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In this episode of The Health Revival Show, I dive into three critical topics affecting your health. First, we discuss the recent FDA decision to remove the black box warning on hormone replacement therapy (HRT), shedding light on the implications for women's health. Next, I tackle the controversial subject of flu shots, exploring their effectiveness and the factors influencing your decision to get vaccinated. Lastly, I provide actionable insights on how to recover after experiencing a stomach bug, focusing on nutrition and hydration strategies that can help restore your gut health. Join me for an informative and engaging conversation that empowers you to make informed health choices.
The ongoing conflict in the Middle East continues to create both challenges and opportunities. On In The Market with Janet Parshall this week we spoke with dedicated evangelist to the people of Iran who shared with us the difficulty that people are living through as the regime in power continues to exert control amidst water and electricity shortages. He told us despite the hardships more young people are turning away from Islam and discovering the life-giving hope of Christ and the gospel. Then we looked at the confusing actions of the FDA on abortion pills. A highly respected doctor who is on the front lines of the fight for the preborn explains why there are no protections for women who are encouraged to take the drugs, what these pills actually to the mother and baby and why it is important to tell women that there are other options and protections for them and their child. What can cause you to lose the joy and intimacy of your spiritual relationship with God? Our guest said that there are lies that many believers fall prey to that do that sort of damage to the believers walk. He explained those lies and gave us some clear biblical guidance of how to replace those lies with solid biblical truth. Sometimes the road of the Christian life seems to be full of potholes and speed bumps, but those difficulties are no surprise to a sovereign God who uses these obstacles to grow and mature His children in their faith. Our guest explained how living out your faith is the only way to navigate these challenges. We turned to one our favorite guests, a highly respected bible teacher and author to help us understand a vital part of the Christian life that many do not really understand or know how to implement in their lives, worship. He took us back to scripture to show us the necessity of worship and how it can transform and deepen your walk with the Lord. The end of the week is here, and we invite you to join our favorite husband and wife duo as they instruct us on how to use the Word to measure the confusing and misleading ideas that populate the marketplace of ideas.Become a Parshall Partner: http://moodyradio.org/donateto/inthemarket/partnersSee omnystudio.com/listener for privacy information.
A longstanding measurement of success for any President is the state of the economy. President Trump is no exception. A recent survey from the Associated Press and the NORC Center for Public Affairs Research finds that only one in three adults approve of President Trump's handling of the economy. FOX Business's White House correspondent Edward Lawrence joins the Rundown to discuss the Trump administration's handling of the issue of affordability for Americans. Later, Dr. Dorothy Fink, Deputy Assistant Secretary for Health & Women's Health at the Department of Health and Human Services, joins to discuss what led to the FDA's decision to remove its longstanding boxed warning from hormone-based menopause drugs. Learn more about your ad choices. Visit podcastchoices.com/adchoices
On this episode of Vitality Radio, Jared dives deep into one of the most fascinating frontiers in functional nutrition—brain energy. He unpacks how ATP fuels your mind, why BDNF acts like “fertilizer for neurons,” and how lifestyle stressors, toxins, and poor sleep can dim your mental lightbulb. From there, he explores the natural tools that can reignite focus, memory, and long-term cognitive vitality. You'll hear how powerhouse nutrients can support mitochondrial performance, boost brain-derived neurotrophic factor, and promote sharper thinking—without the crash of caffeine or pharmaceuticals. Jared wraps up with three practical, results-driven protocols: one for focus and ADHD support, one for immediate memory and cognition, and one for long-term prevention of cognitive decline. Each stack can be customized to fit your individual goals so you can think clearer, focus longer, and age smarter—naturally.Brain Boosting Protocol CollectionShop the collection! Bundle and save - no code needed, just add to your cart to get:Buy 2 at 10% offBuy 3-4 at 15% offBuy 5+ at 25% offAdditional Information:Brain Boosting Protocol Blog Post#335: The Latest Research on Preventing and Reversing Dementia and Alzheimer's with Dr. Dale Bredesen#570: Liquid Yoga & Mind Fuel: Harnessing Mushrooms and Herbs for Focus and Calm#511: Unraveling NAD+ and NMN for Longevity and Anti-AgingVisit 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 the latest episode, Holly, Amy, and Kristen engage with Dr. Ben Schwartz about the complexities of hormonal changes, particularly during menopause. With the recent removal of misleading FDA warnings on hormone replacement therapy, this episode is timely and informative for women seeking clarity and support during this transformative phase of life. What can you do to help you feel like yourself again? And what about the changes men experience in the season Dr. Ben calls "manopause"? What about their changes and what they need? We talk about it! Join us for the conversation.
A longstanding measurement of success for any President is the state of the economy. President Trump is no exception. A recent survey from the Associated Press and the NORC Center for Public Affairs Research finds that only one in three adults approve of President Trump's handling of the economy. FOX Business's White House correspondent Edward Lawrence joins the Rundown to discuss the Trump administration's handling of the issue of affordability for Americans. Later, Dr. Dorothy Fink, Deputy Assistant Secretary for Health & Women's Health at the Department of Health and Human Services, joins to discuss what led to the FDA's decision to remove its longstanding boxed warning from hormone-based menopause drugs. Learn more about your ad choices. Visit podcastchoices.com/adchoices
A longstanding measurement of success for any President is the state of the economy. President Trump is no exception. A recent survey from the Associated Press and the NORC Center for Public Affairs Research finds that only one in three adults approve of President Trump's handling of the economy. FOX Business's White House correspondent Edward Lawrence joins the Rundown to discuss the Trump administration's handling of the issue of affordability for Americans. Later, Dr. Dorothy Fink, Deputy Assistant Secretary for Health & Women's Health at the Department of Health and Human Services, joins to discuss what led to the FDA's decision to remove its longstanding boxed warning from hormone-based menopause drugs. Learn more about your ad choices. Visit podcastchoices.com/adchoices
This episode covers: • Cocoa Extract Cuts Heart Deaths A massive COSMOS trial found that older adults taking high flavanol cocoa extract daily saw a 27 percent reduction in cardiovascular deaths along with drops in inflammation markers like HSCRP. Women showed unique anti inflammatory cytokine shifts, pointing to a broader longevity effect. Dave explains why cocoa extract is becoming a foundational nutrient for vascular health rather than a dessert ingredient. Source: https://www.sciencedaily.com/releases/2025/09/250926135957.htm • AI Stethoscope for Home Diagnostics Lapsi Health's Keikku 2.0 just became the first FDA cleared AI powered digital stethoscope for both clinicians and home users. It records heart and lung sounds, analyzes them instantly, and flags early warning signs before symptoms appear. Dave breaks down why tools like this move you from reactive to predictive medicine and why they belong in every quantified self toolkit. Source: https://www.prnewswire.com/news-releases/lapsi-health-unveils-keikku-2-0-worlds-first-fda-cleared-digital-stethoscope-with-integrated-ai-scribe-302585083.html?utm_source=chatgpt.com • Beef Organ Supplements Surge Beef organ supplements have exploded more than 8,000 percent this year, driven largely by women reporting improvements in energy, hormones, mood, and skin. Liver, kidney, and heart deliver vitamin A, heme iron, B12, copper, and choline that modern diets often lack. Dave covers sourcing concerns, purity standards, and why this shift reflects a move from fear based nutrition to evolutionary nutrition. Source: https://www.verywellhealth.com/beef-organ-supplement-11710185?utm_source=chatgpt.com • Spirulina for Collagen and DNA Protection New research highlights spirulina's ability to support collagen production, reduce oxidative stress, protect DNA, and improve glucose and lipid balance. It is becoming a staple of eco focused anti aging routines and is driving the viral green stacking trend with chlorella and chlorophyll. Dave explains why spirulina functions as a clean daily defense against oxidative stress. Source: https://www.news-medical.net/news/20250707/Is-Spirulina-the-Next-Anti-Aging-Superfood.aspx • Health Data Privacy Reform A new Senate bill aims to extend HIPAA level protections to wearables, genomic tools, glucose monitors, and wellness apps. The goal is to give users control over who sees their biometrics, how they are stored, and whether they can be sold. Dave outlines why this matters for anyone using Oura, Whoop, CGMs, or genetic testing and why your biology should belong to you and not the cloud. Source: https://natlawreview.com/article/federal-healthcare-update-november-7-2025 All source links provided for easy reference to the original reporting and research above. This is essential listening for fans of biohacking, hacking human performance, functional medicine, and longevity who want actionable tools from Host Dave Asprey and a guest who embodies what it means to age with energy, clarity, and vitality. Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade brings you the knowledge to take control of your biology, extend your longevity, and optimize every system in your body and mind. Each episode delivers cutting-edge insights in health, performance, neuroscience, supplements, nutrition, biohacking, emotional intelligence, and conscious living. New episodes are released every Tuesday, Thursday, Friday (audio-only), and Sunday (BONUS). Dave asks the questions no one else will and gives you real tools to become stronger, smarter, and more resilient. Keywords: cocoa extract, flavanols, heart health, nitric oxide pathways, COSMOS trial, AI stethoscope, digital diagnostics, Keikku device, predictive health tech, beef organ supplements, women's hormonal health, nutrient dense foods, ancestral nutrition, spirulina benefits, collagen support, oxidative stress defense, green stacking, chlorella pairing, DNA protection, wearable privacy laws, HIPAA reform, biometric data rights, longevity news, biohacking updates Thank you to our sponsors! Essentia | Go to https://myessentia.com/dave and use code DAVE for $100 off The Dave Asprey Upgrade. ECHO Water | Go to http://echowater.com/dave and use code DAVE10 for 10% off your ECHO Flask. Resources: • Subscribe to my weekly newsletter: https://substack.daveasprey.com/welcome • Danger Coffee: https://dangercoffee.com/discount/dave15 • My Daily Supplements: SuppGrade Labs (15% Off) • Favorite Blue Light Blocking Glasses: TrueDark (15% Off) • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Upgrade Collective: https://www.ourupgradecollective.com • Upgrade Labs: https://upgradelabs.com • 40 Years of Zen: https://40yearsofzen.com Timestamps: 0:00 – Intro 0:19 – Cocoa Extract & Heart Health 1:52 – AI Digital Stethoscope 3:01 – Beef Organ Supplements 4:24 – Spirulina for Longevity 5:42 – Substack Announcement 6:53 – Health Data Privacy Reform 8:23 – Weekly Upgrade Protocol 9:46 – Outro See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
A grisly discovery thrusts the heroes deeper into the Gloaming, where the forest awakens and the shadows grow hungry. Watch the video here: https://youtu.be/gO3EleVdT4g Enter the Shadowdark at your gaming table by visiting https://www.thearcanelibrary.com/?utm_source=glasscannon This episode was sponsored by Foundry VTT and Norse Foundry. See why tabletop gamers everywhere have made the switch to Foundry Virtual Tabletop at https://foundryvtt.com/gcp For all your random number-generating needs, visit Norse Foundry at https://norsefoundry.com For simple, online access to personalized and affordable care for hair loss, visit https://hims.com/GCN (Individual results may vary. Based on studies of topical and oral minoxidil and finasteride. Featured products include compounded drug products, which the FDA does not approve or verify for safety, effectiveness, or quality. Prescription required. See website for full details, restrictions, and important safety information.) Executive Producer and Gamemaster: Troy Lavallee Cast: Sydney Amanuel, Matthew Capodicasa, Skid Maher and Joe O'Brien Cinematographer: Matt Brodie Producer and Editor: Francis Mrema Audio Engineer and Graphics: CJ Paschall Production Coordinator: Michael Mooridian Art Direction: Josh Fisher Intro Song: "In the Shadowdark" by Jason Charles Miller Performed by: Jason Charles Miller with Sydney Amanuel Access exclusive podcasts, ad-free episodes, and so much more with a 30-day free trial using code "GCN30" at http://www.jointhenaish.com For more podcasts and livestreams or to catch the next stop on the tour, visit https://hubs.li/Q03cmWCk0 Watch new episodes when they premiere every Thursday at 8PM ET on youtube.com/theglasscannon. Learn more about your ad choices. Visit megaphone.fm/adchoices
It's Nurse Practitioners Week, and today, we have a special episode to highlight a historic moment in time. On November 11, the FDA changed the labeling on hormone replacement therapy. Join me for a short, focused episode where I read a recently published JAMA article detailing those changes, to keep you up to date on this significant development. IN THIS EPISODE, YOU WILL LEARN: How recent FDA updates are changing menopausal hormone therapy The history of estrogen's role in heart and bone health How past research sparked fear around hormone therapy What the new labeling means for patients and prescribers How individualized treatment is reshaping dosage and timing decisions. Updated FDA labeling now distinguishes between systemic and topical therapies Key considerations for menopause-related urinary and genital health How these updates will potentially impact women's long-term health Connect with Cynthia Thurlow Follow on X, Instagram & LinkedIn Check out Cynthia's website Submit your questions to support@cynthiathurlow.com
Muscle-bound bodybuilders may line up for testosterone replacement therapy – and increasingly, so do menopausal women. Susan Dominus, staff writer at The New York Times Magazine, joins host Krys Boyd to discuss why middle-aged women are raving about its benefits — despite possible side effects — and why the FDA hasn't approved any use of the hormone for women. Her article is “‘I'm on Fire': Testosterone Is Giving Women Back Their Sex Drive — and Then Some.” Learn about your ad choices: dovetail.prx.org/ad-choices
In this special episode, Ali is bringing you the unforgettable keynote from style expert, author, and powerhouse storyteller Lilliana Vasquez at Fertility Rally Live. Lilliana opens up about her deeply personal journey to motherhood, including the emotional twists, cultural layers, and unexpected turns her family-building path took. With her signature candor, humor, and heart, she shares what it was like to navigate infertility while living in the public eye—and how it ultimately reshaped her identity, her career, and her purpose. She talks about resilience, community, representation, and the importance of seeing yourself reflected in the stories around you. Lilliana also dives into the powerful role that vulnerability plays in healing, and offers encouragement for anyone who's still in the messy middle of their journey.EPISODE SPONSORS: BEAUTIFUL BIRD AND WORK OF ARTAli's Children's Book Series about IVF, IUI and Family Building Through Assisted Reproductive Technology https://www.infertileafgroup.com/booksThe latest book in the Work of ART series, “Beautiful Bird” tells the story of three parents, one incredible boy and a family built with love—and a little bit of science.Pre-orders are available now! The first 150 copies will be Personalized, Signed and Numbered! Don't miss out on this limited edition! Tap the link in bio and stories to order your copy today.When Helen decides to have a baby on her own, she welcomes Jack Bird into the world through IUI with the help of her friend, Aaron. But when Jack is born and needs extra care in the NICU, Aaron and his partner, Blake, fall in love with Jack, too. Together, the three join forces to raise Jack, proving that family isn't about how you start—it's about how you grow.Order yours now at https://www.infertileafgroup.com/booksFERTILITY RALLYIG: @fertilityrallywww.fertilityrally.comNo one should go through infertility alone. Join the Worst Club with the Best Members at fertilityrally.com. We offer 5 to 6 support groups per week, three private Facebook groups, tons of curated IRL and virtual events, and an entire community of more than 500 women available to support you, no matter where you are in your journey.Join today at link in bio on IG @fertilityrally or at www.fertilityrally.com/membershipPHERDALIG: 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.Support 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
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: It's World Diabetes Day and we have a LOT of news to get to! Daily oral insulin tested to prevent T1D, mothers and sons and a T1D link, stem cell updates, Tandem Android news, Omnipod's workplace campaign and more! Find out how to submit your Community Commercial Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. It's world diabetes day! It is marked every year on 14 November, the birthday of Sir Frederick Banting, who co-discovered insulin along with Charles Best in 1922. WDD was created in 1991 by International Diabetes Federation (IDF) and the World Health Organization and became an official United Nations Day in 2006 with the passage of United Nations Resolution 61/225. There will be a ton of stuff in your feeds today and that's great! I'm going to keep this to a pretty normal in the news episode.. although I do have my own World Diabetes Day announcement – I want YOUR community commercials. You could have an ad for your event or your blog or your project right here! There's a post on the website explaining it all and I'll come back at the end of the episode and tell you more. XX The Primary Oral Insulin Trial (POInT) is the first large-scale clinical trial to test whether giving at-risk children daily oral insulin could prevent or delay type 1 diabetes (T1D). Conducted by researchers from Helmholtz Munich and the Technical University of Munich across five European countries, the study enrolled more than 1,000 children with a genetic risk for T1D. Results published in The Lancet show that while oral insulin did not prevent the development of islet autoantibodies—an early sign of diabetes—it was safe and well tolerated. Importantly, researchers found that some children who received oral insulin developed diabetes more slowly than those given a placebo, suggesting potential protective effects in certain genetic subgroups. Further analysis revealed that the response to treatment depended on the child's insulin gene variant. Children with genetic versions that raise diabetes risk appeared to benefit, showing delayed onset of the disease, while those without the risk variant did not. These findings point toward a future of personalized prevention, where genetic screening could help identify which children might benefit most from oral insulin. Researchers will continue following the participants until age 12 to assess long-term effects. The study marks a major milestone in decades of diabetes prevention research, highlighting both the promise and complexity of developing tailored, early interventions against type 1 diabetes. XX Joint US-Chinese research looking at generating new beta cells from stomach cells. Upon turning on the "genetic switch," the human stomach cells were converted to insulin-secreting cells within the mice and resembled pancreatic beta cells with respect to gene and protein expression. Encouragingly, when those experiments were done with diabetic mice, insulin secreted from the transformed human cells helped control blood sugar levels and ameliorated diabetes. The scientists hope that a similar approach can be taken to convert cells from a patient's own stomach into insulin-secreting cells directly within the body. Importantly, additional studies are needed to address if this approach is safe and effective to be used in patients. https://www.technologynetworks.com/cell-science/news/human-stomach-cells-tweaked-to-make-insulin-406694 XX A new study in Nature Metabolism may help explain why children born to mothers with type 1 diabetes are less likely to develop the disease early in life compared to those whose fathers or siblings have it. Researchers looked at nearly 2,000 mothers and their children and found that kids whose moms have type 1 diabetes show changes in their DNA that may actually help protect them. These aren't genetic mutations, but epigenetic changes — chemical tags that turn certain genes on or off. The study found these changes in genes tied to the immune system and type 1 diabetes risk, suggesting that a mother's condition during pregnancy can shape her child's immune response in a protective way. Scientists identified more than 500 areas of DNA where these changes occurred, many in regions that control how the body's immune system works. Most of the changes appeared to calm down the kind of overactive immune response that leads to type 1 diabetes. Researchers even created a "methylation score" to help measure this protective effect. They say the next step is to confirm these results in more diverse groups and figure out exactly how these DNA changes help prevent early diabetes. https://www.news-medical.net/news/20251110/Maternal-type-1-diabetes-may-protect-children-from-developing-the-disease.aspx XX A new study from Karolinska Institutet and Stockholm University reveals that sons born to mothers with type 1 diabetes may develop early vascular dysfunction—independently of metabolic health. The finding may help shape future strategies to prevent cardiovascular disease early in life. Children of women with type 1 diabetes are known to be at increased risk of developing cardiovascular diseases. This new study, published in Cell Reports Medicine, is the first to show that the risk is linked to early dysfunction in blood vessel cells in sons, even before any metabolic issues arise. The team is now investigating the long-term effects of maternal diabetes, with a particular focus on why sons seem to be affected earlier than daughters. https://medicalxpress.com/news/2025-11-sons-mothers-diabetes-early-vascular.html XX A new study presented at Kidney Week 2025 has shown that the drug finn-uh-near-own a nonsteroidal mineralocorticoid-receptor antagonist, significantly reduced albuminuria—a key marker of kidney damage—in people with type 1 diabetes (T1D) and chronic kidney disease (CKD). This is the first major breakthrough for this population in more than 30 years. Researchers found that patients taking finerenone saw a 25% average reduction in albuminuria compared to placebo, an improvement that suggests a lower long-term risk for dialysis or kidney transplant. The phase 3 FINE-ONE trial involved 242 adults with T1D and CKD, and results showed benefits as early as three months. The drug was generally well tolerated, with side effects similar to those seen in patients with type 2 diabetes, though mild hyperkalemia (high potassium levels) was slightly more common. Experts say the findings could change the way doctors treat kidney complications in type 1 diabetes, an area that hasn't seen new therapies since the early 1990s. Currently, treatment options rely on blood pressure and blood sugar management, along with renin-angiotensin system (RAS) inhibitors. Finerenone, which is already approved for type 2 diabetes-related CKD, targets overactivation of a receptor that drives kidney damage. Based on these results, Bayer plans to seek FDA approval in 2026 for use in people with T1D and CKD. Researchers and clinicians alike are calling the study "groundbreaking," noting that it opens the door to future research on how finerenone might not just slow kidney decline—but possibly prevent it altogether. https://www.medscape.com/viewarticle/finerenone-offers-hope-kidney-disease-type-1-diabetes-2025a1000uzi?form=login XX This week, Tandem Diabetes Care (Nasdaq:TNDM) announced a major milestone for its Mobi miniature durable insulin pump system. San Diego-based Tandem revealed that it received FDA approval for the Android version of its Mobi mobile app. Clearance brings Mobi — which the company describes as the world's smallest, durable automated insulin delivery system — to more users. The pump, which pairs with Tandem's Control-IQ+ algorithm, previously worked with iOS software. Tandem — one of the largest diabetes tech companies in the world — expects to begin a limited rollout next month, followed by full commercial availability in early 2026. This marks the latest milestone for the company, which continues to expand its offerings and widen its reach within the diabetes patient population. We had a great interview with Tandem on our previous episode, but as I said at the time, it was coming before their earnings call. So here's an update: The company plans to submit the tubeless mobi to the fda before the end of this year.. possible approval and shipping date is hoped for by middle of 2026. Trials for their fully closed loop next-generation algorithm which we tlkaed abou ton the show should be launched in 2026 The Sigi patch pump will be developed and launched as a next-generation version of the Mobi Great job by Dr. David ? Ahn – he posted on IG after getting a message from tandem CEO John Sheridan? 1. First, the Tandem X3 *is* still absolutely in development, contrary to my speculation In yesterday's video. As many of you appropriately pointed out, there is definitely a market for a 300 unit pump, a pump with a screen, and a pump that does not require smartphone control. So from our brief chat, the sense I got that is that the X3 would be more of a refresh of the X2 with newer components, such as a USB-C connector and better memory, rather than a total redesign from the ground up. In terms of timing, all I could get was that it was "not too far distant in the future," which could mean anything I guess, but at least it's still on the way! 2. Next up, he also reassured me that they are working closely with Dexcom to support the G7 15 Day sensor within the next few months. I suspected as much, but it's always good to hear confirmation. 3. Lastly, he did confirm that Tandem is far along in developing a Caregiver/Follow app to allow the remote viewing of glucose and insulin data from a Tandem pump. He explained that it will be based on Sugarmate, the popular diabetes data dashboard app that Tandem acquired back in Jun 2020. While I don't know if every feature will make it into the Tandem caregiver app, Sugarmate is well-liked for its highly customizable dashboard and highly configurable alerts. Sugarmate even has the option to send a text message or phone call for urgent lows. Regardless, a true follow/Caregiver app will be welcomed with open arms by all caregivers and Tandem users who use Libre 3 Plus. https://time.com/7318020/worlds-top-healthtech-companies-2025/ XX Senseonics submits Eversense 365 – their year long implantable CGM for a CE mark, European Approval and expect to launch there soon. Eversense will be integrated with the sequel twist pump – again I'm hearing soon but no timeline. Intersting to note that one year inseration was approved in the US just about a year ago, so the first patients will be having their CGMs changed out – for the first time – pretty soon. https://www.drugdeliverybusiness.com/senseonics-q2-2025-sales-beat-ce-mark/ XX A confusing study out of Rutgers - these researcher say metformin reduces some of the key benefits normally gained from regular physical activity. These include improvements in blood vessel health, physical fitness, and the body's ability to regulate blood sugar. Since 2006, doctors have typically encouraged patients with elevated blood sugar levels to combine metformin with exercise, expecting that the two proven treatments would produce stronger results together. However, the new research suggests this may not be the case. In this study, Exercise alone improved vascular insulin sensitivity, meaning blood vessels responded better to insulin and allowed more blood flow to muscles. This matters because insulin's ability to open blood vessels helps shuttle glucose out of the bloodstream and into tissues, lowering blood sugar after meals. But when metformin was added, the improvements shrank. The drug also diminished gains in aerobic fitness and reduced the positive effects on inflammation and fasting glucose. The findings don't mean people should stop taking metformin or exercising, Malin said. Instead, it raises urgent questions for doctors about how the two treatments can be combined and the need for close monitoring. Malin hopes future research will uncover strategies that preserve the benefits of both. https://scitechdaily.com/popular-diabetes-drug-metformin-may-cancel-out-exercise-benefits-study-warns/ XX XX https://www.medtechdive.com/news/Revvity-Sanofi-diabetes-test-Kihealth-seed-round/802133/ XX Dexcom recalled an Android app for its G6 glucose sensor due to a software problem that could cause the app to terminate unexpectedly. The issue could cause users to miss alarms, alerts or notifications related to estimated glucose values, according to a Food and Drug Administration database entry posted Oct. 30. The glucose sensor and the app are still available, but Dexcom required users to update the app to a new version. Dexcom began the recall on Aug. 28. The FDA designated the event as a Class 1 recall, the most serious kind. Dexcom sent a notification to customers in September about the software bug, which applies to version 1.15 of the G6 Android app. To use the app, customers must update it to a new version, according to the entry. https://www.medtechdive.com/news/dexcom-recall-g6-cgm-app/804630/ XX https://www.medscape.com/viewarticle/automated-insulin-delivery-boosts-glycemic-control-youth-2025a1000ub3 XX Tidepool partners with smart ring maker OURA.. press release says: to support a groundbreaking dataset intended to be broadly available for diabetes research, with participation limited to individuals who opt in through Tidepool. Tidepool will pair biometric data from Oura Ring – sleep, activity, heart rate, temperature trends, and menstrual cycles – with diabetes device data, including continuous glucose monitors (CGMs) and insulin pumps. The result will provide researchers with an unprecedented dataset to accelerate the development of new clinical guidelines, next-generation diabetes technology, and personalized care models. Recruitment is expected to launch in early 2026 through an IRB-approved study. By opting in to this study, participants consent to sharing their data with Tidepool's Big Data Donation Project, where data is de-identified and, with participant consent, shared with academics, researchers, and industry innovators to accelerate diabetes research. https://aijourn.com/tidepool-collaborates-with-oura-to-advance-inclusive-diabetes-research-through-wearables/ XX Eli Lilly launches two new clinical trials for baricitinib. These phase 3 trials will investigate whether the drug can delay T1D onset or progression and will open for recruitment soon. Baricitinib has the potential to extend the "honeymoon period" of T1D, meaning that it could preserve remaining insulin-producing beta cells earlier in disease progression. More beta cells mean better blood sugar management—and potentially reduced long-term complications. JAK inhibitors, including baricitinib, are already FDA-approved for other autoimmune diseases, such as rheumatoid arthritis, alopecia, and more. JAK signaling pathways are associated with overactive immune responses, so blocking this pathway may turn down the immune response. The phase 2 Breakthrough T1D-funded BANDIT study was key in showing that this drug is safe and effective in T1D. Importantly, baricitinib is a once-daily oral pill—meaning its use is simple and easy. https://www.breakthrought1d.org/news-and-updates/two-new-trials-baricitinib-to-delay-t1d/ XX Insulet is taking diabetes awareness into the workplace. Having found 79% of people with diabetes have faced bias or misunderstanding at work, the medtech giant is rolling out a range of resources intended to trigger changes in how workplaces approach the condition. Lots going on for Diabetes Awareness month.. some notables.. Insulet's "The Day Diabetes Showed up to Work" campaign. based on a survey of almost 10,000 people 79% of people with diabetes have faced bias or misunderstanding at work,. Almost 90% of people with diabetes surveyed reported experiencing barriers at work due to their condition, and more than 40% of people with diabetes and caregivers said they have workplace-related anxiety tied to the metabolic disease. Around one-quarter of respondents reported fears that diabetes could limit opportunities or lead to workplace discrimination and judgment, and a similar proportion of people said they conceal their condition. https://www.fiercepharma.com/marketing/widespread-workplace-challenges-people-diabetes-spark-insulet-campaign XX New directive issued by the Trump administration could mean people seeking visas to live in the U.S. might be rejected if they have certain medical conditions, including diabetes or obesity. The guidance, issued in a cable the State Department sent to embassy and consular officials and examined by KFF Health News, directs visa officers to deem applicants ineligible to enter the U.S. for several new reasons, including age or the likelihood they might rely on public benefits. The guidance says that such people could become a "public charge" — a potential drain on U.S. resources — because of their health issues or age. The cable's language appears at odds with the Foreign Affairs Manual, the State Department's own handbook, which says that visa officers cannot reject an application based on "what if" scenarios, Wheeler said. The guidance directs visa officers to develop "their own thoughts about what could lead to some sort of medical emergency or sort of medical costs in the future," he said. "That's troubling because they're not medically trained, they have no experience in this area, and they shouldn't be making projections based on their own personal knowledge or bias." Immigrants already undergo a medical exam by a physician who's been approved by a U.S. embassy. https://www.npr.org/2025/11/12/nx-s1-5606348/immigrants-visas-health-conditions-trump-guidance XX SAN DIEGO---Nov. 14, 2025—DexCom, Inc. (NASDAQ: DXCM), the global leader in glucose biosensing, today unveiled 16 new diabetes advocates to represent people living with diabetes globally as part of Dexcom's World Diabetes Day campaign. The advocates – ranging from ages six to 68, spanning various types of diabetes, and hailing from four continents and five countries – were selected from 1,000 open call submissions based on their experiences advocating for people with diabetes in their communities. While each person's experience with diabetes is unique, they share a common passion for advocacy – and use of Dexcom's glucose biosensing technology. "Through advocacy, I strive to show others, especially children and newly diagnosed patients, that diabetes is not a limitation but an opportunity to grow stronger, inspire resilience and pursue ambitious goals," said Maria Alejandra Jove Valerio, one of Dexcom's new advocates. "What began as a diagnosis at age seven has grown into a lifelong mission to uplift others." This effort represents the first time Dexcom has sourced voices from the broader diabetes community specifically for its World Diabetes Day campaign, reinforcing Dexcom's history of and commitment to giving real people with diabetes a platform to share their story on a global stage. Through engaging, editorial-style portraits and deeply personal stories, the campaign highlights each advocate's personal experience with diabetes, what misconceptions about diabetes they'd like to dispel and how they want to inspire others with diabetes to discover what they're made of. To prepare for the spotlight, the group of advocates met in Los Angeles for a World Diabetes Day photoshoot which included a surprise visit from Grammy-nominated artist, actor, producer and Dexcom Warrior Lance Bass and author, producer, actress and Stelo*Ambassador Retta. This visit offered the advocates an opportunity to exchange stories and personal perspectives on the meaning of diabetes advocacy and how they live it each day. Behind the lens at the shoot was another member of the diabetes community—photographer Tommy Lundberg who lives with Type 1 diabetes. "Directing this photoshoot was nothing short of inspiring. Each of these advocates has a unique an XX On what would have been the 100th birthday of its visionary founder Alfred E. Mann, MannKind Corporation (Nasdaq: MNKD), in partnership with Alfred E. Mann Charities and The Diabetes Link, announced the launch of the Centennial Al Mann Scholarship. The new program will distribute $100,000 in scholarship funds to support at least 10 young adult students living with diabetes as they pursue higher education in life sciences. Launched in Diabetes Awareness Month, the scholarship program honors Alfred E. Mann's enduring legacy of innovation, philanthropy, and his lifelong commitment to improving the quality of human life through medical advancement. Deeply passionate about giving back, Mr. Mann believed that his success should continue to serve humanity long after his passing, a belief that lives on through this initiative. Each scholarship recipient will be awarded up to $10,000, distributed in annual installments of $2,500 throughout the course of their studies. Depending on the length of their degree program, recipients may receive between two and four installments (up to the full $10,000 per student). The first awards will be made for the 2026 academic year. "Al Mann dedicated his life to helping people with serious medical conditions live longer, healthier lives. This scholarship is a reflection of that spirit," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "By supporting students living with diabetes who are pursuing careers in the life sciences and adjacent fields, we're honoring Al's legacy and investing in the future of innovation and care. This program is about giving back to the community we serve and empowering the next generation to carry forward Al's mission of making a meaningful difference in people's lives." Alfred E. Mann Charities and MannKind will partner with The Diabetes Link to launch the program to serve young adults (aged 18-22) living with either type 1 or type 2 diabetes with their higher education goals. Those eligible will include incoming freshmen and current students pursuing 2- or 4-year degrees. The application window will open in early 2026, and for those interested in receiving notifications, an early interest form is available. More information about the scholarship will be shared on thediabeteslink.org. "We're honored to partner with MannKind to expand access to higher education for young adults with diabetes," said Manuel Hernández, Chief Executive Officer of The Diabetes Link. "At a time when the cost of college continues to rise, this scholarship helps ease the financial burden and carries forward the spirit of Al Mann, whose vision and legacy continue to inspire us." Mr. Mann was MannKind's Chairman of the Board from 2001 until his passing in February 2016 and served as Chief Executive Officer from November 2003 until January 2015. Driven by a desire to improve lives and fill unmet medical needs, for more than six decades he founded 17 companies and developed breakthrough medical devices, including insulin pumps, cochlear implants, cardiac pacemakers and retinal prostheses. In 1997, Mr. Mann saw the potential of a dry powder insulin formulation to change the way diabetes is treated and invested nearly $1 billion to help bring Afrezza® (insulin human) Inhalation Powder to market. About MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. About Alfred E. Mann Charities, Inc. Alfred E. Mann Charities, Inc. became active in 2016, following the passing of the organization's benefactor, Alfred E. Mann. Throughout his life, Al was passionate about philanthropy and was dedicated to prolonging and improving the quality of human lives through innovation in the fields of healthcare and the use of medical devices. It was important to Al that his success and assets continue to better human lives even after his own passing. Alfred E. Mann Charities, Inc. (formerly known as Alfred E. Mann Family Foundation) has similarly placed its primary focus on healthcare and medical innovation, as our organization believes this is where we can have the greatest impact on humanity and human health throughout the world. Alfred E. Mann Charities, Inc. is also dedicated to promoting arts, culture, education, and community development across Los Angeles and throughout the world in order to best serve people and this planet. Learn more at aemanncharities.org. About The Diabetes Link The Diabetes Link is the only national nonprofit organization dedicated to empowering young adults living with diabetes. Founded by and for young adults, The Link serves this community through peer support, leadership opportunities, and practical, evidence-based resources designed for real life. Its network of campus and community chapters, active online community, and robust Resource Hub help young adults navigate the transitions of early adulthood while managing diabetes. The organization envisions a future where every young adult living with diabetes has
Send Zorba a message!ProPublica (an independent, non-profit news organization) recently reported on the FDA's handling of potential safety issues concerning generic drugs we get from overseas manufacturers. Some of their findings include:· For decades, the FDA has blacked out the names of generic drugs on inspection reports for foreign factories that were found to have safety and quality violations. · This has prevented patients, doctors, and pharmacists from knowing whether manufacturing failures have made medications ineffective or unsafe. You can find the ProPublica article here(Recorded Nov 10, 2025)Support the showProduction, edit, and music by Karl Christenson Send your question to Dr. Zorba (he loves to help!): Phone: 608-492-9292 (call anytime) Email: askdoctorzorba@gmail.com Web: www.doctorzorba.org Stay well!
Natasha is joined by Dr. Lisa Diamond and Dr. Scout on this episode of the Natasha Helfer Podcast. This is a powerful episode as, in Lisa's words: "Scout and I have witnessed the entire birth and now destruction of the field of queer and trans mental and physical health (Scout is 60, I'm 54), so we have lived through this whole weird arc of seeing lgbtq health become a legitimate profession, and now it's being threatened—it's both personally and professionally devastating for both of us to witness this happening. "It is astounding that at a time when we recently survived a global pandemic that left so many people feeling isolated in ways that has profoundly affected our mental and physical health… and at a time when we have very clear data on the risk of suicide and lessened wellbeing for the LGBTQI+ community due to societal discrimination… that the government is choosing to dismantle and destroy so many departments/entities meant to support the health, science and data collection of ALL Americans." Dr. Diamond and Dr. Scout have created a survey for anyone affected by the current administration. Please consider filling it out. "We launched the study with zero funding, it's driven by pure love and panic, and it's affecting EVERYONE who loves or works with queer or trans people, including family members, friends, social workers, physicians, school, teachers, therapist, educators, EVERYONE. All of us are going through something, and we are going through this at the same time that the federal government has CEASED all data collection on our health. So Scout and I figured "OK, you don't wanna do this? We're just gonna have to do it ourselves." Go here to fill out the survey: https://csbsutah.co1.qualtrics.com/jfe/form/SV_9WyKRPONJuL67Yy?fbclid=IwY2xjawOEdthleHRuA2FlbQIxMABicmlkETFoOW43aDJMdnNGb1kwSThZc3J0YwZhcHBfaWQQMjIyMDM5MTc4ODIwMDg5MgABHkWvMqhUx7OYFY_0kbvt2yVu911j1Ch5DAnsBloLDDgUw1CHSZ3BRNwBhq3A_aem_2e27bX8Xk_kP7utbPv482g Also, if you're an organization that would like to partner with this project reach out to: research@cancer-network.com From Natasha: I loved Lisa's reminder that we survive oppression and destruction through connection. This is a small thing we can do to make a difference and that in of itself is healing and empowering. Please take the 20-25 minutes to fill out this survey. And please forward it to anyone you know who is impacted. Scout, PhD (they/he) is the Executive Director of the National LGBTQI+ Cancer Network and the principal investigator of both the CDC-funded LGBTQI+ tobacco-related cancer disparity network and Out: The National Cancer Survey. They spend much of their time providing technical assistance for tobacco and cancer focusing agencies expanding their reach and engagement with LGBTQI+ populations. Scout has a long history in health policy analysis and a particular interest in ensuring research and surveillance activities include LGBTQI+ people. They have faculty appointments at Dartmouth Cancer Center and Boston University's school of public health. They are a member of FDA's Tobacco Products Scientific Advisory Committee, on the Advisory Panel for NIH's All of Us initiative, and a former member of NIH Council of Councils as well as former Co-Chair of the NIH Sexual and Gender Minority Research Office Work Group. Their work has won them recognition from the U.S. House of Representatives, two state governments, and many city governments. Scout is an openly nonbinary and trans father of three, an avid hiker, and is currently training for the aptly named Dopey Challenge races at Disney. Lisa M. Diamond, Ph.D., is a Distinguished Professor of Psychology and Gender Studies at the University of Utah and a past president of the International Academy for Sex Research. For nearly 30 years, she has studied gender and sexuality across the lifespan, with current work centered on social safety and its impact on the health and well-being of LGBTQ+ individuals. Dr. Diamond is internationally recognized for her pioneering research on sexual fluidity, including her award-winning book Sexual Fluidity (Harvard University Press). She co-edited the first APA Handbook of Sexuality and Psychology, is a fellow of two APA divisions, and has published over 150 scholarly works. Her research has been supported by major national foundations, and she has delivered more than 200 invited talks worldwide, including a TED Talk with over 700,000 views. — Join Natasha February 11-17th 2026 on a cruise leaving out of Tampa, Florida. You can grab a package and work with Natasha on the ship. Sign up before January 1st and you get the early bird special: Natasha packages: $750 per couple $675 per couple - early bird (before January 1st) Payment plans are available. For further questions, email Mimi at unleashedvacations@gmail.com. Book now to make sure you don't miss out! See you on board. — To help keep this podcast going, please consider donating at natashahelfer.com and share this episode. To watch the video of this podcast, you can subscribe to Natasha's channel on Youtube and follow her professional Facebook page at natashahelfer LCMFT, CST-S. You can find all her cool resources at natashahelfer.com. The information shared on this program is informational and should not be considered therapy. This podcast addresses many topics around mental health and sexuality and may not be suitable for minors. Some topics may elicit a trigger or emotional response so please care for yourself accordingly. The views, thoughts and opinions expressed by our guests are their own and do not necessarily reflect the views or feelings of Natasha Helfer or the Natasha Helfer Podcast. We provide a platform for open and diverse discussions, and it is important to recognize that different perspectives may be shared. We encourage our listeners to engage in critical thinking and form their own opinions. The intro and outro music for these episodes is by Otter Creek. Thank you for listening. And remember: Symmetry is now offering Ketamine services. To find out more, go to symcounseling.com/ketamine-services. There are also several upcoming workshops. Visit natashahelfer.com or symcounseling.com to find out more.
In this episode of Molecule to Market, your host Raman Sehgal discusses the pharmaceutical and biotechnology supply chain with Jean-François Brepson, Chief Executive Officer at PathoQuest. The conversation covers: Navigating 20 years of global leadership roles at Ipsen before moving from the corporate world into an investor-led entrepreneurial adventure The tough decision to refocus PathoQuest from diagnostics into a pure play CRO and pharma services business How a major strategic partnership transformed the company's trajectory and why Jean sees partnerships as a competitive weapon Riding the tailwind of the FDA's move away from animal testing and offering something game-changing in the CMC and GMP space The opportunities ahead for CROs and CDMOs in helping unlock the next wave of innovation Jean-François Brepson is a dedicated leader with deep experience in biotechnology and pharmaceuticals. Since becoming CEO of PathoQuest in 2015, he has built the company into a leading global CRO specializing in quality control of biological drugs using Next Generation Sequencing (NGS). Over his career, he has advanced innovative technologies and solutions that bridge scientific progress with real-world application. Prior to joining PathoQuest, Jean was Senior Vice President at Ipsen, where he led the global GI-Oncology and Endocrinology franchise. Molecule to Market is sponsored by Bora Pharma, Charles River, and Lead Candidate. Please subscribe, tell your industry colleagues, and help us celebrate the value of the global life science outsourcing space. We'd also appreciate a positive rating!
In this episode, Brent is joined by endocrinologist and longtime FDA leader Dr. G. Alexander Fleming to break down one of the most consequential diseases of modern life: type 2 diabetes. Dr. Fleming explains the real difference between type 1 and type 2, why insulin resistance is the root problem, and how biomarkers like fasting glucose, A1C, and fasting insulin work together to reveal your true metabolic health. He also discusses the promises and pitfalls of blockbuster medications like metformin and semaglutide, the public-health failures that helped fuel today's metabolic crisis, and why strength training may be one of the most important longevity tools we have. Hope you enjoy.
Ask Me A Question For Next Week's Episode!Included in this week's episode: Personal story with the politicization of fitness and it's affects on my community today. Brief history of fitness and politics. Modern politics and fitness in the military and presidents. The socioeconomic and class division of fitness and politics. Pilates. Fitness in America today is highly individualized. Fitness in liberalism and conservatism inappropriately integrates morality, religion and political beliefs into fitness and food. The nuances of extremist political conclusions of food and fitness. Food as a human right around the world and in America. Political impacts on your fitness in government like the EPA, FDA, healthcare, federal standards and more. Final message: whatever your government is willing to do to the least of the society or those abroad, they will do to you. Full stop. The government will no hesitate to withhold food from it's civilians just like it does on the global setting. The beliefs and standards you hold for individualized fitness and food is where the government will stop. If you believe it's a personal issues, then your government will not help you. Ask more of the system you pay for. You are most similar to someone on SNAP than you are to a representative. We are all one moment away from needing a subsidy to help us live. Remember, most importantly, the government officials and law makers and the wealthiest of those in our country exist because of subsidy that YOU pay for. Demand more from your government. They are already used to providing it.
The Friday Five for November 14, 2025: iPhone Pocket Brings Back… Pockets. CMS Rural Health Transformation Program Government Shutdown Update Most-Favored Nation Drug Pricing CMS GENEROUS Model Get Connected:
Biochemist Lingyin Li survived breast cancer at just 30 and now works to harness the human immune system to fight cancers that have long evaded treatment. T cells, she says, are powerful cancer killers, but they can be oblivious. She and her lab colleagues have discovered a masking enzyme that squelches the immune system's “danger signals” and are now developing drugs to block that enzyme. She likens her work to an arms race between cancer and immunotherapy. “The cancers are not getting smarter, but we are,” Li tells host Russ Altman on this episode of Stanford Engineering's The Future of Everything podcast.Have a question for Russ? Send it our way in writing or via voice memo, and it might be featured on an upcoming episode. Please introduce yourself, let us know where you're listening from, and share your question. You can send questions to thefutureofeverything@stanford.edu.Episode Reference Links:Stanford Profile: Lingyin LiConnect With Us:Episode Transcripts >>> The Future of Everything WebsiteConnect with Russ >>> Threads / Bluesky / MastodonConnect with School of Engineering >>> Twitter/X / Instagram / LinkedIn / FacebookChapters:(00:00:00) IntroductionRuss Altman introduces guest Lingyin Li, a professor of biochemistry at Stanford University.(00:03:38) Research MotivationLingyin explains how her breast cancer diagnosis inspired her research.(00:04:31) How T-Cells WorkT-cell mechanisms and why they struggle to reach solid tumors.(00:05:38) Immune System OverviewInnate and adaptive immunity and how mutations make cancer recognizable.(00:07:28) Awakening the Immune SystemEfforts to stimulate innate immune cells to detect and expose tumors.(00:10:54) The Cancer SignalDiscovery of cancer-derived DNA signals that alert the immune system.(00:13:01) Cancer's Evasion MechanismHow tumors destroy immune signals to hide from detection.(00:14:26) ENPP1 EnzymeIdentification of ENPP1 as the enzyme enabling immune evasion.(00:15:22) Balancing Immunity and SafetyRole of ENPP1 in autoimmunity and the challenge of targeting it safely.(00:19:30) ENPP1 InhibitorsDevelopment of molecules to block ENPP1 and enhance immune signaling.(00:24:55) Preclinical FindingsThe promising results against aggressive solid tumors in animal studies(00:28:05) From Lab to ClinicThe progress toward FDA approval and preparation for human testing.(00:31:04) Future In a MinuteRapid-fire Q&A: innovation, collaboration, and the outlook for cancer treatment.(00:33:14) Conclusion Connect With Us:Episode Transcripts >>> The Future of Everything WebsiteConnect with Russ >>> Threads / Bluesky / MastodonConnect with School of Engineering >>>Twitter/X / Instagram / LinkedIn / Facebook Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Today, we're talking to Dr. David Darrow for a second time. Check out episode 30 for our first discussion. David is a neurosurgeon and assistant professor in the departments of neurosurgery and psychiatry at the University of Minnesota. Many of you will also know that he is a researcher and the primary investigator of the successful and ongoing E-Stand trial, which uses epidural stimulation and optimization protocols for delivering functional outcomes for the SCI community. We discussed the E-Stand trial, how it's progressing, and highlights from its now eight years of running. We also talk about the FDA and the quandary of determining what is meaningful in the eyes of research participants, as well as with regulators. And we get into spinal cord stimulation data sharing, the exciting horizon of combinatorial therapies, and much, much more. As you will hear on this call, David is a smart, innovative, forward-thinking ally of the SCI community. More info: https://u2fp.org/get-educated/curecast/episode-135.html
Send us a textIn this comprehensive episode, canna-lawyer Tom dives into the recent changes in federal hemp laws and their impact on the industry. Drawing from his extensive experience in the field, Tom provides an in-depth analysis of the new hemp regulations, including the redefinition of hemp, the inclusion of THCA, and the stringent guidelines for THC concentration. He also discusses the implications for hemp businesses, particularly in the context of banking and legal compliance.
The FDA requests boxed warnings be removed from HRT product labels; Caplyta approved for MDD; Darzalex Faspro gains new indication; investigational MS treatment looks promising; trial investigates simplified HIV regimen.
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into several groundbreaking advancements and strategic shifts in the industry that promise to reshape the landscape of patient care and therapeutic innovations.The U.S. Food and Drug Administration has introduced a novel regulatory pathway aimed at expediting the approval process for custom gene-editing therapies. Articulated by FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., this new approach is set to revolutionize personalized medicine, particularly for genetic disorders where tailored interventions are crucial. Gene editing technologies, like CRISPR-Cas9, have opened unprecedented avenues for addressing genetic conditions directly at their source. However, the regulatory framework has struggled to keep pace with these advances, often hampering innovation with lengthy and complex approval processes.This proposed pathway seeks to streamline these requirements by adopting a risk-based assessment model that considers the unique properties of gene-editing therapies. Unlike traditional drugs, which follow a uniform clinical trial path, gene-editing treatments require a more nuanced regulatory approach due to their precision and potential off-target effects. The framework emphasizes adaptive trial designs—allowing for modifications based on interim results—and integrates real-world data to create a dynamic regulatory process. This not only promises faster development times but also fosters innovation by making it easier for companies to bring cutting-edge therapies to market.The implications are far-reaching. For researchers and biotech firms, this represents a chance to reduce time-to-market significantly while maintaining high safety standards. It also sets a precedent for future regulatory models that prioritize patient-centric approaches, acknowledging the diverse genetic landscapes of individuals with rare diseases. On a broader scale, this shift underscores the increasing recognition of personalized medicine's potential to transform healthcare delivery.In parallel developments, Gilead Sciences has achieved positive phase 3 results for its single-tablet regimen combining bictegravir and lenacapavir for HIV treatment. This milestone offers hope for simplifying treatment protocols for patients currently on multi-tablet regimens, potentially enhancing adherence and improving health outcomes. Gilead's preparation for regulatory filings marks an essential step forward in their therapeutic portfolio.Turning to cancer treatment advancements, Kyowa Kirin's collaboration with Kura Oncology has led to FDA approval for an oral medication targeting a subset of acute myeloid leukemia patients. This approval highlights the power of strategic partnerships in expediting the development of targeted cancer therapies and brings new hope to patients with limited treatment options.Meanwhile, several pharmaceutical companies, including Fresenius, Sun Pharma, and Teva, have been involved in product recalls ranging from hospital drugs to antibiotics and ADHD medications. These recalls underscore ongoing challenges in maintaining drug safety standards and emphasize the need for rigorous quality control measures across the industry.Zealand Pharma has opted to pause development of its dual GLP-1/GLP-2 agonist, dapiglutide, due to an increasingly crowded metabolic disorder treatment landscape. By reallocating resources towards programs with greater clinical differentiation potential, Zealand reflects broader industry trends prioritizing investments in areas with clearer paths to market success.In malaria treatment advances, Novartis has achieved significant progress with its next-generation drug 'Ganlum,Support the show
Garrett Schumacher is Business Unit Director of Product Security at Velentium Medical and the co-founder and CTO of GeneInfoSec. Garrett discusses his journey from medical student to cybersecurity expert and educator, dedicating his career to securing medical devices. He shares insights on the intersection of cybersecurity and healthcare, highlighting the challenges of protecting genetic data. Garrett gives honest advice about navigating cybersecurity and data privacy concerns, how to be a good leader, and what medtech startups should consider as they design and develop their devices. Guest links: https://velentiummedical.com/ | https://www.geneinfosec.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical EPISODE TRANSCRIPT Episode 068 - Garrett Schumacher [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to another episode of the Leading Difference Podcast. I'm your host, Lindsey, and today I am excited to introduce you to my guest, Garrett Schumacher. Garrett is the Business Unit Director of Product Security at Velentium Medical, where he has led the cybersecurity efforts on 200 plus medical device products and systems. He is the co-founder and CTO of GeneInfoSec, a startup focused on securing the world's most valuable and private data, our genetic information. In his work, Garrett has trained engineers, developers, manufacturers, healthcare delivery organizations, and laboratories across the globe in cybersecurity, and is an active member of several related industry working groups. He also teaches secure product development and medical device cybersecurity at the graduate level for the University of Colorado Boulder's Department of Computer Science as an adjunct professor in the little bit of time left in his days, Garrett is either rock climbing or spending time with family. Thank you so much for being here, Garrett. I'm so excited to speak with you today. [00:01:48] Garrett Schumacher: Yeah. Thank you for having me. [00:01:49] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind, by starting out and sharing a little bit about yourself and your background and what led you to medtech. [00:01:59] Garrett Schumacher: Yeah. So I guess my background, I mean, it started as I always thought I was gonna be a doctor. I did my undergrad in physiology, thought I was gonna do med school, the whole nine yards. And towards the end of my, let's say junior year, just started being like, "I don't think this is what I want to do." I always had a fascination with tech. I was really involved with a lot of the tech groups on campus at the University of Colorado Boulder, early days of Hack CU, one of the largest collegiate hackathons. And I really regretted not doing a computer science degree, but I was three quarters of the way done. So sometimes you just gotta finish it up, right? Get the degree, find out what's next. After that I went and did a master's in genetics. I wasn't sure exactly what I wanted to do either yet, but hey, a master's degree is not a bad thing to do if you're unsure. And actually I was in a PhD program and dropped out early with a master's. Different story. But yeah. And then I started I helped the University of Colorado Boulder start their cybersecurity programs. So it was getting into the cyber world. I did a, I guess it was a bootcamp, at the University of Denver in cybersecurity. And so that all culminated in me always focusing on healthcare and cybersecurity together. And then COVID happened and that made the world change for a lot of people. And basically I was looking for a new job and I found Velentium, and I think that's where it really spoke to me, where I could do my love of medical and human health with cybersecurity and technology development. And so yeah, I think that's really how I got into it. I had been doing projects related to that before, but Velentium's where it really culminated and I found a place that let me do all the things I love, not just one or the other. [00:03:39] Lindsey Dinneen: That's awesome and such a wonderful gift. So can you share a little bit about what you do now and sort of your growth trajectory even throughout Velentium 'cause I know you've had quite an interesting and exciting career through the company as well. [00:03:56] Garrett Schumacher: Yeah. Yeah. So I started out as a cybersecurity engineer, and just started helping internal projects, external projects with groups that were seeking FDA approval on a medical device and trying to navigate these kind of new cybersecurity requirements. That's where it started. And even since then I've been, so I teach a class at the University of Colorado Boulder on Medical Device Cybersecurity. We're going into our sixth year of that, seventh semester, starting here in the fall. And I also co-founded a startup in the genetic information security space. So, and we can talk about that later. And so I, yeah, talk about what I do. It's all of those things and, it's not, doesn't happen in 40 hours, I promise you that. But after working as a cyber engineer for about a year, I think I got promoted to like Senior Staff Cybersecurity Engineer. Then probably three years ago, I took over more of an operational leadership role within the unit, the team, where I was doing project management and overseeing the other engineers and still doing engineering work. Definitely decided project management is not for the faint of heart and apparently my heart's very faint. It's not for me. So anyways, and then fast forward to just here in like January, February, Velentium made some really awesome changes. They rebranded as Velentium Medical to make sure everyone knew we do medical. And then they created four business units so that they could really say, "Look, we have different core areas of our business. Each of them have their own different operational needs and what have you." So, I was promoted into Business Unit Director of Product Security. And so now we're a business unit. We're a business within a business trying to better serve our clients and implement the processes we need for our small scope of work compared to a large contract development and manufacturing organization. So just that's been my growth goal so far is, come in as an engineer, work my way up to the leadership roles while also still loving to be an educator and and still having my own startup space in the biotech side of the house. [00:05:58] Lindsey Dinneen: Yeah. Excellent. Well, first of all, congratulations on all of that. That is very exciting and it's really fun to see that growth and that development. And I'm also so curious now, can we talk a little bit about your startup? So first of all, let's talk about that and then I wanna talk about the crossover between the two, if that's okay. So. [00:06:16] Garrett Schumacher: Absolutely. Yeah. So, well the name is GeneInfoSec, so it's just short for genetic information security. We're not trying to hide anything there. We focus on protecting the world's most sensitive data. At least that's our opinion is genetic information affects you. And the data you have today is not gonna be any different, for the most part, from the data that you have in, 10, 20, 40 years. But then even beyond that it's partially your children's data, your grandchildren, great-grandchildren, and then even on the, in the inverse, all the way up to your great-great-grandparents, right? You share some, to an extent, some genetic makeup with them. And so it's this really interesting space where networked privacy is-- it's a very different form of networked privacy. It's not just that I upload a photo to LinkedIn and now I could be implicating someone else that's in the photo. It's, I share my info, and I'm also sharing info that belongs to my cousins in, in, in a sense. And so if you think of the Golden State Killer case in California, that was a really interesting one where the federal authorities had genetic information or samples from a cold case in the eighties. And they sequenced that. They uploaded it to a third party, an open public genetic database, and said, "Hey, here's my data. Who am I related to?" And through that they were able to triangulate like, "Okay here it is. This is the guy that did it" many years later. So, there's a case where it's, there could be positives. We want to use it to find that kind of information and protect people. But at the same time, that brings up a lot of privacy implications. And then you can go all the way to the extreme, the sci-fi of designer bio weapons, maybe tailored to certain persons or ethnicities or groups of people. So during grad school, a couple guys and I, we founded this startup, and that's what we focus on through a technology that really our founder, Dr. Sterling Sawaya, he invented, called molecular encryption. It's a way of encrypting molecules before we generate data from them so that the generated genetic data is already, quote unquote encrypted, or at least protected in some manner. So, so that's what we do. And yeah, I guess why we do it a bit. [00:08:27] Lindsey Dinneen: Yeah. Wow. So, okay, so that brings up a really interesting question. I can guess the answer to this, but is there any safe way to-- this is a funny way to put it-- but recreationally to test your genetic data in the sense of the way that a lot of us would think about it in terms of, "Oh, I'd really love to learn more about my ancestors and things like that." But there are so many security concerns, like you've pointed out. So is there any quote unquote, safe way to do so at this time? [00:08:58] Garrett Schumacher: You know that-- it's a great question. There's been a lot of things going on in the news recently, like with, I'm sure people have heard of 23 & Me, and how they went bankrupt and now a company called Regeneron is buying them and all their assets for a lot of money, but not that much compared to what 23 & Me was worth a few years ago. So that brings up a lot of issues, right? 23 & Me still owns a lot of samples, like maybe around 10 million samples. And the sequencing they've been doing is very small. So if your genome's a whole book, they've been kind of flipping through the pages and picking specific letters, and that's the data they have. So that's not the most sensitive, it's not the full story. But if you have the samples, you can always generate the full book someday. And as that cost of full human genome sequencing decreases rapidly, someone's probably gonna want to do that someday. So, okay, so back to your question though, is there a safe way? What I would say is that I, I don't tell people not to do it. I would say if you have health reasons, concerns, and your doctor suggests a genetic test, a lot of those tests are also that similar, picking a few letters, a few known letters and trying to just read that for a very specific purpose. If your doctor and you come to the agreement that you should do that, you should just do that. However, I do not promote, and even to my family members, I highly don't recommend, using these services. I used to really love who's that group out of Utah? Ancestry.com. They used to be a great group. They were trying to sequence the world's DNA for understanding basically the family tree of everyone. Because anyways, they have interest in understanding who's related to who and how that relates to their religion. So they used to do it for internal purposes, keep it on pretty tight, secure. Well then, they sold to a venture capital group. So, it's really tough to say that there's these groups that there's a good place out there to do it. There are some companies that have security or privacy focused DNA sequencing services. But it's really odd, like you have to set up a cryptocurrency account, pay with cryptocurrency, set up a PO box so that you're not like actually shipping to and from your home. And then ultimately the price of it and how they're getting it to be cost effective is China's doing the sequencing. So you do all those privacy measures and your sample gets sent off to another country. And the FBI has disclosed that they know that when certain countries like that are doing the sequencing, whether you want them to do a little tiny test, like a COVID test or whatever it is, they're sequencing the whole thing. They're keeping the data. This is known, disclosed, not conjecture. So, yeah, so sorry-- long-winded answer of saying, I'm interested too, I wanna learn about this. I've got family members that have done it. But right now I recommend just thinking very carefully and critically about whether the immediate fun of it is worth the potential long-term impacts, and maybe if you're someone that's security or privacy conscious, maybe wait a few years because there are some things on the horizon that will make this a lot better. [00:12:02] Lindsey Dinneen: All right! Thank you for the honest answer. I really appreciate it. So, okay, I wanna go back to your work with Velentium specifically and talk about-- you've gotten to work with so many different clients over the years and you've seen so many different variations on a theme. And I'm curious, what are some of the common mistakes or pitfalls you might see a younger startup make when they are perhaps first designing their device, and cybersecurity is maybe not quite top of mind. So what are some of the things that you see that are challenges we can overcome? [00:12:41] Garrett Schumacher: Yeah I think one of the biggest challenges is that a lot of people aren't maybe aware yet of the scrutiny and the requirements that the FDA-- and not just FDA, but the European union's medical device regulations and the bodies over there that review submissions. And any, if you look across the board, pretty much almost every regulatory market has, very much in the last couple years, placed a lot of scrutiny on cybersecurity. So a lot of companies, especially smaller ones starting out in the space, may not be aware of this. And so then oftentimes they'll find out too late, they'll submit. They'll get feedback back, "Oh no, we have 90 days to respond and we didn't do cyber. We gotta do cyber now." And they don't know how to spell it yet, which is a joke. But there's that. And then there's also, or they'll get in just late at the game, "Hey, we're submitting in a month or three" and "Oh, we gotta do this thing retroactively." And so then therefore, we haven't been able to support someone through the full process, at the proper time, doing the right design things to inform the design during the design, not after. So I think that's probably the biggest mistake is not seeking that external support early and often. And if you're getting that, it shouldn't just be someone that can help you navigate the regulatory space. It shouldn't be someone that can just do the pen testing for you at the end. Really I think in that context, you need a partner that can do everything end to end. So that's what we've really tried to make our processes and our services geared towards is being that partner. And whether you have the bandwidth and you will do a lot of the documentation and work, but you just need someone to guide you, consult you, give you the materials to do so, or if you are truly looking for, no, we need to augment our own team and have you do a lot more of the work for us. That's great. We can do that. So, so that's, I think, the biggest challenge. And I think that the answer is just getting the right partner early and working with them often throughout that entire development, not at the end. [00:14:37] Lindsey Dinneen: Yeah, absolutely. And I really appreciate that perspective. I think that there's a lot more awareness, it seems like even in the industry that, "Oh, cybersecurity is a thing now." But as you said, getting to partner with somebody who does know the ins and outs from the start and can really help guide you through is really critical. Now you do quite a bit of speaking and presenting. You're obviously still teaching a college class and all of those wonderful things. I'm curious how that has played into your career as well, and is that something that you will always want to do? You've got this educator side of you as well. [00:15:13] Garrett Schumacher: Yeah, I mean, I love it. I actually taught at a high school for one year between my master's program and my undergraduate, decided that that's not for me, but that teaching at those higher levels where people are really wanting to be in the room. So now I teach at the graduate level, half of the students will be older than me. And now everybody wants to be there and we can have very mature conversations and they even can challenge me with some really great questions that I'm not ready for, right? And I think the best way to learn is to teach. Absolutely. That's, yeah. I think a lot of people have said that. I completely agree. So I plan to always do that. I mean, I love, even with our internal engineers and external clients, like the idea of helping people understand something and humanizing it for 'em. That's really my big flag I'm waving right now is humanizing it. We don't have to use alphabet soups and crazy language. We can make it easy to understand and we can humanize it for the masses. So that's really what I'm trying to do, one of my big pushes. And so I don't foresee myself ever going away from that, I even do a lot of international training on the cyber biosecurity space where I go to all these countries and these biosafety laboratories and help biologists understand cybersecurity as a fundamental practice and how they can improve their personal security, their professional security. And to me that's the most rewarding thing. [00:16:36] Lindsey Dinneen: Yeah. Oh my goodness. That's so cool. Thank you for sharing about that. So, as you are looking towards the future in the industry itself, but also I suppose your own career, what are some things that you're excited about? What are some trends that you see as being positive? I know that, recently, it's been a little bit challenging-- as a nice word-- for a lot of medical device companies and they're a little worried about funding and those kinds of things, and so, that's maybe a trend that's a little not as fun, but what are the things that are empowering and exciting to you as we move forward? [00:17:13] Garrett Schumacher: So not to make it about artificial intelligence or machine learning, 'cause everybody does. It's definitely, its hype curve. But that is actually one of the things that I think I'm most excited about, but also most scared about. We've seen a lot of companies with layoffs because they believe this artificial intelligence enables them to be more efficient and therefore they can do more with fewer people. And that saves money. And I understand that. I think that one of my big pushes right now is trying to help people understand that AI, at least right now, it's not taking over human jobs-- that it can instead augment, improve how we do those jobs. But people have to be ready for it. So even in, in my own space, like, making sure that our team and our people are ready for that. Because if you aren't getting into that space, if you aren't with the curve, then you're gonna fall behind. And yes, you could be replaced in that sense that someone has done it and so now they're doing it better than you. And so if you're not using these tools, these resources to, to improve your efficiency and to just maximize your capability-- like for example, my team, maybe I don't need to hire a person. Maybe we can build out things that enable us to, with the same amount of people, to better serve more clientele. So that's what I'm really trying to navigate. But it is scary thinking about that future and am I even gonna be ready and technically savvy enough to navigate that new future in the next year, in the next five, 10 years. And especially as someone who I've always had this, this goal of maybe someday, and I'm getting talked out of it very quickly, but maybe like being a Chief Information Security Officer at a large company or a Chief Product Security Officer, something like that. And yeah, quickly, I'm-- "Eh, we'll see." But it's those kind of things that, if we can navigate them correctly, may maybe that is something in my future. So that's, I think, one of my big fears and also passion projects right now. And then also, same on that funding vein-- with my startup, we're experiencing that as well. And we actually, we had a lot of funding potential pre COVID. And then even though our technology-- like in some ways COVID brought the need for our technology to the forefront of people's minds-- it also killed a lot of funding opportunity. And so yeah, I mean, navigating that space of how do you get funding and then does it come from venture capital backed or equity, private equity, and I've seen those worlds. I even advise startups. So I mean, that is also probably one of the biggest challenges I'm facing currently as well. [00:19:41] Lindsey Dinneen: Yeah. Yeah. It's gonna be really interesting to see how things evolve, and it's been fascinating to read the news and see even the headlines where it's like, the FDA is using AI to review submissions and all sorts of things, and you really do wonder how we'll move forward and time will tell, I suppose. [00:20:01] Garrett Schumacher: Yeah. [00:20:02] Lindsey Dinneen: So you have stepped into quite a number of leadership roles fairly young in your career, if you don't mind me just saying so, and so I'm curious how you have navigated that growth for yourself. First of all, do you feel like you were a natural leader or were those skills things you developed along the way? And secondly, what advice might you have for younger leaders? [00:20:27] Garrett Schumacher: Great questions. Yeah, definitely nothing is natural about it. I think for anyone, I mean, it's nothing that you just do and you're just like, "Yep, I'm a leader. That's easy." So it definitely something, just like all aspects of work and maturity, is you have to work on it. But I think how I got there was-- and someone told me a couple tips early in my career, I suppose-- and it was a couple are: find a mentor, and as the mentee you have to put in the effort. If you set up meetings and they're not there, whatever, like they're busy, and you are asking them to give their time for you. So, find mentors and then be a good mentee, meet up with them. I had several people that were critical in my early career. One was Bunky Davis and she was amazing. She was no longer with us, but her and I grabbed coffee every single month. She had navigated biotech startups for like 50 years, was also just a phenomenal cyclist, Olympian, like just amazing. And we'd meet up every month for coffee without missing. And we did that for several years. And, and I had another mentor from the University of Colorado Boulder, Lloyd Thrall, who came from the Department of Defense, and just a spectacular, stellar guy, and we would go meet up all the time. And so learning from these people I think I saw-- well, there's that. And then everybody has their bosses and their horror stories from work, whether that's a high school job or professional later on. And so you see the ways that people can be, you don't want to be. And so that, that makes it easy. But without having those mentors, yeah, I don't know if I would've exposed myself to the good ways, right, and the better ways, and be challenged. So that was really critical was finding a good mentor and then being a good mentee. And then I think the other thing is interacting with people and just listening, active listening. So going to the professional shows and meeting people, listening to them, reading a lot of great books out there on how to be a leader, and you don't take all that exactly word for word, but there are golden little nuggets that you can just pick up out of all those things. So, no, definitely something that I have actively worked on and still am trying to work on. And then I'm constantly trying to listen and being that, have that open door policy for my people too. Because if I hire really smart people, I want them to do the thinking and therefore I need to listen. [00:22:44] Lindsey Dinneen: There you go. I love it. All right, so. You've had a really interesting and exciting career so far, and you're obviously very passionate about medtech and cybersecurity and biotech and all those things, and I'm wondering if along the way there are any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time." [00:23:09] Garrett Schumacher: Yeah. Yeah. One was we had a really special project where and I won't give any names away, but basically my stepmother has an implant inside of her and it's it's not life sustaining, but it's one that you want working just so that your body's working normally, and so that you're not, not embarrassed. You can go into public spaces and be a normal person, right? And whether it's pain management, incontinence, those kind of things. So she had this implant and it was, she had one that came from the leading provider of that at the time. And it, the battery life, right, is supposed to last like 10 or 15 years, and it seemed like pretty much seven or eight was all she was getting out of it. And after decades of having far more surgeries than she needed, all the way up to the very last device she got in her-- it failed within the first year, I think-- so it was like, okay, time to pivot. And we found this new company and they've become a huge leader in the space, recently acquired by another one of the big leaders in medtech in general. And we were hired to do the security work for that project. And the only reason that I actually found out-- because my stepmother was literally like in the process of getting this new device inside of her-- I was at that client's facility doing a pen testing and security testing engagement and some consulting and just visiting them. And I FaceTimed my family in the break room and there was a sign behind me and they're like, "Oh my gosh. We're literally, we just got that implanted in your stepmother like, a couple weeks ago. It's working great. She's so happy with it. It's smaller, it works better, all these things." And it's like, "Wow." So I got to lead the security effort and what they're actually doing is adding remote programming capabilities so a doctor can, over the phone, be improving that therapy for you. But that leads to a lot of cybersecurity implications, right? That kind of connectivity. And so I gotta lead the security work on that for something that is in a near and dear, your family member. And it's those kind of things where it's not, you're not just helping patients. It's, I'm helping someone that I care very deeply about. And it hits home differently when it's not just, "Oh, I want this device to be secure. I want them to get FDA clearance. I want whatever." It's, "No, I need now, I need for my own family member for it to be the best." And it's not that project got special scrutiny from us-- we bring that to every project-- but it helps to have the actual experience of one of those projects. [00:25:33] Lindsey Dinneen: Yeah. And to have that real-- well, you were mentioning it-- not just patients that I kept thinking, "Yeah. Not just patients, people," and the idea of it's sometimes probably necessary honestly, to have a little bit of separation from a clinical point of, "I'm helping all of these patients, and that's a really good thing." But then if you could take a step back and go, "And these patients are human beings that rely on what I'm doing for safety and for security and for this lifesaving, life enhancing device." That's-- what a gift to get to experience something like that. [00:26:04] Garrett Schumacher: It is, it's especially like, if you work in the diabetes-- we've had several projects with insulin pumps-- and insulin's a drug that is, highly toxic if given in the wrong dosage. 99% of the world population would die if it's in the wrong dosage if it's too high. And the only reason the other 1% exist is 'cause they're insulin intolerant. They just, they don't respond to insulin and that's why they have their own type of diabetic issues. And I've got several cousins, a brother-in-law, that also use that stuff every day, rely on those kind of technologies. So, yeah, just it's a little bit more special when it's when you get to do that. But we try to do that for everyone. We try to think of everyone's that person that we're trying to help. [00:26:42] Lindsey Dinneen: Yeah, absolutely. All right. Well, this has been so great, but pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. What would you choose to teach and why? [00:26:59] Garrett Schumacher: Ooh. Well, yeah, first of all, a million dollars for-- I feel like I, I'd have to go with something like that I know deeply, very deeply on. But okay, if I wanna have some fun here, I would say rock climbing, because rock climbing is my other big passion. It's the one thing that takes me away from a computer screen typically. And so if you're paying me a million dollars to teach rock climbing, A, these people really wanna learn how to be good rock climbers, so they're gonna be very engaged. And B, that's going to mean that I can go now actually make money on something that has only ever been a passion for me. So, that would be fun. That would be awesome. [00:27:33] Lindsey Dinneen: Awesome. [00:27:33] Garrett Schumacher: If you're offering, Lindsey, I'll accept. [00:27:35] Lindsey Dinneen: Okay, deal, right? Yeah. I'm gonna have to earn my first million first, and then I'll let you know. [00:27:40] Garrett Schumacher: I'll wait. [00:27:41] Lindsey Dinneen: Okay, fair? Fair enough. What got you into rock climbing? [00:27:45] Garrett Schumacher: Oh man. Well, so my mother was, I grew up in like a small farming town in the northeast corner of Colorado. There's not a mountain for, until you get to Denver area, right? In the summers, she worked at the local college, and in the summers she ran the ropes course and they had a giant rock wall. So, I mean, as a 10-year-old, I'm just hanging out there. I didn't know that there was routes or certain ways or techniques. I just, who can get up the fastest, right? But that was always fun. That was my summers. I always, and I was, shoot, I was always told I was a monkey. I was always on stuff climbing something. I've had my share of injuries from it, trust me. And then in college, it just was natural. I went to CU Boulder, as I've probably already said, and a lot of outdoor climbing opportunities. A lot of, they, they built a new gym there inside the school. And so that then it became this thing where, oh, I can actually-- as you move away from high school sports, basketball and American football and those things, you miss that. You can miss some competitiveness and some team-based things. So now I had another active thing that I could-- and I, again, I wasn't so formal in technique or things like that-- so now I could work with people, socialize and work on that technique in something that I was able to do at that level, instead of, I'm not gonna go beat myself up playing football again. So, yeah, I think that's where it came from. And then it's just been my big hobby ever since. And I mean, now I have a bunch of friends down in Austin, Texas, and we go on a big climbing trip once a year, and I see them once a year. It's fun. So it's like expanded my friend group and it keeps me sane. [00:29:14] Lindsey Dinneen: Huh. Excellent. Yes. That's wonderful. All right. How do you wish to be remembered after you leave this world? [00:29:22] Garrett Schumacher: Oh, that's a good one. How do you humbly answer that? When part of the answer I would wanna say is humble, but that's something I always try to work on, is I just wanna be a good guy. I want people to remember that, he was kind, considerate-- would do something at the drop of a hat for you without expecting anything in return-- just kind, generous. And I think a family guy would be a big one. My, my friends and family first and foremost. And maybe second to that, hardworking. Yeah. [00:29:46] Lindsey Dinneen: Yeah. I love that. All right. And final question. What is one thing that makes you smile every time you see or think about it? [00:29:55] Garrett Schumacher: Oh, my wife. I wake up to her every day and that's she's the best part about everything. So yeah, she's my favorite person, and I'm lucky enough to, when I'm not traveling, wake up next to her and see her at night, and that's the best part. [00:30:08] Lindsey Dinneen: Yeah, absolutely. What a wonderful thing. Well, this has been a fantastic conversation, Garrett. I'm so thankful for your time today. Thank you for sharing some of your stories, some of your advice. And I just honestly wish you the most continued success as you work to change lives for a better world. [00:30:26] Garrett Schumacher: Thank you. Thank you, Lindsey, for having me. This was my first podcast ever. So it went great. Yeah, it was fine. [00:30:32] Lindsey Dinneen: Awesome. You rocked it. Good job. That's wonderful. All right, well, celebrating that and celebrating all your future successes to come. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and thank you so much for being here and thank you for doing what you do. [00:31:05] Garrett Schumacher: Thank you. [00:31:07] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:31:19] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.
In this second part of the conversation, Dr. Scott Sherr returns to unpack one of the most fascinating compounds in modern mitochondrial medicine — methylene blue. Once used as the first FDA-approved antimicrobial drug, methylene blue is now being rediscovered as a powerful mitochondrial optimizer that helps the body both produce and detoxify energy at the same time. Dr. Sherr breaks down how it enhances ATP production, improves focus, endurance, and recovery, and even helps with travel fatigue and brain fog. He explains how methylene blue works at the cellular level, why quality and dosing matter, and clears up common myths and controversies — including its relationship with nitric oxide, serotonin, and safety concerns. Whether you're an athlete, entrepreneur, or anyone seeking more consistent, sustainable energy, this episode will help you understand how to use methylene blue safely and effectively to support performance and longevity. Follow Scott @drscottsherr Follow Chase @chase_chewning ----- 00:01 What Is Methylene Blue? — A 150-year-old molecule repurposed for mitochondrial health 02:13 From Blue Jeans to Medicine — The strange evolution from textile dye to the first FDA-approved drug 04:48 How It Works — The only compound that helps your cells both make and detoxify energy 06:52 Cyanide Antidote — How methylene blue restores mitochondrial function, even in toxin exposure 09:05 Real-World Results — Patient stories of fatigue recovery and performance optimization 11:34 Who It's For — From chronic illness to high performers seeking clean energy 13:31 Performance & Recovery Benefits — Endurance, anaerobic performance, and muscle recovery 16:18 Recovering Faster, Training Harder — How methylene blue enhances oxygen use and heart rate recovery 18:20 How to Cycle It — When and how often to take methylene blue for best results 20:31 Travel & Jet Lag Protocols — How methylene blue acts like oxygen at altitude and in airplanes 23:29 Methylene Blue for the Everyday Person — Calm, clean energy without the crash 26:33 The Importance of Quality & Purity — How to identify pharmaceutical-grade methylene blue and avoid contaminants 27:57 What to Look for in a Supplement — USP grade, certificates of analysis, and testing standards 30:51 Counterfeit Supplements & Amazon Scams — Why most methylene blue products don't meet purity claims 33:54 How to Take It — Solubility, timing, and why troches work best 36:09 Stacking with Red Light Therapy — Synergy between methylene blue and photobiomodulation 39:10 Dosage Guidelines — How to titrate, start low, and find your personal sweet spot 42:08 Who Should Avoid It — Blood pressure medications, SSRIs, pregnancy, and other contraindications 43:48 Clearing Up the Controversy — Why experts disagree on nitric oxide and serotonin effects. 45:23 The Nitric Oxide Debate — How dose determines whether methylene blue helps or hinders 47:51 Blue Brain Myths & Social Media Clickbait — The truth about the "blue brain" narrative 49:30 Final Thoughts — Safe dosing, cycling, and the future of mitochondrial optimization ----- Episode resources: Part one "The #1 Thing Killing Your Mitochondra & How to Stop it Today" Watch and subscribe on YouTube Learn more at Troscriptions.com/everforward
In this episode, ARK's Cathie Wood and Brett Winton sit down with Sean McClain, Founder and CEO of AbSci, to explore how generative AI is reshaping drug discovery, development timelines, and clinical costs. Sean walks through real-world examples of AI-designed antibodies—such as AbSci's breakthrough HIV antibody and a regenerative treatment for hair loss—and explains how these platforms are helping unlock previously “undruggable” biology.They discuss AbSci's Phase 2-ready hair growth antibody (BS201), the company's partnerships with Caltech and AMD, and why the FDA's evolving embrace of AI could accelerate the end of animal testing. The conversation closes with a forward-looking discussion on the role of regenerative medicine in longevity—and why AI drug discovery might just pull biotech out of its multi-year bear market.Key Points From This Episode:(00:00:00) How AbSci uses generative AI to design antibodies from scratch(00:02:42) HIV, ion channels, and the promise of targeting "undruggable" biology(00:06:28) AbSci's BS201 drug for hair regrowth: mechanism, speed, and cost advantages(00:13:20) Clinical timeline: From concept to Phase 2 readout in 3.5 years(00:15:34) Bringing costs down: $100–150M vs. the industry average of $2.4B(00:17:36) Why AI enables “keys designed for specific locks” in drug targeting(00:22:58) What AbSci's models are trained on—and how prompts work in drug inference(00:25:32) The future of clinical testing: AI replacing animal models(00:36:43) Sarcopenia, strength loss, and regenerative approaches to aging(00:48:10) BS201 as a long-acting pulse therapy—and how it compares to transplants
In this episode, Psychedelic Medicine Podcast host, Dr. Lynn Marie Morski, provides the latest updates from the field of psychedelic medicine. Dr. Morski discusses the breakthrough therapy designation which a number of psychedelic compounds have received in the past few years, the most recent of which is BPL-003, a nasal spray formulation of 5-MeO-DMT. One of the exciting aspects of this new compound, Dr. Morski notes, is that it is shorter-acting than most serotonergic psychedelics—a feature which may make treatment with this substance less expensive and more accessible. Another exciting development is the COMPASS Pathways phase 3 trial of COMP360 psilocybin. Dr. Morski shares that the company believes they are nine to twelve months ahead of schedule, which means that if all goes well, this psilocybin compound could be approved for treatment resistant depression as early as sometime in 2027. She also discusses why the US FDA said they rejected MDMA for PTSD and what this governing body would like to see from subsequent research before reconsidering this decision. In closing, Dr. Morski shares excitement about the development of novel psychoplastogens—the non-hallucinogenic psychedelics—which may help bring many of the same healing benefits to populations currently unable to be served by the existing compounds under investigation. In this episode, you'll hear: Which psychedelics currently have breakthrough therapy designation and for which indications Details of recent ketamine research for inpatient depression care and why these results are not as negative as they may seem The current horizons of psychedelic research and what indications may soon be explored Sources of hope in the current state of psychedelic research and the legal landscape Quotes: "[BPL-003] showed rapid and durable antidepressant outcomes after a single dose. … here we have something that is under an hour [of psychedelic experience] for treatment resistant depression." [7:43] "Keeping patients blinded to whether or not they got the placebo or MDMA is a big focus that [the FDA] wanted to emphasize for these future phase 3 trials." [19:07] "I know we had a big setback last year. I think a lot of us thought by this time we'd be a year into MDMA being approved and we're not. However, there are so many things on the horizon that are worth being excited about." [23:48] Links: Psychedelic Medicine Podcast on Instagram Psychedelic Medicine Podcast on YouTube Jelovac A, McCaffrey C, Terao M, et al. "Serial Ketamine Infusions as Adjunctive Therapy to Inpatient Care for Depression: The KARMA-Dep 2 Randomized Clinical Trial" JAMA Psychiatry, 2025. Beckley Psytech Limited Phase 2 Trial: BPL-003 Efficacy and Safety in Treatment Resistant Depression COMPASS Pathways Phase 3 Trial: Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD Food and Drug Administration (FDA) Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder Psychedelic Alpha Psychedelic Drug Development Bullseye Chart Psychedelic Medicine Association Porangui
Episode 320: The Truth About Red Light Therapy with Steve Marchese, CEO of LightStimGuest: Steve MarcheseWebsite: www.LightStim.comExclusive Code: Use THRIVE for 10% off your order at LightStim.comEpisode OverviewIn this episode, Jay sits down with Steve Marchese, CEO of LightStim, the largest manufacturer of red light therapy devices in the United States ~ trusted by over 50,000 professionals and more than one million consumers worldwide.If you've ever been curious (or skeptical) about red light therapy, this conversation is your inside look at what's real, what's hype, and what actually moves the needle for recovery, performance, and longevity.Steve pulls back the curtain on how LightStim became the gold standard in LED technology ~ from FDA-cleared handhelds to full-body wellness beds and how the company built its reputation on science, safety, and results.What You'll LearnThe real science behind red and infrared light therapy ~ how it impacts mitochondria, ATP production, and circulation.Why the FTC recently issued warnings to the health and wellness industry about misleading claims, and what you should know before you buy any red light device.The difference between a legitimate medical-grade LED system and the cheap panels flooding social media.The LightStim story ~ how a family's personal experience led to pioneering the modern red light movement.Why LightStim's FDA-cleared devices set the standard for safety, efficacy, and long-term results.Practical takeaways for fitness, recovery, skin health, and performance and how to use red light therapy correctly for real benefits.Key TakeawaysNot all red light is created equal. Wavelength, intensity, and FDA clearance matter.Beware of marketing myths. Steve explains how to separate facts from internet fiction.LightStim's approach is different. Backed by science, engineered for results, and built in the USA.Performance is cellular. When your mitochondria perform better, you perform better.Connect with LightStimWebsite: www.LightStim.comInstagram: @LightStimUse code THRIVE for 10% off your purchaseJay's TakeawayThis episode is a wake-up call for anyone who's serious about optimizing recovery and performance. The red light therapy industry is booming, but few companies are doing it right and LightStim is leading the charge with integrity, science, and results.If you want to feel better, recover faster, and perform at your peak, this conversation is a must-listen.
“I realized that rather than talking one-to-one with patients in the exam room, you could talk one-to-many on social media,” says Dr. Kevin Pho, explaining the origins of KevinMD, the highly influential information sharing site he created for physicians, medical students and patients twenty years ago. Since then, KevinMD has become a valuable space for clinicians and patients to share stories and perspectives on topics from burnout and moral injury to technology and trust. In this conversation with Raise the Line host Michael Carrese, Dr. Pho reflects on the dual paths that have defined his career: as a practicing internal medicine physician and as one of healthcare's most trusted online voices. And despite the challenges of doing so, Dr. Pho encourages other medical providers to follow his lead. “Patients are going online, and if physicians are not there, they're going to get information that's perhaps politically-driven or simply inaccurate.”This thoughtful conversation also explores: How social media has reshaped health communicationThe risks and rewards for clinicians of having an online presence Why medical schools should teach negotiating skillsMentioned in this episode:KevinMDEstablishing, Managing and Protecting Your Online Reputation 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
Spinocerebellar ataxia is a group of inherited, heterogeneous neurodegenerative diseases affecting coordination, speech, and vision. There are currently no FDA approved therapies for the more than 50 known types of SCA, but there is a growing pipeline of therapeutic candidates. We spoke to Andrew Rosen, CEO of the National Ataxia Foundation, about the challenges of developing therapies for spinocerebellar ataxia, the critical role of patient-led organizations in early-stage research and advocacy, and the recent surge of therapeutic activity targeting these neurodegenerative conditions.
There's been a lot of fear and confusion around the avian flu and how it might affect our cats… especially those on a raw food diet. In this episode, we sit down with Sabrina, the founder of RAWR cat food, to talk about her recent experience with the FDA and what she's learned through it all. She'll shed light on what's really happening with the avian flu, what cat parents need to know, and why understanding the facts - not the fear - is so important when it comes to feeding our cats a fresh, species-appropriate diet.If you've been wondering whether it's safe to feed raw right now, this is a podcast you don't want to miss. Learn more about RAWR here: https://www.eatlikealion.com/
For more than 50 years, the Association for the Advancement of Medical Instrumentation (AAMI) has helped healthcare professionals define best practices for employees, equipment and patients. AAMI standards are written through careful debate and consensus. They inform the way we work and are our guideposts for protecting patient safety. Staying up to date on AAMI documents is critical for all Sterile Processing professionals. In episode 138, host Casey Czarnowski speaks with Horlando Cintron and Damien Berg about AAMI's latest standards and innovations. They discuss new AAMI working groups, important standards updates, upcoming technical information reports (TIRs), and the impact of these publications on our work. Cintron and Berg also explain the AAMI process, share opportunities for participation and encourage you to get involved. ABOUT OUR GUESTS Horlando Cintron, Manager of Peri-Operative Support Services and Central Processing, Memorial Sloan Kettering Cancer Center Horlando Cintron, BS, CRCST, CHL, has 27 years of healthcare experience advancing patient safety through infection prevention, education and standards development. He co-chairs AAMI Working Group 40, leading the revision of ANSI/AAMI ST79, and received the AAMI Technical Award for co-chairing the ST58 standard recognized by the FDA. His leadership roles include Director, HSPA Foundation Board (2024–2027) and President, New Jersey Healthcare Central Service Association (2025–2026). Damien Berg, VP of Strategic Initiatives, HSPA Damien Berg, BA, BS, CRCST, AAMIF, serves as HSPA's Vice President of Strategic Initiatives and is an HSPA Past-President (2018–2019). Additionally, he works closely with regulatory bodies and standards-making groups, such as the Association for the Advancement of Medical Instrumentation (AAMI) and the International Standards Organization (ISO). Berg also serves on the Executive Committee for the World Federation For Hospital Sterilisation Sciences (WFHSS). Earn CE Now
Would you want to know if the food you were eating came from a cloned animal?New Health Canada regulations set to kick in next year don't require beef and pork manufacturers to label whether or not their products were from cloned animals. After consultations with the general public and stakeholders, Health Canada decided to remove cloned meat from their 'novel foods' category.Cloned animals are made through assisted reproductive processes such as artificial insemination. Sometimes, the cloned animals' offspring is what makes it to the meat counter.However, questions have been raised regarding the lack of transparency around the regulation change, and whether or not consumers deserve to know where and how the meat they buy is made.Host Maria Kestane speaks to Sylvain Charlebois, director of the Agr-Food Analytics Lab at Dalhousie University to discuss how important accurate food labels are to Canadian consumers, and whether or not cloned meat is safe for you. We love feedback at The Big Story, as well as suggestions for future episodes. You can find us:Through email at hello@thebigstorypodcast.ca Or @thebigstoryfpn on Twitter
In this episode of AUANews Inside Tract, join Dr. Kyle A. Richards and Dr. Kathryn Marchetti as they celebrate Bladder Health Month by talking about innovations in bladder cancer. In this conversation, they explore the rapidly evolving landscape of non–muscle invasive bladder cancer (NMIBC) — from FDA-approved advances like ZUSDURI (mitomycin gel) to emerging chemoablation therapies, the BCG shortage, and the promise of gene-based treatments for BCG-unresponsive disease. This episode is supported by Natera.
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of compelling updates that underscore the dynamic nature of our industry, marked by scientific breakthroughs, strategic shifts, regulatory advancements, and more.Starting with Pfizer's ambitious endeavors in oncology, the company has initiated Phase 3 trials for its bispecific antibody PF-08634404, targeting non-small cell lung cancer. This innovative approach aims to supersede Keytruda by simultaneously targeting the PD-1 and VEGF pathways, crucial in tumor growth and immune evasion. Pfizer is making substantial strides with its PD-1xVEGF bispecific antibodies by announcing seven near-term trials, including a pivotal phase 3 trial comparing this agent to Keytruda in non-small cell lung cancer. This underscores Pfizer's commitment to developing next-generation immunotherapies that could redefine cancer treatment paradigms by offering more targeted options. The implications are significant; by enhancing therapeutic efficacy through this dual-targeted strategy, Pfizer could set new standards in lung cancer treatment, potentially improving patient outcomes and redefining first-line therapies.Meanwhile, a strategic merger between Mallinckrodt and Endo has culminated in a $6.7 billion transaction, resulting in the rebranding of the combined entity as Keenova. This merger is particularly notable for its decision to spin off the Par Health generics business. Such a move indicates a focused shift towards specialty pharmaceuticals aimed at rare diseases—a trend increasingly seen across the industry as companies pivot towards niche markets with high unmet needs.In financing news, Vor Bio's successful $100 million public offering highlights growing investor confidence in companies addressing autoimmune diseases. This capital will likely accelerate Vor Bio's clinical-stage programs, potentially transforming patient care in this challenging therapeutic area through new and effective treatments.On the regulatory front, Glenmark's Ryaltris has secured approval from China's National Medical Products Administration for treating moderate to severe allergic rhinitis. This approval is pivotal as Glenmark expands its footprint in respiratory therapeutics with innovative small molecule therapies designed to alleviate allergy symptoms—a sign of their strategic growth within this domain.Recent clinical trial results also offer promising news. CeleCor Therapeutics' zalunfiban has shown Phase 3 success for segment elevation myocardial infarction, while UbiVac's DPV-001 has demonstrated improved survival rates in head and neck squamous cell carcinoma. Engene's Detalimogene voraplasmid exhibited a 63% response rate in bladder cancer patients unresponsive to BCG therapy. These findings reflect ongoing advances in targeted therapies and personalized medicine approaches that continue to reshape the oncology landscape.In policy changes, the UK government has unveiled a five-year roadmap aimed at replacing animal testing with AI and 3D tissue models. This initiative marks a pivotal shift towards more ethical and technologically advanced methods in drug development, potentially accelerating discovery processes while reducing reliance on animal models—a significant move that aligns with global trends towards more humane scientific practices.Meanwhile, Richard Pazdur's appointment as director of the FDA's Center for Drug Evaluation and Research signals strategic leadership changes amidst ongoing organizational investigations. His extensive experience in oncology is expected to guide regulatory oversight during this transformative period for the agency. Dr. Richard Pazdur's appointment as director of CDER representsSupport the show
The House races to vote on a resolution that could end the government shutdown, the FDA removes "black box" warnings for hormone replacement therapy drugs, and we look at the role media bias played in shaping Americans' views on the shutdown. Get the facts first with Morning Wire. - - - Wake up with new Morning Wire merch: https://bit.ly/4lIubt3 - - - Today's Sponsors: Boll & Branch - Get 25% off sitewide plus free shipping and extended returns at https://bollandbranch.com/WIRE and use code WIRE Shopify - Go to https://Shopify.com/morningwire to sign up for your $1-per-month trial period and upgrade your selling today. Beam - Go to https://shopbeam.com/WIRE, use code WIRE, and get up to 50% off during Beam's Cyber Sale. - - - Privacy Policy: https://www.dailywire.com/privacy morning 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
Dave Rubin of "The Rubin Report" talks about "The View's" Sunny Hostin trying to shame Democrat John Fetterman live on-air for voting to end the government shutdown only to have it blow up in her face; CNN's Harry Enten showing shocking new polling data of who is most likely to replace Chuck Schumer; BBC CEO Deborah Turness resigning from her post after Donald Trump's lawsuit over the BBC's January 6th documentary was exposed for having purposely misleading edits to defame Donald Trump; Piers Morgan apologizing to Novak Djokovic on "Piers Morgan Uncensored" for his attack on him for being unvaccinated during the COVID pandemic; Russell Brand's appearance on "Real Time with Bill Maher," where he roasted MSNBC's John Heilemann for media bias; Donald Trump's tense exchange with Fox News' Laura Ingraham over H-1B visas and Chinese immigrants who take the slots in America's universities that could go to Americans; Palmer Luckey explaining to Shawn Ryan how H-1B visas are abused in Silicon Valley; World War II veteran Alec Penstone telling "Good Morning Britain" why he regrets his sacrifice to the UK on Remembrance Day; and much more. WATCH the MEMBER-EXCLUSIVE segment of the show here: https://rubinreport.locals.com/ Check out the NEW RUBIN REPORT MERCH here: https://daverubin.store/ ---------- Today's Sponsors: Morgan & Morgan - Morgan & Morgan is America's Largest Injury Law Firm, with over 1,000 attorneys operating in all 50 states. Go to: https://ForThePeople.com/Rubin Juvent - Stop joint pain and stiffness with the Juvent Micro-Impact Platform. In the US, the Juvent device is considered investigational for the treatment of osteoporosis or improvement/maintenance of bone mineral density. Our claims have not been reviewed or cleared by the FDA to treat any disease or condition. The JUVENT® Micro-Impact Platform® is registered as a Class I medical device for exercise and rehabilitation." Go to http://Juvent.com/RUBIN and use the code RUBIN to save $300 on your own Juvent. Tax Network USA - If you owe back taxes or have unfiled returns, don't let the government take advantage of you. Whether you owe a few thousand or a few million, they can help you. Call 1(800)-958-1000 for a private, free consultation or Go to: https://tnusa.com/dave
A mainstream “hit piece” targeting HHS Secretary Robert F. Kennedy Jr. for linking Tylenol to autism is backfiring. Newly uncovered internal emails reportedly show the drug's manufacturer acknowledging concerns about prenatal Tylenol use and neurodevelopmental disorders. Now, Texas Attorney General Ken Paxton is suing major pharma companies for deceptively marketing Tylenol to pregnant mothers—and ICAN has petitioned the FDA to add pregnancy warnings to acetaminophen labels.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.
Angel Studios https://Angel.com/HermanJoin the Angel Guild today and know you are not just watching, you're helping make bold, faith driven stories like Disciples in the Moonlight possible. That's Angel.com/HermanRenue Healthcare https://Renue.Healthcare/ToddYour journey to a better life starts at Renue Healthcare. Visit https://Renue.Healthcare/Todd Bulwark Capital https://KnowYourRiskPodcast.comRegister now for the free Review/Preview Webinar November 20th 3:30pm Pacific, schedule your free Know Your Risk Portfolio Review, and subscribe to Zach's Daily Market Recap at (SLOW) Know Your Risk Podcast dot com. Alan's Soaps https://www.AlansArtisanSoaps.comUse coupon code TODD to save an additional 10% off the bundle price.Bonefrog https://BonefrogCoffee.com/toddThe new GOLDEN AGE is here! Use code TODD at checkout to receive 10% off your first purchase and 15% on subscriptions.SNAP Fraud Should Be GREAT for Jesus & Families // Should Life-Saving be Legal? // Yeah, but WHICH Jesus?Episode Links:Nationwide Fraud of SNAP and EBT Program. Arrests being made where businesses are caught on hidden camera paying .50 cents on the dollar for people's SNAP benefits cardsIllegals accused of stealing more than $150,000 in SNAP benefits in Ohio. Ohio has reported to losing $17M in SNAP benefits from fraud since 2023. Biden's invaders are stealing taxpayer funded resources from AmericansJUST IN: South Carolina woman Briana Simmons arrested and facing charges for allegedly defrauding taxpayer funded SNAP program of nearly $57K. But Democrats said this never happens…'Dilbert' creator's desperate plea shines spotlight on alternative prostate cancer drug What to know about Pluvicto, the FDA-approved prostate cancer drug gaining national attentionBREAKING: Legendary author Scott Adams just revealed that Donald Trump Jr., HHS Secretary RFK Jr., and CMS Administrator Dr. Oz personally called to make sure he gets the help and treatment he needs to help him fight cancer.
Congress is 43 days into the government shutdown, severely disrupting air traffic control, but hope rises as eight Senate Democrats vote to advance an end to the standoff. Mike McCormick, former Vice President of the FAA's Air Traffic Organization, discusses how the shutdown has led to many issues that are exacerbating an already understaffed system, then he shares his insights on how to rebuild the controller pipeline, and the challenges of restoring normal operations before the holiday travel season. The FDA is removing its long-standing boxed warning from hormone-based menopause drugs, a change that could reshape treatment for millions of women. For years, warnings about heart attack, stroke, and dementia discouraged many from using the therapy despite its benefits for hot flashes and other symptoms. Dr. Dorothy Fink, Deputy Assistant Secretary for Health & Women's Health at the Department of Health and Human Services, joins the Rundown to explain what led to the FDA's decision, the science behind Hormone Replacement Therapy, and why women's health issues associated with menopause deserve more attention. Plus, commentary from Ruthless Podcast co-host John Ashbrook Learn more about your ad choices. Visit podcastchoices.com/adchoices
The FDA recently announced it will be removing warning labels on hormone replacement therapy medications. In an exclusive conversation with Martha, Health and Human Services Secretary Robert F. Kennedy Jr. explains the FDA's decision and why these labels are now considered misleading. Later, Martha revisits her conversation with FOX News contributor and board-certified radiologist, Dr. Nicole Saphier, who explains the risks of hormone replacement therapy as a treatment for menopause and some of the common misconceptions. Learn more about your ad choices. Visit podcastchoices.com/adchoices
On this episode, Jared shares the powerful lessons he learned during a recent journey that changed him in profound ways. What began as a simple trip became a time of reflection, revelation, and rediscovery—shaping how he now views devotion, integrity, and purpose. He opens up about what he discovered about himself, the difference between knowing and doing, and why living with true integrity means showing up with consistency and heart. Jared believes these insights hold something valuable for everyone—if you'll listen with an open heart and mind.Products:LifeSeasons Visibili-T Advanced Eye Support - Vitality Radio POW! Product of the Week 50% off when you purchase 2 or more with PROMO CODE: POW17Visit the podcast website here: VitalityRadio.comYou can follow @vitalitynutritionbountiful and @vitalityradio on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.
In this episode of More Than A Pretty Face, Dr. Azi talks with Dr. Rishi Chopra, a New York–based dermatologist recognized as the Pfizer Rising Derm Star of 2021. They discuss filler fatigue, the shift toward skin tightening treatments, and new innovations in regenerative aesthetics such as Avava laser and PDRN injectables. Dr. Chopra shares insights on emerging devices, collagen banking, and his go-to treatments for natural, long-lasting results. Timeline of what was discussed: 00:00 – Introduction 01:05 – Meet Dr. Rishi Chopra 02:00 – Why patients are developing "filler fear" 03:10 – How overfilling and poor training led to unnatural results 04:05 – The missing link: skin tightening vs. constant filling 05:00 – Introducing Avava, the first laser that tightens and lifts skin 06:00 – How Avava compares to Thermage, Softwave, and Ulthera 06:50 – The science behind Avava's energy delivery & collagen stimulation 07:45 – Visible results: why Dr. Chopra calls it the "Benjamin Button" laser 08:20 – Downtime, safety, and results for different skin types 08:48 – Transition to regenerative injectables & biostimulators 09:00 – What is PDRN (salmon DNA) and how it works for skin rejuvenation 10:05 – FDA status and why Korea is leading in regenerative aesthetics 11:00 – Comparing PDRN, exosomes, and PRP 11:55 – Long-term collagen regeneration & skin quality improvements 12:45 – Discussion on SkinVive and its subtle hydration benefits 13:40 – Biostimulators (Sculptra, Radiesse) for natural rejuvenation 14:45 – Addressing safety & facelift myths around biostimulators 15:55 – Rapid-fire Q&A with Dr. Chopra 16:10 – Favorite treatment right now: Avava laser 1 6:50 – Downtime and results for all skin types 17:30 – Quick lifestyle Q&A: Hamptons or cabin? Brooklyn summers? 18:25 – Research vs. hands-on dermatology 19:10 – Where to find Dr. Rishi Chopra 19:35 – Dr. Azi's closing thoughts & outro ______________________________________________________________ Follow Rishi Chopra on Instagram: @rishichopramd Book an appointment with Dr. Chopra: www.unionderm.com/doctors/dr-rishi-chopra/ Dr. Rishi Chopra is a board-certified dermatologist based in New York City and the 2021 Pfizer Rising Derm Star. He specializes in medical and cosmetic dermatology with a focus on injectables, regenerative aesthetics, and laser innovation. Dr. Chopra practices at UnionDerm, where he's known for his evidence-based approach, cutting-edge techniques, and natural-looking results. ______________________________________________________________ Submit your questions for the podcast to Dr. Azi on Instagram @morethanaprettyfacepodcast, @skinbydrazi, on YouTube, and TikTok @skinbydrazi. Email morethanaprettyfacepodcast@gmail.com. Shop skincare at https://azimdskincare.com and learn more about the practice at https://www.lajollalaserderm.com/ The content of this podcast is for entertainment, educational, and informational purposes and does not constitute formal medical advice. © Azadeh Shirazi, MD FAAD.
It has been a very big week for women's health. After years of experts like Dr. Rachel Rubin fighting to have the black box warnings on vaginal estrogen products removed, the FDA has agreed to remove it from select HRT products. This week, we are replaying Dr. Rachel Rubin's episode where she shares the importance of vaginal estrogen for women's health. Dr. Rubin is a nationally-recognized urology and sexual medicine physician and she recently joined several of our former guests and menopausal experts on a panel in front of the FDA to explain why the black box warnings do more harm than good. As of November 10, 2025, the FDA plans to remove the black box warning on certain HRT products including vaginal estrogen. Thank you to all the experts! Show Notes: www.hotflashescooltopics.com Find Us Here! Website I [http://hotflashescooltopics.com/] Mail I [hotflashescooltopics@gmail.com] Instagram I [https://www.instagram.com/hotflashesandcooltopics/] Facebook : [www.facebook.com/hotflashescooltopics] YouTube I [https://www.youtube.com/@HotFlashesCoolTopics] Pinterest I [https://www.pinterest.com/hcooltopics/] Want to Leave a Review for Hot Flashes and Cool Topics? Here's How: For Apple Podcasts on an iPhone or iOS device: Open the Apple Podcast App on your device. Click on the “search” icon Type into the search bar “Hot Flashes and Cool Topics” and click on the show Towards the bottom, look for “Ratings and Reviews” Click on “Write a Review” and leave us your thoughts and comments! For Apple Podcasts on a computer: On the Apple Podcasts website, go to the search bar and type “Hot Flashes and Cool Topics” After clicking on the show, find the “Listen on Apple Podcasts” button and click on it The “Hot Flashes and Cool Topics” podcast should open on the Apple Podcasts application Keep scrolling on the page until you see “Ratings and Reviews” Click on “See All” If you want to give us a five-star rating, hover over the empty stars! • • If you want to leave your thoughts and comments, click on “Write a Review”!
On today's Gist Healthcare Podcast: The Senate passes a spending bill to end the government shutdown without extending Affordable Care Act subsidies. The FDA plans to remove black box warnings from hormone replacement therapies for menopause. And UnitedHealthcare pulls back coverage for remote patient monitoring. Hosted on Acast. See acast.com/privacy for more information.
Why does so much of our food make us hungrier instead of healthier—and what role does the law play in keeping it that way? In this episode of Cut to the Chase:, Gregg Goldfarb sits down with Dr. Marion Nestle, world-renowned food politics expert, nutritionist, and author of "What to Eat Now", to expose how corporate power, weak regulation, and profit-driven policies shaped America's food system. From ultra processed foods engineered for addiction to the legal loopholes that let companies hide additives and mislead consumers, Gregg and Marion unpack the truth about what's really on our plates—and how attorneys, policymakers, and everyday citizens can fight back. This eye-opening conversation dives into the GRAS loophole, FDA limits, marketing to kids, and how deregulation turned nutrition into a corporate playground. Whether you're a lawyer, advocate, or just trying to eat better, this episode will change how you think about food, health, and accountability. What to expect in this episode: What makes food "ultra processed" (and why it's hard to stop eating) How deregulation and shareholder profit reshaped the American diet The shocking food-tobacco connection and addiction by design Why the FDA can't always protect consumers The GRAS Loophole: How companies self-approve additives The SNAP and school lunch debate—public aid or corporate subsidy? The marketing war for kids' attention and its legal fallout State reforms in California and Texas targeting harmful additives Real steps toward food system reform and smarter policy Stay tuned for more updates, and don't miss our next deep dive on Cut to the Chase: Podcast with Gregg Goldfarb! Subscribe, rate, review, and share this episode of the Cut to the Chase: Podcast! Resources: Pre-order "What to Eat Now" by Dr. Marion Nestle & Find her other books: https://www.foodpolitics.com/about Connect with Dr. Marion Nestle on LinkedIn: https://www.linkedin.com/in/marion-nestle-9515ba8 Twitter: @marionnestle Instagram: @marionnestle This episode was produced and brought to you by Reignite Media.
Raven announced that he will be out for the next week and a half, and gives Anna the breakdown of his next ten days. Is there a trigger word or phrase that immediately makes you furious? Anna can't stand it when her husband says “we'll see”, and there are two words that Anna and Raven agree you should never send in a text message! After Anna heard that Raven needed to get all of his “errands” done before taking his time off, she asked him to detail exactly what those were! Pick'em News! Raven gets to choose one of three stories Anna has found to hear all about! His options are a porto-potty prank gone awry, a wildlife houseguest, and a mom banned from the school pick-up line due to an ad on her car! What do you do that makes the people around you freak out? Anna was at a wedding last weekend and kept doing something that made her daughter lose her mind! Do you have a hell of a story? If you want to be the storyteller and share your experience with Anna and Raven, go to AnnaAndRaven.com and click on Helluva Story! Today, Diana tells the story of how she prevented a dog-napping! Raven goes over all of the last instructions he received to prepare himself for his procedure, and he and Anna discuss downtime and recovery! What food is impossible to reheat? Anna had a confrontation with a busboy because she refused to bring home her fries. They never taste the same reheated! Luckily, Chef Plum has some tips on how to make any reheated food delicious! Anna was shocked to see a rule about sleeping on the job in her employee handbook, until she remembered that she's occasionally been guilt of it herself! Where is the strangest place you've ever fallen asleep? Have you ever given a stranger a ride in your car? Anna gave someone a lift to a party and proceeded to have one of the most irritating and potentially expensive car rides of her life! Anna has three more crazy news stories for Raven to choose from! This time his options are a redundant FDA warning, a crime spree on the most wholesome street in America, or a family brawl over Chinese food! Couples Court – Brynn and Carson have been dating for three weeks. Brynn is upset that even though they were at an event together, Carson posted pictures of the event on his social media but cropped her out of photos. He said he's not ready to be social media official. Do you think that's rude, or is he right? Can't Beat Raven – Mark has a chance to win $3200! Can he take down Raven and claim the cash?
THE WORLD IS CHANGING!!! Erasing fear with evidence, science and facts! This conversation delves into the significant impact of hormone replacement therapy (HRT) on women's health, particularly in the context of menopause. Dr. Rubin, Casperson and Makary discuss the recent FDA decision to remove black box warnings associated with HRT, which have perpetuated fear and misinformation for decades. They emphasize the importance of educating both clinicians and patients about the benefits and risks of HRT, highlighting the long-term health advantages it offers, such as reducing the risk of heart disease and osteoporosis. The discussion also addresses the need for informed consent and the importance of empowering women to make educated decisions about their health. Takeaways 50 to 70 million women have been denied health benefits from HRT. The FDA's removal of black box warnings is monumental. Misconceptions about HRT have persisted for decades. Education is crucial for both clinicians and patients. Hormone therapy can significantly reduce heart disease risk. Women often face barriers in accessing HRT. Informed consent is essential for women's health decisions. Long-term benefits of HRT include reduced risk of osteoporosis. The healthcare system needs to better address women's health issues. A collaborative approach is needed to improve women's health outcomes. FDA DIRECT podcast Dr. Makary's "Blind Spots" book To my fellow clinicians: listen to this podcast on Pinnacle for FREE to earn CME credit Listen to my Tedx Talk: Why we need adult sex ed Take my Adult Sex Ed Master Class: My Website Interested in my sexual health and hormone clinic? Waitlist is open Learn more about your ad choices. Visit podcastchoices.com/adchoices
The FDA is removing the black box warning on estrogen therapy after two decades. Should it?Women who want to use estrogen to treat menopause symptoms often face a difficult choice.That's because those hormone treatments contain a “black-box warning.”The Food and Drug Administration uses black box warnings to indicate a medication has potentially life threatening side effects.In the case of estrogen for menopause symptoms, an increased risk of endometrial cancer, cardiovascular disorders, dementia and breast cancer.Well those warnings are going away. For sponsor-free episodes of Consider This, sign up for Consider This+ via Apple Podcasts or at plus.npr.org. Email us at considerthis@npr.org.This episode was produced by Mia Venkat and Erika Ryan. It was edited by Courtney Dorning and Scott Hensley.Our executive producer is Sami Yenigun.Learn more about sponsor message choices: podcastchoices.com/adchoicesNPR Privacy Policy
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