Podcasts about us food

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.

Ozempic and similar medications have remained at the center of the weight loss conversation this week, with new studies and high-profile voices like Oprah Winfrey bringing both excitement and nuanced caution. Major clinical research just published in a leading medical journal demonstrates that higher, triple doses of semaglutide, sold under names like Ozempic and Wegovy, are driving even more significant weight loss in people with obesity. According to researchers led by Dr Sean Wharton at a leading Canadian weight management clinic, adults without diabetes who took the highest 7 point 2 milligram dose weekly saw an average weight loss approaching nineteen percent of their body weight, notably higher than what's been seen with typical doses. Nearly half of those patients lost twenty percent or more of their body weight in these trials, suggesting very real potential for those struggling with severe obesity. The same trials found that people with type two diabetes saw weight drops of thirteen percent using the highest dose. Importantly, the higher dose still appeared safe and generally well tolerated, with common side effects including nausea and diarrhea that mostly resolved over time. The study did not find a higher risk of dangerous drops in blood sugar or other serious complications. These results are meaningful because they expand the promise of these drugs for patients not reaching their goals on standard doses. However, experts stress that further research is essential to fully understand the long term effects of such a powerful regimen and whether the benefits continue to outweigh any risks as time goes on.Beyond the numbers, more people are sharing their personal stories about these new drugs, and Oprah Winfrey continues to be among the most influential. In new interviews and her recent podcast episode, Oprah has confirmed that she uses a prescription GLP dash 1 agonist, the same class of medication as Ozempic, as part of her ongoing wellness journey. She has not named the specific brand, but her openness has made it clear that for her, this is not just a quick fix or shortcut. Instead, Oprah describes the decision as a mental shift—acknowledging obesity as a chronic disease that is best managed with a partnership between lifestyle changes and medical treatment. She has been explicit that the medication alone is not magic. Oprah credits her progress to a holistic routine that includes daily exercise, often hiking three to five miles, planful eating with her last meal in the late afternoon, and close attention to water intake and overall health habits. She has left behind the self blame that characterized her earlier struggles and now uses her platform to challenge the idea that using medication means failure. Instead, she frames it as using every available tool responsibly—paired with self compassion and ongoing commitment.As these drugs become more widely used, big questions remain. A new RAND Corporation report finds that nearly one in eight Americans have tried Ozempic or a similar medication. Use is particularly high among women aged fifty to sixty four. Yet significant numbers report troublesome side effects—most commonly nausea and diarrhea—though these are usually manageable. There are persistent concerns about access and continuity, too. Research just presented at the European Association for the Study of Diabetes finds that about half of patients stop using these drugs within a year, mostly due to high cost, with prices remaining out of reach for many, especially younger people and those with lower incomes. Muscle loss, especially among older adults and women, is another emerging potential downside discussed in the latest studies, reminding users to stay mindful of their overall health—not just what the scale shows. And despite the massive popularity, there are still new legal warnings and lawsuits over rare but serious complications, such as gastroparesis, which can slow digestion to a dangerous degree. The US Food and Drug Administration has continued to update warning labels as new risks are identified.For listeners considering this medication, the message from both doctors and people like Oprah is clear. Ozempic and its cousins can be life changing, but only as part of a larger strategy, with realistic understanding of the risks and the need for sustained healthy habits. Science is still catching up to the real life experience of millions as both hope and caution shape the next chapter of the weight loss revolution.Thanks for listening, please subscribe, and remember—this episode was brought to you by Quiet Please podcast networks. For more content like this, please go to Quiet Please dot Ai. Come back next week for more.Some great Deals https://amzn.to/49SJ3QsFor more check out http://www.quietplease.aiThis content was created in partnership and with the help of Artificial Intelligence AI

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

The three major averages on Wall St rose to record territory on Tuesday as investors looked past current concerns over the US economic stability and bought into market opportunities. The Dow Jones rose added 0.43%, the S&P500 climbed 0.27% and the tech-heavy Nasdaq ended the day up 0.37%. Revisions to payrolls data of late has been the key catalyst spooking investors with the latest revision by the labour department coming in at a reduction of 911,000 for the 12-months to March this year signalling weakness in the US labour stability. In Europe overnight, markets closed mostly higher with the STOXX600 rising 0.09%, while Germany's DAX fell 0.37%, the French CAC added 0.23% and, in the UK, the FTSE100 ended the day up 0.23%.Across the Asia region on Tuesday, markets closed mixed with Japan's Nikkei falling 0.42% while South Korea's Kospi index gained 1.26%, Hong Kong's Hang Seng rose 1.19% and China's CSI index fell 0.7%.The local market sell-off to start September has extended into the new trading week with the key index ending Tuesday's session down 0.52% as investor sentiment has been hit lately by further tariff, US economic and rate outlook uncertainty.Westpac consumer confidence data for September and NAB business confidence data for August were also both released yesterday with declines in both readings more than economists were expecting amid uncertainty on an economic level.Energy stocks continued their slide this week following OPEC+'s weekend decision to increase production of oil starting in October.Telix Pharmaceuticals (ASX:TLX) gained over 2% after reaching a deal with the US Food and Drug Administration to file a revised application for its brain cancer imaging agent, incorporating further clinical data. What to watch today:On the commodities front this morning oil is trading 0.71% higher at US$62.71/barrel, gold is up 0.12% at US$3640/ounce and iron ore is up 0.42% at US$104.93/tonne.The Aussie dollar has weakened against the greenback to buy 65.84 US cents, 97.06 Japanese Yen, 48.62 British Pence and 1 New Zealand dollar and 11 cents.Ahead of the midweek trading session the SPI futures are anticipating the ASX will open the day down 0.05%. Trading Ideas:Bell Potter has increased the 12-month price target on Lynas Rare Earths (ASX:LYC) from $7.65 to $9.35 and maintain a sell rating on the leading rare earths producer following the company highlighting its ‘Towards 2030 strategy'. The analyst sees LYC is priced for perfection, with little room for error, highlighting FY25 had higher depreciation which drove a miss on results, however, does recognise that the current themes pushing LYC higher are likely to persist as tailwinds over the short term.And Trading Central has identified a bearish signal on Breville Group (ASX:BRG) following the formation of a pattern over a period of 33-days which is roughly the same amount of time the share price may fall from the close of $30.89 to the range of $25 - $26.25 according to standard principles of technical analysis.

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/

Uploaded every Friday, Nikkei Asia News Roundup delivers a collection of articles from Nikkei's English language media, Nikkei Asia. ・A selection of news headlines ・A glimpse into a notable story for deeper understanding ・A highlight of our best stories Today we focus on:“China's snooker craze and US food chains scramble in Southeast Asia” ・You can read more at: https://asia.nikkei.com/Spotlight/Podcast/Podcast-News-Roundup  

When a shortage of brand-name weight-loss drugs like Ozempic and Wegovy cleared the way for companies like Hims to fill the gap with cheaper, compounded versions, customers came flocking. But in February, the US Food and Drug Administration announced the shortage was over, leaving the company's strategy in flux and some investors worried. On today’s Big Take podcast, host David Gura and Bloomberg healthcare reporter Madison Muller track how Hims became the king of copycat weight-loss drugs and what’s next for the company as it fights to hold onto the crown. Read more: How Hims Became the King of Knockoff Weight-Loss Drugs Cheap Ozempic Knockoffs Are Suddenly Everywhere. Are They Safe? The Weight-Loss Drug Boom’s Prescription Problem Listen and follow The Big Take on Apple Podcasts, Spotify or wherever you get your podcasts.See omnystudio.com/listener for privacy information.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration's Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49). More On These Topics From The Pink Sheet Will Tidmarsh's Industry Experience Translate As US FDA's Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/ Business Background Of New CDER Director George Tidmarsh: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/business-background-of-new-cder-director-george-tidmarsh-BROCYQDUYFE3LIQDJ2JNBDWD6Y/ US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-cancer-reviewers-heading-for-the-exits-potentially-impacting-review-timelines-YMOFTXDFDZBGVGBIKFXHJY5XTY/ US FDA's Biologics Center Departures Grew Before More Than 100 RIFs Exited: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-biologics-center-departures-grew-before-more-than-100-rifs-exited-2LR3ZFYOBND3DLIWXSFFWWLFYE/ After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/after-sarepta-reversed-course-on-elevidys-could-an-adcomm-be-next-ZA5ODQB3DJF4LBDFODMB52DM3M/ Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-asks-sarepta-to-stop-elevidys-shipments-after-third-death-linked-to-gene-therapy-vector-GLJ2YJDJGNBPLD3SSKKE6UVM34/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why Center for Biologics Evaluation and Research Director Vinay Prasad cited an unproven theory alleging politics influenced the 2020 COVID-19 vaccine emergency use authorizations to justify his decision to overrule reviewers on more recent indication updates (:35). They also consider the impact of hundreds of staff departures after the US Food and Drug Administration's reduction-in-force was allowed to proceed, including 600 in the Center for Drug Evaluation and Research (20:14). More On These Topics From The Pink Sheet Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/prasad-cites-unproven-theory-defending-his-covid-19-vaccine-decisions-QFAGD35QOFA5VCZS4WXDPCNWV4/ US FDA's Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-center-lost-hundreds-of-staff-through-june-with-600-rifs-coming-GYSWOX6RIZEXTK5LZ4KWF3PPDY/

This week, something extraordinary happened: menopause took center stage at the highest levels of US government in an unprecedented way. The US Food and Drug Administration (FDA) convened leading experts from across the country to discuss what millions of women have been waiting to hear: their experiences matter, their suffering is real, and there may be evidence-based solutions that have been withheld. This historic hearing offers tremendous hope for women navigating menopause.Are you ready to awaken your sensuality and feel more empowered in your body? Access the FREE Pleasure Upgrade Bundle at https://www.pleasureinthepause.com/gift.I am your host, Gabriella Espinosa, and in this special episode, I dive into the profound implications of this gathering. The FDA panel, the first of its kind in over two decades, aimed to fundamentally reimagine how we approach women's health during menopause, going beyond mere symptom management. This signifies a cultural awakening, recognizing that dismissing this universal experience has real consequences for women's health, careers, relationships, and quality of life.In this episode, we discuss:The End of Silence: Menopause, once a shamed and dismissed topic, has finally entered serious public discourse, moving beyond quiet endurance to high-level recognition.A Personal Story Driving Change: The head of the FDA shared his personal story about his mother who suffered greatly due to outdated fears around hormone therapy, emphasizing that bone fractures in older women can be fatal.Dismantling Dogma: Experts revealed that vaginal estrogen is categorically safe for all women, with no systemic absorption, directly challenging the black box warning.The Cost of Fear: Data revealed that tens of thousands of women died over the past two decades simply by avoiding estrogen, highlighting the tragic triumph of fear over facts.Brain and Bone Health: Researchers presented alarming data on how estrogen decline impacts brain function and bone density, emphasizing that hormone therapy can be a critical prevention tool, not just a treatment for the elderly.This hearing signals a critical shift: women's health matters, our experiences are valid, and we deserve care based on current science, not outdated assumptions. Whether or not you choose hormone therapy, there is now hope that you can make informed decisions based on facts.Your voice matters in this conversation!The FDA is opening a public comment period on this topic. Please go to the FDA YouTube channel, listen to the full hearing, and leave your public comment. This is our opportunity to ensure today's expert testimony translates into policy changes that will help millions of women.Help us spread more pleasure in the world!Please subscribe, rate, and review this episode, and share it with someone you love. Your voice is crucial in creating ripples of pleasure and connection throughout our communities.Until we meet again, remember, your pleasure matters.FDA HearingFDA InstagramCONNECT WITH GABRReclaim your sensuality and step into a powerful new chapter. The Midlife Pleasure Collective is a monthly membership designed to help midlife women reconnect with their bodies, embrace their desires, and cultivate deeper pleasure. Join the founding members for just $20/month - spots are limited, so apply now at pleasure-in-the-pause.com/collective. Full episodes on YouTube.

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.

The US Food and Drug Administration recently announced that, for the development of certain…

This spring, the US Food and Drug Administration made legally available a treatment for…

The US Food and Drug Administration recently announced that, for the development of certain drugs, it will be phasing out animal testing in favor of more effective, human-centered methods —...

This spring, the US Food and Drug Administration made legally available a treatment for a parasitic disease that commonly affects fish often kept in home aquariums and outdoor ponds. Informally...

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==

Stakeholders from across the healthcare industry, including members of Congress, the US Food and Drug Administration, and the Center for Medicare and Medicaid Services, recently convened in Washington D.C. for the Medical Device Manufacturers Association (MDMA) Annual Meeting. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Nate Beaton, and Bill McConagha, and associate Danny Machado share their key takeaways from the meeting, including compliance hot topics and what the industry can expect in terms of regulatory enforcement in 2025.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why seemingly routine comments from Vinay Prasad, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, that he would stay away from daily review decisions were notable (:26), as well as the impact of proposed FDA budget cuts by the White House and the House of Representatives (17:16). More On These Topics From The Pink Sheet Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors: https://insights.citeline.com/pink-sheet/rare-diseases/prasad-says-involvement-in-us-fda-product-approvals-will-mirror-prior-cber-directors-KF4LJWX5U5DLBMSM6D4YFL7ZOA/ To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/to-compete-with-china-us-fda-must-deregulate-early-gene-therapy-studies-car-t-inventor-says-VDVXZGZIJZFHHNGGQXYILBI7RM/ FDA's FY 2026 Budget Request Lacks New Policy Proposals: https://insights.citeline.com/pink-sheet/legislation/fdas-fy-2026-budget-request-lacks-new-policy-proposals-WV3LE2AYBRAC7LIYJEU4WZDNGU/ User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-funded-staff-would-drop-in-fy-2026-us-fda-budget-TQZMEB57V5GELNPMYGTY5BEGOY/ House Gives US FDA More Non-User Fee Funds Than Requested: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/house-gives-us-fda-more-non-user-fee-funds-than-requested-PCQZCBHOB5ARPICMJJQ6VYIJ5M/

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        

The Smart 7 is an award winning daily podcast, in association with METRO that gives you everything you need to know in 7 minutes, at 7am, 7 days a week...With over 18 million downloads and consistently charting, including as No. 1 News Podcast on Spotify, we're a trusted source for people every day and the Sunday 7 won a Gold Award as “Best Conversation Starter” in the International Signal Podcast Awards If you're enjoying it, please follow, share, or even post a review, it all helps...Today's episode includes the following guests:Guests Dr Morgaine Gaye - Food Futurologist and Phd in Quantum Philosophy Dr David Kessler - Author and former Commissioner with the US Food and Drug AdministrationWill Guyatt - The Smart 7's Tech Guru Butch Wilmore & Sunni Williams - NASA Astronauts Dr Sam Chapman - Co-Founder and Executive Director of Kenoteq Lucy Black - Kenoteq's Head of Business Development Robert F Kennedy Jr - United States Secretary of Health Doctor Molly O'Shea - Spokesperson for the American Academy of Pediatrics Marcus Beard - Former Government Digital Counter-Misinformation StrategistJamie Christon - CEO of Chester Zoo Ros Clubb - Head of Wild Animal Science and Policy at the RSPCA Contact us over @TheSmart7pod or visit www.thesmart7.com or find out more at www.metro.co.uk Presented by Jamie East, written by Liam Thompson, researched by Lucie Lewis and produced by D Hosted on Acast. See acast.com/privacy for more information.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential comments that US Food and Drug Administration Commissioner Martin Makary and other senior agency leaders could receive during their pharma CEO listening tour (:30), as well as the impact of Health and Human Services Secretary Robert F. Kennedy Jr.'s decision to change US Centers for Disease Control and Prevention policy and no longer recommend healthy children and pregnant women receive COVID-19 vaccines (15:47). More On These Topics From The Pink Sheet US FDA Makary's Pharma CEO Tour Goes Against Transparency Rhetoric: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-makarys-pharma-ceo-tour-goes-against-transparency-rhetoric-3E5RP5IATVD73DRPQHZPSTHKRA/ HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role: https://insights.citeline.com/pink-sheet/vaccines/hhs-rescinds-covid-19-vaccine-advice-usurping-us-cdc-role-YNFI7TU5CFGERIGFG7ISOJ4X5Q/

A recent US Food and Drug Administration decision updates the rule for "healthy" claims for seafood, allowing seafood products that meet the new FDA criteria to voluntarily make "healthy" claims on their packaging and other marketing materials. Under the final rule, the FDA notes that seafood without added ingredients except for water automatically qualifies for use of the “healthy” claim due to its nutritional attributes and role in healthy diets as recommended by the Dietary Guidelines for Americans.In this interview, Anna Benevente, director of regulatory affairs for Registrar Corp, discusses the impact this change will have on the seafood industry, including:FDA's new "healthy" claim regulation shifts focus from individual nutrients to overall dietary patterns, benefiting seafood marketersSeafood (including high-fat fish like salmon) now automatically qualifies for the "healthy" claim if single-ingredient or water-packed.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the limited label that Novavax received for its new COVID-19 vaccine Nuvaxovid, the impact of the new COVID-19 vaccine development policy announced by the US Food and Drug Administration and additional upcoming indicators of the evolving policy. More On These Topics From The Pink Sheet Novavax's COVID-19 Vaccine Label Narrowed After Political Officials Intervened: https://insights.citeline.com/pink-sheet/vaccines/novavaxs-covid-19-vaccine-label-narrowed-after-political-officials-intervened-56OPC7DJ6NCXFLQYGE27SVTEH4/ Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy: https://insights.citeline.com/pink-sheet/vaccines/legal-process-problems-may-plague-new-us-fda-covid-19-vaccine-policy-HAUDHEREXZCA5DAZ47HZ6L544U/ Observational, Retrospective Trials Could Retest Vaccines, HHS' Kennedy Says: https://insights.citeline.com/pink-sheet/vaccines/observational-retrospective-trials-could-retest-vaccines-hhs-kennedy-says-BOFKDMMHGVDNXKXMFEILOXAH4E/ US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems: https://insights.citeline.com/pink-sheet/vaccines/us-fda-covid-19-booster-strategy-may-not-be-as-controversial-as-it-seems-ZEAHMHE5LJB6HLBT2WRZW4L3AY/ US FDA Punts On New COVID-19 Framework's Impact On Fall Shots: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-punts-on-new-covid-19-frameworks-impact-on-fall-shots-QSB6OPEB4ZCEFLS36JG3Y7XSPE/

The US Food and Drug Administration (FDA) is set to revise its approval process for COVID-19 vaccines, potentially limiting future boosters to older adults and those at higher risk of severe illness. The move has sparked questions about how this change could influence Australia's vaccine strategy and access to boosters in the future.

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW's Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. Our news highlights this time focus on two major regulatory agencies, in a week that saw the European Commission (EC) launch a new fund designed to tempt US researchers to EU countries, and the US Food and Drugs Administration (FDA) roll out extensive new AI systems. You can listen below, or find The Drug Discovery World Podcast on Spotify, Google Play and Apple Podcasts. 

Recently, there has been a lot of interest generated by a new FDA approval. Suzetrigine (Journavx) was recently approved by the US Food and Drug Administration for the management of pain. Although there is a lot of excitement about having a new tool in the toolbox, there are certain limitations that are important to consider. In this episode of Verified Rx, Dave Peterson, pharmacist and drug information specialist for the University of Utah Health joins us to discuss this exciting new non opioid medication.   Guest speakers:  Dave Peterson, PharmD, BCPS Drug Information Specialist University of Utah Drug Information Service   Host:  Kerry Schwarz, PharmD, MPH Senior Clinical Manager, Evidence-Based Medicine and Outcomes Center for Pharmacy Practice Excellence (CPPE) VerifiedRx Host   Show Notes:  [00:54-02:24] Information about Suzetrigine [02:25-04:06] What distinguishes suzetrigine from other non-opioid analgesics [04:07-05:09] What suzetrigine is indicated for [05:10-06:14] How suzetrigine is being studied [06:15-08:40] Surgical models and the endpoints that we commonly see in these studies [08:41-10:25] Making sense of discordant study results [10:26-12:02] Moving beyond the evidence to real world utilization of suzetrigine [12:03-14:03] How cost factors into real-world utilization [14:04-16:21] What Dave is keeping his eye on in terms of clinical concerns [16:22-17:28] What Dave is excited about with the advent of suzetrigine   Links | Resources: No pain, much gain?   Subscribe Today! Apple Podcasts Amazon Podcasts Spotify Android RSS Feed

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider early excitement and concern about Vinay Prasad's potential impact on product development as director of the US Food and Drug Administration's Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00). More On These Topics From The Pink Sheet Tougher Approval Standards May Follow Vinay Prasad's Appointment To Lead US FDA's CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PGDGE44/ US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-guidance-roadblock-writing-continues-but-publication-has-slowed-or-stopped-TZF4DMPEMVHT3JJPRUX7LJJIHU/

SPONSOR: Fast Growing Trees makes it easy to order online, and your plants are delivered to your door in just a few days. Big yard, small yard, no yard? Fast Growing Trees has over 6,000 plants to fit any space, from indoor plants to fruit trees to full-sized privacy trees and more! Every plant comes with instructions and tips to care of your new plants so they can grow to their fullest potential. This Spring Fast Growing Trees has the best deals, for your yard, up to half off on select plants and other deals. Go to: https://www.Fast-Growing-Trees.com/ And get 15% OFF your first purchase when using the code RICK at checkout. SPONSOR: - BlazeTV - In a world full of noise, we need a stronghold for bold voices, free thinkers, and fearless commentary that helps make sense of the chaos. At BlazeTV, we’ve built a home for some of the strongest, smartest voices in conservative media—people who tell it like it is, ask the tough questions the mainstream won’t touch, and aren’t afraid to challenge the narrative. When you subscribe to BlazeTV, you’re not just watching content—you’re supporting a movement. You’re backing creators who think for themselves, speak boldly, and refuse to be silenced by Big Tech or corporate media. You’re supporting investigative journalism that exposes corruption and original documentaries that shine a light on the deep state. So, if you’re ready to keep winning, shop your values and make sure we don’t lose the ground we’ve gained — go to https://www.BlazeTV.com/RICK and subscribe today, and you’ll save 20 bucks right now off our annual plan. See omnystudio.com/listener for privacy information.

Gene-editing technology which makes pigs immune to a highly infectious virus, developed at Edinburgh University's Roslin Institute, has been approved for use by the US Food and Drug Administration. The virus causes a disease called PRRS or Porcine Reproductive and Respiratory Syndrome, which causes premature births in pigs as well as other painful symptoms and costs the pig industry billions. Current legislation doesn't permit its use in the UK. We speak to one of the scientists who's been working on the project for more than seven years.All week we've been taking a closer look at pulses, the dried seeds of crops like beans, lentils and peas, for both human and animal food. In the UK the peas we eat are generally frozen or fresh but dried peas are a major source of protein to millions of people around the world. Scientists at the John Innes Centre in Norwich have been working with researchers in China, the USA and France to uncover the genome of 700 different varieties of pea, from many different countries, to help develop better commercial varieties.The sudden suspension of England's biggest environmental scheme, the Sustainable Farming Incentive, earlier this year was met with horror and disbelief by farmers and environmentalists alike - we preview a special documentary which charts the transition of agricultural policy from the old EU farm subsidy system and the Common Agricultural Policy to the new 'public money for public goods' approach that we have in England today. Presenter = Caz Graham Producer = Rebecca Rooney

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of the departures of several senior leaders in the US Food and Drug Administration's facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary's intent to combine the agency's many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16). More On These Topics From The Pink Sheet US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-retirements-continue-unabated-with-drug-inspectorate-leaders-former-chief-counsel-JRKHCHZHMBC4RLRJRBDTSIP7E4/ FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-leadership-shuffle-continues-lowell-zeta-returns-as-opdp-ogd-leaders-depart-FONMRWR37VGAFL2JJ5S27QIU2E/ US FDA's Makary Floats Vague ‘Plausible Mechanism' Approval Pathway For Rare Diseases: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/us-fdas-makary-floats-vague-plausible-mechanism-approval-pathway-for-rare-diseases-RJJJCPDUDFHINMPDE5VK4OFDVQ/ US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-makary-wants-to-combine-adverse-event-reporting-systems-UJ4QUEM72ZC25J7JHAC3LAKKKA/ Political Influence And The US FDA: A New Era?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/political-influence-and-the-us-fda-a-new-era-SL6ZBNKHNVFEXCLQLCYTDJIETQ/

AP correspondent Haya Panjwani reports on the phasing out of artificial dyes in the US food supply.

Send us a textOn this episode we speak with Dr. Jesse Goodman about the spread of the H5N1 virus.  We will discuss what a virus is, how viruses migrate from animal populations to humans and assess the chances for a new pandemic.Jesse L. Goodman, M.D., M.P.H., directs Georgetown COMPASS, which focuses on science based policy and research to address unmet public health needs with an emphasis on product development and access and antimicrobial resistance and stewardship. Until February 2014 he served as the Chief Scientist of the US Food and Drug Administration (FDA), a position he assumed in 2009 along with Deputy Commissioner for Science and Public Health (2009-2012). As FDA's Chief Scientist he had broad responsibility for strategic leadership of crosscutting scientific and public health efforts, including developing and implementing FDA's Strategic Plan for Regulatory Science and FDA's public health preparedness and response and medical countermeasures efforts.A graduate of Harvard, Dr. Goodman received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training in Medicine, Infectious Diseases and Oncology at the Hospital of the University of Pennsylvania and at the University of California in Los Angeles (UCLA), where he was also Chief Medical Resident. https:/natureandsciencepodcast.com

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the impact of the 1 April reduction-in-force on the US Food and Drug Administration, which targeted about 3,500 employees (:30). They also consider how and whether service levels will change (13:28), and new Commissioner Martin Makary's first address to the drastically smaller staff the day after the RIF was announced (29:22). More On These Topics From The Pink Sheet Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-layoffs-us-likely-to-lose-its-first-approver-advantage-5C37YQ73DNBEFF7SHRYV4MJUIA/ Are Bigger Ad Policy Changes Coming After US FDA's Drug Promotion Office Hit Hard By Layoffs?: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/are-bigger-ad-policy-changes-coming-after-us-fdas-drug-promotion-office-hit-hard-by-layoffs-FQLHKJ4GWRCXLEIZCEMX37SUYU/ Dramatic HHS Layoffs A Response To ‘Existential Crisis,' Kennedy Advisor Argues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dramatic-hhs-layoffs-a-response-to-existential-crisis-kennedy-advisor-argues-XZKO5PJF6RHGHLABD2TZY7K2N4/ CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cdrh-staff-cuts-focus-on-administrative-workers-spare-reviewers-DL3L63CAGFGYTDAICFSXG5JP34/ Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-pledges-to-uphold-gold-standard-science-but-first-address-confuses-some-us-fda-staff-WE7A5TQARBHX3MS6LGDIQT5CRY/ US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-restructuring-may-be-next-after-drugs-center-loses-more-than-1000-people-HOZ7IYGEC5BYBMNNUPAT2TBNI4/

‘Friendship benches', a mental health intervention first piloted in Zimbabwe, are now being handed over to the government in that country. It is hoped that this will allow the program to become more widespread.Also on the show, a new device can convert brain signals to speach in nearly real time for those who have been paralysed, a medicine for rare genetic disorders could also make human blood deadly to mosquitos, and the US Food and Drug administration has approved a new first-in-class antibiotic for uncomplicated urinary tract infections.Presenter: Claudia Hammond Producer: Margaret Sessa-Hawkins and Katie Tomsett

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Senior Editor Sue Sutter discuss the impact of the 3,500 layoffs on the US Food and Drug Administration, including the areas where the agency could lose some autonomy (:28). They also consider worries that the agency's preparations for user fee reauthorization negotiations may be slowing because of the upcoming staffing cuts (24:09). More On These Topics From The Pink Sheet Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/power-play-us-fda-likely-losing-more-than-just-staff-with-restructured-health-department-BT5YZ4U7WNANBEZN7OBF42LCEE/ US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-staffing-uncertainty-could-impact-upcoming-user-fee-negotiations-EAUTZOANHVB3PK6NKCLJCYTOLA/ Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/can-new-us-fda-commissioner-makary-calm-agency-during-turbulent-times-STBAXTWCIFEGJPDYZ6LZKMRPE4/

Prothrombin complex concentrates (PCCs) are frequently used off label for the management of factor Xa inhibitor-associated major bleeding. In 2018, accelerated approval was granted for andexanet alfa, a specific factor Xa inhibitor reversal agent, for reversal of apixaban and rivaroxaban in the setting of life-threatening or uncontrolled bleeding. Following accelerated approval, some clinical practice guidelines were updated to include recommendations for andexanet alfa preferentially over PCCs for reversal of life-threatening or uncontrolled bleeding due to rivaroxaban or apixaban. Other guidelines stated no preference of andexanet alfa over PCC. In 2020, Vizient convened an expert panel to critically appraise the literature and provide consensus-based, expert opinions on the utilization of pharmacological reversal agents for factor Xa-related major bleeding. Since then, the body of literature evaluating these agents has expanded to include a randomized controlled trial, ANNEXa-I, the results of which were submitted to the US Food and Drug Administration to convert the approval of andexanet alfa from accelerated to full approval. Dr. Lisa Baumann-Kreuziger, Associate Professor of Hematology and Oncology, Medical College of Wisconsin and medical director of the Antithrombotic Therapy Management Program at Froedtert Health discusses the current status of management of factor Xa inhibitor-associated major bleeding with Dr. Kerry Schwarz, Senior Clinical Manager of Evidence-Based Medicine and Outcomes with the Vizient Center for Pharmacy Practice Excellence, and your program host.   Guest speakers:  Liza Baumann-Kreuziger, MD, MS Investigator, Blood Research Institute, Versiti  Associate Professor of Hematology and Oncology, Medical College of Wisconsin Medical Director, Antithrombotic Therapy Management Program at Froedtert Health   Host:  Kerry Schwarz, Pharm.D, MPH Senior Clinical Manager of Evidence-Based Medicine and Outcomes  Vizient Center for Pharmacy Practice Excellence   Show Notes: [02:25-04:26] The current state of hemostatic management in the setting of factor Xa inhibitor-related major bleeding [04:27- 05:35] Limitations of available evidence making clinical practice and formulary decision making so challenging [05:35 – 10:52] Publication of the first randomized controlled trial, ANNEXa-I, comparing andexanet alfa to usual care [10:52-14:49] Meeting of the FDA advisory committee and subsequent complete response letter [14:50-16:45] How we can approach clinical management of patients and formulary decision-making in the current state   Subscribe Today! Apple Podcasts Amazon Podcasts Spotify Android RSS Feed

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss industry stakeholders' complaints about US Food and Drug Administration productivity declines in the weeks since President Trump took office and began making changes and the potential recourse for industry (:24). They also review the expected and emerging problems with the agency requiring nearly all of its Washington, D.C.-area staff to return to in-office work at its White Oak headquarters and consider its impact on workflow going forward (15:35). More On These Topics From The Pink Sheet US FDA's Speed Of Work Under Trump Quietly Raising Industry Concerns: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-speed-of-work-under-trump-quietly-raising-industry-concerns-ZWM522FIDJAO7DVAJYZRLLDFAI/ US FDA Survives First Day Of Return To In-Office Work, But True Test Upcoming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-survives-first-day-of-return-to-in-office-work-but-true-test-upcoming-AZOWC5ITNNGGVG3TIGGWR5VMBA/ Cramped Quarters, Limited Parking And Water Concerns Await US FDA's Return To Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cramped-quarters-limited-parking-and-water-concerns-await-us-fdas-return-to-office-YWHJRM6RTZF4NJP2MZX4Y6LLQA/

See omnystudio.com/listener for privacy information.

Episode 10 highlights examples of how patient advocacy groups influenced pharmaceutical decisions at the US Food and Drug Administration (FDA). In a conversation with health policy researcher, author and activist, Sharon Batt PhD, we explore regulatory decisions on Relyvrio (AMX0035), Avastin (bevacizumab), and Addyi (flibanserin) within the context of our latest report “What Needs to Change at the FDA?Protecting and Advancing Public Health.”Pharmanipulation is produced by PharmedOut, a project at Georgetown University Medical Center that advances evidence-based prescribing. Additional Resources Full Report “What Needs to Change at the FDA? Protecting and Advancing Public Health”: https://georgetown.box.com/s/n87us836fpmdhtcvdaqopyobfwx7bymx  Webinar on “What Needs to Change at the FDA?”: https://www.youtube.com/watch?v=4g9br3wZW-k&t=11s  Article on “How some drug companies manipulate patient advocates” by Judith Garber: https://lowninstitute.org/how-some-drug-companies-manipulate-patient-advocates/  

The initial months of the Trump administration have been marked by a flurry of executive orders and significant activity by the Department of Government Efficiency (DOGE). The US Food and Drug Administration is a key target of these efforts. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Ben Haas and associate Danny Machado explore how FDA may be affected, particularly as it relates to novel tobacco and nicotine products, which can be a bellwether for approval and enforcement trends more generally.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The US Food and Drug Administration (FDA) issued new draft regulatory guidance for pulse oximeters related to skin pigment. The guidance is a step forward but it may have unintended consequences. Authors Michael Lipnick, MD, and Philip Bicker, MD, PhD, professors of anesthesia at University of California, San Francisco, discuss this and more with JAMA Executive Editor Gregory Curfman, MD. Related Content: Pulse Oximetry and Skin Pigmentation—New Guidance From the FDA Adherence to FDA Guidance on Pulse Oximetry Testing Among Diverse Individuals, 1996-2024 Addressing Racial and Ethnic Bias in Pulse Oximeters—A Wicked Problem Evaluating the Accuracy of Pulse Oximetry in Children According to Race

Palestinian civilians are expected to be allowed to return to northern Gaza if a ceasefire and hostage exchange deal is finalized. At her confirmation hearing today, President-elect Donald Trump's pick for attorney general said she wouldn't enforce an “enemies list.” Firefighters in California face several more critical hours of dangerous winds fuelling wildfires. The US Food and Drug Administration is cracking down on a popular ingredient. Plus, America's largest fuel pipeline is temporarily shut off. Learn more about your ad choices. Visit podcastchoices.com/adchoices

We'll tell you why power to more than 20,000 households in Southern California could be intentionally shut off. Pete Hegseth, President-elect Donald Trump's pick for defense secretary, is walking back some previous statements during his confirmation hearing. We have the latest on a ceasefire and hostage exchange deal between Israel and Hamas. The US Food and Drug Administration wants packaged food labels to have more information. Plus, a country known for high temperatures is hitting record lows. Learn more about your ad choices. Visit podcastchoices.com/adchoices