Podcasts about us fda

Wockhardt's FDA approval of Zaynich marks a historic first, the only drug entirely discovered and developed by an Indian company to clear US-FDA scrutiny. ET’s pharma editor Vikas Dandekar and Rica Bhattacharyya talk to Habil Khorakiwala, Chairperson of Wockhardt who unpacks the 25-year innovation journey behind this milestone. From a deliberate pivot to antibiotics when big pharma was exiting the space, to navigating financial turbulence, asset sales, and regulatory hurdles, Khorakiwala reflects on strategic patience and scientific conviction. He also outlines peak sales projections of $1.5–2 billion, the US commercial roadmap led by daughter Zahabiya, and a robust pipeline of blockbusters ahead.You can follow Vikas Dandekar on his social media: X or Linkedin and Rica Bhattacharyya on her X and Linkedin Check out other interesting episodes like:ET Deep Dive: Swipe Left on Reality,India wants manufacturing at 25% of GDP — will AI in factories help?, Tanay Kothari Wants To Kill The Keyboard, From Doer to Director: The LinkedIn Playbook for the AI Agea, Semaglutide Goes Generic: Big Pharma’s Moat Breaks and much more. Catch the latest episode of ‘The Morning Brief’ on The Economic Times Online, Spotify, Apple Podcasts, JioSaavn, Amazon Music and Youtube.See omnystudio.com/listener for privacy information.

Trade ministers from the Group of Seven industrialised nations have tried to find common ground, amid geopolitical tensions and trade uncertainty. In a clear swipe at China, they pledged to cooperate on securing supply chains of critical minerals. Also in the show: France's finance minister says airlines have enough jet fuel for May and June, and the US FDA makes a U-turn in approving flavoured vapes. 

Animal models have been the mainstay for testing hypotheses about human diseases and their treatment in academic research and drug development. However, these models raise ethical concerns and are costly and time-consuming. Most importantly, animal models often have low predictive power for the behavior of novel treatments in humans. Ethically, animal testing is arguably justifiable only if it can meaningfully predict outcomes in humans. Financially, committing millions of dollars and years of development to models with limited informative value is equally hard to defend. As governments and regulators, such as the US FDA, push to reduce animal testing, researchers from academia, pharma, and biotech are increasingly turning to new approach methodologies (NAMs) for preclinical and nonclinical testing. In this episode of the BioRevolution podcast, Louise von Stechow and Andreas Horchler discuss what is needed to shift from animal testing to NAM models which could be more meaningful for human biology. In particular, AI-based approaches offer a scalable alternative to animal testing that can make predictions based on a variety of data sources to provide a better understanding of human disease biology. Disclaimer: Louise von Stechow & Andreas Horchler and their guests express their personal opinions, which are founded on research on the respective topics, but do not claim to give medical, investment or even life advice in the podcast. Learn more about the future of biotech in our podcasts and keynotes. Contact us here: scientific communication: https://science-tales.com/ Podcasts: https://www.podcon.de/ Keynotes: https://www.zukunftsinstitut.de/louise-von-stechow References 1. https://www.biopharmatrend.com/business-intelligence/from-animals-to-algorithms-how-ai-brings-drug-testing-closer-to-human-biology/ 2. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00298-9/fulltext 3. https://pubmed.ncbi.nlm.nih.gov/39805539/ 4. https://www.nature.com/articles/s41587-025-02690-0 5. https://www.nature.com/articles/d41586-025-03344-6 6. https://pubmed.ncbi.nlm.nih.gov/35865092/ 7. https://pubmed.ncbi.nlm.nih.gov/32868897/ 8. https://pubmed.ncbi.nlm.nih.gov/32324077/ 9. https://pubmed.ncbi.nlm.nih.gov/18357347/ 10. https://pmc.ncbi.nlm.nih.gov/articles/PMC9100373/ 11. https://pubmed.ncbi.nlm.nih.gov/31291566/ 12. https://aacrjournals.org/cancerdiscovery/article/8/9/1069/10253/Fundamental-Mechanisms-of-Immune-Checkpoint 13. https://www.nature.com/articles/s41746-025-02068-1 14. https://pubmed.ncbi.nlm.nih.gov/33356151/ 15. https://pubmed.ncbi.nlm.nih.gov/39836754/ 16. https://pubmed.ncbi.nlm.nih.gov/37676606/ 17. https://www.frontiersin.org/journals/artificial-intelligence/articles/10.3389/frai.2023.1269932/full 18. https://www.nature.com/articles/s41598-023-31169-8 19. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vioxx-rofecoxib-questions-and-answers 20. https://onlinelibrary.wiley.com/doi/10.1002/pds.1207 21. https://www.nature.com/articles/s41467-023-42933-9

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

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

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

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

Renée Aguiar-Lucander, CEO of Hansa Biopharma, discussed the company's leading asset, its journey toward US FDA approval and the trials and tribulations of completing a Phase III program.

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

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

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss details recently unearthed about the role center directors play in the Commissioner's National Priority Voucher review process and the influence they could have over the review division (:32). They also discuss the CNPV Review Council's membership (16:58) and the program's resource needs (27:28). More On These Topics From The Pink Sheet US FDA CNPV Reviews Clarified: Center Director Approval Recommendations Not Binding, HHS Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-cnpv-reviews-clarified-center-director-approval-recommendations-not-binding-hhs-says-GRCFLKAPVZCWPGPT3I36B2WXI4/ FDA Voucher Program Approvals Will Come From Product Centers, But Ambiguity Lingers: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/fda-voucher-program-approvals-will-come-from-product-centers-but-ambiguity-lingers-KBX2KFYONBEEVF4AJN3PV2AH4A/ US FDA Adds Facility Data To Commissioner's Priority Voucher Pre-Submission Requirements: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-adds-facility-data-to-commissioners-priority-voucher-pre-submission-requirements-2XYJICOLOFBUNJVOTSXFNXSBSE/

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

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

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

A liquid biopsy is a blood test that detects signs of cancerous tumors, including tumour cells and cancer cell DNA. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Andrew Newland, CEO of ANGLE, about why live cell liquid biopsies should become standard in oncology. Newland explains how current US FDA-approved tests can detect some types of advanced cancers, predict prognosis, and help healthcare providers make treatment decisions. And importantly, Newland describes how live cell liquid biopsies are a UK-developed technology that aligns with national efforts to modernise cancer diagnostics, as well as potentially reduce healthcare costs by minimising ineffective treatments. You can listen to episode 238 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for talent" (many jobs, few candidates) to a market flooded with applicants, often overwhelming internal recruitment teams. This shift, exacerbated by simple application processes like LinkedIn's Easy Apply, makes it challenging for good candidates to cut through the noise and for companies to manage high application volumes.To thrive in this new environment, MedTech professionals, particularly those in Quality Assurance (QA) and Regulatory Affairs (RA), must expand their focus beyond technical competence. Elena stresses the growing importance of transverse skills (the essential human skills like communication, negotiation, and leadership) and, critically, AI literacy. With the pressure on companies to "do more with less," AI is creating an environment where smaller, highly productive teams are favored. This doesn't mean roles will disappear, but professionals must embrace technology to eliminate tedious tasks and focus on high-value, strategic work.Navigating the job market now requires a more intentional and proactive approach, especially to access the hidden job market where the best unadvertised roles reside. Tactics include direct networking with hiring managers and active professional branding. Furthermore, the global regulatory environment's fragmentation—especially between the US (FDA) and EU (MDR/IVDR)—is impacting how companies build their teams, favoring remote work and strategic location choices that factor in the local talent pool and employment laws.Key Timestamps1:50 - The MedTech Talent Shift: From "War for Talent" to a "Reset"4:45 - The impact of high volume and "easy apply" on candidate experience6:15 - Immediate disqualification criteria and "gaming" the application system7:35 - Strategies for accessing the hidden job market (networking and strategy)9:20 - The controversial impact of AI on QA/RA roles and the need for efficiency11:30 - Future-proofing your career: Why leaders and junior professionals must embrace AI13:55 - Understanding transverse skills (soft skills) and business acumen15:40 - The QA/RA role in the age of AI: Focusing on the 30% of high-value expertise17:00 - Tactics for achieving AI literacy: Small wins, experimentation, and habit stacking19:45 - Why the "hidden job market" exists (confidentiality, exclusivity, and pipeline)21:30 - Positioning yourself externally: The power of active contribution on LinkedIn23:45 - The importance of speaking at industry events (e.g., RAPS) to build credibility24:55 - Strategic advice for founders building remote, global teams26:15 - The impact of US vs. EU regulatory fragmentation on talent selectionQuotes“It's not going to be enough to just be good at your job. You're going to need to have a little bit more understanding of how to position yourself, how to brand yourself, how building skills outside of just your technical competency [is important].” - Elena Kyria“This is a massive opportunity... to step up and get started... you can use the technology but then you're focused on strategy, relationships, [and] the human side of it versus the people that are still very manual.” - Elena KyriaTakeawaysPrioritize AI Literacy: MedTech professionals must proactively experiment with AI tools (like note-takers and regulatory intelligence systems) to automate up to 70% of tedious tasks. Waiting for...

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18). More On These Topics From The Pink Sheet US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fda-cder-director-richard-pazdur-retiring-SUPZZ4JEQ5GVHEEH4RPDLCNIBY/ Tracy Beth Høeg Named New Acting US FDA CDER Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tracy-beth-hoeg-named-new-acting-us-fda-cder-director-3AYJZJAMBVG6HNPX3FJ7IBCDHQ/ US FDA Sending Pazdur Back To Oncology Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-sending-pazdur-back-to-oncology-office-KVBDIDT2RVF4JAZ7FCZHN46XXU/

In this week's Digital Health Roundup, Medtech Insight's Marion Webb highlights her interviews with leaders at brain-computer interface developers Synchron and INBRAIN about funding, clinical trials and partnerships. Brian Bossetta discusses Oura's goal to secure US FDA clearance for a blood pressure feature for its smart ring. Elizabeth Orr highlights an FDA expert panel considering regulation of generative AI tools for mental health and Shubham Singh shines a light on Choice's efforts to develop a new form of contraceptive for women.

In this episode, Psychedelic Medicine Podcast host, Dr. Lynn Marie Morski, provides the latest updates from the field of psychedelic medicine. Dr. Morski discusses the breakthrough therapy designation which a number of psychedelic compounds have received in the past few years, the most recent of which is BPL-003, a nasal spray formulation of 5-MeO-DMT. One of the exciting aspects of this new compound, Dr. Morski notes, is that it is shorter-acting than most serotonergic psychedelics—a feature which may make treatment with this substance less expensive and more accessible.  Another exciting development is the COMPASS Pathways phase 3 trial of COMP360 psilocybin. Dr. Morski shares that the company believes they are nine to twelve months ahead of schedule, which means that if all goes well, this psilocybin compound could be approved for treatment resistant depression as early as sometime in 2027. She also discusses why the US FDA said they rejected MDMA for PTSD and what this governing body would like to see from subsequent research before reconsidering this decision. In closing, Dr. Morski shares excitement about the development of novel psychoplastogens—the non-hallucinogenic psychedelics—which may help bring many of the same healing benefits to populations currently unable to be served by the existing compounds under investigation.   In this episode, you'll hear: Which psychedelics currently have breakthrough therapy designation and for which indications Details of recent ketamine research for inpatient depression care and why these results are not as negative as they may seem The current horizons of psychedelic research and what indications may soon be explored Sources of hope in the current state of psychedelic research and the legal landscape   Quotes: "[BPL-003] showed rapid and durable antidepressant outcomes after a single dose. … here we have something that is under an hour [of psychedelic experience] for treatment resistant depression." [7:43] "Keeping patients blinded to whether or not they got the placebo or MDMA is a big focus that [the FDA] wanted to emphasize for these future phase 3 trials." [19:07] "I know we had a big setback last year. I think a lot of us thought by this time we'd be a year into MDMA being approved and we're not. However, there are so many things on the horizon that are worth being excited about." [23:48]   Links: Psychedelic Medicine Podcast on Instagram Psychedelic Medicine Podcast on YouTube Jelovac A, McCaffrey C, Terao M, et al. "Serial Ketamine Infusions as Adjunctive Therapy to Inpatient Care for Depression: The KARMA-Dep 2 Randomized Clinical Trial" JAMA Psychiatry, 2025. Beckley Psytech Limited Phase 2 Trial: BPL-003 Efficacy and Safety in Treatment Resistant Depression COMPASS Pathways Phase 3 Trial: Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD Food and Drug Administration (FDA) Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder Psychedelic Alpha Psychedelic Drug Development Bullseye Chart Psychedelic Medicine Association Porangui

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

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

In this episode, Eric Hardter and guest Kelsey Lenoch discuss recent US FDA developments, including leadership changes at CBER and CDER, staffing impacts on orphan product reviews, and the new Rare Disease Evidence Principles aimed at accelerating approvals for rare and ultra-rare conditions. They also explore evolving trial endpoints in oncology (including surrogate measures and ctDNA), transparency moves such as the public release of Complete Response Letters and the industry's reactions, updates on the National Priority Voucher Program, and the FDA Pre-Check initiative to boost domestic drug manufacturing. Tune in for an in-depth discussion offering timely updates and expert perspectives on what may be ahead for drug development stakeholders.

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

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

Chris Magee, Head of Policy and Media for the UK advocacy group Understanding Animal Research, and Naomi Charalambakis, Director of Science Policy & Communications at the US based advocacy group Americans for Medical Progress, joins me to discuss new directives from the US FDA and the EU regarding lab animal use. Join us to cover the realities of lab animal use today, as well as the history or public misinformation dating back before Charles Darwin!

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

In Vivo spoke with Annette Bakker, CEO of the Children's Tumor Foundation, a medical research foundation developing an innovative approach to reviving shelved pharmaceutical assets, resulting in the recent US FDA approval of mirdametinib, a treatment for rare tumors.

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

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

What if a cochlear implant could adapt and improve throughout a patient's lifetime? Hearing health advocate and author Gael Hannan sits down with Brendan Murray, Vice President of CI Product Portfolio at Cochlear, to discuss the launch of the Cochlear™ Nucleus® Nexa™ System. The Nexa is the first cochlear implant platform with upgradeable firmware, allowing recipients to benefit from future innovations beyond traditional sound processor upgrades.The system includes the Nucleus Nexa Implant along with the new Nucleus 8 Nexa and Kanso 3 Nexa Sound Processors. Key features include internal memory to securely store individualized hearing settings, Smart Sync for rapid restoration of maps when replacing a processor, and Dynamic Power Management for improved efficiency. The Nucleus 8 Nexa Sound Processor is also 9% smaller and 12% lighter than its predecessor, while still delivering all-day battery life.In this conversation, Murray outlines how the Nexa represents the first major cochlear implant redesign in more than 20 years, bringing advances in patient self-management, expanded diagnostic tools for clinicians, and a platform that can adapt to future hearing innovations.Press release announcing US FDA approval of Nexa Implant System: https://hearinghealthmatters.org/hearing-technologies/2025/cochlear-nexa-implant-fda-approval/Be sure to subscribe to our channel for the latest episodes each week and follow This Week in Hearing on LinkedIn, Instagram and X.https://x.com/WeekinHearinghttps://www.instagram.com/thisweekinhearing/https://www.linkedin.com/company/this-week-in-hearingVisit us at: https://hearinghealthmatters.org/thisweek/

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

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

Today we discuss sex and vaccines, reality and renegades. First: men can no longer compete in women's sports—from Trump's Executive Order, to the NCAA's response, to William “Lia” Thomas having his records rescinded at Penn, reality is prevailing. Other evidence includes the UK Supreme Court declaring that “man” and “woman” refer to biological reality; and the U.S. Supreme Court writing an opinion that forcing LGBTQ+ books on children in public elementary schools is unconstitutional. Men cannot magically turn into women, nor boys into girls, no matter what they believe or are told. Then: from the ACIP (Advisory Committee on Immunization Practices) to Vinay Prasad's latest presentation at the FDA: the federal government is being populated by a combination of true renegades and middle ground scramblers who are dressed like renegades. A good toolkit for understanding how to make sense of the claims being made is necessary, and we all should be rooting for the renegades to win.*****Our sponsors:CrowdHealth: Pay for healthcare with crowdfunding instead of insurance. It's way better. Use code DarkHorse at JoinCrowdHealth.com to get 1st 3 months for $99/month.ARMRA Colostrum is an ancient bioactive whole food that can strengthen your immune system. Go to http://www.tryarmra.com/DARKHORSE to get 15% off your first order.Helix: Excellent, sleep-enhancing, American-made mattresses. Go to www.HelixSleep.com/DarkHorse for 27% Off - an offer exclusive for listeners of DarkHorse!*****Join us on Locals! Get access to our Discord server, exclusive live streams, live chats for all streams, and early access to many podcasts: https://darkhorse.locals.comHeather's newsletter, Natural Selections (subscribe to get free weekly essays in your inbox): https://naturalselections.substack.comOur book, A Hunter-Gatherer's Guide to the 21st Century, is available everywhere books are sold, including from Amazon: https://amzn.to/3AGANGg (commission earned)Check out our store! Epic tabby, digital book burning, saddle up the dire wolves, and more: https://darkhorsestore.org*****Mentioned in this episode:Trump's EO: https://www.whitehouse.gov/presidential-actions/2025/02/keeping-men-out-of-womens-sports/Paula Scanlan speaks about men in women's sports:https://x.com/xx_xyathletics/status/1940381615131332719U.K. Supreme Court: https://www.supremecourt.uk/cases/uksc-2024-0042The Lancet – sex isn't binary! https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00834-7/fulltextU.S. Supreme Court – Mahmoud vs Taylor: https://www.supremecourt.gov/opinions/24pdf/24-297_4f14.pdfWilliam Thomas in the record books: https://www.outkick.com/sports/lia-thomas-upenn-womens-swimming-record-books-updated-acknowledges-transgender-swimmer-noteRFK Jr on Tucker: https://www.youtube.com/watch?v=w_fzlwxJZAAACIP committee with Robert Malone and Retsef Levi: https://x.com/janjekielek/status/1939482343313453423Prasad on myocarditis: https://x.com/US_FDA/status/1940111214497210425Prasad makes full professor: https://x.com/bretweinstein/status/1554849287300792320Earlier clips of ZDogg and Prasad and Makary: https://x.com/alexandrosm/status/1574530850565558272Support the show

Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency.  So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated.  Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations.  And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: 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. Follow today's speakers:    Dr. Diwakar Davar    @diwakardavar    Dr. Jason Luke @jasonlukemd Follow ASCO on social media:     @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn   Disclosures:     Dr. Diwakar Davar:      Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences     Consulting or Advisory Role: Instil Bio, Vedanta Biosciences     Consulting or Advisory Role (Immediate family member): Shionogi     Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences     Research Funding (Inst.): Zucero Therapeutics     Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy     Dr. Jason Luke:     Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX     Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine     Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure     Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)     Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

What is BJain Pharmaceuticals? What products are they producing? Join me and my guest Nishant Jain as we talk about the incredible contribution of BJain Pharmaceuticals in the field of homeopathy, their specialization in homeopathy books, their collaboration with Archibel for their Homeopathic Software, and their active role in the growth and development of homeopathy as a medicine in India and other parts of the world. Nishant Jain is the Managing Director of BJain Pharmaceuticals. He earned his Masters in Business Administration from SP Jain Mumbai. He joined the family business at a very young age. He is a very hard-working individual who started his journey at the grassroots level, where he was responsible for the sales of homeopathic software. His work made him travel around the country, and he got extensive exposure to the market. He was also the key person responsible for the diversification of the business into pharmaceuticals. He has been able to set up a world-class pharma facility and was amongst the very few pharma companies who were approved by the US FDA for the manufacturing of medicines. B Jain is one of the top few homeopathic pharma companies in the country. He is a member of various homeopathic government organizations and plays an active role in policy framing and medicinal research. Check out these episode highlights: 03:05 - How did Nishant become acquainted with homeopathy 04:14 - Nishant's biggest motivation to keep going with homeopathy 05:06 - An overview of the various departments at BJain Pharmaceuticals 06:28 - Homeopathic ingredients for cosmetics 08:28 - What type of teaching does BJain Pharmaceuticals provide 10:32 - The nature of the events that BJain Pharmaceuticals offers 15:16 - BJain Pharmaceuticals is a family business 17:25 - How many different remedies does Bjain have 18:09 - The biggest anomaly in homeopathy 23:40 - Fresh herbs vs dried herbs in homeopathy 25:20 - What direction is homeopathy headed with VJain Pharmaceuticals Connect with Nishant  Website: https://www.bjain.com/ For the Pharmaceutical Products https://bjainpharma.com/ If you would like to support the Homeopathy Hangout Podcast, please consider making a donation by visiting www.EugenieKruger.com and click the DONATE button at the top of the site. Every donation about $10 will receive a shout-out on a future episode.   Join my Homeopathy Hangout Podcast Facebook community here: https://www.facebook.com/groups/HelloHomies   Here is the link to my free 30-minute Homeopathy@Home online course: https://www.youtube.com/watch?v=vqBUpxO4pZQ&t=438s   Upon completion of the course - and if you live in Australia - you can join my Facebook group for free acute advice (you'll need to answer a couple of questions about the course upon request to join): www.facebook.com/groups/eughom

On May 30, 2025, the FDA sent a letter of approval to the pharmaceutical company Moderna to manufacture and sell its new COVID-19 vaccine.1 But even more dismaying, Robert F. Kennedy, Jr., the world's most prominent advocate for vaccine safety, has now gone out on a political limb and committed himself to promoting Moderna's latest version of the mRNA Covid jab.2 In doing so, Kennedy is supporting the continuation of the world's most lethal medical or wartime assault on humanity, one that many see as a bioweapons attack on America by the globalists, including Communist China.   There are more than 38,000 reports of death to date to the CDC and FDA from the COVID-19 vaccines. Nothing like this catastrophe has ever before happened in medicine or public health. In addition, there is a deluge of reports and independent studies verifying the almost infinite harms caused by these mRNA vaccines. These harms include infertility, a declining birth rate, multiple harms to infants and mothers, cardiovascular disorders, including myocarditis in children and strokes in adults, tumors, a wide range of neurological and psychiatric disorders, and Acquired Immunodeficiency Syndrome (AIDS), which results in greater susceptibility to infections and cancer. But for every reported death and other serious adverse event, we know that there are more than 100 actual deaths or harms. These “vaccines” are killing and maiming millions in America and millions more around the world.3   Here is Kennedy's entire defense of his atrocious actions:     Actually, there is nothing “limited” about the approval letter. The letter specifically empowers Moderna to manufacture and distribute the drug. They will go ahead with this before completing any additional studies supposedly promised to Kennedy, which would take years more. Besides, once a drug company has spent multi-millions getting a drug approved, as they have already done, I've never seen a company actually complete additional studies that could invalidate their drug. Moderna's survival is at stake, and drug companies don't commit economic suicide. And this one has the backing of Bill Gates!   Kennedy has broken many recent promises to get himself into this bizarre situation of betraying his previously voiced ideals. He is approving the Moderna COVID-19 vaccine without so much as a placebo-controlled clinical trial or even a review by the FDA Vaccine Committee. On top of that, pregnant women are not protected as he promised to do. But worst of all, he has never even promised to stop the heavily documented murder of the elderly who are killed by the mRNA covid vaccines at a rate of eight times more than the rest of the population.4   Many of us will remain eternally grateful for RFK, Jr's support for Donald Trump's election campaign. But now he must resign or be removed.   Kennedy's acceptance of the FDA's approval of Moderna's Covid vaccine is more than sufficient reason to fire him. But in addition, he is also grossly undermining the Trump administration and literally threatening the well-being of all our citizens by advocating the use of extremely dangerous neurotoxins, including methylene blue, MDMA or Ecstasy, and psychedelics. Trump's choice for Surgeon General, based on Kennedy's recommendation, is devoted to psychedelics! It's as if  RFK, Jr. has become a toxic mole within the America First movement.   For an in-depth scientific analysis and presentation about everything in this synopsis, please read the full article: RFK, Jr. blatantly supports the mRNA COVID shots and must be forced to resign - Full Article   End Notes:   1 May 30, 2025 Approval Letter – MNEXSPIKE   2 Secretary Kennedy on X: “I want to address those of you who have anxieties about @US_FDA's limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine, which is similar to the existing mRNA vaccine but uses a smaller” / X. Actually, there is nothing “limited” about the approval letter. Besides,  once a drug has spent multi-millions getting a drug approved, I've never seen one fulfill a promise to do studies that could invalidate their drug.   Besides, if a study of safety is still needed, it's ridiculous to put off until after it's been approved, by which time many could be harmed.   3 New FDA Plans for the Covid Vaccines Will Kill Millions More   4 New FDA Plans for the Covid Vaccines Will Kill Millions More   ______   Learn more about Dr. Peter Breggin's work: https://breggin.com/   See more from Dr. Breggin's long history of being a reformer in psychiatry: https://breggin.com/Psychiatry-as-an-Instrument-of-Social-and-Political-Control   Psychiatric Drug Withdrawal, the how-to manual @ https://breggin.com/a-guide-for-prescribers-therapists-patients-and-their-families/   Get a copy of Dr. Breggin's latest book: WHO ARE THE “THEY” - THESE GLOBAL PREDATORS? WHAT ARE THEIR MOTIVES AND THEIR PLANS FOR US? HOW CAN WE DEFEND AGAINST THEM? Covid-19 and the Global Predators: We are the Prey Get a copy: https://www.wearetheprey.com/   “No other book so comprehensively covers the details of COVID-19 criminal conduct as well as its origins in a network of global predators seeking wealth and power at the expense of human freedom and prosperity, under cover of false public health policies.”   ~ Robert F Kennedy, Jr Author of #1 bestseller The Real Anthony Fauci and Founder, Chairman and Chief Legal Counsel for Children's Health Defense.

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

An expert from ISACA shares her insights into medtech's Voluntary Improvement Program (VIP), a collaboration among participants, ISACA, MDIC, and US FDA formed to enhance patient safety and product quality in medical device manufacturing. Listen to learn more about attaining measurable improvements with the VIP.

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

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/

Dr. Don and Professor Ben talk about the risks of consuming dairy products given recent cuts to FDA Dr. Don - not risky

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/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax's COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33). More On These Topics From The Pink Sheet Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2IOFY/ How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch: https://insights.citeline.com/pink-sheet/vaccines/how-states-and-courts-could-insulate-america-from-an-anti-vaccine-executive-branch-DARDVWDMLVFCHM6DE75AJQHSBQ/ US FDA Commissioner's Office Plans Involvement In Many Approvals In Potential Major Change: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioners-office-plans-involvement-in-many-approvals-in-potential-major-change-JFPWOQ2VF5D2JAFKXKGK54REZU/ US FDA Miss On Stealth's Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts: https://insights.citeline.com/pink-sheet/product-reviews/us-fda-miss-on-stealths-elamipretide-boosts-signal-of-broader-delays-due-to-staff-cuts-5ITZREGXX5H75ID6IL4Q2MHKBE/

On episode #78 of the Infectious Disease Puscast, Daniel and Sara review the infectious disease literature for the weeks of 3/27/25 – 4/9/25. Hosts: Daniel Griffin and Sara Dong Subscribe (free): Apple Podcasts, RSS, email Become a patron of Puscast! Links for this episode Viral Demise of the Milwaukee protocol for rabies (CID) A natural experiment on the effect of herpes zoster vaccination on dementia (Nature) Taking a shot at dementia(microbeTV: TWiV) Recommendations from the 10th European Conference on Infections in Leukaemia for the management of cytomegalovirusin patients after allogeneic haematopoietic cell transplantation and other T-cell-engaging therapies (LANCET: Infectious Diseases) Epstein-Barr virus exposure precedes Crohn`s disease development (Gastroenterology aga) Bacterial Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older (GSK) GSK wins FDA nod for first oral UTI antibiotic in almost 30 years(BioSpace) Efficacy and safety of individualised versus standard 10-day antibiotic treatment in children with febrile urinary tract infection (INDI-UTI): a pragmatic, open-label, multicentre, randomised, controlled, non-inferiority trial in Denmark (LANCET: Infectious Diseases) Frequency and severity of Myasthenia Gravis exacerbations associated with the use of ciprofloxacin, levofloxacin, and azithromycin (Muscle & Nerve) The cost of blood cultures: a barrier to diagnosis in low-income and middle-income countries (LANCET: Microbe) Rethinking blood culture (LANCET: Microbe) Trends in Anaplasmosis Over the Past Decade: A Review of Clinical Features, Laboratory Data and Outcomes(CID) Fungal The Last of US Season 2 (YouTube) Cracks in the curriculum: the hidden deficiencies in fungal disease coverage in medical books (OFID) Kazachstania slooffiae fungemia: a case report and literature review on an emerging opportunistic pathogen in humans (OFID) Plasma microbial cell-free DNS metagenomic sequencing for diagnosis of invasive fungal diseases among high risk outpatient and inpatient immunocompromised hosts (CID) Parasitic Fatal Case of Splash Pad–Associated Naegleria fowleri Meningoencephalitis — Pulaski County, Arkansas, September 2023 (CDC: MMWR) Notes from the Field: Fatal Acanthamoeba Encephalitis in a patient who regularly used tap water in an electronic nasal irrigation device and a continuous positive airway pressure machine at home — new Mexico, 2023 (CDC: MMWR) Malaria (NEJM) Miscellaneous FDA grants marketing authorization of first home test for chlamydia, gonorrhea and trichomoniasis (FDA) Music is by Ronald Jenkees Information on this podcast should not be considered as medical advice.

Alan's Soaps https://www.AlansArtisanSoaps.comUse coupon code TODD to save an additional 10% off the bundle price.Bioptimizers https://Bioptimizers.com/toddEnter promo code TODD to get 10% off your order of MassZymes today.Bizable https://GoBizable.comUntie your business exposure from your personal exposure with BiZABLE.  Schedule your FREE consultation at GoBizAble.com today.  Bonefrog https://BonefrogCoffee.com/toddThe new GOLDEN AGE is here!  Use code TODD at checkout to receive 10% off your first purchase and 15% on subscriptions.Bulwark Capital Bulwark Capital Management (bulwarkcapitalmgmt.com)Get a second opinion on the health of your retirement portfolio today. Schedule your free Know Your Risk Portfolio review. go to KnowYourRiskRadio.com today.Renue Healthcare https://Renue.Healthcare/ToddYour journey to a better life starts at Renue Healthcare. Visit https://Renue.Healthcare/ToddYou might have missed this, but it was World Health Day. But why do I feel sick? Why does the nation feel physically, mentally, and spiritually sick? Abraham Hamilton III joins the show.Episode Links:This pretty funny coming from the World “Health” Organization: Today is #WorldHealthDay! The health of mums and babies affects every single one of us. Yet, millions lose their life each year due to causes that could be prevented with timely, high quality care. Health is a right, not a privilege. Let's work together and invest in healthy beginnings and #HopefulFutures for all. This week, I announced Operation Stork Speed to expand options for safe, reliable, and nutritious infant formula for American Families. The @US_FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them. Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.USDA Secretary of Agriculture Brooke Rollins, in an exclusive Breitbart interview following her Wall Street Journal piece, has pulled bird flu vaccines off the table for good. Initially, she thought vaccinating hundreds of millions of chickens might end the crisis faster. But after digging into the data, she found countries like Mexico, which vaccinate egg-laying hens, still see 80-83% of those birds contract avian flu—despite getting jabbed 3-5 times eachThis teacher tells her student to take off his MAGA hat. When he refuses she swipes it off his head and slams it to the ground. He picks it up & puts it back on. She then tells him to get out of her classroom and starts physically shoving him out. She should be fired immediately.

In his weekly clinical update, Dr. Griffin and Vincent Racaniello lament about the continuing measles outbreak, whether or not the measles outbreak was predicted, the FACTS about vaccination, high pathogenic influenza, H5N1 contaminated raw pet food, children's deaths, before Dr. Griffin reviews recent statistics on RSV, influenza and SARS-CoV-2 infections and vaccination schedules and the efficacy of Moderna's seasonal mRNA vaccine, societal burden of COVID-19 and influenza, the FDA missed deadline for approving Novovax COVID vaccine, the WasterwaterScan dashboard, where to find PEMGARDA, provides information for Columbia University Irving Medical Center's long COVID treatment center, where to go for answers to your long COVID questions, long COVID interventions, and Canada's long COVID dashboard. Subscribe (free): Apple Podcasts, RSS, email Become a patron of TWiV! Links for this episode CDC buried a measles forecast that stressed the need for vaccinations….TRANSPARENCY? (Politico) Measles cases and outbreaks (CDC Rubeola) Measles 159 in Texas…. (Texas Health and Human Services) 2025 Measles outbreak guidance (New Mexico Health) Measles and rubella weekly monitoring report (Government of Canada) Enhanced epidemiological summary Measles in Ontario (Public Health Ontario) Measles and rubella weekly monitoring report (Government of Canada) Enhanced epidemiological summary Measles in Ontario (Public Health Ontario) Measles exposures in Ontario (Public Health Ontario) Measles vaccine recommendations from NYP (jpg) Get the FACTS about measles (NY State Department of Health) Measles (CDC Measles (Rubeola)) Measles vaccine (CDC Measles (Rubeola)) Presumptive evidence of measles immunity (CDC) Contraindications and precautions to measles vaccination (CDC) Measles (CDC Measles (Rubeola)) Raw cat food tests positive for H5N1 (CIDRAP) Influenza: Waste water scan for 11 pathogens WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Respiratory virus activity levels (CDC Respiratory Illnesses) FDA-CDC-DOD: 2025-2046 influenza vaccine composition (FDA) RSV: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) RSV-Network (CDC Respiratory Syncytial virus Infection) Early impact of RSV vaccination in older adults in England (Lancet) Waste water scan for 11 pathogens (WastewaterSCan) COVID-19 deaths (CDC) COVID-19 national and regional trends (CDC) COVID-19 variant tracker (CDC) SARS-CoV-2 genomes galore (Nextstrain) Evaluating the effectiveness of 2024-2025 seasonal mRNA-1273 vaccination against covid-19-associated hospitalizations and medically attended covid-19 among adults aged ≥ 18 years in the united states(medRxiv) Current Moderna vaccine 53% effective against COVID hospitalization?(CIDRAP) Preliminary estimates of COVID-19 burden for 2024-2025 (CDC COVID-19) Estimated range of annual burden of flu in the US from 2010 – 2024 (CDC-flu burden) US FDA missed the deadline for decision on Novavax's COVID-19 vaccine (Reuters) Interim clinical considerations for use of COVID-19 vaccines in the United States (CDC Vaccines & Immunizations) Where to get pemgarda (Pemgarda) EUA for the pre-exposure prophylaxis of COVID-19 (INVIYD) Fusion center (Prime Fusions) CDC Quarantine guidelines (CDC) NIH COVID-19 treatment guidelines (NIH) Metformin alleviates inflammatory response and severity rate of COVID-19 infection in elderly individuals(Scientific Reports) Drug interaction checker (University of Liverpool) Infectious Disease Society guidelines for treatment and management (ID Society) Cost-effectiveness analysis of nirmatrelvir/ritonavir for high-risk individuals with COVID-19….does this mean use the big button calculator? (OFID) Molnupiravir safety and efficacy (JMV) Convalescent plasma recommendation for immunocompromised (ID Society) What to do when sick with a respiratory virus (CDC) When your healthcare provider is infected/exposed with SARS-CoV-2 (CDC Managing healthcare staffing shortages (CDC) Steroids, dexamethasone at the right time (OFID) Anticoagulation guidelines (hematology.org) Daniel Griffin's evidence based medical practices for long COVID (OFID) Long COVID hotline (Columbia : Columbia University Irving Medical Center) The answers: Long COVID Reinfection with SARS-CoV-2 in the omicron era is associated with increased risk of post-acute sequelae of SARS-CoV-2  infection: a recover-EHR cohort study(medRxiv) CAN-PCC RecMap, your one-stop shop for recommendations about Post COVID-19 Condition (Long COVID) (Canadian Guidelines for post COVID-19 condition) Letters read on TWiV 1206 Dr. Griffin's COVID treatment summary (pdf) Timestamps by Jolene Ramsey. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv Content in this podcast should not be construed as medical advice.

(2:00) Omni-BS Part Deux — Epic Fraud, Epic FailWith the horrible bill by Speaker Mike Johnson rejected, what was the poison pill in Plan B that also failed?What will a government shut down look like?Can Musk be Speaker of the House when he's already President?(35:11) LIVE comments (43:23) Pump & Dump: Bitcoin Reserve Idea is Trashed by PowellTrump euphoria takes a hit a bit early as Powell throws cold water on the idea of a Bitcoin ReserveWhat are other central banks saying?What will happen when Trump doesn't immediately deliver all the things he promised?It's not just Bitcoin, Powell trashed stocks, bonds, gold, silver to varying degreesSome say Powell's comments were a deliberate market manipulation.  Isn't that the point of the Fed Reserve?The world's central banks are starting inflation up again!(1:04:02) LIVE comments / questions, & thank you to supporters (1:16:43) Flatulent Earth SocietyInsane, unhinged, recycled false prophecies about Climate floods on coastal areasEPA boasts about the "first climate arrest" - for someone using refrigerant (that used to be mandated)(1:34:45) Green Grift PotatoesEuropeans don't want GMO foofd so one corporations describes their GMO potatoes as "climate resistant".  Did it work? (1:41:35) Free Energy?  Open Source designs invites people to give it a try (1:55:22) They all knew about the bioweapon shotThe rats are jumping off the ship and one of the biggest rats, former CDC Director Redfield, is throwing shade at Fauci's lies and mandatesDNA-Gate: Australia's equivalent of the US FDA lied to people about DNA harms — and now emails show they conspired to liePelosi Profits — Look at the unbelievable way she profited from PPP during the pandemic(2:28:30f) Mask Mania is coming back at hospitals but one Canadian woman suffering from asthma gets compensated for the unconscionable bullying she suffered over not wearing a mask (2:46:04) "Sweeping Parental Rights Bill" or are they sweeping the problem under the rug? (2:54:58) Is Santa Claus a false idol to replace ChristMegyn Kelly may tell us "everyone knows Santa is white" but do you really know what Santa is?If you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-show Or you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7 Money should have intrinsic value AND transactional privacy: Go to DavidKnight.gold for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to TrendsJournal.com and enter the code KNIGHTBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-david-knight-show--2653468/support.

(2:00) Omni-BS Part Deux — Epic Fraud, Epic FailWith the horrible bill by Speaker Mike Johnson rejected, what was the poison pill in Plan B that also failed?What will a government shut down look like?Can Musk be Speaker of the House when he's already President?(35:11) LIVE comments (43:23) Pump & Dump: Bitcoin Reserve Idea is Trashed by PowellTrump euphoria takes a hit a bit early as Powell throws cold water on the idea of a Bitcoin ReserveWhat are other central banks saying?What will happen when Trump doesn't immediately deliver all the things he promised?It's not just Bitcoin, Powell trashed stocks, bonds, gold, silver to varying degreesSome say Powell's comments were a deliberate market manipulation.  Isn't that the point of the Fed Reserve?The world's central banks are starting inflation up again!(1:04:02) LIVE comments / questions, & thank you to supporters (1:16:43) Flatulent Earth SocietyInsane, unhinged, recycled false prophecies about Climate floods on coastal areasEPA boasts about the "first climate arrest" - for someone using refrigerant (that used to be mandated)(1:34:45) Green Grift PotatoesEuropeans don't want GMO foofd so one corporations describes their GMO potatoes as "climate resistant".  Did it work? (1:41:35) Free Energy?  Open Source designs invites people to give it a try (1:55:22) They all knew about the bioweapon shotThe rats are jumping off the ship and one of the biggest rats, former CDC Director Redfield, is throwing shade at Fauci's lies and mandatesDNA-Gate: Australia's equivalent of the US FDA lied to people about DNA harms — and now emails show they conspired to liePelosi Profits — Look at the unbelievable way she profited from PPP during the pandemic(2:28:30f) Mask Mania is coming back at hospitals but one Canadian woman suffering from asthma gets compensated for the unconscionable bullying she suffered over not wearing a mask (2:46:04) "Sweeping Parental Rights Bill" or are they sweeping the problem under the rug? (2:54:58) Is Santa Claus a false idol to replace ChristMegyn Kelly may tell us "everyone knows Santa is white" but do you really know what Santa is?If you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-show Or you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7 Money should have intrinsic value AND transactional privacy: Go to DavidKnight.gold for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to TrendsJournal.com and enter the code KNIGHTBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-real-david-knight-show--5282736/support.

New survey data from the Federal Reserve Bank of New York shows that the percentage of Americans who expect to get laid off in the next four months has gone up. On the other hand, the share of Americans who expect to get a job offer in the next four months is also up. So what gives? We'll get into the labor market unease and why the Federal Reserve will be paying close attention. Then, we’ll smile about a new tool that could help prevent death from life threatening injuries. Here’s everything we talked about today: “Expectation of Losing One's Job at Record High in NY Fed Survey” from Bloomberg “More and more Americans are worried they will lose their job” from CNN Business “US FDA clears use of Cresilon’s gel to stop severe bleeding in seconds” from Reuters Tweet from Jesse Byrnes about errors in the Democratic Party’s 2024 platform We love to hear from you. Email your comments and questions to makemesmart@marketplace.org or leave us a voicemail at 508-U-B-SMART.

New survey data from the Federal Reserve Bank of New York shows that the percentage of Americans who expect to get laid off in the next four months has gone up. On the other hand, the share of Americans who expect to get a job offer in the next four months is also up. So what gives? We'll get into the labor market unease and why the Federal Reserve will be paying close attention. Then, we’ll smile about a new tool that could help prevent death from life threatening injuries. Here’s everything we talked about today: “Expectation of Losing One's Job at Record High in NY Fed Survey” from Bloomberg “More and more Americans are worried they will lose their job” from CNN Business “US FDA clears use of Cresilon’s gel to stop severe bleeding in seconds” from Reuters Tweet from Jesse Byrnes about errors in the Democratic Party’s 2024 platform We love to hear from you. Email your comments and questions to makemesmart@marketplace.org or leave us a voicemail at 508-U-B-SMART.