that address specific genetic mutations in cancer patients, reflecting a broader trend towards precision medicine.Meanwhile, Moderna is investing heavily in mRNA production capabilities with a new $140 million facility in Norwood, Massachusetts. This development underscores Moderna's commitment to mRNA technology, which gained significant attention during the COVID-19 pandemic. The facility aims to establish robust domestic manufacturing infrastructures to mitigate supply chain vulnerabilities—a critical move considering recent global disruptions.Novartis is also making headlines with its plans for a flagship production hub in North Carolina. This expansion is expected to create 700 jobs and expand its manufacturing footprint by 700,000 square feet, highlighting Novartis's strategic emphasis on scaling up operations to meet growing demands and enhance production efficiency.In another strategic collaboration, Antheia has joined forces with Teva's TAPI division to enhance the commercialization prospects for its biosynthetic pipeline. This alliance marks a significant step toward advancing biologically derived pharmaceuticals, promising to revolutionize drug production through more sustainable and scalable alternatives to traditional chemical synthesis.On the regulatory front, Merck has received broad EU approval for a subcutaneous formulation of Keytruda. This development could significantly expand Keytruda's market reach across Europe, demonstrating how regulatory agility can extend drug lifecycles and maximize therapeutic impact across diverse patient populations.Compliance challenges remain prevalent, as illustrated by Pfizer and Tris Pharma's settlement of allegations related to ADHD medication Quillivant's quality control issues for $41.5 million. This case highlights ongoing efforts to ensure stringent quality standards within pharmaceutical manufacturing processes.Abbott is expanding its diagnostics portfolio through a $23 billion acquisition of Exact Sciences, known for its Cologuard colorectal cancer test. This acquisition indicates a strategic shift towards enhancing diagnostic capabilities alongside therapeutic offerings—a trend increasingly evident in holistic healthcare solutions.GSK is embarking on a $7 billion collaboration with biotechs Quotient and Profound through Flagship Pioneering. This partnership aims to leverage novel protein and genomic technologies to drive innovation in drug discovery and development, illustrating the industry's focus on integrating advanced biotechnological insights into traditional pharmaceutical frameworks.These developments collectively underscore crSupport the show

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the intricate tapestry of scientific advancements, regulatory decisions, and strategic maneuvers shaping our industry.One of the notable stories involves Agios Pharmaceuticals, which is pushing forward with its sickle cell disease treatment, Pyrukynd, for FDA approval. This comes despite mixed results from their Phase 3 clinical trials, which led to a significant drop in their stock value. This scenario underscores the complexities of navigating clinical trial outcomes while pursuing breakthroughs in treating challenging diseases like sickle cell.Arrowhead Pharmaceuticals has marked a significant milestone with the FDA's approval of Plozasiran. This achievement not only marks Arrowhead's entry into the commercial sector but also highlights the competitive dynamics within biotech, as companies like Ionis Pharmaceuticals vie for market dominance with innovative therapies. Further strengthening its position, Arrowhead also received FDA approval for Redemplo, a siRNA-based therapeutic for rare genetic metabolic disorders. Despite facing volatility due to safety concerns in its partnership with Sarepta Therapeutics, this approval underscores RNA interference therapies' potential in precision medicine.In corporate strategy news, Alkermes is making moves to acquire Avadel Pharmaceuticals, offering up to $2.37 billion and overshadowing a competing bid from Lundbeck. Such acquisitions are part of a broader trend of consolidation in the industry aimed at expanding portfolios and market reach. Avadel's decision to accept Alkermes' revised offer over Lundbeck's bid highlights ongoing consolidation trends as companies expand their portfolios in competitive markets like narcolepsy drugs.On the investment front, Celltrion has committed $478 million to upgrade a U.S. manufacturing facility acquired from Eli Lilly. This expansion is crucial for increasing manufacturing capabilities within the biosimilars sector, where demand for cost-effective therapeutics is on the rise. Additionally, Celltrion's exploration beyond biosimilars with a potential $350 million deal involving Trioar's antibody platform demonstrates ambition to diversify its portfolio towards innovative biologics.Teva Pharmaceuticals is fostering innovation by inviting startups to tackle key challenges within biopharma through a global platform. This initiative reflects a growing trend toward open innovation and collaboration, seeking novel solutions to complex issues across research and development and manufacturing efficiencies.In regulatory news, the controversial $7.4 billion settlement plan involving the Sackler family and Purdue Pharma has received approval from a bankruptcy judge. This paves the way for Purdue's transformation into Knoa Pharma and highlights ongoing legal and ethical reckonings related to opioid liabilities within the industry.Cytokinetics remains committed to its independent path as it awaits FDA approval for its cardiovascular drug Aficamtem. The company's determination to commercialize without big pharma support reflects a trend where smaller biotech firms strive for autonomy while bringing first-in-class drugs to market.On an infectious disease front, Merck has demonstrated significant progress with its HIV treatment Islatravir in Phase 3 trials. This places Islatravir as a potential competitor against Gilead's Biktarvy, showcasing ongoing innovation within antiviral drug development.Additionally, Dexcom has gained clearance for its type 2 diabetes software integrating continuous glucose monitoring technology. This advancement exemplifies how digital health technologies are transforming chronic disease management bySupport the show

Bioelectronic medicine is changing how we treat inflammation, autoimmunity, and chronic disease, and this episode shows you exactly how nerve stimulation could redefine human performance, longevity, and brain optimization. You will learn how electricity, neurotransmitters, and targeted neural pathways can replace drugs, control inflammation, and help you hack the vagus nerve with precision instead of guesswork. Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR Host Dave Asprey is joined by Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes for Medical Research at Northwell Health, pioneer of vagus nerve research, and author of The Great Nerve. He is one of the world's most cited scientists in inflammation and neuroscience, and his discoveries created the field now known as bioelectronic medicine. He identified the therapeutic action of anti TNF antibodies, mapped the inflammatory reflex, and revealed how vagus nerve signaling controls immunity. With more than 450 scientific publications and over 120 U.S. patents, he is a trusted authority whose work drives the future of anti-aging, functional medicine, metabolism, and neural therapies. Dr. Tracey and Host Dave Asprey explore how the vagus nerve truly operates, why it contains 200,000 fibers with different functions, and what happens when you stimulate specific pathways that regulate inflammation, HRV, neurotransmitters, and immune signaling. You will learn how nerve impulses transmit information, how voltage gated ion channels shape behavior and biology, and why certain forms of stimulation create measurable improvements in mitochondria, metabolic control, sleep optimization, and emotional regulation. They break down the science behind surgical vagus nerve implants, focused ultrasound, gamma entrainment, cytokine control, and real neuromodulation. They also explore why cold plunging, breath work, HRV training, nootropics, and consumer devices vary so widely in their effects, and how to evaluate these tools with practical biohacking frameworks. You will hear what actually works, what remains experimental, and what the next decade of nerve based therapies could unlock for brain optimization, longevity, ketosis, fasting, supplements, and AI guided interventions in human biology. You'll Learn: • How vagus nerve stimulation reduces inflammation through the inflammatory reflex • Why bioelectronic medicine can replace drugs in autoimmune conditions • How nerve fibers relay electrical and chemical signals inside the body • Why cold immersion, breath work, and HRV training activate specific vagal pathways • How 40 hertz gamma entrainment may influence cognitive decline • Which stimulation methods have clinical validation and which do not • Why high vagal tone is linked to better metabolism, immunity, and emotional stability • What future nerve based technologies may unlock for human performance Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade brings you the knowledge to take control of your biology, extend your longevity, and optimize every system in your body and mind. Each episode delivers cutting-edge insights in health, performance, neuroscience, supplements, nutrition, biohacking, emotional intelligence, and conscious living. New episodes are released every Tuesday, Thursday, Friday, and Sunday (BONUS). Dave asks the questions no one else will and gives you real tools to become stronger, smarter, and more resilient. Keywords: Kevin J. Tracey, vagus nerve stimulation, bioelectronic medicine, inflammatory reflex, SetPoint Medical, cytokine control, neuromodulation therapy, autonomic nervous system, HRV optimization, inflammation reduction, rheumatoid arthritis treatment, focused ultrasound therapy, gamma entrainment, mitochondrial signaling, anti-aging science, neural pathway hacking, functional medicine research, immune system regulation, brain and body performance, human longevity science Thank you to our sponsors! -AquaTru | Go to https://aquatruwater.com/daveasprey and save $100 on all AquaTru water purifiers. -MASA Chips | Go to https://www.masachips.com/DAVEASPREY and use code DAVEASPREY for 25% off your first order. -Timeline | Head to https://www.timeline.com/dave to get 10% off your first order. -Calroy | Head to https://calroy.com/dave for an exclusive discount Resources: • Learn More About Kevin's Work: https://feinstein.northwell.edu/institutes-researchers/our-researchers/kevin-j-tracey-md • Danger Coffee: https://dangercoffee.com/discount/dave15 • My Daily Supplements: SuppGrade Labs (15% Off) • Favorite Blue Light Blocking Glasses: TrueDark (15% Off) • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Upgrade Collective: https://www.ourupgradecollective.com • Upgrade Labs: https://upgradelabs.com • 40 Years of Zen: https://40yearsofzen.com Timestamps: 0:00 - Trailer 1:12 - Bioelectronic Medicine 3:23 - FDA Approval 6:48 - RA Treatment Explained 11:35 - Vagus Nerve Function 15:12 - External vs Implanted Stimulation 18:06 - Focused Ultrasound 26:11 - Ear Stimulation Science 30:51 - Clinical Evidence 37:10 - Alzheimer's Link 42:15 - Future Applications 46:48 - Cold Exposure Effects 53:51 - Common Misconceptions 55:38 - Final Thoughts See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this episode of the Oncology Brothers podcast, we dived into the exciting world of cancer treatment with a focus on the recent FDA approval of Ziftomenib for relapsed refractory NPM1 mutated acute myeloid leukemia (AML).  We were joined by Dr. Eunice Wang from Roswell Park Comprehensive Cancer Center as our guest. Dr. Wang shared insights from the KOMET-001 study, detailing the study design, efficacy, and safety profile of Ziftomenib. With a response rate of nearly 30% and significant overall survival benefits for patients, this new treatment option is a promising step forward in managing heavily pretreated AML. Key topics covered in this episode included: The mechanism of action of Ziftomenib as a menin inhibitor Study findings from KOMET-001 and patient response rates Management of side effects, including differentiation syndrome and QTc prolongation Comparison with other menin inhibitors like Revumenib Future directions for combination therapies and sequencing of treatments Whether you're a healthcare professional, a patient, or simply interested in the latest advancements in cancer therapy, this episode is packed with valuable information.  Follow us on social media: X/Twitter: https://twitter.com/oncbrothers ⁠Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ Don't forget to like, subscribe, and check out our other episodes for more insights into FDA approvals, toxicity management, and practice-changing conference highlights. #Ziftomenib #MeninInhibitor #AML #NPM1 #Leukemia #FDAapproval #OncologyBrothers

Want a legal career blending Intellectual Property (IP), Biotechnology, and Business? We sit down with Jenna Matheny (Vice-President & Managing Director at APIOiX) to break down the path to a high-impact career in medical innovation. This episode is essential listening for law students and those interested in patent law who also have a passion for science, revealing a world of opportunities beyond traditional law firm life.In this episode, we discuss:The Innovation Lifecycle: How lawyers are involved from invention disclosure and patent strategy to regulatory approval (FDA) and commercialization.The Business of IP: The critical, often-overlooked importance of contracting and compliance in developing and licensing medical technology.Finding Your Niche: Jenna's unique career path through university Tech Transfer offices, incubators, and accelerators—and how law students can get their foot in the door.Beyond Science: The growing field of social innovation and how non-science majors can find rewarding IP careers focused on copyright and trademark.Practical Law School Advice: Which broad-based courses (like securities and international tax) set you up for success, and the value of clinics and residencies.(00:00) - Introduction: Blending Law, Science, and Business in an IP Career (01:43) - Meet Jenna Matheny: Expert in Medical Technology IP and Tech Consulting (04:28) - Defining Biotech vs. MedTech: Law's Role in FDA Approval (05:42) - The Core Practice Areas: Patents, Contracting, and Regulatory Compliance (10:09) - Career Pivot: From Medicine Interest to Patent Attorney Path (11:32) - Tech Transfer Offices (TTOs): How Law Students Can Gain Experience (14:28) - Incubators & Accelerators: Consulting and Internship Roles for Attorneys (20:39) - Practical Advice: Essential Law School Courses (Securities, Tax) and Clinics (24:26) - Serendipity & Networking: How Connections Change the Course of a Legal Career (25:59) - Social Innovation: IP Opportunities without a Science Background (Copyright & Trademark) Click here to view the episode transcript.

Send us a textGood 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 myriad of pivotal changes and advancements that have been shaping our industry.The competitive nature of acquisitions within the biopharma sector has been exemplified by recent strategic buyouts. Lundbeck's decision to outbid Alkermes for Avadel Pharmaceuticals highlights how companies are leveraging acquisitions to expand their capabilities and portfolios. Similarly, Pfizer's finalized acquisition of Metsera after a fierce bidding war with Novo Nordisk underscores the importance of securing valuable assets to strengthen positioning in critical therapeutic areas, such as obesity treatment, where demand continues to rise.Regulatory milestones remain at the heart of industry progress. Organon and Henlius's Poherdy recently received FDA approval as a biosimilar to Roche's Perjeta, offering a new treatment avenue for HER2-positive breast cancer patients. This approval is noteworthy as biosimilars play an essential role in oncology by providing similar efficacy to original biologics but at reduced costs, thereby enhancing healthcare affordability and accessibility. In Europe, the EMA's Committee for Medicinal Products for Human Use has endorsed several innovative drugs, including Otsuka's Dawnzera for hereditary angioedema and Lilly's Inluriyo for certain cancer types. These endorsements reflect the growing pipeline of treatments addressing both rare genetic disorders and widespread diseases.Merck & Co.'s acquisition of Cidara Therapeutics for $9.2 billion underscores a strategic pivot towards bolstering its antiviral portfolio. This deal is particularly significant given Cidara's promising influenza antiviral candidate, initially abandoned by Johnson & Johnson. In an era where infectious diseases pose ever-evolving challenges, Merck's investment in antivirals reflects a commitment to advancing therapeutic solutions in this crucial area.However, drug development's inherent uncertainties were highlighted by Bristol Myers Squibb and Johnson & Johnson's joint anticoagulant venture, which faced termination due to a Phase 3 trial failure. This setback emphasizes the challenges and risks entailed in developing novel therapeutics, particularly within high-stakes areas like cardiovascular health.Leadership changes can significantly impact corporate strategy, as seen with Bavarian Nordic following an unsuccessful private equity takeover attempt. Such shifts can influence investor confidence and reshape strategic directions.Investment trends also paint an optimistic picture for innovation within the sector. European life sciences investor Medicxi's successful raising of €500 million signifies robust financial support for biotech ventures. This influx of capital is vital for propelling early-stage research and development efforts across Europe, fostering breakthroughs in chronic and rare disease treatments.In terms of scientific innovation, advancements in bispecific antibody production through AI/ML-driven molecular design promise higher yields and enhanced quality. These technological innovations could revolutionize complex biologics manufacturing, potentially accelerating timelines and expanding therapeutic possibilities.The regulatory landscape is seeing significant activity as well. Notably, FDA officials introduced a novel pathway aimed at accelerating gene editing therapies' development and approval. By facilitating faster market entry for personalized medicines, this regulatory innovation could pave the way for treatments tailored to individual genetic profiles.Kyowa Kirin's collaboration with Kura Oncology reached a milestone with FDA approval for an oral medication targeting acute myeloidSupport the show

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into several groundbreaking advancements and strategic shifts in the industry that promise to reshape the landscape of patient care and therapeutic innovations.The U.S. Food and Drug Administration has introduced a novel regulatory pathway aimed at expediting the approval process for custom gene-editing therapies. Articulated by FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., this new approach is set to revolutionize personalized medicine, particularly for genetic disorders where tailored interventions are crucial. Gene editing technologies, like CRISPR-Cas9, have opened unprecedented avenues for addressing genetic conditions directly at their source. However, the regulatory framework has struggled to keep pace with these advances, often hampering innovation with lengthy and complex approval processes.This proposed pathway seeks to streamline these requirements by adopting a risk-based assessment model that considers the unique properties of gene-editing therapies. Unlike traditional drugs, which follow a uniform clinical trial path, gene-editing treatments require a more nuanced regulatory approach due to their precision and potential off-target effects. The framework emphasizes adaptive trial designs—allowing for modifications based on interim results—and integrates real-world data to create a dynamic regulatory process. This not only promises faster development times but also fosters innovation by making it easier for companies to bring cutting-edge therapies to market.The implications are far-reaching. For researchers and biotech firms, this represents a chance to reduce time-to-market significantly while maintaining high safety standards. It also sets a precedent for future regulatory models that prioritize patient-centric approaches, acknowledging the diverse genetic landscapes of individuals with rare diseases. On a broader scale, this shift underscores the increasing recognition of personalized medicine's potential to transform healthcare delivery.In parallel developments, Gilead Sciences has achieved positive phase 3 results for its single-tablet regimen combining bictegravir and lenacapavir for HIV treatment. This milestone offers hope for simplifying treatment protocols for patients currently on multi-tablet regimens, potentially enhancing adherence and improving health outcomes. Gilead's preparation for regulatory filings marks an essential step forward in their therapeutic portfolio.Turning to cancer treatment advancements, Kyowa Kirin's collaboration with Kura Oncology has led to FDA approval for an oral medication targeting a subset of acute myeloid leukemia patients. This approval highlights the power of strategic partnerships in expediting the development of targeted cancer therapies and brings new hope to patients with limited treatment options.Meanwhile, several pharmaceutical companies, including Fresenius, Sun Pharma, and Teva, have been involved in product recalls ranging from hospital drugs to antibiotics and ADHD medications. These recalls underscore ongoing challenges in maintaining drug safety standards and emphasize the need for rigorous quality control measures across the industry.Zealand Pharma has opted to pause development of its dual GLP-1/GLP-2 agonist, dapiglutide, due to an increasingly crowded metabolic disorder treatment landscape. By reallocating resources towards programs with greater clinical differentiation potential, Zealand reflects broader industry trends prioritizing investments in areas with clearer paths to market success.In malaria treatment advances, Novartis has achieved significant progress with its next-generation drug 'Ganlum,Support the show

Thank you to Polygon for supporting this podcast. 03:26 Introduction to Peptides 05:03 Disclaimer and FDA Approval Discussion 21:47 Cultural Movement and Personal Journey 26:53 Peptide Market and Supply Chain 34:57 Introduction to Testing Methods 35:41 Endotoxin and Heavy Metals Screening 36:59 Comparison with The Ordinary 39:41 Community Testing and Group Buys 41:04 Sourcing and Manufacturing Challenges 43:32 Product Popularity and FDA Approval 44:57 Deplatforming  48:12 Personal Reflections on Peptides 58:23 Housekeeping and Final Thoughts  

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of groundbreaking advancements and strategic collaborations that promise to transform drug development and patient care.In the autoimmune space, Boehringer Ingelheim has made a significant move by securing a $570 million agreement with CDR-Life. This deal centers on a trispecific antibody, a novel therapeutic approach that targets multiple pathways simultaneously, potentially revolutionizing treatments for autoimmune diseases. Boehringer's commitment to these cutting-edge modalities highlights their strategy to leverage novel technologies for more effective therapeutic solutions.Similarly, Celltrion has entered a $744 million collaboration with Kaigene, focusing on two preclinical autoimmune drugs. This partnership marks Celltrion's strategic shift from biosimilars to novel biologics, positioning the company at the forefront of biologic therapeutics. By investing in early-stage research, Celltrion aims to introduce transformative therapies for autoimmune conditions, showcasing the industry's willingness to bet on groundbreaking scientific advancements.In gene editing, Azalea Therapeutics is gaining attention with its focus on permanent genome editing using a dual-vector approach. Backed by $82 million in funding and support from CRISPR pioneer Jennifer Doudna, Azalea is poised to develop potentially curative solutions through single-dose treatments. The credibility lent by a Nobel laureate adds anticipation to their research outcomes, with the potential to significantly impact gene therapy.Shifting focus to clinical trials, Sarepta Therapeutics faces challenges after missing the primary endpoint in its confirmatory trial for Duchenne muscular dystrophy drugs. Despite this setback, Sarepta is pursuing full FDA approval, emphasizing the complex interplay between clinical data and regulatory strategies. This situation underscores the critical importance of robust confirmatory trials in securing drug approvals and ensuring patient access to new therapies.Merck is making strategic moves in oncology by regaining full control over an early-phase asset and securing $700 million from Blackstone for its oncology pipeline. This dual focus on asset acquisition and financial fortification reflects Merck's aggressive growth strategy aimed at expanding its cancer treatment offerings.Emerging from stealth mode, Neok Bio has secured a $75 million investment to advance bispecific antibody-drug conjugates into clinical trials. These bispecific ADCs represent the forefront of targeted cancer therapies, aiming for precision targeting of cancer cells while minimizing off-target effects. Neok Bio's progress could significantly enhance oncology treatment paradigms through improved therapeutic indices.Turning to regulatory landscapes, Teva's recall of over half-a-million bottles of prazosin hydrochloride due to potential carcinogenic impurities highlights ongoing challenges in ensuring drug safety and quality control within manufacturing processes. Such recalls underscore the critical importance of maintaining high standards in pharmaceutical production.In broader industry developments, we see dynamic trends where scientific innovation meets strategic business decisions and regulatory considerations. The potential impact on patient care is profound, with breakthroughs in autoimmune treatments, gene editing technologies, and targeted cancer therapies poised to alter therapeutic landscapes significantly.UCB has achieved another milestone with FDA approval for Kygevvi, an ultra-rare disease medication marking their third approval in rare conditions within three years. This success underscores UCB's strategic focus on niche markets that offer less competition but significant patient impact. Advancements in genetic research aSupport the show

This Week in Review covers 5 episodes from October 27 to October 31, featuring major developments in the pharmaceutical and biotech industries.Episodes included:1. Pharma Shifts: Dual-Action Obesity Drugs & Regulatory Waves2. Navigating Pharma's New Frontiers: Breakthroughs and Challenges3. Gene Therapy Challenges and Regulatory Shifts: Industry Innovations4. Biotech Breakthroughs: Transformative Acquisitions and FDA Milestones5. Novartis' $12B RNA Therapeutics BreakthroughKey topics covered:- Strategic acquisitions and partnerships- Regulatory updates and FDA approvals- Clinical trial results and breakthroughs- Industry trends and market developmentsStay informed with Pharma Daily's comprehensive coverage of the pharmaceutical and biotech world.Support the show

Most people assume that if a drug sits on the shelf at Costco or Walgreens, it must be pretty safe. But what if some of the most common over-the-counter (OTC) medications are among the riskiest drugs in America? On this episode of Vitality Radio, Jared exposes the hidden dangers behind everyday pain relievers, sleep aids, and heartburn drugs—medicines that cause thousands of deaths every year when misused or taken long-term. You'll learn how a drug becomes “OTC,” what happens when pharmaceutical companies push for that switch, and why the FDA's approval process might not tell the whole story. Jared dives into the startling realities of PPIs like Prilosec, NSAIDs like ibuprofen, and acetaminophen (Tylenol)—uncovering their risks to the liver, kidneys, bones, and brain. He also discusses how marketing convinces consumers these drugs are harmless. Finally, Jared offers a resource for safe, natural alternatives for reflux, pain, inflammation, sleep, and immune support—options that nourish the body instead of depleting it. This episode will change the way you look at “harmless” OTC drugs and help you take real control of your health.Just Ingredients Lemon Swish Protein Powder Vitality Radio POW! Product of the Week $29.99 per bag (regular price $59.99) with PROMO CODE: POW15Additional Information:#341: Your Digestive Health Supplement User's Guide. From IBS to Acid Reflux - Learn How to Balance Your Gut Health With Natural Products. #522: Q&A Show #5 - Jared Answers Your Questions About Energy and Sleep!#471: Boosting Your Immune System Ahead of Winter #553: Boswellia & Curcumin: Nature's Dream Team for Pain & Inflammation with Dr. Lexi LochVisit the podcast website here: VitalityRadio.comYou can follow @vitalitynutritionbountiful and @vitalityradio on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.

In this episode, host Nick engages in a captivating conversation with Steve Marchese, a pioneering figure in the beauty and wellness industry and the CEO of LightStim. They explore the fascinating world of light therapy, delving into its myriad benefits, common misconceptions, and the intricate science that underpins it. Steve shares his remarkable journey from the car detailing business to becoming a leader in wellness technology, offering insights into the challenges and breakthroughs he encountered while developing effective LED devices. Throughout the conversation, Steve emphasizes the critical importance of FDA clearance in validating the efficacy and safety of LED products. He also sheds light on the role of influencers in shaping public perception and the potential pitfalls of misinformation in the wellness industry. As they delve into the future of light therapy, they discuss the growing interest in health and wellness technologies and the transformative impact these innovations can have across various sectors. Listeners will gain a deeper understanding of how different wavelengths of light can promote skin health and overall wellness, as well as the technical hurdles that must be overcome to achieve successful outcomes. Steve's personal anecdotes and professional experiences provide a compelling narrative that underscores the potential of LED therapy to revolutionize the way we approach beauty and health. Chapters 00:00 Introduction to Light Therapy and Steve Marchese 04:27 Transition from Car Detailing to Wellness Technology 08:38 Understanding Light Therapy: Basics and Benefits 12:55 The Science Behind Red and Infrared Light Therapy 17:17 The Role of Nitric Oxide in Health and Wellness 21:51 Light Therapy in Sports: Enhancing Athletic Performance 26:02 Debunking Myths: Misconceptions About Light Therapy 30:23 Navigating the Market: Choosing the Right Light Therapy Device 34:51 The Future of Light Therapy and Industry Regulations 39:42 FDA Approval for Light Therapy Devices 50:03 How LED Therapy Cured Steve's Son's Dangerously High Blood Pressure 01:06:02 Why You Should Not Trust Influencers Selling LED Masks Find Steve Marchese here: Instagram: https://www.instagram.com/lightstim LinkedIn: https://www.linkedin.com/in/steve-marchese-04168472/ Facebook: https://www.facebook.com/lightstim YouTube: https://www.youtube.com/c/LightStim Website: https://lightstimpro.com/ - CODE: NICK for 10% off! Find Nick Thompson here: Instagram: https://www.instagram.com/nthompson513/ | https://www.instagram.com/the_ucan_foundation/ YouTube: https://www.youtube.com/@EyesWideOpenContent LinkedIn: https://www.linkedin.com/in/nickthompson13/ UCAN Foundation: https://theucanfoundation.org/ Website: https://www.engagewithnick.com/

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 several significant shifts in the industry, marked by scientific advancements, regulatory changes, and strategic corporate maneuvers.Starting with a major acquisition, Novartis has strategically purchased Avidity Biosciences, a San Diego-based biotech company specializing in muscular dystrophy treatments, for a striking $12 billion. This substantial investment underscores Novartis's dedication to expanding its neuroscience portfolio. Avidity's innovative RNA-based therapies show great promise for treating neuromuscular diseases, highlighting a broader industry trend where large pharmaceutical companies are investing heavily in late-stage biotech firms to bolster their pipelines with cutting-edge technologies. Such moves are pivotal as they align with the growing emphasis on precision medicine and the development of novel therapeutic options for conditions with limited existing treatments.In other acquisition news, Eli Lilly has expanded its gene therapy portfolio through acquiring Adverum Biotechnologies for up to $262 million. This acquisition is expected to bolster Eli Lilly's position in the gene therapy space, particularly in ophthalmology. Gene therapy offers transformative potential by directly addressing underlying genetic causes of diseases, with Adverum's focus on ophthalmic conditions potentially offering innovative solutions for unmet medical needs in eye-related disorders. The acquisitions by Novartis and Eli Lilly reflect broader trends within the pharmaceutical industry where companies actively seek to diversify their pipelines through mergers and acquisitions. These transactions emphasize strategic incorporation of advanced biotechnologies such as RNA therapeutics and gene therapy into development portfolios aiming to deliver breakthroughs in patient care.On the regulatory front, Bayer has achieved a milestone with the U.S. FDA approval of Lynkuet (elinzanetant), a nonhormonal medication designed to manage menopause symptoms. This approval represents a significant step forward in providing alternative treatment options to a traditionally hormone-reliant segment, emphasizing the industry's shift towards diversifying therapeutic solutions and addressing unmet medical needs. This move highlights continuous efforts to address women's health issues through new pharmacological interventions.Meanwhile, Merck's Winrevair has received an updated FDA label following successful results from the Phase 3 Zenith trial. This label expansion is anticipated to enhance its market position, potentially propelling Winrevair to blockbuster status. These developments highlight the critical role of rigorous clinical trials in validating drug efficacy and safety, which ultimately influence regulatory decisions and market dynamics.BridgeBio has also made headlines with its successful Phase 3 trial for a rare disease candidate. By demonstrating significant improvements in clinical outcomes and biomarkers, BridgeBio is poised to file for FDA approval. This reflects an increasing focus on precision medicine within the industry, particularly in addressing rare and genetic disorders.In diabetes management news, Innovent and Eli Lilly's mazdutide has outperformed Novo Nordisk's semaglutide in a head-to-head study focused on glucose regulation and weight loss. As a GLP-1/glucagon dual receptor agonist, mazdutide offers broader therapeutic effects, showcasing the competitive landscape in metabolic disorders where novel mechanisms are vying for superiority.Regulatory activities remain pivotal, as demonstrated by Syndax receiving a second indication for its leukemia drug Revuforj. Such expansions underscore the importance of ongoing clinical research and regulatory engagement in maximizing a drug's therapeutic reach.NSupport the show

In today's episode, we had the pleasure of speaking with Armeen Mahvash, MD, about the FDA approval of SIR-Spheres Y-90 resin microspheres for the treatment of patients with unresectable hepatocellular carcinoma. Dr Mahvash is a professor in the Department of Interventional Radiology in the Division of Diagnostic Imaging at The University of Texas MD Anderson Cancer Center in Houston, as well as an assistant professor in the Department of Diagnostic and Interventional Imaging at The University of Texas Medical School at Houston. In our exclusive interview, Dr Mahvash discussed the significance of this approval, key clinical findings that led to the approval, and how multidisciplinary collaboration is crucial for implementing radioembolization in practice.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most significant shifts and strategies shaping our industry.Novartis's acquisition of Avidity Biosciences for a staggering $12 billion marks a pivotal moment in the pharmaceutical landscape this year. With this acquisition, Novartis underscores its commitment to bolstering its neuromuscular disease pipeline. Avidity Biosciences has made a name for itself with its cutting-edge RNA therapeutic technologies, particularly its Antibody Oligonucleotide Conjugates (AOCs). This platform uniquely combines monoclonal antibodies with oligonucleotides, enhancing precision in targeting specific cell types. The integration of Avidity's technology into Novartis's research efforts could accelerate the development of new therapies, potentially transforming patient care with more effective and targeted treatment options. This move not only highlights the industry's focus on specialized therapeutic areas but also anticipates future advances in RNA therapeutics, extending beyond neuromuscular disorders to areas like oncology.In a similar vein, the FDA has shown its willingness to reconsider drugs that previously faced setbacks. GSK's Blenrep has made a return to the U.S. market after receiving approval for treating certain myeloma patients. This approval is particularly noteworthy given the drug's earlier negative advisory committee vote and postponed decision. It marks a significant rebound for GSK's oncology portfolio and reflects the FDA's dynamic approach towards drugs that show potential in specific therapeutic combinations.Meanwhile, Sanofi continues to make waves with Dupixent, achieving over €4 billion in quarterly sales due to its expanded indications. This success contrasts with a decline in Sanofi's vaccine sales, demonstrating shifting dynamics within pharmaceutical portfolios where biologics and specialty drugs are increasingly pivotal. Sanofi's recent financial report highlighted a notable 17% drop in vaccine sales due to reduced demand and pricing challenges in Europe. In response, companies must navigate fluctuating public health demands and economic pressures effectively.On the global stage, efforts to make transformative therapies like Vertex's Trikafta more accessible are gaining momentum through innovative trade-policy workarounds. A buyers club aims to introduce a lower-cost alternative produced by Bangladesh's Beximco, highlighting ongoing challenges and creative strategies in global drug accessibility.Roche's expansion through Chugai's $200 million M&A deal for an IgA nephropathy asset underscores the strategic importance of regional markets in driving growth. Similarly, Lonza's acquisition of a California biologics site aligns with its goals to meet increasing biomanufacturing demands.The industry is also adapting to technological advancements, with AI integration into life sciences commercialization being touted as a frontier for growth. Despite this potential, many organizations remain unprepared to harness AI fully. Leading companies embedding AI solutions aim for measurable outcomes that could significantly drive strategic decision-making and operational efficiencies.Eli Lilly's acquisition of Adverum Biotechnologies aligns with its strategic interests in gene therapy, focusing on promising therapeutic programs that address unmet medical needs. This acquisition centers around Ixo-vec for wet age-related macular degeneration (AMD), highlighting broader industry trends towards investing heavily in innovative therapies that address unmet needs.Conversely, Sanofi's halt on an RSV vaccine development highlights the inherent risks in vaccine development pipelines. Meanwhile, Regeneron's decision to discontinue a CAR T candidate acquired from 2seventy bio showcases ongoing reassessment witSupport the show

This week in review covers 5 episodes from October 20 to October 24, featuring major developments in pharmaceutical and biotech industries including strategic acquisitions, regulatory updates, and clinical trial results.Episodes included:1. Pharma Innovations: AI's Impact and Strategic Shifts2. Strategic Acquisitions and AI Revolutionize Pharma Landscape3. Industry Shifts: Novo Nordisk's Revamp & ADC Breakthroughs4. Transformative Advances in Precision Oncology and ADCs5. Transformative Oncology Breakthroughs and Regulatory ShiftsKey topics covered:- Strategic acquisitions and partnerships- Regulatory updates and FDA approvals- Clinical trial results and breakthroughs- Industry trends and market developmentsStay informed with Pharma Daily's comprehensive coverage of the pharmaceutical and biotech world.Support the show

In today's episode, we had the pleasure of speaking with Vishal A. Patel, MD, FAAD, FACMS, about the FDA approval of adjuvant cemiplimab-rwlc (Libtayo) for the treatment of patients with high-risk cutaneous squamous cell carcinoma (CSCC). Dr Patel is an associate professor of dermatology at the GW School of Medicine & Health Sciences, as well as the director of the Cutaneous Oncology Program at the GW Cancer Center in Washington, DC. In our exclusive interview, Dr Patel discussed the clinical relevance of this approval, key details about the pivotal phase 3 C-POST trial (NCT03969004), and the safety profile of cemiplimab in patients with CSCC.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most significant shifts occurring in these industries, touching on strategic restructuring, regulatory milestones, and groundbreaking scientific advancements that are shaping the future of drug development and patient care.Let's begin with a major corporate shakeup at Novo Nordisk. The company has announced a significant leadership transition as former CEO Lars Rebien Sorensen is set to become the new chairman of the board. This change follows the resignation of seven board members and indicates a strategic realignment within the company. The Novo Foundation's involvement suggests a deeper strategic shift, potentially aligning with new organizational objectives and innovations. Such moves are pivotal as they could influence Novo Nordisk's market position and future product development.Turning to scientific breakthroughs, Merck's collaboration with Kelun-Biotech has yielded promising results with their Trop2 antibody-drug conjugate, sacituzumab-tmt. This ADC has shown success in two Phase 3 trials targeting lung and breast cancers, underscoring the therapeutic potential of ADCs in oncology. By selectively targeting cancer cells while minimizing damage to healthy tissues, ADCs could significantly improve patient outcomes and represent a powerful modality in cancer treatment.In regulatory affairs, Kenvue is challenging the FDA over proposed safety warnings for Tylenol linked to autism during pregnancy. This dispute highlights the ongoing debates surrounding drug safety and regulatory oversight. The outcome could have significant implications for labeling practices and consumer trust in over-the-counter medications. Meanwhile, Summit Therapeutics plans to file for FDA approval of ivonescimab, highlighting ongoing innovation in drug development pipelines. Similarly, Novo Nordisk's semaglutide pill Rybelsus has received FDA expansion approval to reduce major adverse cardiovascular events. This sets a new benchmark for oral metabolism drugs by demonstrating their potential beyond glycemic control to positively impact cardiovascular health.As we explore industry trends, there's growing interest in direct-to-consumer drug sales. While this approach offers patients access to medications at reduced costs, it raises concerns about privacy and the quality of care without traditional healthcare provider interactions. Additionally, a notable decline in pharmaceutical TV ad spending by 19% in Q3 suggests a shift towards digital engagement strategies. Amidst these narratives, the Biotechnology Innovation Organization (BIO) has launched an awareness campaign to combat misinformation about vaccines. This effort underscores the importance of immunizations in public health and aims to reinforce trust amid rising disinformation.In another scientific advancement, GSK has released positive Phase 3 data for Spero Therapeutics' oral antibiotic candidate. The oral formulation's efficacy comparable to intravenous options could lead to broader use and improved patient adherence—critical advancements as antibiotic resistance remains a global health challenge.Investment activities reflect strategic shifts within the industry as well. Curewell Capital's investment in Wilmington PharmaTech aims to enhance U.S. active pharmaceutical ingredient production capacity—a crucial step given recent global supply chain disruptions. Similarly, India's ACG is making a $200 million investment in its first U.S. empty-capsule production facility, highlighting the strategic importance of manufacturing capabilities on American soil.Galapagos' decision to wind down its cell therapy unit marks a significant strategic pivot from its previous focus on this modality. This shift reflects broader industry trends where companies reassess priorSupport the show

John Gerardi asks the tough questions about the Trump administration's slow action on restricting the abortion pill, including the FDA's approval of a new generic version. With Jonathan Keller, he explores the legal, political, and moral stakes of Mifepristone regulation, why it matters for abortion numbers nationwide, and the challenge of holding pro-life leaders accountable.  

In today's episode, we had the pleasure of speaking with J. Thaddeus Beck, MD, FACP, about the FDA approval of pembrolizumab and berahyaluronidase alfa-pmph (subcutaneous pembrolizumab; Keytruda Qlex) for subcutaneous injection in adult and pediatric patients at least 12 years of age with solid tumors for which the intravenous formulation of pembrolizumab (Keytruda) is indicated.

John and Jonathan unpack the FDA's surprise approval of a generic abortion pill, the political and legal fallout, and why pro-lifers are demanding a real fight over Mifepristone.

Israelis celebrate reports of a ceasefire; on Culture Friday, John Stonestreet covers the FDA approval of generic mifepristone and Bari Weiss at CBS; and Collin Garbarino reviews Tron: Ares. Plus, the Friday morning newsSupport The World and Everything in It today at wng.org/donateAdditional support comes from Cedarville University—a Christ-centered, academically rigorous university located in southwest Ohio, equipping students for Gospel impact across every career and calling. Cedarville integrates a biblical worldview into every course in the more than 175 undergraduate and graduate programs students choose from. New online undergraduate degrees through Cedarville Online offer flexible and affordable education grounded in a strong Christian community that fosters both faith and learning. Learn more at cedarville.edu, and explore online programs at cedarville.edu/onlineFrom Covenant College, where Christian faculty equip students for their callings through hard ideas, deep questions, and meaningful work. covenant.edu/worldAnd from Ambassadors Impact Network, helping entrepreneurs who are looking for more than just funding. Discover a community of Christian faith-led investors. More at ambassadorsimpact.com

In today's episode, we had the pleasure of speaking with Joseph Jacob, MD, MCR, about the FDA approval of the gemcitabine intravesical system (formerly TAR-200; Inlexzo)​ for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer. Dr Jacob is an associate professor of urology and the director of Urologic Oncology in the Department of Urology at State University of New York Upstate Medical University in Syracuse. In our exclusive interview, Dr Jacob discussed the significance of this approval, key efficacy findings from the pivotal phase 2b SunRISe-1 trial (NCT04640623), and the TAR-200 administration procedure, which he describes as straightforward for practitioners and convenient for patients.

In this episode of Disruption/Interruption, host KJ sits down with Jim Foote, CEO and founder of First Ascent Biomedical. Jim shares his personal journey from technology executive to cancer care innovator, after his son’s diagnosis changed his life. Discover how he’s disrupting the status quo in oncology with AI-driven, personalized medicine that’s giving new hope to patients and families. Key Takeaways: The Problem with Standard Cancer Care [3:53]The standard of care treats patients as if they are the same, but everyone is unique. This approach works two-thirds of the time, but leaves one-third of patients with few options. Functional Precision Medicine [13:04]Jim’s company tests up to 152 FDA-approved drugs on a patient’s biopsy to find the most effective treatment, providing doctors with data-driven options tailored to each individual. AI and Technology are Transforming Oncology [28:05]Advances in AI, robotics, and cloud computing have converged, making personalized cancer treatment faster, more affordable, and more effective than ever before. Impact and Future Vision [26:51]Jim’s goal is for every cancer patient to receive individualized treatment from the moment of diagnosis, improving outcomes and reducing unnecessary side effects. Quote of the Show (14:40):“I literally have gone from trying and hoping to testing and choosing.” — Jim Foote Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Jim Foote: LinkedIn: http://www.linkedin.com/in/jim-foote Company Website: https://firstascentbiomedical.com/ How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

In today's episode, we had the pleasure of speaking with Lyudmila Bazhenova, MD, about the FDA approval of sunvozertinib (Zegfrovy) for patients with EGFR-mutated metastatic non–small cell lung cancer (NSCLC). Dr Bazhenova is a clinical professor of medicine at the University of California San Diego (UCSD); as well as a medical oncologist at the UCSD Moores Cancer Center. In our exclusive interview, Dr Bazhenova discussed the significance of this approval, key efficacy and safety data from the pivotal the phase 1/2 WU-KONG1B trial (NCT03974022), and how the use of sunvozertinib in the NSCLC treatment paradigm may propel future possibilities for the use of EGFR-directed agents in this disease.

Guest: Robyn ChambersMinistry: Focus on the FamilyPosition: Vice President of Advocacy for ChildrenTopics: significance of March for Life + analysis of pro-life developmentsWebsites: focusonthefamily.com/pro-life; thedailycitizen.org

Guest: Robyn ChambersMinistry: Focus on the FamilyPosition: Vice President of Advocacy for ChildrenTopics: significance of March for Life + analysis of pro-life developmentsWebsites: focusonthefamily.com/pro-life; thedailycitizen.org

In this episode of Lung Cancer Considered, host Dr. Stephen Liu discusses the recent FDA approval of maintenance lurbinectedin plus atezolizumab for extensive stage small cell lung cancer, based on the phase III IMforte trial. Dr. Hossein Borghaei joins the podcast to explain the results and offer perspective on the impact of maintenance therapy for SCLC. Guest: Dr. Hossein Borghaei, DO, MS Chief, Division of Thoracic Medical Oncology Professor, Department of Hematology/Oncology Fox Chase Cancer Center

In this episode of the Oncology Brothers podcast, we dive deep into the latest advancements in treating extensive stage small cell lung cancer (SCLC), focusing on the IMforte data and its clinical implications. We welcomed esteemed thoracic medical oncologists Drs. Isabel Preeshagul, Ticiana Leal, and Dr. Stephen Liu to discuss the findings presented at ASCO 2025 and World Lung 2025. Key topics included: • Overview of the IMforte study design and patient population • The role of lurbinectedin and atezolizumab as maintenance therapy • Significant improvements in progression-free survival (PFS) and overall survival (OS) • Management of side effects and the importance of prophylactic growth factors • Patient selection criteria for this new standard of care With a focus on bridging the gap between community and academia, this episode provides valuable insights for medical oncologists and patients alike. Tune in to learn how these advancements are changing the landscape of SCLC treatment and improving patient outcomes.  Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ Don't forget to like, subscribe, and check out our other discussions on recent approvals, treatment algorithms, and challenging cases. We are the Oncology Brothers! #IMforte #SCLC #Lurbinectedin #MaintenanceTherapy #ASCO2025 #OncologyBrothers #ES-SCLC

In today's episode, we had the pleasure of speaking with Anne Chiang, MD, PhD, and Stephen Liu, MD, about the FDA approval of lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after frontline induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide. Chiang is an associate professor of medicine in the Section of Medical Oncology and the associate cancer center director of Clinical Initiatives at the Yale School of Medicine in New Haven, Connecticut. Dr Liu is an associate professor of medicine at Georgetown University, as well as the director of Thoracic Oncology and head of Developmental Therapeutics at the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC. In our exclusive interview, Drs Chiang and Liu discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 IMforte trial (NCT05091567), and how the addition of this regimen in the ES-SCLC treatment paradigm may affect clinical practice.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Trump has announced a 100% tariff deadline for pharmaceutical companies starting on October 1. However, companies that have already begun construction on manufacturing facilities in the U.S. are exempt from these tariffs. This move is part of the administration's efforts to lower drug prices and improve access to treatments for patients.In other news, Crinetics Pharmaceuticals has received FDA approval for their once-daily treatment for acromegaly, a rare pituitary condition. This approval marks a significant milestone for Crinetics and is expected to have a positive impact on patients' lives.Additionally, Lilly's oral SERD has been approved by the FDA for the treatment of breast cancer. This treatment has shown improved progression-free survival compared to standard therapy, offering new hope for patients battling this disease.The Trump administration is also preparing a proposed rule to further lower drug prices in the U.S., as part of an ongoing effort to align drug prices with other economically similar countries. These developments in the pharmaceutical industry are aimed at improving access to treatments and lowering costs for patients.

IASLC Lung Cancer Considered: FDA Approval: Subcutaneous Immunotherapy by IASLC

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a comeback in the obesity market with the acquisition of Metsera for $4.9 billion, rejuvenating its portfolio after facing challenges with three discontinued assets. Meanwhile, Stealth BioTherapeutics has received expedited FDA approval for the first-ever treatment for Barth syndrome, and Sanofi's decision on their oral multiple sclerosis drug has been postponed to December. The ACIP committee has expressed concerns about a lack of knowledge and experience within the reconstituted committee. Biotility offers industry-recognized credentials to advance bioscience careers, Novartis is exploring ways to reduce drug costs in the US, and Merck has received approval for a subcutaneous formulation of Keytruda. Stay tuned for more updates on the psychedelics space, rare disease treatments, and other developments in the biopharmaceutical industry.

Martha Carlin, CEO and founder of the Bio Collective, details the significant influence of the microbiome on overall health. Martha discusses her unconventional path from accounting to microbiome research, sparked by her husband's Parkinson's diagnosis. Together, they explore the complex connections between gut health and diseases like Parkinson's, autism, and even Alzheimer's. Martha sheds light on groundbreaking research funded by NIH grants, the potential of machine learning and AI in understanding microbiome patterns, and the future prospects of personalized probiotics. Practical advice on maintaining a healthy microbiome, the impact of diet and exercise, and the intriguing intersections between gut health, neurochemistry, and systemic diseases are highlighted. The discussion also covers challenges in integrating microbiome research into clinical practice and potential future therapies.

Dr. Hoffman continues his conversation with Martha Carlin, CEO and founder of the Bio Collective.

The FDA just approved the cyclobenzaprine (Tonmya, Flexeril) for fibromyalgia. We look at three risks that medication raises in psychiatry.CME: Take the CME Post-Test for this EpisodePublished On: 09/01/2025Duration: 16 minutes, 42 secondsChris Aiken, MD and Kellie Newsome, PMHNP have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.

In today's episode, supported by Chimerix, we spoke with Patrick Y. Wen, MD, about the FDA approval of dordaviprone (Modeyso) for the treatment of adult and pediatric patients at least 1 year of age with H3K27M-mutated diffuse midline glioma who have progressive disease following prior therapy. Dr Wen is the director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute; as well as a professor of neurology at Harvard Medical School in Boston, Massachusetts. In our conversation, Dr Wen discussed the significance of this accelerated approval across patient age groups, key efficacy and safety data that supported this approval, and the importance of biomarker testing in patients with glioma. He also highlighted potential next steps for expanding the investigation of dordaviprone in patients with glioma and emphasized the ways that multidisciplinary collaboration can provide patients with personalized, optimized care. 

In his weekly clinical update, Dr. Griffin with Vincent Racaniello are dismayed about the recent attack on public health the firing of the director of the CDC as well as resignation of 3 others members of the agency's leadership, the continued Legionnaire's outbreak in Harlem, suspension of Ixchiq the Chikungunya virus attenuated infectious vaccine, the first US case of New World screwworm before Dr. Griffin deep dives into recent statistics on the measles epidemic, RSV, influenza and SARS-CoV-2 infections, the Wasterwater Scan dashboard, Johns Hopkins measles tracker, association Guillian-Barré syndrome with RSV vaccination, guidelines for using RSV vaccines, whether or not the NB.1.8.1 should be included in the fall 2025 vaccines, the American College Obstetricians and Gynecologists recommendations for the COVID, RSV and influenza vaccines, FDA approval letters for Pfizer, moderna and Novagax COVID vaccines including label changes for use in those between 5 through 64 years, where to find PEMGARDA, long COVID treatment center, where to go for answers to your long COVID questions, and contacting your federal government representative to stop the assault on science and biomedical research. Subscribe (free): Apple Podcasts, RSS, email Become a patron of TWiV! Links for this episode White House Says New C.D.C. Director Is Fired, but She Refuses to Leave (NY Times) CDC director refuses to leave after White House order (BBC) Legionnaires' Disease: In Harlem(NYC Health) New York City Health Department Provides Update on Community Cluster of Legionnaires' Disease in Central Harlem(NYC Health: Promoting and protecting the City's health) FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live) (FDA) Vimkunya (Bavarian Nordiac) U.S. and Panama for the control of the Screwworm pest (COPEG) Rare human case of flesh-eating parasite New World screwworm identified in US(CNN) USDA Announces Sweeping Plans to Protect the United States from New World Screwworm (USDA) HHS details New World screwworm response after human case(CIDRAP) Wastewater for measles (WasterWater Scan) Measles cases and outbreaks (CDC Rubeola) Tracking Measles Cases in the U.S. (Johns Hopkins) Weekly measles and rubella monitoring (Government of Canada) Measles (WHO) Get the FACTS about measles (NY State Department of Health) Measles (CDC Measles (Rubeola)) Measles vaccine (CDC Measles (Rubeola)) Presumptive evidence of measles immunity (CDC) Contraindications and precautions to measles vaccination (CDC) Measles (CDC Measles (Rubeola)) Measles vaccine recommendations from NYP (jpg) Adverse events associated with childhood vaccines: evidence bearing on causality (NLM) Measles Vaccination: Know the Facts(ISDA: Infectious Diseases Society of America) Deaths following vaccination: what does the evidence show (Vaccine) Influenza: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) Respiratory virus activity levels (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Relative effectiveness of high-dose versus standard-dose influenza vaccine against hospitalizations and mortality according to frailty score (JID) FDA-CDC-DOD: 2025-2046 influenza vaccine composition (FDA) RSV: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) ENFLONSIA: novel drug approvals 2025 (FDA) RSV-Network (CDC Respiratory Syncytial virus Infection) Vaccines for Adults (CDC: Respiratory Syncytial Virus Infection (RSV)) Evaluation of Guillain-Barré Syndrome (GBS) following Respiratory Syncytial Virus (RSV) Vaccination Among Adults 65 Years and Older (FDA) Economic Analysis of Protein Subunit and mRNA RSV Vaccination in Adults aged 50-59 Years (CDC: ACIP) Evidence to Recommendations Framework (EtR): RSV Vaccination in Adults Aged 50–59 years (CDC: National Center for Immunization and Respiratory Diseases) Waste water scan for 11 pathogens (WastewaterSCan) COVID-19 deaths (CDC) Respiratory Illnesses Data Channel (CDC: Respiratory Illnesses) COVID-19 national and regional trends (CDC) COVID-19 variant tracker (CDC) SARS-CoV-2 genomes galore (Nextstrain) Antigenic and Virological Characteristics of SARS-CoV-2 Variant BA.3.2, XFG, and NB.1.8.1 (bioRxiV) Veering from CDC, ACOG recommends maternal vaccination against COVID-19 (CIDRAP) ACOG Releases Updated Maternal Immunization Guidance for COVID-19, Influenza, and RSV (American College of Obstericians and Gynecologists) COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care (American College of Obstericians and Gynecologists) Pfizer and BioNTech's COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19 (Pfizer)  COMIRNATY approval letter (FDA) Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2 (FEEDS) SPIKEVAX approval letter (FDA) Novavax's Nuvaxovid 2025-2026 Formula COVID-19 Vaccine Approved in the U.S (Novavax) NUVAXOVID approval letter (FDA) Where to get pemgarda (Pemgarda) EUA for the pre-exposure prophylaxis of COVID-19 (INVIYD) Infusion center (Prime Fusions) CDC Quarantine guidelines (CDC) NIH COVID-19 treatment guidelines (NIH) Drug interaction checker (University of Liverpool) Paxlovid (Pfizer) Infectious Disease Society guidelines for treatment and management (ID Society) Molnupiravir safety and efficacy (JMV) Convalescent plasma recommendation for immunocompromised (ID Society) What to do when sick with a respiratory virus (CDC) Managing healthcare staffing shortages (CDC) Steroids,dexamethasone at the right time (OFID) Anticoagulation guidelines (hematology.org) Daniel Griffin's evidence based medical practices for long COVID (OFID) Long COVID hotline (Columbia : Columbia University Irving Medical Center) The answers: Long COVID Reaching out to US house representative Letters read on TWiV 1248 Dr. Griffin's COVID treatment summary (pdf) Timestamps by Jolene Ramsey. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv Content in this podcast should not be construed as medical advice.

In today's episode, supported by Nuvation Bio, we spoke with Joel Neal, MD, PhD, and Christian Rolfo, MD, PhD, about the FDA approval of taletrectinib (Ibtrozi) for the treatment of patients with locally advanced or metastatic, ROS1-positive non–small cell lung cancer (NSCLC). Dr Neal is a professor of medicine in the Division of Oncology at the Stanford Cancer Institute at Stanford University in Palo Alto, California. Dr Rolfo is the director of the Division of Medical Oncology at The Ohio State University Comprehensive Cancer Center—James and a professor in the College of Medicine at The Ohio State University in Columbus. In our conversation, Drs Neal and Rolfo discussed the significance of this approval, key data from the pivotal phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials, and taletrectinib's current role in the NSCLC treatment paradigm.

In today's episode, supported by Boehringer Ingelheim, we spoke with Ticiana Leal, MD, and Misako Nagasaka, MD, PhD, about the FDA approval of zongertinib (Hernexeos) for previously treated patients with HER2 TKD–mutant advanced non–small cell lung cancer (NSCLC). Dr Leal is an associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia; as well as medical director of the Clinical Trials Office and leader of the Lung Cancer Disease Team at the Winship Cancer Institute of Emory University. Dr Nagasaka is an associate professor of medicine in the Division of Hematology and Oncology at the University of California, Irvine (UCI) School of Medicine; as well as a medical oncologist at UCI Health. In our conversation, Drs Leal and Nagasaka discussed the significance of this approval, key efficacy and safety findings from the pivotal phase 1 Beamion LUNG-1 trial (NCT04886804), and where zongertinib currently fits into the NSCLC treatment paradigm.

Send us an inquiry through a text message here!Welcome to a very special episode of The Veterinary Roundtable! In this episode, the ladies welcome Dr. Linda Black, CEO of Gallant, to discuss how stem cells work, the efficacy of stem cell therapy in dogs and cats, the company's goals for the future, and so much more.Do you have a question, story, or inquiry for The Veterinary Roundtable? Send us a text from the link above, ask us on any social media platform, or email theveterinaryroundtable@gmail.com!Episodes of The Veterinary Roundtable are on all podcast services along with video form on YouTube!Connect with Linda on LinkedIn: https://www.linkedin.com/in/lindablackdvmphd/ Gallant Website: https://www.gallant.com/ TIMESTAMPS00:00 Intro02:15 Dr. Linda Black03:49 Maintaining Mental Health07:02 An Overview of Gallant11:04 Gallant's Use of a Uterus14:00 What Gallant Does When They Need More Pets17:00 How Stem Cells Work21:00 The Potential Candidates For Stem Cell Therapy24:09 FDA Approval and Side Effects27:33 Using With Multiple Therapeutics37:41 The Option of Equine Medicine39:07 Timeline of Expectations43:58 Replacing Treatments That Exist Now45:13 Vaccinations46:35 Gallant's Biggest Hurdle50:40 Dr. Linda Black's Journey57:41 Books We're Reading01:02:37 The Goal of the Podcast01:05:53 One Thing Listeners Should Take Away01:06:50 Outro

Welcome back to the Oncology Brothers podcast! In this episode, Drs. Rohit & Rahul Gosain are joined by Dr. Joshua Sabari from the NYU Langone Cancer Center to discuss the exciting recent approval of Zongertinib, the first oral TKI for HER2-positive lung cancer. We dived deep into the prevalence of HER2 mutations in non-small cell lung cancer, the study design and findings from the Beamion LUNG-1 trial, and the implications of this new therapy in clinical practice. Dr. Sabari shared insights on the efficacy of Zongertinib, including impressive response rates and progression-free survival data, as well as its side effect profile compared to other treatments like trastuzumab deruxtecan (T-DXd). Key topics covered in this episode: •⁠  ⁠Overview of HER2 mutations in lung cancer •⁠  ⁠Study design and results of the Beamion LUNG-1 •⁠  ⁠Comparison of Zongertinib and T-DXd in treatment settings •⁠  ⁠Management of common side effects associated with Zongertinib •⁠  ⁠Future directions for HER2-targeted therapies Join us for this informative discussion as we explore the latest advancements in lung cancer treatment and what they mean for patients and clinicians alike. Don't forget to subscribe for more episodes on new approvals, side effect management, and practice-changing data in oncology! Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/

Did you know that nearly one in three people with obesity may have fatty liver disease without even knowing it? In this episode, I talk about groundbreaking news in obesity and liver health, focusing on the FDA's recent approval of WeGovy to treat metabolic dysfunction associated steatohepatitis (MASH) with moderate to advanced fibrosis. I share a personal story about a friend who once struggled with fatigue, abnormal liver tests, and fatty liver disease, highlighting how limited treatment options used to be. I explain what MASH is, why it's so serious, and how common it is, especially among people with obesity and metabolic syndrome.  Furthermore, I dive into the ESSENCE trial, which showed that WeGovy not only improved liver inflammation and scarring but in some cases even reversed the disease, all while emphasizing that it works best when combined with lifestyle changes like healthy eating and regular activity.  Don't miss this episode where I break down the latest breakthrough in liver and weight loss care that could change your health journey!   Episode Highlights: FDA approval of WeGovy for treating MASH with fibrosis The ESSENCE trial results showing improvements in liver health Understanding what MASH is and why it's so common Importance of combining medication with lifestyle changes Connect with Dr. Alicia Shelly: Website | drshellymd.com Facebook | www.facebook.com/drshellymd Instagram | @drshellymd Linked In | www.linkedin.com/in/drshellymd Twitter | @drshellymd About Dr. Alicia Shelly Dr. Alicia Shelly was raised in Atlanta, GA. She received her Doctorate of Medicine from Case Western Reserve University School of Medicine in Cleveland, OH.  Dr. Shelly has been practicing Primary Care and Obesity medicine since 2014.  In 2017, she became a Diplomat of the American Board of Obesity Medicine. She is the lead physician at the Wellstar Medical Center Douglasville. She started a weekly podcast & Youtube channel entitled Back on Track: Achieving Healthy Weight loss,  where she discusses how to get on track and stay on track with your weight loss journey. She has spoken for numerous local and national organizations, including the Obesity Medicine Association, and the Georgia Chapter of the American Society of Metabolic and Bariatric Surgeons. She has been featured on CNN, Fox 5 News, Bruce St. James Radio show, Upscale magazine, and Shape.com. She was named an honoree of the 2021 Atlanta Business Chronicle's 40 under 40 award. She also is a collaborating author for the, “Made for More: Physician Entrepreneurs who Live Life and Practice Medicine on their own terms''.   Resources: FREE! Discover the 5 Reasons Your Weight-Loss Journey Has Gotten Derailed (And How To Get Back On Track!)

If injectable weight loss drugs like Zepbound can help people lose 20% of their weight, what about a once-a-day pill that achieves 12% weight loss, without the needles and sky-high cost? In this episode, Lisa Oldson, MD shares Andrea's journey through the maze of weight loss medications and introduces the promising new drug orforglipron. You'll hear how this oral GLP-1 agonist compares to popular injectables, why it could be a game-changer for millions, and the top five reasons to consider medication as part of a comprehensive weight loss plan. Whether you're curious about new treatments, concerned about side effects, or looking for affordable options, this episode breaks down what you need to know about orforglipron and the future of weight loss medicine.Thanks for listening! If you'd like more support during your SMART weight loss & health focused journey, sign up for our FREE newsletter by emailing us at Team@SmartWeightLossCoaching.com, or check out our program at: www.SmartWeightLossCoaching.com. We would love to help you reach your happy weight, and transform the way you talk to yourself about your body and the number on the scale. Negative thoughts about yourself don't have to take up so much brain space, and we'd be honored to help you reframe those thoughts. Also…We'd be grateful if you'd follow us and share our podcast with your friends & family. We're here to help you improve your health, live longer, healthier, and lose weight the SMART way! This episode was produced by The Podcast Teacher: www.ThePodcastTeacher.com.

An update on natural thyroid availability and the FDAA correction on disseminated sarcoidosis and stressI'm a former smoker. Should I be concerned about beta carotene in the Alpha Base multivitamin?A comment from a user of lithium orotate for the last eleven yearsDoes long-term use of Horse Chestnut cause a thiamin deficiency?

In this episode of the Oncology Brothers podcast, Drs. Rohit & Rahul Gosain welcome Dr. Jacob Sands, a thoracic medical oncologist from the Dana-Farber Cancer Institute, to discuss the recent FDA approval of Dato-DXD (datopotamab deruxtecan) for previously treated EGFR-mutated non-small cell lung cancer (NSCLC). Key Topics: •⁠  ⁠Overview of Dato-DXd and its FDA approval •⁠  ⁠Mechanism of action and study design of the TROPION Lung trials •⁠  ⁠Efficacy and safety profile of Dato-DXd •⁠  ⁠Management of side effects and clinical pearls •⁠  ⁠Treatment sequencing for EGFR-mutated NSCLC Join us as we dive into the details of the TROPION Lung trials that led to this significant approval, the mechanism of action of Dato-DXd, and the implications for patients with various EGFR mutations.  Dr. Sands shared insights on the study design, efficacy, and tolerability of this new antibody-drug conjugate, as well as important clinical pearls for managing side effects such as stomatitis, dry eyes, and interstitial lung disease (ILD). We also explored the current treatment landscape for EGFR-mutated NSCLC, including the sequencing of therapies and the potential role of Dato-DXd in clinical practice. Tune in for an informative discussion that highlights the exciting advancements in oncology and the hope they bring to patients. Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ Don't forget to like, subscribe, and check out our other episodes for more insights into the world of oncology!

In today's episode, we spoke with Nisha Joseph, MD, and Hans Lee, MD, about the FDA's accelerated approval of linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Joseph is an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia. Lee is the director of Myeloma Research at the Sarah Cannon Research Institute in Nashville, Tennessee.  In our conversation, Drs Lee and Joseph discussed the significance of this approval, key data from the pivotal phase 1/2 LINKER-MM1 trial (NCT03761108), and where linvoseltamab fits into the relapsed/refractory myeloma treatment paradigm alongside other approved agents. 

Novo Nordisk (NVO) jumped higher after the FDA approved the company's Wegovy drug as a liver disease treatment. Dayforce (DAY) rallied more than 25% off reports that Thoma Bravo is looking to acquire the company. Nvidia (NVDA) has more bullish momentum heading into next week's earnings thanks to price target hikes from Morgan Stanley and Cantor Fitzgerald. Sam Vadas explains the biggest market movers starting the trading week.======== Schwab Network ========Empowering every investor and trader, every market day. Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/ About Schwab Network - https://schwabnetwork.com/about

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: FDA approves the first fast-acting biosimilar insulin in the US, Tandem issues warning, DOJ stands up for remote monitoring in schools, GLP1 use protects against dementia, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out 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 Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX We've got the first and only biosimilar FDA approved and moving to market. Kirsty – insulin aspart, which is a biosimilar to Novolog will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. KIRSTY has been available in Europe and Canada since 2022. This same company makes Semglee, the first biosimilar for long acting? Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA. https://www.globenewswire.com/news-release/2025/07/15/3115973/0/en/Biocon-Biologics-Expands-Diabetes-Portfolio-with-FDA-Approval-of-Kirsty-the-First-and-Only-Interchangeable-Rapid-Acting-Insulin-Aspart-in-the-United-States.html XX Tandem Diabetes Care (Nasdaq:TNDM) has issued an urgent medical device correction for some t:slim X2 automated insulin pumps. In a July 22 notice, the San Diego-based company warned of pumps that may exhibit a higher rate of speaker failure. During normal use, the insulin pump software monitors current flowing through the speaker during use. Measurements that fall within a pre-determined range indicate a functioning speaker. Meanwhile, measurements falling outside the range indicate a speaker failure.   When the measurements land outside the expected range, the system declares a malfunction, referred to as “Malfunction 16.” If the pump declares this malfunction, insulin delivery will stop and the pump will no longer be operational. Malfunction 16 terminates communication between the pump and continuous glucose monitor (CGM), as well as the t:slim mobile app.   If not addressed, the issue can lead to hyperglycemia, which can result in hospitalization or medical intervention. The company reports 700 adverse events and 59 reported injuries to date, with no reports of death.   Tandem identified that certain speaker versions have a higher rate of Malfunction 16 events due to a wiring issue within the speaker. Users can continue using their pump but with added precautions because Malfunction 16 can occur at any time. They should use the t:slim mobile app with push notifications turned on so the app alerts them if the malfunction occurs, the company said.   Additionally, Tandem intends to release a software update aimed at enhancing the early detection of speaker failure. The update also introduces persistent vibration alarms to help reduce potential safety risk. Tandem plans to notify affected pump users when it makes the update available. https://www.drugdeliverybusiness.com/tandem-warns-insulin-pump-speaker-malfunction/ XX BIG WIN! The DOJ protects T1D rights again! The US Attorney's office for the Western District of Washington State reached a settlement with a public school district that once again confirms remotely monitoring students' CGMs is a reasonable accommodation that schools must provide to comply with the Americans with Disabilities Act. If its true for one state its true for all states under federal law! If your local schools still refuse to remotely monitor CGMs of their students, provide them with this letter to compel them to FOLLOWT1Ds and FOLLOW Federal Laws. If they still refuse contact us! https://followt1ds.org/ XX new study finds people taking GLP-1 agonists had a significantly lower cumulative risk of developing dementia, when compared to metformin users. Past studies show that people who have type 2 diabetes — a chronic condition where the body does not use its insulin properly — are at a higher risk of developing dementia. The study found that when comparing the neuroprotective abilities of two diabetes medications — metformin and glucagon-like peptide-1 receptor agonists (GLP-1 agonists) — participants taking GLP-1 agonists had a significantly lower cumulative risk of developing dementia, when compared to metformin.   https://www.medicalnewstoday.com/articles/glp-1s-may-offer-better-dementia-protection-than-metformin XX Front office changes coming to Dexcom.  CEO Kevin Sayer will step down  & give the reins to current Chief Operating Officer Jake Leach. Scheduled for January 1, 2026, Leach will also join Dexcom's board of directors where Sayer will remain  executive chairman. One of our frequent guests here.. Leach has worked at Dexcom for 21 years. He served as chief technology officer from 2018 to 2022 before he was named COO in late 2022. He was given the title of president in May. https://www.medtechdive.com/news/dexcom-ceo-change-kevin-sayer-jake-leach/756382/ XX A major international study has revealed that many children and young adults in Sub-Saharan Africa who are diagnosed with type 1 diabetes (T1D) may actually have a different, non-immune-based form of the condition. Unlike the traditional autoimmune version of T1D, this form appears to develop without the immune system attacking the insulin-producing cells. This finding could significantly reshape how diabetes is diagnosed and treated across the region, potentially leading to more precise care and better health outcomes. The researchers found that many young people in Sub-Saharan Africa diagnosed with T1D often don't have the usual markers in their blood (called islet autoantibodies) typically seen in people with T1D in other parts of the world. Specifically, 65% of participants with T1D in this region did not have islet autoantibodies. When the researchers compared this data to studies in the U.S., they found a smaller but significant proportion (15%) of Black participants diagnosed with T1D had a similar form of diabetes found in Sub-Saharan Africa – characterized by negative autoantibodies and a low T1D genetic risk score.   However, white Americans with T1D showed the typical autoimmune pattern, even if they didn't have detectable autoantibodies, their genetics still pointed to autoimmune diabetes.   “The identification of this T1D diabetes subtype in Sub-Saharan African populations and among individuals of African ancestry in the U.S. suggests a potential ancestral or genetic link,” Dabelea notes. “These findings highlight the need to consider alternative etiologies in this group and a deeper understanding of the underlying mechanisms may provide important insights for future prevention and treatment strategies.”     https://scitechdaily.com/new-diabetes-subtype-discovered-in-africa-challenges-global-assumptions/   XX Formal recognition for the specialty of Diabetology.   Diabetology is the specialty focused on the full continuum of diabetes care — encompassing diagnosis, treatment, prevention, technology integration, education, and cardiometabolic management. While it intersects with endocrinology, primary care, and public health, diabetology is uniquely defined by its depth and focus on diabetes alone.       The American College of Diabetology (ACD) is the national professional organization representing clinicians who specialize in diabetes care. ACD advances clinical excellence and education to improve the lives of those affected by diabetes. https://www.businesswire.com/news/home/20250725766248/en/American-College-of-Diabetology-Announces-Formal-Taxonomy-Classification-for-Diabetology   XX Tidepool announces cloud-to-cloud integration with Abbott's FreeStyle Libre portfolio. From the release: This integration allows people living with diabetes using the FreeStyle Libre portfolio to connect their data to their Tidepool account seamlessly. For healthcare providers, this means more comprehensive insights and streamlined workflows, with FreeStyle Libre systems data flowing continuously into the Tidepool Data Platform. https://www.tidepool.org/blog/abbott-freestyle-libre-integration-launched XX Stelo dexom ai food XX With high drug prices remaining an ongoing concern for U.S. politicians, Roche is considering following in the footsteps of some of its peers with a direct-to-consumer (DTC) model to cut out the middlemen.     About 50% of the money spent on drugs in the U.S. healthcare system goes straight to PBMs instead of the companies that create the medicines, Roche CEO Thomas Schinecker called out in a press conference on Thursday.   Bringing the drugs directly to the consumer could be a solution to positively impact pricing for patients “without destroying innovation,” Schinecker added on a separate Thursday call with investors, noting that the company has discussed the matter with the U.S. government and its Department of Health and Human Services. The pricing talks come after President Donald Trump inked a “Most Favored Nation” executive order in May, aiming to tie U.S. drug prices to lower prices in other developed nations. The plan was quickly called out by industry voices such as the PhRMA trade group, which labeled it a “bad deal” for U.S. patients. https://www.fiercepharma.com/pharma/roche-weighing-direct-consumer-drug-sales-ease-us-drug-pricing-woes-cut-out-pbms-ceo-says XX SAB BIO secures substantial $175M financing to advance T1D therapy with impressive investor lineup and extended cash runway until 2028. Most critically, this financing fully funds the pivotal Phase 2b SAFEGUARD study evaluating SAB-142 for delaying progression of autoimmune Type 1 diabetes in newly diagnosed patients. By extending the cash runway into mid-2028, SAB has effectively eliminated near-term financing risk and provided clear visibility through this crucial clinical trial and potential commercialization preparation. Participation from strategic investor Sanofi, along with new investors RA Capital Management, Commodore Capital, Vivo Capital, Blackstone Multi-Asset Investing, Spruce Street Capital, Forge Life Science Partners and Woodline Partners LP, and existing investors Sessa Capital, the T1D Fund, and ATW Partners         https://www.stocktitan.net/news/SABS/sab-bio-announces-oversubscribed-175-million-private-fwsf2t91ek4z.html   XX In a landmark 14-year study, researchers have found that artificially sweetened drinks raise the risk of developing type 2 diabetes by more than a third, significantly higher than those loaded with sugar. It challenges the long-standing perception of diet drinks being a healthier alternative and suggests they may carry metabolic risks of their own. In the first longitudinal study of its kind, led by Monash University, researchers tracked 36,608 participants over an average period of 13.9 years to assess how both sugar-sweetened beverages (SSBs) and artificially sweetened beverages (ASBs) impacted health outcomes. The self-reported health data, from the Melbourne Collaborative Cohort Study, was drawn from participants aged 40 to 69 years at the time of recruitment.   What they found was that drinking just one can of artificially sweetened soda increased the risk of developing type 2 diabetes by 38%, compared to people who didn't consume these drinks at all. For those consuming the same amount of sugary drinks, the risk was 23% higher. This suggests there's more than obesity at play. The researchers believe this result is due to an independent metabolic effect, possibly gut microbiome disruption or a change in glucose metabolism.   While the study didn't identify which artificial sweeteners were at play,   Evidence suggests that artificial sweeteners can alter the composition and function of gut bacteria, leading to glucose intolerance – a precursor to type 2 diabetes. And that some sweeteners may trigger insulin release, desensitize metabolic responses over time, or confuse the body's glucose regulation system – even without actual sugar in the picture.   Another hypothesis is that regular exposure to the kind of intense sweetness that artificial products deliver may condition the body to anticipate sugar calories that never come, affecting appetite regulation, insulin sensitivity and broader metabolic pathways. However, the authors suggest that how sweeteners affect the gut microbiota and glucose regulation are the most likely drivers of increased diabetes risk.   https://newatlas.com/diet-nutrition/one-drink-diabetes-risk/ XX After months of deliberation, information gathering and public testimony, a state board unanimously agreed Monday that two common medications for type-2 diabetes and other conditions appear to pose an affordability challenge to the state and Marylanders.   The state Prescription Drug Affordability Board approved two resolutions saying that prescription drugs Jardiance and Farxiga likely pose an “an affordability challenge for the state health care system” and the state should look for ways to bring down those costs.   Health care advocates call the long-awaited resolution an “important first step” in the process in bringing down prescription costs for those on the state's health plan.       That milestone has been years in the making. Created in 2019 by the General Assembly, the Prescription Drug Affordability Board was slow to launch due in part to a veto from former Gov. Larry Hogan (R) amid pandemic-induced economic uncertainty in 2020 that delayed the board's formation. The board also cited out-of-pocket costs for consumers and state and local spending on those drugs as indicators that there may be an affordability challenge.   The board will now look at options to address the potential affordability challenge, which could include setting an upper payment limit on those drugs. But it's not clear when the state will see cost savings.   That said, some members of the health care system and the pharmaceutical industry say that policies such as upper payment limits could weaken access to life-saving drugs. Others say that the board has not engaged enough viewpoints from the health care industry. https://marylandmatters.org/2025/07/29/state-board-determines-two-type-2-diabetes-drugs-may-be-unaffordable/   XX One year after it was revealed that Chrissy Teigen and John Legend's son, Miles, was diagnosed with type 1 diabetes, Teigen is revealing how she's making her son feel more included. Teigen first opened up about her 7-year-old son's diagnosis after she and her two oldest kids, Miles and 9-year-old daughter Luna were at the 2024 summer Olympics cheering on Simone Biles. Teigen posted a photo of Miles and Luna holding up a sign. Also visible in the picture was the insulin pump on Miles' arm. Now, Teigen is sharing some insight into how she's making Miles more comfortable with having type 1 diabetes, including giving LeBron James' Barbie doll type 1 diabetes as well. In a video shared on Instagram, Teigen is seen taking the T1D Barbie, removing her insulin pump and gluing the pump onto LeBron James' Barbie. “Turning T1D Barbie into T1D Lebron James for my son,” Teigen captioned the video, revealing James is Miles' hero. 41 million followers https://www.yahoo.com/lifestyle/articles/chrissy-teigen-gives-lebron-james-154608782.html