Podcasts about fda

We expect that FDA-approved drugs have been shown to be safe and effective. But, that isn't always the case.

On this episode of Vitality Radio, Jared shares a deeply personal story that led him to reluctantly request an antibiotic for the first time ever. After undergoing the removal of two long-standing root canals, Jared faced unexpected complications—including intense pain, possible systemic infection, and a difficult decision about antibiotics. He unpacks the root causes (pun intended) of his health issues and explores how dead teeth and lingering oral infections may contribute to chronic inflammation, autoimmune reactions, and even joint pain. Jared also breaks down the stark contrast between conventional and biological dentistry, offering insights into why root canals could be impacting more than just your mouth. If you've ever had a root canal—or are considering one—this is a must-listen.Additional Information:#539: Your Mouth Might Be Making You Sick – Health-Based Dentistry Explained with Dr. Michelle JorgensenVisit 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.

This Week: Holy shit. Normally we don't curse around these parts, but damn. It's an abject mess of theocracy, authoritarianism, and outright attacks on rights, freedoms, and the nation's public schools this week. On Friday the Court handed down the last of its rulings from the 2024 term, and there are several major implications for public education… all terrible. In Mahmoud v. Taylor they ruled that schools have to allow families to opt out of content about LGBTQ+ people for religious reasons, enshrining a chilling effect in the nation's curricula and effectively empowering right wing religious folks to dictate what does, and doesn't, get included. In Trump v. CASA they held that lower courts can no longer issue nationwide injunctions against Trump's unconstitutional actions, effectively paving the way for continued terrorism over immigrant communities, and the undoing of birthright citizenship guaranteed in the 14th Amendment. Black and Brown folks, watch your 6. And in a case nobody's talking about - FDA v. RJ Reynolds - they're paving the way for tobacco companies to expand vaping products, which plague our young people, and make it dramatically easier for corporate interests to challenge any government regulation. Manuel and Jeff discuss. MAXIMUM WOKENESS ALERT -- get your All of the Above swag, including your own “Teach the Truth” shirt! In this moment of relentless attacks on teaching truth in the classroom, we got you covered. https://all-of-the-above-store.creator-spring.com Watch, listen and subscribe to make sure you don't miss our latest content!Listen on Apple Podcast and Spotify Website: https://AOTAshow.comStream all of our content at: linktr.ee/AOTA  Watch at: YouTube.com/AlloftheAboveFollow us at: LinkedIn, Facebook.com/AOTAshow, Twitter.com/AOTAshow 

FDA approves triple-drug polypill, a change of opinion, a deep dive into invasive pulmonary embolism therapies, heart disease trends, and diabetes care is on fire are the topics John Mandrola, MD, discusses in this week's podcast. This podcast is intended for healthcare professionals only. To read a partial transcript or to comment, visit: https://www.medscape.com/twic I FDA News in HTN FDA announcement https://george-medicines.com/george-medicines-announces-fda-approval-of-widaplik-telmisartan-amlodipine-and-indapamide-a-new-single-pill-combination-treatment-for-hypertension-in-adults-including-initial-treatment/ Lancet Study https://doi.org/10.1016/S0140-6736(24)01744-6 JACC study vs placebo https://www.jacc.org/doi/abs/10.1016/j.jacc.2024.08.025 JAMA Cardiology Meta-analysis https://jamanetwork.com/journals/jamacardiology/fullarticle/2804313 II Invasive PE Therapy EHJ-Open review: https://academic.oup.com/ehjopen/article/5/3/oeaf071/8156689 PEITHO Trial https://www.nejm.org/doi/10.1056/NEJMoa1302097 REAL PE Observational Study https://pmc.ncbi.nlm.nih.gov/articles/PMC11308131/ III Heart Disease Trends King et al https://www.ahajournals.org/doi/10.1161/JAHA.124.038644 IV Diabetes Coverage Medscape Link https://www.medscape.com/viewcollection/37830 You may also like: The Bob Harrington Show with the Stephen and Suzanne Weiss Dean of Weill Cornell Medicine, Robert A. Harrington, MD. https://www.medscape.com/author/bob-harrington Questions or feedback, please contact news@medscape.net

CDC to Vote on Mercury-Based Flu Vaccine (01:04:18 – 01:13:14) ACIP is set to vote on flu vaccines containing thimerosal, a mercury-based preservative long criticized for neurotoxicity. Commentary highlights years of CDC denial, FDA adverse event data, and the continued presence of mercury in vaccines for pregnant women and children. Medical Coercion and Propaganda in Vaccine Push (01:13:33 – 01:21:06) Multiple personal testimonies describe coercion by doctors to accept RSV shots, vaccine mandates in military and pediatric settings, and the financial incentives influencing provider behavior. RFK Jr. Promotes Biometric Wearables Nationwide (01:31:31 – 01:37:33) RFK Jr. announces a federal push to have every American using biometric wearables within four years as part of his Make America Healthy Again agenda, drawing sharp criticism over privacy, surveillance, and transhumanist implications. RF Radiation Health Risks from Wearables (01:43:05 – 01:45:22) Children's Health Defense warns that wearables emit harmful radiofrequency radiation linked to cancer, reproductive harm, and neurological damage, especially for children and long-term users. Arizona Pastor Crucified in Ritual Killing Spree (01:52:50 – 01:58:34) A man confesses to murdering a pastor in Arizona as part of a planned 14-victim anti-Christian crusade. Details include religious motives, ritual symbolism, and plans to kill across multiple states. Nuclear Weapons, Insurgency, and Firsthand Combat Experience (02:03:27 – 02:04:48) Jack Lawson recounts his background disarming nuclear bombs, fighting communist insurgents in Africa, and serving on a major U.S. police review board to frame the realism behind his civil defense advice. Water System Fragility and Collapse Preparedness (02:06:08 – 02:14:35) Details how municipal water systems depend on fragile supply chains for chlorine and filtration, warning that contamination or delivery failure would force a shutdown and endanger urban populations. Takers vs. Preparers in Collapse Scenarios (02:17:57 – 02:19:01) Contrasts two types of survivalists: those who prepare with food and water and those who plan to steal. Warns that predatory behavior will backfire and communities will retaliate harshly. Area Emergencies vs. Catastrophic Events (02:21:14 – 02:22:55) Explains the difference between temporary disruptions and long-term grid-down disasters, emphasizing that survival depends on advance community coordination and resource storage. Foreign Blowback and U.S. Militarism (02:32:46 – 02:36:04) Draws on military and personal experience to illustrate how U.S. foreign policy generates global resentment. Argues that Americans are shielded from the consequences of wars abroad. Hyperinflation Warning and Zimbabwe Currency Example (02:55:02 – 02:55:34) Highlights the instability of fiat currency by referencing Zimbabwe's hyperinflated $100 trillion banknote, warning that without food and water, currency and even precious metals lose meaning. Mao's Cultural Revolution as a Blueprint for Modern America (03:10:21 – 03:15:48) Xi Van Fleet draws direct parallels between Mao's Cultural Revolution and current American ideological trends, especially in education and identity politics. She identifies CRT and DEI as rebranded Marxist tools. Struggle Sessions and Public Shaming in the West (03:15:49 – 03:20:20) Describes how Maoist struggle sessions mirror modern Western practices of ideological confession and humiliation, such as DEI training and cancel culture. State Ownership of Children and Family Undermining (03:23:10 – 03:26:49) Explains how the CCP broke familial bonds to assert state control over children, drawing parallels to current U.S. trends in education and parental rights erosion. Gender Androgyny as a Political Weapon (03:28:41 – 03:32:34) Details Maoist efforts to erase gender distinctions and how current gender ideology similarly promotes androgyny as a form of ideological conformity and control. Religion Suppressed and Replaced by State Worship (03:33:00 – 03:36:27) Recounts how Chinese churches were forced to display Mao's image and push party ideology. Warns of similar patterns in the West where the state seeks total moral authority. Controlled Speech and the Mandate to 'Live by Lies' (03:38:18 – 03:41:41) Invokes Solzhenitsyn's warning to resist speaking lies under tyranny. Argues Americans are increasingly pressured to affirm falsehoods on race, gender, and elections. Follow the show on Kick and watch live every weekday 9:00am EST – 12:00pm EST https://kick.com/davidknightshow Money should have intrinsic value AND transactional privacy: Go to https://davidknight.gold/ for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to https://trendsjournal.com/ and enter the code KNIGHT Find out more about the show and where you can watch it at TheDavidKnightShow.comIf you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-showOr you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7Become a supporter of this podcast: https://www.spreaker.com/podcast/the-david-knight-show--2653468/support.

I wanted to share something really personal with you—my keynote presentation from the AWHONN Convention in Orlando, FL. In this talk, I open up about two moments that completely changed my life: being banned from donating blood in nursing school for being gay, and having my first panic attack after a long shift in the ICU.These moments could've broken me. But instead, they lit a fire. One pushed me to start Banned4Life and help lift the FDA's gay blood ban. The other led me to create my Nurse Blake social media accounts as a way to share my story & overcome burnout. Life gives us moments—some beautiful, some painful, some totally unexpected. My hope is that as you listen, you'll look at your own defining moments and realize: they don't have to hold you back. You have the power to take them, shape them, and turn them into something meaningful.___________I hope to see you later this Fall during my But Did You Die? Comedy Tour! Tickets on sale now at: nurseblake.com ___________I want to shoutout AWHONN for selecting me to be their Keynote and to everyone who attended my session!

In this episode, we sit down with Victoria Litman, M.Div., J.D., LL.M., to discuss why the future of psychedelic access in the United States is being shaped not by federal agencies, but by the bold actions of individual states. As a legal scholar and writer focusing on drug policy, Victoria breaks down the significance of the FDA's 2024 rejection of psychedelic-assisted therapy, and why that decision might be less of a setback than it seems. We explore how state-level initiatives like Oregon's Psilocybin Services Act and Colorado's Natural Medicine Health Act are setting the stage for a new model of access—one rooted in harm reduction, personal liberty, and existing regulatory infrastructure. Victoria discusses the importance of the Tenth Amendment and the Anti-Commandeering Doctrine, which allow states to move forward regardless of federal inaction. Rather than waiting for slow-moving federal institutions, Victoria argues that states can build safe, scalable systems now—especially by leveraging cannabis infrastructure for psychedelic regulation. She also touches on the ethical and cultural implications of this transition, including protections for spiritual and religious use. If you're wondering what psychedelic policy will look like in the years ahead, this episode offers an insightful and hopeful roadmap. Link to CATO article

CDC to Vote on Mercury-Based Flu Vaccine (01:04:18 – 01:13:14) ACIP is set to vote on flu vaccines containing thimerosal, a mercury-based preservative long criticized for neurotoxicity. Commentary highlights years of CDC denial, FDA adverse event data, and the continued presence of mercury in vaccines for pregnant women and children. Medical Coercion and Propaganda in Vaccine Push (01:13:33 – 01:21:06) Multiple personal testimonies describe coercion by doctors to accept RSV shots, vaccine mandates in military and pediatric settings, and the financial incentives influencing provider behavior. RFK Jr. Promotes Biometric Wearables Nationwide (01:31:31 – 01:37:33) RFK Jr. announces a federal push to have every American using biometric wearables within four years as part of his Make America Healthy Again agenda, drawing sharp criticism over privacy, surveillance, and transhumanist implications. RF Radiation Health Risks from Wearables (01:43:05 – 01:45:22) Children's Health Defense warns that wearables emit harmful radiofrequency radiation linked to cancer, reproductive harm, and neurological damage, especially for children and long-term users. Arizona Pastor Crucified in Ritual Killing Spree (01:52:50 – 01:58:34) A man confesses to murdering a pastor in Arizona as part of a planned 14-victim anti-Christian crusade. Details include religious motives, ritual symbolism, and plans to kill across multiple states. Nuclear Weapons, Insurgency, and Firsthand Combat Experience (02:03:27 – 02:04:48) Jack Lawson recounts his background disarming nuclear bombs, fighting communist insurgents in Africa, and serving on a major U.S. police review board to frame the realism behind his civil defense advice. Water System Fragility and Collapse Preparedness (02:06:08 – 02:14:35) Details how municipal water systems depend on fragile supply chains for chlorine and filtration, warning that contamination or delivery failure would force a shutdown and endanger urban populations. Takers vs. Preparers in Collapse Scenarios (02:17:57 – 02:19:01) Contrasts two types of survivalists: those who prepare with food and water and those who plan to steal. Warns that predatory behavior will backfire and communities will retaliate harshly. Area Emergencies vs. Catastrophic Events (02:21:14 – 02:22:55) Explains the difference between temporary disruptions and long-term grid-down disasters, emphasizing that survival depends on advance community coordination and resource storage. Foreign Blowback and U.S. Militarism (02:32:46 – 02:36:04) Draws on military and personal experience to illustrate how U.S. foreign policy generates global resentment. Argues that Americans are shielded from the consequences of wars abroad. Hyperinflation Warning and Zimbabwe Currency Example (02:55:02 – 02:55:34) Highlights the instability of fiat currency by referencing Zimbabwe's hyperinflated $100 trillion banknote, warning that without food and water, currency and even precious metals lose meaning. Mao's Cultural Revolution as a Blueprint for Modern America (03:10:21 – 03:15:48) Xi Van Fleet draws direct parallels between Mao's Cultural Revolution and current American ideological trends, especially in education and identity politics. She identifies CRT and DEI as rebranded Marxist tools. Struggle Sessions and Public Shaming in the West (03:15:49 – 03:20:20) Describes how Maoist struggle sessions mirror modern Western practices of ideological confession and humiliation, such as DEI training and cancel culture. State Ownership of Children and Family Undermining (03:23:10 – 03:26:49) Explains how the CCP broke familial bonds to assert state control over children, drawing parallels to current U.S. trends in education and parental rights erosion. Gender Androgyny as a Political Weapon (03:28:41 – 03:32:34) Details Maoist efforts to erase gender distinctions and how current gender ideology similarly promotes androgyny as a form of ideological conformity and control. Religion Suppressed and Replaced by State Worship (03:33:00 – 03:36:27) Recounts how Chinese churches were forced to display Mao's image and push party ideology. Warns of similar patterns in the West where the state seeks total moral authority. Controlled Speech and the Mandate to 'Live by Lies' (03:38:18 – 03:41:41) Invokes Solzhenitsyn's warning to resist speaking lies under tyranny. Argues Americans are increasingly pressured to affirm falsehoods on race, gender, and elections. Follow the show on Kick and watch live every weekday 9:00am EST – 12:00pm EST https://kick.com/davidknightshow Money should have intrinsic value AND transactional privacy: Go to https://davidknight.gold/ for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to https://trendsjournal.com/ and enter the code KNIGHT Find out more about the show and where you can watch it at TheDavidKnightShow.comIf you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-showOr you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7Become a supporter of this podcast: https://www.spreaker.com/podcast/the-real-david-knight-show--5282736/support.

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: loads of news from American Diabetes Association Scientific Sessions, GLP1 for T1D, Tech updates, diabetes in space, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Top story – looking back at The American Diabetes Association Scientific Sessions conference. I won't recap everything here – but I'll link up to a few more comprehensive article. Here's just a taste! XX A single infusion of a new stem cell-based treatment helped 10 out of 12 people with severe type 1 diabetes stop using insulin, researchers report. The treatment, called zimislecel, was made by Vertex Pharmaceuticals. It's an infusion of lab-grown islet cells. A year after getting the therapy, 10 patients no longer needed insulin shots. The other two were able to reduce how much insulin they needed.  The treatment requires patients to take immunosuppressive drugs, which may raise the risk of infections or cancer in the long run, experts said. https://www.usnews.com/news/health-news/articles/2025-06-24/stem-cell-treatment-may-free-some-with-type-1-diabetes-from-insulin XX New study shows inhaled insulin is safe and effective for children with type 1 diabetes. This is Mannkind's Afrezza, which takes the place of rapid-acting mealtime insulin. Findings indicate that inhaled insulin delivers glycemic control comparable to injected rapid-acting insulin. Inhaled insulin was also associated with less weight gain and slightly higher patient and parent preference scores. These findings add to outcomes shared from INHALE 1 late last year. Based on the findings of the inhaled insulin study, MannKind looks to seek FDA approval to expand Afrezza's indication to children. The company also aims to evaluate inhaled insulin at diagnosis and in automated insulin delivery systems in additional studies. https://www.drugdeliverybusiness.com/study-mannkind-inhaled-insulin-safe-effective-children/ XX Positive outcomes in two different studies looking at GLP 1 medications for type 1. Semaglutide – brand name Ozempic or Wegovy - reduced glucose levels and weight among patients with type 1 diabetes and obesity. 26-week, double-blind trial of 72 adults, those taking Ozempic spent More than 70% time spent in sensor glucose range (70-180 mg/dL) Less than 4% time spent in hypoglycemia (

Why are politicians trying to ban the safer alternatives to cigarettes… while leaving cigarettes untouched? What's the real motivation behind targeting products like Zyn and vapes? Is this about protecting public health—or protecting power and control? Studio Sponsor: Cardio Miracle - "Unlock the secret to a healthier heart, increased energy levels, and transform your cardiovascular fitness like never before.": CardioMiracle.com/TBNS In this punchy, eye-opening episode of The Brian Nichols Show, we dive headfirst into the war on nicotine alternatives. Host Brian Nichols sits down with health policy analyst and harm reduction fellow Sophia Hamilton to break down why the government is so obsessed with regulating—if not outright banning—products like Zyn pouches. Spoiler: it has nothing to do with safety and everything to do with outdated narratives, political grandstanding, and generational ignorance. Sophia walks us through how the government's crackdown on Juul created a black market mess, how Zyn emerged as a cleaner, safer alternative, and why politicians like Chuck Schumer are frothing at the mouth to ban it next. Even though studies show these products are far less harmful than traditional tobacco, that's not stopping the Nanny State from stepping in. Brian and Sophia also dig into the generational divide fueling this hysteria—highlighting how Gen Z is rejecting alcohol and cigarettes but is being punished for making safer, informed choices. The hypocrisy is rich: the same boomers who once fell for Big Tobacco ads now want to control what young people can and can't use, despite overwhelming data and personal autonomy. And let's not forget the role of the FDA, which seems more interested in gatekeeping and bureaucracy than in approving harm-reduction products that actually help people quit smoking. This isn't just a public health failure—it's a prime example of government overreach making life worse, not better. You do not want to miss this one. ❤️ Order Cardio Miracle (CardioMiracle.com/TBNS) for 15% off and take a step towards better heart health and overall well-being!

For months, the “buy Canadian” movement has inspired Canadians to shift their shopping habits away from American goods. While this has mostly been a patriotic move, some experts say recent cuts at the Food and Drug Administration, the agency responsible for inspecting 80 per cent of American food, might give Canadians another reason to think twice about buying American products at the grocery store.Kate Helmore is The Globe's agriculture and food policy reporter. She's on the show to talk about why the cuts at the FDA have some experts concerned, how intertwined the U.S. and Canadian food systems are, and why it's so challenging to disentangle them.Questions? Comments? Ideas? Email us at thedecibel@globeandmail.com

Is there a safe, non-surgical way to get stronger, longer-lasting erections, without pills or painful procedures?In this eye-opening episode, we dive into a powerful yet often misunderstood device. This device is FDA-approved for treating erectile dysfunction and improving overall sexual health. You'll discover how it works, who it's for, and the real science behind its surprising benefits. If you're ready to take your performance and confidence to the next level, don't miss this one. Tune in now or risk staying in the dark about a game-changing solution millions of men are already using.--------------Resources mentioned:Recommended PumpModern Man Crib Store--------------If you liked this episode, please SUBSCRIBE, like, leave a comment, and share so we can keep bringing you valuable content that gets results!--------------Curious about how you can boost your bedroom game and build lasting confidence? Check out the course at getwoodnow.com and start your journey to feeling like yourself again!--------------If you enjoyed this episode and want to learn more and get more tips, subscribe to The Modern Man newsletter for exclusive content delivered straight to your inbox! https://dranne.co/themodernman--------------Follow Me On:InstagramTwitterFacebookTikTokYouTube--------------For all links and resources mentioned on the show and where to subscribe to the podcast, please visit https://sexualhealthformenpodcast.storychief.io/how-to-use-a-penis-pump-for-erectile-dysfunction--------------Want to regain control of your sex life? It's time to reverse the effects of ED on your life. Join the Modern Man Club and embark on your journey to complete recovery and community.--------------Reveal the FREE treatment most men ignore that solves thousands of erectile dysfunction cases every year, plus the 5 biggest mistakes you must avoid if you want to say goodbye to your ED. Uncover it all in my free eBook, available to download now.https://dranne.co/ebook

Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency.  So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated.  Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations.  And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:    Dr. Diwakar Davar    @diwakardavar    Dr. Jason Luke @jasonlukemd Follow ASCO on social media:     @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn   Disclosures:     Dr. Diwakar Davar:      Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences     Consulting or Advisory Role: Instil Bio, Vedanta Biosciences     Consulting or Advisory Role (Immediate family member): Shionogi     Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences     Research Funding (Inst.): Zucero Therapeutics     Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy     Dr. Jason Luke:     Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX     Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine     Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure     Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)     Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

Send us a textSurveys show that 97-99% of participants who participate in one clinical research study would sign up for another. We wind out why in this episode, recorded in front of a live audience. Dr. Michael Koren and Nalini Jones, CCRC are joined by three clinical research patients to review the good, the bad, and the ugly in the history of clinical research. They also discuss the ins and outs of how the clinical research process works and share patient stories of their experiences as research participants. Step into a behind-the-scenes look at how we get from medical ideas to medical treatments and how the process leaves a lasting impact on patients and the legacy of knowledge.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!

 Today on Beating Cancer Daily, Saranne welcomes functional medicine expert Jacqui Bryan for an honest discussion about the much-hyped apricot seed and its supposed cancer-fighting properties. Sparked by Saranne's experience of eating one apricot seed daily—a practice recommended by her local health food store—the conversation raises urgent questions about nutritional safety, toxic risks, and the science behind amygdalin (often marketed as vitamin B17) found in apricot seeds. Jacqui meticulously reviews the difference between bitter and sweet apricot seeds, explores their historical use in cancer treatments, and highlights the real dangers of cyanide poisoning, all while emphasizing the importance of evidence-based guidance for those touched by cancer. Jacqui Bryan is a certified nutrition specialist, whole health educator, health coach, and registered nurse. With extensive training in functional medicine, Jacqui is dedicated to helping cancer survivors, patients, and their loved ones navigate the complex world of food and holistic health. Her commitment to science-backed, individualized care makes her a trusted expert for those seeking informed choices on their cancer journey. “If something sounds too good to be true, it is. So I want to explore and dig a little bit deeper.” ~ Jacqui Bryan Today on Beating Cancer Daily:·     Eating apricot seeds in excess poses a significant risk of cyanide poisoning, which can be fatal·     Bitter apricot seeds contain higher amounts of amygdalin than sweet apricot seeds and pose a greater risk·     Amygdalin, marketed as vitamin B17, is not an FDA-regulated substance and can vary in potency and toxicity·     There are documented historical uses of amygdalin and Laetrile in cancer treatment, but these were largely abandoned due to toxicity.·     Cancer patients in active treatment may be more vulnerable to the toxic effects of amygdalin due to compromised organ systems.·     Consuming apricot seeds should only be considered after consulting with a healthcare provider, especially in conjunction with other medications and supplements.·     Common side effects of cyanide poisoning include nausea, vomiting, confusion, weakness, and muscle aches—symptoms that may overlap with chemotherapy side effects.·     Whole apricots (the fruit) offer notable health benefits, such as antioxidants and support for digestion and skin health, without the risks associated with seeds. Guest Contact Information: Jacqui Bryan Ranked the Top 5 Best Cancer Podcasts by CancerCare News in 2024 & 2025, and #1 Rated Cancer Survivor Podcast by FeedSpot in 2024 Beating Cancer Daily is listened to in over 130 countries on 7 continents and has over 365 original daily episodes hosted by Stage IV survivor Saranne Rothberg!   To learn more about Host Saranne Rothberg and The ComedyCures Foundation:https://www.comedycures.org/ To write to Saranne or a guest:https://www.comedycures.org/contact-8 To record a message to Saranne or a guest:https://www.speakpipe.com/BCD_Comments_Suggestions To sign up for the free Health Builder Series live on Zoom with Saranne and Jacqui, go to The ComedyCures Foundation's homepage:https://www.comedycures.org/ Please support the creation of more original episodes of Beating Cancer Daily and other free ComedyCures Foundation programs with a tax-deductible contribution:http://bit.ly/ComedyCuresDonate THANK YOU! Please tell a friend whom we may help, and please support us with a beautiful review. Have a blessed day! Saranne

Ryan Phelan is a partner and patent attorney at Marshall Gerstein. He discusses his journey from a background in computer science and fintech to becoming a prominent IP attorney serving clients in the MedTech industry and beyond. He shares insights on the importance of protecting intellectual property, especially for startups, and the burgeoning role of AI in medical technology. This succinct yet fascinating conversation highlights the critical intersection of law, technology, and medical innovation. Guest links: https://www.marshallip.com | https://www.patentnext.com/  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 058 - Ryan Phelan [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 I am so looking forward to my conversation today with Ryan Phelan. Ryan is a partner and patent attorney at the Chicago based intellectual property law firm, Marshall Gerstein, where he counsels medtech companies on protecting their valuable IP. Ryan ultimately believes that AI is an important technology to embrace, but cautions medical device and related companies to approach it pragmatically, developing a policy to govern and protect intangible assets and innovation. All right. Well, thank you so much for being here, Ryan. I'm so excited to speak with you today. [00:01:29] Ryan Phelan: Yeah. Thank you for having me. Thank you, Lindsey. [00:01:31] Lindsey Dinneen: Of course. Well, I'd love if you'd start off by sharing a little bit about your background and what led you to medtech. [00:01:39] Ryan Phelan: Sure, absolutely. So I'm an attorney by trade. And I started off in probably a different place than most people in MedTech, but I have a computer science degree and I worked in industry first for Accenture, doing a lot of programming and consulting in the FinTech world. So, high frequency trading and programming some pretty complicated data algorithms in order to trade stocks and bonds and securities, and things like this. That let me see aspects of intellectual property that people were doing with respect to the code I was writing. So I got curious with IP and law, and that led me to law school, Northwestern Law, in pursuing a joint JD, MBA program, which I finished in 2010. And I went into IP law with a passion for technology, pretty much in the computing space. And then in the last decade or so, IP practitioners, not unlike doctors, like to practice in specific areas and one of the ones that I focused on is software medical devices. And so that, that kind of led me into the realm of medtech. [00:02:48] Lindsey Dinneen: Very nice. Okay. So you have had such an interesting career trajectory and I'm wondering, back in the day, say you're a six year old Ryan, could six year old Ryan have predicted that you would be a lawyer and particularly intellectual property? [00:03:04] Ryan Phelan: Absolutely not. I mean, first of all nobody in my family, at least immediate family, was a lawyer. And so going to law school was not on the radar. I grew up in Louisiana in a small town, basically farm life, so certainly technology and stuff like that wasn't available in the city. But I did have a passion for things that were tech. I was certainly a kid that loved to take things apart and put them back together and build all kinds of Legos and stuff like that. So that basic kind of STEM acumen or desire was always there from the beginning. And so, as I, I grew up and got exposed to more things, certainly in college, it became kind of a passion. And so, I ended up doing that. We did have some medical issues in my family, including cardiac and cancer and stuff like that. So, those types of things always hit home with me and you're getting to a chance to kind of lean into medtech, at least on the software side, with medtech devices that include or incorporate medical technology became very interesting to me personally. [00:04:07] Lindsey Dinneen: Yeah, of course. And so going back just a smidgen when you decided to go into law and you know, you've come from this background that was the software engineering and you've got this fintech background and you have all of these amazing skill sets already, what led you specifically to say, "Okay, I want to focus on intellectual property, and so this is going to be my, my sweet spot." [00:04:33] Ryan Phelan: Yeah. So when you go to law school, you get exposed to a lot of different classes. In fact, in your first year law school, you're required to take a bunch of baseline courses like criminal law and all these things. And so you quickly figure out what you like and what you don't like. And so for me, a computer science degree is always kind of the beating heart of what I loved. And so I wanted to, I tended to like, classes that were up that alley, so to speak. And the IP course that I took was definitely there because it was all about technology, inventions, people making things, and how those inventions played out in court. So I found my greatest joy in law school to be in those classes. So I spoke up the most in class and did the best. There's common saying that "you should do things that you love because you never have to work a day in your life" kind of thing. So I always try to think about that, and certainly fun today because I practice in IP and picked that direction. [00:05:27] Lindsey Dinneen: Yeah, absolutely. So, in addition to all of the other credentials you have, you are also a published author and you are a speaker. And I would love if you would share maybe a little bit more about how you got into being a thought leader as well in your industry and how that path has taken you. [00:05:51] Ryan Phelan: Yeah, for sure. It's the same kind of thing. I've always liked to write as well. And I feel that when I write about something, I really get to understand it. And so in my field, there's a lot of stuff happening all the time. Like a court will come out with a new case, an IP and medtech or AI or something like this, and I really like to dig into it to figure out how can I use this court decision as a tool for clients, or how does this change things up? What will clients ask me questions going forward, or how can this be an interesting topic to either write about or to speak about? And so, I try to learn when I'm reading, and then I write it, and that teaches me, and I think and hope that others get a benefit from that too when I publish, so. [00:06:34] Lindsey Dinneen: Yes, of course. Of course. And you are also, if I'm not mistaken, an adjunct professor. So, first of all, do you sleep? And second of all, tell me more about this as well, please. [00:06:47] Ryan Phelan: Yeah, so I'm an adjunct professor at Northwestern Law. I teach a course on patenting software inventions. I do sleep because it's only once a year for a power week. You know, I think it's like three days out of the year. There's the long classes, they're like a few hours each, but we pack in several 30 minute core sessions into a day. So one day, maybe we'll go for three hours or two hours. And, you know, we will get the benefit of several weeks of coursework by doing all of that at once in those three days. And so, I teach on that. We teach fundamentals of patenting softwares and inventions, which includes medtech software devices. For example, the FDA classifies software, medical inventions in, in, in certain ways, like their software as a medical device where you have the software only such as, you have database with medical data and you're either formatting it or storing it or processing in some unique way, or you have software in a medical device where you actually have a physical device. It's a cardiac device where the software is running or at least partially running that device. And so we talk about ways to, to patent those inventions primarily with US law. So. [00:07:59] Lindsey Dinneen: Very nice. So specifically thinking about your medtech clients, because I know you probably have clients in many industries, but specifically in medtech, what are some of the common mistakes you see medtech companies making? Especially say, you know, an earlier startup or something like that, when maybe they haven't thought through an aspect that really should be thought through a little bit earlier in the process. What are some common things that you see that people should be aware of? [00:08:27] Ryan Phelan: Yeah, I mean, easily one of them is not filing a patent application early. And if they are a startup company and they have their biggest selling product, or what they think will be their biggest selling product, and they don't file a patent application on it, that could be bad because you have one year to get to the patent office with that, at least in the U. S. to file something once it's been publicly disclosed. And if you miss that deadline, then effectively you're allowing your competitors to copy it. And if you're a startup company, the last thing you want is for your product to become extremely successful and then a big Fortune 500 company gets wind of it, figures out you don't have a patent, and then just starts making it themselves and it takes away your market share. So that would be, you know, I think that's every inventor of startups like worst nightmare, right? So, getting that patent on file before the deadline is pretty important. [00:09:22] Lindsey Dinneen: Yeah, of course. Now, I noticed you had recently written an article on LinkedIn about when to file this patent. And I know part of maybe some concerns that might arise are, "Well, we don't necessarily want this to be in public awareness yet." So how do you walk that line between "This is our IP, we're really trying to keep it very tight," versus, "But I also need this protection, this legal protection." So how do you navigate things like that? [00:09:54] Ryan Phelan: Yeah, so the point at which you need to make your invention publicly available or to disclose it because you need to, you know, maybe you're going to pitch competition and you need to show your invention on like a PowerPoint deck in front of hundreds of people. Then that's probably a good point to start thinking about filing a patent application if you're still developing it, and it's like in your basement, so to speak, and nobody's seen it. It's still secret then. You don't need to necessarily file a patent application at that point. Although, there's a funny thing in patent law where, if you have an idea, sometimes there's somebody else thinking about it too, and the first one to get the patent office, wins, and so, you certainly don't want to wait around too long and find out years later that you filed your patent application the day after somebody else. This actually happened with Thomas Edison and the light bulb and he had lots of fights about the other person that was claiming the same thing that lost, and we don't remember his name today because of that. So anyway, so that's one thing to keep in mind when you're starting out. [00:10:54] Lindsey Dinneen: Yeah. Well, and speaking of those kinds of stories, are there any that particularly stand out to you as you've worked with all of these incredible clients who have seriously life changing products they're creating. Are there any that really stand out to you in your memory as affirming, "Oh my goodness, this is why I'm here. This is why I'm doing what I'm doing." [00:11:17] Ryan Phelan: Yeah, for sure. One that stands out is one in the opioid or the narcotics market. In my family, we have an individual who is unfortunately affected by this. And so, I had a client that reached out to me to create a VR program that helps to eliminate or to reduce cravings in this field. And that one was really impactful because using technology and non pharmaceutical way in order to reduce cravings for people that are struggling with addiction of some type, I felt to be very important. So I thoroughly enjoyed working with that inventor and helping to, to create that patent application for that invention. [00:11:59] Lindsey Dinneen: Yeah, of course. Yeah. Thank you for sharing about that. I think sometimes those really personal connection kinds of stories are the ones that really stick in your mind because it, it helps to have this moment of realization, like you know that what you do matters, of course, but then having that extra layer of confirmation that "Yes, this is helping somebody who could literally be a family member or a close friend or relative" is really impactful. [00:12:25] Ryan Phelan: Exactly. [00:12:26] Lindsey Dinneen: Yeah. So considering all of the industries that you currently serve, and of course, you have this incredibly varied background, which can only be wonderful to draw on from this rich history and experience of yours. What are some interesting crossovers you see between industries that can be useful in terms of, maybe one industry approaches something in a way that you've seen could actually really benefit folks in medtech or vice versa. Are you seeing trends like that? [00:12:59] Ryan Phelan: Yeah, absolutely. I mean, one of the biggest ones that I can think of now is artificial intelligence coming into play with medtech. I mean, certainly, medtech kind of runs the gamut of, you know, like, like we mentioned before software only to physical devices that incorporate software. And so AI is interesting because you can load it and AI model onto one of these physical devices, or you can have an AI model that's medtech based sitting on a server somewhere that can help doctors look or find particular cause or whatnot like that, based on symptoms that a patient may walk into, or maybe there's a device, like a needle, that allows that has an AI model on it that helps with injection or something like this. And so, these AI tools are becoming smarter. And I think that they help in the field of medtech and they require a different level of expertise with these inventions to not only create them because they're complex, but also to bring them to market because they require specific FDA regulations. Even the FDA right now is trying to figure out AI. They have approved several AI devices, but it usually comes down to, you know, is your AI device going to change in the near future because you're going to update the model? And if so, does that change it enough to require like a new submission? So the fact that AI moves so rapidly doesn't really mix well with the FDA's process of approving the device and having it set in stone at that approval state. [00:14:30] Lindsey Dinneen: Yeah. So where do you anticipate that this will take medical devices? Do you think it'll become so naturally ingrained in many of them that it's just sort of part of our reality, or do you think we'll still have those --what do we want to call them-- not AI functionality devices? [00:14:48] Ryan Phelan: Yeah, I think both will exist. You know, certainly a spectrum of these devices, right? Certainly there's surgical tools that exist now that have hundreds of years, or a hundred years, just in different, maybe better forms. So, those will stay, stick around. The AI assisted ones, I'm sure will find their niche, and live alongside the the existing tools. [00:15:10] Lindsey Dinneen: Yeah, absolutely. If you could narrow it down, what would be maybe your top piece of advice for a MedTech startup founder from your perspective, in your role? [00:15:23] Ryan Phelan: Yeah, I guess the number one would be again to, you know, make sure you're not giving away your crown jewels. Have your patent filed before you step out. If you're trying to raise money, just be careful that you're not sharing information publicly. You have to share with a potential investor, consider an NDA or if they won't sign an NDA, you can file a provisional patent application with the patent office. That shows that you have something on file before you talk to others. And as long as you describe the invention sufficiently in the four corners of your provisional application, then that's often the best way to protect yourself going out. So I think, as an IP attorney, that, that would be the number one advice that I would give a startup company in the medtech space. [00:16:10] Lindsey Dinneen: That's incredible. Thank you for that. That's really appreciated advice. So, it's so interesting because when I was looking at your LinkedIn profile, of course you have all of this incredible experience, and one thing actually really stood out to me, and that was that at least at some point you have been a and --I'm sure you've done this throughout your career multiple times-- but a pro bono lawyer for Lawyers for the Creative Arts. And I was curious about that and how you got involved, and can you share a little bit about that journey? [00:16:40] Ryan Phelan: Yeah. So LCA or Lawyers for the Creative Arts is an organization here in Chicago that deals with artists of limited means. You know, usually they have some type of basic issue that they want handled and it mainly deals with IP. Typically, I work on a different capacity for these because I see them as like kind of fun learning opportunities. I usually work in the copyright space and the clients that I work with need help either filing a copyright for maybe a piece of art that they've created, or maybe have a question about how their IP is being used or sold in some way, and they need to figure out if their IP has been infringed. And so, we'll work with them in a pro bono capacity to help write a letter to a company or to file a copyright registration and things like that. [00:17:28] Lindsey Dinneen: Well, as a, as my side thing as also an artist, I just want to say thank you because it is so great that you're doing things like that for the artist community. It is not always easy. So, oh, that's great, appreciate it. Yeah. So as you look towards your own future, what are you excited about say in the next year or two? [00:17:50] Ryan Phelan: Very excited to see how, I guess, AI is playing out with medtech. You're seeing regulations and guidelines coming out that The United States Patent and Trademark Office and also the Copyright Office about how these laws will impact artists. I've sat on a panel with the Copyright Office and the United States Patent and Trademark Office as they're thinking through these decisions and putting out these guidelines. There is questions about, is the new administration going to change things up with respect to guidance and guidelines that have come out. So, you know, artists are looking at AI is like a tool, like a paintbrush. And the law is kind of looking at it, obviously from the legal perspective and it doesn't seem like those two things are aligned yet. There's common in, in history that the law typically lags the technology by, you know, a decade or two or more. And so that's certainly the case with AI. For example, there is a famous -- I wouldn't call it a case-- but a denial of a copyright registration at the copyright office for a gentleman that had created an AI piece of artwork, won the Colorado state fair, I think in 2022, and tried to file a copyright registration, but was denied. And he told the copyright office, basically he had entered in 500 plus prompts in order to generate, or at least partially generate, this work of art, but was still denied . Not because of his effort, just because of the way the law is written under current copyright statutes. And so, things like that seem to be, at least from a policy perspective, incorrect. And so it'd be great to see exciting how this plays out. Will Congress care enough to change it or how will artists be impacted under these types of laws and policy considerations going forward? [00:19:35] Lindsey Dinneen: Yeah, absolutely. So pivoting the conversation a little bit just for fun, imagine that you were to be offered a million dollars masterclass on anything you want. It can be within your industry or part of your amazing background, or it could be about something entirely different. What would you choose to teach? [00:19:55] Ryan Phelan: Yeah. Wow. You know, I guess I would teach what I'm currently teaching. Cause I, I do enjoy the class I teach now. I'm at Northwestern, my alma mater, which I love. It's down the street from the office, get to go in same place where I went to school and teach the law and things that I do every day, which is patenting software inventions, including the medtech space. If I could get a million dollars to teach what I do now, that would be wonderful, in this hypothetical, so. [00:20:22] Lindsey Dinneen: Right. I love it. Excellent. And how do you wish to be remembered after you leave this world? [00:20:30] Ryan Phelan: Wow. I hope people remember me as someone who was fun loving and enjoyed tech and hopefully brought some information to the world that helped them in some way. [00:20:42] Lindsey Dinneen: Yeah, of course. And final question, what is one thing that makes you smile every time you see or think about it? [00:20:51] Ryan Phelan: Oh, wow. I guess there's a lot of stuff. I also like to do some type of sports. Currently, the ski season is ending, so I certainly enjoy skiing, so when I see or think about that's one of those things, and now coming is the golf season, so I transitioned into that. We're looking forward to some good weather here, finally, in Chicago. It was 80 degrees last week, and it snowed yesterday, so things are changing from golf to ski season, but one of those is always fun, so. [00:21:17] Lindsey Dinneen: That's awesome. That's fantastic. Yeah. If folks who are listening are in a position, would there be a way for them to get in contact with you and then how early should they do that actually? [00:21:31] Ryan Phelan: Yeah. There's multiple stages. They can get in touch with me anytime they want. You can always find me at our firm's website, Marshall Gerstein. Or if you want to, you can go to patentnext.com, just patent and the word next. com. That's my blog that I write on typically, and it has my contact information there, including my email address. [00:21:51] Lindsey Dinneen: Perfect. Well, thank you so much. Well, Ryan, it has been a joy to speak with you today. I really appreciate you sharing a little bit about your career and your insights, your advice, especially appreciate that for MedTech founders who might, you know, not quite know where to start with this whole legal element that they really need to consider. So I really appreciate you sharing kind of when and how to do that. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. And thank you again so much for being here. This has been a wonderful conversation, and I just wish you the most continued success as you work to change lives for a better world. [00:22:41] Ryan Phelan: Thank you, Lindsey. My pleasure. Happy to be here too. Thank you for having me. [00:22:44] Lindsey Dinneen: Of course. And for our listeners, thank you so much for tuning in. 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. [00:22:56] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Former FDA official Peter Marks criticized the agency's new risk-based COVID-19 vaccine framework, stating it contradicts the administration's transparency and science standards. The CDC's advisory committee recommended Merck's infant RSV vaccine, and Novavax's approval delay raised concerns about politicization of drug approval processes. Lilly's Verve deal revealed regulatory turmoil following Marks' resignation. Meanwhile, Trump's CDC pick supports vaccine safety, Novartis made a large bet on cardiovascular disease targets, and RFK cut US funding from vaccine alliance Gavi. The biopharma industry is hiring less international talent, and pharma companies face challenges with failed immuno-oncology projects. Evotec is hosting a webinar on preserving quality in the pharmaceutical industry.

This week we hear from Dr. Will Van Derveer about about the proven benefits of Psychedelic Assisted Therapy. Dr. Van Derveer shared how after working with veterans he became discouraged by the conventional treatments like talk therapy and endless medications which often fail to treat the root cause of conditions like anxiety, bi-polar, depression and PTSD. After two decades of developing innovative approaches to address the root causes of symptoms, in 2018 he co-founded the Integrative Psychiatry Institute. A leader on a mission to transform mental healthcare, VanDerveer set a goal to train 10,000 providers in psychedelic-assisted therapy. We started with a discussion about the failures of standard mental health treatment protocols. Dr. Van Derveer shared data on the effectiveness of psychedelics, and updates on current VA, FDA trials, including MDMA, and Psilocybin. And how many vets are forced to “free-lance their own care” by going to Mexico to gain access to Ibogaine therapy. Dr Van Derveer also shared the vicious mental cycle a PTSD patient endures, what a psychedelic treatment session is like, and how psychedelics are proving effective at helping veterans heal. For more on psychedelic-assisted therapy, resources and training programs for mental care providers, check out The Integrative Psychiatry Institute: https://psychiatryinstitute.com/ Connect with CBS Eye on Veterans, Host, Phil Briggs phil@connectingvets.com To learn more about listener data and our privacy practices visit: https://www.audacyinc.com/privacy-policy Learn more about your ad choices. Visit https://podcastchoices.com/adchoices

In this episode, hear Allison Butts, PharmD, BCOP and Danielle Roman, PharmD, BCOP, share their insights on the best practices for incorporating antibody–drug conjugates (ADCs) into clinical practice including:An overview of ADC structure and mechanism of actionA topline review of data supporting the current FDA-approved indications for ADCs targeting HER2 and TROP-2 across multiple tumor typesAn in-depth look at common and serious adverse events with each approved ADC along with an overview of management strategiesEditor's note: On June 23, 2025, the FDA granted accelerated approval for a new indication for datopotamab deruxtecan, one of the antibody drug conjugates discussed in this podcast. Datopotamab deruxtecan is now also approved for adults with locally advanced or metastatic EGFR-mutated NSCLC who have received previous EGFR-targeted therapy and platinum-based chemotherapy. Program faculty:Allison Butts, PharmD, BCOPPharmacist Manager, OncologyClinical Pharmacist, Breast OncologyUK HealthCareMarkey Cancer CenterLexington, KentuckyDanielle Roman, PharmD, BCOPManager, Oncology Clinical Pharmacy ServicesAllegheny Health NetworkPittsburgh, PennsylvaniaProgram page:https://bit.ly/4lr7cT6

Criminal Complaint Filed Over 'Warp Speed Cancer' (01:00:45 – 01:07:05)A complaint filed in France alleges mRNA vaccines caused deadly turbo cancers, implicating global health agencies while ignoring U.S. officials who enabled vaccine rollout. The term 'Warp Speed Cancer' is used to link aggressive cancers with the vaccine campaign.FDA Study Finds Excess DNA in COVID Vaccines (01:12:06 – 01:14:00)An FDA study confirms high levels of DNA contamination in Pfizer's mRNA vaccine, raising concerns over cancer risk and regulatory negligence. Critics compare the lax response to how pollution or car emissions would be handled.COVID Vaccine Removed from CDC Schedule for Children (01:25:54 – 01:27:49)RFK Jr. announces removal of COVID vaccines from the CDC schedule for healthy children and pregnant women, though skepticism is expressed over the true intent and lingering influence of vaccine advocates.CDC Panel Head Accused of Downplaying Vaccine Injuries (01:33:12 – 01:36:50)The new CDC vaccine panel head is criticized for opposing pauses on J&J shots and ignoring adverse event reports, leading to claims of pro-vaccine bias and lack of transparency about injury risks.Cargo Ship Fire Tied to EV Battery Hazards (01:53:00 – 01:59:30)An EV-laden cargo ship sinks after a prolonged fire, raising environmental concerns over lithium battery safety and whether such incidents are factored into EVs' environmental impact.Tesla Robo-Taxi Glitches Spark Regulatory Scrutiny (02:00:36 – 02:07:42)Videos show Tesla's driverless taxis behaving erratically, including stopping in intersections and veering off course. Observers criticize the premature rollout and ineffective safety measures.Markets Shrug Off U.S.-Israel Strike on Iran (02:25:30 – 02:27:04)Gold, silver, oil, and Bitcoin show minimal reaction to joint U.S.-Israel strikes, suggesting either disbelief in the severity of events or market manipulation by major financial actors.Christian Zionism Criticized as Political Idolatry (02:48:33 – 02:52:57)Christian Zionism is condemned as a distortion of theology, accused of leading believers to support war and foreign interventions at the expense of persecuted Christian communities.Pro-Israel Loyalty Test in Conservative Politics (02:52:58 – 03:01:38)Conservative figures are accused of prioritizing loyalty to Israel over American interests. A generational shift is predicted as younger conservatives push back against foreign entanglements.BIS vs IMF: Stablecoin Suppression and CBDC Agenda (03:01:39 – 03:03:04)The BIS targets stablecoins in what's described as a battle over who will control future digital money, with CBDCs positioned as tools of global financial dominance.Bitcoin Seen as Hedge Against Fiat Collapse (03:03:05 – 03:07:01)Extreme Bitcoin price forecasts are discussed in the context of fiat currency debasement, with Bitcoin framed as a finite refuge from an increasingly unstable monetary system.Self-Driving Cars as Surveillance and Control Tools (03:13:14 – 03:18:00)Explores how autonomous vehicles collect and transmit driver data, affect social credit scores, and raise concerns about accountability, privacy, and control.War Powers Debate: Trump, Iran, and Congressional Authority (03:18:01 – 03:24:17)Critiques Trump's bombing of Iran without Congressional approval and rebuts claims by Mike Johnson and J.D. Vance that the War Powers Resolution limits presidential authority.MAGA Civil War: Candace Owens vs. Trump on Vaccines and Israel (03:24:18 – 03:29:55) Candace Owens distances herself from Trump over foreign policy while she gave him a pass on Warp Speed vaccines, with commentary on her past praise and growing populist pushback.Trump's Nobel Peace Prize Nomination Mocked (03:30:40 – 03:31:35) Trump is nominated for a Nobel Peace Prize following the Iran ceasefire, provoking ridicule given his role in launching strikes days earlier.Mark Levin vs. Steve Bannon: Neocon Populist Feud over Israel (03:34:20 – 03:39:01)Levin calls for escalated military support for Israel, while Bannon and populist circles reject U.S. involvement. The rift signals deeper ideological divides on the right.Damage from Iranian Missile Strikes on Israel (03:45:10 – 03:47:55)Reports and footage highlight destruction caused by Iranian retaliation, while commentary accuses elites of profiting from wars at civilian expense.Iranian Officials Reported Dead Resurface (03:48:40 – 03:50:35) High-ranking Iranian figures previously declared dead by Israeli sources are shown to be alive, raising doubts about the success of targeted strikes.Follow the show on Kick and watch live every weekday 9:00am EST – 12:00pm EST https://kick.com/davidknightshow Money should have intrinsic value AND transactional privacy: Go to https://davidknight.gold/ for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to https://trendsjournal.com/ and enter the code KNIGHT Find out more about the show and where you can watch it at TheDavidKnightShow.comIf you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-showOr you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7Become a supporter of this podcast: https://www.spreaker.com/podcast/the-david-knight-show--2653468/support.

Why are politicians trying to ban the safer alternatives to cigarettes… while leaving cigarettes untouched? What's the real motivation behind targeting products like Zyn and vapes? Is this about protecting public health—or protecting power and control? Studio Sponsor: ⁠Cardio Miracle⁠ - "Unlock the secret to a healthier heart, increased energy levels, and transform your cardiovascular fitness like never before.": ⁠CardioMiracle.com/TBNS⁠ In this punchy, eye-opening episode of The Brian Nichols Show, we dive headfirst into the war on nicotine alternatives. Host Brian Nichols sits down with health policy analyst and harm reduction fellow Sophia Hamilton to break down why the government is so obsessed with regulating—if not outright banning—products like Zyn pouches. Spoiler: it has nothing to do with safety and everything to do with outdated narratives, political grandstanding, and generational ignorance. Sophia walks us through how the government's crackdown on Juul created a black market mess, how Zyn emerged as a cleaner, safer alternative, and why politicians like Chuck Schumer are frothing at the mouth to ban it next. Even though studies show these products are far less harmful than traditional tobacco, that's not stopping the Nanny State from stepping in. Brian and Sophia also dig into the generational divide fueling this hysteria—highlighting how Gen Z is rejecting alcohol and cigarettes but is being punished for making safer, informed choices. The hypocrisy is rich: the same boomers who once fell for Big Tobacco ads now want to control what young people can and can't use, despite overwhelming data and personal autonomy. And let's not forget the role of the FDA, which seems more interested in gatekeeping and bureaucracy than in approving harm-reduction products that actually help people quit smoking. This isn't just a public health failure—it's a prime example of government overreach making life worse, not better. You do not want to miss this one. We have a new show on Lions of Liberty! The Politicks Podcast! Be sure to subscribe to the standalone Politicks Podcast feed. This is the absolute best way to support the show! Listen and subscribe on Apple Podcasts and Spotify. And remember, they're all Blood Suckers! ❤️ Order ⁠Cardio Miracle⁠ (⁠CardioMiracle.com/TBNS⁠) for 15% off and take a step towards better heart health and overall well-being!

Step right up to the medieval ophthalmology booth where your chalazion gets cured with garlic, mustard seeds, and just a dash of cow bile. This week, I take you on a Renaissance Festival-style journey through the weirdest eye treatments in history and how some of those relics have been rebranded for the modern wellness crowd. There's leech therapy, eye “massagers,” and influencers promising vision miracles with homeopathic potions that would make a 13th-century snake oil vendor proud. Also: how do I keep my sanity posting online every day while avoiding ye olde digital burnout? Let's joust. Takeaways: If your eye treatment sounds like something a plague doctor brewed—maybe don't. Medieval eye salves made from onions and bile are more like Renaissance cosplay than science… unless you're on TikTok. Some modern devices claim to fix your vision but operate with the same logic as 15th-century eye pokers. The FDA was practically invented to protect us from “miracle” eye tonics like these. Posting about medicine online can feel like performing in the town square—here's how I avoid getting metaphorically pelted with tomatoes. — To Get Tickets to Wife & Death: You can visit Glaucomflecken.com/live  We want to hear YOUR stories (and medical puns)! Shoot us an email and say hi! knockknockhi@human-content.com Can't get enough of us? Shucks. You can support the show on Patreon for early episode access, exclusive bonus shows, livestream hangouts, and much more! –⁠⁠⁠⁠⁠⁠⁠⁠⁠ http://www.patreon.com/glaucomflecken⁠⁠⁠⁠⁠⁠⁠⁠⁠  Also, be sure to check out the newsletter: https://glaucomflecken.com/glauc-to-me/ If you are interested in buying a book from one of our guests, check them all out here: https://www.amazon.com/shop/dr.glaucomflecken If you want more information on models I use: Anatomy Warehouse provides for the best, crafting custom anatomical products, medical simulation kits and presentation models that create a lasting educational impact.  For more information go to Anatomy Warehouse DOT com. Link: https://anatomywarehouse.com/?aff=14 Plus for 15% off use code: Glaucomflecken15 -- A friendly reminder from the G's and Tarsus: If you want to learn more about Demodex Blepharitis, making an appointment with your eye doctor for an eyelid exam can help you know for sure. Visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠http://www.EyelidCheck.com⁠⁠⁠⁠⁠⁠⁠⁠⁠ for more information.  Today's episode is brought to you by DAX Copilot from Microsoft. DAX Copilot is your AI assistant for automating clinical documentation and workflows helping you be more efficient and reduce the administrative burdens that cause us to feel overwhelmed and burnt out. To learn more about how DAX Copilot can help improve healthcare experiences for both you and your patients visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠aka.ms/knockknockhi⁠⁠⁠⁠⁠⁠⁠⁠⁠. To learn more about Pearson Ravitz go to ⁠⁠⁠⁠⁠⁠⁠⁠http://www.pearsonravitz.com/knockknock⁠⁠⁠⁠⁠⁠⁠⁠. Produced by⁠⁠⁠⁠⁠⁠⁠⁠⁠ Human Content Learn more about your ad choices. Visit megaphone.fm/adchoices

Criminal Complaint Filed Over 'Warp Speed Cancer' (01:00:45 – 01:07:05)A complaint filed in France alleges mRNA vaccines caused deadly turbo cancers, implicating global health agencies while ignoring U.S. officials who enabled vaccine rollout. The term 'Warp Speed Cancer' is used to link aggressive cancers with the vaccine campaign.FDA Study Finds Excess DNA in COVID Vaccines (01:12:06 – 01:14:00)An FDA study confirms high levels of DNA contamination in Pfizer's mRNA vaccine, raising concerns over cancer risk and regulatory negligence. Critics compare the lax response to how pollution or car emissions would be handled.COVID Vaccine Removed from CDC Schedule for Children (01:25:54 – 01:27:49)RFK Jr. announces removal of COVID vaccines from the CDC schedule for healthy children and pregnant women, though skepticism is expressed over the true intent and lingering influence of vaccine advocates.CDC Panel Head Accused of Downplaying Vaccine Injuries (01:33:12 – 01:36:50)The new CDC vaccine panel head is criticized for opposing pauses on J&J shots and ignoring adverse event reports, leading to claims of pro-vaccine bias and lack of transparency about injury risks.Cargo Ship Fire Tied to EV Battery Hazards (01:53:00 – 01:59:30)An EV-laden cargo ship sinks after a prolonged fire, raising environmental concerns over lithium battery safety and whether such incidents are factored into EVs' environmental impact.Tesla Robo-Taxi Glitches Spark Regulatory Scrutiny (02:00:36 – 02:07:42)Videos show Tesla's driverless taxis behaving erratically, including stopping in intersections and veering off course. Observers criticize the premature rollout and ineffective safety measures.Markets Shrug Off U.S.-Israel Strike on Iran (02:25:30 – 02:27:04)Gold, silver, oil, and Bitcoin show minimal reaction to joint U.S.-Israel strikes, suggesting either disbelief in the severity of events or market manipulation by major financial actors.Christian Zionism Criticized as Political Idolatry (02:48:33 – 02:52:57)Christian Zionism is condemned as a distortion of theology, accused of leading believers to support war and foreign interventions at the expense of persecuted Christian communities.Pro-Israel Loyalty Test in Conservative Politics (02:52:58 – 03:01:38)Conservative figures are accused of prioritizing loyalty to Israel over American interests. A generational shift is predicted as younger conservatives push back against foreign entanglements.BIS vs IMF: Stablecoin Suppression and CBDC Agenda (03:01:39 – 03:03:04)The BIS targets stablecoins in what's described as a battle over who will control future digital money, with CBDCs positioned as tools of global financial dominance.Bitcoin Seen as Hedge Against Fiat Collapse (03:03:05 – 03:07:01)Extreme Bitcoin price forecasts are discussed in the context of fiat currency debasement, with Bitcoin framed as a finite refuge from an increasingly unstable monetary system.Self-Driving Cars as Surveillance and Control Tools (03:13:14 – 03:18:00)Explores how autonomous vehicles collect and transmit driver data, affect social credit scores, and raise concerns about accountability, privacy, and control.War Powers Debate: Trump, Iran, and Congressional Authority (03:18:01 – 03:24:17)Critiques Trump's bombing of Iran without Congressional approval and rebuts claims by Mike Johnson and J.D. Vance that the War Powers Resolution limits presidential authority.MAGA Civil War: Candace Owens vs. Trump on Vaccines and Israel (03:24:18 – 03:29:55) Candace Owens distances herself from Trump over foreign policy while she gave him a pass on Warp Speed vaccines, with commentary on her past praise and growing populist pushback.Trump's Nobel Peace Prize Nomination Mocked (03:30:40 – 03:31:35) Trump is nominated for a Nobel Peace Prize following the Iran ceasefire, provoking ridicule given his role in launching strikes days earlier.Mark Levin vs. Steve Bannon: Neocon Populist Feud over Israel (03:34:20 – 03:39:01)Levin calls for escalated military support for Israel, while Bannon and populist circles reject U.S. involvement. The rift signals deeper ideological divides on the right.Damage from Iranian Missile Strikes on Israel (03:45:10 – 03:47:55)Reports and footage highlight destruction caused by Iranian retaliation, while commentary accuses elites of profiting from wars at civilian expense.Iranian Officials Reported Dead Resurface (03:48:40 – 03:50:35) High-ranking Iranian figures previously declared dead by Israeli sources are shown to be alive, raising doubts about the success of targeted strikes.Follow the show on Kick and watch live every weekday 9:00am EST – 12:00pm EST https://kick.com/davidknightshow Money should have intrinsic value AND transactional privacy: Go to https://davidknight.gold/ for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to https://trendsjournal.com/ and enter the code KNIGHT Find out more about the show and where you can watch it at TheDavidKnightShow.comIf you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-showOr you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7Become a supporter of this podcast: https://www.spreaker.com/podcast/the-real-david-knight-show--5282736/support.

For a more than a century, the Food and Drug Administration has worked to protect public health. In his research, Harvard University physician-researcher Jerry Avorn has examined how the FDA's once-rigorous gold standard approval process has been affected by a powerful shortcut known as the Accelerated Approval Program—originally designed for desperate AIDS and cancer patients. He says that change in the 1990s has allowed more than half of all new drugs onto the market before drug companies have proven they actually help people.In his new book Rethinking Medications: Truth, Power and the Drugs We Take, Avorn cites numerous examples: from a cold medicine that doesn't de-congest to billion-dollar cancer treatments that only shrink lab results to the controversial Alzheimer's drug Aduhelm—approved despite no clear cognitive benefits. In this episode, Avorn explores whether some prescriptions in your medicine cabinet are safe, effective and worth the money.

"Older adults have this special clarity about who they are and what they want, which is incredibly inspiring," says Dr. Julia Hiner, explaining, in part, why she loves her work as a geriatrician in Houston, Texas. She also enjoys the challenge of the medical complexity these patients present and the opportunity it creates to see the patient as a whole person. In fact, as you'll hear in this upbeat conversation with Raise the Line host Lindsey Smith, there's almost nothing about geriatrics that Dr. Hiner does not enjoy, which explains her passion for teaching the subject at McGovern Medical School at the University of Texas Health Science Center in Houston and trying to convince more students to pursue it as their specialty.  The need is great, given that there are only 8,000 geriatricians in the US despite a rapidly growing senior population. Tune in to learn why Dr. Hiner thinks clinicians avoid the field and the steps that can be taken to improve the situation, including requiring courses in geriatrics. You'll also learn about the importance of capacity assessments, the troubling, and under-reported, problem of elder mistreatment, ageism among health professionals and much more in this super informative episode. Mentioned in this episode:University of Texas Health Science Center at Houston McGovern Medical School  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/raisethelinepodcast

In this episode of the Dental Board Room Podcast, Wes Read CPA, CFP, continues AI in Dentistry series with a very special guest, Dr. Wardah Inam, founder and CEO of Overjet AI. With a background from MIT and Harvard, Dr. Wardah Inam is at the forefront of AI innovation in dental care.Overjet is the first FDA-cleared dental AI platform for both caries detection and bone level measurements. It's used by solo practitioners, DSOs, insurers, and dental schools alike.Dr. Wardah Inam walks us through how AI is reshaping diagnosis, patient communication, insurance verification, and revenue cycle management inside dental offices. We explore the use cases, adoption challenges, and the exciting path ahead for AI in dentistry.Whether you're a dentist, DSO leader, or simply AI-curious, this episode is packed with actionable insights.Key PointsWhat is Overjet AI:First FDA-cleared dental AI for cavities and bone measurementsTrusted by clinicians, DSOs, insurers, and educatorsMission: Standardize diagnostic precision and elevate patient careOverjet's Core Offerings:Smart Imaging: AI-integrated radiograph analysis from image capture to diagnosisAI Overlays: Enhances existing imaging and PMS softwareRevenue Cycle Management Tools: Insurance verification, real-time treatment cost estimatesReal-World Use Case:Insurance verification days before the appointmentCo-diagnosis in the operatory using AI visualsTreatment plan clarity with insurance coverage breakdownsSupport for morning huddles, treatment follow-ups, and care consistencyAI for Diagnosis and Patient Communication:Color-coded visuals improve patient understanding and trustBoosts treatment acceptance by 10–20%Helps uncover underdiagnosed conditions like periodontal diseaseWhere AI is Going in Dentistry:Moving beyond the operatory into operations and admin efficiencyFuture possibilities in note-taking, billing, and clinical support#DentalAI #OverjetAI #AIinDentistry #DentalTech #DSO #DentalInnovation #PatientExperience #DentalBoardRoomPodcast #SmartDentistry #DentalDiagnosis #CaseAcceptance #FutureOfDentistry

In this must-listen episode of The Period Whisperer, I'm joined by Dr. Cheruba Prabakar, a board-certified OBGYN and minimally invasive surgeon, to talk about a crucial health topic for women in perimenopause: cervical cancer. Dr. Prabakar is here to shed light on the latest developments in cervical cancer screening, including the revolutionary self-collection HPV test—an FDA-approved, less invasive alternative to the traditional Pap smear.As we navigate the hormonal changes of perimenopause, understanding cervical cancer prevention and knowing how to get screened properly are vital steps in protecting our health. In this episode, Dr. Prabakar answers the questions you've been wondering about, from what causes cervical cancer to how you can take proactive steps for prevention. If you're a woman in perimenopause, this episode is packed with valuable information to help you take control of your health.Key Takeaways:

The FDA calls it a groundbreaking step in new drug development. A plan to phase out animal testing will steer hundreds of millions of dollars toward high-tech alternatives. In this episode of Open Record, FOX6 Investigator Bryan Polcyn explains how scientists here in Wisconsin are leading the effort to transform pharmaceutical research. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Dr. Neeraj Agarwal and Dr. Jeanny Aragon-Ching discuss important advances in the treatment of prostate, bladder, and kidney cancers that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News Podcast. I am Dr. Neeraj Agarwal, your guest host of the ASCO Daily News Podcast today. I am the director of the Genitourinary Oncology Program and a professor of medicine at the University of Utah Huntsman Cancer Institute and editor-in-chief of the ASCO Daily News.  I am delighted to be joined by Dr. Jeanny Aragon-Ching, a GU medical oncologist and the clinical program director of the GU Center at the Inova Schar Cancer Institute in Virginia. Today, we will be discussing some key abstracts in GU oncology that were presented at the 2025 ASCO Annual Meeting.  Our full disclosures are available in the transcript of this episode.  Jeanny, it is great to have you on the podcast. Dr. Jeanny Aragon-Ching: Oh, thank you so much, Neeraj. Dr. Neeraj Agarwal: Jeanny, let's begin with some prostate cancer abstracts. Let's begin with Abstract 5017 titled, “Phase 1 study results of JNJ-78278343 (pasritamig) in metastatic castration-resistant prostate cancer.” Can you walk us through the design and the key findings of this first-in-human trial? Dr. Jeanny Aragon-Ching: Yeah, absolutely, Neeraj. So this study, presented by Dr. Capucine Baldini, introduces pasritamig, a first-in-class T-cell redirecting bispecific antibody that simultaneously binds KLK2 on prostate cancer cells and CD3 receptor complexes on T cells. KLK2 is also known as human kallikrein 2, which is selectively expressed in prostate tissue. And for reference, KLK3 is what we now know as the PSA, prostate-specific antigen, therefore making it an attractive and specific target for therapeutic engagement. Now, while this was an early, first-in-human, phase 1 study, it enrolled 174 heavily pretreated metastatic CRPC patients. So many were previously treated with ARPIs, taxanes, and radioligand therapy. So given the phase 1 nature of this study, the primary objective was to determine the safety and the RP2D, which is the recommended phase 2 dose. Secondary objectives included preliminary assessment of antitumor activity. So, pasritamig was generally well tolerated. There were no treatment-related deaths. Serious adverse events were rare. And in the RP2D safety cohort, where patients received the step-up dosing up to 300 mg of IV every 6 weeks, the most common treatment-related adverse events were low-grade infusion reactions. There was fatigue and grade 1 cytokine release syndrome, what we call CRS. And no cases of neurotoxicity, or what we call ICANS, the immune effector cell-associated neurotoxicity syndrome, reported. Importantly, the CRS occurred in just about 8.9% of patients. All were grade 1. No patients required tocilizumab or discontinued treatment due to adverse events. So, this suggests a favorable safety profile, allowing hopefully for outpatient administration without hospitalization, which will be very important when we're thinking about bispecifics moving forward. In terms of efficacy, pasritamig showed promising activity. About 42.4% of evaluable patients achieved a PSA50 response. Radiographic PFS was about 6.8 months. And among patients with measurable disease, the objective response rate was about 16.1% in those with lymph node or bone metastases, and about 3.7% in those with visceral disease, with a median duration of response of about 11.3 months. So, altogether, this data suggests that pasritamig may offer a well-tolerated and active new potential option for patients with metastatic CRPC.   Again, as a reminder, with the caveat that this is still an early phase 1 study. Dr. Neeraj Agarwal: Thank you, Jeanny. These are promising results for a bispecific T-cell engager, pasritamig, in prostate cancer. I agree, the safety and durability observed here stand out, and this opens the door for further development, possibly even in earlier disease settings.  So, shifting now from immunotherapy to the evolving role of genomics in prostate cancer. So let's discuss Abstract 5094, a real-world, retrospective analysis exploring the prognostic impact of homologous recombination repair gene mutations, especially BRCA1 and BRCA2 mutations, in metastatic hormone-sensitive prostate cancer. Can you tell us more about this abstract, Jeanny? Dr. Jeanny Aragon-Ching: Sure, Neeraj. So this study was presented by Dr. David Olmos, represents one of the largest real-world analyses we have evaluating the impact of homologous recombination repair, or what we would call HRR, alterations in metastatic hormone-sensitive prostate cancer. So, this cohort included 556 men who underwent paired germline and somatic testing. Now, about 30% of patients had HRR alterations, with about 12% harboring BRCA1 or BRCA2 mutations and 16% having alterations in other HRR genes. Importantly, patients were stratified via CHAARTED disease volume, and outcomes were examined across treatment approaches, including ADT alone, doublet therapy, and triplet therapy. The prevalence of BRCA and HRR alterations were about similar between the metastatic hormone-sensitive prostate cancer and the metastatic castrate-resistant prostate cancer, with no differences observed, actually, between the patients with high volume versus low volume disease.  So, the key finding was that BRCA and HRR alterations were associated with poor clinical outcomes in metastatic hormone-sensitive prostate cancer. And notably, the impact of these alterations may actually be even greater in metastatic hormone-sensitive prostate cancer than previously reported in metastatic CRPC. So, the data showed that when BRCA mutations are present, the impact of the volume of disease is actually limited. So, poor outcomes were observed across the board for both high-volume and low-volume groups. So, the analysis showed that patients with HRR alterations had significantly worse outcomes compared to patients without HRR alterations. Median radiographic progression-free survival was about 20.5 months for the HRR-altered patients versus 30.6 months for the non-HRR patients, with a hazard ratio of 1.6. Median overall survival was 39 months for HRR-altered patients compared to 55.7 months for the non-HRR patients, with a hazard ratio of 1.5. Similar significant differences were observed when BRCA-mutant patients were compared with patients harboring non-BRCA HRR mutations. Overall, poor outcomes were independent of treatment of ARPI or taxanes. Dr. Neeraj Agarwal: Thank you, Jeanny. So, these data reinforce homologous recombination repair mutations as both a predictive and prognostic biomarker, not only in the mCRPC, but also in the metastatic hormone-sensitive setting as well. It also makes a strong case for incorporating genomic testing early in the disease course and not waiting until our patients have castration-resistant disease. Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. And I think this really brings home the point and the lead up to the AMPLITUDE trial, which is LBA5006, a phase 3 trial that builds on this very concept of testing with a PARP inhibitor, niraparib, in the hormone-sensitive space. Can you tell us a little bit more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure. So, the AMPLITUDE trial, a phase 3 trial presented by Dr. Gerhardt Attard, enrolled 696 patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations. 56% of these patients had BRCA1 and BRCA2 mutations. Patients were randomized to receive abiraterone with or without niraparib, a PARP inhibitor. The majority of patients, 78% of these patients, had high-volume metastatic hormone-sensitive prostate cancer, and 87% of these patients had de novo metastatic HSPC. And 16% of these patients received prior docetaxel, which was allowed in the clinical trial. So, with a median follow-up of nearly 31 months, radiographic progression-free survival was significantly prolonged with the niraparib plus abiraterone combination, and median was not reached in this arm, compared to abiraterone alone, which was 29.5 months, with a hazard ratio of 0.63, translating to a 37% reduction in risk of progression or death. This benefit was even more pronounced in the BRCA1 and BRCA2 subgroup, with a 48% reduction in risk of progression, with a hazard ratio of 0.52. Time to symptomatic progression also improved significantly across all patients, including patients with BRCA1, BRCA2, and HRR mutations. Although overall survival data remain immature, early trends favored the niraparib plus abiraterone combination. The safety profile was consistent with prior PARP inhibitor studies, with grade 3 or higher anemia and hypertension were more common but manageable. Treatment discontinuation due to adverse events remained low at 11%, suggesting that timely dose modifications when our patients experience grade 3 side effects may allow our patients to continue treatment without discontinuation. These findings support niraparib plus abiraterone as a potential new standard of care in our patients with metastatic hormone-sensitive prostate cancer with HRR alterations, and especially in those who had BRCA1 and BRCA2 mutations. Dr. Jeanny Aragon-Ching: Thank you, Neeraj. This trial is especially exciting because it brings PARP inhibitors earlier into the treatment paradigm. Dr. Neeraj Agarwal: Exactly. And it is exciting to see the effect of PARP inhibitors in the earlier setting.  So Jeanny, now let's switch gears a bit to bladder cancer, which also saw several impactful studies. Could you tell us about Abstract 4502, an exploratory analysis from the EV-302 trial, which led to approval of enfortumab vedotin plus pembrolizumab for our patients with newly diagnosed metastatic bladder cancer? So here, the authors looked at the outcomes in patients who achieved a confirmed complete response with EV plus pembrolizumab. Dr. Jeanny Aragon-Ching: Sure, Neeraj. So, EV-302 demonstrated significant improvements in progression-free and overall survival for patients previously treated locally advanced or metastatic urothelial cancer, I'll just call it metastatic UC, as a frontline strategy, establishing EV, which is enfortumab vedotin, plus pembro, with pembrolizumab as standard of care in this setting.  So, this year at ASCO, Dr Shilpa Gupta presented this exploratory responder analysis from the phase 3 EV-302 trial. Among 886 randomized patients, about 30.4% of patients, this is about 133, in the EV+P arm, and 14.5% of the patients in the chemotherapy arm, achieved a confirmed complete response. They call it the CCR rates. So for patients who achieved this, median PFS was not reached with EV+P compared to 26.9 months with chemotherapy, with a hazard ratio of 0.36, translating to a 64% reduction in the risk of progression. Overall survival was also improved. So the median OS was not reached in either arm, but the hazard ratio favored the EV+P at 0.37, translating to a 63% reduction in the risk of death. The median duration of complete response was not reached with EV+P compared to 15.2 months with chemotherapy. And among those patients who had confirmed CRs at 24 months, 78% of patients with the EV+P arm remained progression-free, and around 95% of the patients were alive, compared to 54% of patients who were progression-free and 86% alive of the patients in the chemotherapy arm. Safety among responders were also consistent with prior reports. Grade 3 or higher treatment-related adverse events occurred in 62% of EV+P responders and 72% of chemotherapy responders. Most adverse events were managed with dose modifications, and importantly, no treatment-related deaths were reported among those who were able to achieve complete response.  So these findings further reinforce EV and pembro as the preferred first-line therapy for metastatic urothelial carcinoma, offering a higher likelihood of deep, durable responses with a fairly manageable safety profile. Dr. Neeraj Agarwal: Thank you for the great summary, Jeanny. These findings underscore the depth and durability of responses achievable with this combination and also suggest that achieving a response may be a surrogate for long-term benefit in patients with metastatic urothelial carcinoma.  So now, let's move to Abstract 4503, an exploratory ctDNA analysis from the NIAGARA trial, which evaluated perioperative durvalumab, an immune checkpoint inhibitor, in muscle-invasive bladder cancer. So what can you tell us about this abstract? Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. So, in NIAGARA, presented by Dr. Tom Powles, the addition of perioperative durvalumab to neoadjuvant chemotherapy, gem/cis, significantly improved event-free survival, overall survival, and pathologic complete response in patients with cisplatin-eligible muscle-invasive bladder cancer. Recall that this led to the U.S. FDA approval of this treatment regimen on March 28, 2025.  So, a planned exploratory analysis evaluated the ctDNA dynamics and their association with clinical outcomes, which was the one presented recently at ASCO. So, the study found that the incidence of finding ctDNA positivity in these patients was about 57%. Following neoadjuvant treatment, this dropped to about 22%, with ctDNA clearance being more common in the durvalumab arm, about 41%, compared to the chemotherapy control arm of 31%. Notably, 97% of patients who remained ctDNA positive prior to surgery failed to achieve a pathologic CR. So, this indicates a strong association between ctDNA persistence and lack of tumor eradication. So, postoperatively, only about 9% of patients were ctDNA positive. So, importantly, durvalumab conferred an event-free survival benefit regardless of ctDNA status at both baseline and post-surgery. Among patients who were ctDNA positive at baseline, durvalumab led to a hazard ratio of 0.73 for EFS. So, this translates to a 27% reduction in the risk of disease recurrence, progression, or death compared to the control arm. In the post-surgical ctDNA-positive group, the disease-free survival was also improved with a hazard ratio of 0.49, translating to a 51% reduction in the risk of recurrence.  So, these findings underscore the prognostic value of ctDNA and suggest that durvalumab provides clinical benefit irrespective of molecular residual disease status. So, the data also supports that ctDNA is a promising biomarker for future personalized strategies in the perioperative treatment of muscle-invasive bladder cancer. Dr. Neeraj Agarwal: Thank you, Jeanny. It is great to see that durvalumab is improving outcomes in these patients regardless of ctDNA status. However, based on these data, presence of ctDNA in our patients warrants a closer follow-up with imaging studies, because these patients with positive ctDNA seem to have a higher risk of recurrence. Dr. Jeanny Aragon-Ching: I agree, Neeraj.  Let's round out the bladder cancer discussion with Abstract 4518, which reported the interim results of SURE-02, which is a phase 2 study evaluating neoadjuvant sacituzumab govitecan plus pembrolizumab in cisplatin-ineligible muscle-invasive bladder cancer. Can you tell us more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure, Jeanny. So, Dr Andrea Necchi presented interim results from the SURE-02 trial. This is a phase 2 study evaluating neoadjuvant sacituzumab govitecan plus pembrolizumab, followed by a response-adapted bladder-sparing treatment and adjuvant pembrolizumab in patients with muscle-invasive bladder cancer.  So, in this interim analysis, 40 patients were treated and 31 patients were evaluable for efficacy. So, the clinical complete response rate was 38.7%. All patients achieving clinical complete response underwent bladder-sparing approach with a repeat TURBT instead of radical cystectomy. Additionally, 51.6% of patients achieved excellent pathologic response with a T stage of 1 or less after neoadjuvant therapy. The treatment was well tolerated, with only 12.9% of patients experiencing grade 3 or higher adverse events without needing dose reduction of sacituzumab. Molecular profiling, interestingly, showed that clinical complete response correlated with luminal and genomically unstable subtypes, while high stromal gene expression was associated with lack of response.  These results suggest that sacituzumab plus pembrolizumab combination has promising activity in this setting, and tolerability, and along with other factors may potentially allow a bladder preservation approach in a substantial number of patients down the line. Dr. Jeanny Aragon-Ching: Yeah, agree with you, Neeraj. And the findings are very provocative and support completing the full trial enrollment and further exploration of this strategy in muscle-invasive bladder cancer in order to improve and provide further bladder-sparing strategies. Dr. Neeraj Agarwal: Agree. So, let's now turn to the kidney cancer, starting with Abstract 4505, the final overall analysis from CheckMate-214 trial, which evaluated nivolumab plus ipilimumab, so dual checkpoint inhibition strategy, versus sunitinib in our patients with metastatic clear cell renal cell carcinoma. Dr. Jeanny Aragon-Ching: Yeah, absolutely, Neeraj. So, the final 9-year analysis of the phase 3 CheckMate-214 trial confirms the long-term superiority of nivolumab and ipilimumab over sunitinib for first-line treatment of advanced metastatic renal cell carcinoma. So, this has a median follow-up of 9 years. Overall survival remains significantly improved with the combination. So, in the ITT patient population, the intention-to-treat, the hazard ratio for overall survival was 0.71. So, this translates to a 29% reduction in the risk of death. 31% of patients were alive at this 108-month follow-up compared to 20% only in those who got sunitinib. So, similar benefits were observed in the intermediate- and poor-risk groups with a hazard ratio of 0.69, and 30% versus 19% survival at 108 months.  Importantly, a delayed benefit was also seen in those favorable-risk patients. So, the hazard ratio for overall survival improved from 1.45 in the initial report and now at 0.8 at 9 years follow-up, with 35% of patients alive at 108 months compared to 22% in those who got sunitinib. Progression-free survival also favored the nivo-ipi arm across all risk groups. At 96 months, the probability of remaining progression-free was about 23% compared to 9% in the sunitinib arm in the ITT patient population, 25% versus 9% in the intermediate- and poor-risk patients, and 13% compared to 11% in the favorable-risk patients. Importantly, at 96 months, 48% of patients in the nivo-ipi responders remained in response compared to just 19% in those who got sunitinib. And in the favorable-risk group, 36% of patients who responded remained in response, although data were not available for sunitinib in this subgroup.  So, this data reinforces the use of nivolumab and ipilimumab as a durable and effective first-line effective strategy for standard of care across all risk groups for advanced renal cell carcinoma. Dr. Neeraj Agarwal: Thank you, Jeanny. And of course, since ipi-nivo data were presented, several other novel ICI-TKI combinations have emerged. And I'm really hoping to see very similar data with TKI-ICI combinations down the line. It is really important to note that we are not seeing any new safety signals with the ICI combinations or ICI-based therapies, which is very reassuring given the extended exposure. Dr. Jeanny Aragon-Ching: Absolutely agree with you there, Neeraj.  Now, going on and moving on to Abstract 4514, which is the KEYNOTE-564 trial, and they reported on the 5-year outcomes of adjuvant pembrolizumab in clear cell RCC in patients who are at high risk for recurrence. Can you tell us a little bit more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure. So, the KEYNOTE-564 trial established pembrolizumab monotherapy as the first adjuvant regimen to significantly improve both disease-free survival and overall survival compared to placebo after surgery for patients with clear cell renal cell carcinoma. So, Dr Naomi Haas presented the 5-year update from this landmark trial.  A total of 994 patients were randomized to receive either pembrolizumab or placebo. The median follow-up at the time of this analysis was approximately 70 months. Disease-free survival remained significantly improved with pembrolizumab. The median DFS was not reached with pembrolizumab compared to 68.3 months with placebo, with a hazard ratio of 0.71, translating to a 29% reduction in risk of recurrence. At 5 years, 60.9% of patients receiving pembrolizumab remained disease-free compared to 52.2% with placebo. Overall survival also favored pembrolizumab. The hazard ratio for OS was 0.66, translating to a 34% reduction in risk of death, with an estimated 5-year overall survival rate of 87.7% with pembrolizumab compared to 82.3% for placebo. Importantly, these benefits were consistent across all key subgroups, including patients with sarcomatoid features. In addition, no new serious treatment-related adverse events have been reported in the 3 years since treatment completion.  So, these long-term data confirm pembrolizumab as a durable and effective standard adjuvant therapy for patients with resected, high-risk clear cell renal cell carcinoma. Dr. Jeanny Aragon-Ching: Thank you for that wonderful summary, Neeraj. Dr. Neeraj Agarwal: That wraps up our kidney cancer highlights. Any closing thoughts, Jeanny, before we conclude? Dr. Jeanny Aragon-Ching: It's been so wonderful reviewing these abstracts with you, Neeraj. So, the 2025 ASCO Annual Meeting showcased a lot of transformative data across GU cancers, from first-in-class bispecifics to long-term survival in RCC. And these findings are already shaping our clinical practices. Dr. Neeraj Agarwal: I agree. And we have covered a broad spectrum of innovations in GU cancers with strong clinical relevance.  So, thank you, Jeanny, for joining me today and sharing your insights.  And thank you to our listeners for joining us. You will find links to the abstracts discussed today in the transcript of this episode. If you find these conversations valuable, please take a moment to rate, review, and subscribe to the ASCO Daily News Podcast wherever you listen. Thank you so much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:    Dr. Neeraj Agarwal     @neerajaiims     Dr. Jeanny Aragon-Ching   Follow ASCO on social media:       @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn       Disclosures:   Dr. Neeraj Agarwal:   Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences  Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas  Dr. Jeanny Aragon-Ching:   Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc., Pfizer/EMD Serono   Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant, Exelixis,    Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb, Astellas/Seattle Genetics

El Dr. Elmer Huerta explica los últimos anuncios de la FDA sobre las vacunas contra la COVID-19, indicando que, a partir de ahora, solo la población vulnerable tendrá acceso a ellas.

Join Scrip editors Mandy Jackson and Mary Jo Laffler and Pink Sheet editor Sarah Karlin-Smith as they discuss the general mood at the recent BIO International Convention in Boston and around the current US economic and biopharma policy environment in general, along with other key topics at BIO including vaccines, deal and financing and the rise of China's innovation. https://insights.citeline.com/scrip/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-ID7TBPASUFG4HKFSH56TK44DUM/ https://insights.citeline.com/pink-sheet/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-VGDKPJ2QQRBV5B6TY36ROPKE4Q/ Time stamps (0:45) Economic and policy environment in the US (2:50) BIO leadership surprisingly open about the industry's challenges, and willingness to call out Trump government (4:20) Most-favored nation policy proposal: storm in a teacup or existential threat (7:57) DTC sales: new opportunities to sidestep middlemen? GLP-1s leading the way (10:52) Impact of FDA staff cuts and changes on regulatory practices and policy, and on biopharma companies (16:47) Reaction of vaccine companies, health providers, insurers and other stakeholders to ACIP panel dismissal and policy uncertainty (22:27) Climate for biopharma dealmaking and financing; demand for assets (27:28) Advice for startups in challenging times (29:49) China's biopharma industry in the ascendant (33:27) Rare diseases policy, regulation and industry focus (38:15) Priorities for BIO

Struggling to lose weight despite doing everything right?In this powerful episode of Sweat Success, we sit down with Dr. Aly Cohen, a triple board-certified physician and environmental health expert, to uncover the real reason why so many people can't see results… even with proper diet and training.We go beyond calories and cardio to reveal how hidden toxins in your food, water, personal care products, and environment may be disrupting your hormones, storing more fat, and blocking your gym results. If you're on a journey toward fat loss, better health, and long-term performance, this is the episode you need to hear.Whether you're a coach, athlete, or someone working hard to feel better, this conversation with Dr. Aly Cohen will give you new tools and a fresh perspective on what actually creates health.

Ezra CEO Emi Gal breaks down how AI is revolutionizing full-body MRI cancer screening. Learn how FDA-cleared tools accelerate scan time, assist radiologists, and empower patients with easy-to-understand reports—all for just $499. Discover why early detection matters, especially for younger adults, and how Ezra is scaling access to lifesaving diagnostics.

Hi friends, happy Wednesday!  So you guys know I love dictators. And you ended up *LOVING* the Caesar episode… So it made me wonder what other, *older* dictators were out there who I assumed were boring but actually had these scandalous lives.  And that's when I found out about a certain emperor we're gonna talk about today. Not only did he mass murder an entire group of people, but he *personally* killed just about everyone who got close to him.  And you might think okay, typical bloodthirsty tyrant. Been there, done that. But … no. No one has ever matched this guy's freak.  Some of the dictators we've talked about are actually failed artists. And then they take revenge on the world by taking it over.  But this guy… it's almost like he didn't care about being in power at all. All he wanted to do was sing. And dance. And have insane orgies with eunuchs. But instead… he was forced by his mother to rule Rome.  Today I am coming to you with the insane TRUE story of one of the world's first tyrants. This is the Dark History of NERO.  I appreciate you for coming by, and tune in next week for more Dark History. I sometimes talk about my Good Reads in the show. So here's the link if you want to check it out. IDK. lol: https://www.goodreads.com/user/show/139701263-bailey ________ FOLLOW ME AROUND Tik Tok: https://bit.ly/3e3jL9v Instagram: http://bit.ly/2nbO4PR Facebook: http://bit.ly/2mdZtK6 Twitter: http://bit.ly/2yT4BLV Pinterest: http://bit.ly/2mVpXnY Youtube: http://bit.ly/1HGw3Og Snapchat: https://bit.ly/3cC0V9d Discord: https://discord.gg/BaileySarian* RECOMMEND A STORY HERE: cases4bailey@gmail.com Business Related Emails: bailey@underscoretalent.com Business Related Mail: Bailey Sarian 4400 W. Riverside Dr., Ste 110-300 Burbank, CA 91505 ________ This podcast is Executive Produced by: Bailey Sarian & Kevin Grosch and Joey Scavuzzo from Made In Network Head Writer: Allyson Philobos Writer: Katie Burris Additional Writing: Jessica Charles Research provided by: Dr. Thomas Messersmith Special thank you to our Historical Consultant: Dr. Dustin Cranford Director: Brian Jaggers Additional Editing: Julien Perez and Maria Norris Post Supervisor: Kelly Hardin  Production Management: Ross Woodruff Hair: Angel Gonzalez Makeup: Bailey Sarian ________ No matter what your summer brings: Tear. Pour. Live More. Go to https://www.liquidiv.com and get 20% off your first order with code DARKHISTORY at checkout. Personal styling for everyone—get started today at https://www.stitchfix.com/darkhistory. Start listening and discover what's beyond the edge of your seat. New members can try Audible now free for 30 days and dive into a world of new thrills. Visit https://www.audible.com/DARKHISTORY or text DARKHISTORY to 500-500. Start your initial free online visit today at https://www.forhers.com/DARKHISTORY. That's https://www.forhers.com/DARKHISTORY for your personalized hair loss treatment options. Individual Results may vary. Compounded products are not FDA-approved or verified for safety, effectiveness, or quality. Prescription required. Price varies based on product and subscription plan. See website for full details, restrictions, and important safety information.

On this episode of Vitality Radio, Jared welcomes back Dr. Kate Rhéaume to dive deep into the root causes and natural solutions for stress, anxiety, and sleeplessness. Together, they explore the mounting pressures of modern life, how our brains and bodies respond to chronic stress, and how these responses impact sleep, digestion, weight, and mood. They also break down some of nature's most powerful tools—like L-theanine, GABA, saffron extract, and magnesium—sharing clinical insights and practical tips for using them safely and effectively. Jared and Dr. Kate discuss the differences between forms of GABA and theanine, how stress influences cortisol and sleep, and the surprising science behind a newcomer called Peaceful Zzz. Whether you're looking to calm your racing mind, find deeper sleep, or support a stressed-out child, this episode is packed with evidence-based strategies to help restore balance naturally.Products DiscussedAdditional Information:#339: Vitamin K2 and the Calcium Paradox - Everything You Need To Know with Dr. Kate Rheaume#378: Emotional Vitality: Using Curiosity to Take Back Control of Your Subconscious MindVisit 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.

John Stemberger is president of Liberty Counsel Action & Senior Counsel of Liberty Counsel. He's been a conservative policy advocate for over 30 years. Abigail Forman is public policy analyst and a writer for Liberty Counsel Action. She is a former Minnesota state legislator and former Director of Public Policy for Right to Life UK. She is primary author of a groundbreaking, academic white paper exposing the horror of aborted babies from chemical abortions being flushed into our water system. For multiple decades, regardless of the administration in Washington, we've heard the mantra about clean air and water. As a result, environmental policies are set. In light of that, Jim noted a new report that has recently been issued titled: Abortion in our Water: Chemical Home Abortions and the Disposition of Aborted Fetal Remains. It notes that under the Trump administration, having the cleanest air and water in the world for generations is a priority. However, on a daily basis, our waterways are being contaminated by chemical abortion drugs and human remains. This is due to the fact that American women are often left alone at home to endure the agonizing process of expelling their pregnancy as they're often instructed by abortion providers to dispose of the remains of their aborted babies by flushing them down the toilet. This edition of Crosstalk covers much ground as it begins by looking at the back-story of this topic which takes us back to the year 2000 when chemical abortions were first approved by the FDA. At that time, such abortions were small in number. Today, they represent somewhere between 64% to 70% of all abortions.

In this episode of The Ultimate Assist, John Stockton and Ken Ruettgers sit down with filmmaker Matthew Lynn Guthrie, director of Follow the Silenced, a powerful and controversial documentary exposing the vaccine-injured and the system that tried to erase them. Guthrie unpacks how censorship, propaganda, and regulatory betrayal collided during COVID—and why telling the truth has now become an act of resistance. From covert FDA admissions to horrifying testimonies from silenced patients and whistleblowers, this episode explores the real-life thriller behind the rollout. Guthrie also gives a sneak peek into Bad Medicine, his next explosive film on hospital protocols and medical tyranny.

Send Vanessa a Text MessageIf you appreciate the work here and want to support Intentionally Well, consider becoming a monthly supporter below. Every bit helps keep meaningful conversations coming your way: Become a Monthly SupporterAlso, there's a one-time support link at the very bottom of this page you might want to check out. It's a simple way to show your support.In this powerful episode, I sit down with Dr. Adam Urato, a practicing Maternal-Fetal Medicine Specialist and Harvard-trained physician who is breaking the silence on what he has seen over decades of working with pregnant women and their babies.Dr. Urato has been on the front lines of high-risk pregnancies, and what he has witnessed compelled him to compassionately speak up. He is now actively challenging the FDA to update the labeling on SSRIs (commonly known as antidepressants), due to their potential impact on fetal development.But keep in mind, this conversation is not just for pregnant women.It is for anyone who has ever trusted a prescription, followed medical advice without question, or wondered why our healthcare system continues to spend more while producing some of the worst outcomes among developed nations.In this episode, we explore: • The real risks of antidepressant use during pregnancy • What the science actually says and why it is often buried • How regulatory bodies and pharmaceutical companies shape the narrative • Why informed consent is more critical than ever • How the system is working for profits, not healthThis episode is a must-listen for anyone who wants to make truly informed choices about their body, their healthcare, and their family.Connect with Dr. Adam Urato: • Learn more about Dr. Adam Urato on X Connect with Vanessa and the show:All My Favorites + Exclusive Discounts: Linktree Podcast on Instagram: @well.with.vanessaVanessa on Instagram: @thegiftofgoodsVanessa on Threads: @thegiftofgoodsPodcast on YouTube: @IntentionallyWellPodcastPodcast on TikTok: @well.with.vanessaPodcast on X (Twitter): @wellwithvanessaEmail: intentionallywellpodcast@gmail.comSupport the showPodcast Website: Intentionally Well with Vanessa LopezThis episode is for informational purposes only. Please consult a trusted health practitioner for individual concerns.

The FDA approved lenacapavir, a twice-yearly injectable PrEP shown to be 99% effective in preventing HIV, though high cost may limit global access. A phase 3 trial found that adding pembrolizumab to standard care improved event-free survival in head and neck cancer, especially in patients with high PD-L1 expression. MASLD-related deaths in the U.S. have quadrupled since 2006, rising most sharply in older adults and rural areas, and are expected to continue increasing.

What if one small valve could change the lives of millions suffering from chronic venous insufficiency? In this episode, we sit down with Rob Berman, CEO of EnVVeno Medical, to explore how his team is disrupting vascular care with the groundbreaking VenoValve—the first surgical solution for deep vein reflux. Rob shares how this innovation is restoring quality of life, slashing wound care costs, and opening doors for future transcatheter therapies like ENVE. You'll hear hard-earned lessons on leadership, FDA navigation, and raising $135 million to bring first-in-class technology to market. From the OR to investor boardrooms, Rob's journey is packed with grit, insight, and purpose. If you're innovating in medtech, this one's a masterclass.

In this episode of Medsider Radio, we had a really engaging conversation with James (Jim) Corbett, CEO of AVITA Medical.AVITA Medical's RECELL system uses Spray-On Skin Cell technology to accelerate healing for patients with severe burns and wounds.  Jim brings nearly 40 years of medical device leadership experience to AVITA Medical. His career spans global commercial and operational roles, including President of Boston Scientific and General Manager of Scimed Life Systems. Jim has served as CEO of six companies, including three publicly traded entities — Microtherapeutics, ev3, and Alphatec Spine — as well as CathWorks, Home Diagnostics, and Vertos Medical.In this interview, Jim shares lessons from a career spanning global medtech leadership positions — including the importance of hands-on fundraising, adapting sales strategies as products mature, and how generating clinical evidence beyond FDA requirements serves commercial adoption.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Jim Corbett.

John Stemberger is president of Liberty Counsel Action & Senior Counsel of Liberty Counsel. He's been a conservative policy advocate for over 30 years. Abigail Forman is public policy analyst and a writer for Liberty Counsel Action. She is a former Minnesota state legislator and former Director of Public Policy for Right to Life UK. She is primary author of a groundbreaking, academic white paper exposing the horror of aborted babies from chemical abortions being flushed into our water system. For multiple decades, regardless of the administration in Washington, we've heard the mantra about clean air and water. As a result, environmental policies are set. In light of that, Jim noted a new report that has recently been issued titled: Abortion in our Water: Chemical Home Abortions and the Disposition of Aborted Fetal Remains. It notes that under the Trump administration, having the cleanest air and water in the world for generations is a priority. However, on a daily basis, our waterways are being contaminated by chemical abortion drugs and human remains. This is due to the fact that American women are often left alone at home to endure the agonizing process of expelling their pregnancy as they're often instructed by abortion providers to dispose of the remains of their aborted babies by flushing them down the toilet. This edition of Crosstalk covers much ground as it begins by looking at the back-story of this topic which takes us back to the year 2000 when chemical abortions were first approved by the FDA. At that time, such abortions were small in number. Today, they represent somewhere between 64% to 70% of all abortions.

Jackie recounts a harrowing experience trying to buy candle pillars for grandma Gloria, has a religious experience with a pink canvas Bottega jacket, and regurgitates the timeless story of backdoor Rhonda.Thanks for supporting my sponsors!Pique: Nourish your body the right way. Get 20% off, plus a free rechargeable frother and glass beaker at Piquelife.com/BibleAddyi: Check out the FDA-approved treatment for certain premenopausal women who are bothered by low libido and want their sex drive back at www.Addyi.comHome Chef: For a limited time, get 50% off and free shipping for your first box, plus free dessert for life at www.HomeChef.com/BIBLESee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Tuesday, June 24th, 2025Today, Iran fires missiles at US bases in Qatar, Bahrain, Kuwait and Iraq in what is seen as a performative retaliation to Trump's unconstitutional bombing of Iranian nuclear enrichment sites; the Supreme Court has blocked a judge's order forbidding removal of immigrants to third countries; lawyers for Gavin Newsom have asked the district court to consider a preliminary injunction to block Trump's deployment of the military to California as a violation of the Posse Comitatus Act; Democrats in the Senate are winning their arguments before the parliamentarian on multiple provisions in the Billionaire Bailout Bill; ICE detains Marine Corps veteran's wife who was still breastfeeding their baby; Democrats will protest Trump's takeover of the Kennedy Center with a pride event; there is an underground resistance inside the VA against Trump's ban on care for transgender veterans; and Allison and Dana deliver your Good News.Thank You, Naked WinesTo get 6 bottles of wine for $39.99, head to nakedwines.com/DAILYBEANS and use code DAILYBEANS for both the code and password.Thank You, Native PathGet up to 66% Off, free shipping, and a 365-Day Money Back Guarantee at nativekrill.com/dailybeans StoriesG.O.P. Can't Include Limits on Trump Lawsuits in Megabill, Senate Parliamentarian Rules | The New York TimesICE detains wife of veteran and mother of newborn after routine green card appointment | ABC NewsDemocrats to Protest Trump's Takeover of Kennedy Center With Pride Event | The New York TimesInside the Veterans Affairs Department's underground resistance to Trump's care ban for transgender vets | The Advocate Good Trouble With Guest Anna BowerAnna Bower: "I rarely post personal things. But I need to talk about my 4-year-old niece, Hope. She has a rare disease. A drug called elamipretide has helped her survive. But the FDA recently denied its approval. Now, her health hangs in the balance. Please share her story & urge the FDA to reconsider.

Del and Jefferey dive into the troubling numbers behind Merck's new RSV shot for infants, recently greenlit by the FDA. Trial data revealed higher rates of deaths and severe respiratory illness in vaccinated babies, yet the FDA overlooked this concerning trial data.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

Welcome to episode 180 of Growers Daily! We cover: if natural dyes will become a market for small-scale growers, how to manage yourself in the heat, and then how to manage the garden.  We are a Non-Profit! 

This episode is brought to you by Natural Cycles: The company changing the contraception game with the world's first FDA-cleared birth control app. Whether you're looking to prevent pregnancy or plan for it, the Natural Cycles app offers a non-hormonal, non-invasive alternative to traditional birth control. Right now, you can get 15% off an annual subscription plus a free Bluetooth thermometer when you visit https://www.naturalcycles.com and use promo code VALERIA at checkout. Natural Cycles is for 18+ and does not protect against STIs. Always read and follow the instructions for use. In this episode, Valeria sits down with digital pioneer, designer, and mom of two Aimee Song for an intimate and honest conversation about identity, motherhood, and the evolution of personal ambition. Aimee opens up about building her career before the influencer industry even existed, the highs and hidden lows of success, and why her definition of fulfillment has completely shifted in recent years. They talk postpartum depression, therapy breakthroughs, creative burnout, and the magic of slowing down to reconnect with what really matters. Aimee also shares what inspired her return to interior design and the intention behind her new fashion brand, Amiya. It's a raw, funny, and deeply personal look at what happens when you let go of the hustle and finally come home to yourself. Follow Aimee: https://www.instagram.com/aimeesong/  Shop Lulu + Georgia Collab: http://bit.ly/43PbQUQ  Shop Amiya: http://bit.ly/3HOWRl8  Shop my look from this episode: https://shopmy.us/collections/1811792  Follow me: https://www.instagram.com/valerialipovetsky/  What we talked about:  00:55 Navigating Early Career Challenges 01:48 Reflecting on Industry Changes 05:52 The Impact of Social Media on Mental Health 08:12 Therapy and Self-Discovery 15:54 The Hoffman Process 24:18 Redefining Success and Happiness 35:26 Diving into New Ventures 35:46 Reflecting on Career Choices 37:05 The Importance of a Strong Foundation 38:32 Embracing Cringe Moments 39:06 Returning to Interior Design 40:31 Feng Shui and Home Harmony 47:04 Launching a New Brand: Amiya 56:19 Lessons from Motherhood 59:12 Embracing Aging and Redefining Milestones 01:04:28 Concluding Thoughts and Future Plans Learn more about your ad choices. Visit megaphone.fm/adchoices

On Saturday night, the U.S. military attacked several Iranian nuclear facilities in an attempt to eliminate their potential. Following the announcement, President Trump addressed the nation, boasting the U.S. "obliterated" Iran's nuclear capabilities. Some Americans fear this may drag the United States into an open-ended war. However, the Trump administration rejects those claims. Chairman of the House Intelligence Committee, Rep. Rick Crawford (AR-01) joins the Rundown to discuss what inspired the President to act in a swift, secretive manner while enabling the U.S. military to strike the Iranian nuclear facilities. He shares his hope that the strike will embolden the Iranian people to rise against their repressive regime.  President Donald Trump is taking a closer look at infant formula, a topic that the Food and Drug Administration (FDA) hasn't thoroughly examined in decades. The last comprehensive review of infant formula was conducted in 1998, over two decades ago. Currently, a new FDA panel is seeking answers regarding childhood diseases, such as obesity and diabetes. Former FDA Commissioner Dr. David Kessler, the author of "Diet, Drugs, and Dopamine: The New Science of Achieving a Healthy Weight," joins to discuss strategies for improving health, the popularity of Ozempic-like drugs, and whether or not food companies are trying to get us addicted to junk food. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman. Photo Credit: AP Learn more about your ad choices. Visit podcastchoices.com/adchoices

Katherine Eban, Special Correspondent for Vanity Fair, and Dina Doll, well known legal analyst to the Meidas Mighty, join host Dr. Vin Gupta for an inside look within RFK Jr's HHS. Katherine discusses her most recent piece on the rise of Trump's top health advisor, Calley Means, while Dina discusses the real world impacts to American families of the cuts we're seeing across the FDA, CDC, and NIH.  Learn more about your ad choices. Visit megaphone.fm/adchoices