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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/

Episode transcript [Music] From Washington State University Extension, welcome to Food Safety in a Minute. From a food science perspective, ultra-processed foods are foods altered from their original form through processing, lacking a “legal” definition. Ultra-processed foods often include additives considered less healthy such as sugar, salt, colorings, flavorings, and less healthy fats; linked to chronic health conditions and obesity. Additives in ultra-processed food and their relationship to food safety and health are legitimate concerns. However, it's important to note that many additives in processed food come from the Food and Drug Administration's Generally Recognized as Safe or GRAS list. The usage of additives on this list is based on science and a long history of safe use. We'll talk about the GRAS list in an upcoming podcast. I'm Susie Craig. Thanks for listening. [Music] Resources: Carlos Augusto Monteiro, Cannon, G., Lawrence, M., Costa Louzada, M.L., and Pereira Machado, P. Food and Agriculture Organization of the United Nations. Ultra-processed foods, diet quality, and health using the NOVA classification system. Rome, 2019. Accessed online 1/15/25. https://openknowledge.fao.org/server/api/core/bitstreams/5277b379-0acb-4d97-a6a3-602774104629/content. US Food and Drug Administration. Code of Federal Regulations. Part 170 – Food Additives. Accessed online 2/5/25. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170.

Video Version Only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center speak with Laurel Messer, PhD, RN, senior director of medical affairs at Tandem Diabetes Care, about the latest advancements in Control-IQ+, the company's next-generation automated insulin delivery (AID) technology. With clearance received from the US Food and Drug Administration (FDA) in February 2025, Tandem announced on March 18, 2025, that the Control-IQ+ hybrid closed-loop algorithm is now available for use in adults with type 2 diabetes (T2D) aged ≥18 years alongside people with type 1 diabetes (T1D) aged ≥2 years. Enhancements to the algorithm included a broader weight range (20–440 lbs) and insulin dosing parameters (5–200 units), representing a more inclusive algorithm. In this episode, Messer highlighted other new features in the updated algorithm, such as temp basal rate adjustments for exercise or illness and an extended bolus option of up to eight hours, which enhances flexibility in insulin management during meals. Messer also emphasized that Control-IQ+ offers a unique advantage: the ability to fine-tune correction factors, allowing providers to tailor insulin delivery for improved glycemic control. With the AutoBolus feature, Control-IQ+ predicts and corrects hyperglycemia every hour, significantly benefiting individuals who struggle with consistent mealtime bolusing. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Important Safety Information: RX ONLY. Indicated for patients with type 1 diabetes, 2 years and older and for patients with type 2 diabetes, 18 years and older. BOXED WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds, as those are the required minimum values needed for Control-IQ+ to operate safely. Safety info: tandemdiabetes.com/safetyinfo.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration's early retirement and buyout programs to further cut its workforce (:25), leadership departures in the Center for Biologics Evaluation and Research (9:13), the quick arrival and resignation of a new FDA chief counsel (12:35), and Commissioner nominee Martin Makary closing in on confirmation, as well as the impact of the staffing changes on the agency he likely will be running (22:45). More On These Topics From The Pink Sheet US FDA Reviewers, Inspectors Not Eligible For HHS Buyouts: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-reviewers-inspectors-not-eligible-for-hhs-buyouts-PHAPCCR7NZBCRKRL6NPQANGGW4/ User Fee Deadline Concerns Emerge As US FDA Buyout Offer Sweetened With Paid Leave: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-deadline-concerns-emerge-as-us-fda-buyout-offer-sweetened-with-paid-leave-WRCP4JYKTJHZPP3QTLGJQPTS54/ CBER Losing Cell, Gene Therapy Leadership As Workforce Culling Continues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cber-losing-cell-gene-therapy-leadership-as-workforce-culling-continues-CAWLALTKUVFADETC7HZEXMJQKA/ US FDA May Lose Some Autonomy Under Health Department's General Counsel Reorg: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-may-lose-some-autonomy-under-health-departments-general-counsel-reorg-VUS3GIMCLBE2TC2BUL7UHMIEP4/ Makary US FDA Nomination Advances, Last Minute Hiccup May Offer Clues On Mifepristone: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-us-fda-nomination-advances-last-minute-hiccup-may-offer-clues-on-mifepristone-XQXLBN7HRNGUPCNV3XEUHR3ASA/ Don't Ask, Don't Tell: Senate Democrats Ready To Embrace Makary Heading US FDA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dont-ask-dont-tell-senate-democrats-ready-to-embrace-makary-heading-us-fda-AOZR6OAM5RHF5ECCOYGQPV77HQ/

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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

SymPhysis Medical, the Galway MedTech company seeking to address the distressing condition of fluid in the chest in cancer patients, has announced a significantly strengthened senior team and plans for rapid growth as it prepares for its device's US launch. With clearance from the US Food and Drug Administration (FDA) targeted by 2026, SymPhysis Medical aims to launch its device within the next 18 months and to reach €40M in revenue by 2030. Founded by CEO Tim Jones and Chief Scientific Officer, Dr Michelle Tierney, SymPhysis Medical has developed a device, releazeTM, which can be used by cancer patients who are receiving palliative care to relieve the symptoms of fluid in the chest. These symptoms include shortness of breath, discomfort and pain. The condition, experienced by approximately 50% of late-stage cancer patients, limits movements and activities, while necessitating regular medical appointments at a time when many wish to be at home and spending time with loved ones. The company founders expect their device's launch in the US to mark a transformation in the care, and quality of care, of these patients. In the most recent funding round, SymPhysis Medical has raised €2.8M and expects to close a further €3.7M from a combination of current and new investors by April 2025. Investors have been impressed by SymPhysis Medical's ambitious growth plans and focus on a market, worth €860M in the US and Europe alone, which has lacked innovation over the last 25 years. The company was endorsed by the European Innovation Council (EIC) in February 2025, receiving the Seal of Excellence, which highlights the value and impact of the innovation. SymPhysis Medical expects to represent 20% of the US market by 2030 and 10% of the European market in the same period. This will mean that 35,000 patients could be benefiting from releazeTM by 2030. Driving SymPhysis Medical's post-launch growth and momentum will be an enhanced senior team whose track record covers some of the world's largest MedTech and life sciences companies. Their expertise includes sales and distribution of medical devices, business strategy and regulatory affairs. Joe Villanova, VP Sales and Marketing, will drive SymPhysis Medical's penetration of the US market. He has more than 35 years of experience in commercialising medical devices, with 15 years of experience in those addressing fluid in the chest. He has held leadership roles in multinationals including Baxter Healthcare and Becton Dickinson. Meanwhile, Niamh St John Lynch, Director of Quality Assurance and Regulatory Affairs, has 30 years of international experience in the pharmaceutical and medical device industries. Her knowledge of medical device regulations, FDA clearance and risk management, through previous work with Johnson & Johnson and Boston Scientific, among others, will help to drive global regulatory approval and adoption of releazeTM. The team will also benefit from a strengthened board of directors. David Uffer has almost 35 years of experience in the life sciences industry. His experience has seen him lead business development for multinationals including Boston Scientific, Abbott and Medtronic. With extensive experience in the commercialisation and launch of early stage medical device companies, he will be pivotal to SymPhysis Medical's launch and success in the US. Meanwhile, Gerard Ryan is a serial entrepreneur and experienced investor. Gerard founded Longboat Clinical (sold to Advarra in 2020 in a multimillion Euro deal) and Firecrest (sold in 2011 to ICON plc for €50M). One of SymPhysis Medical's first investors, Ryan will help to drive SymPhysis Medical's strategic direction. Tim Jones, CEO, SymPhysis Medical, said: "This is an exciting time for our company. For six years, we have been laser-focused on our mission to help late-stage cancer patients - and, indirectly, their loved ones - to ease a very distressing condition at an extremely difficult time for them. I am immensely proud of our...

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the issues that dominated the Senate confirmation hearing for US Food and Drug Administration Commissioner nominee Martin Makary, including vaccines (1:03) and mifepristone (14:45), as well as several questions that were not asked (23:31). They also consider the potential impact of his answers on the agency. More On These Topics From The Pink Sheet Makary Plans To Review Mifepristone Data, Raising Concerns Of Abortion Pill Access Rollbacks: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-plans-to-review-mifepristone-data-raising-concerns-of-abortion-pill-access-rollbacks-24NTRIXLKJD23OKNBB5Z7UAFL4/ Senators Scrutinize US FDA Commissioner Nominee Makary Over VRBPAC Cancellation: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/senators-scrutinize-us-fda-commissioner-nominee-makary-over-vrbpac-cancellation-HVW5VNH55ZFUPBL64BK2VNOYJA/ Science Vs. Politics: Hearing Could Reveal Makary's Approach To Unusual Administration Involvement: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/science-vs-politics-hearing-could-reveal-makarys-approach-to-unusual-administration-involvement-LGWBJEWWNRCIXPVEJ4AEAJRLN4/

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

In a new show from Macrodose:The Curve, James Meadway and Grace Blakeley break down the week's biggest economic stories and what they mean for all of us.In this excerpt, they discuss the recent German federal election results and how Die Linke managed to turn things around (1:08).In the full episode, James and Grace look at how US food imports are at a record level, and some recommended reading on the global debt crisis.FULL SHOW: ⁠⁠Patreon.com/macrodose

In this podcast recorded in early February, David Phizackerley and Julian Treadwell (DTB Associate Editor) provide an overview of the March 2025 issue of DTB. Julian talks about his work as an academic GP based at Bristol University. He explains why and how he developed the GP Evidence website (https://gpevidence.org/) as a resource for health professionals to use as part of a shared decision making process, and talks about the importance of providing patients with information on the absolute benefits and harms of different treatment options for long-term conditions.   The editorial discusses a paper published in The Lancet on the population-health impact of new drugs recommended by NICE and highlights the tension between NICE's role in ensuring that treatments are a cost-effective use of taxpayers' money and its role in championing the for-profit life-sciences - https://dtb.bmj.com/content/63/3/34. A DTB Select item summarises safety alerts issued by the US Food and Drug Administration and the European Medicines Agency on liver problems associated with fezolinetant (▼Veoza), a drug licensed for the treatment of moderate-to-severe vasomotor symptoms associated with the menopause - https://dtb.bmj.com/content/63/3/36. The main article provides an overview of systemic anticancer treatments and conventional cytotoxic drugs - https://dtb.bmj.com/content/63/3/37.   Links GP Evidence (https://gpevidence.org/)   Naci H, Murphy P, Woods B, et al. Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000–20: a retrospective analysis. The Lancet 2025;405:50–60. (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02352-3/fulltext)    Please subscribe to the DTB podcast to get episodes automatically downloaded to your mobile device and computer. Also, please consider leaving us a review or a comment on the DTB Podcast iTunes podcast page. If you want to contact us please email dtb@bmj.com. Thank you for listening.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr, discuss the US Food and Drug Administration's decision to call back many workers that were laid off and the next steps for the Trump Administration's effort to reduce the size of the federal government (:29), the FDA decision to cancel an upcoming Vaccines and Related Biological Products Advisory Committee meeting on strain selection for the 2025-2026 flu vaccine (12:42), and the motives for Eli Lilly's plan to increase domestic manufacturing (23:18). More On These Topics From The Pink Sheet Drug Reviewers And Legal Staff Among Those Called Back to US FDA, But Why?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/drug-reviewers-and-legal-staff-among-those-called-back-to-us-fda-but-why-YWONQYDHARESFLLY26YEP6RIHI/ DOGE-ing US FDA: Three Scenarios For What Comes Next: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/doge-ing-us-fda-three-scenarios-for-what-comes-next-XUDLPX3WNNH55JCHOMTOS2NXBA/ Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/breaking-us-fda-cancels-upcoming-adcomm-discussing-2025-2026-flu-vaccine-AGBZQHYGZFHZLOK2PU5CCKBNK4/ Lilly $27Bn US Manufacturing Investment Linked To Trump's Tariff, Tax Agenda: https://insights.citeline.com/pink-sheet/compliance/manufacturing/lilly-27bn-us-manufacturing-investment-linked-to-trumps-tariff-tax-agenda-FN55MQ3V75EU5J42TIYTFLTH4Q/

Percheron Therapeutics Ltd has submitted a non-binding proposal to an international pharmaceutical company to in-license a new drug development program for a rare neurological disease. The program is described as ‘clinic ready' and prepared for human trials. Negotiations for a definitive agreement are expected to take 8-12 weeks, with plans to begin human clinical trials in early 2026, subject to a successful investigational new drug (IND) application with the US Food and Drug Administration (FDA). Percheron stated that investor interest in the company's next steps remained high. CEO Dr James Garner noted that extensive due diligence had been conducted across a broad range of programs, leading to discussions on business terms with the preferred candidate. The company believes this represents a strong opportunity for shareholders. Alongside preparing its IND submission, Percheron will continue assessing alternative clinical opportunities as a contingency measure and for potential future expansion. The company intends to provide updates as discussions progress. #PercheronTherapeutics #DrugDevelopment #RareDiseases #NeurologicalDisorders #ClinicalTrials #Biopharma #Pharmaceuticals #FDAApproval #INDApplication #MedicalResearch #BiotechInvestment

Celebrate, The Savior is Here!Jesus Christ is Alive!Get to know Jesus Christ, He will change your life!!!Go to GOD for discernment and wisdom.Know the Truth as the Truth will make you free! (John 8:32)___The Pledge of AllegianceNEO420 = Real News + Real Information for WE THE PEOPLEWE THE PEOPLE are at war with the deepstate criminal cabal!!!Turn off your tv, radio, and stop listening to paid professional liars spreading propaganda.***SUPPORT Independent Free Speech Reporting***Thank you for the SUPPORT & SHARING the TRUTH!!!___Podcast  link is here http://neo420.com/talks-podcast/The video channel link is here. https://odysee.com/@NEO420TALKS:4The Viral Delusionhttp://www.theviraldelusion.com/HAARPDARPA BlackjackAshli Babbit false flag Jan 6 video evidence___NEVER FORGET 9 11!!!Rumsfeld admitted $2.3 Trillion missing from Pentagon Sept 10 2001.  https://odysee.com/@NEO420TALKS:4/rumsfeld-2.1Trillionunaccountedforb-ccriminalsstoleit:7Planes did NOT bring down the two towers.AE911Truth.orgGeorge Bush Sr was CIA director before being Vice President then President.Towers that fell:-Building 1-Building 2-Building 7 (seldom reported even though BBC reporter reported building down before it happened) https://www.youtube.com/watch?v=J0VFMqi--Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for "fair use" for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.Support the show

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr and HBW Insight Managing Editor Malcolm Spicer, discuss the most up-to-date information on the layoffs at the US Food and Drug Administration that were instituted by the Trump Administration (:42). They also consider the layoffs' impact on the drug, device and consumer health divisions, including application review and facility inspections, as well as industry's response to them (17:58). More On These Topics From The Pink Sheet US FDA Staff Cuts: Biopharma Industry Braces For Impact, But First Wants Clarity On Losses: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-staff-cuts-biopharma-industry-braces-for-impact-but-first-wants-clarity-on-losses-C45JIJX7IRD5FON2BNNKHTTBZU/ CMS Layoffs Broader Than Reports Indicate, Former Administrator Brooks-LaSure Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/cms-layoffs-broader-than-reports-indicate-former-administrator-brooks-lasure-says-A6XEKATFPRFXZCHSD7VDKO53HA/ Weekend US FDA Layoffs Cost Device Center Many AI And Digital Health Staffers: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/weekend-us-fda-purge-costs-device-center-many-ai-and-digital-health-staffers-VSCWD67JAJARTP7S3EZYB6KSIQ/ US FDA Food Safety Leader Resigns In Protest Of White House-Ordered Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-food-safety-leader-resigns-in-protest-of-white-house-ordered-layoffs-ZJSIV3VWTNBB7MPGPOV7TUWWJU/ FDA Cosmetics Office Braces For Agency-Wide Staff Cuts; MoCRA Implementation Likely Delayed: https://insights.citeline.com/hbw-insight/beauty/policy-and-regulation/fda-cosmetics-office-braces-for-agency-wide-staff-cuts-mocra-implementation-likely-delayed-5CNPONAL2JBGRIOVLTPSISLCFY/ PhRMA Still All In For Trump Despite Chaos Hitting US Health Sector: https://insights.citeline.com/pink-sheet/market-access/phrma-still-all-in-for-trump-despite-chaos-hitting-us-health-sector-MSNPGI66H5AABGVJVGG2MLNZIA/

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals. Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories included the US Food and Drug Administration's (FDA) acceptance of a Biologics License Application (BLA) for a cholesterol-lowering drug, long-term data on a dermatologic treatment for hidradenitis suppurativa, an expanded dosing label for a blinding eye disease treatment, and more! With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here's your quick dive into the top stories for the week of February 09, 2025—let's jump in! Interested in oncology news? Check out The OncFive, from our sister publication OncLive. Top News for Healthcare Providers from the Week of 02/09 1. FDA Accepts Lerodalcibep BLA for LDL-C Reduction in High-Risk Patients The FDA accepted the BLA for lerodalcibep, targeting reductions in low-density lipoprotein cholesterol (LDL-C) levels in patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD) and primary hyperlipidemia. The agency set a Prescription Drug User Fee Act (PDUFA) action date of December 12, 2025, and announced no plans to hold an advisory committee meeting. 2. Travere Therapeutics Plans FSGS Submission for Sparsentan Travere Therapeutics announced its intent to submit a supplemental New Drug Application (sNDA) for sparsentan (Filspari) with the FDA for the treatment of focal segmental glomerulosclerosis (FSGS) at the end of Q1. The announcement arrived soon after the completion of a Type C meeting with the FDA, with the sNDA based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies. 3. Bimekizumab Long-Term Hidradenitis Suppurativa Data Support Efficacy, Safety Profile Bimekizumab (Bimzelx) was associated with sustained disease control for up to 2 years in patients with hidradenitis suppurativa (HS), according to presentation of long-term data from the BE HEARD trials. Presented at the 14th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), bimekizumab reduced the symptoms of HS, achieved a low rate of flares, and improved health-related quality of life. 4. Rosnilimab Demonstrates Historic Responses for Rheumatoid Arthritis Rosnilimab achieved historic American College of Rheumatology (ACR) and clinical disease activity index (CDAI) low disease activity (LDA) responses in patients with rheumatoid arthritis (RA), according to new Phase 2b findings. A depleter and agonist of PD-1+ T cells, rosnilimab was evaluated in the global 424-patient RENOIR trial for efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with moderate-to-severe RA on background conventional disease-modifying antirheumatic drugs (cDMARDs). 5. FDA Expands Dosing Label for Avacincaptad Pegol for Geographic Atrophy The FDA approved an expanded label for avacincaptad pegol intravitreal solution (IZERVAY) for geographic atrophy (GA), extending the approved dosing beyond 12 months. Announced by Astellas Pharma, the decision comes after the company resubmitted its supplemental New Drug Application (nDA) in December 2024, based on feedback received from the FDA. The company received a Complete Response Letter (CRL) the month prior. See you next week! Editor's note: this was created with the assistance of AI tools. 

  The US Food and Drug Administration, or FDA, recently approved a generic version…

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs, and special guest Michael McCaughan of Prevision Policy look at new Health and Human Services Secretary Robert F. Kennedy Jr.'s first assignment, a presidential commission on reducing chronic disease (:29), as well as former US Food and Drug Administration Commissioner Scott Gottlieb's suggestion that industry extend the existing user fee program rather than negotiate a new agreement in the current political environment (13:30). They also discuss the impact of President Trump's executive order mandating a reduction in force across the federal government on the US Food and Drug Administration and communications questions affecting the agency's advisory committee schedule (25:16). More On These Topics From The Pink Sheet Commission Led By HHS Secretary Kennedy Will Probe ‘Threats' To Children, Including Medicines: https://insights.citeline.com/pink-sheet/agency-leadership/commission-led-by-hhs-secretary-kennedy-will-probe-threats-to-children-including-medicines-Q5YF65T23JEOXDWQ7I72X556KQ/ Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step: https://insights.citeline.com/pink-sheet/agency-leadership/bracing-for-rfk-at-hhs-vaccine-safety-commission-likely-first-step-O5XKOSVYYVE7RMQUAIHZ4I2OLY/ User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/user-fees-industry-should-push-for-extension-of-current-agreement-in-reconciliation-bill-gottlieb-says-YOWZW2CMSZA4BDP23MR2FLQJB4/ Could PDUFA VIII Align With Trump's Efficiency Emphasis?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/could-pdufa-viii-align-with-trumps-efficiency-emphasis-5WGLRU6N2FG4XABILEMHBYDXYI/ US FDA Advisory Committee Freeze Raises Concerns Of Delayed, More Controversial Approvals: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-freeze-raises-concerns-of-delayed-more-controversial-approvals-CWT2HOAQ3JBHNCMKSSOOXVAYYU/ ‘This Is Not Good For Business': Trump's Workforce Shakeups Could Harm Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/this-is-not-good-for-business-trumps-workforce-shakeups-could-harm-industry-JJTMQ5RXOFDC7DQDVIZ3S2NJG4/

  The US Food and Drug Administration, or FDA, recently approved a generic version of florfenicol, called Paqflor [PACK-floor], for certain species of freshwater-reared fish. The medication contains the same...

A class action lawsuit launched in Auckland today questioning Johnson and Johnson cold and flu products follows similar suits worldwide. JGA Saddler has filed a suit in the High Court, claiming the producer knowingly sold an ineffective product. The US Food and Drug Administration has ruled a key ingredient in Codral, Sudafed, and Benadryl cold and flu products is ineffective when taken orally. JGA Saddler director, Rebecca Jancauskas says it's sparked a wave of legal action. "Our firm filed a claim in Australia, in December. A Canadian firm filed a class-action about 12 months ago, and there's also quite a number of claims on foot in America." LISTEN ABOVESee omnystudio.com/listener for privacy information.

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the many commitments Robert F. Kennedy Jr. gave Sen. Bill Cassidy, R-LA, to secure his vote to move his Health and Human Services Secretary nomination to the Senate floor (:25). They also consider the slow restoration of some US Food and Drug Administration public communications and the impact of HHS postponing activities not deemed “mission-critical” (10:36). More On These Topics From The Pink Sheet HHS Nominee Kennedy's Behind-The-Scenes Vaccine Reassurances Win Senate Swing Vote: https://insights.citeline.com/pink-sheet/vaccines/hhs-nominee-kennedys-behind-the-scenes-vaccine-reassurances-win-senate-swing-vote-F45HDCJQJJDIDKJOFXYODP6DJQ/ Kennedy Would Issue Trial Diversity Guidance, But Not Necessarily Roll Back All Anti-DEI Actions: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/kennedy-would-issue-trial-diversity-guidance-but-not-necessarily-roll-back-all-anti-dei-actions-4SDSMJ5V7NFPHKVUX5XYBMRMEE/ FDA Communications In Flux As HHS Assesses Mission-Critical Activities: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-communications-in-flux-as-hhs-assesses-mission-critical-activities-H5UQ7BRSSZBVJDJBAXSVTDLIR4/ As US FDA Communications Freeze Thaws, Approvals Accumulate: https://insights.citeline.com/pink-sheet/product-reviews/approvals/as-us-fda-communications-freeze-thaws-approvals-accumulate-JA4WVLHMGJEZDHYB7LRNZAOYT4/

In this episode, Clancy interviewed Eugenia Gusev, a senior food systems professional specializing in Agriculture, Food Security, and Nutrition for refugee and immigrant populations at the International Rescue Committee (IRC). They talked about the food systems from a global perspective, the role of refugees and immigrants in the US food system, and challenges in combating food insecurity.

WhatsApp says Israeli spyware targeted journalists and civil service workers, Myanmar extends emergency rule for another six months, Italy blocks DeepSeek AI over privacy concerns, The UK marks the fifth anniversary of Brexit, Nicaragua approves constitutional reforms establishing a co-presidency, Black boxes are recovered from the tragic Washington DC aviation accident, President Donald Trump says that 25% tariffs on Canada and Mexico are imminent, In France, convicted rapist Dominique Pélicot is linked to cold cases from the 1990s, The US Food and Drug Administration approves a non-opioid painkiller, and NBA star Terry Rozier is the focus of a federal sports betting probe. Sources: www.verity.news

Subscribe to UnitedHealthcare's Community & State newsletter.Health Affairs' Jeff Byers welcomes Senior Editor Ellen Bayer to the program to examine the US Food & Drug Administration's most recent work on food and nutrition policy, as well as what was done in the final days of the Biden administration and where things stand today.Health Affairs will be releasing a theme issue focusing on Food, Nutrition, & Health in April 2025.Next week, Health Affairs will be releasing their February 2025 issue that will feature a health policy road map for a new US administration. The papers featured in this road map have been published ahead-of-print. Order your copy today. Related Articles:FDA Finalizes Updated “Healthy” Nutrient Content ClaimFront-of-Package Nutrition LabelingPresident Trump Enacts Regulatory Freeze and Halts Public Communications for Federal Agencies (The National Law Review) Subscribe to UnitedHealthcare's Community & State newsletter.

Video Version Available on YouTube! In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, explored the approval and impending launch of Qlosi (pilocarpine HCL ophthalmic solution) 0.4%, a groundbreaking pharmacologic option for managing presbyopia, with Elad Kedar, MBA, chief executive officer of Orasis Pharmaceuticals. A condition that affects nearly all adults as they age, presbyopia is characterized by the gradual loss of near vision due to reduced lens elasticity. Sheth and Kedar highlighted the significance of finding non-invasive treatment options for this pervasive issue, given the limitations of traditional solutions like reading glasses or surgical interventions. In October 2023, the US Food and Drug Administration (FDA) approved Qlosi, a preservative-free, low-dose eye drop for presbyopia, based on strong efficacy, safety, and tolerability data reported in the pivotal Phase 3 NEAR-1 and NEAR-2 clinical trials. On Day 8, patients treated with Qlosi achieved statistically significant ≥3-line gain in distance-corrected near visual acuity (DCNVA) and no loss of ≥1-line in distance visual acuity. Sheth and Kedar delved into Qlosi's innovative mechanism of action, emphasizing how it leverages a unique pharmacologic approach to improve near vision. By modulating pupil dynamics, Qlosi enhances the depth of focus, effectively allowing patients to perform near-vision tasks without additional aids. Together, Sheth and Kedar walked through the drug's clinical development journey, highlighting his journey through the founding of Orasis and the company's name in Greek, meaning “good vision or sight.” The discussion included insights into the populations most likely to benefit from Qlosi and the practical considerations for prescribing. Sheth offered a nuanced take on how this therapy could fit into the broader landscape of presbyopia management, addressing questions about patient education, adherence, and expectations. Sheth also shared his perspective on the potential impact of Qlosi on clinical practice, noting that its ease of use and non-invasive nature could appeal to both patients and providers. He reflected on how treatments like Qlosi are part of a broader trend toward personalized medicine, focusing on solutions that improve the quality of life for aging populations. This episode concluded with a thoughtful look at future research directions and the impending launch of Qlosi. Expected soon, Kedar expressed an interest in sharing more details on the product and its position in the presbyopia treatment landscape once the drug comes to market. Every episode of New Insight is available on HCPLive.com. Watch full episodes on our YouTube channel and listen wherever you get your podcasts. Direct all podcast-related inquiries to show producer Connor Iapoce (ciapoce@mjhlifesciences.com) and keep an eye out for more from New Insight! Key Episode Timestamps 00:05 Introduction to Elad Kedar and Orasis 04:34 Orasis' Journey and Initial Development 06:45 Elad Kedar's Background and Company Growth 08:36 Transition from Product Development to Team Building 11:42 Phase Three Study Results and Efficacy 13:39 Safety, Comfort, and Tolerability 15:00 Genesis of the Company Name Orasis 18:26 Challenges and Strategic Planning 21:57 Market Position and Future Outlook 27:27 Conclusion and Future Plans

Pink Sheet reporter and editors try to answer some emerging questions about the US Food and Drug Administration now that President Donald Trump has taken office. They discuss the FDA's acting leadership (:43), an ongoing communications freeze (7:45), along with the hiring freeze and travel ban (20:49). They also discuss the impact of several executive orders on the US Centers for Medicare and Medicaid Services (26:23) and try to put the entire week's events into perspective (33:40). Editor's Note: This episode was recorded prior to Sara Brenner being officially named acting FDA commissioner, but the discussion about other aspects of the presidential transition still is relevant. More On These Topics From The Pink Sheet Who's Running The US FDA? Interim Team May Not Have Assumed Control: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/whos-running-the-us-fda-interim-team-may-not-have-assumed-control-S5HIPYKBZNFY3J2VHNJRY4JDYQ/ Deciphering Trump's Executive Order On Medicare, Medicaid Payment Models: https://insights.citeline.com/pink-sheet/market-access/government-payers/medicare/deciphering-trumps-executive-order-on-medicare-medicaid-payment-models-MEWAWGHDNVES3IHTJJUJNAZJVI/ US FDA's Trump Transition Relatively Smooth, Except For Diversity, Equity Work: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/us-fdas-trump-transition-relatively-smooth-except-for-diversity-equity-work-V367EFJBVRGLBIVJ7VGWIYUSJ4/

A landmark Gaza cease-fire and hostage deal is reached, South Korea's impeached Pres. Yoon is arrested, the UN says that over 1M people are internally displaced in Haiti, UK Treasury Minister Tulip Siddiq resigns, Pres. Biden bolsters Indo-Pacific ties in the final days of his presidency, while Biden moves to drop Cuba from the US terrorism list, Pres.-elect Trump says he'll create an “External Revenue Service” for tariffs, the US Securities and Exchange Commission sues Elon Musk over his Twitter acquisition, a newly-proposed definition of obesity would de-emphasize Body Mass Index, and the US Food and Drug Administration bans Red Dye No. 3 from food and ingested drugs. Sources: www.verity.news

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

BUFFALO, NY - December 30, 2024 – A new #editorial was #published in Oncotarget's Volume 15 on December 24, 2024, titled “Pitfalls and perils from FDA-approved germ-line cancer predisposition tests." Authored by Dr. Wafik S. El-Deiry, Editor-in-Chief of Oncotarget, and Dr. Eli Y. Adashi from Brown University, the article highlights concerns about the risks of a newly approved genetic test for cancer risk. This test, called the “Invitae Common Hereditary Cancers Panel," was approved in 2023 and examines 48 genes linked to inherited cancers, including breast, ovarian, and Lynch syndrome-related cancers. Although the test increases access to genetic information, the authors warn that using it without professional guidance may lead to confusion, stress, and potential harm. One concern is that people can order this test online without consulting healthcare professionals or genetic counselors. Without expert help, users might struggle to understand their results especially if they indicate risks that are unclear or difficult to act on. This can cause unnecessary anxiety and confusion. “The DTC option of germ-line testing for cancer susceptibility should be discouraged given the risks of anxiety, lack of adequate interpretation for variants not strongly associated with cancer, potential for minors to be tested outside the healthcare system and potential for loss of follow-up if test results are not shared with health care professionals or never make it into the medical record.” The editorial also points out ethical and medical issues when minors use these tests. If a child's test is done without medical oversight, results might not be added to their health records, making follow-up care harder to manage and potentially risking their long-term health. Cost is another issue. These tests are often not covered by insurance, which can place a financial burden on families who might need additional testing or medical advice. The researchers emphasize that genetic testing for cancer risk should always include healthcare providers and genetic counseling. This ensures users fully understand their results and receive proper guidance. The authors also call on the US Food and Drug Administration (FDA) to provide clear rules for using these tests, particularly for minors. In conclusion, while genetic testing holds great potential for improving cancer prevention and care, its benefits must not come at the cost of safety and public health. Responsible use of these tests will require collaboration between regulators, healthcare professionals, and testing companies to address the risks and ensure these tools are used effectively. DOI - https://doi.org/10.18632/oncotarget.28677 Correspondence to - Wafik S. El-Deiry - wafik@brown.edu Video short - https://www.youtube.com/watch?v=DjKpiBNDWHo Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ About Oncotarget Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science. Oncotarget is indexed and archived by PubMed/Medline, PubMed Central, Scopus, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science). To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM

In this JCO Article Insights episode, Giselle de Souza Carvalho provides a summary on  "Navigating Treatment Pathways in Metastatic Hormone Receptor–Positive, HER2-Negative Breast Cancer: Optimizing Second-Line Endocrine and Targeted Therapies" by Bhardwarj, et al and "US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA/AKT1/PTEN Alterations" by Dilawari et al published in the Journal of Clinical Oncology.  TRANSCRIPT Giselle Carvalho: Hello and welcome to JCO Article Insights episode for the December issue of the Journal of Clinical Oncology. I'm your host Giselle Carvalho, Medical Oncologist in Brazil focusing on breast cancer and melanoma skin cancers and one of the ASCO Editorial Fellows at JCO this year. Today, I will be discussing two articles. The first one is “Navigating Treatment Pathways in Metastatic Hormone Receptor–Positive, HER2-Negative Breast Cancer: Optimizing Second-Line Endocrine and Targeted Therapies,” and the second one is the “US FDA Approval Summary on Capivasertib with Fulvestrant  for HR-positive HER2-negative Locally Advanced or Metastatic Breast Cancer with PIK3CA/AKT1/PTEN Alteration.”  As we know, 65% to 70% of all breast cancers are HR-positive HER2-negative and this is also the most common subtype of metastatic breast cancer. The current standard of care for frontline therapy of patients with luminal metastatic disease is a CDK4/6 inhibitor in combination with endocrine therapy. However, as new endocrine and targeted therapies gain approval, choosing the best systemic therapy upon disease progression after frontline therapy is a topic of ongoing debate. Nearly 40 to 50% of HR-positive breast cancers have actionable genomic alterations and molecular testing should be a routine recommendation for patients with metastatic HR-positive HER2-negative disease. This can be performed repeating tissue biopsy at the time of progression or from archival tissue. Treatment options after progression on CDK4/6 inhibitors include alpelisib in combination with fulvestrant in patients with PIK3CA mutant tumors as seen in the SOLAR-1 trial, or capivasertib with fulvestrant in patients with a tumor mutation in (PI3K)–AKT–PTEN pathway as seen in the CAPItello-291 study, which will be discussed further.  In approximately 30% of patients, progression on frontline endocrine plus CDK4/6 inhibitor treatment is caused by endocrine resistance, frequently involving activating mutations in ESR1. For those tumors, elacestrant, an oral SERD is an option as demonstrated in the EMERALD trial. For patients with a BRCA mutation, PARP inhibitors represent another option. If no mutations are detected, everolimus, an mTOR inhibitor, can be used based on the BOLERO-2 results. The phase 2 MAINTAIN and PACE trials, along with the phase 3 postMONARCH trial support changing the endocrine therapy backbone with or without switching the CDK4/6 inhibitor. In less resourced areas, fulvestrant monotherapy is still an option to delay cytotoxic chemotherapy, though its efficacy is limited when used as a single agent. Finally, after progression on at least one line of chemotherapy, antibody drug conjugates including sacituzumab govitecan or trastuzumab deruxtecan may be an option.  Now focusing on the PI3K AKT PTEN signaling pathway, activating mutations in PIK3CA and AKT1 and inactivating alterations in PTEN occur in approximately half of luminal breast cancers. In June 2023, the CAPItello-291 trial was published and treatment with fulvestrant plus capivasertib, a PTEN AKT inhibitor, demonstrated a 3.6 month PFS benefit compared to fulvestrant alone, regardless of the presence of AKT pathway alterations. However, for those with tumors without AKT pathway alteration, an exploratory analysis showed that although there was a numerical improvement in PFS, it did not meet statistical significance, indicating that the biomarker positive population primarily drove the positive results noted in the overall population. Therefore, capivasertib plus fulvestrant was approved by the US FDA in November 2023 exclusively for patients with PI3K/AKT1/PTEN tumor alterations after progression on an aromatized inhibitor with or without a CDK4/6 inhibitor. The approved schedule of capivasertib is slightly different from that of other agents used in breast cancer. It is 400 milligrams taken orally twice a day for four days per week every week in a 28-day cycle in combination with fulvestrant. Diarrhea, rash and hyperglycemia were the most commonly reported grade three or four adverse events in the interventional group. I would like to highlight that even though the CAPItello trial excluded patients with glycosylated hemoglobin levels higher than 8% or those diagnosed with diabetes who required insulin, hyperglycemia occurred in 19% of biomarker positive patients treated with capivasertib, with nearly 2% of this population experiencing grade 3 or 4 hyperglycemia and some patients experiencing life threatening outcomes such as diabetic ketoacidosis.  By way of comparison, hyperglycemia of any grade was three times higher with alpelisib therapy in the SOLAR-1 trial, occurring in 64% of the patients and grade three or higher hyperglycemia was seen in 37% of the patients. Diarrhea was the most common treatment related adverse event experienced by 77% of the biomarker positive population. Prompt use of the antidiarrheal drugs when needed, such as loperamide must be encouraged as untreated diarrhea can lead to dehydration and renal injury. Cutaneous rash occurred in 56% of the biomarker positive population in the interventional group and 15% experienced a grade 3 or 4 rash. Nearly half of the patients with cutaneous adverse reactions required treatment and this was the leading reason for dose reduction of capivasertib.  In the biomarker positive population, the improvement in medium PFS were 4.3 months by investigator assessment. Overall survival data from the CAPItello-291 trial is still immature, but quality of life data was recently published in September this year and was assessed by the 30 item QLQ C30 questionnaire and the QLQ BR23, the breast module. According to Oliveira et al, global health status and quality of life were maintained for a longer period with capivasertib fulvestrant than with placebo fulvestrant except for symptoms of diarrhea which were significantly worse in the capivasertib group. The median time of deterioration of global health status and quality of life was twice as long in the capivasertib group being almost 25 months versus 12 months in the placebo fulvestrant group. These data reinforced the use of capivasertib in combination with fulvestrant for the treatment of HR-positive HER2-negative advanced breast cancer patients with PIK3CA/AKT1/PTEN tumor alterations who have progressed after an aromatase inhibitor-based therapy with or without a CDK4/6 inhibitor.  Thank you for listening to JCO Article Insights. This is Giselle Carvalho. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcasts. See you next time.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.  

For the millions of dogs suffering from skin allergy conditions, there's a new drug that may help control symptoms. In September 2024, the US Food and Drug Administration, or FDA,...

Looking 4 Healing Radio with Nikki Florio – Aerosols themselves create the general foundation for engineering weather (and seismic events). These are dispersed from airplanes, drones, rockets, and transoceanic ships. Controlling societies through starvation is nothing new. Famine from accidental weather events has been documented throughout history. Directly withholding food from prisoners or withholding...

Looking 4 Healing Radio with Nikki Florio – Aerosols themselves create the general foundation for engineering weather (and seismic events). These are dispersed from airplanes, drones, rockets, and transoceanic ships. Controlling societies through starvation is nothing new. Famine from accidental weather events has been documented throughout history. Directly withholding food from prisoners or withholding...

Bitcoin has passed another major milestone, but will it ever be able to compete with more traditional asset classes? MARKET WRAP: ASX200: up 0.15%, 8,474 GOLD: $2,672 US/oz BITCOIN: $158,915 AUD Tech stocks rising by 1.1% Block rising 5.6%, Technology One up 2.8%, and Wisetech Global gaining 1.9% Shares in gold miner Perseus lifted 6.5% to $2.80 after good news out of one of its projects in Tanzania.  Auckland Airport emerged from a trading halt, up 3.3% to $7.50 after the Auckland Council decided to sell a near-10% stake in the NZ terminal. Biotech company Mesoblast suffered a fall of 5.1% to $1.67 despite the company's Revascor drug getting designation by the US Food and Drug Administration. Goodman Group dropped 2.1%, Stockland lost 1% and Charter Hall fell by 1.6% James Hardie, down 2.4%, while Amcor fell 1.9%   CURRENCY UPDATE: AUD/USD: 64.44 US cents AUD/GBP: 50.6 pence AUD/EUR: 61 Euro cents AUD/JPY: 96 Japanese yen AUD/NZD: 1.09 NZ dollars  See omnystudio.com/listener for privacy information.

President-elect Donald Trump named billionaire Scott Bessent as his pick to serve as the next secretary of the Department of the Treasury. Plus, Trump announced his picks for critical remaining public health roles in his incoming administration -- Dr. Janette Nesheiwat as US surgeon general; Dr. Marty Makary as US Food and Drug Administration commissioner; and Dr. Dave Weldon, a former congressman from Florida, as director of the US Centers for Disease Control and Prevention. Learn more about your ad choices. Visit podcastchoices.com/adchoices

A recent Special Communication published in JAMA points out that the FDA has already approved nearly 1000 devices using AI. Author Robert M. Califf, MD, commissioner of the US Food and Drug Administration, joins JAMA+ AI Editor in Chief Roy H. Perlis, MD, MSc, to discuss AI regulation. Related Content: FDA Commissioner Robert Califf on Setting Guardrails for AI in Health Care JAMA AI Interview With Robert M. Califf, MD FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine

The Next 70 Dangerous Days. Eric Metaxas Talks to Naomi Wolf. The Eric Metaxas Show Naomi Wolf  Nov 12 2024   Other Episodes Naomi Wolf joins the program to discuss life post election.   Book Mentioned- The Pfizer Papers: Pfizer's Crimes Against Humanity  by The WarRoom/DailyClout Pfizer Documents Analysts (Author), & 3 more   The Pfizer Papers features new reports written by WarRoom/DailyClout research volunteers, which are based on the primary source Pfizer clinical trial documents released under court order and on related medical literature. The book shows in high relief that Pfizer's mRNA COVID-19 vaccine clinical trial was deeply flawed and that the pharmaceutical company knew by November 2020 that its vaccine was neither safe nor effective. The reports detail vaccine-induced harms throughout the human body, including to the reproductive system; show that women suffer vaccine-related adverse events at a 3:1 ratio; expose that vaccine-induced myocarditis is not rare, mild, or transient; and, shockingly, demonstrate that the mRNA vaccines have created a new category of multi-system, multi-organ disease, which is being called “CoVax Disease.”   Despite the fact that Pfizer committed in its own clinical trial protocol to follow the placebo arm of its trial for twenty-four months, Pfizer vaccinated approximately 95 percent of placebo recipients by March 2021, thus eliminating the trial's control group and making it impossible for comparative safety determinations to be made.   Just as importantly, The Pfizer Papers makes it clear that the US Food and Drug Administration knew about the shortfalls of Pfizer's clinical trial as well as the harms caused by the company's mRNA COVID vaccine product, thus highlighting the FDA's abject failure to fulfill its mission to “[protect] the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”   The Pfizer Papers offers an in-depth look at how Big Pharma, the US government, and healthcare entities stand protected behind the broad legal immunity provided by the Public Readiness and Emergency Preparedness Act (PREP Act) when creating, prescribing, and administering vaccines; and, under that shield of protection, do what is best for their bottom lines rather than for the health and well-being of Americans.   --------------------------------------------------------------------  Check out our ACU Patreon page: https://www.patreon.com/ACUPodcast   HELP ACU SPREAD THE WORD!  Please go to Apple Podcasts and give ACU a 5 star rating. Apple canceled us and now we are clawing our way back to the top. Don't let the Leftist win. Do it now! Thanks. Also Rate us on any platform you follow us on. It helps a lot. Forward this show to friends. Ways to subscribe to the American Conservative University Podcast Click here to subscribe via Apple Podcasts Click here to subscribe via RSS You can also subscribe via Stitcher FM Player Podcast Addict Tune-in Podcasts Pandora Look us up on Amazon Prime …And Many Other Podcast Aggregators and sites ACU on Twitter- https://twitter.com/AmerConU . Warning- Explicit and Violent video content.   Please help ACU by submitting your Show ideas. Email us at americanconservativeuniversity@americanconservativeuniversity.com   Endorsed Charities -------------------------------------------------------- Pre-Born! Saving babies and Souls. https://preborn.org/ OUR MISSION To glorify Jesus Christ by leading and equipping pregnancy clinics to save more babies and souls. WHAT WE DO Pre-Born! partners with life-affirming pregnancy clinics all across the nation. We are designed to strategically impact the abortion industry through the following initiatives:… -------------------------------------------------------- Help CSI Stamp Out Slavery In Sudan Join us in our effort to free over 350 slaves. Listeners to the Eric Metaxas Show will remember our annual effort to free Christians who have been enslaved for simply acknowledging Jesus Christ as their Savior. As we celebrate the birth of Christ this Christmas, join us in giving new life to brothers and sisters in Sudan who have enslaved as a result of their faith. https://csi-usa.org/metaxas   https://csi-usa.org/slavery/   Typical Aid for the Enslaved A ration of sorghum, a local nutrient-rich staple food A dairy goat A “Sack of Hope,” a survival kit containing essential items such as tarp for shelter, a cooking pan, a water canister, a mosquito net, a blanket, a handheld sickle, and fishing hooks. Release celebrations include prayer and gathering for a meal, and medical care for those in need. The CSI team provides comfort, encouragement, and a shoulder to lean on while they tell their stories and begin their new lives. Thank you for your compassion  Giving the Gift of Freedom and Hope to the Enslaved South Sudanese -------------------------------------------------------- Food For the Poor https://foodforthepoor.org/ Help us serve the poorest of the poor Food For The Poor began in 1982 in Jamaica. Today, our interdenominational Christian ministry serves the poor in primarily 17 countries throughout the Caribbean and Latin America. Thanks to our faithful donors, we are able to provide food, housing, healthcare, education, fresh water, emergency relief, micro-enterprise solutions and much more. We are proud to have fed millions of people and provided more than 15.7 billion dollars in aid. Our faith inspires us to be an organization built on compassion, and motivated by love. Our mission is to bring relief to the poorest of the poor in the countries where we serve. We strive to reflect God's unconditional love. It's a sacrificial love that embraces all people regardless of race or religion. We believe that we can show His love by serving the “least of these” on this earth as Christ challenged us to do in Matthew 25. We pray that by God's grace, and with your support, we can continue to bring relief to the suffering and hope to the hopeless.   Report on Food For the Poor by Charity Navigator https://www.charitynavigator.org/ein/592174510   -------------------------------------------------------- Disclaimer from ACU. We try to bring to our students and alumni the World's best Conservative thinkers. All views expressed belong solely to the author and not necessarily to ACU. In all issues and relations, we hope to follow the admonitions of Jesus Christ. While striving to expose, warn and contend with evil, we extend the love of God to all of his children. ----------------------------------------------------------------------------------------- 

Explore the basis for and controversy surrounding the US Food and Drug Administration requiring a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. Full text of the manuscript is available at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.2034.

In this episode of Don't Eat Poop!, our hosts Matt and Francine are joined by Doug Farquhar, the Director of Government Affairs of the National Environmental Health Association, at the 2024 FDA Retail Food Seminar & IEHA Annual Education Conference.Doug is on a mission to encourage US states to adopt more recent versions of the FDA Food Code (only 4 states have adopted the most recent version so far) but this gets really tricky because of federalism.Tune in as he sheds some light on just how independent every single state, county, and municipality is from the federal government and what that ultimately means for US food safety.In this episode:

In July 2023, the US Food and Drug Administration (FDA) approved Opill, a daily progestin-only oral contraceptive for over-the-counter sale to people of all ages. Daniel Grossman, MD, discusses this and more with JAMA Associate Editor Melissa A. Simon, MD, MPH. Related Content: Over-the-Counter Oral Contraceptives Over-the-Counter Oral Contraceptive Pills Over-the-Counter Progestin-Only Oral Contraceptives

In this fascinating conversation for the MindHealth360 Show, Pam Conboy and Leia Linder discuss an imminent and radical approach to mental health treatment: psychedelic therapy. When combined with spirituality, community, and functional medicine, this approach can be incredibly powerful for brain restoration, neuroplasticity, and mental healing. Pam Conboy is a biologist and clinical laboratorian who has worked most of her life in medical marketing but has been working in Naturopathic Functional Medicine spheres for the last 7 years, transforming her approach and understanding of medicine.  Leia Linder is a naturopathic physician. Following significant patient interest in the healing power of psychedelics, she was blown away by the wealth of research on the power of psilocybin to successfully address depression, anxiety, PTSD, and many other mental health conditions as a breakthrough therapy endorsed by the 2018/19 US Food and Drug Administration. Reconnecting a year ago, they discovered how psilocybin can be used legally and therapeutically in the context of a religious entity. Founders of the Setas Seminary Church of Spiritual Integration, the first legitimate non-profit church using psilocybin for therapeutic use under the Religious Freedom Act, their treatments sincerely incorporate elements of naturopathic medicine, holistic spirituality, and psychedelic-assisted therapy. In this groundbreaking interview, they explain the remarkable effects of psilocybin on our biochemistry to reveal why it can not only powerfully and sustainably address mental health issues such as depression, anxiety, and PTSD when used in an integrative and therapeutic way but can also be truly life-changing for those who use it. In this episode, learn about: How the Religious Freedom Act enables the use of psilocybin within the church setting. Ways psilocybin kickstarts the healing process, and why it works significantly more effectively than antidepressants via the 5-HT serotonin receptors. How microdosing can help individuals taper off SSRIs. Why the therapeutic space is key and the importance of the therapist witnessing/holding in the healing journey. How recreational use can go wrong, and why the Church hasn't seen a 'bad trip.' Why the psilocybin used in the Church is safer than SSRI medications, where their psilocybin is sourced, and the rigorous testing involved. The three therapeutic psilocybin dosing categories, and the circumstances in which they are applied: 1) micro-dosing 2) moderate dose 3) full dose Ways the full dose generates a significant psychedelic experience, why it is taken in ceremony and how it works long-term. How psilocybin can create neural pathways/connections, as shown in MRI scans, and how it can vastly increase neuroplasticity and the growth of brain cells quickly – giving sufferers a jump start into better mental health. Why whole mushrooms, rather than molecules, are used and ways they are anti-inflammatory. Why psilocybin is only one of many tools in the healing toolkit, and why the integration of community, naturopathic medicine, EMDR, light therapy, etc., is also vital, and how the Church facilitates this approach. The early research showing that psilocybin can prevent neurodegenerative diseases and stabilize the endocrine system, pointing toward its potential to treat many areas of poor health. Some incredible case stories from churchgoers, ways it can unexpectedly bring to the forefront and heal past traumas, and why psilocybin therapy can be life-changing. For further insights, visit www.mindhealth360.com – your comprehensive guide to mental well-being.

A bag of Doritos in the US has some dangerously different ingredients than it would in the rest of the world. This is primarily due to the operations of the FDA, which has had many policy changes since its 1906 debut. So why do American snacks have these questionable ingredients and how do companies get away with it? Join our hosts Jon Weigell and Caya, as they take you through our most interesting stories of the day. Grab the free Entrepreneurship Kit here https://clickhubspot.com/ent Follow us on social media: TikTok: https://www.tiktok.com/@thehustle.co Instagram: https://www.instagram.com/thehustledaily/ Thank You For Listening to The Hustle Daily Show. Don't forget to hit Subscribe or Follow us on Apple Podcasts so you never miss an episode! If you want this news delivered to your inbox, join millions of others and sign up for The Hustle Daily newsletter, here: https://thehustle.co/email/  Plus! Your engagement matters to us. If you are a fan of the show, be sure to leave us a 5-Star Review on Apple Podcasts https://podcasts.apple.com/us/podcast/the-hustle-daily-show/id1606449047 (and share your favorite episodes with your friends, clients, and colleagues).

In this episode Natalie and Paige discuss snipers where you wouldn't expect them, buzz/drama surrounding the book and movie "It Ends With Us," and a shocking surprise that involved CA's prop 65 warning label. If you or someone you know is experiencing domestic violence, help is available. The hotline.org offers 24/7 support, information, and advocacy for those in abusive relationships. Music from #Uppbeat: https://uppbeat.io/t/andrey-rossi/seize-the-day License code: JZ0ILHZWR0XIC731 Learn more about your ad choices. Visit megaphone.fm/adchoices