Podcasts about vegf

What if the most talked-about healing peptide in biohacking came from your own stomach — and carried a risk nobody in the space is talking about?BPC-157, nicknamed "the Wolverine Peptide," has taken over fitness forums, longevity podcasts, and regenerative medicine circles. The preclinical data on tissue repair is remarkable. But the same biological mechanism that drives its healing power is the exact mechanism tumors use to survive and grow.BPC-157 is a synthetic 15 amino acid sequence isolated from human gastric juice, first identified in the early 1990s. It drives tissue repair through six mechanisms: angiogenesis via VEGF upregulation, nitric oxide pathway modulation, FAK paxillin signaling activation, growth hormone receptor upregulation in tendons and ligaments, anti-inflammatory cytokine downregulation, and free radical scavenging for cell protection. An active Phase II randomized controlled trial is currently evaluating BPC-157 for acute hamstring muscle strain repair. Its pro-angiogenic properties raise a theoretical cancer risk in individuals with undiagnosed early-stage tumors. WADA has banned it for competitive athletes. The FDA has reclassified its availability and the FDA Pharmacy Compounding Advisory Committee is reviewing its status on the approved bulk substances list.Dr. Joy Kong talks about:00:00 Meet The Wolverine Peptide02:40 Discovered Inside Human Gastric Juice03:42 Six Pathways That Drive Healing07:33 The First Real Human Trial07:58 Why The FDA Cracked Down09:24 The Hidden Cancer RiskAdditional Resources:✨ Visit My Clinic: Chara Health

Dr. William Li: Eat to Beat Disease, Extend Longevity, and Hack Your Vascular Health Your body already has a built-in cancer defense system, and the foods you eat can rival prescription drugs at activating it. In this episode, you'll discover what 720,000 living centenarians reveal about longevity, why microplastics are reaching your brain through your nose, and how your blood vessels hold the real key to biological aging. -Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR Host Dave Asprey sits down with Dr. William Li, an internationally renowned physician, scientist, and two-time New York Times bestselling author of "Eat to Beat Disease" and "Eat to Beat Your Diet." As President and Medical Director of the Angiogenesis Foundation, Dr. Li's groundbreaking research has led to the development of more than 40 new medical treatments impacting care for over 70 diseases including diabetes, heart disease, blindness, and obesity. His TED Talk, "Can We Eat to Starve Cancer?", has surpassed 11 million views, making him one of the most trusted voices at the intersection of functional medicine and food as medicine science. Together they dig into the biology of SuperAgers, the vascular markers that predict how long you'll live, and why flow-mediated dilation may be the most underrated biohacking measurement tool available today. Dave shares what happened after four separate gene therapies, including klotho and VEGF, and Dr. Li explains why your metabolism, mitochondria, and gut microbiome show up in the data on every centenarian ever studied. They also get into the microplastic crisis, the cribriform plate pathway that delivers airborne particles directly to your brain, and why your tongue is the first place your body quietly stores fat. You'll Learn: What centenarian research reveals about immune function, gut health, and vascular resilience Why 50% of food extracts matched or outperformed cancer drugs in head-to-head angiogenesis testing How microplastics travel through your nose directly to your central nervous system What flow-mediated dilation and pulse wave velocity tell you about your true biological age Why your hind-third tongue fat is an overlooked early warning sign for sleep apnea and metabolism problems What Dave's four gene therapies (klotho, VEGF, follistatin) actually did to his body How the vagus nerve connects gut health to brain optimization, stress resilience, and longevity Why genetics now accounts for roughly half of longevity outcomes, and what that means for the future of gene therapy How to use biohacking tools to compound your health the same way you compound financial returns Thank you to our sponsors! - Beyond Wonderland Conference | Oct 13 - 14, 2026. Get your ticket now at wonderlandconference.com. - Amp | If you're ready to make fitness fit into your life, go to amp.ai to check it out - Caldera + Lab | A small habit with big results. Go to CalderaLab.com/DAVE and use code DAVE for 20% off your first order. - Calroy | Go to Calroy.com/DAVE for exclusive discounts on Arterosil HP, Vascanox HP and all Calroy products. 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 inhealth, 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: William Li, Dr. William Li, Eat to Beat Disease, angiogenesis, food as medicine, centenarians, SuperAgers, longevity, anti-aging, biohacking, vascular health, flow-mediated dilation, pulse wave velocity, microplastics, cribriform plate, gene therapy, klotho, VEGF, follistatin, mitochondria, metabolism, gut health, vagus nerve, sleep apnea, functional medicine, human performance, brain optimization, cancer prevention, inflammation, immune system Resources: • Learn More About Dr. Li's Work At: https://drwilliamli.com • Get My 2026 Clean Nicotine Roadmap | Enroll for free at https://daveasprey.com/2026-clean-nicotine-roadmap/ • Dave Asprey's Latest News | Go to https://daveasprey.com/ to join Inside Track today. • 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 • Join My Substack (Live Access To Podcast Recordings): https://substack.daveasprey.com/ • Upgrade Labs: https://upgradelabs.com Timestamps: 00:00 – Trailer 02:33 – William's Background 06:21 – Food vs. Cancer Drugs 14:09 – Gene Therapy 23:50 – Centenarian Research 27:41 – Stress & the Vagus Nerve 37:31 – Vascular Health 42:34 – Microplastics 53:19 – Novel Biomarkers See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In Part 2 of the ASCO 2026 Highlights series, hosts Dr. Narjust Florez and Dr. Stephen Liu are joined by Dr. Julie Brahmer and Dr. Solange Peters to discuss some of the most notable immunotherapy advances presented at the 2026 ASCO Annual Meeting. The conversation explores emerging data for PD-1/VEGF and PD-L1/VEGF bispecific antibodies, the growing role of antibody-drug conjugates in combination with immunotherapy, and promising new strategies targeting KRAS-mutant lung cancers, highlighting how these approaches may reshape the future treatment landscape. Guests: Julie R. Brahmer, MD, MSc, FASCO, FAIO The Marilyn Meyerhoff Professor of Thoracic Oncology Co-Leader, Cancer Immunology Research Program Co-Director, Upper Aerodigestive Cancers Program Director, Johns Hopkins Kimmel Cancer Center, Bayview Campus Professor Solange Peters, MD, PhD Chair of Medical Oncology Director of Oncology Department - CHUV Lausanne University Hospital

Please visit answersincme.com/ADC860 to participate, download slides and supporting materials, complete the post test, and get a certificate. Presented by Jordana Goren Fein, MD, MS. In this activity, an expert in retinal vein occlusion (RVO) reviews diagnostic best practices, newer-generation anti-VEGF therapies, and patient-centered management strategies. Upon completion of this activity, participants should be better able to: Describe best practices for diagnosing RVO; Differentiate between the clinical profiles of available newer-generation intravitreal anti-VEGF therapies for macular edema (ME) secondary to RVO; and Propose optimized, patient-centered treatment plans for the multidisciplinary management of patients with RVO.

En este segundo RECAP de la Reunión Anual de la Sociedad Americana de Oncología Clínica, el Dr. Fabián Martínez conversa con la Dra. Mónica Meneses, oncóloga médica adscrita al Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán.Uno de los hitos más significativos de esta edición fue la presentación del estudio RASolute 302, un ensayo clínico evaluó la eficacia de daraxonrasib —un inhibidor de RAS en su conformación activa— frente al tratamiento con quimioterapia en pacientes con adenocarcinoma de páncreas previamente tratado.En el ámbito de la oncología torácica, se discutió el estudio LIBRETTO-432, que evaluó el uso de selpercatinib durante 3 años en el escenario adyuvante para pacientes con cáncer de pulmón de células no pequeñas (CPCNP) en etapas IB-III que albergan fusiones del gen RET. Por otra parte, en el escenario metastásico, el estudio HARMONi-6 evaluó la eficacia en primera línea de ivonescimab (un anticuerpo biespecífico dirigido contra VEGF y PD-1) combinado con quimioterapia estándar (carboplatino y paclitaxel) frente a tislelizumab (anti-PD-1) más quimioterapia en pacientes con CPCNP de histología epidermoide avanzado.La sesión abordó múltiples estrategias en cáncer colorrectal (CCR). En la enfermedad metastásica con mutación BRAF V600E—asociada a un peor pronóstico—, se presentaron los resultados de la cohorte 3 del estudio BREAKWATER, que evaluó la combinación de encorafenib (inhibidor de BRAF) y cetuximab (anti-EGFR) combinados con el esquema de quimioterapia FOLFIRI como tratamiento de primera línea, comparado con FOLFIRI más bevacizumab. En el escenario adyuvante, abordaron la evidencia del estudio EPISODE-III, un ensayo clínico fase III que evaluó la adición de la aspirina durante 3 años a la quimioterapia adyuvante estándar en pacientes con CCR etapa III resecado.Finalmente, cierran el episodio con la discusión de un estudio observacional que evaluó la duración de la inmunoterapia en pacientes con CCR con inestabilidad microsatelital (MSI) o deficiencia en las proteínas de reparación (dMMR) tras lograr una respuesta clínica completa, así como las consecuencias de prolongar el uso de la inmunoterapia de mantenimiento.Referencia:Este contenido se basa en la interpretación crítica de la evidencia científica disponible, así como en la experiencia clínica del o los ponentes como profesionales de la salud en instituciones de referencia.Para profundizar en los conceptos discutidos, se recomienda al profesional de la salud consultar literatura científica vigente, guías clínicas internacionales y la normatividad aplicable en su país.

With an abundance of therapeutic options for managing diabetic macular edema (DME), what patient characteristics inform your treatment decisions? Does the number of loading doses influence long-term macular fluid outcomes? How are you managing insurance-mandated step-therapy in your patients? In today's episode, host Dr. Jay Sridhar invites Drs. Durga Borkar and Carl Danzig to share how they've integrated new anti-VEGF therapies into clinical practice. For all episodes or to claim CME credit for selected episodes, visit www.aao.org/podcasts.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a myriad of events shaping the industry, ranging from regulatory hurdles to strategic acquisitions and scientific breakthroughs. A significant milestone has been achieved by Outlook Therapeutics with its product Lytenava (bevacizumab), which recently won an appeal with the FDA for wet age-related macular degeneration treatment. This antibody therapy, aimed at VEGF inhibitors, marks a notable advancement in ophthalmology, potentially transforming management strategies for this debilitating condition. Monoclonal antibodies like Lytenava continue to underscore their importance in treating chronic diseases, offering hope for patients and setting benchmarks for similar therapeutic innovations. On a less favorable note, AstraZeneca encountered a setback when their breast cancer treatment camizestrant faced rejection from an FDA advisory committee. Despite robust phase 3 data for hormone receptor-positive breast cancer, the advisory committee's decision delays the drug's review process. This serves as a stark reminder of the stringent requirements oncology treatments must meet and highlights the critical need for comprehensive clinical data to ensure patient safety and drug efficacy in this competitive field. Amidst these developments, Astellas is proactively addressing upcoming patent expirations, particularly for Xtandi in 2026. The company has announced a five-year growth strategy focused on pipeline acquisitions, illustrating broader industry trends where diversifying portfolios through acquisitions and partnerships is crucial for maintaining competitiveness and delivering innovative therapies. Business development activities continue to be a highlight within the sector. Apogee Therapeutics and Blackstone Life Sciences have entered into a $1.3 billion royalty financing agreement to advance an eczema drug, underscoring ongoing investments in autoimmune treatments. Similarly, AGC Biologics' partnership with Teikoku Seiyaku on microbial CDMO services aims at advancing musculoskeletal therapies, showcasing how collaborations can leverage specialized manufacturing capabilities for therapeutic progress. Clinical trials also made headlines as Junshi Biosciences reported that its drug toripalimab met primary endpoints in phase 3 trials for non-small cell lung cancer perioperative treatment. This achievement underscores the growing influence of immunotherapies in oncology, promising improved surgical outcomes and enhancing their role within cancer treatment paradigms. Funding continues to play a pivotal role in sustaining innovation within the industry. Editas Medicine recently raised $125 million to propel its CRISPR-based gene therapy pipeline forward. Such financial backing is instrumental in transitioning promising therapies from preclinical stages to market readiness, ensuring that groundbreaking science translates into patient-accessible treatments. Regulatory landscapes remain dynamic, with ongoing discussions about updating COVID-19 vaccine formulations to target emerging subvariants. The FDA's commitment to adapting vaccine guidelines reflects a proactive stance in infectious disease management, crucial for maintaining vaccine efficacy against evolving pathogens. In acquisition news, Olympus' purchase of Bioprotect for $270 million adds biodegradable balloon spacer technology to its prostate cancer radiation therapy offerings. This acquisition highlights how medical device innovations can complement pharmaceutical approaches, enhancing treatment efficacy and patient quality of life. These developments collectively paint a vibrant picture of the biotech and pharmaceutical industries—a landscape where scientific advancements, regulatory challenges, strategic planning, and financial investments converge. The implications are far-reaching, potentially redefining treatment paradigms across various therapeutic areas as these sectors continue their pursuit of innovation and improved patient care outcomes. Navigating this landscape also involves addressing broader challenges such as policy shifts and pricing pressures within key markets like the United States. Companies must remain adaptable, balancing growth strategies with compliance demands amidst changing regulatory environments—a theme echoed by recent surveys indicating heightened pressure on healthcare firms to maintain profitability. Moreover, geopolitical considerations are influencing cross-border investments in biotechnology as policymakers debate strategies best suited for managing foreign influence—reflecting broader concerns about national security and economic competitiveness within this critical sector. As we continue monitoring these dynamic shifts within pharmaceuticals and biotechnology, it's evident that scientific innovation remains tightly interwoven with regulatory scrutiny and financial dynamics. The ongoing dance between these elements will undoubtedly shape future trajectories in healthcare advancements globally, promising new horizons in patient care while addressing pressing health challenges worldwide. That's all for today's episode of Pharma Daily—where we keep you informed on the latest developments driving progress within pharmaceuticals and biotechnology. Thank you for tuning in; until next time!Support the show

Eli Lilly has been as acquisitive as ever, striking five new deals in the past week alone. On Tuesday, the company dove into the deep end of vaccine development with three separate buys in the space. Outside of vaccines, Lilly scooped up preclinical biotech Engage Bio for $202 million and teamed up with AI company Collaborative Drug Discovery for its life sciences data management solutions.These deals and Lilly's skyrocketing revenue pushed the Indianapolis-based company to the top of IDEA Pharma's list of best inventors and innovators.Lilly also continues to make headlines for its impressive data readouts, especially in the weight-loss space that it now reigns supreme. Last week, Lilly announced that next-gen asset retatrutide led to weight loss of 70 pounds, or 28.3% at 80 weeks, setting a new benchmark for the space.Moderna also made news this week with a surprising uptick in its share price that analysts are attributing to the so-called “fear trade” that is rising amid reports of a cluster of cases of hantavirus. Moderna also announced that its mRNA flu shot—initially turned away from the FDA but later accepted for review—will be discussed at an advisory committee on June 18.The annual conference of the American Society of Clinical Oncology starts on Friday in Chicago, where all eyes will be on Revolution Medicines' investigational pancreatic cancer pill and Akeso's Phase 3 trial HARMONi-6 for its Summit Therapeutics-partnered PD-1/VEGF bispecific ivonescimab.Finally, sign up for BioPharma Executive to receive this week's special edition breaking down executive compensation packages across the biggest pharmas.

Too busy to read the Lens? Listen to our weekly summary here! In this week's episode we discuss:A new TriNetX study shows NSAID use is associated with lower risk of exudative and non-exudative AMD. A large retrospective cohort study shows anti-VEGF injections within 6 weeks of a stroke or MI has no significant risk of cardiovascular outcomes compared with holding anti-VEGF injections. In a large prospective cohort study, nearly half of eyes changed ≥1.0 D over 5 years once axis was considered, suggesting caution when considering toric IOLs in children.A new AI fundus tool called Reti-Pioneer, while not accurate enough yet, is a start for a low cost tool to screen for systemic disease such as diabetes, gout, hypertension, and hyperlipidemia.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

Good therapeutic options for metastatic colorectal cancer are limited after the fluoropyrimidine-based options are exhausted. This week, we explore the role of trifluridine-tipiracil (Lonsurf) and bevacizumab (VEGF inhibitor), and a newish kid on the block, fruquitinib, an oral tyrosine kinase inhibitor and vascular endothelial growth factor receptor. While not perfect, they do represent later-line options for patientsStudies discussed in this episode:SUNLIGHTFRESCO-2 For more episodes, resources and blog posts, visit www.inquisitiveonc.comPlease find us on Twitter @InquisitiveOnc!If you want us to look at a specific trial or subject, email us at inquisitiveonc@gmail.comArt courtesy of Taryn SilverMusic courtesy of AlisiaBeats: https://pixabay.com/users/alisiabeats-39461785/Disclaimer: This podcast is for educational purposes only. If you are unwell, seek medical advice.Oncology for the Inquisitive Mind is recorded with the support of education grants from our foundation partners Pfizer and Merck Pharmaceuticals. Our partners have access to the episode at the same time you do and have no editorial control over the content. Hosted on Acast. See acast.com/privacy for more information.

Improve real-world DME outcomes by mastering the interpretation of evolving biomarkers and the latest evidence on long-acting anti-VEGF therapies. Credit available for this activity expires: [04/28/27] Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/diabetic-macular-edema-express-q-whats-new-2026a1000czk?ecd=bdc_podcast_libsyn_mscpedu

CME credits: 1.00 Valid until: 10-04-2027 Claim your CME credit at https://reachmd.com/programs/cme/enhancing-collaborative-care-in-retinal-diseases-a-focus-on-injection-therapies/37715/ This rebroadcast of a live regional meeting series, part of The Focused Sight Initiative: Quality Improvement Interventions in Retinal Diseases, brings together retina specialists and eye care professionals to address systemic gaps in the timely diagnosis, referral, and management of patients with retinal diseases, including age-related macular degeneration (AMD), diabetic retinopathy (DR), and retinal vein occlusion (RVO). Faculty discuss the clinical consequences of treatment delays, highlight real-world challenges to intravitreal anti-VEGF therapy adherence, and examine disparities in access to care. Learners will explore best practices for identifying patients at risk for progression, optimizing referrals from optometry to retina specialists, and implementing patient-centered communication strategies to improve outcomes. Emphasis is placed on leveraging imaging tools for earlier detection, addressing cultural and socioeconomic barriers, and adopting practice-level interventions to reduce loss to follow-up.=

Please visit answersincme.com/AGN860 to participate, download slides and supporting materials, complete the post test, and get a certificate. Presented by Ferhina Ali, MD, MPH, FASRS. In this activity, an expert in retinal diseases discusses anti-VEGF treatment of diabetic macular edema. Upon completion of this activity, participants should be better able to: Recognize factors that contribute to patients' treatment burden with intravitreal anti–vascular endothelial growth factor (VEGF) therapies for diabetic macular edema (DME); Assess the clinical profiles of long-acting intravitreal anti-VEGF agents for DME; and Recommend individualized strategies to enhance long-term treatment outcomes for patients with DME.

Please visit answersincme.com/AGN860 to participate, download slides and supporting materials, complete the post test, and get a certificate. Presented by Ferhina Ali, MD, MPH, FASRS. In this activity, an expert in retinal diseases discusses anti-VEGF treatment of diabetic macular edema. Upon completion of this activity, participants should be better able to: Recognize factors that contribute to patients' treatment burden with intravitreal anti–vascular endothelial growth factor (VEGF) therapies for diabetic macular edema (DME); Assess the clinical profiles of long-acting intravitreal anti-VEGF agents for DME; and Recommend individualized strategies to enhance long-term treatment outcomes for patients with DME.

Send us Fan MailThe science, hype, and unknowns surrounding popular peptides like BPC-157 & TB-500 ("Wolverine stack") for injury recovery & tissue repair.Nick & Dr. Flynn McGuire discuss the surge in peptide use for injury recovery. They cover peptide basics, the preclinical evidence for BPC-157 and TB-500, mechanisms like angiogenesis and tissue repair, the lack of robust human trials, sourcing risks, regulatory bans, and the gap between anecdotal reports and scientific certainty.TOPICS DISCUSSED:Peptide basics: Short amino acid chains (e.g., insulin, GLP-1 agonists); BPC-157 derived from gastric juice, TB-500 a fragment of thymosin beta-4.Rise in popularity: Driven by podcasts, social media, biohacking culture, and post-COVID distrust in institutions; “bro science” often precedes formal research.BPC-157 mechanisms: Pleiotropic effects including VEGF upregulation, nitric oxide pathways, angiogenesis, reduced fibrosis, and possible neuromuscular stabilization.TB-500 & “stacking”: Often combined with BPC-157 for presumed synergy; marketed as “Wolverine stack” for rapid healing.Evidence limitations: Strong rodent data for tendon/muscle repair, but almost no high-quality human trials; one small retrospective study and ongoing phase 2 trial in China.Safety and risks: Unknown long-term effects, potential cancer concerns via angiogenesis; no established dosing, potency, or administration route in humans.Sourcing & quality issues: Often obtained as “research chemicals” online; variable purity, stability concerns, no reliable regulation or third-party verification for most users.ABOUT THE GUEST: Flynn Mcguire, MD is a physical medicine and rehabilitation resident at the University of Utah; he conducts clinical work in neurologic recovery and musculoskeletal care and has authored a narrative reviews on peptides for musculoskeletal healing.RELATED EPISODE:M&M 252: Scarring, Fibrosis, Oxidative Stress, and Psilocybin & Aging | Louise HeckerReference Paper:Paper | Regeneration or Risk? A Narrative Review of BPC-157 for MusculoskeleSupport the showHealth Products by M&M Partners:SporesMD: Premium mushrooms products (gourmet mushrooms, nootropics, research). Use code 'nickjikomes' for 20% off.Lumen device: Optimize your metabolism for weight loss or athletic performance. MINDMATTER gets you 15% off.AquaTru: Water filtration devices that remove microplastics, metals, bacteria, and more from your drinking water. Through link, $100 off AquaTru Carafe, Classic & Under Sink Units; $300 off Freestanding models.Seed Oil Scout: Find restaurants with seed oil-free options, scan food products to see what they're hiding, with this easy-to-use mobile app.KetoCitra—Ketone body BHB + electrolytes formulated for kidney health. Use code MIND20 for 20% off any subscription (cancel anytime)For all the ways you can support my efforts

Drs. Akshay Thomas and Sarwar Zahid join for a journal club episode.Anti-VEGF and Vitreous Hemorrhage Surgery (https://www.ophthalmologyretina.org/article/S2468-6530(26)00024-2/fulltext)ILM Flaps Long-Term Outcomes (https://www.ophthalmologyretina.org/article/S2468-6530(26)00048-5/abstract)Protocol AC Post-Hoc Analysis (https://www.ophthalmologyretina.org/article/S2468-6530(26)00054-0/abstract)‍ ‍Listeners, we are 3 episodes away from our 500th episode! Episode 500 will be a Q&A session featuring your questions and thoughts. It's your chance to have your voice heard on the podcast!Please record an audio/video of your question and upload it to the linked form (https://forms.gle/nyv3fvCHZJ4XzQe67). We are excited to hear what you have to say and look forward to a spectacular 500th episode!

Dr Deb Muth 00:03Well, welcome back to Let’s Talk Wellness Now. I am your host, Dr. Deb. And what is the most talked-about peptides in functional medicine? aren’t actually FDA approved. Not because they don’t work, but because no one’s funded the research to prove it yet. The truth is, some of the compounds that dominate wellness forums, BPC-157, TB-500, thymosin beta-4, epitalin, occupy a fascinating space between breakthrough science and unregulated experimentation. In today’s episode, we’re stepping into that grey zone, the world of investigational peptides, to separate mechanism from marketing. I’m going to walk you through the science that actually shows and where it stops, how to evaluate claims when human data don’t yet exist, and the quality, purity, and safety red flags that you need to recognise. Dr Deb Muth 01:06I created it in a previous episode, so go check that one out. And why honesty is the most important prescription in peptide medicine. If you’ve ever wondered whether these research-only peptides are the frontier of healing or the next functional medicine fad, this episode is for you. So grab your cup of tea or coffee, get comfortable, and let’s talk about what it really means to use peptides that are promising but still under investigation. So we’re going to break just for a second here and have a word from our sponsor. It is because of them that we stay on the air. So thank you for this. And we will be right back. Did you know sweating can literally heal your cells? Infrared saunas don’t just relax you. They detox your body, balance hormones, and boost mitochondrial energy. I’m obsessed with my Health Tech sauna. And right now, you can save $500 with my code at healthtechhealth.com slash dr-muth-req-25. Dr. Deb Muth 02:15All right, guys, welcome back. Let’s dive into investigational peptides, the evidence gap. So the following peptides we’re about ready to discuss are extensively in integrative, functional, and regenerative medicine circles. They may have intriguing mechanisms and promising preclinical data. However, they lack FDA approval, and the evidence quality varies dramatically. from interesting preliminary research to essentially no human data at all. And this distinction is really critical for maintaining scientific integrity. So let’s talk about immune-modulating peptides. There’s thymus and alpha-1, and this is an international story on the thymic peptides. Thymusin alpha-1, known as TA1, is marketed internationally as zidaxin. Dr. Deb Muth 03:16It’s a 28-amino acid polypeptide originally isolated from thymusin fraction 5, which was extracted from bovine thymus tissue. Modern production uses synthetic peptide synthesis. The thymus gland is located behind the sternum and is the primary site for T cell maturation, and thymic peptides like TA1 play roles in human system development and regulation. Now, I love thymus peptides. I love thymus glandular products. I’ve used thymus glandular products for decades. Ground-up animal thymus gland is basically what it is. There are a couple of different supplement companies that I’ve used over the years that are amazing with this. And they do a fantastic job, and they really do help to support the immune system. So when thymus peptides came out, it was really exciting because it took the whole idea of thymus support to a new level. Dr. Deb Muth 04:17The mechanism actually behind the thymus in alpha-1 is complex and involves multiple aspects of immune function. At the cellular level, TA1 enhances T cell maturation and differentiation, particularly the development of helper T cells and cytotoxic T cells. It modulates T cell receptor expression and can influence the balance between Th1 cell-mediated immunity and Th2 humoral immunity responses. And it also enhances the natural killer cell activity and modulates dendritic cell function, which are critical for antigen presentation. and initiation of adaptive immune responses. And on the cytokine level, TA1 influences production of interleukin-2, IL-2, interferon gamma, IFN-γ, and interleukin-10, IL-10. Dr. Deb Muth 05:19These create immune modulatory rather than simple immune stimulatory effects. This is a very important distinction because TA1 appears to help balance the immune system rather than simply ramping this up, which theoretically makes it safer in conditions where immune overstimulation would be a problem, such as an autoimmune disease. Hashimoto’s, autoimmune, lupus, Sjogren’s, any of those autoimmune diseases, we don’t want to overstimulate their immune system. So you want to use a product like this that’s non-stimulating. Now, the regulatory status on TA1 is geographically variable and represents one of the challenges in discussing this peptide with patients. It is not FDA-approved in the United States. However, it is approved in several other countries for specific conditions. Dr. Deb Muth 06:19In Italy, it’s approved for the treatment of chronic hepatitis B and hepatitis C. In China, it’s approved for chronic hepatitis B and adjunct immune compromised patients receiving vaccinations or suffering from certain infections. It has an orphan drug designation in the United States for certain cancer indications, but its designation does not constitute approval. It simply provides regulatory incentives for further development. So the evidence base for thymosin alpha-1 is substantial in some areas but comes primarily from non-US populations and research groups, which creates challenges in evaluating quality and generalizable information. So in hepatitis B and C, multiple clinical trials, many conducted in China and Italy, have examined TA1 as an adjunct to antiviral therapy. Dr. Deb Muth 07:21A meta-analysis by Wu and colleagues published in the Journal of Viral Hepatitis in 2013 examined 23 randomized controlled trials, including over 2,000 patients with chronic hepatitis B. The analysis found that combining TA1 with nucleoside analogs like LAMVDUDE or an and TCAVAR improved the hepatitis antigen seroconversion rates by HBV DNA clearance compared to its nucleoside analogs alone. And the effect sizes were modest but statistically significant, with the HBE-AG seroconversion rates improving from about 24% with antivirals alone to 38% in combined therapy. Now in hepatitis C, early trials before the development of direct-acting antivirals showed that TA1 combined with interferon alpha improved sustained virological responses, and compared to interferon alpha, Dr. Deb Muth 08:30Furon alone, particularly in difficult-to-treat populations like those with a genotype one or a high viral load. However, the advent of highly effective direct acting antivirals that achieve SRV rates, sorry, SVR rates exceeding 95%, the role of TA1 in hepatitis C has become less clear. Now in sepsis and critical illness, more recent interest has focused on TA1 in severe cases of sepsis and septic shock. Ren and colleagues published a systematic review and meta-analysis in the Frontiers of Immunology in 2022, analyzing 18 randomized controlled trials, including 1787 patients with severe sepsis or septic shock the pooled analysis showed that ta1 administration was associated with reduced 28-day mortality relative risk at 0.70 meaning a 30 reduction in mortality compared to the standard care alone and the effect appeared Dr. Deb Muth 09:39most pronounced in patients with sepsis-induced immunosuppression measured by HLA-DR expression in monocytes. Now, this is amazing because going forward, we’re going to talk about something that’s commonly known as cytokine storm. Now, cytokine storm really became apparent since 2020 with the viral infection that we’re dealing with in the world today. But they were already looking at this kind of cytokine storm produced by sepsis or sepsis-induced immunosuppression. And it triggered this hyperinflammatory response called the cytokine storm. And many patients who survived the initial phase of the immune suppressed stata, characterized by a T cell exhaustion, reduced antigen presentation, and increased susceptibility to secondary infections. Thymusin alpha-1, TA1, may help restore this immune competence in this phase. However, it’s important to note that patient selection and timing are critical. Dr. Deb Muth 10:43Giving this immune stimulant during a hyperinflammatory phase could theoretically worsen outcomes. So you don’t want to give it to them while they’re in the flare up or the sepsis or the infection, but given to them during the immunosuppression phase afterwards might be beneficial. Now there is also some cancer immunotherapy that we see with TA1 and has been studied as an adjunct in cancer treatment with the hypothesis that it could enhance immune surveillance and response to tumors. And a comprehensive review of Garci and colleagues published in Expert Opinion on Biological Therapy in 2007 examined multiple trials in melanoma, lung cancer, hepatocellular carcinoma, and other malignancies. And the results were mixed. Some trials showed improvement in the immune parameters, increased CD4 in T-cells. improved lymphocyte proliferation responses and some actually showed trends toward improved progression free survival but overall survival benefits were inconsistent and the heterogeneity of the cancer types treatment protocols and outcome measures makes a definitive conclusion difficult as a vaccine adjunct several studies particularly from china have examined ta1 as an adjunct to enhance vaccine responses Dr. Deb Muth 12:11in immune-compromised populations, including the elderly, dialysis patients, and transplant recipients. The rationale is sound. These populations often mount suboptimal antibody responses to vaccines, and TA1’s immune-enhancing effects might improve protection. There are small trials. They have shown improvement in seroconversion rates of hepatitis B vaccines and influenza vaccine in these populations. And though large-scale confirmatory studies are limited, there is a possibility here. Now, on their safety profile, one of the appealing aspects of thymusin alpha-A TA1 is that it’s apparently favorable safety profile in clinical trials. There are some injection site reactions with a little redness, a mild discomfort, and most commonly reported adverse effects. is that their severe adverse events attributable to TA1 have been rare in published trials. However, comprehensive long-term safety data are limited Dr. Deb Muth 13:13And theoretically, concern exists that immune modulation could potentially trigger or exasperate autoimmune conditions in susceptible individuals. Though this hasn’t been clearly demonstrated in clinical trials, integrative medicine considerations for integrative practitioners concerning the thymus and alpha-1, several factors require careful thought. First, sourcing and quality control are critical concerns. Since it’s not FDA approved, TA1 available in the United States typically will come from a compounding pharmacy or an international supplier with variable quality assurance. And pharmaceutical grade product with certificates of analysis showing purity, sterility, and endotoxin testing is essential, but it is readily available from many of these companies. Second, patient selection matters immensely. TA1 should be considered in complex cases where conventional approaches have been insufficient, such as chronic viral infections not responding adequately Dr. Deb Muth 14:21to standard antivirals, post-viral syndromes with evidence of immune dysfunction, cancer patients with immune suppression in consultation with oncology, and it should generally be avoided in active autoimmune disease unless there’s a compelling rationale and close monitoring. Now, TA1 is not a standalone therapy. In cases of chronic viral infection, Comprehensive immune support includes addressing nutritional deficiencies, optimizing vitamin D levels to be between 50 and 80, adequate zinc, selenium, and vitamin A, optimizing gut health since 80% of our immune function is in the gut, you need to optimize gut function. Managing stress from the HPA access dysfunction, chronic cortisol elevation, suppression, and immunity, ensuring adequate sleep, immune memory consolidations during sleep, addressing any metabolic dysfunction, insulin resistance, repairs in the immune function, and the bottom line on thymus and alpha-1 is Dr. Deb Muth 15:26is that it represents legitimate medicine in other countries with a substantial evidence base in specific contexts, but it remains experimental in the U.S., and practitioners using it should provide comprehensive, informed consent about its regulatory status, evidence quality, and source verification. while ensuring it’s part of comprehensive protocols. It is not a magic bullet. And again, what you’re gonna hear me say quite often here is that many of these peptides should be used in conjunction with something else. They should not be used alone. And can peptides be stacked? The answer is yes, they can. So if somebody has an insulin resistance, or a metabolic dysfunction, they can tier TA1 with a GLP-1 like terzepatide or semiglutide. That is not a problem to do that. You need to just work with a practitioner that understands how to do that effectively. So let’s look at BPC-157. Dr. Deb Muth 16:26This is a phenomenon I love BPC-157. Let’s separate it from marketing to actual mechanism of actions here. So BPC-157 stands for Body Protection Compound 157. It is a chain of 15 amino acids that are described as a partial sequence of body protection compound, a protein found in human gastric juice. It has become one of the most hyped peptides in regenerative medicine inside the athletic performance and biohacking communities with claims ranging from healing tendons and ligaments to repairing gut lining or reversing organ damage. The challenge is separating the legitimate mechanisms of science from the marketing hype. The proposed mechanism of BPC-157 are biologically plausible and intriguing. The research suggests that it may influence several growth factor pathways, including vascular endothelial growth factor, VEGF, which promotes new blood vessel formation and has improved better supply of blood flow to injured tissues, theoretically accelerating healing. Dr. Deb Muth 17:40It may also affect fibrous blast growth factor, FGF, and transforming growth factor beta, TGF beta pathways. both involved in tissue repair and remodeling. And some studies actually suggest that BPC-157 modulates inflammatory cascades, potentially reducing excessive inflammation while promoting the resolution phase that allows tissue rebuilding. Now I want to talk just a few moments here about these different tests that we’re talking about tgf beta veg f for those of you who are in our mold world you are very familiar with these uh lab tests we do this to see if you have a mold exposure what’s happening to your body and it’s been very challenging to try to heal this part of the mold illness and manipulate these VEGFs and TGF betas. And so with the fact that BPC helps us modulate this inflammatory cascade, BPC can be very helpful in the world of mold or mycotoxin illness in repairing those parts of the body that have been damaged by the mycotoxins. Dr. Deb Muth 18:48Now there is animal research on BPC-157. It is extensive and primarily from a research group led by pre-drag, oh, I can never say these names, Cyrek at the University of Zagreb in Croatia. Published studies in animal models have shown accelerated healing in a remarkable variety of injury types. A 2011 paper by Chang and colleagues in the Journal of Applied Physiology demonstrated that BPC-157 improved therapy tendon healing in rats with Achilles tendon injuries, and the treated rats showed increased tendon outgrowth, better cell survival in the injured area, enhanced cell migration to the injury site, and improved biochemical strength of the healed tendon compared to controls. Multiple other animal studies have shown similar promising effects. Ligament tears, healing faster in rabbits, muscle damage recovering more quickly in rodent models, gastric ulcers healing in rats given experimental induced ulcerations, inflammatory bowel lesions improving in mouse models of colitis, and even bone to tendon healing showing enhancement in animal studies. Dr. Deb Muth 20:02The breadth of injury types showing benefit in preclinical models explains the enthusiasm of this peptide. However, this is critical. These animal studies, primarily in rodents and rabbits, animal models of injury healing don’t reliably translate to human clinical outcomes. And the doses used in these animal studies when converted to human equivalent doses vary widely. And optimal human dosing is completely unknown at this point. it is all considered experimental and perhaps most importantly there are essentially no peer-reviewed controlled clinical trials in human published in humans published in major medical journals in a 2001 review of arthroscopy and the journal of arthroscopic and related surgery specifically examined in the evidence of bpc 157 and other peptides in musculoskeletal medicine The authors concluded bluntly that BPC-157 lacks evidence from randomized controlled trials and has an unknown safety profile in humans. Dr. Deb Muth 21:09 They emphasized that the jump from animal data to recommending peptides for humans use bypasses the fundamental requirement for Phase I safety studies, Phase II dose-finding studies, and Phase III efficacy trials that would establish whether BPC-157 actually works in humans and whether or not it’s safe. The absence of human safety data is particularly concerning given BPC-157’s proposed mechanisms. Peptides that influence growth factor signaling and angiogenesis could theoretically have off-target effects. Uncontrolled angiogenesis, for instance, is a hallmark of cancer progression. Tumors require blood vessel formation to grow beyond a certain size. And while there’s no evidence that BPC 157 promotes cancer, The complete absence of long term human safety studies means we simply don’t know. This isn’t fear mongering. It’s acknowledging uncertainty and uncertainty exists and understanding that if you’re choosing to use peptides like BPC 157, you are doing it in an experimental model. Dr. Deb Muth 22:17We’re experimenting with the doses that are being used. And there is potential for it to cause cancer cells in your body to grow. And you need to be aware of this and understand the risks that you’re taking when you’re using an investigational or off label use peptide. Now, quality control issues with BPC also exist. It’s not FDA approved for any indication in the US. It’s not approved in any major regulatory jurisdiction worldwide. It’s marketed as a research chemical explicitly to bypass FDA oversight. And commercial sources selling BPC-157 range from compounding pharmacies, which have some quality standards but are not FDA inspected. You can take that for what you want to believe on that one. to overseas suppliers operating with absolutely no quality assurance whatsoever. If you are choosing to use BPC-157, you have to understand who’s manufacturing it for you, where you are getting it from, how pure it is. Dr. Deb Muth 23:26You want to make sure that you have the certificate of analysis and that it does not contain bacterial endotoxins that can contaminate the peptide or degrade the peptide and cause other issues for you. So when you talk about peptides with patients regarding BPC-157 or if you’re listening to this and you’re already using BPC-157 or other peptides, that are quote-unquote not for human consumption, an evidence-based response acknowledges both the appeal and the limitations. And you want to talk about the animal data that’s definitely showing some progress and some potential, but we don’t know what we don’t know in humans. If people are willing to take that risk, that is up to them to do that. But using BPC right now is experimental and people need to be aware of that. Are there evidence-based alternatives for patients with tendon or ligament injuries? Dr. Deb Muth 24:26And there are. There’s PRP, which has been studied in multiple randomized controlled trials. for conditions like lateral epicondylitis, tennis elbow, Achilles issues, patellar issues, knee issues. However, I want to caution you on this too. So the study that was done by Cox and colleagues in muscles, ligaments, and tendons in the Journal of 2014 showed modest benefits in pain and function compared to controls. And though the effects vary by injury type, PRP preparations can be helpful. You have to understand that a lot of times when people are doing PRP injections in their office, they are not doing it exactly the same way it was done in the study. And not to mention, if you’re using your own PRP to heal a ligament or a tendon or help your arthritis and you’re 60 or 70 years old, That is not good quality protein rich plasma. It is old protein rich plasma. And you’re not going to see necessarily the same benefits that you would see if you were using placental tissue or umbilical tissue. Dr. Deb Muth 25:33You also want to address the nutritional deficiencies or support that’s needed for connective tissue healing. And these are collagen peptides dosed at 15 grams a day. And this has been shown in a study by Shaw and colleagues in the American Journal of Clinical Nutrition in 2017 to augment collagen synthesis when combined with intermittent loading. Vitamin C is also an essential cofactor for collagen production and stabilization of collagen structure at a dose of around 500 to 1000 milligrams a day to support this process. You also need to have good adequate intake of copper and zinc. These are cofactors in collagen. Silica is also important. This comes from horsetail extract. This provides additional support as well. So more importantly, I think remembering that rehabilitation matters as well. Doing these protocols without doing some rehab is not going to get you where you want to go. Dr. Deb Muth 26:33There’s a research study by Alfredson and others for Achilles tendinopathy using the control lengthening of muscle tendon units under load to promote tendon remodeling and healing. These protocols have solid evidence and cost nothing beyond professional guidance from a physical therapist. They are important for patients seeking cutting edge regenerative approaches. Stem cell therapies, growth factors, concentrates derived from patients’ own tissues like PRP. These have a lot of good endogenous materials and they have good safety profiles. BPC-157 represents the perfect example of how promising Preclinical science gets marketed far beyond the evidence and it may eventually prove to be valuable. I think it will. But right now that determination does require some human studies and hopefully with the administration that we have right now and Bobby Kennedy, we will actually start to see some of that occur. Now the next peptide I want to talk about is TB4, thymus and beta-4. Dr. Deb Muth 27:36This is a wound healing peptide. It is a 43 amino acid peptide that’s naturally present in virtually all human cells except red blood cells. It’s actually one of the most abundant peptides in the human body, particularly concentrated in blood platelets, wound fluid, and many tissues. It’s naturally ubiquity makes it mechanistically interesting. The body wouldn’t produce it in such abundance if it didn’t serve a function. So the primary role of TB4 involves building G-actin. It’s a form of monomeric actin. And it’s structural protein that forms the microfilaments within the cells, providing cellular structure and enabling cell movement. TB4 prevents from F-actin filaments. I’m not going to talk too much about this. It’s really critical for wound healing as cells need to migrate into the injury sites. Dr. Deb Muth 28:37so the cell shape changes and the cellular response to the injury. So think of this as though you tore your meniscus and the body created all this TB4 to come to that injury to try to heal that site. That’s exactly what the TB4 is doing inside the body when there’s an injury. It’s been shown in research to help produce new blood vessel formation, promote endothelial cells, It helps modulate inflammatory cytokines, potentially reducing TNF-alpha, IL-1, and possibly protecting in programmed cell death, which we call apoptosis. And some studies suggest that it is cardioprotective in its effects in animal models of myocardial infarction, so heart attack, and neuroprotective in other models for brain injury. Now, these remain to be preliminary, but they are being seen. So the regulatory status on TB4 can create some confusion. Dr. Deb Muth 29:40The natural TB4 molecule itself is not FDA approved as a drug. However, TB4 based drug candidates called RGN259, formerly TB4, has been in the development by regen tree for corneal injuries of the dry eye disease. And as of recent updates, this drug is completed phase three trials for its neurotrophic keratopathy, severe corneal condition. But the FDA approval is still pending. So that means that the most advanced TB4-based pharmaceuticals hasn’t yet crossed the finish line for approval. The commercial peptide market further muddies the picture with TB500, which is often described as the synthetic fragment of TB4. However, this extract’s relationship between TB500 and TB4 varies depending on the source. Dr. Deb Muth 30:41So some claim that TB500 is identical to TB4, but positions 1 through 4 suggest it’s a different fragment. and the quality control across suppliers is not existent. So this confusion is part of why recommending TB500 becomes problematic for practitioners and patients, often because they aren’t certain what molecule they’re actually getting. The evidence base for TB4 in humans is limited, primarily to eye research, and the studies from Sohn’s and colleagues published in journals like Vitamins and Hormones in 2016 have examined topical TB4 for corneal injuries and neurotrophic keratopathy, dry eye, and other surface diseases. Now, these studies showed some promise in promoting this, and there is, however, a topical application to the cornea that is vastly different from a systemic injection. So for systemic use in wound healing, musculoskeletal issues, Dr. Deb Muth 31:42cardiac protection, neuroprotection, human clinical trials. There is scarce to non-existent evidence in humans. Most of the evidence remains in animal models or cell culture studies. And a review by Flip and colleagues in the Journal of Investigational Dermatology in 2006 detailed TB4’s effects on the matrix remodeling during wound repair in animal models, showing effects on collagen disposition, granulation, tissue reformation, and wound contraction. Another review by Ho and colleagues in expert opinion on biological therapy in 2007 discussed TB4’s potential in tissue regeneration and regenerative medicine, but noted the field remained largely blank. preclinical. So this is really important again to understand that there is just not enough human data. So there is a concern with cell division and migration. This theoretically exists Dr. Deb Muth 32:45for the potential effects on cancer cells, which would also rely on migration and division and other intended consequences of disrupting normal cellular architecture. These aren’t proven risks, but they are unexplored questions that we need to be aware of when we’re using peptides. This can cause cancerous tissue to grow. Very similar to what we talked about with BPC-157. These are also sold as research chemicals. There is no FDA oversight. So purity, potency, contaminations all still exist for these peptides. Now from an integrative perspective, the natural presence of TB4 in wound fluid and its biological roles in healing are legitimate science. in presence does not equal therapeutic utility. The body tightly regulates where and when and how much TB4 is present through natural production and bypassing that regulation with external dosing may or may not cause us to have beneficial or introduce risk. Dr. Deb Muth 33:49So we need to know that this is experimental use. Those people who are seeking wound healing and tissue repair the evidence-based approach of the body’s own capacity to heal is huge definitely want to be increasing your protein intake optimizing your zinc copper vitamin c and vitamin a and then managing glucose is really important during this time as well so let’s talk about a fun topic now and that’s growth hormone secretagogues this is the anti-aging hype machine these peptides in this category are things like semoralin ipameralin cjc 1220 1295 and others and among the most aggressively marketed in anti-aging and longevity medicine they all share a common goal stimulating the pituitary gland to release more growth hormone and the appeal is understandable. GH levels decline with age, and this decline is associated with increased fat mass, decreased lean muscle, reduced bone density, and other aspects of aging. Dr. Deb Muth 34:55The other times we’ll see growth hormone levels decline significantly is with chronic illness, and the logic is to restore youthful GH levels and youthful physiology. Now, semirelin from an FDA approved diagnostic to compound anti-aging product. Semirelin is a 29 amino acid peptide representing the first 29 amino acids of the full 44 amino acid human growth releasing hormone, GHRH. We talked about this on another episode of the podcast. And you can go back and listen to that one a little bit if you want. This fragment contains the complete biological activity of the full GHRH molecule and it binds to GHRH receptors in the anterior pituitary and stimulates growth releasing peptides, growth hormone releasing peptides. Semirelin was previously FDA approved as diagnostic testing of growth hormone secretion, essentially, to determine if the pituitary could still respond to GHRH stimulation in patients being evaluated for growth hormone deficiency. Dr. Deb Muth 36:06However, the manufacturer was discontinued and there was no longer an FDA approved semirelin product on the market in the United States. What exists now is semirelin available from compounding pharmacies used off label for anti-aging, body composition, and general growth hormone optimization purposes. This represents a significant gray area. Again, compounding medications serve a very important role, but they need to meet certain recommendations and regulations, as we’ve talked about in the past. You want to make sure that your compounding pharmacy that you’re obtaining semirelin from is qualified to do that, that they are doing best practices, and that you’re getting a good product. The theoretical advantage to semirelin over direct growth hormone administration is that it preserves more of the physiological growth hormone secretion patterns. Natural GH is released in pulses, primarily during sleep, not as a continuous elevation. Dr. Deb Muth 37:07So semirelin stimulates the pulses rather than providing a constant super physiological growth hormone level. And that pulsatile pattern is thought to reduce some of the side effects and metabolic concerns that we have with continuous growth hormone exposure. However, the evidence supporting semirelin for anti-aging and body composition in healthy adults is minimal. Most of the data comes from studies conducted in the 1990s when the FDA approved product existed. Not that that means it’s bad. We have drugs that have been in the market for over a hundred years that are still there, that still have the research and are still being used successfully and safely today. So we don’t want to let that really make us think that this product isn’t safe. So a 2006 review from Walker in Clinical Interventions of Aging suggested that semirelin might be a better approach than direct GH for adult onset growth hormone insufficiency, but they do acknowledge that the evidence was limited. Dr. Deb Muth 38:12And although we don’t have any large scale trials that we can examine for semirelin’s efficacy, it is now commonly prescribed. And the optimal dosing for anti-aging purposes is still unknown. It is considered experimental and it does vary from person to person, but it is still unstudied. The effects on cancer risk, cardiovascular disease, metabolic dysfunction over long time periods are also still unknown. I would argue that the side effects or the risk factors of not having growth hormone are equally as bad as the unknowns that we have here. We’re not looking to try to get super physiological doses. We’re trying to restore youthful GH levels. Typically, we’re not trying to restore back to a 20-year-old. We’re trying to restore back maybe 10 years. That is a better way of doing this. And I think that’s important for people to understand. Now, ipamirelin is the ghrelin mimicker. Dr. Deb Muth 39:12Ipamirelin is a pent-up peptide, five amino acid, that acts as a growth hormone secretagogue receptor, a GHS-R agonist. It mimics the action of ghrelin, the hunger hormone, that also stimulates growth hormone release. The proposed advantage over earlier secretagogues is that ipamirelin stimulates growth hormone release without significantly affecting cortisol, prolactin, or other glucose things, which can be increased by growth hormone secretagogues. The regulatory status is clear. Ipamirelin is not FDA approved for any indication. It’s sold as a research chemical. Human evidence is thin. It’s limited to single dose studies examining how quickly it’s absorbed and metabolized with minimal data on dosing and clinical outcomes. Now there are marketing claims for ipamirelin and they are extensive. Dr. Deb Muth 40:13It increases lean muscle mass, it decreases body fat, it improves sleep quality, faster recovery from workouts, enhanced injury healing, better skin quality. The evidence supporting these claims in humans is not available we don’t have it these are claims that are made by the effects that we know from growth hormone so it’s not necessarily a bad thing we know what growth hormone does we know growth hormone does all of these things if ipamorelin is a precursor to that it will obviously help improve those things making that correlation of what growth hormone does So there are safety concerns that mirror the same as any other growth hormone elevating therapy. It can cause fluid retention, joint pain, carpal tunnel syndrome, insulin resistance, glucose intolerance, and theoretically, can it increase calcium? cancer risks? It can because IGF-1 promotes cell proliferation and can inhibit apoptosis in cancer cells. Now remember, your body makes IGF-1. Dr. Deb Muth 41:15If it’s not making enough of it, that’s a problem. If it’s making too much of it, That’s a problem. So just understand that if you are adding these things, and especially in elevated doses, you are taking a potential risk. So there is also now CJC 1295 is a modified GHRH analog of 30 amino acid peptide based on GHRH structure, but with modifications. So it includes the addition of drug affinity complex, DACC, DAC, which involves conjugation with a small albumin binding molecule, dramatically extends the peptide’s half-life from minutes to as much as potentially a week or more. And this creates sustained growth hormone elevation rather than that pulsatile release. There are actually two versions of this. There’s CJC 1295 with DAC, longer acting version, and CJC 1295 without DAC, which is essentially a shorter duration of semirelin. Dr. Deb Muth 42:19And so when we’re comparing products, it is… only the difference between long acting and short acting. The human evidence for CJC 1295 is limited to a single published phase one study by Techman and colleagues in the Journal of Clinical Nutrition and Metabolism in 2006. And the study involves 18 healthy young adults showed that CJC 1295 with DAC produced a sustained elevation of GH and IGF-1 lasting several days after the injection. That’s essentially the entire published human evidence of this peptide. There are no phase two studies examining optimal dose. So that is all considered experimental. And there is no phase three studies examining clinical efficacy. So the sustained GH levels created by CJC 1295 with DAC raises specific concerns because the natural GH secretion It goes up and down, up and down, up and down. Dr. Deb Muth 43:19And that constant elevation may have a different metabolic and cellular effect. And we just really don’t know what that’s going to be yet. So we can understand that elevated IGF-1 levels can theoretically increase cancer concerns and metabolic risks. So rather than always injecting peptides, which are very expensive… You can do other things. And there was a study by Hartman and colleagues in the Journal of Clinical Endocrinology and Metabolism in 1992 that demonstrated the 48-hour fast increased integrated growth hormone secretion five-fold through increased GH levels. Now, the problem with this is fasting for 48 hours is a challenge. And how long is it going to increase the growth hormone secretion without causing issues? Or in general, how long is it going to go up? Dr. Deb Muth 44:19So we have to be cautious about that as well. Sleep optimization is non-negotiable. The majority of growth hormone secretion occurs during sleep, slow wave sleep, typically the first sleep cycle, and poor sleep quality or insufficient sleep typically. can dramatically affect your growth hormone levels. And then high intensity interval training, HIIT resistance training can stimulate growth hormone as well. This was seen in a study by Godfrey and colleagues in sports medicine in 2003 and was examined in exercise-induced growth hormone responses to athletes. So we definitely see these kinds of things. So let’s talk about some longevity peptides now. These expand the telomere. So there’s epitalin and epithalamin and when these are used in anti-aging they can produce some amazing results. Dr. Deb Muth 45:22So epitalin is a synthetic terapeptide, just four amino acids. It was originally synthesized as a simplified version of epithalamine. a pineal gland extract containing multiple peptides. The synthetic four amino acid version was created to isolate what researchers believed might be the active anti-aging component. The mechanism produced for epitalin centers on telomere and telomerase, Telomeres are protective caps at the end of the chromosomes consisting of repetitive DNA sequencing. And every time a cell divides, telomeres shorten slightly because DNA polymers cannot fully replicate the ends of the linear chromosomes. So this progressive shortening acts as a molecular clock. After 50 or 70 divisions, the telomeres become critically short, triggering a cellular senescence. Dr. Deb Muth 46:22This telomere shortening is one mechanism of cellular aging and telomeres in the enzyme that can rebuild telomeres by adding these caps back onto the end of the chromosome. It’s active in stem cells, germ cells, and unfortunately in about 85 to 90% of the cancer cells. In most adult somatic cells, telomerase is inactive or present at very low levels, allowing the telomeres to shorten with division. The research on epitalin suggests it might activate this telomeres act telomeres process primarily from a research group led by Vladimir in Russia. Vladimir Kavasan in Russia. He is a huge peptide researcher or was he passed away with publications dating back to the early 2000s and a study published in bio gerontology in 2000 by Kavasan Dr. Deb Muth 47:25and colleagues examined the effect of epitalin on the lifespan of fruit flies, and they treated fruit flies that showed a modest increase in mean and maximum lifespan compared to its controls by approximately 10 to 15% lifespan extension in some experimental groups. And there were other studies in 2003 that examined epitalamine in a female Swiss-derived mouse. This was done by Ann Simove and colleagues. And the researchers reported that epitalin treatment was associated with increased lifespan as well. And the most cited mechanistic work comes from cell culture studies. And that is also Cavason’s group that published this research in 2003, showing increased telomeres activity in cultured somatic cells again. More recently, between 20 and 25, the series of publications have continued to explore epithelial effects on telomere dynamics in cell cultures. Dr. Deb Muth 48:32So there is a lot of research that’s been done. The mass majority has been done on epithelin. And most of it has been done by a single research group in Russia. There is some restrictions on some of the cell culture data that we’re seeing. And it does show that epithelin sometimes can be described as a regulating hormone. Carcadian rhythm for melatonin production, which is derived by the penile extracts. And however the evidence for this affects minimally and mechanistically unclear, the pineal gland primarily functions as melatonin secretion in that light-dark cycles. So Epithalin or epitalin is not FDA approved. It is not approved for any major regulatory jurisdiction. It is sold as a research chemical only. Dr. Deb Muth 49:33So you need to follow the same safety profiles that we’ve talked about in other episodes and in today’s episodes. And when we’re talking about epithalin, and we’re excited about it being an anti-aging science, we should balance this with the honesty and the evidence of the quality of that evidence. We don’t know its safety effect. We don’t know if it’s going to increase the risk of cancer. We can’t verify that. And we need to be using it in an experimental use of unknown risks only. Of course, diet, physical activity, stress management, sleep quality, all of those things are important for us to be looking at when we’re looking at these peptides. Now, I want to get into some of the brain peptides. This is the nootrophic frontier. C-Max and C-Lank, there is Russian pharmacology that’s done. C-Max and C-Lank represent an interesting case study in how different regulatory environments and research traditions Dr. Deb Muth 50:36create challenges in evaluating this evidence. Both peptides were developed in Russia, are approved for their specific indications and have substantial Russian language and literature supporting their use. However, the FDA approval in the United States is still not there. C-Max is a seven amino acid. It’s a synthetic analog. It is a fragment, particularly ACTH 4 through 10. It’s sometimes called the melanocortin effects because it involves the melanocortin receptors of the central nervous system. CMAX was developed by the Institute of Molecular Genetics of Russia Academy of Sciences and is approved in Russia for several indications, including acute stroke, transient ischemic attacks, cognitive disorders. It has Russian approval and is based on clinical trials primarily in Russia. Dr. Deb Muth 51:39It does help to increase brain-derived neurotrophic factor, BDNF, a protein critical for neuroplasticity, the brain’s ability to form new connections and adapt to the challenges. BDNF supports neuronal survival and promotes growth of these new neurons. C-Max also influences neurotransmitter systems, particularly dopamine and serotonin, and there is some research that suggests it affects on metabolism as well, and endogenous opioid peptides that involve pain reception and mood regulation. So it has some good potentials there. There is also C-Link, which is a hepatopeptide structurally similar to Tufts’ and an immune modulatory peptide. It was also developed in Russia and was approved for anxiety disorders as a neurotropic. Its effects involve anxiolytic effects, possibly through the GABAnergic system or the GABA system of the brain, and immune modulation. Dr. Deb Muth 52:44The Russian research is examined by C-Link for anxiety disorders. and finding reductions in anxiety without sedation. There is a dependency potential or cognitive impairment does not exist like it does with benzodiazepines with C-Link. So that is really good. And they do report attention and memory improvement using C-Link. There is a study that was done in neuroscience and behavioral psychology in 2018 that examined C-Linx effects and proposed that it exerts cytoprotective effects through BDNF pathways similar to C-Max. So both of these are Russian research-based They’re not wrong or fraudulent. It’s just that they are from Russia and we all have our concerns with Russia. However, that does not necessarily mean their research doesn’t hold quality. Dr. Deb Muth 53:49Neither peptide is approved by the FDA, and so you are using this off-label. The same rules apply for all of the other peptides that we’ve talked about that are produced off label. You want to do the same things that you would do with anything else. Good protein, omegas, B vitamins, acetylcarnitine, exercise, sleep, all of that still applies when we’re using these peptides. So I want to talk briefly about clinical decision and framework when we’re looking at this. First and foremost, we always want to go to FDA-approved peptides. Secondly, we would look at international approval with peptides that are established in other countries but lack FDA approval. And then preclinical evidence only or experimental peptides. These can be used, but they are not ethically recommended in the traditional medicine world. Dr. Deb Muth 54:50 If patients use them, we need to have appropriate counseling about the evidence surrounding them, the safety, and where to find them. how to find them and how to ask for these certificates of analysis. So I think it’s really good that we were exploring all these peptides and understanding what they are. There’s a lot of controversy out there. There’s a lot of concern out there. And what we can say with confidence is that peptides are powerful biological signaling molecules. Some peptide based medications, semi-glutide, triseptide, PT 141, Lupron that are all FDA approved. can dramatically improve outcomes in patients that are obviously selected for the correct ones. There are many other peptides that we address that are integrative and longevity space in the regenerative medicine. These peptides are all experimental. That does not automatically make them wrong. Dr. Deb Muth 55:50It just means that we need to be honest about what we’re doing with them and we need to be cautious with the patients so that they can make a decision to be part of an experimental study. in looking at how to use these peptides. So peptides are tools like any other tools. They work best in the hands of skilled people, and they are applied to appropriate situations, integrating into comprehensive approaches that address root causes. The most powerful peptide administered to a patient with untreated inflammation, hormonal chaos, nutritional deficiencies, and disorders of sleep will disappoint. The simplest evidence-based interventions apply. to a patient whose foundational physiology has been optimized. And this is the art of the science of peptide, right? If done right, respecting both the power of these molecules and the complexity of human beings that we are privileged to serve can make a difference in their lives. So thank you for listening to this episode. Dr. Deb Muth 56:52I hope this was helpful. If you can know of somebody that might benefit from this, please like, share, and subscribe. It means a lot to us. And I hope you join us for our next episode of Let’s Talk Wellness Now. Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you. Please note that the views and information shared by our guests are their own and do not necessarily reflect those of Let’s Talk Wellness Now, its management, or our partners. Each affiliate, sponsor, and partner is an independent entity with its own perspectives. Today’s content is provided for informational and educational purposes only and should not be considered specific advice, whether financial, medical, or legal. While we strive to present accurate and useful information, we cannot guarantee its completeness or relevance to your unique circumstances. We encourage you to consult with a qualified professional to address your individual needs. Dr. Deb Muth 57:54Your use of information from this broadcast is entirely at your own risk. By continuing to listen, you agree to indemnify and hold Let’s Talk Wellness Now and its associates harmless from any claims or damages arising from the use of this content. We may update this disclaimer at any time and changes will take effect immediately upon posting or broadcast. Thank you for tuning in. We hope you find this episode both insightful and thought-provoking. Listener discretion is advised.The post Episode 258 – Investigational Peptides: What's Promising, What's Hype & What You Must Know first appeared on Let's Talk Wellness Now.

Drs. Vakharia and Danzig highlight new AAO 2025 data on high-dose aflibercept, sleep apnea as a potential AMD risk factor, and an AI-guided anti-VEGF regimen that cuts injections while maintaining vision. Together, these advances point toward more personalized, efficient care for patients with neovascular AMD and DME.

CME credits: 0.75 Valid until: 04-03-2027 Claim your CME credit at https://reachmd.com/programs/cme/So-You-Think-You-Want-a-TKI/54102/ This activity examines the evolving role of tyrosine kinase inhibitors (TKIs) in treating exudative retinal diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Experts discuss limitations of current anti-VEGF therapies, emphasizing challenges with durability and adherence. The series further explores TKI mechanisms and their formulation into sustained-release delivery systems. Detailed overviews of clinical programs (eg, LUGANO, LUCIA, SOL-1, SOL-R) highlight ongoing phase 3 studies evaluating efficacy and treatment intervals. Real-world case discussions further illustrate patient types who may benefit from these investigational agents. The conversation concludes with considerations for integrating TKIs into future practice. *Please stay tuned for additional content to this activity available for credit. The maximum amount of credit(s) available for the entire activity is 0.75.

CME credits: 0.75 Valid until: 04-03-2027 Claim your CME credit at https://reachmd.com/programs/cme/Who-Needs-a-TKI-Identifying-the-Right-Candidates/54101/ This activity examines the evolving role of tyrosine kinase inhibitors (TKIs) in treating exudative retinal diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Experts discuss limitations of current anti-VEGF therapies, emphasizing challenges with durability and adherence. The series further explores TKI mechanisms and their formulation into sustained-release delivery systems. Detailed overviews of clinical programs (eg, LUGANO, LUCIA, SOL-1, SOL-R) highlight ongoing phase 3 studies evaluating efficacy and treatment intervals. Real-world case discussions further illustrate patient types who may benefit from these investigational agents. The conversation concludes with considerations for integrating TKIs into future practice. *Please stay tuned for additional content to this activity available for credit. The maximum amount of credit(s) available for the entire activity is 0.75.

CME credits: 0.75 Valid until: 04-03-2027 Claim your CME credit at https://reachmd.com/programs/cme/To-Implant-or-to-Inject/54100/ This activity examines the evolving role of tyrosine kinase inhibitors (TKIs) in treating exudative retinal diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Experts discuss limitations of current anti-VEGF therapies, emphasizing challenges with durability and adherence. The series further explores TKI mechanisms and their formulation into sustained-release delivery systems. Detailed overviews of clinical programs (eg, LUGANO, LUCIA, SOL-1, SOL-R) highlight ongoing phase 3 studies evaluating efficacy and treatment intervals. Real-world case discussions further illustrate patient types who may benefit from these investigational agents. The conversation concludes with considerations for integrating TKIs into future practice. *Please stay tuned for additional content to this activity available for credit. The maximum amount of credit(s) available for the entire activity is 0.75.

CME credits: 0.75 Valid until: 04-03-2027 Claim your CME credit at https://reachmd.com/programs/cme/TKI-The-New-TKO-for-Retinal-Diseases/54099/ This activity examines the evolving role of tyrosine kinase inhibitors (TKIs) in treating exudative retinal diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Experts discuss limitations of current anti-VEGF therapies, emphasizing challenges with durability and adherence. The series further explores TKI mechanisms and their formulation into sustained-release delivery systems. Detailed overviews of clinical programs (eg, LUGANO, LUCIA, SOL-1, SOL-R) highlight ongoing phase 3 studies evaluating efficacy and treatment intervals. Real-world case discussions further illustrate patient types who may benefit from these investigational agents. The conversation concludes with considerations for integrating TKIs into future practice. *Please stay tuned for additional content to this activity available for credit. The maximum amount of credit(s) available for the entire activity is 0.75.

CME credits: 0.75 Valid until: 04-03-2027 Claim your CME credit at https://reachmd.com/programs/cme/The-Struggle-Is-Real/54098/ This activity examines the evolving role of tyrosine kinase inhibitors (TKIs) in treating exudative retinal diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Experts discuss limitations of current anti-VEGF therapies, emphasizing challenges with durability and adherence. The series further explores TKI mechanisms and their formulation into sustained-release delivery systems. Detailed overviews of clinical programs (eg, LUGANO, LUCIA, SOL-1, SOL-R) highlight ongoing phase 3 studies evaluating efficacy and treatment intervals. Real-world case discussions further illustrate patient types who may benefit from these investigational agents. The conversation concludes with considerations for integrating TKIs into future practice. *Please stay tuned for additional content to this activity available for credit. The maximum amount of credit(s) available for the entire activity is 0.75.

Drs. Kat Talcott and Nita Valikodath join for a journal club episode discussion of three recent publications:‍ ‍ ‍ ‍Hemorrhagic PVD Follow-Up (https://www.aaojournal.org/article/S0161-6420(25)00791-2/fulltext)‍ ‍GLP-1 Agonists and AMD (https://www.ophthalmologyretina.org/article/S2468-6530(25)00597-4/abstract)‍ ‍Preoperative Anti-VEGF for Diabetic Vitrectomy (https://www.ophthalmologyretina.org/article/S2468-6530(25)00600-1/abstract)‍ ‍

Guest: Courtney Crawford, MD, FACS Guest: Raj Maturi, MD While anti-VEGF therapy can deliver vision gains with consistent, frequent injections in clinical trials, it may be challenging to sustain this in real-world practice.1 Ocular gene therapy could be a potential option for patients with neovascular age-related macular degeneration if approved. With this approach, transgenes are delivered to the eye by adeno-associated viruses (AAVs).2-4 Learn more with Drs. Courtney Crawford and Raj Maturi, who shared their perspectives on investigational gene therapy, patient conversations, and surgical considerations at the 2025 American Academy of Ophthalmology annual meeting in Orlando, Florida. Dr. Crawford is a board-certified retina specialist and founder of Star Retina in Burleson, Texas. He previously served for 10 years as a physician in the U.S. Army, where he attained the rank of Lieutenant Colonel. Dr. Maturi is a board-certified retina specialist at the Midwest Eye Institute and founder of Retina Partners Midwest in Carmel, Indiana, where he focuses on macular, retina, and vitreous care. References: Weng CY, Singh RP, Gillies MC, Regillo CD. Optimizing visual outcomes in patients with neovascular age-related macular degeneration: the potential value of sustained anti-VEGF therapy. Ophthalmic Surg Lasers Imaging Retina. 2023;54:654–659. Petrich J, Marchese D, Jenkins C, Storey M, Blind J. …

Please visit answersincme.com/YMM860 to participate, download slides and supporting materials, complete the post test, and get a certificate. Presented by Nitish Mehta, MD; and Sarwar Zahid, MD. In this activity, experts in diabetic retinopathy discuss long-acting anti-VEGF agents and strategies to improve outcomes for patients with diabetic macular edema (DME). Upon completion of this activity, participants should be better able to: Recognize factors that contribute to patients' treatment burden with intravitreal anti-VEGF therapies for diabetic macular edema (DME); Assess the clinical profiles of long-acting intravitreal anti-VEGF agents for DME; and Recommend individualized strategies to enhance long-term treatment outcomes for patients with DME.

Sexual health and wellness aren't just about pleasure; they are a critical health marker revealing what's happening inside your body. If you've noticed changes in your libido, you're receiving valuable information about your overall wellness. Are you ready to decode what your body is telling you?Host Jenn Trepeck welcomes Dr. Diane Mueller, a leading authority in sexual wellness and functional medicine, to explore why your libido is a health marker you can't afford to ignore. Together, they uncover the connections between sexual desire, cardiovascular health, hormonal balance, and stress management, while addressing the physical, personal, and relational barriers that impact your intimate wellness.What You Will Learn in This Episode:✅ Why sexual health serves as a critical health marker revealing underlying imbalances in your cardiovascular system, hormones, and neurological function✅ How oxytocin is released during intimacy provides powerful stress relief by lowering cortisol levels and supporting bone health, brain health, and connection✅ The three pillars of low libido root causes: physical factors like pelvic floor health and blood flow, personal barriers including body image and shame, and relational communication challenges✅ Practical interventions including specific supplements like citrulline for nitric oxide production, proper testing for thyroid health including reverse T3, and movement practices for embodimentThe Salad With a Side of Fries podcast, hosted by Jenn Trepeck, explores real-life wellness and weight-loss topics, debunking myths, misinformation, and flawed science surrounding nutrition and the food industry. Let's dive into wellness and weight loss for real life, including drinking, eating out, and skipping the grocery store.TIMESTAMPS: 00:00 Libido as a health marker and why sexual wellness impacts overall well-being and longevity04:04 Defining healthy libido and why medical definitions of hypoactive sexual desire disorder are inadequate08:33 The connection between relationship health, weekly intimacy frequency, and happiness quotients in partnerships09:44 Understanding oxytocin levels during orgasm versus cuddling and the profound impact on stress management14:13 Advice for single individuals on self-pleasure, the Lioness device, and building body confidence independently18:47 Why testosterone alone doesn't solve low libido and the multiple root causes requiring comprehensive approaches25:21 Physical root causes, including pelvic floor health, blood flow, thyroid function, and neurological inflammation34:43 Supplementation strategies using citrulline, nitric oxide precursors, magnesium, and VEGF enhancement through movement37:43 Personal barriers around body image and shame processing through embodied movement and sensual dance practices46:14 Relational communication in the bedroom and how 92% of satisfying sex lives involve open dialogueKEY TAKEAWAYS:

Dr. Joshua Reuss is back on the podcast to discuss the full update to the living guideline on stage IV NSCLC without driver alterations. He discusses the new evidence and how this impacts the latest recommendations on first-line and subsequent therapeutic options. Dr. Reuss emphasizes the need for shared decision-making between clinicians and patients. He shares ongoing research that the panel will review in the future for further updates to this living guideline, and puts the updated recommendations into context for clinicians treating patients with stage IV NSCLC. Read the full living guideline update "Therapy for Stage IV Non-Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2026.3.0" at www.asco.org/thoracic-cancer-guidelines" TRANSCRIPT This guideline, clinical tools and resources are available at www.asco.org/thoracic-cancer-guidelines. Read the full text of the guideline and review authors' disclosures of potential conflicts of interest in the Journal of Clinical Oncology,  https://ascopubs.org/doi/10.1200/JCO-25-02825    Brittany Harvey: Hello and welcome to the ASCO Guidelines podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges, and advances in oncology. You can find all the shows, including this one, at asco.org/podcasts. My name is Brittany Harvey, and today I am interviewing Dr. Joshua Reuss from Georgetown University, co-chair on "Therapy for Stage IV Non-Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2026.3.0." It is great to have you back on the show today, Dr. Reuss. Dr. Joshua Reuss: Happy to be here, Brittany. Brittany Harvey: Just before we discuss this guideline, I would like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO Conflict of Interest Policy is followed for each guideline. The disclosures of potential conflicts of interest for the guideline panel, including Dr. Reuss who has joined us here today, are available online with the publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes. Dr. Reuss, this living clinical practice guideline for systemic therapy for patients with stage IV non-small cell lung cancer without driver alterations is updated on an ongoing basis. So, what prompted this latest update to the recommendations? Dr. Joshua Reuss: Our committee is tasked with making routine updates to the living guidelines and really keeping them living, right? So, evaluating new data as it is coming in to see, is this practice changing? Is this data that should inform and potentially alter our guideline recommendations so that practitioners and other care providers could really make the best treatment decisions for their patients? So that is something that happens on a more routine basis, but periodically, we are tasked with performing a more comprehensive update of our guideline where we really evaluate every one of our point recommendations, the data associated with these recommendations, to be sure that these are up to date, these are comprehensive, and to see if we need to alter anything in the language of these updates. Brittany Harvey: Excellent. Thank you for providing that background. And yes, this is truly a comprehensive update that goes through all the latest literature. Given that, I would like to review what has changed and what is new in the recommendations. So, what are the updated recommendations on first-line therapy for patients with stage IV non-small cell lung cancer without driver alterations? Dr. Joshua Reuss: So there are two main guidelines that we recommend from this panel. One is a driver mutation-positive guideline and the other is a driver mutation-negative guideline. And I think on first blush, one might look at kind of the recent flurry of approvals and new data and say, well, all the excitement, you know, is in the driver mutation-positive guideline. But I would say that the driver mutation-negative guideline is equally as important and really has several unique challenges associated with it. You know, first and foremost is that there are really a multitude of regimens that can be considered for any one patient. And how to choose between one can be quite difficult and a stressful challenge that clinicians can have, particularly since there are really no randomized studies comparing these regimens in a head-to-head fashion. In addition, you know, these guidelines are really broken down by two key factors. One is disease histology, so namely squamous versus non-squamous histology. And the other is PD-L1 status, broken down into one of three tertiles: PD-L1 high, which is greater than or equal to 50% expression; PD-L1 low, which is 1% to 49% expression; and then PD-L1 negative or unknown. So what you are really looking at, if you do that math, is really six unique patient subpopulations where we need to make a recommendation on one of the multitude of treatment regimens that is approved. And what that means is you are oftentimes really looking at subset and sub-subset level data to help inform clinicians in their treatment decision making, which can be quite challenging because as those small subsets of data is more and more parsed, there are many confounders that can be interjected there. And so I think the committee is tasked with really quite a challenge in terms of how to really communicate and broadcast that data in a way that informs clinicians in making a decision on what is the right treatment for their patient. Brittany Harvey: Absolutely. It can be challenging to interpret that subgroup data across several different studies that are reporting on different regimens and different outcomes. And I appreciate you mentioning the driver mutation-positive guideline as well. Listeners can check out the companion episode with Dr. Puri for more information on what is changed in the driver mutation-positive guideline. Based on that primer, what is new for first-line therapy for patients with stage IV non-small cell lung cancer without driver alterations? Dr. Joshua Reuss: Even though I will say there is not a lot of new trial data that was incorporated into this guideline, there were some updates and just some meaningful long-term data that we incorporated. I think first and foremost, there is a new top-level recommendation in this guideline pertaining to molecular testing, which is absolutely critical in both the driver mutation-positive and driver mutation-negative space. I think we tend to think that, oh, well, molecular testing really only pertains to then finding a driver mutation. But the lack of a mutation is absolutely critical as well, right? Because that is what leads us down the mutation-negative pathway. We also need this molecular testing to assess PD-L1 status. We are seeing emerging data on molecular mutations that might confer resistance to certain immunotherapy-based strategies. So the committee felt strongly that a recommendation on molecular testing is critical to include in both the driver mutation-positive guideline and the driver mutation-negative guideline. I will also say that we are now seeing five and six-year updates from some of the landmark trials of immunotherapy in driver mutation-negative non-small cell lung cancer. It is really incredible to see that in some of these trials, we are seeing very impressive durability of the treatment in the patient subsets that we are commenting on. In others, perhaps that durability is less clear, and I think that leads to challenges in making a recommendation on any one particular regimen. And I think that is nowhere more clear than in the squamous subset. I think that was one perhaps subtle change that is in this guideline where, particularly in the PD-L1 negative squamous population, the committee felt that no one regimen really was worthy of standing above the others. Sometimes I think it is important to really champion one unique regimen if we feel that the data is there to support it. But I think it is equally important to list multiple regimens where the data is less clear. I think another point is that while perhaps there were no new regimens that we have added or that led to other clear changes in the prioritization of one regimen over another, there are other unique data subsets that I think come into play in making a decision and that really are important when looking at the discussion on any one recommendation from this guideline. For example, we know there is emerging data on perhaps the significance of molecular alterations in KEAP1 or STK11 and how that might influence frontline decision-making. You know, there is not a prospective phase III trial in this population, but I think we still need to use that data in certain scenarios to make recommendations for a particular patient. Another example of a trial that, again, did not change our recommendations, but I think one can incorporate in their decision making is the KEYNOTE-598 trial. Now, this is not a new study, but what it studied was pembrolizumab versus pembrolizumab plus ipilimumab in a PD-L1 high subset, and found that the addition of ipilimumab to pembrolizumab in the PD-L1 high population did not significantly improve clinical efficacy. And so while pembrolizumab plus ipilimumab is not an approved regimen, it is hard to extrapolate that to our combination treatments that are approved. I think some clinicians might find that data valuable when making a frontline treatment decision on a patient who has PD-L1 high status. So a bit of a whirlwind tour, but I think there are still multiple factors that went into this guideline that are important to review when making treatment decisions for any one patient. Brittany Harvey: Absolutely. I think what you just mentioned in having that upfront molecular testing is really key for individualized patient care. And the evidence summaries that you provide in addition to the recommendations are really important for clinicians to be able to refer to as they are making decisions in their clinic. So then beyond those changes for first-line therapy, what is updated for second-line and subsequent therapies? Dr. Joshua Reuss: For second-line and subsequent therapies, we did see one new treatment recommendation join these ranks, and that was telisotuzumab vedotin. Telisotuzumab vedotin, quite a mouthful. That is an antibody-drug conjugate. I like to think of that as smart chemotherapy, targeted chemotherapy, where you are trying to utilize some aspect of a marker that is selectively expressed or overexpressed on the cancer surface to then shepherd in the anticancer molecule, a highly potent chemotherapeutic in the case of currently approved antibody-drug conjugates, to exert antitumor killing effect. So in this case, the antibody-drug conjugate telisotuzumab vedotin targets MET overexpression. So telisotuzumab is an antibody targeting MET, and that is conjugated to an MMAE highly potent chemotherapeutic payload called vedotin. So we know MET can be selectively expressed and overexpressed in non-small cell lung cancer in both driver mutation-positive and mutation-negative subsets. The data that led to this approval was from the phase II LUMINOSITY trial which evaluated telisotuzumab vedotin, or Teliso-V, in many subsets. But the subset that really showed promise and was expanded was the EGFR wild-type, non-squamous, non-small cell lung cancer population with MET overexpression. And so in 78 patients with high levels of expression, the response rate here was 34.6%, median progression-free survival of 5.5 months, and a median overall survival of 14.6 months. With an overall acceptable safety profile; grade 3 or higher adverse events, neuropathy was perhaps the most common at 7%, also increased ALT at 3.5%, and pneumonitis at 2.9%. Now this was phase II data that led to an accelerated approval. There is an ongoing phase III study randomizing patients with high expression to Teliso-V versus docetaxel. That is the phase III TeliMET study. But it is nice that we now have another option for patients, perhaps a more biomarker-directed option with, again, this MET overexpression. And again, it further reinforces the importance of molecular testing in patients with traditionally driver mutation-negative non-small cell lung cancer, whether that is upfront or at progression, and in particular utilizing immunohistochemistry to assess MET expression in these patients. And this does join another ADC that we had previously made an update in our recommendation, which is trastuzumab deruxtecan, which is approved for those patients with HER2-overexpressing non-small cell lung cancer. So just again to reiterate the importance of molecular testing in patients both at the outset of their treatment and upon progression on frontline therapy. Brittany Harvey: Definitely. It is great to have this new antibody-drug conjugate join the treatment options, and as you mentioned, very important in this case to have that molecular testing done at the outset and at progression. So then in your view, what should clinicians know as they implement this living guideline, and how do these changes impact patients with non-small cell lung cancer? Dr. Joshua Reuss: Because there are so many different regimens that one can consider for any one patient, I think it is easy to become overwhelmed and stress on, "Am I making the right choice for my patient?" And I think one of the key take home points is that in many cases, there is no one right regimen. And I think one has to weigh several factors. It is the treatment schedule. It is the toxicity profile. It is the molecular profile of the patient. It is the patient preference. You know, there are so many factors here. And I would like to draw the reader and viewer's attention to an important section of these guidelines, particularly the Patient and Clinician Communication section, where we have a box focused on discussion points between patients and clinicians, which I think focuses on several of the high-level points that one can emphasize in making these decisions, ranging on things from: what are the goals of the treatment? What are the risks and benefits to any one approach? What are comorbidities that should be factored in? Common concerns, toxicity management, clinical trial consideration. All of these factors that I think are incredibly important in making that frontline treatment decision and implementing a regimen that both the clinician and, more importantly, the patient feels comfortable with. Brittany Harvey: It is really important that there is shared decision-making in these scenarios. And I think that patient-clinician communication section can tease out some of those preferences from the patient end and talk through the risks and benefits of different regimens as well. As we mentioned at the top of this episode, this guideline is a living guideline and updated on an ongoing basis. So what is the panel examining and keeping an eye on for future updates to this guideline? Dr. Joshua Reuss: So I think there are a lot of exciting new therapies and more up-to-date trials that we are anxiously awaiting the results of on our committee, and I think the oncology community in general is awaiting the results of. When we will have these results, I think, is a bit of an open-ended question, but I can give some insight on several of the trials that our committee is really keeping a close eye on. One that we have mentioned for several guideline iterations is the ECOG-ACRIN INSIGNA trial. This is a phase III clinical trial comparing pembrolizumab versus pembrolizumab plus carboplatin and pemetrexed chemotherapy in PD-L1 positive, non-squamous, non-small cell lung cancer. We talk about there being different regimens that can be considered in PD-L1 positive and PD-L1 high subsets, namely immunotherapy alone or immunotherapy plus chemotherapy, but there is no direct head-to-head comparison here. So this trial hopefully will answer that question. It has now finished accrual. There are other very interesting molecules and trials. I think another interesting compound is ivonescimab. This is a PD-1/VEGF bispecific antibody that is currently approved in China as monotherapy in patients with PD-L1 positive non-small cell lung cancer based off of the HARMONi-2 trial, where the progression-free survival of this bispecific antibody, ivonescimab, appeared superior to pembrolizumab. And we are looking closely at ongoing trials to see if these results will be replicated in an ex-China population. And if so, I think it could have a real impact and change on our guidelines. Still other very interesting things. There are obviously confirmatory studies for antibody-drug conjugates, such as the TeliMET study that I alluded to earlier, and many promising antibody-drug conjugates, both bispecific and trispecific antibody-drug conjugates, that hopefully can inform practice. And then there are several unique subsets of populations that I think we now are utilizing data on to make decisions, but a lot of that is retrospective in small subsets where we do not have that prospective data. And there are several trials ongoing in some of these subsets to try to gain clarity on what regimen may be the best for patients. One example is the phase III TRITON trial, which is looking at comparing CTLA-4 containing regimen, particularly the POSEIDON regimen of durvalumab plus tremelimumab and chemotherapy, versus the KEYNOTE-189 regimen, which is pembrolizumab plus carboplatin and pemetrexed, in patients with non-squamous, non-small cell lung cancer that have alterations in either KRAS, KEAP1, and/or STK11. There is a lot of both preclinical and clinical data to suggest that patients with these alterations in STK11 and KEAP1 may be more resistant to a PD-1 based treatment approach, and perhaps the incorporation of CTLA-4 can lead to a more meaningful response in this unique subset. Obviously, that data, it is retrospective, it is in small subsets. And when you add in a CTLA-4 molecule, you are also introducing greater risk for toxicity. So this trial is going to be very important in elucidating: is there a benefit in that unique subset? Does that data that we see retrospectively in this small subset hold true when evaluated in a prospective fashion? So while our guideline, our most recent comprehensive panel update, may not have had a lot of new data in it that has influenced frontline treatment decision-making, I think the future is bright and there are a lot of novel studies and novel treatments on the horizon that will hopefully improve the outcomes for our patients. Brittany Harvey: Absolutely. We will look forward to the results of those ongoing trials to provide more options and particularly clarity for patients with non-small cell lung cancer and to inform this guideline and its many updates to come. So I want to thank you so much for your work to rapidly and continuously update this guideline, and thank you for your time today, Dr. Reuss. Dr. Joshua Reuss: Thank you so much. Brittany Harvey: And finally, thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the full guideline, go to www.asco.org/thoracic-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines App available in the Apple App Store or the Google Play Store. If you have enjoyed what you have heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  

Too busy to read the Lens? Listen to our weekly summary here! In this week's episode we discuss…When the American Joint Committee on Cancer's classification for uveal melanoma is challenged, a new staging system is proposed that incorporates tumor volume, clinical risk factors, and genetic alterations.GLP-1 receptor agonists are linked to a >90% reduced risk over 10 years of developing nonexudative age-related macular degeneration when compared to other weight-loss drugs in obese, non-diabetic individuals.Migraines are independently associated with higher rates of central serous chorioretinopathy when compared to controls.Eye drops containing siRNA (GalNAc-modified siHOTAIR) are comparable to anti-VEGF injections, suppressing inflammation, vascular mediators, endothelial permeability, and angiogenesis in diabetic rats.

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 events shaping the industry, from innovative drug formulations and regulatory challenges to the dynamic IPO landscape and clinical trial outcomes.Starting with Novo Nordisk, their oral formulation of Wegovy is witnessing substantial uptake, showcasing a strong demand for novel obesity treatments. This rapid adoption underscores a competitive environment where companies like Eli Lilly, with its Zepbound launch, are vying for market share. The introduction of innovative delivery methods in obesity management not only drives immediate commercial success but also highlights a critical area of therapeutic advancement due to the rising global prevalence of obesity.From a regulatory perspective, alignment with bodies like the FDA remains crucial. Companies such as Beam Therapeutics and Cabaletta Bio emphasize this at events like the J.P. Morgan Healthcare Conference, highlighting the importance of clear regulatory pathways in ensuring the successful approval of promising therapies. Conversely, Atara Biotherapeutics' recent setback with an unexpected FDA rejection demonstrates the unpredictability inherent in regulatory processes, which can significantly impact drug development timelines.The IPO market in biotech remains vibrant despite broader market uncertainties. Noteworthy are Agomab Therapeutics and Spyglass Pharma, each preparing for substantial public offerings. Agomab focuses on ALK5 inhibitors for inflammatory diseases, while Spyglass advances drug delivery implants for chronic eye conditions. This wave of IPOs highlights investor confidence in innovative therapies that address unmet medical needs and reflects a broader trend toward precision medicine and novel treatment modalities.In clinical research, AbbVie and Genmab faced a setback when their bispecific antibody failed to meet a crucial endpoint in a Phase III lymphoma study. Such challenges underscore the high stakes involved in oncology drug development, where successes can significantly alter treatment paradigms, yet failures remind us of the inherent risks.Turning to Alzheimer's disease, there is palpable excitement around next-generation treatments under investigation. These candidates promise to reshape the landscape by offering new hope in a field where effective therapies are desperately needed. This is complemented by advancements in manufacturing capabilities recognized as essential to strategic planning beyond 2026, ensuring that production processes can scale efficiently to meet global demands.On the workforce front, Takeda's decision to reduce its U.S. headcount, impacting its neurology teams, reflects industry trends where resource allocation is increasingly focused on core growth areas. Such strategic recalibrations are part and parcel of navigating competitive pressures and evolving market demands.In another realm, ImmunityBio's Phase 1 results for its CD19 CAR-NK cell therapy offer promising insights into innovative oncology approaches. The use of natural killer cells engineered with chimeric antigen receptors could revolutionize cancer treatment by providing targeted therapeutic options for hematological malignancies and potentially solid tumors.Regulatory approvals also continue to shape industry dynamics. SOBI's Aspaveli receiving EU approval for rare kidney diseases marks significant progress in complement inhibition therapies. Meanwhile, Bayer's Eylea approval for retinal vein occlusion-related visual impairment reinforces the vital role of VEGF inhibitors in ophthalmology.Strategic collaborations are also making headlines, as seen with Abelzeta and AstraZeneca's expanded partnership on GPC3 CAR-T therapy through an acquisition focused on China rights. This move illustrates the global interest inSupport the show

AbbVie bet nearly $5 billion for the ex-China rights to RemeGen's PD-1/VEGF bispecific and Novartis struck a $1.5 billion Alzheimer's-focused deal with China-based SciNeuro Pharmaceuticals as the 2026 J.P. Morgan Healthcare Conference got underway on Monday. These and other recent tie-ups speak to the therapeutic trends predicted to be hot this year by experts who spoke with BioSpace, who particularly noted that cancer and neuroscience would remain top of the list.  Meanwhile, attendees are still waiting for that “one big M&A deal.” Could it come from Merck? CEO Rob Davis expressed high confidence during the company's JPM presentation on Monday, revealing that Merck is open to deals in the range of “multi tens of billions of dollars.” On the weight loss front, Eli Lilly and Novo Nordisk both updated attendees on the state of play, with Lilly expressingconfidence in its supply chain to support the launch of obesity pill orforglipron and Novo continuing to lament the business it is still losing to compounders.  Just in time for JPM, the IPO window cracked open, with Aktis Oncology debuting on the public markets last week and Veradermics and Eikon Therapeutics announcing their bids to follow suit. A similar thaw occurred last year before the window slammed shut again as myriad policy changes frightened investors. How will this year play out?  2025 had its challenges, especially on the policy front. In his annual letter, Flagship CEO Noubar Afeyan cited “growing contempt” in the U.S. for the scientific method and arapidly emerging Chinese biopharma ecosystem among the greatest challenges facing the industry. And while the funding may now be flowing, it still favors later-stage companies. A .J.P. Morgan report released prior to the conference showed VC funding was down across the board last year, but especially for biotechs recruiting early rounds.  Finally, while JPM is the primary focus, the FDA hasn't taken the week off. Just prior to recording, the regulator requestedthat Lilly and Novo remove the suicide warning from the labels of certain GLP-1 medications after a comprehensive review found no increased risk of suicidal ideation and behavior with these drugs. On the policy front, the FDA continued its quest to accelerate the development of cell and gene therapies with new manufacturing exemptions.  The regulator also took action on two applications this week, approving a rare disease drug developed by Sentynl Therapeutics and Fortress Biotech and denying a cell therapy submitted by Atara Biotherapeutics. To learn about key upcoming FDA action, check out 6 FDA Decisions To Watch in Q1 2026 in ClinicaSpace this week.

Host Dr. Jay Sridhar welcomes Drs. Michael Ip and Sophie Bakri to discuss the challenges in caring for patients with macular edema secondary to retinal vein occlusion (RVO). The panel reviews the current approach to treatment using anti-VEGF agents and factors that may suggest a need for more intensive, long-term treatment. For all episodes or to claim CME credit for selected episodes, visit www.aao.org/podcasts.

What if the most powerful “sugars” aren't fuel at all, but messages your immune system has been waiting to hear? We sit down with Dr John Lewis, a former professor whose lab uncovered striking cognitive improvements in people with moderate to severe Alzheimer's after 12 months on a formula built from aloe and rice bran polysaccharides. The science takes us beyond calories and cravings into complex carbohydrates as signaling molecules—shaping inflammation, immune balance, and possibly neuroplasticity.We unpack polysaccharides 101, separating starch from functional giants like aloe acemannan and rice bran compounds. You'll hear how these dense, 3D structures can influence CD4/CD8 ratios, natural killer cell activity, TNF-alpha, VEGF, and even CD14 cells tied to neural repair. The clinical story is matched by lived moments from caregivers who witnessed language and daily function return. We also dig into why conventional funding passed on this line of research, the dominance of amyloid-focused paradigms, and the gap between public talk about nutrition and what actually gets resourced.If you've wondered whether food could deliver these effects, we cover the practical realities: aloe gel is mostly water, rice bran is milled off white rice, and even daily brown rice may not supply meaningful doses—especially for older adults managing chronic inflammation. That's where concentrated, third-party tested, GMP-produced supplementation can fit: small grams-per-day inputs that favor immune modulation without stimulants or sugar spikes. Along the way we explore prevention, aging, and how steady immune signaling may guard brain health long before problems start.Subscribe for more deep, evidence-led conversations on brain health, nutrition science, and longevity. If this episode challenged your view of “sugar,” share it with a friend and leave a review to help others find the show.https://drlewisnutrition.com/ Use "Lufkin10" for 10% off.Lies I Taught In Medical School : Free sample chapter- https://www.robertlufkinmd.com/lies/Complete Metabolic Heart Scan (LUFKIN20 for 20% off) https://www.innerscopic.com/Fasting Mimicking Diet (20% off) https://prolonlife.com/Lufkin At home blood testing (20% off) https://siphoxhealth.com/lufkin Web: https://robertlufkinmd.com/X: https://x.com/robertlufkinmdYoutube: https://www.youtube.com/robertLufkinmdSubstack: https://robertlufkinmd.substack.com Instagram: https://www.instagram.com/robertlufkinmd/LinkedIn: https://www.linkedin.com/in/robertlufkinmd/TikTok: https://www.tiktok.com/@robertlufkinThreads: https://www.threads.net/@robertlufkinmdFacebook: ...

JCO PO author Dr. Shilpa Gupta at Cleveland Clinic Children's Hospital shares insights into her article, "Fibroblast Growth Factor Receptor 3 (FGFR3) Alteration Status and Outcomes on Immune Checkpoint Inhibitors (ICPI) in Patients with Metastatic Urothelial Carcinoma". Host Dr. Rafeh Naqash and Dr. Gupta discuss how FGFR3 combined with TMB emerged as a biomarker that may be predictive for response to ICPI in mUC. TRANSCRIPT Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, podcast editor for JCO Precision Oncology and Associate Professor at the OU Health Stephenson Cancer Center. Today I am excited to be joined by Dr. Shilpa Gupta, Director of Genitourinary Medical Oncology at the Cancer Institute and co-leader of the GU Oncology Program at the Cleveland Clinic, and also lead author of the JCO PO article titled "Fibroblast Growth Factor Receptor 3 Alteration Status and Outcomes on Immune Checkpoint Inhibitors in Patients With Metastatic Urothelial Carcinoma." At the time of this recording, our guest's disclosures will be linked in the transcript. Shilpa, welcome again to the podcast. Thank you for joining us today. Dr. Shilpa Gupta: Thank you, Rafeh. Honor to be here with you again. Dr. Rafeh Naqash: It is nice to connect with you again after two years, approximately. I think we were in our infancy of our JCO PO podcast when we had you first time, and it has been an interesting journey since then. Dr. Shilpa Gupta: Absolutely. Dr. Rafeh Naqash: Well, excited to talk to you about this article that you published. Wanted to first understand what is the genomic landscape of urothelial cancer in general, and why should we be interested in FGFR3 alterations specifically? Dr. Shilpa Gupta: Bladder cancer or urothelial cancer is a very heterogeneous cancer. And while we find there is a lot of mutations can be there, you know, like BRCA1, 2, in HER2, in FGFR, we never really understood what is driving the cancer. Like a lot of old studies with targeted therapies did not really work. For example, we think VEGF can be upregulated, but VEGF inhibitors have not really shown definite promise so far. Now, FGFR3 receptor is the only therapeutic target so far that has an FDA approved therapy for treating metastatic urothelial cancer patients, and erdafitinib was approved in 2019 for patients whose tumors overexpressed FGFR3 mutations, alterations, or fusions. And in the landscape of bladder cancer, it is important because in patients with non-muscle invasive bladder cancer, about 70 to 80% patients can have this FGFR3. But as patients become metastatic, the alterations are seen in, you know, only about 10% of patients. So the clinical trials that got the erdafitinib approved actually used archival tumor from local cancer. So when in the real world, we don't see a lot of patients if we are trying to do metastatic lesion biopsies. And why it is important to know this is because that is the only targeted therapy available for our patients right now. Dr. Rafeh Naqash: Thank you for giving us that overview. Now, on the clinical side, there is obviously some interesting data for FGFR3 on the mutation side and the fusion side. In your clinical practice, do you tend to approach these patients differently when you have a mutation versus when you have a fusion? Dr. Shilpa Gupta: We can use the treatment regardless of that. Dr. Rafeh Naqash: I recently remember I had a patient with lung cancer, squamous lung cancer, who also had a synchronous bladder mass. And the first thought from multiple colleagues was that this is metastatic lung. And interestingly, the liquid biopsy ended up showing an FGFR3-TACC fusion, which we generally don't see in squamous lung cancers. And then eventually, I was able to convince our GU colleagues, urologists, to get a biopsy. They did a transurethral resection of this tumor, ended up being primary urothelial and synchronous lung, which again, going back to the FGFR3 story, I saw in your paper there is a mention of FGFR3-TACC fusions. Anything interesting that you find with these fusions as far as biology or tumor behavior is concerned? Dr. Shilpa Gupta: We found in our paper of all the patients that were sequenced that 20% had the pathognomonic FGFR3 alteration, and the most common were the S249C, and the FGFR3-TACC3 fusion was in 45 patients. And basically I will say that we didn't want to generate too much as to fusion or the differences in that. The key aspect of this paper was that historically there were these anecdotal reports saying that patients who have FGFR alterations or mutations, they may not respond well to checkpoint inhibitors because they have the luminal subtype. And these were backed by some preclinical data and small anecdotal reports. But since then, we have seen that, and that's why a lot of people would say that if somebody's tumor has FGFR3, don't give them immunotherapy, give them erdafitinib first, right? So then we had this Phase 3 trial called the THOR trial, which actually showed that giving erdafitinib before pembrolizumab was not better. That debunked that myth, and we are actually reiterating that because in our work we found that patients who had FGFR3 alterations or fusions, and if they also have TMB-high, they actually respond very well to single agent immunotherapy. And that is, I think, very important because it tells us that we are not really seeing that so-called potential of resistance to immunotherapy in these patients. So to answer your question, yeah, we did see those differences, but I wouldn't say that any one marker is more prominent. Dr. Rafeh Naqash: The analogy is kind of similar to what we see in lung cancer with these mutations called STK11/KEAP1, which are also present in some other tumors. And one of the questions that I don't think has been answered is when you have in lung cancer, if you extrapolate this, where doublet or single agent immunotherapy doesn't do as well in tumors that are STK11 mutated. But then if you have a high TMB, question is does that TMB supersede or trump the actual mutation? Could that be one reason why you see the TMB-high but FGFR3 altered tumors in your dataset responding or having better outcomes to immunotherapy where potentially there is just more neoantigens and that results in a more durable or perhaps better response to checkpoint therapy? Dr. Shilpa Gupta: It could be. But you know, the patients who have FGFR alterations are not that many, right? So we have already seen that just patients with TMB-high respond very well to immunotherapy. Our last podcast was actually on that, regardless of PD-L1 that was a better predictor of response to immunotherapy. So I think it's not clear if this is adding more chances of response or not, because either way they would respond. But what we didn't see, which was good, that if they had FGFR3, it's not really downplaying the fact that they have TMB-high and that patients are not responding to immunotherapy. So we saw that regardless, and that was very reassuring. Dr. Rafeh Naqash: So if tomorrow in your clinic you had an individual with an FGFR3 alteration but TMB-high, I guess one could be comfortable just going ahead with immunotherapy, which is what the THOR trial as you mentioned. Dr. Shilpa Gupta: Yes, absolutely. And you know, when you look at the toxicity profiles of pembrolizumab and erdafitinib, really patients really struggle with using the FGFR3 inhibitors. And of course, if they have to use it, we have to, and we reserve it for patients. But it's not an easy drug to tolerate. Currently the landscape is such that, you know, frontline therapy has now evolved with an ADC and immunotherapy combinations. So really if patients progress and have FGFR3 alterations, we are using erdafitinib. But let's say if there were a situation where a patient has had chemotherapy, no immunotherapy, and they have FGFR3 upregulation and TMB-high, yes, I would be comfortable with using only pembrolizumab. And that really ties well together what we saw in the THOR trial as well. Dr. Rafeh Naqash: Going to the clinical applications, you mentioned a little bit of this in the manuscript, is combination therapies. You alluded to it a second back. Everything tends to get combined with checkpoint therapy these days, as you've seen with the frontline urothelial, pembrolizumab with an ADC. What is the landscape like as far as some of these FGFR alterations are concerned? Is it reasonable to combine some of those drugs with immune checkpoint therapy? And what are some of the toxicity patterns that you've potentially seen in your experience? Dr. Shilpa Gupta: So there was indeed a trial called the NORSE trial. It was a randomized trial but not a comparative cohort, where they looked at FGFR altered patients. And when they combined erdafitinib plus cetrelimab, that did numerically the response rates were much higher than those who got just erdafitinib. So yeah, the combination is definitely doable. There is no overlapping toxicities. But unfortunately that combination has not really moved forward to a Phase 3 trial because it's so challenging to enroll patients with such kind of rare mutations on large trials, especially to do registration trials. And since then the frontline therapy has evolved to enfortumab vedotin and pembrolizumab. I know there is an early phase trial looking at a next generation FGFR inhibitor. There is a triplet combination looking in Phase 1 setting with a next generation FGFR inhibitor with EV-pembro. However, it's not a randomized trial. So you know, I worry about such kinds of combinations where we don't have a path for registration. And in the four patients that have been treated, four or five patients in the early phase as a part of basket trial, the toxicities were a lot, you know, when you combine the EV-pembro and an FGFR3 inhibitor, we see more and more toxicity. So the big question is do we really need the "kitchen sink" approach when we have a very good doublet, or unless the bar is so high with the doublet, like what are we trying to add at the expense of patient toxicity and quality of life is the big question in my mind. Dr. Rafeh Naqash: Going back to your manuscript specifically, there could be a composite biomarker. You point out like FGFR in addition to FGFR TMB ends up being predictive prognostic there. So that could potentially be used as an approach to stratify patients as far as treatment, whether it's a single agent versus combination. Maybe the TMB-low/FGFR3 mutated require a combination, but the TMB-high/FGFR mutated don't require a combination, right? Dr. Shilpa Gupta: No, that's a great point, yeah. Dr. Rafeh Naqash: But again, very interesting, intriguing concepts that you've alluded to and described in this manuscript. Now, a quick take on how things have changed in the bladder cancer space in the last two years. We did a podcast with you regarding some biomarkers as you mentioned two years back. So I really would like to spend the next minute to two to understand how have things changed in the bladder cancer space? What are some of the exciting things that were not there two years back that are in practice now? And how do you anticipate the next two years to be like? Maybe we'll have another podcast with you in another two years when the space will have changed even more. Dr. Shilpa Gupta: Certainly a lot has happened in the two years, you know. EV-pembro became the universal frontline standard, right? We have really moved away from cisplatin eligibility in metastatic setting because anybody would benefit from EV-pembro regardless of whether they are candidates for cisplatin or not, which historically was relevant. And just two days ago, we saw that EV-pembro has now been approved for localized bladder cancer for patients who are cisplatin ineligible or refusing. So, you know, this very effective regimen moving into earlier setting, we now have to really think of good treatment options in the metastatic setting, right? So I think that's where a lot of these novel combinations may come up. And what else we've seen is in a tumor agnostic trial called the DESTINY-PanTumor trial, patients who had HER2 3+ on immunohistochemistry, we saw the drug approval for T-DXd, and I think that has kind of reinvigorated the interest in HER2 in bladder cancer, because in the past targeting HER2 really didn't work. And we still don't know if HER2 is a driver or not. And at ESMO this year, we saw an excellent study coming out of China with DV which is targeting HER2, and toripalimab, which is a Chinese checkpoint inhibitor, showing pretty much similar results to what we saw with EV-pembro. Now, you know, not to do cross-trial comparisons, but that was really an amazing, amazing study. It was in the presidential session. And I think the big question is: does that really tell us that HER2-low patients will not benefit? Because that included 1+, 2+, 3+. So that part we really don't know, and I think we want to study from the EV-302 how the HER2 positive patients did with EV and pembro. So that's an additional option, at least in China, and hopefully if it gets approved here, there is a trial going on with DV and pembro. And lastly, we've seen a very promising biomarker, like ctDNA, for the first time in bladder cancer in the adjuvant setting guiding treatment with adjuvant atezolizumab. So patients who were ctDNA positive derived overall survival and recurrence-free survival benefit. So that could help us select moving forward with more studies. We can spare unnecessary checkpoint inhibitors in patients who are not going to benefit. So I think there is a lot happening in our field, and this will help do more studies because we already have the next generation FGFR inhibitors which don't have the toxicities that erdafitinib comes with. And combining those with these novel ADCs and checkpoint inhibitors, you know, using maybe TMB as a biomarker, because we really need to move away from PD-L1 in bladder cancer. It's shown no utility whatsoever, but TMB has. Dr. Rafeh Naqash: Well, thank you so much, Shilpa, for that tour de force of how things have changed in bladder cancer. There used to be a time when lung and melanoma used to lead this space in terms of the number of approvals, the biomarker development. It looks like bladder cancer is shifting the trend at this stage. So definitely exciting to see all the new changes that are coming up. I'd like to spend another minute and a half on your career. You've obviously been a leader and example for many people in the GU space and beyond. Could you, for the sake of our early career especially, the trainees and other listeners, describe how you focused on things that you're currently leading as a leader, and how you shaped your career trajectory over the last 10 years? Dr. Shilpa Gupta: That's a really important question, Rafeh, and you and I have had these discussions before, you know, being an IMG on visas like you, and being in different places. I think I try to make the most of it, you know, instead of focusing on the setbacks or the negative things. Like tried to grab the opportunities that came along. When I was at Moffitt, got to get involved with the Phase 1 trial of pembrolizumab in different tumor types. And just keeping my options open, you know, getting into the bladder cancer at that time when I wanted to really do only prostate, but it was a good idea for me to keep my options open and got all these opportunities that I made use of. I think an important thing is to, like you said, you know, have a focus. So I am trying to focus more on biomarkers that, you know, we know that 70% patients will respond to EV-pembro, right? But what about the remaining 30%? Like, so I'm really trying to understand what determines hyperprogressors with such effective regimens who we really struggle with in the clinic. They really don't do well with anything we give them after that. So we are doing some work with that and also trying to focus on PROs and kind of patient-reported outcomes. And a special interest that I've now developed and working on it is young-onset bladder cancer. You know, the colorectal cancer world has made a lot of progress and we are really far behind. And bladder cancer has historically been a disease of the elderly, which is not the case anymore. We are seeing patients in their 30s and 40s. So we launched this young-onset bladder cancer initiative at a Bladder Cancer Advocacy Network meeting and now looking at more deep dive and creating a working group around that. But yeah, you know, I would say that my philosophy has been to just take the best out of the situation I'm in, no matter where I am. And it has just helped shape my career where I am, despite everything. Dr. Rafeh Naqash: Well, thank you again. It is always a pleasure to learn from your experiences and things that you have helped lead. Appreciate all your insights, and thank you for publishing with JCO PO. Hopefully we will see more of your biomarker work being published and perhaps bring you for another podcast in a couple of years. Dr. Shilpa Gupta: Yeah, thank you, Rafeh, for the opportunity. And thanks to JCO PO for making these podcasts for our readers. So thanks a lot. Dr. Rafeh Naqash: Thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcast. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. DISCLOSURES Dr. Shilpa Gupta Stock and Other Ownership Interests: Company: BioNTech SE,  Nektar Consulting or Advisory Role: Company: Gilead Sciences, Pfizer, Merck, Foundation Medicine, Bristol-Myers Squibb/Medarex, Natera, Astellas Pharma, AstraZeneca, Novartis, Johnson & Johnson/Janssen Research Funding: Recipient: Your Institution Company: Bristol Myers Squibb Foundation, Merck, Roche/Genentech, EMD Serono, Exelixis, Novartis, Tyra Biosciences, Pfizer, Convergent Therapeutics, Acrivon Therapeutics, Flare Therapeutics, Amgen Travel, Accommodations, Expenses: Company: Pfizer, Astellas Pharma, Merck    

How should retina specialists integrate next-generation anti-VEGF agents into real-world DME care? In this episode of “Anti-VEGFs: The Next Generation,” David Miller, MD, speaks with Esther Kim, MD, and Ehsan Rahimy, MD, about first-line agent selection, when to transition to newer options, how to incorporate steroids thoughtfully, and crafting dosing strategies that balance durability, efficacy, and adherence for working-age patients—without overpromising outcomes.This editorially independent series is supported with advertising by Regeneron.

Please visit answersincme.com/UPU860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, an expert in managing patients with retinal vein occlusion (RVO) discusses the use of longer-acting anti-VEGF treatments for treating RVO. Upon completion of this activity, participants should be better able to: Explain the rationale for exploring longer-acting anti-VEGF treatment for patients with retinal vein occlusion (RVO); Differentiate the clinical profiles of available and emerging anti-VEGF treatments for macular edema following RVO, based on the latest evidence; and Propose optimized, patient-centered treatment plans for the multidisciplinary management of patients with RVO.

Please visit answersincme.com/SYV860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, two experts in retinal vein occlusion (RVO) discuss diagnosis and anti-VEGF treatment of the condition. Upon completion of this activity, participants should be better able to: Explain the rationale for exploring longer-acting anti-VEGF treatment for patients with RVO; Recognize the importance of early diagnosis to address the burden of RVO; and Propose optimized, patient-centered treatment plans for the multidisciplinary management of patients with RVO.

Send us a textThis episode features Dr. Carolina Adams (Emory) and Dr. Faizah Bhatti (Oklahoma Children's Hospital) discussing findings from the CHNC Retinopathy of Prematurity (ROP) Focus Group. Their survey of pediatric ophthalmologists across U.S. centers revealed wide variability in screening practices, communication with neonatologists, sedation protocols, and anti-VEGF dosing. Many clinicians continue using higher bevacizumab doses despite emerging evidence supporting dose reduction. The guests emphasize the need for consistent, collaborative protocols, especially for infants outside standard screening criteria and extremely premature infants now surviving earlier gestational ages. They preview upcoming technology, including handheld NICU-compatible OCT devices, that may enhance early detection, shared decision-making, and long-term visual outcomes.Support the showAs always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sanofi lowers prices, oral pill for T1D prevention studied, updates from Medtronic, Tandem, and Sequel Med Tech, falsely lower A1Cs (and why that happens), Biolinq gets FDA okay for micro-needle CGM 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 French drugmaker Sanofi says it would offer a month's supply of any of its insulin products for $35 to all patients in the U.S. with a valid prescription, regardless of insurance status. The program, originally meant for uninsured diabetes patients, would now include those with commercial insurance or Medicare, the drugmaker said. Patients will be able to purchase any combination, type, and quantity of Sanofi insulins with a valid prescription for the fixed monthly price of $35, starting January 1. Lilly and Novo also have similar programs through which they offer insulin products for $35 a month for U.S. patients regardless of whether the patients have insurance. There is no law at work here – the only legislation that has changed the price of insulin came with the Inflation Reduction Act in 2022 with the Medicare cap. Helping lower the cost here, biosimilars hitting the market and the huge profitability for GLP-1 drugs for Novo and Lilly https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-offer-all-insulin-products-35-per-month-us-2025-09-26/ XX A pill typically prescribed for rheumatoid arthritis and alopecia might help slow the progression of type 1 diabetes, a new study says. Baricitinib (bare-uh-SIT-nib) safely preserved the body's own insulin production in people newly diagnosed with type 1 diabetes.. and their diabetes started progressing once they stopped taking baricitinib, results show. They produced less insulin and had less stable blood sugar levels.   Baricitinib works by quelling signals in the body that spur on the immune system, and is already approved for treating autoimmune conditions such as rheumatoid arthritis, ulcerative colitis and alopecia, researchers said.   “Among the promising agents shown to preserve beta cell function in type 1 diabetes, baricitinib stands out because it can be taken orally, is well tolerated, including by young children, and is clearly efficacious,” Waibel said. “We are hopeful that larger phase III trials with baricitinib are going to commence soon, in people with recently diagnosed type 1 diabetes as well as in earlier stages to delay insulin dependence,” she added. “If these trials are successful, the drug could be approved for type 1 diabetes treatment within five years.”   Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.   https://www.usnews.com/news/health-news/articles/2025-09-23/pill-effective-in-slowing-type-1-diabetes-progression XX An existing transplant drug has shown promise in slowing the progression of type 1 diabetes in newly diagnosed young people, potentially paving the way for the first therapy that modifies the disease after diagnosis. The Drug, called ATG, is currently used together with other medicines to prevent and treat the body from rejecting a kidney transplant. It can also be used to treat rejection following transplantation of other organs, such as hearts, gastrointestinal organs, or lungs. The researchers studied 117 people aged five to 25, who'd been diagnosed with type 1 diabetes within the past three to nine weeks. The participants were from 14 centers across eight European countries and were randomized to be given different doses of ATG (0.1, 0.5, 1.5, or 2.5 mg/kg) or a placebo. ATG was given as a two-day intravenous (IV) infusion. The main goal was to see how well the pancreas could still make insulin after 12 months, measured by C-peptide levels during a special meal test. C-peptide is released into the blood along with insulin by the pancreas.   The findings are promising, showing that ATG, even at a relatively low dose, can slow the loss of insulin-producing cells in young people newly diagnosed with type 1 diabetes. The lower dose also caused fewer side effects, making it a more practical option. https://newatlas.com/disease/antithymocyte-globulin-newly-diagnosed-type-1-diabetes/     XX The FDA has delayed its feedback on Lexicon Pharmaceuticals' application to bring Zynquista (sotagliflozin) to people with type 1 diabetes. The agency had planned to respond this month but will now wait until the fourth quarter after reviewing new data from ongoing studies. Zynquista, an oral drug meant to be used with insulin, has already been approved for heart failure (marketed as Inpefa). But in type 1 diabetes, it faces safety concerns: last year an FDA advisory committee voted 11–3 that its benefits don't outweigh the increased risk of diabetic ketoacidosis (DKA). The FDA later issued a complete response letter rejecting the drug. Lexicon is still pushing forward, hoping its additional submissions will strengthen Zynquista's case for type 1 diabetes approval. https://www.biospace.com/fda/after-fda-rejection-lexicons-type-1-diabetes-drug-hit-with-another-regulatory-delay     XX A common but often undiagnosed genetic condition may be causing delays in type 2 diabetes diagnoses and increasing the risk of serious complications for thousands of Black and South Asian men in the UK—and potentially millions worldwide. A new study found around one in seven Black and one in 63 South Asian men in the UK carry a genetic variant known as G6PD deficiency. Men with G6PD deficiency are, on average, diagnosed with type 2 diabetes four years later than those without the gene variant. But despite this, fewer than one in 50 have been diagnosed with the condition.   G6PD deficiency does not cause diabetes, but it makes the widely used HbA1c blood test—which diagnoses and monitors diabetes—appear artificially low. This can mislead doctors and patients, resulting in delayed diabetes diagnosis and treatment.   The study found men with G6PD deficiency are at a 37% higher risk of developing diabetes-related microvascular complications, such as eye, kidney, and nerve damage, compared to other men with diabetes.   "This study highlights important evidence that must be used to tackle these health inequalities and improve outcomes for Black communities. Preventative measures are now needed to ensure that Black people, especially men, are not underdiagnosed or diagnosed too late." https://medicalxpress.com/news/2025-09-hidden-genetic-delay-diabetes-diagnosis.html XX Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes.   The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5 Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025. XX Interesting news from Sequel Med Tech – they've signed an agreement with Arecor to pair the twiist pump with AT278 an ultra-concentrated (500U/mL), ultra-rapid insulin in development. They also have a deal with Medtronic to develop insulin for new pumps. This insulin isn't yet approved, it's 5 times stronger than standard fast acting  it's hoped that a clinical study will begin next year. Arecor says its insulin could potentially be the only option capable of enabling and catalyzing the next generation of longer-wear and miniaturized automated insulin delivery systems.   https://www.drugdeliverybusiness.com/sequel-arecor-develop-rapid-insulin-twiist/ XX Tandem Diabetes Care announes its t:slim X2™ insulin pump with Control-IQ+ automated insulin delivery (AID) technology is now cleared for use with Eli Lilly and Company's Lyumjev® (insulin lispro-aabc injection) ultra-rapid acting insulin in the United States (U.S.).   – The t:slim X2 insulin pump with Control-IQ+ technology is now cleared for use with Lyumjev for people with type 1 diabetes ages 2 and above and all adults with type 2 diabetes. The companies are continuing to work toward securing Lyumjev compatibility for the Tandem Mobi pump. https://hitconsultant.net/2025/09/29/tandem-diabetes-cares-tslim-x2-pump-cleared-for-use-with-lillys-ultra-rapid-lyumjev-insulin/ XX You can now place your order for the MiniMed™ 780G system with the Instinct sensor, made by Abbott. And if you are already a MiniMed 780G user, you can place an upgrade order today. ​This is a 15 day wear sensor, with no transmitter or overtape required. It looks the same at other Abbot sensors such as the Libre but is proprietary to Medtronic. Shipments are scheduled to start in November.   ​ https://www.drugdeliverybusiness.com/medtronic-launches-minimed-780g-instinct-abbott/   XX The global type 1 diabetes (T1D) burden continues to increase rapidly driven by rising cases, ageing populations, improved diagnosis and falling death rates. ,   The study estimates that T1D will affect 9.5 million people globally in 2025 (up by 13% since 2021), and this number is predicted to rise to 14.7 million in 2040. However, due to lack of diagnosis and challenges in collecting sufficient data, the actual number of individuals living with T1D is likely much higher, researchers say.   In fact, they estimate that there are an additional 4.1 million 'missing people' who would have been alive in 2025 if they hadn't died prematurely from poor T1D care, including an estimated 669,000 who were not diagnosed. This is particularly true in India, where an estimated 159,000 people thought to have died from missed diagnoses. The study predicts that 513,000 new cases of T1D will be diagnosed worldwide in 2025, of which 43% (222,000) will be people younger than 20 years old. Finland is projected to have the highest incidence of T1D in children aged 0-14 years in 2025 at around 64 cases per 100,000. The substantial increases in T1D forecasts between 2025 and 2040 underscore the urgent need for action. As co-author Renza Scibilia from Breakthrough T1D explains, "Early diagnosis, access to insulin and diabetes supplies, and proper healthcare can bring enormous benefits, with the potential to save millions of lives in the coming decades by ensuring universal access to insulin and improving the rate of diagnosis in all countries."   The authors note some important limitations to their estimates, including that while the analysis uses the best available data, predictions are constrained by the lack of accurate data in most countries-highlighting the urgent need for increased surveillance and research. They also note that data on misdiagnosis and adult populations remain limited, and the analysis assumes constant age-specific incidence and mortality over time. Furthermore, incidence data from the COVID-19 period were excluded from part of the modelling to avoid bias. Future updates are expected to improve as new data become available and applied. https://www.news-medical.net/news/20250919/New-study-warns-of-millions-of-undiagnosed-and-missing-people-with-type-1-diabetes.aspx XX A new study has found that semaglutide — the active ingredient found in some GLP-1 medications prescribed for diabetes and to aid weight loss — may help protect the eyes from diabetic retinopathy. Researchers estimate that as much as 40% of all people with diabetes also have diabetic retinopathy — a potentially blinding eye condition caused by blood vessel damage in the eye's retina. There is currently no cure for diabetic retinopathy. The condition is often managed through injections of anti-VEGF medications into the eye, surgery, and blood sugar monitoring and control. For this lab-based study, researchers used samples of human retinal endothelial cells that were treated with different concentrations of semaglutide. The cells were then placed in a solution with both a high glucose level and high level of oxidative stress — where there is an imbalance of antioxidants and free radicals — for 24 hours.   Past studies show that oxidative stress plays a role in the formation of diabetic retinopathy.   At the study's conclusion, researchers found that the retinal cells treated with semaglutide were twice as likely to survive than cells that were untreated. Additionally, the treated cells were found to have larger stores of energy.   Scientists also found that three markers of diabetic retinopathy were decreased in the semaglutide-treated retinal cells. First, the levels of apoptosis — a form of cell death — decreased from about 50% in untreated cells to about 10% in semaglutide-treated cells. The production of the free radical mitochondrial superoxide decreased from about 90% to about 10% in the treated retinal cells.   Researchers also found the amount of advanced glycation end-products — harmful compounds that can collect in people with diabetes and are known to cause oxidative stress — also decreased substantially.   Lastly, scientists reported that the genes involved in the production of antioxidants were more active in the semaglutide-treated cells when compared to untreated cells. Researchers believe this is a sign that semaglutide may help repair damage to the retinal cells.   “Our study did not find that these drugs harmed the retinal cells in any way — instead, it suggests that GLP1-receptor agonists protect against diabetic retinopathy, particularly in the early stages,” Ioanna Anastasiou, PhD, molecular biologist and postdoctoral researcher at the National and Kapodistrian University in Greece, and lead author of this study, said in a press release.   “Excitingly, these drugs may be able to repair damage that has already been done and so improve sight. Clinical trials are now needed to confirm these protective effects in patients and explore whether GLP-1 receptor agonists can slow, or even halt, the progression of this vision-robbing condition.” https://www.medicalnewstoday.com/articles/ozempic-semaglutide-may-help-protect-against-diabetes-related-blindness-retinopathy   XX Biolinq has received De Novo Classification from the U.S. Food and Drug Administration for its lead product, Biolinq Shine, a patch on the forearm that provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. This one is tricky – it's called a needle free CGM but it also says it uses micro needles. By the way, De Novo isn't exactly the same as what we think of for FDA approval for medical devices. It's not as rigorous but it's a streamlined route for novel, low to moderate risk devices with no existing equivalent. We'll see how this one turns out. https://www.hmenews.com/article/biolinq-s-multi-function-biosensor-receives-fda-de-novo-classification

Join us in this episode of the Oncology Brothers podcast as we dive into the highlights from the World Conference on Lung Cancer 2025! We are joined by Dr. Balazs Halmos, a thoracic medical oncologist at the Montefiore Einstein Cancer Center, to discuss three pivotal studies that are shaping the future of lung cancer treatment. In this episode, we covered: •⁠  ⁠FLAURA2 Trial: Discover the significant overall survival benefits of combining osimertinib with chemotherapy for patients with EGFR-positive non-small cell lung cancer, and how it compares to single-agent osimertinib. •⁠  ⁠HARMONi Trial: Explore the intriguing yet complex findings of a new bi-specific antibody targeting PD-1 and VEGF in patients with progressive EGFR-mutated disease, and the implications of its current negative results. •⁠  ⁠ALCHEMIST Trial: Learn about the role of crizotinib in the adjuvant setting for ALK-positive lung cancer and why it reinforces alectinib as the standard of care. Tune in for an insightful discussion on the latest advancements in precision medicine, the importance of ctDNA, and the evolving landscape of lung cancer treatment.  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 hit the notification bell for more updates from the Oncology Brothers!

Welcome to The Egg Whisperer Show! Today's guest is Dr. Mathew Leonardi, an advanced gynecological surgeon, sonologist, and researcher at McMaster University Medical Center in Hamilton, Canada. He's also completing his PhD at the University of Sydney, focusing on the role of ultrasound in the diagnosis and surgical management of endometriosis. Dr. Leonardi is internationally recognized for his work in gynecological surgery and ultrasound, serves as a Junior Ambassador for the World Endometriosis Society, and contributes to clinical guidelines and editorial boards in reproductive medicine. In this episode, we're diving into the latest advances in endometriosis diagnosis, treatment, and whole-patient care, including research into the microbiome, biomarkers, and alternative management strategies. Here are some of the key questions and topics we cover in this conversation: What it means to self-identify as an “endometriosis expert” and why early, accurate testing is so important How the microbiome of the reproductive tract may influence both endometriosis and infertility Why common biomarkers like CA-125 have limited usefulness, and what new research on VEGF and inflammatory markers may reveal Whether genetic testing could one day help identify susceptibility to endometriosis How complementary strategies like pelvic floor physiotherapy, dietary changes, acupuncture, cannabis, and psychotherapy can support fertility patients living with endometriosis Why advocacy (both self-advocacy in the clinic and public advocacy through research and awareness) is key to advancing care for all patients   Resources: Read the full show notes on Dr. Aimee's website. Dr. Mathew Leonardi's website click here. Do you have questions about IVF?Click here to join Dr. Aimee for The IVF Class. The next live class call is on Monday, October 20, 2025 at 4pm PST, where Dr. Aimee will explain IVF and there will be time to ask her your questions live on Zoom.   Dr. Aimee Eyvazzadeh is one of America's most well known fertility doctors. Her success rate at baby-making is what gives future parents hope when all hope is lost. She pioneered the TUSHY Method and BALLS Method to decrease your time to pregnancy. Learn more about the TUSHY Method and find a wealth of fertility resources at www.draimee.org. Other ways to connect with Dr. Aimee and The Egg Whisperer Show: Subscribe to my YouTube channel for more fertility tips!Subscribe to the newsletter to get updates