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This week's stories: Sinclair's This Is the Test: Are we about to see age reversal in humans? At the World Governments Summit 2026 in Dubai, Harvard geneticist David Sinclair told world leaders that ageing could soon be reversible and said the first human clinical trials of epigenetic reprogramming therapies are moving forward. The core idea is that ageing is partly an information problem, how cells read DNA, not just cumulative damage, and that partial reprogramming could restore youthful function without turning tissues into tumors. Dave frames this as a rare binary moment for longevity: either early, localized human trials (starting with tightly controlled tissue targets like the eye) show meaningful functional rejuvenation with acceptable safety, or the field has to recalibrate fast. Either way, the next couple of years will heavily influence where money, regulators, and serious researchers place their bets. • Sources: – World Governments Summit: https://www.worldgovernmentssummit.org/media-hub/news/detail/ageing-could-soon-be-reversible-says-harvard-scientist-at-wgs-2026 – NAD / Life Biosciences coverage: https://www.nad.com/news/fda-greenlights-life-biosciences-human-study-setting-up-pivotal-test-for-aging-theory-from-harvards-david-sinclair AlphaFold 4 in a locked box: DeepMind's private AI drug design engine Isomorphic Labs, DeepMind's drug discovery company, unveiled a proprietary drug design engine that outside scientists are comparing to an AlphaFold 4 moment, but for designing drugs, not just predicting structures. The big shift is that this system is closed: no public weights, no open database, and access appears to flow through partnerships with pharma companies. Dave breaks down why that matters for the longevity world: if AI makes early discovery cheaper and faster, we might see more serious shots on ageing targets over the next decade, but a closed model can also mean less transparency, bigger IP moats, and no guarantee that faster discovery leads to cheaper drugs. • Sources: – Nature: https://www.nature.com/articles/d41586-026-00365-7 – Isomorphic Labs: https://www.isomorphiclabs.com/articles/the-isomorphic-labs-drug-design-engine-unlocks-a-new-frontier Peptides in the freezer: El Mencho's anti aging stash and the dark side of wellness After reports and images from the final hideout linked to Jalisco New Generation Cartel leader Nemesio Oseguera Cervantes (El Mencho), coverage highlighted a detail that feels uncomfortably familiar to anyone in the modern wellness internet: injectable vials stored in a freezer with a schedule attached, including Tationil Plus, a glutathione based injectable marketed in some places for “cellular health,” cosmetic effects, and anti ageing. Dave uses the absurdity as a narrative wedge, not cartel gossip, to talk about how normalized gray market injectables have become, and how marketing (“detox,” “cellular reset”) often outruns evidence and safety. The segment pivots into a practical filter: which compounds are real therapeutics under medical supervision, and which are expensive folklore with sourcing risk and unknown long term downsides. • Sources: – New York Post: https://nypost.com/2026/02/25/world-news/inside-the-luxurious-love-nest-where-mexican-drug-lord-el-mencho-spent-his-final-days/ – Sky News (Reuters photos referenced): https://news.sky.com/story/inside-the-mexican-villa-where-feared-drug-lord-el-mencho-spent-final-hours-13511954 – Reuters photo gallery: https://www.reuters.com/pictures/el-menchos-last-hideout-inside-villa-where-cartel-leader-spent-final-hours-2026-02-25/W7DK5WEXS5IMLLZQO2P3CXGXFM The disease we thought was dead: measles comes roaring back Measles cases have surged in early 2026, with reporting citing at least 588 cases in the U.S. by late January, already more than many full year totals, and additional updates showing continued acceleration into February. Dave reframes this as a healthspan floor issue: you can argue about peptides and mitochondria all day, but measles is so contagious that once community immunity drops, outbreaks move fast and hit the most vulnerable first, especially infants and immunocompromised people. He also flags the systems problem: many clinicians have never seen measles, which increases the odds of delayed recognition and wider exposure in waiting rooms. The actionable move is boring and high ROI: verify MMR status for you and your family and close gaps before outbreaks get closer to home. • Sources: – AMA Morning Rounds (Week of Feb. 2, 2026): https://www.ama-assn.org/about/publications-newsletters/top-news-stories-ama-morning-rounds-week-feb-2-2026 – ABC News (CDC case count coverage): https://abcnews.com/Health/588-us-measles-cases-reported-january-cdc/story?id=129699078 – CIDRAP (case tracking context): https://www.cidrap.umn.edu/measles/us-measles-cases-soar-588-so-far-year-south-carolina-confirms-58-new-infections DC vs your health: Trump's State of the Union health reset President Donald Trump's 2026 State of the Union included a cluster of healthcare themes that function as a directional signal for agencies and payers this year, including drug pricing rhetoric, price transparency, and broader coverage and affordability framing. Dave translates the politics into a practical heuristic for biohackers: federal posture quietly determines what becomes easy versus painful to access in the legitimate system, from GLP 1 coverage rules and prior auth behavior to how friendly the environment is for telehealth, at home diagnostics, and eventually whatever “real longevity medicine” looks like. You do not need every policy detail in a weekly rundown, just the weather report: reimbursement and enforcement trends shape what stays niche, what scales, and what gets friction. • Sources: – Advisory Board: https://www.advisory.com/daily-briefing/2026/02/25/health-policy-roundup – Healthcare Dive: https://www.healthcaredive.com/news/trump-state-of-the-union-healthcare-2026/812962/ – This Week in Public Health analysis: https://thisweekinpublichealth.com/blog/2026/02/25/the-2026-state-of-the-union-what-it-means-for-health-and-public-health/ All source links are provided for direct access to the original reporting and research. This episode is designed for biohackers, longevity seekers, and high-performance listeners who want mechanism-level clarity on circadian biology, neurodegeneration signals, cognitive training, caffeine strategy, and supplement regulation. Host Dave Asprey connects emerging science, behavioral data, and policy shifts into practical frameworks you can use to build a resilient, adaptable health stack. New episodes every Tuesday, Thursday, Friday, and Sunday. Keywords: David Sinclair age reversal, epigenetic reprogramming therapy, Yamanaka factors OSK, Life Biosciences clinical trial, human rejuvenation trial 2026, biological age reset, longevity breakthrough news, DeepMind Isomorphic Labs, AlphaFold 4 drug design, AI drug discovery engine, geroprotective drug development, peptide gray market risks, injectable glutathathione Tationil Plus, GLP-1 regulation FDA warning, wellness industry regulation, measles outbreak 2026 US, MMR vaccine status adults, vaccine trust public health, health policy 2026 State of the Union, GLP-1 access and reimbursement, telehealth longevity care, biohacking news, anti-aging research update Thank you to our sponsors! Resources: • Get My 2026 Clean Nicotine Roadmap | Enroll for free at https://daveasprey.com/2026-clean-nicotine-roadmap/ • Get My 2026 Biohacking Trends Report: https://daveasprey.com/2026-biohacking-trends-report/ • 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: 0:00 - Introduction 0:30 - Story #1: David Sinclair 2026 2:13 - Story #2: Google Drug Discovery 3:48 - Story #3: El Mencho Biohacking5:30 - Story #4: Measles Outbreak 6:51 - Story #5: Trump State of the Union 8:00 - Weekly Roundup 9:10 - Closing See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Cindy Eckert, entrepreneur, investor, and the central figure in the new Paramount+ documentary The Pink Pill: Sex, Drugs & Who Has Control. The documentary film examines the decade-long, uphill battle to get the first FDA-approved medication for female libido, Addyi, approved and brought to market. Directed by Aisling Chin-Yee, the film highlights the stark contrast between the fast-tracked approval of Viagra for men and the intense, often biased scrutiny faced by advocates of "female Viagra.” Eckert fought for 10 years to bring Addyi to market, facing regulatory roadblocks and public skepticism, ultimately revealing systemic gender bias in healthcare. Reality Life with Kate Casey What to Watch List: https://katecasey.substack.com Patreon: http://www.patreon.com/katecasey Twitter: https://twitter.com/katecasey Instagram: http://www.instagram.com/katecaseyca Tik Tok: https://www.tiktok.com/@itskatecasey?lang=en Facebook Group: https://www.facebook.com/groups/113157919338245 Amazon List: https://www.amazon.com/shop/katecasey Like it to Know It: https://www.shopltk.com/explore/katecaseySee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
CardioNerds (Dr. Jenna Skowronski [Heart Failure Council Chair], Dr. Shazli Khan, and Dr. Josh Longinow) are joined by renowned leaders in the field of AHFTC (Advanced Heart Failure and Transplant Cardiology) and mechanical circulatory support, Dr. Jeff Teuteberg and Dr. Mani Daneshmand to continue the discussion of advanced heart failure therapies by taking a deep dive into the world of durable LVADs (Left Ventricular Assist Devices). In this episode, we will review the history of ventricular assist devices, the basics of LVAD function, selection criteria for LVAD therapy, and surgical nuances of LVAD implantation. Audio Editing by CardioNerds intern, Joshua Khorsandi. Enjoy this Circulation 2022 Paths to Discovery article to learn about the CardioNerds story, mission, and values. CardioNerds Heart Success Series PageCardioNerds Episode PageCardioNerds AcademyCardionerds Healy Honor Roll CardioNerds Journal ClubSubscribe to The Heartbeat Newsletter!Check out CardioNerds SWAG!Become a CardioNerds Patron! Pearls There have been significant advances in the field of MCS/LVAD therapy since the first implanted LVAD in the 1960s, to the first FDA approved device in the early 2000's, to now the HM3 LVAD, with the most important change being a centrifugal flow/magnetically levitated design that led to minimized hemocompatibility-related adverse events (HRAE's) (MOMENTUM 3 trial comparing HM2 and HM3). The REMATCH trial in 2001 was a pivotal trial for LVAD therapy, demonstrating that in a population of patients with advanced HF (70% IV inotrope dependent), LVAD therapy significantly improved survival at both 1 and 2 years as compared to medical therapy alone. MOMENTUM 3 trial was a landmark trial for the HM3 device, showing that in a population of end stage HF patients (86% inotrope dependent, 32% INTERMACS 1-2, and 60% DT strategy), 5-year survival with HM3 was 58% and HM3 had lower HRAE's compared with HM2. There are both patient-specific factors and surgical considerations when it comes to candidacy for LVAD therapy. RV function prior to LVAD is a key determinant for success post-LVAD Many patients being considered for LVAD may not have robust RV function, however, predicting RV failure after LVAD is exceedingly difficult. In general, it doesn’t matter how bad the RV may look on imaging; we care more about the pre-LVAD hemodynamics (look at the PAPi and RA/wedge ratio). What happens in the OR may be the most important determinant of how the RV will do with the LVAD! Notes Notes drafted by Dr. Josh Longinow. 1. Historical background of heart pumps and LVADs LVAD Evolution FDA approval year 2001 2008 2012 2017 Pump HeartMate XVE HeartMate II Heartware HVAD HeartMate III Flow/Design Features Pulsatile Technology Continuous flow Axial design Continuous flow Centrifugal design Continuous flow Full MagLev + Centrifugal design The 1960's ushered in the first ‘LVADs', when the first air-powered ‘LVAD' was implanted. It kept the patient alive for four days before the patient expired. The first generation of LVADs were pulsatile pumps The first nationally recognized, FDA approved LVAD was the HeartMate XVE (late 1990s to early 2000s, REMATCH trial). The XVE pump used compressed air (pneumatically driven) to power the pump. Prior to the XVE, OHT was the standard of care for patients with advanced, end-stage heart failure. The second and third generations of LVADs were non-pulsatile, continuous flow devices and included the HVAD, HM2, and HM3 devices. MOMENTUM 3 was a landmark trial for the HM3 device, showing that in a population of sick patients with end stage HF (86% inotrope dependent, 32% INTERMACS 1-2, and 60% DT strategy), 5-year survival with HM3 was 58% and HM3 had lower HRAE's compared with HM2. The only pump that is currently FDA approved for implant is the HM3, although other pumps are in clinical trials (BrioVAD system, INNOVATE Trial). 2. What are LVADs, and how do they work? In simplest terms, the LVAD is a heart pump comprised of several key mechanistic components: Inflow cannula Mechanical pump Outflow cannula Driveline Controller/Power source The HM3 differs from its predecessors (HM2 and HVAD) in several key ways; HM3 is placed intrapericardial whereas the HM2 was placed pre-peritoneal. Perhaps most importantly, the HM3 is a fully magnetically levitated, centrifugal flow pump, whereas the HM2 is an axial flow device. Axial flow pumps are not magnetically levitated, leading to more friction produced between the ruby bearing's contact with the pump rotors, and higher rates of hemocompatibility related adverse events (HRAEs, i.e. pump thrombosis) and the HM2 was ultimately discontinued in favor of the HM3 (MOMENTUM 3 trial). 3. What do the terms ‘Destination Therapy' (DT) or ‘Bridge to Transplant' (BTT) mean when it comes to LVADs? When LVADs first came on the stage, EVERYONE was a BTT; these early pumps weren't designed for long term use (I.e. REMATCH Trial, Heartmate XVE) Destination therapy means the LVAD was placed in leu of transplant because there are contraindications to transplant REMATCH trial brought about the concept of “Destination therapy”, comparing outcomes in patients (with contraindications for transplant) who received an LVAD vs optimal medical therapy Bridge to transplant means we are placing the LVAD in a patient who may not be a transplant candidate at this moment in time (is too sick, or conversely, not sick enough), but may be down the line Bridge to recovery is another term used when the LVAD is being placed for a patient we think may have a recoverable cardiomyopathy 4. What are some factors we should consider when assessing a patient’s candidacy for LVAD, in general, and from a surgical perspective? Patient factors Older age might push us towards thinking LVAD rather than transplant In general, age > 70 is the cutoff for transplant, but this is not a hard cut off and varies institution to institution In general, think about things that help predict recovery after a major surgery; Frailty and Nutritional status are important, we try to optimize these prior to LVAD implant Right ventricular function remains the Achilles heel of LV support We know that needing temporary RV support post LVAD puts you on a different survival curve than patients who don’t need RVAD support Studies have not been able to successfully predict who will develop RV failure after LVAD implantation What happens in the time between when the patient goes to the OR and when they get back to the ICU is an important determinant who might develop RV failure post LVAD Surgical techniques such as implanting the HM3 in the intra-thoracic cavity, rather than intra-pericardial may help maintain LV/RV geometry to help optimize the RV post LVAD Surgical considerations for LVAD candidacy Small, hypertrophied LV: HM3 inflow cannula is small, but small hypertrophied ventricles tend towards chamber collapse during systole causing suction, needing to run slower with lower flow rates Chest size/diameter: pumps have gotten so small now, that for adults, these have become less of a consideration BMI: low BMI used to be more of a concern with the older pumps due to where they were placed, and the relative size of the pump itself, not so much now with the smaller HM 3 pumps Calcified LV apex: would increase risk of stroke, bleeding Driveline tunneling becomes a concern in the super obese population, higher risk for driveline infections (might tunnel these driveline's shorter, and to a less fatty region of the abdomen, could even tunnel out the thoracic cavity in the super obese to limit skin motion) 5. Is there a role for MCS (i.e. temporary LVAD such as Impella) in pre-habilitation of patients prior to LVAD surgery? The theory of being able to improve systemic perfusion, decongest the organs, and make the patient feel better prior to surgery makes sense, but becomes problematic due to the lack of a hard end point/time for prehabilitation which might risk delays in surgery More likely that it can lead to delay in the surgery, with less-than-optimal benefit; you don't want to prolong the wait for surgery and increase the risk for complications prior to surgery An Impella 5.5 is currently FDA approved for 2 weeks of support, not 2 months so timing is important to keep in mind It’s unlikely that you will take a patient and convert them from a malnourished, cachectic person in 2 weeks’ time 6. Is there a role for LVAD therapy in the younger patient population? Should we be thinking of LVAD up front for these patients, with the goal of transplanting down the line? Recovery may be more likely in certain populations, particularly younger females with smaller LV's; in those populations, perhaps bridge to recovery should be the focus, optimizing them on GDMT etc. The replacement of transplant, with MCS (LVAD) in young patients has become a topic of discussion, because these pumps have become better and better, with the thinking that an LVAD could bridge a patient for 10 years or so, and they could get a transplant later It is still a big unknown, but several concerns exist Patients who get LVADs might end up with complications that become contraindication to transplant down the line (stroke, sensitization etc) Patients and providers are more hesitant because of the more recent iteration for the UNOS criteria for OHT listing which no longer gives patients with an uncomplicated LVAD higher priority, and therefore they could end up waiting a longer time for a heart after undergoing LVAD References Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001;345(20):1435-1443. doi:10.1056/NEJMoa012175 Mehra MR, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Left Ventricular Assist Device – Final Report. N Engl J Med. 2019;380(17):1618-1627. doi:10.1056/NEJMoa1900486 Mancini D, Colombo PC. Left Ventricular Assist Devices: A Rapidly Evolving Alternative to Transplant. J Am Coll Cardiol. 2015;65(23):2542-2555. doi:10.1016/j.jacc.2015.04.039 Mehra MR, Goldstein DJ, Cleveland JC, et al. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022;328(12):1233-1242. doi:10.1001/jama.2022.16197 Rose EA, Moskowitz AJ, Packer M, et al. The REMATCH trial: rationale, design, and end points. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. Ann Thorac Surg. 1999;67(3):723-730. doi:10.1016/s0003-4975(99)00042-9 Kittleson MM, Shah P, Lala A, et al. INTERMACS profiles and outcomes of ambulatory advanced heart failure patients: A report from the REVIVAL Registry. J Heart Lung Transplant. 2020;39(1):16-26. doi:10.1016/j.healun.2019.08.017 Mehra MR, Netuka I, Uriel N, et al. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. JAMA. 2023;330(22):2171-2181. doi:10.1001/jama.2023.23204 Mehra MR, Nayak A, Morris AA, et al. Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device. JACC Heart Fail. 2022;10(12):948-959. doi:10.1016/j.jchf.2022.08.002 Bhardwaj A, Salas de Armas IA, Bergeron A, et al. Prehabilitation Maximizing Functional Mobility in Patients With Cardiogenic Shock Supported on Axillary Impella. ASAIO J. 2024;70(8):661-666. doi:10.1097/MAT.0000000000002170
In "Somebody to Lean On," Dr. Osterholm and Chris Dall discuss vaccine updates including the FDA's back-and-forth on the Moderna vaccine, leadership shake-ups at institutions like the CDC, and the current state of measles in the US. Dr. Osterholm will also bring you a respiratory virus update, including current vaccine guidance for flu, COVID and RSV. Op-Ed: The FDA refused to review a flu vaccine, contrary to evidence. Now the agency reversed itself (CIDRAP) The State of US Vaccine Policy (CIDRAP and Unbiased Science)Dentists still write millions of prescriptions a year for an antibiotic with life-threatening risks (CIDRAP) Resources for vaccine and public health advocacy: Voices for Vaccines Families Fighting Flu Vaccinate Your Family Shot@Life Medical Reserve Corps Learn more about the Vaccine Integrity Project MORE EPISODES SUPPORT THIS PODCAST Music: "Beauty Flow" Kevin MacLeod (incompetech.com)Licensed under Creative Commons: By Attribution 4.0 License
Now that the Winter Olympics have wrapped up, the Milan Cortina Paralympic Games kick off on March 6. Dozens of athletes will represent Team USA in sled hockey, skiing, wheelchair curling, and snowboarding. But getting to the Olympics or Paralympics is expensive and costs competitors an average of $12,000 a year. For winter athletes in particular, the costs can be even higher. But first: why the FDA is looking to put the brakes on compounded GLP-1s.
The Trump Administration's rolled out a new, inverted food pyramid that places a stronger emphasis on dairy, red meats and foods higher in fat, while whole grains are at the narrow bottom. This follows HHS Secretary Robert F. Kennedy Jr.'s mission to "Make America Healthy Again" (MAHA), aimed at addressing chronic disease, childhood illnesses and ultra processed foods. The FDA is using the catch-phrase "eat real food" for the campaign they say will ultimately save families money. FOX's Jared Halpern speaks with Kyle Diamantas, the Deputy Commissioner for Human Foods and head of the agency's Human Foods Program, overseeing all FDA nutrition and food safety, who says embracing the new nutritional guidelines will save your family money, and improve your health. Click Here To Follow 'The FOX News Rundown: Evening Edition' Learn more about your ad choices. Visit podcastchoices.com/adchoices
Now that the Winter Olympics have wrapped up, the Milan Cortina Paralympic Games kick off on March 6. Dozens of athletes will represent Team USA in sled hockey, skiing, wheelchair curling, and snowboarding. But getting to the Olympics or Paralympics is expensive and costs competitors an average of $12,000 a year. For winter athletes in particular, the costs can be even higher. But first: why the FDA is looking to put the brakes on compounded GLP-1s.
En este episodio de Café en Mano, nos sentamos con una de las figuras culinarias más importantes de Puerto Rico: el Chef Enrique Piñeiro. Hablamos de todo lo que no se ve en televisión. Desde sus inicios cocinando con su abuela y su paso por restaurantes con Estrellas Michelin en Europa, hasta el difícil salto a la fama ganando "Operación Chef".Piñeiro nos cuenta la verdadera odisea de emprender en la isla: cómo tuvo que fracasar con 10 productos antes de crear su exitoso imperio de sofritos y adobos, los rigurosos retos de manufacturar bajo las leyes de la FDA, y la importancia de apoyar a los agricultores locales. Además, nos da su opinión honesta sobre la serie "The Bear", la realidad del maltrato en las cocinas profesionales, y recuerda su histórico encuentro con el legendario Anthony Bourdain.☕ Este episodio es traído a ustedes por Fuse Telecom, internet sin preocupaciones.Sigue al Chef Piñeiro:Instagram: @chefpineiroFacebook: El Chef PiñeiroNo olvides merch de Café en Mano: juanvi.bigcartel.com¡No olvides suscribirte, darle like y dejarnos en los comentarios qué te pareció la entrevista!00:00 - Intro: La fonda de la abuela y la pasión por la cocina03:15 - De Estrellas Michelin en Europa a ganar "Operación Chef"06:30 - El difícil salto a la televisión y el ego profesional12:35 - Emprendimiento: Vender sus negocios para empezar de cero19:40 - La creación de su marca: 10 fracasos antes del sofrito perfecto24:30 - La cruda realidad de manufacturar y cumplir con el FDA27:49 - El reto de conseguir ingredientes de agricultores locales en PR32:20 - ¿Qué define verdaderamente el sabor del paladar puertorriqueño?35:56 - La evolución de la cocina criolla moderna y sofisticada37:20 - Por qué al Chef Piñeiro NO le gustó la serie "The Bear"40:02 - Influencers de comida vs. Chefs de línea de cocina44:45 - El estrés extremo de una cocina profesional (Tickets y Línea)48:57 - Liderazgo: Cómo manejar a tu equipo y evitar el ambiente tóxico52:30 - Conociendo a la leyenda Anthony Bourdain en Puerto Rico56:52 - El impacto económico de consumir local y despedida
You guys have been asking about peptides… and today we're finally breaking it down.In this episode, I sit down with Dr. Zarrabi from Vitality Med Spa in LA to talk about GLP-1 medications, semaglutide, retatrutide, BPC-157, TB-500, and the growing peptide trend taking over social media.Are peptides safe?Should you use them before plastic surgery?What does “stacking” actually mean?Is this FDA approved… or is it the Wild West?We cover:• GLP-1 medications for weight loss (Ozempic-style drugs)• Microdosing and biohacking• Compounding pharmacies vs brand-name pens• Certificate of analysis & quality control• Peptides for healing and recovery• The potential risks nobody talks about• Why you need to check credentials before injecting anythingIf you're a woman in your 30s prepping for surgery and thinking about losing 15–20 pounds first… this episode is for you.As always, we're not here to sell you hype. We're here to give you clarity.FOLLOW THE CONVERSATION
We're marking Rare Disease Month 2026 by highlighting the powerful story of Shanthi Hegde, a young patient advocate working to transform how bleeding disorders are understood, treated, and supported. This work is fueled by her own arduous journey with two rare bleeding disorders and immune dysregulatory syndrome, and an extended diagnostic odyssey marked by dismissal, underdiagnosis, and structural bias. “I was told many times by many providers that these disorders are not common in Indians and that my bruises were there just because I'm brown.” Admirably, Shanthi pushed past this mistreatment, advocated for her medical needs, and devoted herself to tackling a range of issues confronting rare disease patients from mental health access to affordable drug pricing to research equity. In this remarkable Year of the Zebra conversation with host Lindsey Smith, you'll also learn about: Shanti's work with the Hemophilia Federation of America; How gaps extend beyond treatment to include insurance coverage, provider training, and substance use care; What clinicians can do to improve the work they do with rare disease patients. Join us for a conversation that connects patient voice to system change, and explores what real equity for rare disease communities will require. Mentioned in this episode:Hemophilia Federation of AmericaShanthi's LinkedIn Profile If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/podcast
Psychiatrist, internist, and addiction medicine specialist Muhamad Aly Rifai discusses his article "Psychedelic-assisted therapy: science, safety, and regulation." Muhamad explores the complex landscape of psychedelic medicine, balancing the growing public interest with the necessity of rigorous FDA oversight and safety protocols. The conversation examines the distinction between classic psychedelics like psilocybin and dissociatives like ketamine while highlighting why "set and setting" are critical for therapeutic success in treating depression and trauma. Muhamad emphasizes that these powerful agents are not simple pill swaps but require structured psychological support to translate peak experiences into lasting behavioral change. Discover why the path to effective treatment relies on transparent regulation and clinician humility rather than unsupervised experimentation. Partner with me on the KevinMD platform. With over three million monthly readers and half a million social media followers, I give you direct access to the doctors and patients who matter most. Whether you need a sponsored article, email campaign, video interview, or a spot right here on the podcast, I offer the trusted space your brand deserves to be heard. Let's work together to tell your story. PARTNER WITH KEVINMD → https://kevinmd.com/influencer SUBSCRIBE TO THE PODCAST → https://www.kevinmd.com/podcast RECOMMENDED BY KEVINMD → https://www.kevinmd.com/recommended
On this episode, Jared takes a deep dive into Biocidin, a practitioner-trusted botanical formula long used in functional and integrative wellness settings. Learn what makes this multi-herb blend unique and why it's often included in protocols designed to support oral health, gut health, immune resilience, and overall microbial balance. Jared explains biofilms in simple terms, why they matter for long-term wellness, and how botanical formulas like Biocidin are used to help maintain a balanced microbiome throughout the body. From the mouth and throat to the digestive tract and beyond, this episode explores real-world applications, research insights, and practical considerations for using multi-botanical support as part of a comprehensive wellness strategy. Part one focuses on education and understanding, while part two will cover how practitioners typically structure supportive protocols.Products:Biocidin and Dentalcidin ProductsVitality Radio POW! Product of the Week: Utzy Naturals Magnositol and Utzy Naturals Coll-U-Gen Get 35% off one bag or 45% off two or more bags (mix and match OK!) No Code Needed! (while supplies last)Additional Information:#555: From Gut to Gums: Mastering Microbial Balance Using Biocidin with Dr. Shawn Manske#617: Microbiome Balance from Mouth to Gut: Protocols for Clearing and Rebuilding with Biocidin – Part 2Visit the podcast website here: VitalityRadio.comYou can follow @vitalitynutritionbountiful and @vitalityradio on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.
In this Winter News & Notes episode of The Celiac Project Podcast, Mike and Cam share powerful listener updates and real life celiac journeys. From insurance battles and refractory celiac disease to mental health, OCD, and navigating college gluten free, this episode highlights both the challenges and the progress happening in the community. They also discuss advocacy efforts around FDA labeling and helpful resources for checking whether medications are gluten free.
On this episode of The Gist Healthcare Podcast, we cover the FDA's fast track for rare disease treatments, the end of two major healthcare labor strikes and a measles outbreak in South Carolina nearing 1,000 cases. Hosted on Acast. See acast.com/privacy for more information.
#200 - Miracle Cure or Internet Hype? The Truth About Castor Oil Castor oil is having a moment. Scroll social media for five minutes and you'll see it: “Cured my endometriosis.” “Detoxed my liver.” “Regrew my hairline.” “Healed… well, everything.” And when something is suddenly the solution to literally every problem… it's time to pause. Because while castor oil is absolutely powerful, not every claim floating around the internet deserves your blind trust (or all of your body parts). In this episode, I break down what castor oil actually is, what it's scientifically supported for, what I personally use it for, and what I absolutely would not recommend—especially if you're pregnant or thinking about putting it near your eyeballs. If you've been curious about castor oil packs, anti-aging benefits, hair growth hacks, stretch mark reduction, or lymphatic detox claims… this episode is your grounded, evidence-based (with a dash of anecdotal honesty) guide. What You'll Learn in This Episode What castor oil is made of (and why omega-9 fatty acids matter) FDA-approved uses vs. influencer folklore Whether castor oil actually helps with constipation Skin barrier repair, anti-aging, and collagen support Hair growth, scalp health, and rosemary oil synergy Castor oil for scars, stretch marks, arthritis, and cracked heels The truth about castor oil packs for liver detox Regular vs. Jamaican black castor oil—is there a difference? Side effects, safety, and when to absolutely avoid it Timestamps 00:00 – Castor oil: miracle cure or marketing frenzy? 01:00 – Why the FDA cracked down on exaggerated claims 02:00 – What castor oil actually is (hello, omega-9 fatty acids) 04:30 – What it's officially approved for 05:00 – Would I drink it for constipation? 06:30 – Traditional uses: skin conditions, infections, inflammation, lymphatic support 07:30 – Skin benefits that actually make sense 08:00 – Fine lines, wrinkles, and collagen support (why it may help) 09:00 – How to use it for hair growth 10:30 – Acne: helpful or hormonal disaster? (Bio-individuality matters) 12:00 – Castor oil packs for liver detox—worth it? 13:00 – Thyroid application (yes, I use it for Hashimoto's support) 14:00 – Stretch marks & scars: how to use heat to enhance absorption 16:00 – Anti-aging layering method (this is worth the price of admission) 17:00 – Lips: hyaluronic acid + castor oil combo 18:00 – Cracked heels, cuticles, and nail growth 20:00 – The fern experiment (because why not?) 21:00 – Jamaican black castor oil vs. regular: which is better? 22:00 – Side effects and when not to use it 23:00 – Pregnancy warning (seriously, a hard no) 24:00 – My honest verdict Let's Talk About What's Real Castor oil is rich in ricinoleic acid—an omega-9 fatty acid with anti-inflammatory properties. That's the magic. It's thick. It's deeply emollient. It seals moisture in like a champ. Which makes it excellent for: Dry skin Eczema-prone areas Crepey skin in perimenopause and menopause Fine lines (temporarily plumping through hydration) Cracked heels Dry cuticles Scalp nourishment And when you layer it correctly, it acts like a sealant to hold hydration in. I personally use it nightly on my face, neck, thyroid area, lips, and brows. Am I shiny before bed? Yes. Do I care? Not even a little. What I'd Be Careful With Internal use for constipation (very effective but not my first-line recommendation) Anything near your eyes (I woke up with red, burning, and irritated eyes) Vaginal dryness or sensitive internal use (research first, please) When To Never Use It Pregnancy (it induces labor) Castor Oil & Hormones As estrogen drops in perimenopause and menopause, skin becomes thinner, drier, and less elastic. This is where castor oil shines—literally and figuratively. It supports: Skin barrier repair Moisture retention Elasticity appearance That “spring back” we start to lose Is it Botox? No. Is it still amazing and affordable? Absolutely. Bottom Line Is castor oil a cure-all? Nope. Is it a potent, multi-use, low-risk tool? Yes. In a world where we're constantly sold $200 serums and complicated 12-step regimens, there's something refreshing about a humble glass bottle that's been used for centuries. If you try it: Buy organic Make sure it's in a dark glass bottle Patch test first Use cotton (preferably organic), not polyester, when covering treated areas And maybe—just maybe—pour it into something beautiful so you'll actually remember to use it. One More Thing Pretty Well was shared more than 94% of other shows in Spotify Wrapped this year. That's because of you. You share it. You text it. You send it to friends who need better information without the hype. And that means everything to me. If this episode helped you to decode the castor oil craze (or prevented you from putting it in your eyes), do me a favor and share it with a friend.
Autism, Functional Medicine, and Personalized Interventions: A Conversation with Theresa Lyons, PhD, a Yale-trained scientist and medical strategist who became an autism expert after her daughter's diagnosis and now runs AWEtism.net. Lyons describes dissatisfaction with conventional guidance that offers limited drugs for irritability and primarily ABA (Applied Behavioral Analysis), which is insurance-covered, often recommended at 40 hours/week, uses extrinsic rewards, and may help some skill-learning but has controversies and limitations for social development; she contrasts newer approaches such as RDI (Relationship Development Intervention) and PRT (Pivotal Response), which aim to build intrinsic motivation but are typically not covered by insurance. The discussion covers autism heterogeneity, changes in diagnostic categories (e.g., Asperger's folded into autism), and research including a Boston Children's Hospital study reporting 37% of children in a cohort lost their autism diagnosis over time (diagnosis based on observation). Lyons addresses debates about rising autism prevalence, noting multiple potential contributors and rejecting single-cause explanations, while citing risk-factor examples such as family autoimmune history and air pollution exposure. She outlines a functional medicine “why” approach using constipation as an example (root causes vs. symptomatic treatment), and emphasizes basic, low-risk steps such as evaluating diet, inflammation, hydration/electrolytes, and blood work for nutrients. Specific topics include gluten-free approaches (mechanisms involving gut permeability, immune burden, and CNS effects), dairy/inflammation, vitamin D deficiency and monitoring, melatonin as a well-studied short-term aid in autism (considered safe for a couple of years in studies) while still seeking underlying causes, and omega-3 fatty acids for focus and inflammation. Lyons explains leucovorin (folinic acid, prescription vitamin B9) as a targeted approach for children with folate receptor antibodies (reported in ~70% of autistic children), discusses the value and cost (~$300) of specialized testing from one U.S. lab, and notes reports of major speech and behavior improvements in responders, with dosing nuances. The episode also reviews evidence and cautions around the microbiome, including fecal microbiota transplant (FDA-approved for C. difficile; discussed as having an ~80% response rate in autism-related studies when gut issues are a key driver, but with major donor/compatibility considerations) and probiotics (some small trials and high costs). Other themes include “clean eating,” organic foods and toxin-load considerations tied to genetic detoxification vulnerabilities, discussion of acetaminophen/Tylenol in pregnancy in the context of glutathione pathways and personalized risk, and using genetics to guide interventions. Lyons warns that analysis of top autism TikTok videos found ~70% were inaccurate or overdramatized, recommending social media only for ideas, not decision-making. She also highlights parent stress, citing emerging research on increased PTSD risk among autism parents, and emphasizes support and community. Lyons advises parents to understand their child's specific health drivers and match them to appropriately specialized clinicians, noting her curated doctor listings in The Lyons Report.
Jax and John are on a mission to make gluten labeling clear and safe for everyone. With so many misleading labels, it's crucial for us to advocate for change. Imagine knowing exactly what's in your food! That's what this is all about—ensuring safety and transparency for those of us with celiac disease.Let's share our stories, raise awareness, and push the FDA to listen. Your voice matters!Together, we can make a difference.
On today's Celiac Project Podcast:In this Winter News & Notes episode of The Celiac Project Podcast, Mike and Cam share powerful listener updates and real life celiac journeys. From insurance battles and refractory celiac disease to mental health, OCD, and navigating college gluten free, this episode highlights both the challenges and the progress happening in the community. They also discuss advocacy efforts around FDA labeling and helpful resources for checking whether medications are gluten free.Listen to the full episode here: https://celiacprojectpodcast.libsyn.com/I would love to hear from you! Leave your messages for Andrea at contact@baltimoreglutenfree.com and check out www.baltimoreglutenfree.comInstagramFacebookGluten Free College 101Website: www.glutenfreecollege.comFacebook: http://www.Facebook.com/Glutenfreecollege Hosted on Acast. See acast.com/privacy for more information.
In this episode of Data in Biotech, Ross Katz sits down with Kyle Smith and Jacob Mayer from Aprecia Pharmaceuticals to explore how 3D printing is transforming pharmaceutical manufacturing. They dive into the unique binder jetting process, in-cavity printing, and how real-time data and automation are enabling agile, scalable, and precise drug production. Discover how Aprecia's approach is changing the game for clinical trials and personalized medicine. What you'll learn in this episode: >> How Aprecia developed the world's first FDA-approved 3D printed drug >> Why binder jetting stands out among 3D printing methods in pharma >> How in-cavity 3D printing enables real-time tablet-level data collection >> The future of closed-loop control and digital twins in drug manufacturing >> Why 3D printing is key to agile, distributed, and personalized pharma production Meet our guests: Kyle Smith is President and COO of Aprecia Pharmaceuticals, leading strategic growth and innovation in GMP-regulated pharma manufacturing. With 12+ years at Aprecia, he brings deep expertise in engineering, operations, and technology transfer. Jacob Mayer is Director of Engineering Innovation at Aprecia Pharmaceuticals. With a decade of experience across automation, additive manufacturing, and life sciences, he leads the advancement of 3D printing technologies and integrated pharma systems. About the host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with our guests: Sponsor: CorrDyn, a data consultancyConnect with Jacob Mayer on LinkedIn Connect with Kyle Smith on LinkedIn Connect with us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.
Is chronic babesiosis finally getting the scientific attention it deserves?In this episode of Integrative Lyme Solutions, Dr. K sits down with Dr. Geoff Dow, CEO & President of Sixty Degrees Pharmaceuticals, to discuss a groundbreaking clinical trial targeting chronic babesiosis — a common and often overlooked Lyme co-infection. Originally developed for malaria prevention, the drug Tafenoquine (brand name Kodatef®) is now being studied for its potential to treat persistent Babesia infections and Lyme-related fatigue.They explore the science behind red blood cell parasites, how Babesia differs from malaria, why chronic babesiosis remains controversial, and what makes this new trial the first FDA-reviewed IND study focused on chronic disease. If you or a loved one struggle with Lyme-related fatigue, relapsing babesiosis, or limited treatment options, this conversation offers cautious optimism and a closer look at the future of targeted therapies.Key Takeaways:0:00 Introduction3:10 From Malaria Drug Development to Lyme Co-Infections6:45 How Babesia Infects Red Blood Cells and Causes Fatigue10:40 Why Chronic Babesiosis Is Still Controversial14:50 No FDA-Approved Drugs Specifically for Babesiosis18:30 New Clinical Trials for Chronic and Relapsing Babesiosis24:00 Measuring Fatigue as a Primary Endpoint in Chronic DiseaseResources Mentioned:Sixty Degrees Pharmaceuticals - https://www.sixtydegreespharma.comKodatef® (Tafenoquine) Information - Available via company website aboveMount Sinai (Clinical Trial Site) - https://www.mountsinai.orgYale Babesiosis Case Series (Referenced Study) - https://medicine.yale.eduMedical Disclaimer: This content is for educational purposes only and is not intended to diagnose, treat, cure, or replace professional medical advice. Always consult your physician or qualified healthcare provider regarding any medical condition or treatment decisions. _______________________________The Karlfeldt Center offers the most cutting-edge and comprehensive Lyme therapies. To schedule a Free 15-Minute Discovery Call with a Lyme Literate Naturopathic Doctor at The Karlfeldt Center, call 208-338-8902 or email info@TheKarlfeldtCenter.comCheck out Dr. K's Ebook: Breaking Free From Lyme: A Comprehensive Guide to Healing and Recovery here: https://store.thekarlfeldtcenter.com/products/breaking-free-from-lymeUse the code LYMEPODCAST for a 100% off discount!
Want to know if you may be eligible for Permanent Teeth in 24 Hours? Take the 60-Sec Quiz Here: https://bit.ly/4roLylDHOW MUCH DO DENTAL IMPLANTS COST!? Download the FREE Guide to Dental Implants Here: https://bit.ly/4tIVCYj▬▬▬▬▬▬▬▬ Contents of this video ▬▬▬▬▬▬▬▬▬▬Disclaimer: Nuvia Dental Implant Centers are locally owned and operated by licensed dental practitioners. These locally owned and operated practices are part of a professional network of dental implant centers operated by prosthodontists, oral surgeons, and restorative dentists. Each Nuvia Dental Implant Center has a business affiliation with Nuvia MSO, LLC, a Dental Support Organization that provides non-clinical support to each center.Nuvia Dental Implant Centers are able to provide patients with a bridge made with an FDA approved permanent material, zirconia, in 24-hours. No temporary denture. Not all those who come in for a consultation are medically cleared to receive permanent zirconia teeth in 24-hours. Follow up appointments are required to confirm implant integration and make adjustments if necessary. Results may vary in individual cases. Patients represented in videos are actual NUVIA patient(s) and may have been compensated for their time in telling their story.While soft foods immediately after surgery are generally approved by our clinical team, the local surgeon may give individual instruction on dental implant aftercare according to the specific circumstances applicable to each case.From 2022 through 2024 Nuvia had a documented 99.18% dental implant success rate. During a documented pressure test Nuvia's 24Z teeth withstood 2330 Newtons of Force before breaking.Copyright 2024. Nuvia Dental Implant Centers. All rights reserved.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a compelling array of advancements and strategic shifts that are shaping the healthcare landscape across the globe.In recent times, the pharmaceutical and biotech sectors have showcased remarkable resilience and innovation, driving forward with significant scientific breakthroughs and clinical trial results. A standout achievement comes from Novo Nordisk, whose recent Phase 2 trial results for its triple agonist targeting obesity reported a remarkable weight loss of up to 19.7% in patients over 24 weeks. This promising development positions Novo Nordisk as a formidable contender in the obesity treatment market, potentially affecting giants like Eli Lilly. With obesity being a significant global health challenge, these findings underscore the potential of multi-targeted approaches in managing this complex condition.Regulatory landscapes continue to evolve, with pivotal approvals marking milestones for therapies targeting rare diseases. Immedica Pharma's Loargys received FDA approval for treating hyperargininemia associated with arginase 1 deficiency, highlighting perseverance in overcoming regulatory hurdles after a prior rejection. Additionally, Sanofi and Regeneron's Dupixent achieved its ninth FDA approval, underscoring its versatile potential across multiple indications. These approvals not only reflect regulatory progress but also emphasize the critical role of persistence in drug development.Ethical considerations remain at the forefront of industry discussions, particularly highlighted by Novartis' settlement in a lawsuit concerning the use of Henrietta Lacks' cells without consent. This resolution underscores ongoing ethical challenges within biomedical research, emphasizing the need for ethical vigilance as companies increasingly rely on human-derived materials.Significant business trends are shaping strategic directions within the industry. Pfizer's acquisition of marketing rights for Sciwind's GLP-1 receptor agonist in China exemplifies a calculated move to dominate the obesity treatment market. This strategic acquisition allows Pfizer to leverage China's vast market potential for type 2 diabetes medications and positions it favorably for future weight loss treatments.On the manufacturing front, AbbVie has made substantial investments in U.S. infrastructure, committing $380 million to new North Chicago API plants as part of a decade-long strategy to inject $100 billion into U.S. operations. This initiative highlights a commitment to bolstering domestic production capabilities amidst global supply chain uncertainties.The complexities of drug development are further illustrated by Roche's decision to halt the development of Enspryng for Duchenne muscular dystrophy due to unsatisfactory progress. This shift in focus reflects the inherent challenges of drug repurposing and the necessity of robust clinical evidence to support new indications.Geopolitical factors also play a significant role in shaping industry dynamics, with recent U.S. Supreme Court decisions impacting international trade agreements. Such geopolitical influences can significantly affect pharmaceutical companies' operations and strategic planning.The collaboration between Astellas and Vir Biotechnology reflects another significant trend in strategic partnerships within the industry. Their $1.7 billion deal centered on a novel bispecific T-cell engager for prostate cancer underscores the growing importance of immuno-oncology and innovative approaches to targeting hard-to-treat cancers.The regulatory front continues to see transformative changes with the FDA unveiling draft guidance for a new approval pathway tailored for bespoke gene-editing therapies. This initiative could expedite personalized genetic treatments and transform patSupport the show
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: big updates for stem cell and islet transplants, new pen option for Zepbound, an implantable insulin pump moves forward and more! Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom T1D Screening info All about VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Episode transcription with links: Welcome! I'm your host Stacey Simms and this is an In The News episode.. where we bringing you the top diabetes stories and headlines happening now. A reminder that you can find the sources and links and a transcript and more info for every story mentioned here in the show notes. Quick reminder: I'm just back from MNO DC and I'm exhausted. But it's the best kind of tired. We had an incredible time – hope you can join us in Nashville. With a reminder that we have our first Club 1921 in Nashville – that's our educational dinner series for HCPs and patient leaders. All the info is over at diabetes-connections.com events/ Okay.. our top story this week: XX An "immune system reset" eliminated Type 1, diabetes in mice in a study conducted at Stanford Medicine without immune suppressant medications. This was a combined transplant of blood stem cells and insulin-producing pancreatic islet cells from a donor whose immune profile did not match the recipient. The dual transplant approach both restored insulin production and retrained the immune system. For the full six months of the experiment, the animals did not need insulin injections or immune suppressive medications. Challenges remain using this approach to treat Type 1 diabetes. Pancreatic islets can be obtained only after death of the donor, and the blood stem cells must come from the same person as the islets. It is also unclear whether the number of islet cells typically isolated from one donor would be enough to reverse established Type 1 diabetes. But the researchers are working on solutions, which could include generating large numbers of islet cells in the laboratory from pluripotent human stem cells, or finding ways to increase the function and survival of transplanted donor islet cells. https://scitechdaily.com/stanford-scientists-cure-type-1-diabetes-in-mice-without-insulin-or-immune-suppression/ XX An electronic implant interlaced with islet cells is being looked at to treat type 1. Researchers at the University of Pennsylvania School of Medicine worked with engineers at Harvard University to combine stem-cell biology with soft electronics. They inserted an ultrathin, flexible mesh of conductive wires — thinner than a human hair — into developing pancreatic tissue. As the cells assembled into clusters, the mesh became woven through them. The electronics can record the faint electrical signals produced by the cells that control insulin release. They can also deliver small pulses of electricity back to the cells. After several days, the cells began to behave more like mature islets. Their internal signalling shifted, neighbouring cells started working in concert and insulin release became stronger and better timed. Very early on here – and the transplanted cells still need to be protected from being attacked by the immune system. https://www.thetimes.com/uk/science/article/first-cyborg-pancreas-implants-type-1-diabetes-nxkv8r0fp?gaa_at=eafs&gaa_n=AWEtsqeJYYUF9TMR-GgGUG92hPyog-ISeiqGIgdyaaIKKcpvhtoftGiUaaOtQeG0NWI%3D&gaa_ts=699c50d4&gaa_sig=w-PQ0ArosZSznYDSWEzt8aQg4WC0FF5ZFRt9NedO5sSTL2FyWzupH8eSG7RCy2S8TQnlHOeKCudANWm1MNI59w%3D%3D XX Katie Beth (hand) Eledon trial – aaron kowalski post linkedin. Last fall we told you about promising results from Eledon's drug to prevent islet transplantation rejection in type 1 diabetes. The first six patients no longer had to inject or infuse insulin.. the trials continue and this month one of the patients – Katie Beth Hand – began posting about her experiences one month in, on social media, she says she's off basal insulin already and in range 99 percent of the time. She is also encouraging people to learn more about support the islet act https://lnkd.in/e8pQ7_Y7 XX This is a bill introduced last November which would change the wording on pancreatic cell transplants. The problem is that islets are classified as drugs rather than organs, making transplantations difficult for medical teams and centers to preform due to accessibility. Insurance companies are also less likely to provide reimbursements for treatment, which can cost hundreds of thousands of dollars. The official Journal of The Transplantation Society estimates the cost at about $140,000. The bill went to the senate committee of Health, Education, Labor, and Pensions in early November. No other action has been taken since then. https://www.wtoc.com/2026/02/19/bluffton-family-advocates-islet-act-help-diabetic-son/ XX Big change for the obesity drug Zepbound – now available in the multi dose KwikPen. This is a month's worth of doses in a single pen.. and it's multi dose – you can adjust it. Cash-paying patients can get the multi-dose device, called KwikPen, on the company's direct-to-consumer website, LillyDirect. Prices start at $299 per month for the lowest dose level. Until now, you could only get zepbound in a single dose auto injector or a sing dose vial. In a release, Lilly said the Food and Drug Administration approved a label expansion for Zepbound to include the multi-dose device. The KwikPen is already used for other drugs, such as Lilly's popular diabetes medication, Mounjaro – which is the same medication as zepbound, they're both tirzepitide. https://www.cnbc.com/2026/02/23/eli-lilly-launches-zepbound-obesity-drug-pen-one-month-doses.html XX For years, researchers have observed that people who live at high elevations, tend to develop diabetes less often than those at sea level. Although the trend was well documented, the biological explanation behind it was unclear. Scientists now say they have identified the reason. Their research shows that in low oxygen environments, red blood cells begin absorbing large amounts of glucose from the bloodstream. Their work showed that when oxygen is limited, red blood cells use glucose to generate a molecule that helps release oxygen to tissues. This process becomes especially important when oxygen is in short supply. The researchers also found that the metabolic benefits of prolonged hypoxia lasted for weeks to months after mice were returned to normal oxygen levels. They then evaluated HypoxyStat, a drug recently developed in Jain's lab that mimics low oxygen exposure. HypoxyStat is taken as a pill and works by causing hemoglobin in red blood cells to bind oxygen more tightly, limiting the amount delivered to tissues. In mouse models of diabetes, the medication completely reversed high blood sugar and outperformed existing treatments. https://www.sciencedaily.com/releases/2026/02/260221060952.htm XX Watching this one closely – Portal Diabetes gets FDA breakthrough device designation for its implantable insulin pump system. This is a system that includes not just a device that's implanted into the abdomen, but also a new, temperature stable insulin. It will work with – quote – "modern" CGM technology with a fully closed loop - and aims to deliver a functional cure for type 1. While reports say Portal's system is the first in the US – there was an implantable pump developed and used by about 500 people worldwide, including about 100 in the US – by MiniMed. Medtronic bought the company and in 2007 they stopped that program. Portal Diabetes expects to begin clinical trials on its combination system around the fourth quarter of 2027. https://www.drugdeliverybusiness.com/portal-diabetes-fda-breakthrough-implantable-insulin-pump/ XX Sequel Med Tech and Senseonics (NYSE:SENS) today announced the full U.S. launch of their CGM and insulin pump integration. That's the eversense cgm and twist pump. Sequel said its full launch with Eversense 365 makes twiist available with two compatible CGMs. twiist also pairs with the Abbott FreeStyle Libre 3 Plus sensor. Eversense 365, an implantable system, rests under the skin for the duration of a year. Users can change its external, silicone-based adhesive daily with almost no skin reactions. https://www.drugdeliverybusiness.com/sequel-senseonics-full-launch-twiist-eversense/ XX Right back with a Dexcom update, and a look at which type of diet reduces insulin use overall.. right after this: -- Back to the news.. Dexcom is watching for expanded Medicare coverage of its continuous glucose monitors to people with Type 2 diabetes who don't take insulin. CEO Jake Leach told investors on Thursday that the company has been "sitting here waiting for a coverage decision" from the Centers for Medicare and Medicaid Services Dexcom started to see commercial coverage unlock for Type 2, non-insulin users toward the end of last year, Leach said. He expects broader Medicare coverage for that group would allow nearly 12 million people to access CGMs. In the meantime, the American Diabetes Association updated its guidelines last year to recommend clinicians consider using CGMs for Type 2 diabetes when patients are taking glucose-lowering medications other than insulin. Leach said that real world data the company has been generating supports that decision, and that Dexcom has launched a registry for non-insulin users. https://www.medtechdive.com/news/dexcom-seeks-expanded-medicare-coverage-of-cgms-for-type-2-diabetes/812223/ XX Medtronic's separation of MiniMed is not yet complete.. but continues to move forward. The company has submitted their next pump – MiniMed Flex – to the FDA. This is a pump smaller than the 780G but uses the same reservoirs and infusion sets. It will also work with both the Simplera Sync and Instinct sensors. Medtronic also began a U.S. pivotal study for Vivera, its third-generation algorithm for automated insulin delivery. It also remains set to submit its MiniMed Fit patch pump system to the FDA by the coming fall. https://www.drugdeliverybusiness.com/medtronic-submits-minimed-flex-fda-q3/ XX A study modelling how genes may influence a child's body mass index over time has found that BMI at age 10 and overall growth rate between ages one and 18 might be important factors, as the two are more likely linked to diabetes, high cholesterol, and heart disease in later life. Nearly 66,000 BMI measurements from around 6,300 children and adolescents aged one to 18 were analysed to understand the role of genes. "Future research is needed to help identify the most effective ages to prevent obesity or poor growth for long-term benefit." https://www.ndtv.com/health/bmi-at-age-10-growth-rate-up-to-age-18-are-important-factors-for-diabetes-heart-disease-study-11125146 XX A low-fat vegan diet—without cutting calories or carbs—may help people with type 1 diabetes significantly reduce how much insulin they need. In a new analysis published in BMC Nutrition, participants following the plant-based plan lowered their daily insulin use by 28%, while those on a portion-controlled diet saw no meaningful change. Researchers say the reduced insulin requirement likely reflects improved insulin sensitivity. The original 2024 study reported additional benefits from the vegan diet. Participants lost an average of 11 pounds and showed improvements in insulin sensitivity and glycemic control. Cholesterol levels and kidney function also improved among those following the plant-based plan. https://www.sciencedaily.com/releases/2026/02/260212234212.htm XX Interesting little tidbit from the Winter Olympic Games.. the World Anti-Doping Agency (WADA) was monitoring GLP drug use. An advisory group that makes recommendations about WADA's list of prohibited substances discussed the status of GLP-1 medications, and added semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) to its monitoring program That means patterns of use of these drugs will be tracked both in and out of competition. The finding will be used to make recommendations about whether GLP-1 agonists should be added to the prohibited list, the spokesperson explained. While GLP-1 drug use is not currently prohibited, that could change before the next Summer Olympic Games in Los Angeles in 2028, he noted. https://www.medpagetoday.com/popmedicine/cultureclinic/119770 XX That's it for in the news!
On She Built It®, Florence Baras, Co-Founder of Sockerbit, shares how she and her husband transformed a beloved Swedish tradition, lördagsgodis (Saturday candy), into a thriving U.S. retail and e-commerce brand.From navigating FDA regulations and import logistics to launching vibrant storefronts in New York and Los Angeles, Florence reveals what it really takes to build a profitable retail company from scratch. She opens up about sourcing only from Europe's top candy factories, protecting margins despite rising import costs, surviving COVID with young children at home, and scaling nationwide through partnerships with Target and specialty retailers.If you're building a retail brand, growing an e-commerce business, or scaling through major retail partnerships, this episode is a masterclass in community-driven growth, operational discipline, and long-term brand building.Connect with us:Sockerbit WebsiteSockerbit InstagramSockerbit FacebookSockerbit XWork with She Built It® Media She Built It® Instagram She Built It® CEO, Melanie Barr InstagramMelanie Barr LinkedInShe Built It® LinkedIn
Dr. Hoffman continues his conversation with Nathan Jones, CEO and founder of Xlear, Inc.
Xylitol, FTC Censorship, and the Oral–Heart Health Connection: Nathan Jones, CEO and founder of Xlear, Inc., makers of xylitol-based nasal and dental hygiene products, and a health freedom advocate, discusses Jones' ongoing legal battle with the FTC. He addresses the difficulty of making health claims for hygiene products (including toothpaste and nasal sprays), the role of “weasel words” in supplement marketing, and concerns about regulatory double standards versus pharmaceuticals. He also reviews xylitol's benefits for dental caries and respiratory/ear infections, including references to studies and public-health examples (e.g., Finland and a Belize program reducing dental caries costs), and Jones' efforts to encourage Utah to implement xylitol gum programs in schools. He contrasts fluoride's enamel-strengthening approach with xylitol's effect on the underlying bacterial cause of tooth decay, discusses Utah's fluoride policy change and claims about fluoride's limited benefit, and highlights a correlation between poor oral health and cardiovascular risk via inflammation and bacterial translocation into the bloodstream, including pathogens found in atherosclerotic plaque, and links also discussed for dementia and Parkinson's. They close with commentary on health advocacy in the “MAHA era,” the challenges of entrenched federal bureaucracy, and Jones' preference for advocacy groups that teach industry to push back rather than comply.
For people living with osteoarthritis, news about potential new treatments often comes with more questions than answers. In this episode of The Health Advocates, we slow things down to explain what it really means when a company submits a New Drug Application, or NDA, to the U.S. Food and Drug Administration. Steven Newmark is joined by Erich Horsley and Dr. Yusuf Yazici from Biosplice Therapeutics to walk through this important regulatory milestone and why it matters for patients. Together, they break down what an NDA is, what happens during FDA review, and what patients should and should not expect while a therapy is under evaluation. The conversation also explores the current osteoarthritis treatment landscape, why progress in this disease has been so challenging, and what researchers mean when they talk about disease-modifying approaches. Contact Our HostSteven Newmark, Chief of Policy at GHLF: snewmark@ghlf.orgA podcast episode produced by Ben Blanc, Director, Digital Production and Engagement at GHLF.We want to hear what you think. Send your comments in the form of an email, video, or audio clip of yourself to podcasts@ghlf.orgListen to all episodes of The Health Advocates on our website or on your favorite podcast channel.See omnystudio.com/listener for privacy information.
Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury's analysts assess what the deal does for the Foster City, Calif.-based biotech's pipeline.The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials. Turning to Washington, Steve Usdin offers his takeaways from last week's PhRMA Forum, which focused on China and the Trump administration's most favored nation (MFN) drug pricing policy, and on the lessons that can be drawn from FDA's about-face on the recent vaccine application from Moderna.View full story: https://www.biocentury.com/article/658516#BiotechMA #MultipleMyeloma #ctDNA #DrugPricingPolicy #FDA00:00 - Introduction02:34 - Gilead's Arcellx Buy11:14 - ctDNA Surrogate Endpoints21:59 - PhRMA Forum Takeaways29:19 - FDA Moderna U-turnTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
Anna Kepner's step-brother has been charged with her murder, FDA recalls a bunch of cheese, the ladies of "The View" are mad that Kash Patel celebrated with the USA Men's Hockey team, CNN would NOT cover "Angel Family Day" at the White House, Nick Reiner pleads NOT GUILTY in the murder of his parents, scientists in Germany have discovered an extremely rare fossilized reptile anus, and the latest TikTok trend of bashing your own face with a hammer...
"Why are we paying $10,000 for a $30 drug?"My guest this week is Pramod John, a former Silicon Valley tech entrepreneur who entered the healthcare space to tackle the largest economic problem in the country: skyrocketing healthcare costs. Pramod quickly realized that healthcare's dysfunction is actually not a technology problem - it is a deeply ingrained problem with economic incentives.In this episode, we dive into the murky waters of Pharmacy Benefit Managers (PBMs) and why the traditional model is designed to drive up costs rather than lower them. We discuss the shocking statistics of drug spend (where 2% of people account for 55% of the costs), why FDA approval doesn't always mean a drug is effective (using the infamous Alzheimer's drug as an example), and the implications of recent fiduciary lawsuits like the one against J&J.Pramod explains how we can bring common sense back to healthcare by treating drugs like any other consumer purchase. By utilizing an "open market" drug management model, he argues that we can effectively replace traditional PBMs with transparent transaction processing software - saving plans 30% to 50% without relying on restrictive formularies or rebate games. Tune in this week for a clear roadmap for how to actually fix the irrational economics of our healthcare system.Thank you to our 2026 sponsors!ParetoHealth: ParetoHealth empowers midsize employers with a long-term solution to reduce volatility and lower overall health benefits costs. Visit ParetoHealth.com to learn more.Samaritan Fund: A program that connects those who need help to the support they need. We are proud to offer the Samaritan Fund Program. Visit SamaritanFundProgram.com to learn more.Vālenz Health: We're Vālenz Health, your partner in improving health literacy, reducing plan spend, and delivering high-value healthcare. Visit ValenzHealth.com to learn more.Imagine360: Imagine360 helps self-funded employers save on healthcare with smarter health plans. Cut expenses by 20-30% with custom solutions. Contact us today at Imagine360.com.Chapters:(00:00:00) Intro: Why We Talk About Cost Instead of Quality (00:02:42) From Silicon Valley & Defense Tech to McKesson (00:10:43) Why Healthcare is NOT a Technology Problem (00:15:53) Fiduciary Responsibility & The J&J Lawsuit (00:19:03) The Butter Knife vs. Pareto: The Math of Drug Spend (00:23:54) Building an "Open Market" Alternative to PBMs (00:29:40) Why Doctors Fly Blind on Drug Pricing & Formularies (00:35:42) FDA Approval vs. Real-World Efficacy (00:45:44) How to Actually Fix the Model: The Real-Time "Pause" (00:58:36) Why International Sourcing & PAPs Aren't the Fix (01:11:00) Replacing PBMs with Simple Transaction SoftwareKey Links for Social:@SelfFunded on YouTube for video versions of the podcast and much more - https://www.youtube.com/@SelfFundedListen/watch on Spotify - https://open.spotify.com/show/1TjmrMrkIj0qSmlwAIevKA?si=068a389925474f02Listen on Apple Podcasts - https://podcasts.apple.com/us/podcast/self-funded-with-spencer/id1566182286Follow Spencer on LinkedIn - https://www.linkedin.com/in/spencer-smith-self-funded/Follow Spencer on Instagram - https://www.instagram.com/selffundedwithspencer/
As global demand for meat grows, this episode of Duke University's Leading Voices in Food podcast examines cell-cultivated protein—real meat grown from animal cells—and the evolving U.S. policy landscape shaping its future. Host Norbert Wilson (Duke World Food Policy Center) speaks with postdoctoral researchers Kate Consavage Stanley (Duke/Bezos Center for Sustainable Proteins) and Katariina Koivusaari (NC State/Bezos Center) about their article in Trends in Food Science and Technology on U.S. regulatory and legislative activity. The conversation explains the joint FDA–USDA regulatory approach for cell-cultivated meat (FDA oversight through cell cultivation; USDA oversight from harvest through processing, packaging, and labeling) and FDA oversight for cell-cultivated seafood (except catfish). They discuss timelines companies report for approval (often two to three years), the lack of federal public guidance on naming and labeling so far, and how USDA label approvals are currently handled case by case (e.g., "cell-cultivated chicken" and "cell-cultivated pork"). The episode also covers state-level labeling laws and the likelihood of federal preemption if state requirements conflict with federal statutes, as well as a growing wave of state restrictions and bans—Florida and Alabama in 2024, followed by Indiana, Mississippi, Montana, Nebraska, and Texas in 2025—plus funding restrictions in South Dakota and Iowa. The guests explore implications for consumers, interstate commerce, innovation, investment, and U.S. leadership, noting ongoing lawsuits in Florida and Texas and continued legislative activity such as a proposed ban in Georgia. Interview Transcript Kate, let's begin with you. In the paper, you write about the regulatory frameworks that have been developed for cell-cultivated meat and seafood products in the US. To start, let's talk about what's unique about cell-cultivated products from a regulatory standpoint and how the US Department of Agriculture and US Food and Drug Administration have decided to handle cell-cultivated protein products. Kate - Yes, so as you mentioned in the introduction, Norbert, cell-cultivation is a new technology for use of the food supply. So, the US government had to adapt its existing legal frameworks for food safety regulation. As your listeners may already know seafood is regulated by the FDA, so it was within their scope to also regulate cell-cultivated seafood. The FDA therefore regulates all cell-cultivated seafood products with the exception of catfish. When it came to determining the regulatory approach for cell-cultivated products from livestock, poultry, and catfish, it was a bit more nuanced as the processes and components evolved fell under both USDA and FDA purview. In 2019, the FDA and USDA therefore agreed on a joint regulatory approach where the FDA regulates the early stages of the cell cultivation process, including when those cells are taken from the animal, grown in the bioreactor, and matured into specific cell types such as muscle or fat cells. At the point where those cells are ready to be harvested from the bioreactor to use in a food product, oversight transfers to USDA who oversees that harvesting process as well as food processing, packaging, and labeling. I know this joint regulatory approach may sound complicated, but it's important to note that USDA and FDA already coordinate oversight over other foods in the food supply. I'll give you an example that we all love pizza. A frozen cheese pizza is regulated by the FDA, whereas a frozen pizza with meat toppings like pepperoni is regulated by the USDA. It is therefore not unprecedented that FDA and USDA would agree to jointly regulate cell-cultivated products. And while the process is new, the products go through the same safety checks as other foods in the food supply. In the past few years, we've seen four cell-cultivated meat products go through the joint USDA-FDA regulatory process, meaning they can be sold in the US food supply. And one cell-cultivated seafood product has gone through the FDA regulatory process. Kate, thank you for sharing this. And I've used a pizza example in my class, and it is super complex this regulatory maze that we're talking about. It seems like there has been a lot of collaboration between these two agencies, and so that's important to hear. But it is also the case that it seems challenging for cell-cultivated protein companies to get through this process. Is this a fair assessment and would you elaborate? Kate - Yes, absolutely. We've heard from cell-cultivated companies that it can take two to three years to get through this process. And there certainly is a lot of back and forth between the companies and FDA and USDA. Great, thank you. Katariina, now let's turn to you. How do these regulations extend to labeling and what do we know about the federal government's approach to labeling the sale of cultivated products thus far? Katariina – So, labeling regulations are the most consumer facing part of regulations, really. And they are used to ensure that the product label has information that's truthful, that's not misleading. And that the package has sufficient information and consistent information also across products so that the consumer can make an educated decision on what product they want to purchase. And you'd think that how you label the product or just how you call the product on the label would be simple. But there are certain regulations in place that define how food items can or cannot be called. Now, when it comes to cell-cultivated products, as you and Kate mentioned, they are novel in the food supply. So, there is not a long-established term or nomenclature on how we should call these products. The federal regulators, FDA and USDA, to date have not released any public guidance either on how these products should be called on the label. The USDA did release an advanced notice of proposed rulemaking back in 2021, requesting comments from stakeholders on how these products should be labeled. And the FDA has also requested comments when it comes to labeling cell-cultivated fish and seafood. But to date, no guidance has been published yet. Kate gave an overview of the regulatory process between FDA and UFDA when it comes to labeling this product products. The USDA oversees labeling cell-cultivated meat, and the FDA oversees labeling cell-cultivated fish and seafood. The USDA has a pre-market approval process for labels, similarly to conventional meat industry. So, whenever a company wants to bring to market a new product, they first submit their label to the USDA. And the USDA reviews it and make sure that they agree with the language used in the label. The FDA does not have a similar pre-market approval process for labeling fish or seafood or cell-cultivated fish or seafood. So, currently cell-cultivated meat labels are approved on a case-by-case basis. And we can see from the products that have gone through the regulatory review so far that the USDA seem to approve the use of 'cell-cultivated' as a qualifying term, together with a meaty term such as chicken or pork. So, the products that we've seen approved to date or brought to market to date are called cell-cultivated chicken or cell-cultivated pork. This is really helpful to know what's happened at the federal level. We also know that there are several actions happening at the state level, so several states have proposed their own laws outlining how and what to label these products. Katariina, can you talk us through what this study regarding state labeling? Katariina - To date, about half of the US states have enacted or proposed their own labeling legislation on cell-cultivated products. Missouri became the first state in 2018, so well before any of these products was available on the market. And they specifically prohibited the use of word meat unless the food was from harvested production livestock or poultry. Restricting, therefore, the use of meat not only on cell-cultivated, but also on other alternative protein products such as plant-based meat analogs or fermentation derived proteins. And this is true for many state level labeling laws. That they are applicable not only to cell-cultivated meat, but also other alternative proteins aiming to mimic meat. In addition to Missouri, there are six other states that prohibit the use of meat or meat related terms, such as chicken or pork. Now, the other group of states that have restrictions on cell-cultivated meat labeling do not concentrate on prohibiting the use of word meat, but they require the use of qualifying terms or other additional language that clearly states that the product does not come from livestock or poultry. And this group of states, there are 18 states, have quite a bit of variation in what kind of qualifying terms they require to be used. And I thought I'd give a couple of examples here. For example, Indiana requires the package to include the phrase this is an imitation meat product. Iowa requires the product to be labeled with qualifying terms such as cell-cultivated, cell-cultured, fake, grown in a lab, imitation, lab grown, lab created, meat free, or meatless. What's interesting though is that the federal statutes that regulate the US food supply have actual language that prevents states from establishing laws or regulations that conflict with or are additional to the federal labeling regulations. So, this means that the state level labeling laws are actually likely to be preempted if they conflict with the federal regulations. So, we've only talked about labeling so far. Kate, I want to go back to you. More recently, we've seen a number of states propose greater restrictions on these products. Can you describe these attempts to restrict cell-cultivated meat and their immediate implications? And how have cell-cultivated companies and other stakeholders responded? Kate - In the past few years we've seen quite a few attempts by states to ban or restrict cell-cultivated meats. And these attempts fall into two buckets: bans that aim to restrict the manufacturer sale or distribution of cell-cultivated products and bans that aim to limit the use of state funding to support these products. In 2024, Florida was the first state to pass a ban on the manufacture, sale, and distribution of cell-cultivated meats. Alabama followed shortly thereafter. In 2025, five more states passed similar bans on cell-cultivated products, including Indiana, Mississippi, Montana, Nebraska, and Texas. And many other states proposed bans that ultimately didn't pass. The language on what is banned differs some between states. For instance, Texas only bans the sale of cell-cultivated products. Whereas Florida and others also ban cell-cultivated manufacturing and distribution. But the core message in all these bans is similar. Cell-cultivated meats are not welcome in those states. The time span for the bans differs too. So, Indiana and Texas have two-year bans while Florida and other states passed indefinite bans. And we've seen two states, South Dakota and Iowa pass legislation to restrict the use of state funding to support cell-cultivated products. What's frustrating about these bands and confusing for those in the alternative protein sector is that cell-cultivated technology is largely still in the early stages. Yes, as I mentioned earlier, five products have passed through the regulatory process. But these products have mainly been made available in small tasting events. And only one has actually made it to retail. Most Americans have never had a chance to actually try these products. So, it begs the question, why is there such resistance? State bans on these products mean that Americans will not have the chance to decide for themselves if they like these products, or if and how they want to incorporate them into what they eat. Another big concern is that these bans create a fragmented policy landscape that's challenging for cell-cultivated startups, especially, to navigate. And it raises a lot of concerns about cross state sales. Concerns like these are the basis for two lawsuits against cell-cultivated bans in Florida and Texas. Those lawsuits are still playing out in court, so we don't yet know how those may Kate, this is really fascinating. And as both you and Katariina described, there's a patchwork of policies and a complex landscape for these companies to navigate. It has the potential of keeping consumers from even trying the products, as you've already suggested, when they're made available. And what I'm hearing from both of you is that this is an ongoing project. So even though there's a paper that's published now, it seems like there will be opportunities to keep going back as new laws and new regulations and new lawsuits are decided. So, this is a policy space that we need to keep an eye on. That's something I want to pick up on this last question. In closing, what does this legislation mean for consumers and the future of cell-cultivated products in the US and even globally? Katariina, let's begin with you. Katariina - Yes. In addition to impeding interstate and international commerce of cell-cultivated products, these bans could negatively impact the US investment climate on these products and technologies. For example, China has included developing cell-cultivated meat in their five-year plan. Within Europe, there's some variation. Some countries are being rather supportive of these technologies and products, whereas others have tried to ban them similarly to some US states. But I think it's important to note that even with some states in the US banning these products, the US will still likely remain a significant market area for cell-cultivated products. And it still takes significant investment and infrastructure to produce the products on a large scale enough to even reach the whole country. Another really important thing to mention here is that the global demand for meat is growing. If we look at global population forecasts, global meat or protein consumption forecasts, we need these alternative proteins. Not only cell-cultivated meat, but also for example, plant-based meat alternatives to help meet the increasing demand for protein and complement conventional meat supply. Kate, what about you? Kate – I agree with everything that Katariina said. To add on to her points, I note that the US has been a leader in the cell-cultivated research development and innovation spaces to date. We are one of only a few countries that have both developed a framework for regulating these products and had products successfully pass through that process. The bans tell a different story, and they may restrict US innovation in the cell-cultivated space because companies will be limited to only the states where they can produce and sell these products. What this means for US leadership in the space remains to be seen. However, one could ask will cell-cultivated companies choose to set up shop in the US versus another country that isn't facing such legal challenges? We don't yet know the answer to that. You also mentioned consumers. We don't yet know about how these bans and the media surrounding them may influence consumer perceptions of cell-cultivated foods. Products, as you said, they've never even really had the chance to try. But these bans will certainly restrict consumer access to these products in certain states, and the varying state approaches to labeling that Katariina described are likely to confuse consumers. Going back to something you mentioned earlier, Norbert, we're excited to have this paper out in the world. But this work is certainly continuing to evolve. Just recently, a senator in Georgia proposed a new ban on cell-cultivated meat in the state, and other countries have faced similar legislative challenges against these products. So, we'll be watching and learning as these challenges continue to play out. Bios Katariina Koivusaari, Ph.D. is a postdoctoral researcher at the Bezos Center for Sustainable Protein at North Carolina State University. Her work focuses on stakeholder engagement and the regulatory and policy landscape of alternative proteins, including cell-cultivated products, fermentation-derived proteins, and plant-based proteins. She received her Ph.D. in Public Health Nutrition and M.Sc. in Food Sciences from the University of Helsinki. Prior to her current role, she worked in the biotechnology industry as a Senior Regulatory Scientist, where she focused on scientific strategy and regulatory affairs related to cell-cultured human milk ingredients. Katherine (Kate) Consavage Stanley, Ph.D., serves as a postdoctoral associate within the World Food Policy Center at the Sanford School. In this role, Kate supports Duke's research for the Bezos Center for Sustainable Protein housed at NC State. Her research seeks to detail the complexities of the consumer, market, and policy landscapes for alternative protein products. Kate holds a Ph.D. from Virginia Polytechnic Institute and State University where her research focused on how diverse U.S. food and health systems actors can support sustainable diet transitions through promoting plant-rich dietary patterns and reducing red and processed meat intake. She has also published scholarly work on digital food and nutrition literacy, sugary beverage media campaigns, and incorporating sustainability considerations into dietary guidelines, among others. Prior to starting her doctoral studies, Kate worked for the U.S. Agency for International Development (USAID) where she developed technical, communications, and advocacy-focused materials on key nutrition and maternal and child health issues. Kate holds a Master of Science in global health from Georgetown University and a Bachelor of Science in biology from Emmanuel College.
Last year, the FDA approved adaptive deep brain stimulation for the treatment of people with Parkinson's disease. This is a major step forward in neurology. It allows personalized therapy by adjusting deep brain stimulation settings in real-time based on an individual's brain signals. Our guest on this episode is Dr. Helen Bronte-Stewart, the John E. Cahill Family Professor of Neurology and Director of the Human Motor Control and Neuromodulation Lab at Stanford University. Dr. Bronte-Stewart was interviewed by Dr. Karlo Lizarraga, Associate Professor of Neurology and Director of the Motor Physiology and Neuromodulation program at the University of Rochester. Disclosures: Dr. Bronte-Stewart disclosed equity in QDG Health. Dr. Lizarraga disclosed FHC: Consulting (Course Instructor), BlueRock: Research support.
Vagus nerve stimulators are the trending new device for migraines. FDA-cleared, handheld, marketed as a breakthrough. Sounds promising, right? But if you're wondering whether adding one more device to your migraine toolkit will finally be the answer, or if it's just another expensive band-aid, this episode breaks down what you need to know. You'll learn what the vagus nerve actually does (it powers your entire digestive tract, heart, lungs, and all your internal organs), how these devices work by adding electrical voltage to the nerve, and why they help some people but not others. The truth is this: Stimulating the nerve without addressing the root cause is like putting a band-aid on a cut that keeps reopening. If you're looking for the one thing that will finally crack the case, these devices won't be it. But if you're ready to address all three principles and understand why your body lost its resilience in the first place, this episode will show you the bigger picture. If you're experiencing 8+ migraine days per month and ready to address the root cause instead of just managing symptoms, schedule a free consultation below: https://www.drlesliecisar.com/apply Free Training: 5 Proven Steps to Being Migraine Free (Even if you think you've already tried everything.) https://www.drlesliecisar.com/5SHMN Connect with us: Website: https://www.drlesliecisar.com/ Free Facebook Group: Healing Migraines Naturally, with Leslie Cisar, ND Ready to try something radically different that actually works? Read more about my approach here: https://www.drlesliecisar.com/map In health,Dr. Leslie Cisar
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world.Today, we delve into the latest from an industry that continues to break new ground in both scientific innovation and regulatory landscapes. The pharmaceutical and biotech sectors are buzzing with activity as companies engage in bold strategies and face significant challenges in their quest for groundbreaking treatments.A recent event illustrating the high-stakes nature of this industry involves Novo Nordisk and its decision to conduct a head-to-head clinical trial for Cagrisema against Eli Lilly's Zepbound. This trial, which typically occurs post-approval, was conducted at the candidate stage. Novo Nordisk aimed to establish market dominance by proving superiority early on. However, the trial did not go as planned, with Cagrisema failing to outperform Zepbound. This outcome serves as a reminder of the competitive dynamics in early-stage testing and the strategic risks companies are willing to take in their bid for market leadership.Meanwhile, Gilead Sciences has made a bold move with a $7.8 billion investment in Arcellx, focusing on CAR T-cell therapy. This investment highlights Gilead's commitment to advanced cancer treatments, particularly Anito-cel for relapsed or refractory multiple myeloma. CAR T-cell therapies involve modifying a patient's T-cells to target cancer cells more effectively, representing a significant leap forward in oncological treatments. With an FDA decision anticipated by December 2026, Gilead's investment underscores its strategic focus on transformative therapies that could redefine cancer care.In legal news, Regenxbio has secured a notable victory against Sarepta Therapeutics regarding adeno-associated virus (AAV) technology patents. The appeals court ruling in favor of Regenxbio emphasizes the intricate nature of patent law in biotechnology, where innovations often intersect with naturally occurring biological processes. This decision not only solidifies Regenxbio's intellectual property but also sets a precedent for future patent disputes within the sector.On the regulatory front, Vanda Pharmaceuticals has rebounded from previous setbacks by securing FDA approval for drugs targeting bipolar disorder and schizophrenia. This achievement marks a promising shift for Vanda, demonstrating resilience and adaptability in redirecting focus towards neuropsychiatric conditions. The approval expands therapeutic options for these complex disorders, addressing long-standing unmet needs within mental health care.Despite these advancements, some areas continue to face hurdles. Gene therapies like Casgevy and Lyfgenia for sickle cell disease have struggled to gain traction two years post-launch. These therapies promise a one-time cure by correcting genetic defects but have encountered challenges in achieving widespread adoption. The difficulties reflect broader issues in transitioning from clinical success to market viability.Moreover, workforce reductions at major companies such as Bristol-Myers Squibb and Catalent signal structural changes within the industry. These layoffs may indicate shifts in strategic focus or responses to evolving market pressures as companies strive for efficiency and innovation.Regulatory practices are also undergoing scrutiny as the FDA considers defaulting to single clinical trial requirements for drug approvals. While this move could streamline development processes, it raises concerns about maintaining rigorous safety standards—a balance that remains crucial as companies push to bring innovative treatments to market swiftly yet safely.The dynamic nature of this industry is further highlighted by Candel Therapeutics' recent $100 million royalty deal aimed at launching its prostate cancer treatment. This strategic move underscores growing interest in innovative oncology solutions thaSupport the show
Dagens ämnen: 0:00 Intro 5:05 Rapporter, Bonesupport och blankningar 13:57 Novo Nordisk 21:17 Fastigehetsbolag 26:17 AI 35:53 Index 42:58 FDA 44:13 Veckans Fill or Kill www.instagram.com/fillorkillpodden Tack RoboMarkets! http://gorobo.pro/2aue @RoboMarketsSE Tack @avanzabank! www.avanza.se
"Why are we paying $10,000 for a $30 drug?"My guest this week is Pramod John, a former Silicon Valley tech entrepreneur who entered the healthcare space to tackle the largest economic problem in the country: skyrocketing healthcare costs. Pramod quickly realized that healthcare's dysfunction is actually not a technology problem - it is a deeply ingrained problem with economic incentives.In this episode, we dive into the murky waters of Pharmacy Benefit Managers (PBMs) and why the traditional model is designed to drive up costs rather than lower them. We discuss the shocking statistics of drug spend (where 2% of people account for 55% of the costs), why FDA approval doesn't always mean a drug is effective (using the infamous Alzheimer's drug as an example), and the implications of recent fiduciary lawsuits like the one against J&J.Pramod explains how we can bring common sense back to healthcare by treating drugs like any other consumer purchase. By utilizing an "open market" drug management model, he argues that we can effectively replace traditional PBMs with transparent transaction processing software - saving plans 30% to 50% without relying on restrictive formularies or rebate games. Tune in this week for a clear roadmap for how to actually fix the irrational economics of our healthcare system.Thank you to our 2026 sponsors!ParetoHealth: ParetoHealth empowers midsize employers with a long-term solution to reduce volatility and lower overall health benefits costs. Visit ParetoHealth.com to learn more.Samaritan Fund: A program that connects those who need help to the support they need. We are proud to offer the Samaritan Fund Program. Visit SamaritanFundProgram.com to learn more.Vālenz Health: We're Vālenz Health, your partner in improving health literacy, reducing plan spend, and delivering high-value healthcare. Visit ValenzHealth.com to learn more.Imagine360: Imagine360 helps self-funded employers save on healthcare with smarter health plans. Cut expenses by 20-30% with custom solutions. Contact us today at Imagine360.com.Chapters:(00:00:00) Intro: Why We Talk About Cost Instead of Quality (00:02:42) From Silicon Valley & Defense Tech to McKesson (00:10:43) Why Healthcare is NOT a Technology Problem (00:15:53) Fiduciary Responsibility & The J&J Lawsuit (00:19:03) The Butter Knife vs. Pareto: The Math of Drug Spend (00:23:54) Building an "Open Market" Alternative to PBMs (00:29:40) Why Doctors Fly Blind on Drug Pricing & Formularies (00:35:42) FDA Approval vs. Real-World Efficacy (00:45:44) How to Actually Fix the Model: The Real-Time "Pause" (00:58:36) Why International Sourcing & PAPs Aren't the Fix (01:11:00) Replacing PBMs with Simple Transaction SoftwareKey Links for Social:@SelfFunded on YouTube for video versions of the podcast and much more - https://www.youtube.com/@SelfFundedListen/watch on Spotify - https://open.spotify.com/show/1TjmrMrkIj0qSmlwAIevKA?si=068a389925474f02Listen on Apple Podcasts - https://podcasts.apple.com/us/podcast/self-funded-with-spencer/id1566182286Follow Spencer on LinkedIn - https://www.linkedin.com/in/spencer-smith-self-funded/Follow Spencer on Instagram - https://www.instagram.com/selffundedwithspencer/
Today, Ali talks to Barbara Ginty, host of the Future Rich podcast, for a special crossover episode to share her deeply personal fertility journey — and to talk honestly about the emotional and financial realities of IVF. Barbara froze her eggs in her 30s, not knowing exactly when or how she might use them. Seven years later, she returned to those frozen eggs and went through IVF — and now, as this episode airs, she's on the brink of welcoming her first baby. Barbara shares what it was like to trust a decision she made years earlier, the uncertainty of the process, and the surreal feeling of finally reaching this moment. Barbara also turns the mic on Ali, who opens up about her secondary infertility and IVF journey, including the complicated emotions that can come with trying to grow your family after already having a child. For more, check out www.futurerichpodcast.comEPISODE SPONSORS: THE WORK OF ART BOOK SERIESAli's Children's Book Series about IVF, IUI and Family Building Through Assisted Reproductive Technology https://www.infertileafgroup.com/booksThe 3-book bundle is now just $49 (normally $79)!The latest book in the Work of ART series, “You Are a Work of ART," is for every kiddo born through ART -- and the people who love them.PHERDALIG: @pherdal_sciencePherDal is the world's first and only FDA-cleared, sterile, at-home insemination kit designed to help people build their families in the comfort of home. Created by parents who've been there, PherDal is safe, simple, and affordable—putting more options in your hands as you grow your family. Explore at PherDal.com.Go to PherDal.com today and use code INFERTILEAF for $10 off.Our Sponsors:* Check out BetterHelp: https://www.betterhelp.comSupport this podcast at — https://redcircle.com/infertile-af-infertility-and-modern-family-building-through-art/donationsAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy
About this episode: A recent analysis of FDA documents has found that the agency has historically regulated mifepristone—a medication commonly used to terminate pregnancy—based on available scientific evidence and without ideological bias. In this episode: Caleb Alexander, an author of the study, discusses these findings and their implications for a possible new review of the medication by FDA. Guests: Dr. G. Caleb Alexander, MS, is a practicing internist and drug safety expert at the Johns Hopkins Bloomberg School of Public Health. Host: Lindsay Smith Rogers, MA, is the producer of the Public Health On Call podcast, an editor for Expert Insights, and the director of content strategy for the Johns Hopkins Bloomberg School of Public Health. Show links and related content: The US Food and Drug Administration's Regulation of Mifepristone—JAMA Study: FDA Regulation of Abortion Drug Mifepristone from 2011 to 2023 Shaped by Evidence and Caution—Johns Hopkins Bloomberg School of Public Health F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds—New York Times What Is Mifepristone, aka "The Abortion Pill"?—Johns Hopkins Bloomberg School of Public Health What's at Stake for Access to Medication Abortion and the FDA in the Supreme Court Case FDA v. the Alliance for Hippocratic Medicine?—KFF Transcript information: Looking for episode transcripts? Open our podcast on the Apple Podcasts app (desktop or mobile) or the Spotify mobile app to access an auto-generated transcript of any episode. Closed captioning is also available for every episode on our YouTube channel. Contact us: Have a question about something you heard? Looking for a transcript? Want to suggest a topic or guest? Contact us via email or visit our website. Follow us: @PublicHealthPod on Bluesky @PublicHealthPod on Instagram @JohnsHopkinsSPH on Facebook @PublicHealthOnCall on YouTube Here's our RSS feed Note: These podcasts are a conversation between the participants, and do not represent the position of Johns Hopkins University.
How are these abusive teen rehab centers still open? Why are parents still sending their kids there? Can't they be shut down? Maia Szalavitz is an award-winning author and journalist who covers addiction and neuroscience. Her book, Help at Any Cost: How the Troubled-Teen Industry Cons Parents and Hurts Kids, is the first comprehensive look at systemic abuse in “tough love” programs and helped spur Congressional hearings & GAO investigations. In this episode, you'll hear how the abusive teen rehab centers featured in Netflix's The Program & Wayward (think Straight Inc., The Seed, Synanon & wilderness camps) began with tough love doctrine, why you can legally treat kids worse than prisoners, why parents aren't suing & why regulations just don't stick. We also weave in the perspective of struggling parents who feel that the anti-troubled teen industry is hurting their healing efforts. If you like this episode, you'll also like episode 248: SURVIVING THE TROUBLED TEEN INDUSTRY: SEPARATING IDENTITY FROM EXPERIENCE [REMASTERED] Guest:https://x.com/maiasz https://maiasz.com/ Resources:Boy who was raised as a dog https://a.co/d/0bA3dxmi Pace Center for Girls Pensacola https://www.pacecenter.org/locations/florida/escambia-santa-rosa/ Gulf Coast Kids House https://www.gulfcoastkidshouse.org/ Greenhouse Counseling https://www.ghcpensacola.com/ Host: https://www.meredithforreal.com/ https://www.instagram.com/meredithforreal/ meredith@meredithforreal.comhttps://www.youtube.com/meredithforreal https://www.facebook.com/meredithforrealthecuriousintrovert Sponsors: https://www.jordanharbinger.com/starterpacks/ https://www.historicpensacola.org/about-us/ 02:00 — The cult origins: Synanon begins04:00 — “I must have needed that” psychology05:00 — The rattlesnake assassination attempt07:00 — The Seed and brainwashing teens08:00 — Straight Incorporated goes national10:00 — Why parents don't believe abuse reports12:00 — Utah wilderness programs rise13:00 — The death of Aaron Bacon14:00 — Moral panic & religious fear15:00 — Good parents, fatal decisions16:00 — Why regulation keeps failing17:00 — Regulatory capture in Utah20:00 — Unannounced inspections change everything22:00 — Why traumatized kids need gentleness27:00 — Warehouses of neglect28:00 — Should therapy have an FDA?29:00 — Renaming punishment as treatment32:00 — Exhausted parents & marketing fear34:00 — How small power corrupts42:00 — Why lawsuits rarely succeed44:00 — Private right of action explained45:00 — Does awareness help or hurt?46:00 — Educational consultants & kickbacks54:00 — Local resources for struggling families55:00 — Undoing drugs & keeping people aliveRequest to join my private Facebook Group, MFR Curious Insiders https://www.facebook.com/share/g/1BAt3bpwJC/
This episode's Community Champion Sponsor is Ossur. To learn more about their ‘Responsible for Tomorrow' Sustainability Campaign, and how you can get involved: CLICK HEREEpisode Overview: Stress is the missing vital sign that determines whether treatments succeed or fail.Our next guest, Dr. Andrew Holman, is tackling this challenge as CEO of Inmedix. With 25 years of clinical experience as a practicing rheumatologist, Andrew possesses a unique perspective bridging medicine and diagnostics innovation.Watching billions wasted annually on autoimmune treatments that fail, he developed the CloudHRV platform to measure stress biology with medical-grade precision in just five minutes.Driven by a passion to end the trial-and-error cycle plaguing chronic disease care, Andrew shares how Inmedix tripled remission rates in rheumatoid arthritis patients from 25% to 79%.Join us to discover how stress biology is transforming precision medicine and unlocking new outcomes for the 15 million Americans living with autoimmune diseases. Let's go!Episode Highlights:FOUNDER WISDOM: Surround yourself with smarter people who tell you straight where your strengths and weaknesses are.ORIGIN STORY: A $10 million patent sale at age 46 came from championing fibromyalgia patients when they were dismissed by medicine.CLINICAL BREAKTHROUGH: The FDA-cleared CloudHRV platform tripled remission rates from 25% to 79% by measuring stress biology.FUTURE OF MEDICINE: Autonomic nervous system science may be to this century what antibiotics were to the last.PASSIONATE PIONEER MOMENT: "I try to be a learn-it-all instead of a know-it-all."About our Guest:Dr. Andrew Holman is the CEO of Inmedix. He is a practicing rheumatologist with 25 years of clinical experience who discovered the missing link in healthcare: stress—the unmeasured vital sign that determines whether treatments work or fail.As a physician watching 75% of autoimmune treatments fail while $10 billion is wasted annually on ineffective drugs, he developed Inmedix's FDA-cleared CloudHRV platform to measure stress biology with medical-grade precision in just 5 minutes. His clinical trials tripled remission rates in rheumatology from 25% to 79%, transforming medicine from trial-and-error to precision care in a $3.1 billion market.Dr. Holman brings proven commercial execution alongside clinical expertise: he leads a team with decades of experience scaling diagnostics companies through IPOs and acquisitions at Myriad Genetics, Crescendo Bioscience, and Exagen.Links Supporting This Episode: Inmedix Website: CLICK HEREDr. Andrew Holman LinkedIn page: CLICK HEREMike Biselli LinkedIn page: CLICK HERE
This episode features Ivanny Franklin, Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molecular biology and her decade-long tenure at NAMSA. The conversation centers on the shifting paradigms of medical device investment, specifically how the industry is moving away from service-based models toward a focus on clinical outcomes.Etienne and Ivanny explore the critical intersection of global regulatory bodies—such as the NMPA in China and the FDA in the US—and the necessity of a cohesive clinical evidence strategy. Ivanny emphasizes that for startups, understanding market-specific data requirements is not just a regulatory hurdle but a fundamental component of commercialization and investor conviction.The discussion also dives into the "patient empowerment" movement, fueled by the convergence of wearables, AI, and at-home monitoring. Ivanny shares her bullish outlook on technologies that give patients control over their data, while acknowledging the tension this creates for physicians and the ongoing need for rigorous regulatory oversight to ensure safety and effectiveness.Key Timestamps[03:15] Global Regulatory Strategy: Insights into the NMPA (formerly CFDA) and why China requires in-country clinical evidence.[07:42] Leveraging Data: How to run a single clinical trial to satisfy multiple global regulatory bodies.[10:18] The At-Home Monitoring Shift: The rise of wearables and OTC testing in the wake of COVID-19.[13:45] The "Data Gap": Addressing the friction between patient-gathered data and physician adoption.[18:22] Investment Non-Negotiables: Why revenue-generating companies and clear regulatory classifications are key for MedSight Capital.[23:10] Diligence and Deception: The importance of honesty regarding reimbursement codes and 510(k) vs. PMA paths.[27:45] SPV vs. Hedge Fund Models: A breakdown of how Special Purpose Vehicles allow family offices to be nimble in MedTech.Quotes"FDA and NMPA, for example, are quite strict in clinical evidence coming from in-country... as a startup, you really need to understand can we run a single trial with multiple global sites to achieve clearance cohesively." - Ivanny Franklin"I'm an advocate for [at-home monitoring]. I do think that's the future. However, there is concern around what types of information should patients be receiving and how are they going to act on that information?" - Ivanny FranklinTakeawaysRegulatory is the Roadmap: An investment is often "de-risked" based on the clarity of the regulatory path. If a founder cannot distinguish between a 510(k) and a PMA, it is a major red flag for investors.Harmonize Your Trials: To achieve "economies of scale" in clinical evidence, work with consultants to design trials that meet the stringent requirements of both the FDA and international bodies like the NMPA early on.
David Klein, a longtime healthcare innovator and Founder and CEO of Click Therapeutics, is a pioneer in the field of prescription digital therapeutics, PDT, which are defined as software as medicine. Click has received FDA authorization for an app to treat depression and migraine and had a successful piviotal trial for an app treating negative symptoms of schizophrenia. These digital therapeutics are designed to fill significant gaps in current care and there are opportunities to combine software with drugs and biometric data from wearables to determine personalized treatment plans. David explains, "Click's approach towards digital therapeutics is, I would say, probably the most rigorous from a clinical evidence perspective in the industry. So we really take a drug-like clinical approach to these programs where we discover and then validate these programs in multiple randomized control trials, all culminating usually in a pivotal trial. And on top of that, you'll often see in some other areas of the world or even in this country, to some degree, folks might say randomized control trial, but they're really using standard of care as the control or wait list control, and so on and so forth. We actually test our interventions against sham active control, so against other apps that control for time on task, expectation of benefit, and so on and so forth." "Just a few months ago, we announced with Behringer Ingelheim, our partner in schizophrenia, that we hit our primary endpoint in our pivotal trial for our app that's designed to be a treatment of negative symptoms of schizophrenia. So, the holy grail, in serious mental illness altogether, but certainly in schizophrenia, is trying to mitigate negative symptoms of schizophrenia. This is such a huge patient issue and frankly an economic issue that none of the drugs have been successful at actually hitting it. So that's a unique one because we showed that an app can actually effectively and safely treat a disease that even a drug can't." #ClickTherapeutics #DigitalTherapeutics #DigitalHealth #FDA #MedicalDevices #SoftwareAsMedicine #HealthTech #Innovation #Migraine #Depression #Schizophrenia #PrescriptionApps #PDT #PrescriptionDigitalTherapeutics #ClinicalTrials #HealthcareInnovation clicktherapeutics.com Listen to the podcast here
David Klein, a longtime healthcare innovator and Founder and CEO of Click Therapeutics, is a pioneer in the field of prescription digital therapeutics, PDT, which are defined as software as medicine. Click has received FDA authorization for an app to treat depression and migraine and had a successful piviotal trial for an app treating negative symptoms of schizophrenia. These digital therapeutics are designed to fill significant gaps in current care and there are opportunities to combine software with drugs and biometric data from wearables to determine personalized treatment plans. David explains, "Click's approach towards digital therapeutics is, I would say, probably the most rigorous from a clinical evidence perspective in the industry. So we really take a drug-like clinical approach to these programs where we discover and then validate these programs in multiple randomized control trials, all culminating usually in a pivotal trial. And on top of that, you'll often see in some other areas of the world or even in this country, to some degree, folks might say randomized control trial, but they're really using standard of care as the control or wait list control, and so on and so forth. We actually test our interventions against sham active control, so against other apps that control for time on task, expectation of benefit, and so on and so forth." "Just a few months ago, we announced with Behringer Ingelheim, our partner in schizophrenia, that we hit our primary endpoint in our pivotal trial for our app that's designed to be a treatment of negative symptoms of schizophrenia. So, the holy grail, in serious mental illness altogether, but certainly in schizophrenia, is trying to mitigate negative symptoms of schizophrenia. This is such a huge patient issue and frankly an economic issue that none of the drugs have been successful at actually hitting it. So that's a unique one because we showed that an app can actually effectively and safely treat a disease that even a drug can't." #ClickTherapeutics #DigitalTherapeutics #DigitalHealth #FDA #MedicalDevices #SoftwareAsMedicine #HealthTech #Innovation #Migraine #Depression #Schizophrenia #PrescriptionApps #PDT #PrescriptionDigitalTherapeutics #ClinicalTrials #HealthcareInnovation clicktherapeutics.com Download the transcript here
In this headline-driven episode, Jonathan and Wendy unpack the mounting turbulence inside U.S. public health institutions — from the political fallout over glyphosate and mRNA flu vaccines to FDA reversals, CDC leadership chaos, and a worsening measles outbreak. They examine internal fractures within the Maha movement, the politicization of vaccine policy, and the devastating real-world consequences of misinformation — including a 7-year-old hospitalized with measles encephalitis. The episode blends policy critique, scientific context, and ethical concern, highlighting how regulatory instability and distrust are reshaping American public health in 2026. Connect with us further on https://sciencebasedmedicine.org/author/jonathanhoward/ The Fine Print The content presented in the "We Want Them Infected" Podcast and associated book is intended for informational and educational purposes only. The views and opinions expressed by the speakers, hosts, and guests on the podcast do not necessarily reflect the views of the creators, producers, or distributors. The information provided in this podcast should not be considered as a substitute for professional medical, scientific, or legal advice. Listeners and readers are encouraged to consult with relevant experts and authorities for specific guidance and information. The creators of the podcast and book have made reasonable efforts to ensure that the information provided is accurate and up to date. However, as the field of medical science and the understanding of the COVID-19 pandemic continue to evolve, there may be new developments and insights that are not covered in this content. The creators are not responsible for any errors or omissions in the content or for any actions taken based on the information provided. They disclaim any liability for any loss, injury, or damage incurred by individuals who rely on the content. Listeners and readers are urged to use their judgment and conduct their own research when interpreting the information presented in the "We Want Them Infected" podcast and book. It is essential to stay informed about the latest updates, guidelines, and recommendations related to COVID-19 and vaccination from reputable sources, such as government health agencies and medical professionals. By accessing and using the content, you acknowledge and accept the terms of this disclaimer. Please consult with appropriate experts and authorities for specific guidance on matters related to health, science, and the COVID-19 pandemic.
Why did Walmart fall on strong earnings? And how are Omnicom's big cost cuts boosting its stock? Plus, will a major FDA reversal change Moderna's fortunes? Host Jack Pitcher discusses the biggest stock moves of the week and the news that drove them.Sign up for the WSJ's free Markets A.M. newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices
Why did Walmart fall on strong earnings? And how are Omnicom's big cost cuts boosting its stock? Plus, will a major FDA reversal change Moderna's fortunes? Host Jack Pitcher discusses the biggest stock moves of the week and the news that drove them.Sign up for the WSJ's free Markets A.M. newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices
This episode covers: • Microplastics Are Destroying Male Fertility and Metabolism New research is putting microplastics in a category most men still are not taking seriously: direct reproductive and hormone risk. A 2024 study detected microplastics in every human testicle examined, with polyethylene and PVC among the most common polymers. PVC is especially relevant because it's often tied to chemical additives that can disrupt endocrine signaling. The broader body of evidence points to micro- and nanoplastics crossing barriers like the blood–testis barrier, driving inflammation and oxidative stress in the testes, and showing associations with impaired sperm quality and hormone disruption. The longevity move here is reducing overall load: better water filtration, less plastic food contact, no heating food in plastic, fewer packaged foods, and taking indoor dust and air quality seriously, especially for men thinking about fertility now or hormone resilience over decades. • Sources: – Study (PubMed): https://pubmed.ncbi.nlm.nih.gov/38745431/ – Coverage: https://people.com/microplastics-in-every-human-testicle-infertility-8651215 • Fear of Aging Is Linked to Faster Biological Aging A new study ties aging anxiety to measurable acceleration in biological aging using DNA methylation clocks. People who reported more worry and negative beliefs about aging showed faster epigenetic aging signals, and the molecular differences clustered around stress and inflammatory pathways. In plain terms, chronic threat-mode thinking around aging maps onto biology that looks older on the clocks. For a longevity audience, this is a practical reminder that mental inputs affect physiological outputs. If your day-to-day mindset is constant pressure and decline narratives, that can show up downstream in stress biology and inflammatory tone. A smarter play is building a longevity framework around function, strength, purpose, and community, alongside the usual pillars like sleep, training, and metabolic health. • Source: https://medicalxpress.com/news/2026-02-older-links-health-faster-epigenetic.html • Additional source: https://www.nyu.edu/about/news-publications/news/2026/february/aging-anxiety.html • Retatrutide, the Triple-Agonist Weight-Loss Drug Pushing Bariatric-Level Results Retatrutide is a triple agonist that targets GLP-1, GIP, and glucagon receptors, and the weight-loss numbers being reported are massive. In a 68-week study in people with obesity and knee osteoarthritis, the highest dose group averaged about 28.7% body-weight loss, along with meaningful improvements in knee pain and function. This is the next phase of incretin medicine: multi-agonist drugs that can move body weight by a quarter or more. For biohackers, the performance and longevity angle is implementation: preserving lean mass through resistance training, hitting protein targets, monitoring micronutrients, and building a maintenance plan that doesn't collapse the moment the drug stops. The upside is cardiometabolic risk reduction at scale. The key is running it with structure. • Sources: – Eli Lilly release: https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-weight-loss-average – Coverage: https://nypost.com/2026/02/18/health/people-dropped-out-of-retatrutide-trial-for-losing-too-much-weight/ – Background: https://news.harvard.edu/gazette/story/2026/02/whats-next-for-glp-1s/ • AI Can Predict 130 Diseases From a Single Night of Sleep Stanford's SleepFM project shows how much long-horizon health information is encoded in sleep. Researchers trained a foundation model on roughly 585,000 hours of clinical polysomnography data from about 65,000 people. From a single night of sleep study signals, the model could estimate risk for 130 conditions, including dementia, heart attack, heart failure, chronic kidney disease, stroke, atrial fibrillation, and all-cause mortality, and it generalized across cohorts better than simple demographic baselines. The big implication is that sleep architecture and micro-patterns (stage distribution, fragmentation, breathing stability, micro-arousals) function like a dense biomarker stream for systemic aging and disease risk. Expect better sensors and more validated risk dashboards over time. Right now, this is another reason to treat sleep as a core diagnostic pillar, not just a recovery habit. • Sources: – Stanford Medicine: https://med.stanford.edu/news/all-news/2026/01/ai-sleep-disease.html – Paper (Nature Medicine): https://www.nature.com/articles/s41591-025-04133-4 • Living at High Altitude May Protect Against Diabetes by Turning Red Blood Cells Into Glucose Sinks For years, population data has suggested lower diabetes rates at higher elevations. New mechanistic work is pointing to a surprising driver: red blood cells changing how they handle glucose under low oxygen conditions. In hypoxia, red blood cells can behave like glucose sinks, pulling more sugar out of circulation and improving glucose tolerance, which may help explain the protective association seen at altitude. The downstream potential is a new class of altitude-mimetic approaches that target erythrocyte metabolism as a glucose lever, separate from appetite suppression or classic diabetes pathways. For biohackers, it expands the metabolic toolkit and reinforces that oxygen environment and blood physiology matter more than we've given them credit for. • Source: https://medicalxpress.com/news/2026-02-red-blood-cells-sugar-high.html • Dietary Supplement Regulatory Uniformity Act and the Future of Supplement Access A proposed bill is aiming to stop states from layering extra rules on dietary supplements beyond federal law, creating one national standard instead of a patchwork of state-by-state restrictions. Industry groups are supporting it as a way to reduce confusion and compliance chaos, especially as some states explore age limits or special labeling requirements for certain supplement categories. The strategic implication for biohackers is that regulation shapes access. Uniformity can stabilize availability, but it also raises the stakes of federal decisions on controversial ingredients. This is one of those policy stories that quietly determines what stays on shelves, what disappears, and how much innovation survives in the supplement space. • Sources: – NutritionInsight: https://www.nutritioninsight.com/news/npa-crn-supplements-us-fda-legislation.html – Congressional release: https://langworthy.house.gov/media/press-releases/congressman-langworthy-introduces-dietary-supplement-regulatory-uniformity-act – NutraIngredients: https://www.nutraingredients.com/Article/2026/02/05/new-bill-aims-to-end-state-supplement-regulations/ All source links are provided for direct access to the original reporting and research. New episodes every Tuesday, Thursday, Friday, and Sunday. Keywords: microplastics male fertility, microplastics testosterone decline, blood–testis barrier toxins, endocrine disruption plastics, sperm count microplastics, epigenetic age acceleration, fear of aging methylation, biological aging mindset, stress inflammation aging, retatrutide triple agonist, GLP-1 GIP glucagon weight loss, incretin drugs obesity treatment, muscle preservation on GLP-1, SleepFM AI model, sleep disease prediction, polysomnography risk scoring, dementia risk sleep data, altitude diabetes protection, hypoxia glucose metabolism, red blood cells glucose uptake, altitude mimetic therapy, Dietary Supplement Regulatory Uniformity Act, supplement regulation federal preemption, FDA supplement policy, biohacking news longevity, metabolic health optimization Thank you to our sponsors! - HeartMath | Go to https://www.heartmath.com/dave to save 15% off. - BrainTap | Go to http://braintap.com/dave to get $100 off the BrainTap Power Bundle. Resources: • Get My 2026 Biohacking Trends Report: https://daveasprey.com/2026-biohacking-trends-report/ • 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: 0:00 – Intro 0:19 – Story 1: Microplastics in Testicles 1:44 – Story 2: Fear of Aging Accelerates Aging 3:30 – Story 3: Retatrutide Weight Loss Drug 4:42 – Story 4: Sleep Predicts Disease Risk 6:34 – Story 5: High Altitude & Diabetes 7:57 – Story 6: Supplement Regulation Bill 9:16 – Weekly Summary 10:51 – Outro See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
With national debt up $2.6 trillion in one year and trade deficits exploding despite tariffs, the dollar faces collapse while oil and gold signal inflation's return.- This episode is sponsored by Grammarly. Download Grammarly for free at https://grammarly.com- This episode is also sponsored by Pebl. Go to https://hipebl.ai to get a free estimate.Peter Schiff analyzes mounting evidence that the U.S. dollar is heading for a major decline, driven by exploding deficits and failed trade policies. With the national debt surging $2.6 trillion in just over a year under Trump, and trade deficits widening despite tariffs, Schiff argues that the same deficit spending Republicans blamed for Biden's inflation is now accelerating under the current administration. Oil prices have surged 21% in two months, hitting six-month highs above $66, while gold holds support above $5,000 as central banks continue dumping dollars. The December trade deficit data reveals Trump's tariffs are backfiring spectacularly - imports rising while exports fall, proving Americans pay 90% of tariff costs according to New York Fed studies. Housing markets show severe stress with pending home sales hitting record lows, signaling price corrections ahead. Schiff credits Trump for reducing FDA drug approval requirements from two studies to one, but argues this modest deregulation doesn't address the fundamental problem of government interference in healthcare markets that didn't exist before 1962.Chapters:01:33 Gold & Silver Snapshot: Buy the Dip Below $5,00002:14 Oil Breakout: Why Gas Prices Are Headed Higher05:42 Dollar Weakness #1: Exploding Deficits and the Debt Rollover Bomb09:52 Tariffs, Taxes, and the Myth of 1880s Prosperity15:54 DOGE, Elon Musk, and Why Government Can't Be Efficient20:14 World Ditches the Dollar: Central Banks Buy Gold21:32 Trade Deficit Reality Check: December Numbers Blow Out27:28 Tariffs Backfire: New York Fed Study Says Americans Pay36:20 Twin Deficits → Inflation & Rates: The Macro Chain Reaction39:22 Housing Bubble Math: Rates Up Means Prices Must Fall42:04 Giving Credit Where Due: Trump's FDA Change to One Efficacy Study45:05 Before 1962/1938: How Drug Approval Worked in a Freer Market53:28 Wrap-Up: Newsletter, Gold/Silver, EuroPac Funds & Upcoming Live ShowFollow @peterschiffX: https://twitter.com/peterschiffInstagram: https://instagram.com/peterschiffTikTok: https://tiktok.com/@peterschiffofficialFacebook: https://facebook.com/peterschiffSign up for Peter's most valuable insights at https://schiffsovereign.comSchiff Gold News: https://www.schiffgold.com/newsFree Reports & Market Updates: https://www.europac.comBook Store: https://schiffradio.com/books#Gold #Tariffs #InflationOur Sponsors:* Check out GhostBed: https://ghostbed.com/PETER* Check out TruDiagnostic and use my code GOLD20 for a great deal: https://www.trudiagnostic.comPrivacy & Opt-Out: https://redcircle.com/privacy
The Trump administration appears to be gearing up for a substantial response to Iran, Washington State allegedly spends millions on gender surgeries for inmates, and whiplash hits Moderna as the FDA reverses its decision to not review the company's new flu vaccine. Get the facts first with Morning Wire.- - -Ep. 2640- - -Wake up with new Morning Wire merch: https://bit.ly/4lIubt3- - -Today's Sponsors:Hello Fresh - Go to https://HelloFresh.com/morningwire10fm to Get 10 free meals + a FREE Zwilling Knife (a $144.99 value) on your third box. Offer valid while supplies last.Vanta - Get started at https://Vanta.com/MORNINGWIRE- - -Privacy Policy: https://www.dailywire.com/privacymorning wire,morning wire podcast,the morning wire podcast,Georgia Howe,John Bickley,daily wire podcast,podcast,news podcast Learn more about your ad choices. Visit podcastchoices.com/adchoices
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