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Mace and Jeff put Matt Walsh's antidepressant episode under the clinical microscope — and it does not pass the functional impairment test. They break down the 2022 Molecular Psychiatry umbrella review that dismantled the low-serotonin narrative, explain why that finding doesn't indict SSRIs as a category, and make the case that the “chemical imbalance” pitch was always more pharmaceutical advertising than clinical science. They also tackle what functional impairment actually means in diagnosis, the gender disparity in antidepressant prescribing, whether the SSRI-to-mass-violence argument is causal or just really committed to showing up in the same sentence, and what clinicians should actually be telling clients about medications they can't fully explain. For anyone who has ever explained serotonin to a client and quietly wondered if they knew what they were talking about: this one's for you. Music: “Machine Heart – Instrumental version” by Icarus. Licensed via Artlist Pro License #JeMO9k. Bielefeldt, A. Ø., Danborg, P. B., & Gøtzsche, P. C. (2016). Precursors to suicidality and violence on antidepressants: systematic review of trials in adult healthy volunteers. Journal of the Royal Society of Medicine, 109(10), 381–392. https://doi.org/10.1177/0141076816666805 Brody, D. J., & Gu, Q. (2020). Antidepressant use among adults: United States, 2015–2018. NCHS Data Brief, No. 377. https://www.cdc.gov/nchs/products/databriefs/db377.htm Chua, K. P., Volerman, A., Zhang, J., Hua, J., & Conti, R. M. (2024). Antidepressant dispensing to US adolescents and young adults: 2016–2022. Pediatrics, 153(3), e2023064245. https://doi.org/10.1542/peds.2023-064245 Healy, D., & Mangin, D. (2024). Post-SSRI sexual dysfunction: barriers to quantifying incidence and prevalence. Epidemiology and Psychiatric Sciences, 33, e44. https://doi.org/10.1017/S2045796024000441 Kuehner, C. (2017). Why is depression more common among women than among men? The Lancet Psychiatry, 4(2), 146–158. https://doi.org/10.1016/S2215-0366(16)30263-2 Moncrieff, J., Cooper, R. E., Stockmann, T., Amendola, S., Hengartner, M. P., & Horowitz, M. A. (2023). The serotonin theory of depression: a systematic umbrella review of the evidence. Molecular Psychiatry, 28, 3243–3256. https://doi.org/10.1038/s41380-022-01661-0 Salk, R. H., Hyde, J. S., & Abramson, L. Y. (2017). Gender differences in depression in representative national samples: Meta-analyses of diagnoses and symptoms. Psychological Bulletin, 143(8), 783–822. https://doi.org/10.1037/bul0000102 Stone, M., Laughren, T., Jones, M. L., Levenson, M., Holland, P. C., Hughes, A., Hammad, T. A., Temple, R., & Rochester, G. (2009). Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration. BMJ, 339, b2880. https://doi.org/10.1136/bmj.b2880

Bremelanotide (Vyleesi) was approved by the US Food and Drug Administration in 2019 as an on-demand subcutaneous injectable for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. An editorial in the May-June 2026 issue of the Journal of Clinical Psychopharmacology suggests that the drug may hold promise for HSDD in men without testosterone deficiency but who have other disorders resulting from organic or psychogenic causes. Placebo-controlled and peer-reviewed studies would first be needed to confirm safety and efficacy in men.   The authors of the editorial are Dr. James G. Pfaus, PhD, a researcher from Charles University in Prague who specializes in the neurobiology of sexual behavior, and Dr. Richard Balon, MD, Associate Editor of this journal. Dr. Balon is on the faculty of Wayne State University School of Medicine in Detroit.   In this podcast, the authors discuss their editorial with Dr. Julia Ann Koretski, MD, who is JCP's Digital Editor and a staff psychiatrist at Newton-Wellesley Hospital in Massachusetts.   Article doi: 10.1097/JCP.0000000000002179

Anupama Joshi, vice president of programs at the Center for Science and the Public Interest, talks with Anamya Anurag about the realities on the ground, in comparison to the Make America Healthy Again programme and its policy actions. They uncover contradictions in guidelines, federal inaction and what business can do amid budget cuts.

Updates in US Food and Drug Administration approvals for poly-ADP-ribose polymerase inhibitors in Ovarian Cancer: A society of gynecologic oncology clinical practice reviewModerator:Ursula A. Matulonis, MD; Dana-Farber Cancer InstituteSpeakers:Bhavana Pothuri, MD; Perlmutter Cancer Center, NYU Langone HealthRóisín E. O'Cearbhaill, MD; Gynecologic Medical Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center; Department of Medicine, Weill Cornell Medical CollegeYvette Drew, MBBS, PhD; BC Cancer Centre Vancouver and University of British ColumbiaChristina Washington, MD; Stephenson Cancer Center, University of OklahomaUrsula A. Matulonis, MD, is joined by Bhavana Pothuri, MD, Róisín O'Cearbhaill, MD, Yvette Drew, MBBS, PhD, and Christina Washington, MD, to discuss recent updates in US Food and Drug Administration approvals for poly-ADP-ribose polymerase inhibitors (PARPi) in ovarian cancer. Based on the recent Society of Gynecologic Oncology clinical practice review published in Gynecologic Oncology, the speakers review the evolving role of PARP inhibitors and the clinical implications of updated regulatory approvals.The panel explores current evidence supporting PARP inhibitor use in ovarian cancer, including considerations for patient selection, biomarker testing, maintenance therapy, and safety considerations. The speakers also discuss how recent changes in FDA indications may affect clinical decision-making and treatment sequencing in practice.This podcast highlights practical clinical pearls to help guide practitioners in the appropriate integration of PARP inhibitors into the management of ovarian cancer patients.This podcast was developed by the Society of Gynecologic Oncology for Gynecologic Oncology.Check out more content on the journal's homepage  at https://www.gynecologiconcology-online.net

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss a slew of advances in diabetes technology and treatments, starting with the US Food and Drug Administration (FDA)'s recent approval of the Tandem automated insulin delivery system for use during pregnancy in individuals with type 1 diabetes. The conversation centers on findings from the CIRCUIT trial, which demonstrated significant improvements in time in range among pregnant patients, a population historically challenging to manage because of stringent glycemic targets. Isaacs and Bellini review practical considerations from the study, including the use of continuous sleep mode to target tighter glucose ranges and proactive optimization of basal rates, correction factors, and carbohydrate ratios to improve outcomes. They emphasize that FDA approval now allows clinicians and manufacturers to openly discuss evidence-based best practices for pregnancy management using automated insulin delivery systems.The hosts also highlight the importance of clinician comfort with aggressive insulin automation during pregnancy, noting that increased basal modulation, suspensions, and automated adjustments should be expected as physiologic insulin needs fluctuate throughout gestation. Bellini stresses the importance of reducing patient burden while maintaining intensive glycemic management, tying this theme into Tandem's newly announced compatibility with the Dexcom G7 15-day sensor. Both hosts note strong patient enthusiasm for extending sensor wear time, framing reduced device maintenance as an important quality-of-life improvement even when the practical change appears modest.The discussion then shifts to immunotherapy in type 1 diabetes, focusing on the expanded approval of teplizumab to include children as young as 1 year old for delaying progression from stage 2 to stage 3 disease. Isaacs and Bellini underscore how broader eligibility may strengthen adoption of autoantibody screening among relatives of patients with type 1 diabetes. They review evidence showing that screening substantially lowers rates of diabetic ketoacidosis at diagnosis and discuss the broader clinical significance of delaying symptomatic disease onset, even when delays are shorter than the median duration reported in trials. The hosts note that many families value the possibility of a more gradual transition into insulin dependence, often requiring only minimal insulin therapy initially rather than presenting with severe metabolic decompensation.The conversation also addresses ongoing regulatory developments surrounding teplizumab for newly diagnosed stage 3 type 1 diabetes. Although the anticipated expedited review pathway has been withdrawn, the hosts remain optimistic about eventual approval, citing encouraging data and the growing role of precision medicine approaches in identifying patients most likely to benefit from immune intervention.To conclude the episode, Isaacs and Bellini examine a post hoc analysis from the SURMOUNT-5 trial comparing tirzepatide and semaglutide in adults with obesity and prediabetes. They discuss findings showing high rates of reversion to normoglycemia in both treatment groups, with tirzepatide demonstrating greater efficacy overall. The hosts frame these data within the broader movement to reconceptualize prediabetes as an earlier stage of type 2 diabetes and cardiovascular disease risk rather than a benign precursor state. They emphasize the potential value of earlier therapeutic intervention to prevent progression and reduce long-term cardiometabolic complications while also acknowledging the importance of maintaining multiple treatment options because of variability in medication tolerability and patient response.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: Tandem Diabetes Care. Tandem Diabetes Care's Control-IQ+ Automated Insulin Delivery Technology Now FDA Cleared for Pregnancy in Type 1 Diabetes. April 27, 2026. Accessed May 8, 2026. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-cares-control-iq-automated-insulin-delivery2: Sanofi. Press Release: Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children. April 22, 2026. Accessed May 8, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-05-00-32786503: Galindo RJ, Aronne LJ, Horn DB, et al. Reversion to normoglycemia with tirzepatide vs semaglutide in participants with obesity and prediabetes: a post hoc analysis of SURMOUNT-5. J Endocrinol Invest. Published online April 20, 2026. doi:10.1007/s40618-026-02895-3

Fuel pump not filter!! Totalitarian ‘technocratic takeover' of U.S. food supply now in play – LeoHohmann.com abcsalvation.com

In this week's episode, Blood podcast editor Laurie Sehn interviews Drs. Edward Cliff on his latest research published in volume 147 issue 14 of Blood. Dr. Cliff discusses "Global access to commercial CAR T-cell therapies: a cross-sectional study of health technology assessment across the G20 countries" which maps the mismatch between innovation and implementation across high-income and selected-upper-middle-income countries for US Food and Drug Administration–approved products and indications. 

The US Food and Drug Administration approval of orforglipron (Fondayo) in April 2026 may mark a pivotal shift in obesity care—particularly as the first oral GLP-1 option designed for flexible, real-world use. Within days, Eli Lilly and Company announced broad availability, including a same-day delivery partnership with Amazon Pharmacy, signaling a rapid move toward improved access following years of supply constraints affecting agents like tirzepatide.Watch on HCPLiveIn this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Diana Isaacs, PharmD, and Natalie Bellini, DNP, break down the clinical and logistical implications of launch. They highlight a key development nuance: marketed tablet doses (0.8 mg–17.2 mg) are dose-equivalent to capsule formulations used in phase 3 trials, supporting scalable manufacturing without compromising pharmacokinetics.Access and affordability remain central. Pricing caps out-of-pocket costs at $299/month for higher doses, with lower-cost entry tiers and expanded distribution positioning orforglipron among the most accessible GLP-1 therapies to date. With uptake already high—approximately 1 in 8 adults reporting prior GLP-1 use—the hosts emphasize potential for further acceleration.The discussion also extends beyond obesity and type 2 diabetes, exploring early real-world signals in type 1 diabetes suggesting possible cardiovascular and renal benefits without increased safety risks, underscoring the broader clinical trajectory of GLP-1–based therapies.

One year in, and the MAHA movement has already flipped the food pyramid, removed red dyes, initiated SNAP reform, and is now pushing hospitals to stop serving diabetic patients sugary drinks, but most Americans have no idea how much has changed. I brought Kyle Diamantas and Calley Means back to The Ultimate Human Podcast to give you a real, unfiltered look at what's happening inside the FDA and HHS right now, what the wins actually look like from inside the building, and why this is a 10-year generational movement, not a one-year miracle.  CLICK HERE TO BECOME GARY'S VIP!: https://bit.ly/4ai0Xwg Get Calley & Casey Means's book, “Good Energy”:  https://bit.ly/4sp5xQZ  Connect with Calley Means Website: https://bit.ly/4cv4Fp4  Instagram: https://bit.ly/4ebYebH  Facebook: https://bit.ly/4bYb7Vs  TikTok: https://bit.ly/4tEsaSw  X: https://bit.ly/4cyxQYg  LinkedIn: https://bit.ly/4vk0QdS  Connect with Kyle Diamantas Website: https://bit.ly/4cxBUIj  X: https://bit.ly/41TyGJ1  LinkedIn: https://bit.ly/4dCn703  Thank you to our partners A-GAME: “ULTIMATE15” FOR 15% OFF: http://bit.ly/4kek1ij  AION: “ULTIMATE10” FOR 10% OFF: https://bit.ly/4h6KHAD  AIRES: "ULTIMATE20 " FOR 20% OFF: https://bit.ly/4a3Duze  BAJA GOLD: "ULTIMATE10" FOR 10% OFF: https://bit.ly/3WSBqUa  BODYHEALTH: “ULTIMATE20” FOR 20% OFF: http://bit.ly/4e5IjsV  COLD LIFE: THE ULTIMATE HUMAN PLUNGE: https://bit.ly/4eULUKp  CYMBIOTIKA: "ULTIMATE10" FOR 10% OFF: https://bit.ly/4tjyluP   GENETIC METHYLATION TEST (UK ONLY): https://bit.ly/48QJJrk  GENETIC TEST (USA ONLY): ⁠https://bit.ly/3Yg1Uk9  GOPUFF: GET YOUR FAVORITE SNACK!: https://bit.ly/4obIFDC  H2TABS: “ULTIMATE10” FOR 10% OFF: https://bit.ly/4hMNdgg  HEALF: 10% OFF YOUR ORDER: https://bit.ly/41HJg6S  PEPTUAL: “TUH10” FOR 10% OFF: https://bit.ly/4mKxgcn  SNOOZE: LET'S GET TO SLEEP!: https://bit.ly/4pt1T6V  WHOOP: JOIN & GET 1 FREE MONTH!: https://bit.ly/3VQ0nzW  Watch  the “Ultimate Human Podcast” every Tuesday & Thursday at 9AM EST: YouTube: https://bit.ly/3RPQYX8 Podcasts: https://bit.ly/3RQftU0 Connect with Gary Brecka Instagram: https://bit.ly/3RPpnFs TikTok: https://bit.ly/4coJ8fo X: https://bit.ly/3Opc8tf Facebook: https://bit.ly/464VA1H LinkedIn: https://bit.ly/4hH7Ri2 Website: https://bit.ly/4eLDbdU Merch: https://bit.ly/4aBpOM1 Newsletter: https://bit.ly/47ejrws Ask Gary: https://bit.ly/3PEAJuG Timestamps 00:00 ​Intro of Show 05:07 Kyle Diamantas' Role in FDA (and Pillars) 12:49 Shifting the Generational Challenges 17:17 Big Wins from the MAHA Movement 25:05 GRAS Reform Guidelines: Definition and Impact 36:58 More Accomplishments from the MAHA Movement 43:10 Operation Stork Speed Initiatives 51:09 Media vs. Trump and Kennedy 55:51 How Can People Support the MAHA Movement? Disclaimer: This podcast is for informational purposes only and does not provide medical advice. It is not intended for diagnosing or treating any health condition. Always consult a licensed healthcare professional before making health or wellness decisions. Gary Brecka is the owner of Ultimate Human, LLC which operates The Ultimate Human podcast and promotes certain third-party products used by Gary Brecka in his personal health and wellness protocols and daily life and for which Ultimate Human LLC and / or Gary Brecka directly or indirectly holds an economic interest or receives compensation.  Accordingly, statements made by Gary Brecka and others (including on The Ultimate Human podcast) may be considered. Learn more about your ad choices. Visit megaphone.fm/adchoices

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!On March 26, 2026, the US Food and Drug Administration (FDA) approved Novo Nordisk's insulin icodec-abae under the name Awiqli for patients with type 2 diabetes (T2D).1,2In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, highlight the FDA approval of once-weekly insulin icodec, emphasizing its significance as a major advancement in insulin therapy. They begin by addressing practical considerations, including its high concentration (U-700) and the implications for dosing, noting that weekly administration necessitates substantially higher unit doses compared with daily basal insulin.The discussion focuses on dosing strategy, particularly the need to scale weekly doses approximately sevenfold relative to daily regimens, as well as the rationale for an initial loading dose of 1.5 times the calculated weekly requirement to more rapidly achieve steady state. Isaacs underscores the pharmacokinetic basis for this approach, given the drug's long half-life and delayed time to steady state, while also noting the constraints of dosing in 10-unit increments.Bellini and Isaacs explore the clinical implications of once-weekly insulin, with particular attention to adherence and treatment burden. Bellini emphasizes the potential benefit for insulin-naive patients and those struggling with daily injection adherence, framing weekly insulin as a means to significantly reduce injection frequency and improve consistency. Isaacs expands on this, arguing that reduced dosing frequency may mitigate missed doses and glycemic variability, especially in patients with irregular routines. Both highlight the flexibility afforded by the long half-life, allowing for minor deviations in dosing timing without substantial impact on glycemic control.The conversation also addresses potential risks, including delayed titration and the possibility of over-basalization, particularly in patients with fluctuating nutritional intake or socioeconomic instability. They stress the importance of careful patient selection and monitoring, given the longer interval required to adjust doses.Reviewing clinical trial data from the ONWARDS phase 3 program, the hosts note that once-weekly insulin demonstrated modestly greater A1C reduction compared with daily basal insulin in treat-to-target trials, reinforcing the hypothesis that improved adherence may translate into better glycemic outcomes.They further discuss implementation considerations across care settings, highlighting potential advantages for older adults, caregivers, and patients in long-term care, where reduced injection burden may improve safety, independence, and medication management. The episode also touches on current regulatory limitations, noting that while approval is presently limited to type 2 diabetes in the United States, ongoing studies may expand its indication to type 1 diabetes, with off-label use anticipated in select cases.The hosts conclude by situating weekly insulin within the broader therapeutic landscape, emphasizing renewed innovation in insulin development alongside incretin-based therapies. They note that additional agents in development may soon expand options within this class, signaling a meaningful shift in the management of diabetes toward more patient-centered, lower-burden treatment paradigms.Editor's Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: Novo Nordisk. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. March 26, 2026. Accessed April 3, 2026. https://ml-eu.globenewswire.com/Resource/Download/cb9dda59-1286-4718-a7e5-4256e2397b0c2: Kunzmann K. FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes. HCPLive. March 26, 2026. Accessed April 3, 2026. https://www.hcplive.com/view/fda-approves-awiqli-insulin-icodec-first-once-weekly-basal-insulin-for-type-2-diabetes

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!The US Food and Drug Administration (FDA) has approved orforglipron (Foundayo), a once-daily oral GLP-1 RA, for chronic weight management in adults with obesity or overweight and ≥1 weight-related comorbidity.1In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's decision and the myriad new treatment opportunities afforded by orforglipron's clearance for entry into the market.The approval of orforglipron is supported by the phase 3 ATTAIN clinical development program, which includes 2 global, randomized, double-blind, placebo-controlled trials evaluating efficacy and safety over 72 weeks.¹ The ATTAIN-1 trial enrolled 3,127 adults with obesity or overweight without diabetes, while ATTAIN-2 enrolled more than 1,600 adults with obesity or overweight and type 2 diabetes.1In ATTAIN-1, participants receiving the highest dose of orforglipron achieved a mean weight reduction of approximately 12.4% from baseline at 72 weeks among those who remained on treatment, compared with 0.9% in the placebo group. Reported average absolute weight loss was 27.3 lb versus 2.2 lb, respectively. Across all randomized participants regardless of completion status, mean weight loss was 11.1% with orforglipron compared with 2.1% with placebo.1Secondary outcomes included improvements in cardiometabolic risk markers such as waist circumference, non–high-density lipoprotein cholesterol, triglycerides, and systolic blood pressure. However, detailed peer-reviewed data from ATTAIN-1 and ATTAIN-2 remain limited at the time of reporting, and full efficacy and safety results have not yet been widely published in the medical literature.The safety profile of orforglipron appears consistent with the GLP-1 receptor agonist class. Common adverse events include gastrointestinal symptoms such as nausea, diarrhea, constipation, vomiting, and abdominal pain. A boxed warning highlights a potential risk of thyroid C-cell tumors, based on findings observed with other GLP-1 receptor agonists in rodent studies, though human relevance remains uncertain.1,2The magnitude of weight loss observed with orforglipron in ATTAIN-1 appears clinically meaningful but may be modest relative to leading injectable agents. Cross-trial comparisons should be interpreted cautiously due to differences in study populations and designs. Additionally, treatment persistence rates and discontinuation due to adverse events will be important considerations in real-world use.Ongoing and planned studies are evaluating orforglipron across additional indications, including type 2 diabetes and other cardiometabolic conditions. Future comparative trials against established GLP-1 and dual incretin therapies may help define its role in treatment algorithms.Editor's Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: Eli Lilly. FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions. April 1, 2026. Accessed April 1, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill2: US Food and Drug Administration. FDA Approves First New Molecular Entity Under National Priority Voucher Program. April 1, 2026. Accessed April 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program

I am joined by Charles River's newest Senior Vice President, Chief Scientific & Innovation Officer Dr. Namandjé Bumpus to discuss her amazing career. From hands on research as Professor and Director of the Department of Pharmacology and Molecular Sciences at Johns Hopkins University School of Medicine, to Chief Scientist and later Principal Deputy Commissioner at the US Food and Drug Administration, Dr. Bumpus has seen every angle of the industry. She joins me to discuss her research, the discipline she learned from her father's boxing gym, and her perspective on the industry today. 

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs discuss potential directions for the US Food and Drug Administration's Center for Biologics Evaluation and Research after the departure of Director Vinay Prasad (:32), including similarities between the center's leadership issues and the staffing problems in the Harry Potter saga's Hogwarts School of Witchcraft and Wizardry (7:48), as well as the potential policy implications (10:11). They also discuss the contributions of the agency's Real-Time Oncology Review (RTOR) pilot program to the quick reviews of two Commissioner's National Priority Voucher (CNPV) awardees (17:19). More On These Topics From The Pink Sheet US FDA's Vinay Prasad, Controversial CBER Director, Leaving In April: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-vinay-prasad-controversial-cber-director-leaving-in-april-DJO7ACE73RCNTLZKQWCN2S26LM/ US FDA's CNPV Approvals Ride RTOR Pilot's Coattails: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fdas-cnpv-approvals-ride-rtor-pilots-coattails-3HEGU5MDWJEG7OYHSZQR6TE5NM/

“I will always tell the American people the truth. Pesticides and herbicides are toxic by design, engineered to kill living organisms” writes Robert F. Kennedy Jr., Secretary of the HHS. “Unfortunately, our agricultural system depends heavily on these chemicals… If these inputs disappeared overnight, crop yields would fall, food prices would surge, and America would experience a massive loss of farms… The consequences would be disastrous.” MAHA is split over Kennedy's statement explaining President Trump's recent support for Bayer and their product Roundup (originally from Monsanto). Glyphosate, the active ingredient in Roundup, is an herbicide that has been linked to non-Hodgkin's lymphoma, was labeled “probably carcinogenic” by the International Agency for Research on Cancer, and is the subject of thousands of lawsuits. It is the most-used weedkiller in history. Remi Adeleke is a former Navy SEAL, filmmaker, and author. Born in Nigeria and raised in the Bronx, his life journey from poverty and criminal activity to military service and filmmaking is detailed in his memoir Transformed. Follow at https://x.com/RemiAdeleke⠀Michael Malice is the host of the podcast YOUR WELCOME. He is the author of multiple books including The White Pill: A Tale of Good and Evil, and coauthor of two New York Times best sellers. Follow at https://x.com/michaelmalice⠀Dr. Sina McCullough is a nutrition scientist and best-selling author. She holds a PhD in Nutrition and a BS in Neurobiology, Physiology and Behavior from the University of California, Davis. Learn more at https://www.drsinamccullough.com⠀Zen Honeycutt is the founding Executive Director of Moms Across America and author of UNSTOPPABLE. Learn more at https://momsacrossamerica.com 「 SUPPORT OUR SPONSORS 」 • AUGUSTA PRECIOUS METALS – Thousands of Americans are moving portions of their retirement into physical gold & silver. Learn more in this 3-minute report from our friends at Augusta Precious Metals: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://drdrew.com/gold⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ or text DREW to 35052 ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠• FATTY15 – The future of essential fatty acids is here! Strengthen your cells against age-related breakdown with Fatty15. Get 15% off a 90-day Starter Kit Subscription at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://drdrew.com/fatty15⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ • PALEOVALLEY - "Paleovalley has a wide variety of extraordinary products that are both healthful and delicious,” says Dr. Drew. "I am a huge fan of this brand and know you'll love it too!” Get 15% off your first order at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://drdrew.com/paleovalley⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ • THE WELLNESS COMPANY - Counteract harmful spike proteins with TWC's Signature Series Spike Support Formula containing nattokinase and selenium. Learn more about TWC's supplements at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://twc.health/drew⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ 「 ABOUT THE SHOW 」 This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. Executive Producers • Kaleb Nation - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://kalebnation.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ • Susan Pinsky - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://x.com/firstladyoflove⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Content Producer • Emily Barsh - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://x.com/emilytvproducer⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Hosted By • Dr. Drew Pinsky - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://x.com/drdrew⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Learn more about your ad choices. Visit megaphone.fm/adchoices

Pink Sheet Executive Editor Derrick Gingery and Senior Editor Sue Sutter are joined by special guests Michael Rogers, former US Food and Drug Administration associate commissioner for inspections and investigations, and Douglas Stearn, former principal deputy associate commissioner in the FDA Office of Inspections and Investigations, both now at Canal Row Advisors. They talk about the current state of the agency inspection cadre and resource challenges (1:04) and offer thoughts on the FDA's efforts to increase foreign inspections (25:24), as well as discuss the growing threat that receiving an Official Action Indicated (OAI) classification presents (35:20) and consider whether user fee goals eventually could be impacted (45:02). More On These Topics From The Pink Sheet US FDA Use of ‘Potential Official Action Indicated' Flag Raises Concerns About Facility-Based CRLs: https://insights.citeline.com/pink-sheet/compliance/us-fda-use-of-potential-official-action-indicated-flag-raises-concerns-about-facility-based-crls-3JLUE3CW6BEIFOKQRZ5C4FKFOM/ US FDA's Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ US FDA Remote Assessments Need Clearer Closeout Process, More Transparency, Experts Argue: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-remote-assessments-need-clearer-closeout-process-more-transparency-experts-argue-4P5UQEPW7NDLNDDQERUQY5Y56M/

The founders of Hershey, Good Humor, Stouffer, Heinz, Kellogg, Kraft, and Birdseye, among others, were pioneers looking to bring clean, hygienic, healthy, and trustworthy products to a market saturated with the opposite. Each specialized in a product, be in chocolate, ice cream, prepared meals, ketchup, cereal, cheese, or frozen foods. Recently we have learned that the grandson of the inventor of Reeses's Peanut Butter cups, owned by Hershey today, has accused the company of destroying the original product, changing "milk chocolate" and "peanut butter" to substances that mirror them. Whereas Milton Hershey sourced fresh milk and used minimal ingredients, modern Hershey products are anything but fresh or even what the label implies. Also, at least 111 substances of unknown safety have been added to foods, drinks and supplements sold in the United States without alerting the US Food and Drug Administration, a new investigation found. This is on top of the exposure that has recently been brought to American foods in general, from food coloring to preservatives - leading companies to change their ingredient lists with a promise of never again lying to consumers. What were companies that attempted to bring purity to a contaminated marketplace, largely resulting from overcrowded cities, has turned ironically into the very thing that they were formed to fight. Now under "trusted brands" the foods that poisons Americans a century ago have made a reemergence.*The is the FREE archive, which includes advertisements. If you want an ad-free experience, you can subscribe below underneath the show description.

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs and special guest Dave Wallace, executive editor of Generics Bulletin, discuss the generic industry's future direction and priorities (:27) and the impact of recent policy moves on the biosimilar industry (12:28) following their trade association's annual meeting, as well as US Food and Drug Administration Commissioner Martin Makary's comment on compassionate use and the concern it may have caused industry (20:23). More On These Topics From The Pink Sheet The State Of The Off-Patent Union: AAM's Murphy Sets Out US Achievements And Obstacles: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/the-state-of-the-off-patent-union-aams-murphy-sets-out-achievements-and-obstacles-in-us-IHJH2CZBX5GGTI6UJQVE2WO2G4/ ‘Biology Is Dirty': HHS's Principal Deputy Counsel On How Biosimilar Firms Can Help US FDA: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biology-is-dirty-hhss-principal-deputy-counsel-on-how-biosimilar-firms-can-help-us-fda-2GEAUSXNMRCYNIXPS7P6IAYESE/ Makary's Compassionate Use Comments, Later Clarified, Still May Startle Industry: https://insights.citeline.com/pink-sheet/rare-diseases/makarys-compassionate-use-comments-later-clarified-still-may-startle-industry-XPBVZ6MH7FC7JKP2XEL4ZESWSE/

As global demand for meat grows, this episode of Duke University's Leading Voices in Food podcast examines cell-cultivated protein—real meat grown from animal cells—and the evolving U.S. policy landscape shaping its future. Host Norbert Wilson (Duke World Food Policy Center) speaks with postdoctoral researchers Kate Consavage Stanley (Duke/Bezos Center for Sustainable Proteins) and Katariina Koivusaari (NC State/Bezos Center) about their article in Trends in Food Science and Technology on U.S. regulatory and legislative activity. The conversation explains the joint FDA–USDA regulatory approach for cell-cultivated meat (FDA oversight through cell cultivation; USDA oversight from harvest through processing, packaging, and labeling) and FDA oversight for cell-cultivated seafood (except catfish). They discuss timelines companies report for approval (often two to three years), the lack of federal public guidance on naming and labeling so far, and how USDA label approvals are currently handled case by case (e.g., "cell-cultivated chicken" and "cell-cultivated pork"). The episode also covers state-level labeling laws and the likelihood of federal preemption if state requirements conflict with federal statutes, as well as a growing wave of state restrictions and bans—Florida and Alabama in 2024, followed by Indiana, Mississippi, Montana, Nebraska, and Texas in 2025—plus funding restrictions in South Dakota and Iowa. The guests explore implications for consumers, interstate commerce, innovation, investment, and U.S. leadership, noting ongoing lawsuits in Florida and Texas and continued legislative activity such as a proposed ban in Georgia.   Interview Transcript Kate, let's begin with you. In the paper, you write about the regulatory frameworks that have been developed for cell-cultivated meat and seafood products in the US. To start, let's talk about what's unique about cell-cultivated products from a regulatory standpoint and how the US Department of Agriculture and US Food and Drug Administration have decided to handle cell-cultivated protein products. Kate - Yes, so as you mentioned in the introduction, Norbert, cell-cultivation is a new technology for use of the food supply. So, the US government had to adapt its existing legal frameworks for food safety regulation. As your listeners may already know seafood is regulated by the FDA, so it was within their scope to also regulate cell-cultivated seafood. The FDA therefore regulates all cell-cultivated seafood products with the exception of catfish. When it came to determining the regulatory approach for cell-cultivated products from livestock, poultry, and catfish, it was a bit more nuanced as the processes and components evolved fell under both USDA and FDA purview. In 2019, the FDA and USDA therefore agreed on a joint regulatory approach where the FDA regulates the early stages of the cell cultivation process, including when those cells are taken from the animal, grown in the bioreactor, and matured into specific cell types such as muscle or fat cells. At the point where those cells are ready to be harvested from the bioreactor to use in a food product, oversight transfers to USDA who oversees that harvesting process as well as food processing, packaging, and labeling. I know this joint regulatory approach may sound complicated, but it's important to note that USDA and FDA already coordinate oversight over other foods in the food supply. I'll give you an example that we all love pizza. A frozen cheese pizza is regulated by the FDA, whereas a frozen pizza with meat toppings like pepperoni is regulated by the USDA. It is therefore not unprecedented that FDA and USDA would agree to jointly regulate cell-cultivated products. And while the process is new, the products go through the same safety checks as other foods in the food supply. In the past few years, we've seen four cell-cultivated meat products go through the joint USDA-FDA regulatory process, meaning they can be sold in the US food supply. And one cell-cultivated seafood product has gone through the FDA regulatory process. Kate, thank you for sharing this. And I've used a pizza example in my class, and it is super complex this regulatory maze that we're talking about. It seems like there has been a lot of collaboration between these two agencies, and so that's important to hear. But it is also the case that it seems challenging for cell-cultivated protein companies to get through this process. Is this a fair assessment and would you elaborate? Kate - Yes, absolutely. We've heard from cell-cultivated companies that it can take two to three years to get through this process. And there certainly is a lot of back and forth between the companies and FDA and USDA. Great, thank you. Katariina, now let's turn to you. How do these regulations extend to labeling and what do we know about the federal government's approach to labeling the sale of cultivated products thus far? Katariina – So, labeling regulations are the most consumer facing part of regulations, really. And they are used to ensure that the product label has information that's truthful, that's not misleading. And that the package has sufficient information and consistent information also across products so that the consumer can make an educated decision on what product they want to purchase. And you'd think that how you label the product or just how you call the product on the label would be simple. But there are certain regulations in place that define how food items can or cannot be called. Now, when it comes to cell-cultivated products, as you and Kate mentioned, they are novel in the food supply. So, there is not a long-established term or nomenclature on how we should call these products. The federal regulators, FDA and USDA, to date have not released any public guidance either on how these products should be called on the label. The USDA did release an advanced notice of proposed rulemaking back in 2021, requesting comments from stakeholders on how these products should be labeled. And the FDA has also requested comments when it comes to labeling cell-cultivated fish and seafood. But to date, no guidance has been published yet. Kate gave an overview of the regulatory process between FDA and UFDA when it comes to labeling this product products. The USDA oversees labeling cell-cultivated meat, and the FDA oversees labeling cell-cultivated fish and seafood. The USDA has a pre-market approval process for labels, similarly to conventional meat industry. So, whenever a company wants to bring to market a new product, they first submit their label to the USDA. And the USDA reviews it and make sure that they agree with the language used in the label. The FDA does not have a similar pre-market approval process for labeling fish or seafood or cell-cultivated fish or seafood. So, currently cell-cultivated meat labels are approved on a case-by-case basis. And we can see from the products that have gone through the regulatory review so far that the USDA seem to approve the use of 'cell-cultivated' as a qualifying term, together with a meaty term such as chicken or pork. So, the products that we've seen approved to date or brought to market to date are called cell-cultivated chicken or cell-cultivated pork. This is really helpful to know what's happened at the federal level. We also know that there are several actions happening at the state level, so several states have proposed their own laws outlining how and what to label these products. Katariina, can you talk us through what this study regarding state labeling? Katariina - To date, about half of the US states have enacted or proposed their own labeling legislation on cell-cultivated products. Missouri became the first state in 2018, so well before any of these products was available on the market. And they specifically prohibited the use of word meat unless the food was from harvested production livestock or poultry. Restricting, therefore, the use of meat not only on cell-cultivated, but also on other alternative protein products such as plant-based meat analogs or fermentation derived proteins. And this is true for many state level labeling laws. That they are applicable not only to cell-cultivated meat, but also other alternative proteins aiming to mimic meat. In addition to Missouri, there are six other states that prohibit the use of meat or meat related terms, such as chicken or pork. Now, the other group of states that have restrictions on cell-cultivated meat labeling do not concentrate on prohibiting the use of word meat, but they require the use of qualifying terms or other additional language that clearly states that the product does not come from livestock or poultry. And this group of states, there are 18 states, have quite a bit of variation in what kind of qualifying terms they require to be used. And I thought I'd give a couple of examples here. For example, Indiana requires the package to include the phrase this is an imitation meat product. Iowa requires the product to be labeled with qualifying terms such as cell-cultivated, cell-cultured, fake, grown in a lab, imitation, lab grown, lab created, meat free, or meatless. What's interesting though is that the federal statutes that regulate the US food supply have actual language that prevents states from establishing laws or regulations that conflict with or are additional to the federal labeling regulations. So, this means that the state level labeling laws are actually likely to be preempted if they conflict with the federal regulations. So, we've only talked about labeling so far. Kate, I want to go back to you. More recently, we've seen a number of states propose greater restrictions on these products. Can you describe these attempts to restrict cell-cultivated meat and their immediate implications? And how have cell-cultivated companies and other stakeholders responded? Kate - In the past few years we've seen quite a few attempts by states to ban or restrict cell-cultivated meats. And these attempts fall into two buckets: bans that aim to restrict the manufacturer sale or distribution of cell-cultivated products and bans that aim to limit the use of state funding to support these products. In 2024, Florida was the first state to pass a ban on the manufacture, sale, and distribution of cell-cultivated meats. Alabama followed shortly thereafter. In 2025, five more states passed similar bans on cell-cultivated products, including Indiana, Mississippi, Montana, Nebraska, and Texas. And many other states proposed bans that ultimately didn't pass. The language on what is banned differs some between states. For instance, Texas only bans the sale of cell-cultivated products. Whereas Florida and others also ban cell-cultivated manufacturing and distribution. But the core message in all these bans is similar. Cell-cultivated meats are not welcome in those states. The time span for the bans differs too. So, Indiana and Texas have two-year bans while Florida and other states passed indefinite bans. And we've seen two states, South Dakota and Iowa pass legislation to restrict the use of state funding to support cell-cultivated products. What's frustrating about these bands and confusing for those in the alternative protein sector is that cell-cultivated technology is largely still in the early stages. Yes, as I mentioned earlier, five products have passed through the regulatory process. But these products have mainly been made available in small tasting events. And only one has actually made it to retail. Most Americans have never had a chance to actually try these products. So, it begs the question, why is there such resistance? State bans on these products mean that Americans will not have the chance to decide for themselves if they like these products, or if and how they want to incorporate them into what they eat. Another big concern is that these bans create a fragmented policy landscape that's challenging for cell-cultivated startups, especially, to navigate. And it raises a lot of concerns about cross state sales. Concerns like these are the basis for two lawsuits against cell-cultivated bans in Florida and Texas. Those lawsuits are still playing out in court, so we don't yet know how those may Kate, this is really fascinating. And as both you and Katariina described, there's a patchwork of policies and a complex landscape for these companies to navigate. It has the potential of keeping consumers from even trying the products, as you've already suggested, when they're made available. And what I'm hearing from both of you is that this is an ongoing project. So even though there's a paper that's published now, it seems like there will be opportunities to keep going back as new laws and new regulations and new lawsuits are decided. So, this is a policy space that we need to keep an eye on. That's something I want to pick up on this last question. In closing, what does this legislation mean for consumers and the future of cell-cultivated products in the US and even globally? Katariina, let's begin with you. Katariina - Yes. In addition to impeding interstate and international commerce of cell-cultivated products, these bans could negatively impact the US investment climate on these products and technologies. For example, China has included developing cell-cultivated meat in their five-year plan. Within Europe, there's some variation. Some countries are being rather supportive of these technologies and products, whereas others have tried to ban them similarly to some US states. But I think it's important to note that even with some states in the US banning these products, the US will still likely remain a significant market area for cell-cultivated products. And it still takes significant investment and infrastructure to produce the products on a large scale enough to even reach the whole country. Another really important thing to mention here is that the global demand for meat is growing. If we look at global population forecasts, global meat or protein consumption forecasts, we need these alternative proteins. Not only cell-cultivated meat, but also for example, plant-based meat alternatives to help meet the increasing demand for protein and complement conventional meat supply. Kate, what about you?   Kate – I agree with everything that Katariina said. To add on to her points, I note that the US has been a leader in the cell-cultivated research development and innovation spaces to date. We are one of only a few countries that have both developed a framework for regulating these products and had products successfully pass through that process. The bans tell a different story, and they may restrict US innovation in the cell-cultivated space because companies will be limited to only the states where they can produce and sell these products. What this means for US leadership in the space remains to be seen. However, one could ask will cell-cultivated companies choose to set up shop in the US versus another country that isn't facing such legal challenges? We don't yet know the answer to that. You also mentioned consumers. We don't yet know about how these bans and the media surrounding them may influence consumer perceptions of cell-cultivated foods. Products, as you said, they've never even really had the chance to try. But these bans will certainly restrict consumer access to these products in certain states, and the varying state approaches to labeling that Katariina described are likely to confuse consumers. Going back to something you mentioned earlier, Norbert, we're excited to have this paper out in the world. But this work is certainly continuing to evolve. Just recently, a senator in Georgia proposed a new ban on cell-cultivated meat in the state, and other countries have faced similar legislative challenges against these products. So, we'll be watching and learning as these challenges continue to play out. Bios Katariina Koivusaari, Ph.D. is a postdoctoral researcher at the Bezos Center for Sustainable Protein at North Carolina State University. Her work focuses on stakeholder engagement and the regulatory and policy landscape of alternative proteins, including cell-cultivated products, fermentation-derived proteins, and plant-based proteins. She received her Ph.D. in Public Health Nutrition and M.Sc. in Food Sciences from the University of Helsinki. Prior to her current role, she worked in the biotechnology industry as a Senior Regulatory Scientist, where she focused on scientific strategy and regulatory affairs related to cell-cultured human milk ingredients. Katherine (Kate) Consavage Stanley, Ph.D., serves as a postdoctoral associate within the World Food Policy Center at the Sanford School. In this role, Kate supports Duke's research for the Bezos Center for Sustainable Protein housed at NC State. Her research seeks to detail the complexities of the consumer, market, and policy landscapes for alternative protein products. Kate holds a Ph.D. from Virginia Polytechnic Institute and State University where her research focused on how diverse U.S. food and health systems actors can support sustainable diet transitions through promoting plant-rich dietary patterns and reducing red and processed meat intake. She has also published scholarly work on digital food and nutrition literacy, sugary beverage media campaigns, and incorporating sustainability considerations into dietary guidelines, among others. Prior to starting her doctoral studies, Kate worked for the U.S. Agency for International Development (USAID) where she developed technical, communications, and advocacy-focused materials on key nutrition and maternal and child health issues. Kate holds a Master of Science in global health from Georgetown University and a Bachelor of Science in biology from Emmanuel College.      

About this episode: A recent analysis of FDA documents has found that the agency has historically regulated mifepristone—a medication commonly used to terminate pregnancy—based on available scientific evidence and without ideological bias. In this episode: Caleb Alexander, an author of the study, discusses these findings and their implications for a possible new review of the medication by FDA. Guests: Dr. G. Caleb Alexander, MS, is a practicing internist and drug safety expert at the Johns Hopkins Bloomberg School of Public Health. Host: Lindsay Smith Rogers, MA, is the producer of the Public Health On Call podcast, an editor for Expert Insights, and the director of content strategy for the Johns Hopkins Bloomberg School of Public Health. Show links and related content: The US Food and Drug Administration's Regulation of Mifepristone—JAMA Study: FDA Regulation of Abortion Drug Mifepristone from 2011 to 2023 Shaped by Evidence and Caution—Johns Hopkins Bloomberg School of Public Health F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds—New York Times What Is Mifepristone, aka "The Abortion Pill"?—Johns Hopkins Bloomberg School of Public Health What's at Stake for Access to Medication Abortion and the FDA in the Supreme Court Case FDA v. the Alliance for Hippocratic Medicine?—KFF Transcript information: Looking for episode transcripts? Open our podcast on the Apple Podcasts app (desktop or mobile) or the Spotify mobile app to access an auto-generated transcript of any episode. Closed captioning is also available for every episode on our YouTube channel. Contact us: Have a question about something you heard? Looking for a transcript? Want to suggest a topic or guest? Contact us via email or visit our website. Follow us: @‌PublicHealthPod on Bluesky @‌PublicHealthPod on Instagram @‌JohnsHopkinsSPH on Facebook @‌PublicHealthOnCall on YouTube Here's our RSS feed Note: These podcasts are a conversation between the participants, and do not represent the position of Johns Hopkins University.

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss a series of US Food and Drug Administration proposals for user fee program changes that would advance President Trump's priorities and the concerns they raise (:31). They also consider the impact of the agency's decision to review Moderna's mRNA flu vaccine application shortly after refusing to file it and using accelerated approval for one of the proposed indications (8:37), as well as ideas for sponsors wondering if their development advice is still good (25:24). More On These Topics From The Pink Sheet US FDA Proposing White House-Aligned Policies For User Fee Agreements: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-proposing-white-house-aligned-policies-for-user-fee-agreements-D5JWRDGLCFBT7CYT3FGK3JAZNI/ After Moderna Flu Vaccine, Is US FDA's Accelerated Approval A Pathway Or A Pressure Valve?: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/after-moderna-flu-vaccine-is-us-fdas-accelerated-approval-a-pathway-or-a-pressure-valve-EWMFKFWO3BB3JA6CQHC4E3JWPA/ Moderna Flu Vaccine Debate Could Resolve With Postmarket Study, FDA's Makary Suggests: https://insights.citeline.com/pink-sheet/vaccines/moderna-flu-vaccine-debate-could-resolve-with-postmarket-study-makary-suggests-Y3R657N2JZABRGFOSKADM33YA4/ Horse Trading? Oz, Bourla Exchange MFN Codification, Vaccine Collaboration Requests: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/horse-trading-oz-bourla-exchange-mfn-codification-vaccine-collaboration-requests-X6UDDVOSMRBSTO5WC224IN6PTE/

Most people think nutrition is only about calories and macros.Protein, carbs, fats. Numbers in an app.That's only part of the story.Food is also a delivery system.How it's packaged.How it's stored.How it's heated.And how often that happens … day after day, for decades.Ignore that layer long enough and the system pays the price.This week's YouTube coaching deep-dive breaks down in detail what the new US food guidlines said about plastic food containers and your free testosterone level. ▶️ ⁠Rad and I created a comprehensive video⁠ for you this week where we explain why metabolic health erodes slowly, what the new US Food Guidelines (and food pyramid) finally got right, and how this mirrors the way smart training actually works.

When cravings hit hard, most people blame discipline.They think they're inconsistent.They think motivation is broken.In our experience, that's rarely the truth.More often, the system regulating hunger and energy is out of alignment.This week's YouTube coaching deep-dive breaks down in detail what the new food guidlines said about the gut microbiogme.▶️ ⁠Rad and I created a comprehensive video⁠ for you this week where we explain why metabolic health erodes slowly, what the new US Food Guidelines (and food pyramid) finally got right, and how this mirrors the way smart training actually works.

For years, nutrition debates focused on the wrong enemy.Fat versus carbs.Low-this versus high-that.Meanwhile, something far more damaging went largely ignored.Processing.This week's YouTube coaching deep-dive breaks down in detail what changes were made around food processing.▶️ ⁠Rad and I created a comprehensive video⁠ for you this week where we explain why metabolic health erodes slowly, what the new US Food Guidelines (and food pyramid) finally got right, and how this mirrors the way smart training actually works.

Dinesh Patel, PhD, CEO of Protagonist Therapeutics, discusses the New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) for rusfertide to treat adults with polycythemia vera (PV).PV is characterized by excess red blood cells in the bloodstream, increasing the risk for blood clots. Most cases of PV are acquired and occur more frequently in men than in women. The condition has been associated with genetic changes in the JAK2 and TET2 genes. Rusfertide is an investigational first-in-class subcutaneously administered hepcidin mimetic peptide designed to regulate iron homeostasis and red blood cell production to control hematocrit levels in patients with PV.The NDA submission is based on positive 32-week primary analysis and 52-week results from the phase 3, global, randomized, placebo-controlled VERIFY clinical trial (NCT05210790). In this study, patients receiving rusfertide plus standard of care therapy demonstrated a substantially higher response rate compared to placebo plus standard of care, including durable hematocrit control, a reduction in phlebotomy requirements and improvement in pre-specified patient reported outcome endpoints.Rusfertide has received Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation from the FDA.

For decades, protein was treated like a bonus.Optional.Something you only worried about if you were a bodybuilder.Most people were told 0.8 grams per kilo was “enough.”And they assumed that meant optimal.It never did.This week's YouTube coaching deep-dive breaks down in detail what the protein updates mean for you!▶️ ⁠Rad and I created a comprehensive video⁠ for you this week where we explain why metabolic health erodes slowly, what the new US Food Guidelines (and food pyramid) finally got right, and how this mirrors the way smart training actually works.

Health fails slowly — long before it shows up on paper.Most people seem to think health breaks down suddenly.One bad blood test.One diagnosis.One prescription.It feels like something went wrong overnight.But that's not how metabolic health actually fails. It fails the same way gym overuse injuries occur… quietly, over time.This week's YouTube coaching deep-dive breaks down in detail.▶️ Rad and I created a comprehensive video for you this week where we explain why metabolic health erodes slowly, what the new US Foof Guidelines (and food pyramid) finally got right, and how this mirrors the way smart training actually works.

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration's controversial decision to refuse to file Moderna's mRNA-1010 seasonal influenza vaccine candidate, including the unusual public airing of grievances (2:10), the changing issues sparking RTF actions (5:51), the uncertainty created by the decision and how vaccine sponsors should react going forward (16:54). More On These Topics From The Pink Sheet Moderna Cites Changing Advice As US FDA Refuses To File Flu Vaccine BLA: https://insights.citeline.com/pink-sheet/vaccines/moderna-cites-changing-advice-as-us-fda-refuses-to-file-flu-vaccine-bla-SRLIEHHMOFEWFPTLYJCXFIF5FM/ HHS Defends US FDA Refusal To File Moderna's Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/hhs-defends-us-fda-refusal-to-file-modernas-flu-vaccine-NULTQ6P6R5C6DDXZFMZROE3HRU/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of new data showing US Food and Drug Administration hiring increasing, but net employee losses continuing (1:13), including how the issue could be reflected in the user fee program going forward (7:40) and where the strains will emerge as the agency continues to navigate its workload (11:43). More On These Topics From The Pink Sheet US FDA's Drugs, Biologics Centers See Increased Hiring, But Not Enough To Overcome Departures: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-biologics-centers-see-increased-hiring-but-not-enough-to-overcome-departures-XGMD6U2QHFGULBLCBTRCBWATNQ/ PDUFA VIII: Industry Proposes Funding Changes To Reflect ‘Realistic Ability To Hire Staff': https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/pdufa-viii-industry-proposes-funding-changes-to-reflect-realistic-ability-to-hire-staff-AALJBBI5BJEKLEBGIRFL6ZKDQA/ US FDA's Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ A Strong Year For US FDA Approvals, But Warning Lights Flashing: https://insights.citeline.com/pink-sheet/product-reviews/approvals/a-strong-year-for-us-fda-approvals-but-warning-lights-flashing-OEYQQ4RRDVHEVPAFYXPQ4LRHOA/

The US has released new dietary guidelines, and they’ve already caused a nutrition firestorm. Higher protein targets. More dairy. Fewer carbs. A tougher stance on ultra-processed foods. But do these changes actually matter, especially if you live in Australia? In this episode of The Nutrition Couch, Leanne Ward and Susie Burrell break down what’s changed, why it’s controversial, and what’s genuinely useful versus what can be ignored. Then we get practical, because real nutrition decisions happen in lunchboxes and supermarket aisles, not food pyramids. In this episode: The new US dietary guidelines and why they’ve divided dietitians Higher protein targets, dairy’s comeback, and the carb rethink What this could signal for future Australian guidelines Why ultra-processed foods are finally being called out Plus: A simple lunchbox formula that actually works Why kids’ lunches are often low in protein, and easy fixes The truth about protein meat snacks and “no nitrate” options A high-protein milk worth considering Are fermented veggies really worth it for gut health? If you want clear, practical nutrition advice without hype or fear-mongering, this episode is for you. Hit play, and subscribe so you don’t miss next week’s discussion.See omnystudio.com/listener for privacy information.

Implanon (etonogestrel implant) first received FDA approval in 2006, followed by the improved, radiopaque version, Nexplanon, approved by the FDA in 2010, which is now the only contraceptive implant available in the U.S. It was originally FDA approved for a 3-year use duration, although peer reviewed clinical data had demonstrated efficacy through year 5. Now, as of January 2026, the FDA has formally agreed to extend the label for 5-year use. In this episode, we will review the clinical data that prompted the FDA's decision, based on a multicenter, single-arm, open-label study evaluating contraceptive efficacy and safety during years 4 and 5 of implant use.1. https://www.contemporaryobgyn.net/view/fda-approves-5-year-use-for-etonogestrel-implant-68-mg-contraceptive2. Organon announces US Food and Drug Administration approval of supplemental new drug application extending duration of use of NEXPLANON (etonogestrel implant) 68 mg Radiopaque. Organon. Press release. January 16, 2026. Accessed January 19, 2026. https://www.organon.com/news/organon-announces-us-food-and-drug-administration-approval-of-supplemental-new-drug-application-extending-duration-of-use-of-nexplanon-etonogestrel-implant-68-mg-radiopaque/3. Ali M, Akin A, Bahamondes L, et al. Extended Use Up to 5 Years of the Etonogestrel-Releasing Subdermal Contraceptive Implant: Comparison to Levonorgestrel-Releasing Subdermal Implant. Human Reproduction. 2016. 4. McNicholas C, Swor E, Wan L, Peipert JF. Prolonged Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device: 2 Years Beyond Food and Drug Administration-Approved Duration. American Journal of Obstetrics and Gynecology. 2017. 5. McNicholas C, Maddipati R, Zhao Q, Swor E, Peipert JF. Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device Beyond the U.S. Food and Drug Administration-Approved Duration. Obstetrics and Gynecology. 2015.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs consider the US Food and Drug Administration's average speed of a novel drug application review in 2025 (:34), including the loss of so-called “fast approvals” (5:33) and how reviewers managed to ignore the distractions caused by the changes (7:35). They also consider whether the layoffs and other departures will impact the review system in 2026 (11:16). More On These Topics From The Pink Sheet Average Metrics In A Turbulent Year: US FDA's 2025 Median Review Times Match PDUFA Goals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/average-metrics-in-a-turbulent-year-us-fdas-2025-median-review-times-match-pdufa-goals-FOEPKT27UFAHPDS36HKJFOHOQE/ It's About Time: US FDA's Review Speed For Novel Approvals In 2025: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/its-about-time-us-fdas-review-speed-for-novel-approvals-in-2025-6LMDCANRRZGWTIDSRKFVXCJRPY/ US FDA's 2025 Staffing Turmoil Will Create 2026 Application Review Challenges: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-2025-staffing-turmoil-will-create-2026-application-review-challenges-AJIE7WRQ2ZFS7IOR5PA3OWFE2M/

After a long break, I'm back with a short reflection on the new US Eat Real Food pyramid and why it's a positive step forward.In this episode, I explore how this new US food pyramid "Eat Real Food" emphasizes real, high-quality ingredients and why the true meaning of diet is about lifestyle, not restriction. I also explain how elements like mindful eating, movement, and shared meals—so central to the Mediterranean diet—are essential to long-term health.Finally, I share why the "Eat Real Food" pyramid feels surprisingly Italian, aligning closely with the values behind PDO and PGI products: quality, tradition, and respect for food.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs consider the many concerns Richard Pazdur and others raised about the US Food and Drug Administration's Commissioner's National Priority Voucher Program (CNPV) (:37), including potential legal issues (10:35), as well as the possibility of releasing the full action package for an unapproved application, given the resources that likely would be required (18:16). More On These Topics From The Pink Sheet Commissioner's National Priority Voucher Program Reflects US FDA Review Politicization, Pazdur Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/commissioners-national-priority-voucher-program-reflects-us-fda-review-politicization-pazdur-says-A43CKFRDVBHTLESE6IQE6JXLGM/ US FDA Gauging Impact, Resource Use In Commissioner's Voucher Pilot As Concerns Grow: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-gauging-impact-resource-use-in-commissioners-voucher-pilot-as-concerns-grow-7WQB3TOQERGXJPAIV5465GOBLM/ With Unapproved Drug Complete Response Letters Now Public, Are Action Packages Next?: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/with-unapproved-drug-complete-response-letters-now-public-are-action-packages-next-S4Y5ANUYE5DOTC7YVTALA3GPIE/

Foie Gras is the top by far!The Heart of Tradition Podcast- For everything magnesium but also life changing ideas, European wisdom, health tips and more from the speartip!ALSO: Goodbye Industrial Grade Magnesium claiming to be Zechstein. Hello Clear-stone, Zero Solvent Magnesium !! Can you call the source? With us you can.Always in healthy blue GLASS. Only One Ingredient. Verifiable Zechstein.For our videos check out our website. Click on Videos. OR for our Blog, Click on Blog.20% off with code HEART20 theheartoftradition.com

Mifepristone used with misoprostol is the most common abortion regimen in the US. It is also a focal point of reproductive health policy and politics, with controversy over its legal status and regulation by the US Food and Drug Administration (FDA). Author G. Caleb Alexander, MD, MS, from Johns Hopkins discusses this and more with JAMA Deputy Editor Joseph S. Ross, MD, MHS. Related Content: The US Food and Drug Administration's Regulation of Mifepristone Politics, Science, and the Future of FDA Drug Regulation

1-12-26 7am CT Hour - Monsignor Roger Laundry/ Dr. Brian Donahue John, Glen, and Sarah chat about Iran protests, Pope Leo baptizing 20 infants, NFL football, Clean Your Desk Day. Monsignor Landry reflects on the fruits of the Jubilee Year of Hope in the Church. Dr. Donahue explains the new food pyramid and what they got right for the health of us all in America today.

PreVision Policy Founding Member Michael McCaughan joins Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs to discuss the career and legacy of Richard Pazdur, the long-time head of the US Food and Drug Administration's oncology drug review division and Oncology Center of Excellence. They consider his brief stint as Center for Drug Evaluation and Research director and decision to retire (:55), his impact on oncology (4:36), as well as reflect on his famous “Pazdur Moments” (18:41), the future of legacy programs like Project Orbis (28:52), and whether the FDA can find another leader like him (33:54). More On These Topics From The Pink Sheet US FDA's Richard Pazdur: Appreciating An Extraordinary Career: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-richard-pazdur-appreciating-an-extraordinary-career-YD2GBQ7WOZHM5BNAKWJF4OQVFM/ Modernizing Accelerated Approval: One Of Pazdur's Biggest Legacies: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/modernizing-accelerated-approval-one-of-pazdurs-biggest-legacies-4QPXDRZ7SNBE7EUOG5VWWILGDY/

Send us a textDr. Horowitz got to the bottom of the most pressing dental takeaways with Dr. Brian Novy at this year's Chicago Midwinter Meeting. Tune in for a rundown on everything you need to know about everything from disease management, and (drumroll) Dr. Novy's true thoughts on water fluoridization

The US economy picked up speed over the three months to September, as consumer spending jumped and exports increased but consumer sentiment is low, Rahul Tandon hears from a business about what things are like on the ground. The US Food and Drug Administration (FDA) has approved a pill version of the weight-loss drug Wegovy, according to pharmaceutical giant Novo Nordisk. And, an important moment for Indian female cricket players seeing their match fees doubled for domestic games.(Photo: A person shops for products imported from Asia at a market in Los Angeles, California, USA, 07 April 2025. Credit: ALLISON DINNER/EPA-EFE/REX/Shutterstock)

Cancer screening is evolving beyond a single-organ approach to an approach that evaluates multiple organs throughout the entirety of the body with a simple blood test. In this episode, Dr. Michelle Beidelschies shares how Cancerguard can help health systems detect more cancers earlier, reduce late-stage diagnoses, and improve outcomes. We explore the clinical, operational, and financial implications of adopting multi-cancer early detection testing at scale. Information presented is not clinical, diagnostic, or treatment advice for any particular patient. Providers should use their clinical judgement and experience when deciding how to diagnose or treat patients. Exact Sciences does not recommend or endorse any particular course of treatment or medical choice. The Cancerguard test was developed, and the performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. This test has not been cleared or approved by the US Food and Drug Administration. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: big FDA recall around Freestyle Libre (see more below to find out if you're affected), Dexcom launches their 15.5 day sensor, Omnipod announces enhancements, Tandem tests a fully closed loop (with high fat, high carb meals) and lots more! Find out how to submit your Community Commercial Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. Our top story this week: XX Certain glucose monitors from Abbott Diabetes Care are providing users with incorrect glucose readings, an error that has been linked with the deaths of at least seven people and more than 700 serious injuries worldwide, according to an alert from the US Food and Drug Administration.   Incorrect glucose readings can lead to improper treatment. Abbott warned that about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected, but no other Libre products. Patients can visit FreeStyleCheck.com to see if their sensors are affected and to get a replacement for free.   The FDA has also published specific information about the affected products in its alert. The agency considers this to be a "potentially high-risk issue" and will continue to update its website as information becomes available.   "Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s)," the FDA said.   https://www.cnn.com/2025/12/02/health/abbott-diabetes-glucose-monitors https://www.freestylecheck.com/us-en/home.html XX Omnipod 5 is getting some enhancements.. and Omnipod 6 is announced. The FDA cleared updates including  a lower, 100 mg/dL target glucose option and what they call a more seamless automated experience. "This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022," said Eric Benjamin, Insulet EVP and COO. Insulet said the new 100 mg/dL target glucose expands Omnipod 5's customization range. It now features six settings between 100 mg/dL and 150 mg/dL in 10 mg/dL increments. The company said this flexibility allows healthcare providers to tailor insulin delivery more precisely. It supports individuals seeking tighter glucose management or aiming to meet specific glucose goals. Omnipod 5's latest upgrades also help users stay in "Automated Mode" with fewer interruptions, even during prolonged high glucose events. Insulet plans to launch the updates to the algorithm in the first half of 2026. The company announced plans for an Omnipod 6 – without a lot of detail - at the company's Investor Day event in November. They also talked about a new, fully closed-loop pump for the type 2 diabetes population. https://www.drugdeliverybusiness.com/insulet-fda-clearance-omnipod-5-algorithm-enhancements/ XX Dexcom, the global leader in glucose biosensing, announced today that the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System will launch in the United States on Dec. 1, making it the longest-lasting CGM system with 15.5 days of wear.   Dexcom G7 15 Day will first be available through durable medical equipment (DME) providers on Dec. 1 with full retail launch in the coming weeks. Dexcom G7 15 Day will also be covered for Medicare beneficiaries.   Dexcom G7 15 Day's industry-leading wear-time will provide fewer sensor changes, less disruption and more time for people with diabetes to benefit from life-changing CGM technology.   New with Dexcom G7 15 Day:  Longest lasting CGM system with 15.5 days of wear. Best-in-class accuracy1 with an overall MARD of 8.0%. Easier glucose management with fewer monthly sensor changes and reduced monthly waste. This follows yesterday's announcement – the FDA has cleared Dexcom Smart Basal, the first and only CGM-integrated basal insulin dosing optimizer designed for adults 18 and older with Type 2 diabetes using long-acting insulin. Dexcom Smart Basal will use Dexcom G7 15 Day sensor data and logged doses to calculate personalized daily recommendations to guide users towards a more effective long-acting insulin dose, as directed by their healthcare provider. At launch, Dexcom G7 15 Day will connect with the iLet Bionic Pancreas and Omnipod® 5§§. We are working closely with Tandem and look forward to extending the launch to their customers shortly as they finalize integration. For specific information on pump compatibility and availability with the Dexcom G7 15 Day system, visit Dexcom.com/connectedpumps https://investors.dexcom.com/news/news-details/2025/Dexcom-G7-15-Day-Continuous-Glucose-Monitoring-System-to-Launch-on-Dec--1-in-the-United-States/default.aspx   XX A small study of ten adults with type 1 diabetes tested Tandem's new fully closed-loop "Freedom" insulin system — and the participants put it through a real-world stress test. For 72 hours in a hotel setting, they ate heavy carb-and-fat meals, skipped all meal announcements, and didn't give any mealtime insulin boluses. The system handled almost everything automatically. Researchers said the device stayed in closed-loop mode 97% of the time and there were no incidents of diabetic ketoacidosis or severe hypoglycemia reported. While using the Freedom system, participants spent a median 61% of the day in the glucose target range — slightly higher than the 56% achieved with their usual pump at home. But the biggest improvement came overnight: time in range jumped to 96% with the closed-loop system compared to just under 70% during their home-pump week. With almost zero time spent below 70 mg/dL, researchers concluded that the fully automated Tandem system was both safe and effective even with unannounced, high-impact meals — hinting at a future of diabetes management that demands less effort from users.   XX Novo Nordisk reported promising mid-stage results for its experimental drug amycretin (AM-ee-creht-in) in diabetes patients on Tuesday. Amycretin, targets both GLP-1 and amylin hormones. In this study, it helped patients with type 2 diabetes lose up to 14.5% of their body weight over 36 weeks with weekly injections, far outperforming a placebo. The oral version delivered weight loss of up to 10.1%. Rival Eli Lilly  is surging ahead with its own amylin-based drug, eloralintide, which is advancing to late-stage testing after helping patients shed as much as 20% of their weight in a mid-stage trial. https://www.cnbc.com/2025/11/25/novos-next-gen-obesity-drug-shows-positive-results-heads-to-late-stage-testing.html XX The U.S. Medicare health plan said on Tuesday that newly negotiated prices for 15 of its costliest drugs will save 36% on those medications compared with recent annual spending, or about $8.5 billion in net covered prescription costs. The prices go into effect in 2027, including a monthly price of $274 for Novo Nordisk's popular GLP-1 drug semaglutide, sold as Wegovy for weight loss and Ozempic for diabetes. medicare's recent net price for Ozempic, opens new tab was $428 a month, according to an analysis published in the Journal of Managed Care and Specialty Pharmacy. Medicare put the drug's list price, before confidential rebates and discounts, at $959 a month. Based on such nondiscounted list prices, Medicare said savings on the 15 drugs ranged from 38% to 85%. The annual price negotiations were established under President Joe Biden's signature Inflation Reduction Act (IRA) of 2022. Previously, Medicare was barred by law from negotiating with drugmakers. https://www.reuters.com/business/healthcare-pharmaceuticals/us-negotiated-medicare-prices-15-more-drugs-test-cost-savings-promise-2025-11-25/   XX LifeScan announced its Chapter 11 bankruptcy reorganization plan received U.S. Bankruptcy Court approval. LifeScan said it's positioned to emerge from its financial restructuring process by the end of the year. The CEO says, "This balance sheet restructuring provides a stronger foundation for LifeScan to support our base business, advance new growth strategies, and commence our journey to become one of the most comprehensive players in the glucose management space." https://www.drugdeliverybusiness.com/glucose-monitor-lifescan-emerge-from-bankruptcy/ XX An artificial intelligence (AI)-led Diabetes Prevention Program (DPP) was as effective as a traditional human-led program in achieving recommended goals for weight loss, A1c reduction, and physical activity, according to a randomized trial of adults with prediabetes and overweight or obesity. One example of a push notification: "Looks like you're at the grocery store, Rita! Want a quick list of high-fiber snacks or smart swaps to stay on track this week?" The app also provided location- and goal-based education, with gamification elements to promote engagement. Approximately one third of participants in both the AI and human-led groups achieved the primary outcome (31.7% and 31.9%, respectively). Results were consistent across sensitivity analyses and individual components of the composite endpoint. "As more AI-based programs emerge, head-to-head comparisons among different AI-DPPs will be informative. An AI-led approach will not suit everyone; some individuals benefit more from human interaction and accountability," said Mathioudakis, adding that future research should focus on best matching patients to the modalities they prefer. https://www.medscape.com/viewarticle/ai-directed-diabetes-prevention-program-effective-human-2025a1000xam XX A new study suggets metformin could help people with type 1, reducing the need for insulin.  The researchers were surprised to find that metformin did not improve insulin resistance or change blood sugar levels. This suggests that, unlike in type 2 diabetes, metformin doesn't combat insulin resistance in type 1 diabetes.   However, metformin did reduce the amount of insulin people needed to keep their blood sugar levels stable.   https://www.the-express.com/news/health/192157/diabetes-medicine-insulin-type-1 XX Beyond Type 1 launches #TheBeyondType campaign in India to combat type 1 diabetes stigma. Nick Jonas is one of the founders of Beyond Type 1, his wife, Priyanka Chopra Jonas is his partner in this new non profit. The initiative highlights inspiring individuals living with T1D and partners with local organisations to improve awareness, medical support, and community networks for affected families across the nation. India has more young people living with T1D than any other nation, yet understanding of the condition remains limited. Beyond Type 1 is partnering with grassroots organisations across high-need regions. These include HRIDAY in Delhi–NCR, Nityaasha Foundation in Pune, Gram Jyoti in Jharkhand, and SAMATVAM Trust in Bangalore—each group focusing on improving awareness, providing medical support and building stronger community networks for young people with T1D.

Dr. Tomasz Beer, MD, chief medical officer at Exact Sciences, joins HealthLeaders for a discussion on the clinical research behind Cancerguard tests and how they enable health systems to detect multiple deadly cancers early, streamline diagnostic workflows, and deliver proactive, value-based care. Information presented is not clinical, diagnostic, or treatment advice for any particular patient. Providers should use their clinical judgement and experience when deciding how to diagnose or treat patients. Exact Sciences does not recommend or endorse any particular course of treatment or medical choice. The Cancerguard test was developed, and the performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. This test has not been cleared or approved by the US Food and Drug Administration. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs take a deep dive into the circumstances of George Tidmarsh's departure as director of the US Food and Drug Administration's Center for Drug Evaluation and Research (:30). They also consider the long-term impact on the agency (11:50) and try to place it in context compared to other crises in its history (31:24). More On These Topics From The Pink Sheet Breaking: George Tidmarsh Out As US FDA Drug Center Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-george-tidmarsh-out-as-us-fda-drug-center-director-MI2NEWEM6ZFP7GP66ZQJL76N2Q/ Former US FDA CDER Director Says He Played Key Role In Stealth's Elamipretide Approval: https://insights.citeline.com/pink-sheet/product-reviews/drug-review-profiles/us-fda-cder-director-says-he-played-key-role-in-stealths-elamipretide-approval-VAEUL5PU75GBXCMC3QOYTA32WI/ Tidmarsh Creates More Instability And Uncertainty For US FDA, Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tidmarsh-creates-more-instability-and-uncertainty-for-us-fda-industry-DODHAMVW5REBPPHBUUJHV6PZTU/ US FDA's Richard Pazdur Says ‘No' To CDER Director's Spot: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fdas-richard-pazdur-offered-cder-director-spot-said-no-RZK4BW7EX5F5RLG6HG2JSDCKAE/ FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-office-of-new-drugs-director-mary-thanh-hai-not-interested-in-cder-director-job-XKOFXETTWVAXFB22BQ3MJ7ONQ4/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration announcement that a comparative efficacy study is no longer a prerequisite for biosimilar approval (:35), as well as the upcoming guidance stating the interchangeability switching study requirement will be dropped (11:25). They also discuss agency efforts to clarify the intent of the upcoming inspection force “Simple Reform” (15:13). More On These Topics From The Pink Sheet US FDA's Makary Wants Lower Biosimilar Launch Prices As Clinical Study Mandate Changed: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/us-fdas-makary-wants-lower-biosimilar-launch-prices-as-clinical-study-mandate-changed-5ARJRC6QYBBMTLTQ5S46F5YGXQ/ Biosimilar Interchangeability Guidance Eliminating Switching Studies Coming Soon: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biosimilar-interchangeability-guidance-eliminating-switching-studies-coming-soon-ILNP4IGYJZGZLAJVDZ77URZDNQ/ ‘Simple Reform' Not A Step Back From Program Alignment, US FDA's Elizabeth Miller Argues: https://insights.citeline.com/pink-sheet/compliance/manufacturing/simple-reform-not-a-step-back-from-program-alignment-us-fdas-elizabeth-miller-argues-TCTFWMGBARD6VLRDT7YWUZBJQE/

As evolving food allergy regulations sweep across the US, I dedicated this solo episode to giving you the latest updates on the legal landscape affecting safe dining experiences. This week, it's just me, Tracy Stuckrath, but together we're diving into the details behind newly proposed and enacted legislation from Pennsylvania, California, Illinois, and Texas, along with major changes in the 2022 FDA Food Code and proposed allergen labeling requirements for alcoholic beverages by the TTB. I break down what these changes mean for restaurants, catering professionals, and anyone who wants to ensure food-allergic guests are protected and included. You'll hear candid tips on risk management, advocacy, and the power of positive, inclusive dining stories that build trust and community. Whether you're an event pro or just determined to create safer, more inclusive food experiences, tune in to stay ahead on all things food allergy law and regulation.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs explain the reasons for the US Food and Drug Administration's planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry's current thinking on best practices for navigating the agency's new position on direct-to-consumer ad regulation (18:45). More On These Topics From The Pink Sheet US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/ Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/ US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal's potential impact on the 340B program (16:35). They also consider the Justice Department's alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16). More On These Topics From The Pink Sheet US FDA Commissioner's Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-fda-commissioners-involvement-in-astrazeneca-pricing-deal-raises-ethical-legal-questions-IJV4LMTDA5E65KCOFQUQM76GCA/ EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/emd-serono-ivf-candidate-among-first-us-fda-priority-voucher-recipients-as-part-of-mfn-deal-LKHA6VRTKRE6DJERGNCWCGMBF4/ Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/manufacturer-most-favored-nation-deals-how-they-could-be-protected-from-340b-FALSG7GHM5GQBFN3I5SPERJIYU/ Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange: https://insights.citeline.com/pink-sheet/legalandip/litigation/off-label-promotion-doj-may-take-new-look-at-scientific-information-exchange-R62PQJFQTRBCVGCZE57GWM3Q3Q/

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

This week hosts Tiffany Cross, Angela Rye, and Andrew Gillum cover a VERY important topic: housing and financial literacy. We’re doing some hardcore adulting today y’all. Why is it so hard to buy a home these days? How do we build wealth for a down payment–or anything for that matter? These questions may sound dry but the answers as to how we got into this housing crisis are INVALUABLE. They’ll include some advice and personal stories from our hosts (and guest) on how you can secure your finances and get your life. PLUS stories and tips on how to navigate systemic inequities when it comes to things like securing a loan. Our guest, Elizabeth Booker Houston, is an influencer and political commentator with a Juris Doctorate (scholarly legal mastermind) and a Masters in public health. In 2017, she relocated to Washington, DC to serve in the US Food and Drug Administration. In the years since, she has combined her love of politics, law, science, and comedy into a second career as a political standup comedienne, writer, and content creator. You can find Elizabeth @bookersquared on all platforms. And our hosts answer a couple of fun questions all about TV shows and books submitted by YOU, our audience. If you’d like to submit a question, check out our tutorial video: http://www.instagram.com/reel/C5j_oBXLIg0/ and send to @nativelandpod. We are 481 days away from the midterm elections. Welcome home y’all! —--------- We want to hear from you! Send us a video @nativelandpod and we may feature you on the podcast. Instagram X/Twitter Facebook NativeLandPod.com Watch full episodes of Native Land Pod here on YouTube. Native Land Pod is brought to you by Reasoned Choice Media. Thank you to the Native Land Pod team: Angela Rye as host, executive producer and cofounder of Reasoned Choice Media; Tiffany Cross as host and producer, Andrew Gillum as host and producer, and Lauren Hansen as executive producer; Loren Mychael is our research producer, and Nikolas Harter is our editor and producer. Special thanks to Chris Morrow and Lenard McKelvey, co-founders of Reasoned Choice Media. Theme music created by Daniel Laurent.See omnystudio.com/listener for privacy information.

The author and former commissioner of the US Food and Drug Administration talks to Mark about his new book, Diet, Drugs, and Dopamine: The New Science of Achieving a Healthy Weight; why self-control isn't enough when it comes to losing—and keeping off—weight; the problem with 'eat less, exercise more"; and his own personal weight loss journey.Read an excerpt from DIET, DRUGS, AND DOPAMINE on the Bittman Project: https://bittmanproject.com/diet-drugs-and-dopamine/Subscribe to Food with Mark Bittman on Apple Podcasts, Spotify, or wherever you like to listen, and please help us grow by leaving us a 5 star review on Apple Podcasts.Follow Mark on Twitter at @bittman, and on Facebook and Instagram at @markbittman. Want more food content? Subscribe to The Bittman Project at www.bittmanproject.com. Hosted on Acast. See acast.com/privacy for more information.