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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 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/

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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

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, 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, break down new Phase 3 data from the ESSENCE trial examining semaglutide 2.4 mg (Wegovy) for metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. With results published in The New England Journal of Medicine, hosts are joined by first author Arun J. Sanyal, MD, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, to discuss key takeaways from part 1 of the ESSENCE trial, semaglutide's impact on liver outcomes and weight loss, and what the data could mean for the future of MASH treatment. ESSENCE Once-weekly semaglutide 2.4 mg significantly improved liver outcomes in patients with metabolic dysfunction–associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, according to findings from the ESSENCE trial. In part 1 of the ongoing, double-blind, placebo-controlled trial, 800 patients were evaluated at 72 weeks for two primary endpoints: resolution of steatohepatitis without worsening fibrosis, and fibrosis improvement without worsening steatohepatitis. Spanning 253 sites in 37 countries, the full trial enrolled 1197 biopsy-confirmed patients between May 2021 and April 2023. At the interim analysis, semaglutide achieved both primary endpoints. Resolution of steatohepatitis without fibrosis worsening occurred in 62.9% of patients receiving semaglutide compared with 34.3% in the placebo group (difference, 28.7%; 95% CI, 21.1–36.2; P

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/

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/

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...

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. ----------------------------------------------------------------------------------------- 

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