Podcasts about us food

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.

Monday Motivation is a bite sized snack of inspiration to start your week right. Join Nikki every Monday Morning to get the motivation that will enable you to tackle all of life's challenges with a positive mindset. In this episode Nikki talks about the new US food pyramid Check out Nikki's digital workbooks: https://cinchtraining.store/ Australian Dietary Guidelineshttps://www.eatforhealth.gov.au/sites/default/files/files/the_guidelines/n55a_australian_dietary_guidelines_summary_book.pdfSee 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

The United States of America have brought back the food pyramid with a focus on protein and dairy, but it's drawn some criticism from dieticians and experts.See omnystudio.com/listener for privacy information.

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

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.

In this episode, Mary talks with Paola Brown from Americans for Homeopathy Choice Action about defending access to homeopathic medicines in the United States and why freedom of choice matters for everyone. The FDA Challenge in the USA Paola explains how the US Food and Drug Administration has changed its policy on homeopathic medicines. Products that were once widely available over the counter – such as eye drops and common remedy tablets – are now treated as "unapproved new drugs". This new stance has already removed whole categories of remedies and is making retailers nervous about stocking what is left. It's not just a few products at risk – the same mechanism could be used to restrict many more. Why Freedom of Choice Matters Instead of getting stuck in scientific debates, Paola and her team focus on a simple message when they meet members of Congress: people deserve the freedom to choose safe, non-toxic options for their families. Homeopathy has a long record of safety when properly manufactured, and many families rely on it when conventional options have not helped. Paola shares how years of bladder pain, failed treatments and huge medical bills finally shifted when she turned to homoeopathy – giving her back a full, active life. Americans for Homeopathy Choice Action The organisation is working toward legislation that will protect access to remedies. Volunteers are trained to share their personal stories with congressional offices, explaining how homeopathy changed their health and why losing it would be devastating. They also keep the message clear: the FDA regulates medicines, not the practice of homeopathy itself, and people should be allowed to choose low-risk options that fit their own values. How Listeners Can Help What happens in the US will affect homeopathy worldwide, so Paola invites support from around the globe. People can: Donate to keep the advocacy work going Join the Homeopathy Action Team if they live in the USA Sign up for the Rapid Response Team Rapid Response volunteers are trained to post calm, respectful comments online whenever pro-homeopathy politicians are attacked, showing that many citizens support access to these medicines. Important links mentioned in this episode: Visit Americans for Homeopathy Choice website: https://homeopathychoice.org/rr   Subscribe to our YouTube channel and be updated with our latest episodes. You can also subscribe to our podcast channels available on your favourite podcast listening app below: Apple Podcast: https://podcasts.apple.com/us/podcast/homeopathy247-podcast/id1628767810 Spotify: https://open.spotify.com/show/39rjXAReQ33hGceW1E50dk Follow us on our social media accounts: Facebook: https://www.facebook.com/homeopathy247 Instagram: https://www.instagram.com/homeopathy247 You can also visit our website at https://homeopathy247.com/

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/

This past summer, the US Food and Drug Administration approved Bravecto® [brah-VECK-toe] Quantum, or…

This past summer, the US Food and Drug Administration approved Bravecto® [brah-VECK-toe] Quantum, or fluralaner [FLEUR-ah-lah-ner] extended-release injectable suspension, for use in dogs and puppies over six months old. It's...

The bloodsucking northern fowl mite, or red mite, is the most economically important external parasite of US poultry. In July 2025, the US Food and Drug Administration approved Exzolt™ [egg-ZOLT],...

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

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and senior editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). More On These Topics From The Pink Sheet Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-day-one-us-fda-hiring-mfn-demos-delayed-7LGCITF2WVCJNEVUTWZV5MOZSE/ Closing The Gap? Pfizer Will Set Same US, Foreign Launch Prices In MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/closing-the-gap-pfizer-will-set-same-us-foreign-launch-prices-in-mfn-deal-ZRSNU56KTFGRBBX4Y5OJKLFV6Y/ Questions Persist About How Pfizer's US Agreement Lowers Prices: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/questions-persist-about-how-pfizers-us-agreement-lowers-prices-T2TEWMKVMVHGJHPXDKIFDF2GWA/

Autism New Zealand says it has serious concerns around what it calls "misleading claims" made by Donald Trump and his administration around the link between autism and paracetamol. The US President made the highly-contentious claims in an Oval Office address this morning, announcing the US Food and Drug Administration will be notifying physicians that the use of paracetamol during pregnancy "can be associated with a very increased risk of autism". US correspondent Todd Zwillich spoke to Lisa Owen.

The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW's Bruno Quinney narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. In this week's news, AstraZeneca has halted its £200 million research investment in the UK. Elsewhere, the US Food and Drug Administration (FDA) has fast-tracked a gene therapy, CAR-T therapy could be an effective cancer treatment, and the National Institute for Health and Care Excellence (NICE) has updated its thresholds for ultra-rare disease drugs. You can listen below, or find The Drug Discovery World Podcast on Spotify, Google Play and Apple Podcasts. 

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs look at the potential consequences of the US Food and Drug Administration's upcoming crack down on direct-to-consumer advertising (:30), including the first publicly released letter, which went to AstraZeneca for a Flumist TV commercial (2:50), as well as vaccine policy and other major issues that were listed in the Make America Healthy Again Commission's Strategy Report (21:45). More On These Topics From The Pink Sheet Direct-To-Consumer Ads: Manufacturers Face ‘Cease And Desist' Orders Now, Uncertain Future: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/direct-to-consumer-ads-manufacturers-face-cease-and-desist-orders-now-uncertain-future-6XLXAWS7WJBYNPHSBRAQVTBARU/ Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/limited-detail-in-maha-strategy-report-could-catch-pharma-off-guard-TVL7CCBQONA7PHCLUDJ7WTEJC4/

It seems there are news stories every week about the accelerating pace of innovation in gene therapy, but only about 50 therapies have been approved so far by the US Food and Drug Administration. Our guest today, Dr. Bobby Gaspar, leads a UK-based biotech company, Orchard Therapeutics, that developed one of those treatments using gene-modified stem cells in your blood that self-renew, so a single administration can give you potentially a lifelong effect. “Our approach is about correcting those hematopoietic stem cells and allowing them to give rise to cells that can then correct the disease,” explains Dr. Gaspar.  The therapy in focus is lenmeldy, the first approved treatment for metachromatic leukodystrophy, also known as MLD, a devastating inherited disorder that affects roughly 600 children worldwide. But Dr. Gaspar is optimistic that learnings from Orchard's work on MLD could be useful in treating much more common disorders including frontotemporal dementia, Crohn's disease and others. This highly informative conversation with host Lindsey Smith also explores the importance of newborn screening, community collaboration in advancing clinical trials for rare diseases, and a future in which each gene therapy will be used as a tool for specific applications.  “There will be many gene therapies available, some of which will become the standard of care for certain diseases, but it won't be for every disease.”Mentioned in this episode:Orchard Therapeutics If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit's VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration's COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). More On These Topics From The Pink Sheet COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA's Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/ A US FDA Move to Revoke Pfizer's Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/ Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/

We were joined at The Pit Recording Studio in Sunland, CA by Nitisart “Mike” Chaiburi and Kitti “Ole” Suwan of the great WHISPERS, all the way from Bangkok, Thailand.A truly unbelievable group of people both personally and musically, they've broken through every barrier imaginable through their undeniable spirit, infectiously unique and hard and passionate love for hardcore music.Being the first band from Bangkok to achieve so much of what they have achieved, we're honored to talk to Whispers about their origin from local band in Bangkok who evolved into the definitive band that represents not only their city, but all of Thailand around the world. We can't think of a better group or a better band for the job, and just five minutes of this conversation is all you'll need to hear to understand why.______________________________________ Edited by Steven Grise (@iamoneonenineseven) • Title sequence by Nicholas Marzluf (@marzluf) HardLore: A Knotfest Series Join the HARDLORE PATREON to watch every single weekly episode early and ad-free, alongside exclusive monthly episodes: https://patreon.com/hardlorepodJoin the HARDLORE DISCORD: https://discord.gg/jA9rppggef_____________________________________ Cool links:HardLore Official Website/HardLore Records store: https://hardlorepod.comTry AG1 at DrinkAG1.com/HARDLORE to receive a free 1-year supply of vitamin D and 5 travel packs of AG1.Get 15% off MADD VINTAGE with code HARDLORE15! https://maddvintage.com/___________________________________ FOLLOW WHISPERS:INSTAGRAM | https://www.instagram.com/whispershc/TWITTER | https://www.twitter.com/whispershc FOLLOW MIKE:INSTAGRAM | https://www.instagram.com/mikelaw307/ FOLLOW OLE:INSTAGRAM | https://www.instagram.com/oletalifez/ FOLLOW HARDLORE:INSTAGRAM | https://www.instagram.com/hardlorepod/TWITTER | https://twitter.com/hardlorepodSPOTIFY | https://spoti.fi/3J1GIrpAPPLE | https://apple.co/3IKBss2 FOLLOW COLIN:INSTAGRAM | https://www.instagram.com/colinyovng/TWITTER | https://www.twitter.com/ColinYovng FOLLOW BO:INSTAGRAM | https://www.instagram.com/bosxe/TWITTER | https://www.twitter.com/bosxe #HARDLORE #HARDCORE 00:00:00 - Start00:01:02 - Introduction00:02:20 - Finding Hardcore in Thailand00:08:25 - 555555555555500:10:19 - Their Many Many Vintage Stores00:12:15 - Friendships before Whispers00:13:33 - H8000 Bands00:15:45 - Finding European Hardcore00:18:17 - Activities Outside of Whispers00:20:13 - Mike's Vocal Style00:21:19 - Whispers Through the Years00:24:34 - Bangkok During Covid00:26:00 - Relax Time00:27:57 - Stories With Stéphen Kickback00:31:02 - Pardon This Interruption00:33:40 - Meeting Gap00:37:01 - First Whispers Tour Ever00:39:00 - Asian Countries Played00:39:42 - Response To Whispers Across The World00:41:00 - Linking Up with Speed00:42:09 - Touring Europe00:43:16 - Yom Ma Lok00:47:24 - Flatspot Records00:48:15 - First US Tour00:51:00 - Future Aspirations for Whispers00:51:59 - Tied Down Fest00:53:41 - Tour Essentials (Hot Dogs)00:54:49 - US Food vs Thailand Food01:00:18 - Sound and Fury01:03:21 - Top 4 HC Records01:06:38 - Ghosts?01:10:45 - Patreon Q&A01:11:38 - Top 4 Thai HC01:12:38 - Greatest Breakdown Of All Time01:14:50 - Inspirations / Influences

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.

Resources for the Community:___________________________________________________________________https://linktr.ee/theplussidezpodcast Ro - Telehealth for GLP1 weight management https://ro.co/weight-loss/?utm_source=plussidez&utm_medium=partnership&utm_campaign=comms_yt&utm_content=45497&utm_term=55______________________________________________________________________Dr. David Kessler, former FDA Commissioner and author of Diet, Drugs, and Dopamine, joins us to break down the science behind food addiction, obesity, and GLP-1 medications like Ozempic and Zepbound.He doesn't just study this—he lives it. Dr. Kessler has obesity, takes GLP-1s, and knows firsthand what it's like to battle food noise and weight stigma.In this episode, we discuss:What makes ultra-processed food addictiveHow GLP-1s affect the brain and reduce cravingsWhether some people can stop taking GLP-1sHis personal experience starting, stopping, and restartingWhy weight regain happens and what the body is really fightingHis bold policy ideas to regulate Big Food like Big TobaccoDr. Kessler helped bring HIV drugs to market faster, led Operation Warp Speed, and took on the tobacco industry. Now, he's focused on the next public health crisis: food addiction and obesity.Subscribe to The Plus SideZ Podcast for more expert conversations on GLP-1s, weight, and wellness.Specialist and Community Guest Dr. David KesslerBIO: David. A. Kessler, MD, served as chief science officer of the WhiteHouse COVID-19 Response Team under President Joe Biden and previouslyserved as commissioner of the US Food and Drug Administration underPresidents George H.W. Bush and Bill Clinton. He is the author of the_New York Times_ bestsellers _The End of Overeating_ and_ Capture_ andtwo other books:_ Fast Carbs, Slow Carbs_ and _A Question of Intent_.Dr. Kessler is a pediatrician and has been the dean of the medicalschools at Yale and the University of California, San Francisco. He is agraduate of Amherst College, the University of Chicago Law School, andHarvard Medical School.Social Media:https://x.com/DavidAKesslerMDLink to Book:https://www.audible.com/pd/B0D5KS9P4D?source_code=ASSORAP0511160006&share_location=pdpSpecial community guest Mike on a Health Mission Social MedSend us Fan Mail! Support the showKim Carlos, Executive Producer TikTok https://www.tiktok.com/@dmfkim?is_from_webapp=1&sender_device=pc Instagram https://www.instagram.com/dmfkimonmounjaro?igsh=aDF6dnlmbHBoYmJn&utm_source=qr Kat Carter, Associate Producer TikTok https://www.tiktok.com/@katcarter7?is_from_webapp=1&sender_device=pc Instagram https://www.instagram.com/mrskatcarter?utm_source=ig_web_button_share_sheet&igsh=ZDNlZDc0MzIxNw==

Donate (no account necessary) | Subscribe (account required) Join Bryan Dean Wright, former CIA Operations Officer, as he breaks down today's biggest stories shaping America and the world. Chinese Nationals Charged with Agro-Terrorism in Michigan – The FBI arrests a Chinese student and her boyfriend for smuggling a wheat-killing fungus into the U.S., potentially targeting America's food supply. One suspect expressed loyalty to Xi Jinping and is linked to the Communist Party. FBI Director Kash Patel calls it a wake-up call for food security and national defense. Trump Expands Emergency Powers to Boost Weapons and Rare Earth Mining – In response to Chinese rare earth blackmail and global supply chain vulnerabilities, President Trump invokes the Defense Production Act to increase U.S. arms and mineral output. Allies warn China's squeeze on magnets may signal an impending Taiwan blockade or invasion. Elon Musk vs. Trump Over “Disgusting” Spending Bill – Musk lashes out at Trump's Big Beautiful Bill, calling it reckless and bloated. The rift deepens after Trump withdraws NASA nominee Jared Isaacman and House Republicans defend cuts to EV subsidies and NPR. A rescission bill is introduced to walk back $9.4B in spending. Vietnam Faces U.S. Trade Pressure, South Korea Elects Pro-China Socialist – Vietnam agrees to buy $2B in U.S. goods but resists Trump's demand to curb Chinese transshipping. Meanwhile, South Korea elects Lee Jae-myung, a Bernie Sanders-style leftist who questions U.S. troop presence and cozies up to Beijing, complicating future Taiwan conflict strategy. China's Auto Glut and Rare Earth Strategy Spark Global Tensions – Chinese car dealers beg automakers to slow production as $7,500 vehicles swamp the market. Simultaneously, China ramps up global espionage, especially targeting Dutch chip firms, while tightening its grip on global rare earth exports. Dutch Government Collapses Over Immigration – The Netherlands' ruling coalition falls apart after nationalist leader Geert Wilders demands mass deportations. European voters cite economic hardship and cultural tensions as driving factors. Gaza Aid Effort Stalls, Hamas Rejects Peace Deal – Israeli military progress in Gaza is overshadowed by disrupted food distribution. Hamas kills civilians to create propaganda, and U.S.-backed aid operations struggle internally. Peace remains elusive as Hamas refuses to accept Israel's right to exist. Study Confirms Diverse Diet Key to Long-Term Health – A decade-long international study finds that consuming a variety of colorful fruits and vegetables delivers the best antioxidant and anti-inflammatory benefits - great news for your brain, heart, and longevity. "And you shall know the truth, and the truth shall make you free." – John 8:32        

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